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Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)
Judy Langer, MD, MS - langerj@nrgoncology.org
NCT05174169
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Inclusion Criteria:
The patient must have an ECOG performance status of 0 or 1.
Patients must have histologically/pathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection according to AJCC 8th edition criteria.
No radiographic evidence of overt metastatic disease within 45 days prior to Step 1/Study entry (CT with IV contrast or MRI imaging is acceptable and must include chest, abdomen, and pelvis).
The distal extent of the tumor must be greater than or equal to 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation).
The patient must have had an en bloc complete gross resection of tumor (curative resection). Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible.
The resected tumor specimen and a blood specimen from patients with Stage IIB, IIC, or Stage III colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera (after Step 1/Study entry and before Step2/Randomization). Patient must have sufficient tissue to meet protocol requirements. This blood specimen for the Signatera assay must be collected after surgery (and recommended at least 14 days post surgery).
Tumor must be documented as microsatellite stable or have intact mismatch repair proteins through CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR are excluded.
The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan).
The interval between surgery (post-operative Day 7) and Step 1/Study entry must be no more than 60 days. NOTE: Step 1/Study Entry may occur as early as post operative Day 7, but it cannot occur beyond 60 days from the actual date of the patient's surgery.
Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.
Adequate hematologic function within 28 days before Step 1/Study entry defined as follows:
* Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
* Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.
* BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.
* Platelet count must be greater than or equal to 100,000/mm3; and
* Hemoglobin must be greater than or equal to 9 g/dL.
Adequate hepatic function within 28 days before Step 1/Study entry defined as follows:
* total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and
* alkaline phosphatase must be less than 2.5 x ULN for the lab; and
* AST and ALT must be less than 2.5 x ULN for the lab.
Adequate renal function within 28 days before Step 1/Study entry defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab.
For Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL) NOTE: Adjusted body weight (AdjBW) should be used for patients that have BMI greater than or equal to 28 (less than or equal to 30% above IBW).
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Pregnancy test (urine or serum according to institutional standard) done within 14 days before Step 1/Study entry must be negative (for women of childbearing potential only).
Patients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of INR if they are randomized to Arm 1 or Arm 3 and receive capecitabine.
Eligibility Criteria for Cohort A Arm-2 patients on Second Randomization
Patient must have developed a ctDNA +ve assay during serial monitoring.
Patient's willingness to be re-randomized affirmed.
The patient must continue to have an ECOG performance status of 0 or 1.
No radiographic evidence of overt metastatic disease.
Pregnancy test (urine or serum according to institutional standard) done within 14 days before second randomization must be negative (for women of childbearing potential only).
Adequate hematologic function within 28 days before second randomization defined as follows:
* Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
* Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.
* BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.
* Platelet count must be greater than or equal to 100,000/mm3; and
* Hemoglobin must be greater than or equal to 9 g/dL.
Adequate hepatic function within 28 days before second randomization defined as follows:
* total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and
* alkaline phosphatase must be less than 2.5 x ULN for the lab; and
* AST and ALT must be less than 2.5 x ULN for the lab.
Adequate renal function within 28 days before second randomization defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab.
For Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL)
Exclusion Criteria:
Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).
Pathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected.
Tumor-related bowel perforation.
History of prior invasive colon malignancy, regardless of disease-free interval.
History of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ/tissue donation are not exclusionary.
Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary colon adenocarcinomas for which treatment with neoadjuvant chemotherapy and/or radiation is warranted are not permitted). EXCEPTION: one cycle of chemotherapy (regimen per treating physicians' discretion - 5-FU or capecitabine with or without oxaliplatin) is allowed but not required after consent. The optional cycle of chemotherapy should be started greater than or equal to 4 weeks from surgery and while awaiting Step 2 randomization.
Other invasive malignancy within 5 years before Step 1/Study entry. Exceptions are colonic polyps, non-melanoma skin cancer or any carcinoma-in-situ.
Synchronous primary rectal and/ or colon cancers.
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
Sensory or motor neuropathy greater than or equal to grade 2, according to CTCAE v5.0.
Blood transfusion within two weeks before collection of blood for central ctDNA testing.
Active seizure disorder uncontrolled by medication.
Active or chronic infection requiring systemic therapy.
Known homozygous DPD (dihydropyrimidine dehydrogenase) deficiency.
Patients known to have Gilbert's Syndrome or homozygosity for UGT1A1\*28 polymorphism.
Pregnancy or lactation at the time of Step 1/Study entry.
Co-morbid illnesses or other concurrent disease that would make the patient inappropriate for entry into this study (i.e., unable to tolerate 6 months of combination chemotherapy or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up).
Ineligibility Criteria for Cohort A Arm-2 patients on Second Randomization
Pregnancy or lactation at the time of randomization.
No longer a candidate for systemic chemotherapy (FOLFOX, CAPOX, and mFOLFIRINOX) in the opinion of the treating investigator. DEVICE: Signatera test, DRUG: mFOLFOX6 3-6 month, DRUG: CAPOX 3 month, DRUG: mFOLFIRINOX, DRUG: mFOLFOX6 6 month, DRUG: CAPOX 6 month
Stage III Colon Cancer
ctDNA positive, ctDNA negative, Adjuvant Chemotherapy, Natera, Signatera, mFOLFOX6, Stage III, CAPOX, mFOLFIRINOX, Oxaliplatin, 5-Fluorouracil (5-FU), Capecitabine, Leucovorin, Irinotecan, Stage II
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Study Locations
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| Location | Contacts |
|---|---|
| AIS Cancer Center at San Joaquin Community Hospital Bakersfield, California | |
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Addison Gilbert Hospital Gloucester, Massachusetts | |
| Adena Regional Medical Center Chillicothe, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Advanced Breast Care Center PLLC Warren, Michigan | |
| AdventHealth Littleton Littleton, Colorado | |
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| AdventHealth Parker Parker, Colorado | |
| AdventHealth Porter Denver, Colorado | |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Alegent Health Bergan Mercy Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Immanuel Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Lakeside Hospital Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Mercy Hospital Council Bluffs, Iowa | |
| Allan Blair Cancer Centre Regina, Saskatchewan | |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Allegheny Valley Hospital Natrona Heights, Pennsylvania | Site Public Contact - (Dawnmarie.DeFazio@ahn.org) |
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Altru Cancer Center Grand Forks, North Dakota | |
| American Fork Hospital / Huntsman Intermountain Cancer Center American Fork, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Armes Family Cancer Center Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | Site Public Contact - (Roster@nrgoncology.org) |
| Ascension All Saints Hospital Racine, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Calumet Hospital Chilton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Columbia Saint Mary's Hospital Ozaukee Mequon, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Mercy Hospital Oshkosh, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Elizabeth Hospital Appleton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Francis - Reiman Cancer Center Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Via Christi Hospitals Wichita Wichita, Kansas | Site Public Contact - (research@viachristi.org) |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Medford Hospital Medford, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| AtlantiCare Health Park-Cape May Court House Cape May Court House, New Jersey | |
| AtlantiCare Surgery Center Egg Harbor, New Jersey | |
| Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John, New Brunswick | |
| Atrium Health Cabarrus/LCI-Concord Concord, North Carolina | |
| Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina | |
| Atrium Health Union/LCI-Union Monroe, North Carolina | |
| Atrium Health University City/LCI-University Charlotte, North Carolina | |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aultman Alliance Community Hospital Alliance, Ohio | |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Avera Cancer Institute Sioux Falls, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute - Mitchell Mitchell, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Pierre Pierre, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Yankton Yankton, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute-Aberdeen Aberdeen, South Dakota | Site Public Contact - (oncregulatory@avera.org) |
| BASS Medical Group - Lennon Walnut Creek, California | Site Public Contact - (brenna.lindsey@bassmedicalgroup.com) |
| BCCA-Cancer Centre for the North Prince George, British Columbia | |
| BCCA-Vancouver Cancer Centre Vancouver, British Columbia | |
| BCCA-Vancouver Island Cancer Centre Victoria, British Columbia | |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Health Hamburg Lexington, Kentucky | |
| Baptist Health Lexington Lexington, Kentucky | |
| Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Bay Area Tumor Institute Oakland, California | |
| Bayhealth Hospital Kent Campus Dover, Delaware | |
| Bayhealth Hospital Sussex Campus Milford, Delaware | |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Ben Taub General Hospital Houston, Texas | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care Winchester, Massachusetts | |
| Bethesda North Hospital Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Beverly Hospital Beverly, Massachusetts | |
| Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Blanchard Valley Hospital Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Bon Secours Saint Francis Hospital Charleston, South Carolina | Site Public Contact - (Julia.Johnson@rsfh.com) |
| Boston Medical Center Boston, Massachusetts | |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| CHI Health Good Samaritan Kearney, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas | |
| CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Québec, Quebec | Site Public Contact - (rechclinique@crchuq.ulaval.ca) |
| CIUSSSEMTL-Hopital Maisonneuve-Rosemont Montreal, Quebec | |
| CSSS Champlain-Charles Le Moyne Greenfield Park, Quebec | |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| California Pacific Medical Center-Pacific Campus San Francisco, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Cambridge Medical Center Cambridge, Minnesota | |
| Cambridge Memorial Hospital Cambridge, Ontario | |
| Camden Clark Medical Center Parkersburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Cancer Care Associates of York York, Pennsylvania | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (Roster@nrgoncology.org) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer Partners of Nebraska Lincoln, Nebraska | Site Public Contact - (research@cancerpartners.com) |
| Cancer Specialists of Tidewater Limited Chesapeake, Virginia | Site Public Contact - (casey.morris@rivhs.com) |
| Cancer Specialists of Tidewater-Suffolk Suffolk, Virginia | Site Public Contact - (casey.morris@rivhs.com) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carlisle Regional Cancer Center Carlisle, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Caro Cancer Center Caro, Michigan | |
| CaroMont Regional Medical Center Gastonia, North Carolina | Site Public Contact - (tammy.cozad@caromonthealth.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Case Western Reserve University Cleveland, Ohio | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia | Site Public Contact - (Kevin.Patel@centrahealth.com) |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Garden City Garden City, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Ohio Breast and Endocrine Surgery Gahanna, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont | |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Charleston Oncology - Roper Charleston, South Carolina | Site Public Contact - (Julia.Johnson@rsfh.com) |
| Charleston Oncology - Saint Francis Charleston, South Carolina | Site Public Contact - (Julia.Johnson@rsfh.com) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Chester County Hospital West Chester, Pennsylvania | Site Public Contact - (carolann.hoppes@pennmedicine.upenn.edu) |
| City of Hope Antelope Valley Lancaster, California | |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope South Bay Torrance, California | |
| City of Hope South Pasadena South Pasadena, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Upland Upland, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope at Irvine Lennar Irvine, California | |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Cleveland Clinic Akron General Akron, Ohio | Site Public Contact - (CancerAnswer@ccf.org) |
| Cleveland Clinic Cancer Center Independence Independence, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Cancer Center Mansfield Mansfield, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Cancer Center Strongsville Strongsville, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Mercy Hospital Canton, Ohio | |
| Cleveland Clinic Wooster Family Health and Surgery Center Wooster, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic-Weston Weston, Florida | |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Columbus Oncology and Hematology Associates Dublin, Ohio | |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | |
| CommonSpirit Cancer Center Mercy Durango, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Commonwealth Cancer Center-Corbin Corbin, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Cone Health Cancer Center Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Contra Costa Regional Medical Center Martinez, California | |
| Corewell Health Beaumont Troy Hospital Troy, Michigan | |
| Corewell Health Dearborn Hospital Dearborn, Michigan | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health William Beaumont University Hospital Royal Oak, Michigan | |
| Cox Cancer Center Branson Branson, Missouri | |
| CoxHealth South Hospital Springfield, Missouri | |
| Creighton University Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana Farber-Merrimack Valley Methuen, Massachusetts | |
| Dana-Farber Cancer Institute at Boston Medical Center - Brighton Brighton, Massachusetts | |
| Dana-Farber Cancer Institute at Foxborough Foxborough, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth, Massachusetts | |
| Dartmouth Cancer Center - North Saint Johnsbury, Vermont | Site Public Contact - (cancer.research.nurse@hitchcock.org) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Physician LLC - Englewood Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC - Troy Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Atrium Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Miami Valley South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Wayne Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | |
| Dell Seton Medical Center at The University of Texas Austin, Texas | |
| Denver Health Medical Center Denver, Colorado | Site Public Contact - (ccrp@co-cancerresearch.org) |
| Dillon Health Center/Shaw Cancer Center Dillon, Colorado | |
| Divine Providence Hospital Williamsport, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Doctors Hospital Columbus, Ohio | |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Dublin Methodist Hospital Dublin, Ohio | |
| Duke Cancer Center Cary Cary, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke Cancer Center Raleigh Raleigh, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| Eden Hospital Medical Center Castro Valley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Edward Hines Jr VA Hospital Hines, Illinois | |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Eisenhower Army Medical Center Fort Eisenhower, Georgia | |
| Eisenhower Medical Center Rancho Mirage, California | |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| Ephrata Cancer Center Ephrata, Pennsylvania | |
| Epic Care Cyberknife Center Walnut Creek, California | |
| Epic Care Partners in Cancer Care Emeryville, California | |
| Epic Care-Dublin Dublin, California | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Moose Lake Clinic Moose Lake, Minnesota | |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center-South University Clinic Fargo, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Exeter Hospital Exeter, New Hampshire | |
| FHCC Overlake Bellevue, Washington | |
| FHCC at EvergreenHealth Kirkland, Washington | |
| FHCC at Northwest Hospital Seattle, Washington | |
| FMH James M Stockman Cancer Institute Frederick, Maryland | |
| Fairfield Medical Center Lancaster, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Northland Medical Center Princeton, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Ridges Hospital Burnsville, Minnesota | |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Farmington Health Center Farmington, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Flaget Memorial Hospital Bardstown, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Forbes Hospital Monroeville, Pennsylvania | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Frederick Memorial Hospital Frederick, Maryland | |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Fremont - Rideout Cancer Center Marysville, California | |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Garnet Health Medical Center Middletown, New York | Site Public Contact - (jgerlach@garnethealth.org) |
| Geauga Hospital Chardon, Ohio | |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California | |
| Genesee Hematology Oncology PC Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesis Healthcare System Cancer Care Center Zanesville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| George Washington University Medical Center Washington D.C., District of Columbia | |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Glens Falls Hospital Glens Falls, New York | |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Grady Memorial Hospital Delaware, Ohio | |
| Grand Valley Oncology Grand Junction, Colorado | Site Public Contact - (gvoclinicaltrials@gjhosp.org) |
| Grand View Hospital Sellersville, Pennsylvania | |
| Grant Medical Center Columbus, Ohio | |
| Great Falls Clinic Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Greater Baltimore Medical Center Baltimore, Maryland | |
| Greater Dayton Cancer Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Greater Regional Medical Center Creston, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| HSHS Sacred Heart Hospital Eau Claire, Wisconsin | |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| Health Partners Inc Minneapolis, Minnesota | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hematology Oncology Consultants-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Health Providence Novi Hospital Novi, Michigan | Site Public Contact - (kfife3@hfhs.org) |
| Henry Ford Health Providence Southfield Hospital Southfield, Michigan | Site Public Contact - (kfife3@hfhs.org) |
| Henry Ford Health Saint John Hospital Detroit, Michigan | Site Public Contact - (Kkeenan1@hfhs.org) |
| Henry Ford Health Warren Hospital Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Madison Heights Hospital - Breast Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford River District Hospital East China Township, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - GLCMS Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Highline Medical Center-Main Campus Burien, Washington | |
| Hillcrest Hospital Cancer Center Mayfield Heights, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Holy Cross Hospital Fort Lauderdale, Florida | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hope Cancer Center Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hopital du Sacre-Coeur de Montreal Montreal, Quebec | |
| Hotel-Dieu de Levis Lévis, Quebec | Site Public Contact - (ctsucontact@westat.com) |
| Humber River Hospital Toronto, Ontario | Site Public Contact - (research@hrh.ca) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| IRMC Cancer Center Indiana, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Integris Cancer Institute of Oklahoma Oklahoma City, Oklahoma | |
| Integris Southwest Medical Center Oklahoma City, Oklahoma | Site Public Contact - (Roster@nrgoncology.org) |
| Intermountain Health Platte Valley Hospital Brighton, Colorado | Site Public Contact - (peaksresearch@imail.org) |
| Intermountain Medical Center Murray, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Cherry Hill Hospital Cherry Hill, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jefferson Hospital Jefferson Hills, Pennsylvania | Site Public Contact - (ddefazio@wpahs.org) |
| Jefferson Methodist Hospital Philadelphia, Pennsylvania | |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (Roster@nrgoncology.org) |
| Jewish General Hospital Montreal, Quebec | |
| Jewish Hospital Louisville, Kentucky | |
| Jewish Hospital Medical Center South Shepherdsville, Kentucky | |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| John Muir Medical Center-Walnut Creek Walnut Creek, California | Site Public Contact - (clinicalresearch@johnmuirhealth.com) |
| Jupiter Medical Center Jupiter, Florida | |
| Juravinski Cancer Centre at Hamilton Health Sciences Hamilton, Ontario | |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Kaiser Permanente - Largo Medical Center Largo, Maryland | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Lutherville - Timonium Medical Center Lutherville, Maryland | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Medical Center-Vacaville Vacaville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente Northwest Portland, Oregon | Site Public Contact - (information@kpchr.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente South Bay Harbor City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Tysons Corner Medical Center McLean, Virginia | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente West Los Angeles Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente- Marshall Medical Offices Redwood City, California | |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Baldwin Park Baldwin Park, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Burke Medical Center Burke, Virginia | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente-Capitol Hill Medical Center Washington D.C., District of Columbia | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente-Caton Hill Medical Center Woodbridge, Virginia | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente-Deer Valley Medical Center Antioch, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Franklin Denver, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Gaithersburg Medical Center Gaithersburg, Maryland | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente-Irvine Irvine, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Lone Tree Lone Tree, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Ontario Ontario, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Richmond Richmond, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Riverside Riverside, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Rock Creek Lafayette, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Stockton Stockton, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Woodlawn Medical Center Baltimore, Maryland | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Keck Medicine of USC Koreatown Los Angeles, California | |
| Kettering Medical Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Knox Community Hospital Mount Vernon, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| LDS Hospital Salt Lake City, Utah | Site Public Contact - (officeofresearch@imail.org) |
| LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Lahey Hospital and Medical Center Burlington, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lahey Medical Center-Peabody Peabody, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lakeridge Health Oshawa Oshawa, Ontario | |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Lancaster General Ann B Barshinger Cancer Institute Lancaster, Pennsylvania | |
| Lancaster General Hospital Lancaster, Pennsylvania | |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | |
| Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver, Washington | Site Public Contact - (oncologyresearch@lhs.org) |
| Legacy Good Samaritan Hospital and Medical Center Portland, Oregon | Site Public Contact - (cancer@lhs.org) |
| Legacy Meridian Park Hospital Tualatin, Oregon | |
| Legacy Mount Hood Medical Center Gresham, Oregon | |
| Legacy Salmon Creek Hospital Vancouver, Washington | |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lenox Hill Hospital New York, New York | |
| Levine Cancer Institute-Ballantyne Charlotte, North Carolina | |
| Levine Cancer Institute-SouthPark Charlotte, North Carolina | |
| Licking Memorial Hospital Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Logan Regional Hospital Logan, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| London Regional Cancer Program London, Ontario | |
| Long Beach Memorial Medical Center-Todd Cancer Institute Long Beach, California | |
| Longmont United Hospital Longmont, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| Louisiana State University Health Science Center New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Loyola University Medical Center Maywood, Illinois | |
| Lutheran Hospital - Cancer Centers of Colorado Golden, Colorado | Site Public Contact - (peaksresearch@imail.org) |
| Lyndon Baines Johnson General Hospital Houston, Texas | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson League City League City, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson West Houston Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in Sugar Land Sugar Land, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in The Woodlands Conroe, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri | |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| Macomb Hematology Oncology PC Warren, Michigan | |
| MaineHealth Cancer Care Center of York County Sanford, Maine | |
| MaineHealth Cancer Care and IV Therapy - Sanford Sanford, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center - Biddeford Biddeford, Maine | |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| Margaret R Pardee Memorial Hospital Hendersonville, North Carolina | |
| Marietta Memorial Hospital Marietta, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Marshall Cancer Center Cameron Park, California | Site Public Contact - (cancerservices@marshallmedical.org) |
| Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Wausau Center Wausau, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Ladysmith Ladysmith, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Neillsville Neillsville, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Greeley Medical Center Ames, Iowa | |
| Mayo Clinic Health System-Eau Claire Clinic Eau Claire, Wisconsin | |
| Mayo Clinic Health System-Franciscan Healthcare La Crosse, Wisconsin | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| McKay-Dee Hospital Center Ogden, Utah | Site Public Contact - (officeofresearch@imail.org) |
| MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore, Maryland | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| MedStar Good Samaritan Hospital Baltimore, Maryland | Site Public Contact - (Barbara.rector@medstar.net) |
| Medical Center of Baton Rouge Baton Rouge, Louisiana | Site Public Contact - (Camille.Beck@Ochsner.org) |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital North Colorado Springs, Colorado | |
| Memorial Hospital West Pembroke Pines, Florida | |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Medical Center Modesto, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Memorial Medical Center-Las Cruces Las Cruces, New Mexico | Site Public Contact - (Deborah.Brown@LPNT.net) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri | |
| Mercy Cancer Center - Carmichael Carmichael, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Elk Grove Elk Grove, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Rocklin Rocklin, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Sacramento Sacramento, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center-West Lakes Clive, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Health - Perrysburg Hospital Perrysburg, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Vincent Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health Sylvania Radiation Oncology Center Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Joplin Joplin, Missouri | Site Public Contact - (esmeralda.carrillo@mercy.net) |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Hospital Washington Washington, Missouri | |
| Mercy Infusion Center - Chippewa St Louis, Missouri | |
| Mercy Medical Center Springfield, Massachusetts | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (OncologyResearch@DignityHealth.org) |
| Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin | Site Public Contact - (oncologyclinicaltrials@mhemail.org) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| MetroHealth Medical Center Cleveland, Ohio | Site Public Contact - (ababal@metrohealth.org) |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Midlands Community Hospital Papillion, Nebraska | |
| Mills Health Center San Mateo, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Mills-Peninsula Medical Center Burlingame, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mission Hope Medical Oncology - Santa Maria Santa Maria, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Mobile Infirmary Medical Center Mobile, Alabama | |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Monmouth Medical Center Long Branch, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Monmouth Medical Center Southern Campus Lakewood, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Carmel East Hospital Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Carmel Grove City Hospital Grove City, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Carmel Health Center West Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Carmel New Albany Surgical Hospital New Albany, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Hospital Medical Center Chicago, Illinois | Site Public Contact - (suhi@sinai.org) |
| Mount Sinai South Nassau Valley Stream, New York | Site Public Contact - (surgical.oncology@snch.org) |
| Mount Sinai West New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas | Site Public Contact - (Emily.Carvell@bmhcc.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | |
| National Jewish Health-Western Hematology Oncology Golden, Colorado | Site Public Contact - (glicht@co-cancerresearch.org) |
| Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska | |
| New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire | |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn, New York | Site Public Contact - (Adg9003@nyp.org) |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Newark Radiation Oncology Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Newland Medical Associates-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Newland Medical Associates-Pontiac Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Niagara Health System-Saint Catharines General St. Catharines, Ontario | |
| North Coast Cancer Care Sandusky, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| North York General Hospital Toronto, Ontario | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northern Westchester Hospital Mount Kisco, New York | Site Public Contact - (AMellor@northwell.edu) |
| Northside Hospital Atlanta, Georgia | Site Public Contact - (ClinicalTrials@northside.com) |
| Northside Hospital - Duluth Duluth, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northside Hospital - Gwinnett Lawrenceville, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northwell Health Cancer Institute at Huntington Greenlawn, New York | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwest Cancer Center - Hobart Hobart, Indiana | |
| Northwest Cancer Center - Main Campus Crown Point, Indiana | |
| Northwest Cancer Center - Valparaiso Valparaiso, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Northwest Oncology LLC Dyer, Indiana | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Norton Audubon Hospital and Medical Campus Louisville, Kentucky | |
| Norton Brownsboro Hospital and Medical Campus Louisville, Kentucky | Site Public Contact - (Roster@nrgoncology.org) |
| Norton Hospital Pavilion and Medical Campus Louisville, Kentucky | Site Public Contact - (cancerresearch@nortonhealthcare.org) |
| OSF Saint Anthony's Health Center Alton, Illinois | |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ochsner Hematology Oncology North Shore - Covington (West Region) Covington, Louisiana | Site Public Contact - (Cheryl.kesler@ochsner.org) |
| Ochsner High Grove Baton Rouge, Louisiana | Site Public Contact - (Camielle.beck@ochsner.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | |
| OhioHealth Marion General Hospital Marion, Ohio | |
| Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma | |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | |
| Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Orange Coast Memorial Medical Center Fountain Valley, California | |
| Orion Cancer Care Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Orlando Health Cancer Institute Orlando, Florida | Site Public Contact - (CancerClinicalTrials@orlandohealth.com) |
| Orlando Health Cancer Institute - Lake Mary Lake Mary, Florida | Site Public Contact - (r-adultoncnewops@orlandohealth.com) |
| Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario | |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Overlook Hospital Summit, New Jersey | |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Palo Alto Medical Foundation Health Care Palo Alto, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Camino Division Mountain View, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Fremont Fremont, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Gynecologic Oncology Mountain View, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Santa Cruz Santa Cruz, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Pan American Center for Oncology Trials LLC San Juan, | Site Public Contact - (marcia.cruzcorrea@panoncologytrials.com) |
| Pan American Center for Oncology Trials LLC - Cayey Cayey, | Site Public Contact - (info@panoncologytrials.com) |
| Pan American Center for Oncology Trials LLC - Ciudadela San Juan, | Site Public Contact - (info@panoncologytrials.com) |
| Pan American Center for Oncology Trials LLC - Dorado Dorado, | Site Public Contact - (info@panoncologytrials.com) |
| Pan American Center for Oncology Trials LLC - Mayaguez Mayagüez, | Site Public Contact - (ctsucontact@westat.com) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Parkland Memorial Hospital Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| Parkview Regional Medical Center Fort Wayne, Indiana | |
| Peninsula Cancer Institute-Cancer Specialists of Tidewater Virginia Beach, Virginia | Site Public Contact - (casey.morris@rivhs.com) |
| Peninsula Cancer Institute-Gloucester Gloucester, Virginia | Site Public Contact - (casey.morris@rivhs.com) |
| Peninsula Cancer Institute-Newport News Newport News, Virginia | Site Public Contact - (casey.morris@rivhs.com) |
| Peninsula Cancer Institute-Williamsburg Williamsburg, Virginia | Site Public Contact - (casey.morris@rivhs.com) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Pennsylvania Hospital Philadelphia, Pennsylvania | Site Public Contact - (PennCancerTrials@careboxhealth.com) |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Phelps Memorial Hospital Center Sleepy Hollow, New York | |
| Phoebe Putney Memorial Hospital Albany, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Piedmont Fayette Hospital Fayetteville, Georgia | Site Public Contact - (Roster@nrgoncology.org) |
| Piedmont Henry Hospital Stockbridge, Georgia | |
| Piedmont Hospital Atlanta, Georgia | Site Public Contact - (ORS@piedmont.org) |
| Piedmont Newnan Hospital Newnan, Georgia | Site Public Contact - (ors@piedmont.org) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Premier Blood and Cancer Center Dayton, Ohio | |
| Presbyterian Kaseman Hospital Albuquerque, New Mexico | Site Public Contact - (WBurman@phs.org) |
| Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho, New Mexico | Site Public Contact - (WBurman@phs.org) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Cancer Institute Clackamas Clinic Clackamas, Oregon | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Queens Cancer Center Rego Park, New York | |
| Rapid City Regional Hospital Rapid City, South Dakota | Site Public Contact - (research@monument.health) |
| Reading Hospital West Reading, Pennsylvania | |
| Reading Hospital McGlinn Cancer Institute at Phoenixville Phoenixville, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reid Health Richmond, Indiana | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rex Hematology Oncology Associates-Cary Cary, North Carolina | Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu) |
| Rex Hematology Oncology Associates-Garner Garner, North Carolina | Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridley-Tree Cancer Center Santa Barbara, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Riverside Methodist Hospital Columbus, Ohio | |
| Riverton Hospital Riverton, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Robert Wood Johnson University Hospital Somerset Somerville, New Jersey | Site Public Contact - (Siby.Varughese@rwjbh.org) |
| Rochester General Hospital Rochester, New York | Site Public Contact - (tia.derosa@rochestergeneral.org) |
| Rocky Mountain Cancer Centers-Longmont Longmont, Colorado | Site Public Contact - (ResearchTracking@Centura.Org) |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Roger Williams Medical Center Providence, Rhode Island | Site Public Contact - (fdallesandro@chartercare.org) |
| Roper Hospital Charleston, South Carolina | Site Public Contact - (Julia.Johnson@rsfh.com) |
| Royal Victoria Regional Health Centre Barrie, Ontario | |
| Rush MD Anderson Cancer Center Chicago, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| Rush MD Anderson Cancer Center at Rush Lisle Lisle, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| Rush MD Anderson Cancer Center at Rush Oak Park Oak Park, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Rutgers New Jersey Medical School Newark, New Jersey | |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| STCC at DHR Health Institute for Research and Development Edinburg, Texas | Site Public Contact - (dhrresearch@dhr-rgv.com) |
| Saddleback Memorial Medical Center Laguna Hills, California | |
| Saint Agnes Hospital Baltimore, Maryland | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Ann's Hospital Westerville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Saint Anthony Hospital Lakewood, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.org) |
| Saint Catherine Hospital Garden City, Kansas | Site Public Contact - (Roster@nrgoncology.org) |
| Saint Clare Hospital Lakewood, Washington | |
| Saint Elizabeth Boardman Hospital Boardman, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Elizabeth Hospital Enumclaw, Washington | |
| Saint Elizabeth Regional Medical Center Lincoln, Nebraska | |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Francis Hospital Federal Way, Washington | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint George Regional Medical Center St. George, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital - Cancer Centers of Colorado Denver, Colorado | |
| Saint Joseph Hospital - Orange Orange, California | |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph London London, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Regional Cancer Center Bryan, Texas | |
| Saint Joseph Warren Hospital Warren, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Luke's East - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (aroland@kccop.org) |
| Saint Luke's Hospital of Kansas City Kansas City, Missouri | Site Public Contact - (aroland@kccop.org) |
| Saint Luke's South Hospital Overland Park, Kansas | Site Public Contact - (aroland@kccop.org) |
| Saint Mary Corwin Medical Center Pueblo, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado | Site Public Contact - (ccrp@co-cancerresearch.org) |
| Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan | |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Saint Michael Cancer Center Silverdale, Washington | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Michael's Hospital Toronto, Ontario | |
| Saint Rita's Medical Center Lima, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| Saint Vincent Hospital Erie, Pennsylvania | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Saints Mary and Elizabeth Hospital Louisville, Kentucky | |
| Salinas Valley Memorial Salinas, California | Site Public Contact - (tnielsen2@svmh.com) |
| Sandra L Maxwell Cancer Center Cedar City, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Cancer Center Worthington Worthington, Minnesota | |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Thief River Falls Medical Center Thief River Falls, Minnesota | |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Santa Cruz Radiation Oncology Medical Group Santa Cruz, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Saskatoon Cancer Centre Saskatoon, Saskatchewan | |
| Scott and White Memorial Hospital Temple, Texas | |
| Sechler Family Cancer Center Lebanon, Pennsylvania | Site Public Contact - (doxenberg@wellspan.org) |
| Shaw Cancer Center Edwards, Colorado | |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Siouxland Regional Cancer Center Sioux City, Iowa | |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Westerly Westerly, Rhode Island | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Orange Care Center Orange, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Solinsky Center for Cancer Care Manchester, New Hampshire | |
| South Jordan Health Center South Jordan, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| South Pointe Hospital Warrensville Heights, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Southeastern Medical Oncology Center-Clinton Clinton, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southern Ohio Medical Center Portsmouth, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Springfield Regional Cancer Center Springfield, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Springfield Regional Medical Center Springfield, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Staten Island University Hospital Staten Island, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Stronach Regional Health Centre at Southlake Newmarket, Ontario | |
| Summa Health Medina Medical Center Medina, Ohio | Site Public Contact - (cancerresearch@summahealth.org) |
| Summa Health System - Akron Campus Akron, Ohio | Site Public Contact - (cancerresearch@summahealth.org) |
| Summa Health System - Barberton Campus Barberton, Ohio | Site Public Contact - (cancerresearch@summahealth.org) |
| Summit Health - Florham Park Campus Florham Park, New Jersey | |
| Summit Medical Group Berkeley Heights, New Jersey | |
| Sutter Auburn Faith Hospital Auburn, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Cancer Research Consortium Novato, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Davis Hospital Davis, California | Site Public Contact - (NCIclinicaltrials@sutterhealth.org) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Pacific Medical Foundation Santa Rosa, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Roseville Medical Center Roseville, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Solano Medical Center/Cancer Center Vallejo, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Covenant Hospital Chicago, Illinois | |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| The Cancer Institute of New Jersey Hamilton Hamilton, New Jersey | |
| The Carle Foundation Hospital Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| The Community Hospital Munster, Indiana | |
| The Dana-Farber Cancer Institute at Londonderry Londonderry, New Hampshire | Site Public Contact - (Roster@nrgoncology.org) |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | Site Public Contact - (Gina.Cravey@bsahs.org) |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| The New York Hospital Medical Center of Queens Flushing, New York | Site Public Contact - (Roster@nrgoncology.org) |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | Site Public Contact - (rohta@queens.org) |
| The West Clinic - Wolf River Germantown, Tennessee | Site Public Contact - (afletcher@westclinic.com) |
| ThedaCare Cancer Care - Berlin Berlin, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Shawano Shawano, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Waupaca Waupaca, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Medical Center - Neenah Neenah, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Thomas Hospital Fairhope, Alabama | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Torrance Memorial Physician Network - Cancer Care Torrance, California | Site Public Contact - (courtney.steeneken@tmphysicians.com) |
| Tower Cancer Research Foundation Beverly Hills, California | Site Public Contact - (towercancerresearch@toweroncology.com) |
| TriHealth Cancer Institute-Anderson Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| TriHealth Cancer Institute-Westside Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus Elizabeth, New Jersey | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Medical Center Moline, Illinois | |
| Trinity's Tony Teramana Cancer Center Steubenville, Ohio | |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UC San Diego Medical Center - Hillcrest San Diego, California | Site Public Contact - (rhabbaba@health.ucsd.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth - Cherry Creek Denver, Colorado | Site Public Contact - (Roster@nrgoncology.org) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (Roster@nrgoncology.org) |
| UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado | |
| UCHealth Lone Tree Health Center Lone Tree, Colorado | Site Public Contact - (Roster@nrgoncology.org) |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | Site Public Contact - (ucstudy@uci.edu) |
| UCI Health Laguna Hills Laguna Hills, California | Site Public Contact - (ucstudy@uci.edu) |
| UChicago Medicine AdventHealth Cancer Institute Hinsdale Hinsdale, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | |
| UH Seidman Cancer Center at Saint John Medical Center Westlake, Ohio | |
| UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights, Ohio | |
| UH Seidman Cancer Center at UH Avon Health Center Avon, Ohio | |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland | |
| UM Upper Chesapeake Hematology and Oncology - Aberdeen Aberdeen, Maryland | Site Public Contact - (nfadrwoski@umm.edu) |
| UM Upper Chesapeake Medical Center Bel Air, Maryland | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UNC REX Cancer Center of Wakefield Raleigh, North Carolina | Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu) |
| UNC Rex Healthcare Raleigh, North Carolina | Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu) |
| UPMC Altoona Altoona, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Camp Hill Camp Hill, Pennsylvania | |
| UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center at UPMC McKeesport McKeesport, Pennsylvania | |
| UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania | |
| UPMC Cancer Center-Natrona Heights Natrona Heights, Pennsylvania | |
| UPMC Cancer Center-Uniontown Uniontown, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center-Washington Washington, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center - New Castle New Castle, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center - Passavant - Cranberry Cranberry Township, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center at Butler Health System Butler, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center in Coraopolis Moon Township, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Memorial York, Pennsylvania | |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC Western Maryland Cumberland, Maryland | |
| UPMC-Heritage Valley Health System Beaver Beaver, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown, Pennsylvania | |
| UPMC-Mercy Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Presbyterian Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| UPMC-Shadyside Hospital Pittsburgh, Pennsylvania | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| USC Norris Oncology/Hematology-Newport Beach Newport Beach, California | |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern Simmons Cancer Center - RedBird Dallas, Texas | Site Public Contact - (canceranswerline@utsouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| United Hospital Center Bridgeport, West Virginia | |
| Unity Hospital Fridley, Minnesota | |
| Unity Park Ridge Campus Rochester, New York | Site Public Contact - (ctsucontact@westat.com) |
| University Cancer and Blood Center LLC Athens, Georgia | Site Public Contact - (research@universitycancer.com) |
| University Hospitals Parma Medical Center Parma, Ohio | |
| University Hospitals Portage Medical Center Ravenna, Ohio | |
| University Hospitals Sharon Health Center Wadsworth, Ohio | |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (charlesbaldwin@uabmc.edu) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| University of Illinois Chicago, Illinois | |
| University of Iowa Healthcare Cancer Services Quad Cities Bettendorf, Iowa | Site Public Contact - (katherine-daprile@uiowa.edu) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | Site Public Contact - (slusserb@med.umich.edu) |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of South Alabama Mitchell Cancer Institute Mobile, Alabama | Site Public Contact - (pfrancisco@usouthal.edu) |
| University of Texas Medical Branch Galveston, Texas | Site Public Contact - (clinical.research@utmb.edu) |
| University of Texas at Austin Austin, Texas | Site Public Contact - (irb@austin.utexas.edu) |
| University of Vermont Medical Center Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - Johnson Creek Johnson Creek, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Utah Cancer Specialists-Salt Lake City Salt Lake City, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Utah Valley Regional Medical Center Provo, Utah | Site Public Contact - (officeofresearch@imail.org) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Valley Radiation Oncology Peru, Illinois | |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Virginia Cancer Institute Richmond, Virginia | Site Public Contact - (smoore@vacancer.com) |
| WVUH-Berkely Medical Center Martinsburg, West Virginia | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington Hospital Fremont, California | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Waterloo Regional Health Network Kitchener, Ontario | Site Public Contact - (research@wrhn.ca) |
| Wayne Hospital Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| WellSpan Health-York Cancer Center York, Pennsylvania | |
| WellSpan Health-York Hospital York, Pennsylvania | |
| WellSpan Medical Oncology and Hematology Hanover, Pennsylvania | |
| West Jefferson Medical Center Marrero, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Penn Hospital Pittsburgh, Pennsylvania | |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Western Illinois Cancer Treatment Center Galesburg, Illinois | |
| Wexford Health and Wellness Pavilion Wexford, Pennsylvania | Site Public Contact - (Dawnmarie.DeFazio@ahn.org) |
| Wheeling Hospital/Schiffler Cancer Center Wheeling, West Virginia | |
| William E Kahlert Regional Cancer Center/Sinai Hospital Westminster, Maryland | |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Windsor Regional Cancer Centre Windsor, Ontario | |
| Women's Diagnostic Center - Munster Munster, Indiana | Site Public Contact - (mnicholson@comhs.org) |
| Woodland Memorial Hospital Woodland, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
ctrrecruit@vcu.edu
NCT05111574
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Inclusion Criteria:
* STEP 0 INCLUSION CRITERIA
* Histologically proven mucosal melanoma by local pathology
* Central PD-L1 tumor tissue submission
* STEP 1 INCLUSION CRITERIA
* Receipt of the central PD-L1 testing results available
* Report is required for randomization of resection R0 or R1 patients
* Testing must be started in Step 0 but results can be reported after registration for resection R2 patients
* Disease status-Resected R0 or R1 disease patients. Patients eligible for randomization have resected R0 or R1 disease (with negative margins or positive microscopic margins) that must meet one of the following 4 criteria as defined below:
* Regional lymph node (LN) involvement; OR
* In-transit metastases/satellite primary disease; OR
* Single localized, primary disease meeting one of the following site-specific requirements:
* Head/neck - Sinonasal (including nasopharynx): any primary lesion; Nasal or oral cavity; pT4a or above, given slightly improved OS
* NOTE: Conjunctival: does not meet the qualification for eligibility
* Anorectal - any primary lesion
* Vaginal/cervical - any primary, as they have 5 year OS rates of 5-25%
* Urinary tract - any primary urethral or bladder tumor
* Penile
* Vulvar- American Joint Committee on Cancer (AJCC) cutaneous stage IIB or higher
* Esophageal/gallbladder - any primary
* Locoregionally recurrent following prior resection, meeting at least one of the above criteria
* In addition, patients must have undergone cross-sectional imaging of the brain, chest, abdomen and pelvis with no evidence of distant metastatic disease
* Disease status-Non-resected R2 or metastatic disease patients
* Non-resected R2 or metastatic disease that is assessable and measurable radiographically or by physical examination
* Prior Treatment:
* No prior systemic checkpoint inhibitor therapy of mucosal melanoma, including in the adjuvant setting, is allowed. Prior adjuvant chemotherapy or interferon is allowed.
* No other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator. Exceptions may allow for adjuvant no evidence of disease (NED) cancers undergoing hormone based therapy may be eligible pending the other eligibility criteria are met and the principal investigator (PI) affirms the hormonal agent would not change the melanoma response.
* Any radiation must have completed 28 days prior to randomization and the patient must have adequately recovered from its effects.
* For resectable patients only: Surgery must have completed 28 days prior to randomization.
* For resectable patients only: Surgery must have completed no more than 84 days prior to randomization.
* Not pregnant and not nursing, because this study has an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Creatinine =\< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) \>= 50mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Albumin \>= 2.8 g/dL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
* No cardiovascular disease, including:
* No history of acute coronary syndromes (including myocardial infarction and unstable angina), coronary artery bypass graft (CABG) coronary angioplasty, or stenting within 6 months prior to study entry.
* No history of current class II or higher congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system.
* No refractory hypertension defined as a blood pressure of systolic \> 140 mmHg and/or diastolic \> 90 mmHg despite adequate attempts at anti-hypertensive therapy.
* No history of myocarditis.
* No history of syncope of cardiovascular etiology, uncontrolled cardiac arrhythmia, history of Mobitz II second degree or third degree heart block without a permanent pacemaker in Association (NYHA) class II to IV heart failure, or stroke/transient ischemic attack (TIA) within the past 3 months.
* No corrected QT interval by Fridericia's formula (QTcF) \> 500 msec. Note: if initial QTcF is found to be \> 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is =\< 500 ms, the subject meets eligibility in this regard.
* No underlying hematologic issues, including:
* Congenital bleeding diathesis
* Gastrointestinal (GI) bleeding requiring intervention within the past 6 months, unless directly related to mucosal melanoma
* Active hemoptysis within 42 days prior to study enrollment.
* Active tumor lesions with cavitations or tumor lesions which invade, encase, or abut major blood vessels. The anatomic location and characteristics of primary tumors or metastases as well as the medical history should be carefully reviewed in the selection of subjects for treatment with cabozantinib/placebo.
* Pulmonary emboli or deep vein thromboses (DVT) that require an active anticoagulation regimen.
* No known or suspected history of cytopenia (low white blood cell \[WBC\], hemoglobin or platelet count) of greater than 3 months duration with an unknown cause, myelodysplastic syndrome, or hematologic malignancies.
* No clinical, laboratory or radiographic evidence of an active bacterial, fungal, or viral infection requiring treatment at the time of pre-registration (e.g., active symptoms of COVID-19 infection or a post-infectious symptomatic autoimmune syndrome, serious bacterial infections requiring antibiotics).
* No known or suspected gastrointestinal disorder affecting absorption of oral medications.
* Comorbid conditions:
* No active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
* No history of autoimmune motor neuropathy (e.g., Guillain-Barre syndrome, myasthenia gravis) or non-infectious pneumonitis.
* No history of severe allergic reactions to an unknown allergen or any components of the study drugs or its excipients.
* No history of gastrointestinal perforation or abdominal fistula.
* No clinically suspected central nervous system (CNS) (leptomeningeal or parenchymal) metastases. Patients with a history of CNS metastasis(s) will be allowed as long as
* The metastatic site(s) were adequately treated as demonstrated by clinical and radiographic improvement, AND
* The patient has recovered from the intervention (no residual adverse events \> Common Terminology Criteria for Adverse Events \[CTCAE\] grade 1), AND
* The patient has remained without occurrence of new or worsening CNS symptoms for a period of 28 days prior to enrollment.
* No history of seizure or any condition that may increase the patient's seizure risk (e.g., prior cortical stroke, significant brain trauma) within 2 years.
* No clinically active or chronic liver disease resulting in moderate/severe hepatic impairment (Child-Pugh class B or C), ascites, coagulopathy or bleeding due to liver dysfunction.
* No untreated spinal cord compression or evidence of spinal metastases with a risk of impending fracture or spinal cord compression. Spinal metastases must have completed planned radiation or surgical therapy prior to registration.
* Concomitant medications:
* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 5 days prior to the start of study treatment.
* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 5 days prior to the start of study treatment. PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Scan, DRUG: Cabozantinib S-malate, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, DRUG: Placebo Administration, PROCEDURE: Positron Emission Tomography
Anal Melanoma, Bladder Melanoma, Cervical Melanoma, Esophageal Melanoma, Gallbladder Melanoma, Head and Neck Mucosal Melanoma, Mucosal Melanoma, Nasopharyngeal Mucosal Melanoma, Oral Cavity Mucosal Melanoma, Penile Mucosal Melanoma, Rectal Melanoma, Recurrent Mucosal Melanoma, Sinonasal Mucosal Melanoma, Urethral Melanoma, Urinary System Mucosal Melanoma, Vaginal Melanoma, Vulvar Melanoma
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Show 146 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Avera Cancer Institute Sioux Falls, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| California Pacific Medical Center-Pacific Campus San Francisco, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dayton Physician LLC - Englewood Dayton, Ohio | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| HSHS Sacred Heart Hospital Eau Claire, Wisconsin | |
| Hematology Oncology Associates of CNY at Camillus Camillus, New York | |
| Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York | |
| Jewish General Hospital Montreal, Quebec | |
| Keck Medicine of USC Koreatown Los Angeles, California | |
| Kettering Medical Center Kettering, Ohio | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Greeley Medical Center Ames, Iowa | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| Memorial Medical Center Modesto, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Mills Health Center San Mateo, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario | |
| Palo Alto Medical Foundation Health Care Palo Alto, California | |
| Palo Alto Medical Foundation-Fremont Fremont, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Santa Cruz Santa Cruz, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Premier Blood and Cancer Center Dayton, Ohio | |
| Rapid City Regional Hospital Rapid City, South Dakota | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Sutter Auburn Faith Hospital Auburn, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Pacific Medical Foundation Santa Rosa, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Roseville Medical Center Roseville, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Solano Medical Center/Cancer Center Vallejo, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| The Melanoma and Skin Cancer Institute Englewood, Colorado | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| UCSF Medical Center-Mission Bay San Francisco, California | |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| USC Norris Oncology/Hematology-Newport Beach Newport Beach, California | |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability
ctrrecruit@vcu.edu
NCT04804644
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Inclusion Criteria:
* Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis);
* Patients with de novo or recurrent small cell lung cancer are permitted.
* Brain metastases =\< 4 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =\< 21 days prior to study entry.
* The total tumor volume must be 30 cm\^3 or less. Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g. xyz/2). Alternatively, direct volumetric measurements via slice by slice contouring on a treatment planning software package can be used to calculate the total tumor volume.
* Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and management of small cell lung cancer.
* Brain metastases must be diagnosed on MRI, which will include the following elements:
* REQUIRED MRI ELEMENTS
* Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (Brain Volume Imaging) or 3D Fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm.
* Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged).
* A minimum of one axial T2 FLAIR (preferred) or T2 sequence is required. This can be acquired as a two dimensional (2D) or 3D image. If 2D, the images should be obtained in the axial plane.
* ADDITIONAL RECOMMENDATIONS
* Recommendation is that an axial T2 FLAIR (preferred) sequence be performed instead of a T2 sequence.
* Recommendation is that that pre-contrast 3D T1 be performed with the same parameters as the post-contrast 3D T1.
* Recommendation is that imaging be performed on a 3 Tesla (3T) MRI.
* Recommendation is that the study participants be scanned on the same MRI instrument at each time point.
* Recommendation is that if additional sequences are obtained, these should meet the criteria outlined in Kaufmann et al., 2020.
* If additional sequences are obtained, total imaging time should not exceed 60 minutes.
* If additional metastases not known at the time of registration/randomization or seen in the MRI used for eligibility are subsequently found on the radiation therapy (RT) planning MRI such that the total intacranial volume exceeds 30 cm\^3, the patient is still considered eligible.
* History/physical examination
* Age \>= 18
* Karnofsky performance status of \>= 70
* Creatinine clearance \>= 30 ml/min
* Following the diagnosis of brain metastases, patients can initiate and treat with systemic (chemotherapy and/or immunotherapy) before enrollment only if their brain metastases are asymptomatic and not located in eloquent locations (e.g., brainstem, pre-/post-central gyrus, visual cortex). However, within 21 days prior to enrollment, brain MRI must be repeated to confirm eligibility.
* Patients with symptomatic brain metastases and/or brain metastases in eloquent locations (e.g., brainstem, pre-/post central gyrus, visual cortex) are eligible for enrollment on the trial; however, the specific treatment approach of starting with systemic therapy alone and delaying brain radiation is not recommended for these patients.
* Concurrent immunotherapy with brain radiation (SRS or HA-WBRT) is permitted.
* Negative urine or serum pregnancy test (in women of childbearing potential) within 14 days prior to registration. Women of childbearing potential and men who are sexually active must use contraception while on study.
* Patients may have had prior intracranial surgical resection.
* Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian.
* The patient must provide study-specific informed consent prior to study entry.
* Patients with impaired decision-making capacity are not permitted on study.
* ELIGIBILITY CRITERIA PRIOR TO STEP 2 REGISTRATION
* The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive test will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2.
* NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.
* PRIOR TO STEP 2 REGISTRATION: The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive tests will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2.
NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.
Exclusion Criteria:
* Planned infusion of cytotoxic chemotherapy on the same day as SRS or HA-WBRT treatment. Patients may have had prior chemotherapy. Concurrent immunotherapy is permitted.
* For patients receiving fractionated SRS on an every-other-day basis, planned infusion of cytotoxic chemotherapy is not permitted between SRS treatments.
* Brainstem metastasis \> 10 cm\^3
* Prior allergic reaction to memantine.
* Patients with definitive leptomeningeal metastases.
* Known history of demyelinating disease such as multiple sclerosis.
* Contraindication to MR imaging such as implanted metal devices that are MRI-incompatible, allergy to MRI contrast that cannot be adequately addressed with pre-contrast medications, or foreign bodies that preclude MRI imaging. (Questions regarding MRI compatibility of implanted objects should be reviewed with the Radiology Department performing the MRI).
* Current use of (other N-methyl-D-aspartate \[NMDA\] antagonists) amantadine, ketamine, or dextromethorphan.
* Radiographic evidence of hydrocephalus or other architectural change of the ventricular system resulting in significant anatomic distortion of the hippocampus, including placement of external ventricular drain or ventriculoperitoneal shunt.
* Mild cases of hydrocephalus not resulting in significant anatomic distortion of the hippocampus are permitted.
* Prior radiotherapy to the brain, including SRS, WBRT, or prophylactic cranial irradiation (PCI). PROCEDURE: Biospecimen Collection, PROCEDURE: Magnetic Resonance Imaging, DRUG: Memantine Hydrochloride, OTHER: Neurocognitive Assessment, RADIATION: Stereotactic Radiosurgery, OTHER: Survey Administration, RADIATION: Whole-Brain Radiotherapy
Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Recurrent Lung Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
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Show 223 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Allan Blair Cancer Centre Regina, Saskatchewan | |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Avera Cancer Institute Sioux Falls, South Dakota | |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Baptist Health Lexington Lexington, Kentucky | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe Medical Center Lewes, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | |
| Billings Clinic Cancer Center Billings, Montana | |
| Boston Medical Center Boston, Massachusetts | |
| CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Québec, Quebec | Site Public Contact - (rechclinique@crchuq.ulaval.ca) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carlisle Regional Cancer Center Carlisle, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Caro Cancer Center Caro, Michigan | |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Central Maryland Radiation Oncology in Howard County Columbia, Maryland | |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Chambersburg Hospital Chambersburg, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Clinical and Laboratory Physicians PA Newark, Delaware | |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | |
| Divine Providence Hospital Williamsport, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Ephrata Cancer Center Ephrata, Pennsylvania | |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | |
| Gibbs Cancer Center-Pelham Greer, South Carolina | |
| Goshen Center for Cancer Care Goshen, Indiana | Site Public Contact - (cccois@goshenhealth.com) |
| Grady Memorial Hospital Delaware, Ohio | |
| Grant Medical Center Columbus, Ohio | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| IU Health Methodist Hospital Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| IU Health North Hospital Carmel, Indiana | Site Public Contact - (iutrials@iu.edu) |
| IU Health West Hospital Avon, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Ontario Ontario, California | Site Public Contact - (clinical.trials@kp.org) |
| Karmanos Cancer Institute at McLaren Greater Lansing Lansing, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Logan Health Medical Center Kalispell, Montana | |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| Luminis Health Anne Arundel Medical Center Annapolis, Maryland | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson League City League City, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson West Houston Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in Sugar Land Sugar Land, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in The Woodlands Conroe, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Mary Bird Perkins Cancer Center Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Mary Greeley Medical Center Ames, Iowa | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McLaren Cancer Institute-Bay City Bay City, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Flint Flint, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Lapeer Region Lapeer, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Macomb Mount Clemens, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Northern Michigan Petoskey, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren-Port Huron Port Huron, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLeod Regional Medical Center Florence, South Carolina | Site Public Contact - (dorie.sturgill@mcleodhealth.org) |
| MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore, Maryland | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Health University Medical Center Savannah, Georgia | |
| Memorial Hospital North Colorado Springs, Colorado | |
| Mercy Health - Perrysburg Hospital Perrysburg, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | |
| Northern Westchester Hospital Mount Kisco, New York | |
| Northside Hospital Atlanta, Georgia | Site Public Contact - (ClinicalTrials@northside.com) |
| Northside Hospital-Cherokee Canton, Georgia | Site Public Contact - (clinical.trials@northside.com) |
| Northside Hospital-Forsyth Cumming, Georgia | Site Public Contact - (clinicaltrials@northside.com) |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| OSF Saint Francis Medical Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riverside Methodist Hospital Columbus, Ohio | |
| Rush MD Anderson Cancer Center Chicago, Illinois | |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| SMC Center for Hematology Oncology Union Union, South Carolina | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Luke's Cancer Center - Allentown Allentown, Pennsylvania | |
| Saint Luke's Hospital - Monroe Campus Stroudsburg, Pennsylvania | |
| Saint Luke's Hospital - Upper Bucks Campus Quakertown, Pennsylvania | |
| Saint Luke's Hospital-Anderson Campus Easton, Pennsylvania | |
| Saint Luke's Hospital-Quakertown Campus Quakertown, Pennsylvania | |
| Saint Luke's University Hospital-Bethlehem Campus Bethlehem, Pennsylvania | |
| Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan | |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Saint Vincent Hospital Erie, Pennsylvania | |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Sands Cancer Center Canandaigua, New York | |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Saskatoon Cancer Centre Saskatoon, Saskatchewan | |
| Sechler Family Cancer Center Lebanon, Pennsylvania | Site Public Contact - (doxenberg@wellspan.org) |
| Self Regional Healthcare Greenwood, South Carolina | |
| Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut | |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | |
| Spartanburg Medical Center Spartanburg, South Carolina | |
| State University of New York Upstate Medical University Syracuse, New York | |
| The Carle Foundation Hospital Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | |
| TidalHealth Peninsula Regional Salisbury, Maryland | |
| TidalHealth Richard A Henson Cancer Institute Ocean Pines, Maryland | |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Upper Chesapeake Medical Center Bel Air, Maryland | |
| UPMC Altoona Altoona, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Memorial York, Pennsylvania | |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Presbyterian Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| UPMC-Shadyside Hospital Pittsburgh, Pennsylvania | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Unity Hospital Fridley, Minnesota | |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | |
| University of Maryland Shore Medical Center at Easton Easton, Maryland | Site Public Contact - (Christina.weisenborn@umm.edu) |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| Upstate Cancer Center Radiation Oncology at Oswego Oswego, New York | Site Public Contact - (BinghamE@upstate.edu) |
| Upstate Cancer Center at Hill Radiation Oncology Syracuse, New York | Site Public Contact - (BinghamE@upstate.edu) |
| Upstate Cancer Center at Verona Verona, New York | |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Weisberg Cancer Treatment Center Farmington Hills, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| WellSpan Health-York Cancer Center York, Pennsylvania | |
| WellSpan Health-York Hospital York, Pennsylvania | |
| Wilmot Cancer Institute Radiation Oncology at Greece Rochester, New York | |
| Wilmot Cancer Institute at Webster Webster, New York | |
| Yale University New Haven, Connecticut |
A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
ctrrecruit@vcu.edu
NCT05691478
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Inclusion Criteria:
* Patients must be \< 40 years of age at the time of enrollment.
* Patients must have a body surface area of \>= 0.8 m\^2 at the time of enrollment.
* Patients must have histologic diagnosis (by institutional pathologist) of newly diagnosed high grade osteosarcoma. Primary tumors of all extremity and axial sites are eligible as long as diagnosis of high-grade osteosarcoma is established. Osteosarcoma as a second malignancy is eligible if no prior exposure to systemic chemotherapies.
* Feasibility Phase (NOTE: as of Amendment #2B, the feasibility phase has been completed) Patients must have metastatic disease and a resectable primary tumor. Designation of a primary tumor as resectable will be determined at the time of diagnosis by the institutional multidisciplinary team.
For this study, metastatic disease is defined as one or more of the following:
* Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor. Skip lesions in the same bone as the primary tumor do not constitute metastatic disease. Skip lesions in an adjacent bone are considered bone metastases.
* Lung metastases: defined as biopsy-proven metastasis or the presence of one or more pulmonary lesions \>= 5 mm, OR multiple pulmonary lesions \>= 3 mm or greater in size.
* Bone metastases: Areas suspicious for bone metastasis based on fludeoxyglucose F-18 (18F-FDG)-positron emission tomography (PET) scan (or whole body technetium-99 bone scan if 18F-FDG-PET is unavailable at the treating institution) require confirmatory biopsy or supportive anatomic imaging of at least one suspicious site with either magnetic resonance imaging (MRI) or computed tomography (CT) (whole body 18F-FDG-PET/CT or 18F-FDG-PET/MR scans are acceptable).
* Efficacy Phases (Phase 2/3) NOTE: as of Amendment #2B, the efficacy phase is open for enrollment.
Patients with both localized and metastatic disease are eligible for the efficacy phase, regardless of resectability. Patients will be enrolled to two separate cohorts:
* Cohort 1 (Standard Risk): Patients with non-pelvic primary osteosarcoma deemed to be resectable at the time of diagnosis by the institutional multidisciplinary team, without evidence of metastatic lesions.
* Cohort 2 (High-Risk): Patients with a primary pelvic tumor, a primary tumor designated as unresectable by the institutional multidisciplinary team, AND/OR radiographic evidence of metastatic lesions.
* A serum creatinine based on age/sex as follows (within 7 days prior to enrollment unless otherwise indicated):
* (Age: Maximum Serum Creatinine \[mg/dL\]; Sex)
* 1 month to \< 6 months: 0.4 (male); 0.4 (female)
* 6 months to \< 1 year: 0.5 (male); 0.5 (female)
* 1 to \< 2 years: 0.6 (male); 0.6 (female)
* 2 to \< 6 years: 0.8 (male); 0.8 (female)
* 6 to \< 10 years: 1 (male); 1 (female)
* 10 to \< 13 years: 1.2 (male); 1.2 (female)
* 13 to \< 16 years: 1.5 (male); 1.4 (female)
* \>= 16 years: 1.7 (male); 1.4 (female)
* OR - a 24 hour urine creatinine clearance \>= 70 mL/min/1.73 m\^2
* OR - a glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard).
* Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility.
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment unless otherwise indicated)
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment unless otherwise indicated)
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
* No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias
* Shortening fraction of \>= 27%, or
* Ejection fraction of \>= 50%
* Corrected QT interval by Fridericia (QTcF) \< 480 msec on electrocardiogram. Patients with Grade 1 prolonged QTc (450-480 msec) at time of study enrollment should have correctable causes of prolonged QTc addressed if possible (i.e., electrolytes, medications).
* Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to enrollment unless otherwise indicated)
* Platelet count \>= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment) (within 7 days prior to enrollment unless otherwise indicated)
* Hemoglobin \>= 8.0 g/dL (within 7 days prior to enrollment unless otherwise indicated)
* International normalized ratio (INR) =\< 1.5 (within 7 days prior to enrollment unless otherwise indicated)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible as long as they are NOT receiving anti-retroviral agents that are strong inhibitors or inducers of CYP3A4, CYP2D6, and/or MRP2 transporter protein.
* All patients and/or their parents or legal guardians must sign a written informed consent.
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
* Patients who have received previous systemic therapy for osteosarcoma or a prior oncologic diagnosis.
* Patients who have central nervous system metastases.
* Patients with central cavitating pulmonary lesions invading or encasing any major blood vessels in the lung.
* Patients who are unable to swallow tablets. Tablets cannot be crushed or chewed.
* Patients with gastrointestinal disorders including active disorders associated with a high risk of perforation or fistula formation. Specifically, no clinically significant gastrointestinal (GI) bleeding, GI perforation, bowel obstruction, intra-abdominal abscess or fistula for 6 months prior to enrollment, no hemoptysis or other signs of pulmonary hemorrhage for 3 months prior to enrollment.
* Patients with active bleeding or bleeding diathesis. No clinically significant hematuria, hematemesis, or hemoptysis or other history of significant bleeding within 3 months prior to enrollment.
* Patients with uncompensated or symptomatic hypothyroidism. Patients who have hypothyroidism controlled with thyroid replacement hormone are eligible.
* Patients with moderate to severe hepatic impairment (Child-Pugh B or C).
* Patients who have had primary tumor resection or attempted curative resection of metastases prior to enrollment.
* Patients who have undergone other major surgical procedure (eg, laparotomy) within 14 days prior to enrollment. Thoracoscopic procedures for diagnostic purposes (biopsy of lung nodule) and central access such as port-a-cath placement are allowed.
* Patients with a history of serious or non-healing wound or bone fracture (pathologic fracture of primary tumor is not considered exclusion).
* Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of cabozantinib.
* Patients with previously identify allergy or hypersensitivity to components of the study treatment formulations.
* Patients who are receiving any other investigational agent not defined within this protocol are not eligible.
* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
* Patients who received enzyme-inducing anticonvulsants within 14 days prior to enrollment.
* Patients with a prior history of hypertension (\> 95th percentile for age, height, and sex for patients \< 18 years and \> 140/90 mmHg for patients \>= 18 years requiring medication for blood pressure control.
* Patients who are receiving drugs that prolong QTc.
* Patients receiving anticoagulation with oral coumarin agents (eg warfarin), direct thrombin inhibitors (eg dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (eg, clopidogrel). Low dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH and direct factor Xa inhibitors rivaroxaban or apixaban are allowed in subjects who are on a stable dose for at least 6 weeks before the first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen.
* Patients receiving strong CYP3A4 inducers or strong CYP3A4 inhibitors.
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
* Lactating females who plan to breastfeed their infants.
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of protocol therapy. PROCEDURE: Bone Scan, DRUG: Cabozantinib S-malate, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Doxorubicin Hydrochloride, PROCEDURE: Magnetic Resonance Imaging, DRUG: Methotrexate, PROCEDURE: Surgical Procedure, PROCEDURE: X-Ray Imaging
High Grade Osteosarcoma, Localized Osteosarcoma, Metastatic Osteosarcoma, Secondary Osteosarcoma
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See this study on ClinicalTrials.gov
Show 164 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hospital for Sick Children Toronto, Ontario | |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Jim Pattison Children's Hospital Saskatoon, Saskatchewan | Site Public Contact - (Jessica.Marien@saskhealthauthority.ca) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Loma Linda University Medical Center Loma Linda, California | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Royal Children's Hospital Parkville, Victoria | Site Public Contact - (Jordan.Hansford@rch.org.au) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Federal Way, Washington | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Starship Children's Hospital Grafton, Auckland | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sydney Children's Hospital Randwick, New South Wales | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects
David Kozono, MD, PhD - dkozono@bwh.harvard.edu
NCT04242095
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Inclusion Criteria:
* Received a regimen containing one or more immuno-oncology therapeutics
* Must have experienced one or more of the following:
* One or more serious (Grade 3-4) AEs that are likely immune-related
* One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related
* Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment
\*\* Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded
* Hyperprogression. Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review
* Has not previously been registered to this study PROCEDURE: Biospecimen Collection, OTHER: Medical Chart Review
Malignancy
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See this study on ClinicalTrials.gov
Show 622 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Adena Regional Medical Center Chillicothe, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Advanced Breast Care Center PLLC Warren, Michigan | |
| AdventHealth Littleton Littleton, Colorado | |
| AdventHealth Parker Parker, Colorado | |
| AdventHealth Porter Denver, Colorado | |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alegent Health Bergan Mercy Medical Center Omaha, Nebraska | |
| Alegent Health Immanuel Medical Center Omaha, Nebraska | |
| Alegent Health Lakeside Hospital Omaha, Nebraska | |
| Alegent Health Mercy Hospital Council Bluffs, Iowa | |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Anchorage Oncology Centre Anchorage, Alaska | |
| Anchorage Radiation Therapy Center Anchorage, Alaska | |
| Ann M Wierman MD LTD Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Armes Family Cancer Center Findlay, Ohio | |
| Ascension All Saints Hospital Racine, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Calumet Hospital Chilton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Columbia Saint Mary's Hospital Ozaukee Mequon, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Mercy Hospital Oshkosh, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Elizabeth Hospital Appleton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Francis - Reiman Cancer Center Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Saint Francis Hospital Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital - Franklin Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Audie L Murphy VA Hospital San Antonio, Texas | |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Avera Cancer Institute Sioux Falls, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| BASS Medical Group - Lennon Walnut Creek, California | Site Public Contact - (brenna.lindsey@bassmedicalgroup.com) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Bay Area Breast Surgeons Inc Emeryville, California | |
| Bay Area Hospital Coos Bay, Oregon | Site Public Contact - (cherie.cox@bayareahospital.org) |
| Bay Area Tumor Institute Oakland, California | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe Medical Center Lewes, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Bethesda North Hospital Cincinnati, Ohio | |
| Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Billings Clinic-Cody Cody, Wyoming | Site Public Contact - (research@billingsclinic.org) |
| Blanchard Valley Hospital Findlay, Ohio | |
| Boulder Community Foothills Hospital Boulder, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Brigham and Women's Hospital Boston, Massachusetts | |
| Broadlawns Medical Center Des Moines, Iowa | |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| CHI Health Good Samaritan Kearney, Nebraska | |
| CHI Health Saint Francis Grand Island, Nebraska | |
| CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas | |
| Cambridge Medical Center Cambridge, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Camden Clark Medical Center Parkersburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Cancer Care Associates of York York, Pennsylvania | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | |
| Cancer Care Northwest - Spokane South Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Northwest-North Spokane Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Blood Specialists-Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Cancer and Blood Specialists-Shadow Las Vegas, Nevada | |
| Cancer and Blood Specialists-Tenaya Las Vegas, Nevada | |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Caro Cancer Center Caro, Michigan | |
| CaroMont Regional Medical Center Gastonia, North Carolina | |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Garden City Garden City, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Ohio Breast and Endocrine Surgery Gahanna, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Chambersburg Hospital Chambersburg, Pennsylvania | Site Public Contact - (protocols@AllianceNCTN.org) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Christiana Care - Union Hospital Elkton, Maryland | Site Public Contact - (frank.crum@christianacare.org) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center Wilmington, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Colorado Blood Cancer Institute Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Columbus Oncology and Hematology Associates Dublin, Ohio | |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | |
| CommonSpirit Cancer Center Mercy Durango, Colorado | |
| Commonwealth Cancer Center-Corbin Corbin, Kentucky | |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Contra Costa Regional Medical Center Martinez, California | |
| Cox Cancer Center Branson Branson, Missouri | |
| CoxHealth South Hospital Springfield, Missouri | |
| Creighton University Medical Center Omaha, Nebraska | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dayton Physician LLC - Englewood Dayton, Ohio | |
| Dayton Physicians LLC - Troy Troy, Ohio | |
| Dayton Physicians LLC-Atrium Franklin, Ohio | |
| Dayton Physicians LLC-Miami Valley South Centerville, Ohio | |
| Dayton Physicians LLC-Wayne Greenville, Ohio | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Clinical and Laboratory Physicians PA Newark, Delaware | |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | |
| Desert West Surgery Las Vegas, Nevada | |
| Doctors Hospital Columbus, Ohio | |
| Dublin Methodist Hospital Dublin, Ohio | |
| Duke Cancer Center Cary Cary, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke Cancer Center Raleigh Raleigh, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke University Medical Center Durham, North Carolina | |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | |
| ECU Health Oncology Kenansville Kenansville, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| ECU Health Oncology Kinston Kinston, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| ECU Health Oncology Richlands Richlands, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| Ephrata Cancer Center Ephrata, Pennsylvania | |
| Ephrata Community Hospital Ephrata, Pennsylvania | Site Public Contact - (protocols@AllianceNCTN.org) |
| Epic Care Cyberknife Center Walnut Creek, California | |
| Epic Care Partners in Cancer Care Emeryville, California | |
| Epic Care-Dublin Dublin, California | |
| Fairbanks Memorial Hospital Fairbanks, Alaska | Site Public Contact - (Veronica.Stevenson@foundationhealth.org) |
| Fairfield Medical Center Lancaster, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Northland Medical Center Princeton, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Ridges Hospital Burnsville, Minnesota | |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| First Dayton Cancer Care Kettering, Ohio | |
| Flaget Memorial Hospital Bardstown, Kentucky | |
| Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Genesee Hematology Oncology PC Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesis Healthcare System Cancer Care Center Zanesville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | |
| Grady Memorial Hospital Delaware, Ohio | |
| Grand Valley Oncology Grand Junction, Colorado | Site Public Contact - (gvoclinicaltrials@gjhosp.org) |
| Grant Medical Center Columbus, Ohio | |
| Great Falls Clinic Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Greater Dayton Cancer Center Kettering, Ohio | |
| Greater Regional Medical Center Creston, Iowa | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo, Washington | |
| Health Partners Inc Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas, Nevada | |
| HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas, Nevada | |
| HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas, Nevada | |
| HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas, Nevada | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hematology Oncology Associates of CNY at Camillus Camillus, New York | |
| Hematology Oncology Associates of Central New York-Auburn Auburn, New York | |
| Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York | |
| Hematology Oncology Consultants-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Health Providence Novi Hospital Novi, Michigan | |
| Henry Ford Health Providence Southfield Hospital Southfield, Michigan | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | Site Public Contact - (Kkeenan1@hfhs.org) |
| Henry Ford Health Warren Hospital Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Madison Heights Hospital - Breast Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford River District Hospital East China Township, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Rochester Hospital Rochester Hills, Michigan | |
| Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - GLCMS Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Hi-Line Sletten Cancer Center Havre, Montana | Site Public Contact - (protocols@AllianceNCTN.org) |
| Highline Medical Center-Main Campus Burien, Washington | |
| Holy Cross Hospital Fort Lauderdale, Florida | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Center Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hope Cancer Clinic Livonia, Michigan | |
| Hunterdon Medical Center Flemington, New Jersey | |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Idaho Urologic Institute-Meridian Meridian, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | |
| Iowa Cancer Specialists Davenport, Iowa | |
| Iowa Lutheran Hospital Des Moines, Iowa | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Healthcare Port Townsend, Washington | |
| Jewish Hospital Louisville, Kentucky | |
| Jewish Hospital Medical Center South Shepherdsville, Kentucky | |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Katmai Oncology Group Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Kettering Medical Center Kettering, Ohio | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Knox Community Hospital Mount Vernon, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Las Vegas Cancer Center-Henderson Henderson, Nevada | |
| Las Vegas Cancer Center-Medical Center Las Vegas, Nevada | |
| Las Vegas Prostate Cancer Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Cathedral Rock Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pebble Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pecos Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Smoke Ranch Las Vegas, Nevada | Site Public Contact - (research@smcrf.org) |
| Las Vegas Urology - Sunset Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia | |
| Lewistown Hospital Lewistown, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Licking Memorial Hospital Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Longmont United Hospital Longmont, Colorado | |
| Louisiana State University Health Science Center New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Lourdes Hospital Binghamton, New York | |
| Loyola Center for Health at Burr Ridge Burr Ridge, Illinois | |
| Loyola Medicine Homer Glen Homer Glen, Illinois | |
| Loyola University Medical Center Maywood, Illinois | |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| Macomb Hematology Oncology PC Warren, Michigan | |
| Margaret R Pardee Memorial Hospital Hendersonville, North Carolina | |
| Marietta Memorial Hospital Marietta, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Marion L Shepard Cancer Center - ECU Health Beaufort Hospital Washington, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois | |
| Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin | |
| Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin | |
| Marshfield Clinic-Wausau Center Wausau, Wisconsin | |
| Marshfield Medical Center - Ladysmith Ladysmith, Wisconsin | |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | |
| Marshfield Medical Center - Weston Weston, Wisconsin | |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | |
| Mary Greeley Medical Center Ames, Iowa | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McFarland Clinic - Ames Ames, Iowa | |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Hospital Chattanooga, Tennessee | Site Public Contact - (Jeffh@columbusccop.org) |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Hospital of South Bend South Bend, Indiana | |
| Mercy Cancer Center Merced, California | |
| Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri | |
| Mercy Cancer Center - Carmichael Carmichael, California | |
| Mercy Cancer Center - Elk Grove Elk Grove, California | |
| Mercy Cancer Center - Rocklin Rocklin, California | |
| Mercy Cancer Center - Sacramento Sacramento, California | |
| Mercy Cancer Center-West Lakes Clive, Iowa | |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Health - Paducah Cancer Center Paducah, Kentucky | Site Public Contact - (BJWarner@mercy.com) |
| Mercy Health - Perrysburg Hospital Perrysburg, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Vincent Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Joplin Joplin, Missouri | Site Public Contact - (esmeralda.carrillo@mercy.net) |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital Pittsburg Pittsburg, Kansas | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Hospital Washington Washington, Missouri | |
| Mercy Infusion Center - Chippewa St Louis, Missouri | |
| Mercy Medical Center Springfield, Massachusetts | |
| Mercy Medical Center Springfield, Massachusetts | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Mercy San Juan Medical Center Carmichael, California | |
| MercyOne Genesis Davenport Cancer Center Davenport, Iowa | |
| MercyOne Genesis Davenport Medical Center Davenport, Iowa | |
| MercyOne Genesis Silvis Cancer Center Silvis, Illinois | |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Methodist West Hospital West Des Moines, Iowa | |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Midlands Community Hospital Papillion, Nebraska | |
| Minneapolis VA Medical Center Minneapolis, Minnesota | |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California | |
| Mission Hope Medical Oncology - Santa Maria Santa Maria, California | |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mount Carmel East Hospital Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Carmel Grove City Hospital Grove City, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Carmel Health Center West Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mountain Blue Cancer Care Center - Swedish Englewood, Colorado | |
| MyMichigan Medical Center Alpena Alpena, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Gladwin Gladwin, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Gratiot Alma, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Midland Midland, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Mount Pleasant Mount Pleasant, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | |
| Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Newark Radiation Oncology Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Newland Medical Associates-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Newland Medical Associates-Pontiac Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| North Shore Medical Center Skokie, Illinois | Site Public Contact - (ctsucontact@westat.com) |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northwest Medical Specialties PLLC Tacoma, Washington | |
| OSF Saint Anthony Medical Center Rockford, Illinois | |
| OSF Saint Anthony's Health Center Alton, Illinois | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | |
| OhioHealth Marion General Hospital Marion, Ohio | |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | |
| Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio | |
| Oncology Las Vegas - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oncology Las Vegas - Tenaya Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Orion Cancer Care Findlay, Ohio | |
| Our Lady of the Lake Medical Oncology Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Overlake Medical Center Bellevue, Washington | |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California | |
| Pacific Gynecology Specialists Seattle, Washington | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| PeaceHealth Saint John Medical Center Longview, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | |
| PeaceHealth Southwest Medical Center Vancouver, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth United General Medical Center Sedro-Woolley, Washington | Site Public Contact - (rcrompton@peacehealth.org) |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Portland VA Medical Center Portland, Oregon | |
| Pottstown Hospital Pottstown, Pennsylvania | |
| Premier Blood and Cancer Center Dayton, Ohio | |
| Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Princeton Community Hospital Princeton, West Virginia | |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Cancer Institute Clackamas Clinic Clackamas, Oregon | |
| Providence Hood River Memorial Hospital Hood River, Oregon | Site Public Contact - (canrsrchstudies@provdience.org) |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Regional Cancer Partnership Everett, Washington | Site Public Contact - (marilyn.birchman@providence.org) |
| Providence Regional Cancer System-Aberdeen Aberdeen, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Centralia Centralia, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Shelton Shelton, Washington | |
| Providence Regional Cancer System-Yelm Yelm, Washington | |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California | Site Public Contact - (Najee.Boucher@providence.org) |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Veterans Administration Hospital Providence, Rhode Island | |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Radiation Oncology Associates Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Redeemer Health Meadowbrook, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reid Health Richmond, Indiana | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riverside Methodist Hospital Columbus, Ohio | |
| Rocky Mountain Cancer Centers - Centennial Centennial, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers - Swedish Englewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Aurora Aurora, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Boulder Boulder, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Littleton Littleton, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Longmont Longmont, Colorado | Site Public Contact - (ResearchTracking@Centura.Org) |
| Rocky Mountain Cancer Centers-Midtown Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | |
| Rocky Mountain Cancer Centers-Rose Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Thornton Thornton, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Roger Williams Medical Center Providence, Rhode Island | Site Public Contact - (fdallesandro@chartercare.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| SUNY Upstate Medical Center-Community Campus Syracuse, New York | |
| Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Ann's Hospital Westerville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Saint Anthony Hospital Lakewood, Colorado | |
| Saint Anthony North Hospital Westminster, Colorado | |
| Saint Charles Health System Bend, Oregon | Site Public Contact - (nosall@stcharleshealthcare.org) |
| Saint Charles Health System-Redmond Redmond, Oregon | |
| Saint Clare Hospital Lakewood, Washington | |
| Saint Elizabeth Boardman Hospital Boardman, Ohio | |
| Saint Elizabeth Hospital Enumclaw, Washington | |
| Saint Elizabeth Regional Medical Center Lincoln, Nebraska | |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | |
| Saint Francis Cancer Center Greenville, South Carolina | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Federal Way, Washington | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Federal Way, Washington | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Helena Hospital St. Helena, California | |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital Lexington, Kentucky | |
| Saint Joseph Hospital East Lexington, Kentucky | |
| Saint Joseph London London, Kentucky | |
| Saint Joseph Mount Sterling Mount Sterling, Kentucky | |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | |
| Saint Joseph Regional Cancer Center Bryan, Texas | |
| Saint Joseph Warren Hospital Warren, Ohio | |
| Saint Joseph's Medical Center Stockton, California | |
| Saint Joseph's/Candler - Bluffton Campus Bluffton, South Carolina | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary Corwin Medical Center Pueblo, Colorado | |
| Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan | |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Saint Michael Cancer Center Silverdale, Washington | |
| Saint Patrick Hospital - Community Hospital Missoula, Montana | Site Public Contact - (amy.hanneman@providence.org) |
| Saint Peter's Community Hospital Helena, Montana | |
| Saint Rita's Medical Center Lima, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Saints Mary and Elizabeth Hospital Louisville, Kentucky | |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Cancer Center Worthington Worthington, Minnesota | |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Medical Center Fargo Fargo, North Dakota | |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford South University Medical Center Fargo, North Dakota | |
| Sanford Thief River Falls Medical Center Thief River Falls, Minnesota | |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sechler Family Cancer Center Lebanon, Pennsylvania | Site Public Contact - (doxenberg@wellspan.org) |
| Singing River Hospital Pascagoula, Mississippi | |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Skagit Regional Health Cancer Care Center Mount Vernon, Washington | Site Public Contact - (rcccclinicalresearch@skagitvalleyhospital.org) |
| South Carolina Cancer Specialists PC Hilton Head Island, South Carolina | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southern Ohio Medical Center Portsmouth, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Southpointe-Sanford Medical Center Fargo Fargo, North Dakota | |
| Southwest Illinois Health Services LLP Swansea, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Springfield Regional Cancer Center Springfield, Ohio | |
| Springfield Regional Medical Center Springfield, Ohio | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Covenant Hospital Chicago, Illinois | |
| Swedish Medical Center-Ballard Campus Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Cherry Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Carle Foundation Hospital Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | Site Public Contact - (Gina.Cravey@bsahs.org) |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| The Melanoma and Skin Cancer Institute Englewood, Colorado | Site Public Contact - (ryan.weight@theskincancerinstitute.com) |
| The Women's Imaging Center Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| TidalHealth Nanticoke / Allen Cancer Center Seaford, Delaware | |
| TriHealth Cancer Institute-Anderson Cincinnati, Ohio | |
| TriHealth Cancer Institute-Westside Cincinnati, Ohio | |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | |
| UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland | |
| UM Saint Joseph Medical Center Towson, Maryland | Site Public Contact - (Jeanmarie.downing@umm.edu) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| United Hospital Center Bridgeport, West Virginia | |
| Unity Hospital Fridley, Minnesota | |
| University Cancer Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| UofL Health Medical Center Northeast Louisville, Kentucky | |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Upstate Cancer Center at Oswego Oswego, New York | Site Public Contact - (McDowelE@upstate.edu) |
| Upstate Cancer Center at Verona Verona, New York | Site Public Contact - (McDowelE@upstate.edu) |
| Urology Specialists of Nevada - Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Valley Radiation Oncology Peru, Illinois | |
| Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven, Connecticut | |
| Veterans Affairs Loma Linda Healthcare System Loma Linda, California | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| WVUH-Berkely Medical Center Martinsburg, West Virginia | |
| Walter Knox Memorial Hospital Emmett, Idaho | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne Hospital Greenville, Ohio | |
| Welch Cancer Center Sheridan, Wyoming | |
| WellSpan Health-York Cancer Center York, Pennsylvania | |
| WellSpan Health-York Hospital York, Pennsylvania | |
| WellSpan Medical Oncology and Hematology Hanover, Pennsylvania | |
| WellSpan Medical Oncology and Hematology Hanover, Pennsylvania | |
| West Jefferson Medical Center Marrero, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| West Suburban Medical Center River Forest, Illinois | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Western Illinois Cancer Treatment Center Galesburg, Illinois | |
| Wheeling Hospital/Schiffler Cancer Center Wheeling, West Virginia | |
| Woodland Memorial Hospital Woodland, California | |
| Zuckerberg San Francisco General Hospital San Francisco, California | Site Public Contact - (Paul.Couey@ucsf.edu) |
Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
Kira Venables - venableskg@vcu.edu
NCT05799872
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Inclusion Criteria:
• Age \> or = 18 years old
• Ability to read and speak in English
• DSM-5 diagnosis of AN or atypical AN at admission to higher-level care
• In higher-level care discharging to outpatient care or discharged to outpatient care within the past 3 months
• Current BMI \> or = 18.5 kg/m2 (or will be by time of discharge)
• BMI increase of \> or = 0.5 kg/m2 while in higher-level care
• Ability to designate and sign a release of information for a primary physical or mental health provider for study duration
• Willingness to participate in weekly assessments (e.g., weight monitoring) and audio or video recording of study therapy sessions for study duration
• Access to a smartphone and/or computer permitting engagement in remote therapy and assessment.
Exclusion Criteria:
• Medical instability for outpatient care;
• Pregnancy
• Lifetime DSM-5 primary psychotic or bipolar-I disorder
• Current DSM-5 substance use disorder
• Enrollment in outpatient therapy with highly overlapping content to PAT-AN
BEHAVIORAL: Positive Affect Treatment for Anorexia Nervosa (PAT-AN):, BEHAVIORAL: Psychoeducational and Behavioral Therapy (PBT)
Anorexia Nervosa
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia |
Comprehensive Tobacco Cessation for Cancer Patients and Survivors
Antonice Wall - walla2@vcu.edu
NCT05805722
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Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with study procedures and availability for the duration of the study
* Have a documented history of cancer of any type, whether active or in remission
* Identify as a current or recently-quit tobacco user
Exclusion Criteria:
* Not a VCUHealth patient
* Non English-speaking BEHAVIORAL: Behavioral counseling for tobacco cessation
Tobacco Use Cessation, Cancer
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Massey CPC Team - (masseycpc@vcu.edu) |
Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab
ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com
NCT05206357
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Inclusion Criteria:
• Participants >= 1 and < 18 years old at time of primary diagnosis with Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.
• Disease pathologically confirmed (tumor tissue) by local testing.
• Relapsed or primary refractory disease meeting any of the following criteria:
• Progressive disease at any time during second-line chemoimmunotherapy (CIT).
• Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT.
• Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT.
• Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy.
• Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT.
• Have received cell therapy (allogeneic or autologous transplant or chimeric antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained or maintained a CR.
• Recovery from toxic effects of prior chemoimmunotherapy.
• Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years old at evaluation) score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2 .
• Adequate bone marrow, hepatic, and renal function.
Exclusion Criteria:
• Known central nervous system (CNS) involvement by lymphoma at screening as confirmed by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) brain scans (participants with evidence of CNS disease only in the cerebrospinal fluid (CSF) will be eligible).
• Other malignancy requiring therapy.
• Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.
Drug: Epcoritamab
Non-Hodgkin Lymphoma
Non-hodgkin Lymphoma, ABBV-GMAB-3013, Epcoritamab, Burkitt's or Burkitt-like Lymphoma/Leukemia, Diffuse Large B-cell Lymphoma, Aggressive Mature (CD20+) B-cell Lymphoma, Cancer, Relapsed/Refractory Aggressive Mature B-cell Neoplasms
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Study Locations
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| Location | Contacts |
|---|---|
| Azienda Ospedaliero Universitaria Meyer /ID# 240049 Florence, Firenze | |
| CHU Bordeaux - Hopital Pellegrin /ID# 240832 Bordeaux, | |
| CHU Sainte-Justine /ID# 240766 Montreal, Quebec | |
| CHU de Nantes, Hotel Dieu -HME /ID# 240831 Nantes, Pays-de-la-Loire | |
| Children's Hospital at Westmead /ID# 240091 Westmead, | |
| Children's Hospital of Philadelphia - Main /ID# 239294 Philadelphia, Pennsylvania | |
| Children's Hospital of Richmond at VCU /ID# 242770 Richmond, Virginia | |
| Cincinnati Childrens Hospital Medical Center /ID# 239823 Cincinnati, Ohio | |
| Dokuz Eylul University Medical Faculty /ID# 239954 Izmir, | |
| Fakultni Nemocnice Brno /ID# 239956 Brno, | |
| Fakultni Nemocnice v Motole /ID# 239957 Praha, | |
| Fondazione IRCCS San Gerardo dei Tintori /ID# 245592 Monza, Monza E Brianza | |
| Hospices Civils de Lyon /ID# 240834 Lyon, | |
| Hospital Infantil Universitario Nino Jesus /ID# 240717 Madrid, | |
| Hospital Universitario Vall d'Hebron /ID# 240715 Barcelona, | |
| Hospital for Sick Children /ID# 240767 Toronto, Ontario | |
| IRCCS Ospedale Pediatrico Bambino Gesu /ID# 240039 Rome, Lazio | |
| Institut Gustave Roussy /ID# 240966 Villejuif Cedex, Val-de-Marne | |
| Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 240026 Istanbul, | |
| Kyoto University Hospital /ID# 246907 Kyoto-shi, Kyoto | |
| Levine Children's Hospital /ID# 242765 Charlotte, North Carolina | |
| Lucile Packard Children's Hospitals - Stanford /ID# 240854 Palo Alto, California | |
| NHO Nagoya Medical Center /ID# 246680 Nagoya-shi, Aichi | |
| National Cancer Center Hospital /ID# 246722 Chuo-ku, Tokyo | |
| National Center for Child Health and Development /ID# 246658 Setagaya-ku, Tokyo | |
| National Taiwan University Hospital /ID# 242890 Taipei City, | |
| New York Medical College /ID# 239208 Valhalla, New York | |
| Nicklaus Children's Hospital /ID# 241174 Miami, Florida | |
| Osaka City General Hospital /ID# 246906 Osaka-shi, Osaka | |
| Perth Children's Hospital /ID# 240382 Nedlands, Western Australia | |
| Prinses Maxima Centrum /ID# 239815 Utrecht, | |
| Rambam Health Care Campus /ID# 240037 Haifa, | |
| Royal Children's Hospital /ID# 240384 Parkville, Victoria | |
| Samsung Medical Center /ID# 239895 Seoul, | |
| Schneider Children's Medical Center /ID# 240171 Petah Tikva, | |
| Seoul National University Hospital /ID# 239894 Seoul, | |
| St Jude Children's Research Hospital /ID# 239184 Memphis, Tennessee | |
| The Chaim Sheba Medical Center /ID# 240670 Ramat Gan, Tel-Aviv | |
| Universitaetsklinikum Erlangen /ID# 240861 Erlangen, Bayern | |
| Universitaetsklinikum Giessen und Marburg /ID# 240787 Marburg, | |
| Universitaetsklinikum Muenster /ID# 239970 Muenster, Nordrhein-Westfalen | |
| Universitaetsmedizin Rostock /ID# 240891 Rostock, | |
| Universitair Ziekenhuis Leuven /ID# 242384 Leuven, Vlaams-Brabant | |
| University of Texas Southwestern Medical Center /ID# 240892 Dallas, Texas |
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1) (cAMeLot-1)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT04811560
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Inclusion Criteria:
Phase 1:
* Age 2 years and above (pediatric cohort only), all other cohorts 18 years and above
* Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
* Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations
Phase: 2
* Participants greater than 18 years are eligible
* Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed/refractory disease
* AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only
For Both Phase 1 and 2:
* Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count less than or equal to (\<=) 20\*10\^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate greater than equal (\>=) 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate \>50 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Pediatric participants only: Performance status \>=70 by Lansky scale (for participants less than \[\<\]16 years of age) or \>=70 Karnofsky scale (for participants \>=16 years of age)
* A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
* Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment
Exclusion Criteria:
* Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria
* Active central nervous system (CNS) disease
* Prior solid organ transplantation
* QTc according to Fridericia's formula (QTcF) for males \>= 450 millisecond (msec) or for females \>= 470 msec. Participants with a family history of Long QT syndrome are excluded
* Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant \<=3 months before the first dose of study treatment; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion \<=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses \<=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)
* Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter) DRUG: Bleximenib
Acute Leukemias, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
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| Location | Contacts |
|---|---|
| Asan Medical Center Seoul, | |
| Baylor University Medical Center Dallas, Texas | |
| CHRU Nancy Brabois Vandœuvre-lès-Nancy, | |
| CHU Bretonneau Tours, | |
| CHU Lyon Sud Pierre-Bénite, | |
| CHU de Nantes hotel Dieu Nantes, | |
| Carmel Medical Center Haifa, | |
| Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie Pessac, | |
| China Medical University Hospital Taichung, | |
| City of Hope Duarte, California | |
| Clinica Univ. de Navarra Pamplona, | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| First Affiliated Hospital Medical School of Zhejiang University Hangzhou, | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fukushima Medical University Hospital Fukushima, | |
| Fundacao Antonio Prudente A C Camargo Cancer Center São Paulo, | |
| Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo São Paulo, | |
| Gold Coast University Hospital Southport, | |
| Gunmaken Saiseikai Maebashi Hospital Maebashi, | |
| Gustave Roussy Villejuif, | |
| Guys and St Thomas NHS Foundation Trust London, | |
| Hadassah University Hospita Ein Kerem Jerusalem, | |
| Henan Cancer Hospital Zhengzhou, Henan | |
| Hokkaido University Hospital Hokkaido, Sapporo, | |
| Hopital Jean Minjoz Besançon, | |
| Hopital Maisonneuve Rosemont Montreal, Quebec | |
| Hopital Saint Louis Paris, | |
| Hopital trousseau- APHP Paris, | |
| Hosp Clinic de Barcelona Barcelona, | |
| Hosp Clinico Univ de Salamanca Salamanca, | |
| Hosp Univ Fund Jimenez Diaz Madrid, | |
| Hosp Univ Vall D Hebron Barcelona, | |
| Hosp. Clinico Univ. de Valencia Valencia, | |
| Hosp. Gral. Univ. Gregorio Marañon Madrid, | |
| Hosp. Virgen Del Rocio Seville, | |
| Houston Methodist Hospital Houston, Texas | |
| Institut Paoli Calmettes Marseille, | |
| Institut Universitaire du Cancer Toulouse Oncopole Toulouse, | |
| Institut de Cancerologie Strasbourg Europe ICANS Strasbourg, | |
| Institute of Hematology and Blood Diseases Hospital Tianjin, | |
| Instituto D Or de Pesquisa e Ensino Salvador, | |
| Instituto D Or de Pesquisa e Ensino IDOR São Paulo, | |
| Kanazawa University Hospital Kanazawa, | |
| Karmanos Cancer Institute Detroit, Michigan | |
| Kobe City Medical Center General Hospital KobeShi, Hyōgo | |
| Kyushu University Hospital Fukuoka, Fukuoka, | |
| Leeds Teaching Hospitals NHS Trust Leeds, West Yorkshire | |
| Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte | |
| MD Anderson Houston, Texas | |
| Maine Health Scarborough, Maine | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Medical College of WI at Froedtert Milwaukee, Wisconsin | |
| Ministerio da Saude Instituto Nacional do Cancer Rio de Janeiro, | |
| Monash Medical Centre Clayton, Victoria | |
| Montefiore Medical Center The Bronx, New York | |
| NTT Medical Center Tokyo Tokyo, | |
| NYU Langone Medical Center New York, New York | |
| Nagoya University Hospital Aichi, Nagoya, | |
| Nanfang Hospital of Southern Medical Hospital Guangzhou, | |
| National Cancer Center Hospital East Chiba, Kashiwa, | |
| National Cheng Kung University Hospital Tainan, | |
| National Taiwan University Hospital Taipei, | |
| Norton Cancer Institute Louisville, Kentucky | |
| Oregon Health and Science University Portland, Oregon | |
| Oxford University Hospitals NHS Trust Oxfordshire, | |
| Peking University First Hospital Beijing, | |
| Princess Margaret Cancer Centre University Health Network Toronto, Ontario | |
| Qilu Hospital of Shandong University Jinan, Shandong | |
| Roswell Park Comprehensive Cancer Center Buffalo, New York | |
| Royal Perth Hospital Perth, Western Australia | |
| START Midwest Grand Rapids, Michigan | |
| Samsung Medical Center Seoul, | |
| San Antonio Methodist TX Transplant Physicians Group San Antonio, Texas | |
| Seoul National University Hospital Seoul, | |
| Sheba Medical Center Ramat Gan, | |
| St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Indianapolis, Indiana | |
| Swedish Cancer Institute Seattle, Washington | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| The Christie NHS Foundation Trust Manchester, | |
| The Clatterbridge Cancer Centre Liverpool, | |
| The First Affiliated Hospital of NanChang University Nanchang, Jiangxi | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang | |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology Wuhan, | |
| University College London Hospitals London, | |
| University Hospital of Wales Cardiff, | |
| University Hospitals Plymouth NHS Trust Plymouth, | |
| University of California Irvine Medical Center Orange, California | |
| University of California San Francisco San Francisco, California | |
| University of California San Francisco San Francisco, California | |
| University of Chicago Chicago, Illinois | |
| University of Fukui Hospital Yoshida-gun, Fukui | |
| University of New Mexico Albuquerque, New Mexico | |
| University of Tennessee Medical Center Knoxville, Tennessee | |
| Vancouver Coastal Health Vancouver, British Columbia | |
| Virginia Commonwealth University Richmond, Virginia | |
| West China Hospital Si Chuan University Chengdu, | |
| Yamagata University Hospital Yamagata, Yamagata | |
| Zhongda Hospital Southeast University Nanjin, | |
| the First Hospital of Jilin University Changchun, Jilin |
Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With PTEN/AKT Mutations, A ComboMATCH Treatment Trial
ctrrecruit@vcu.edu
NCT05554380
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Inclusion Criteria:
* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-S3 based on the presence of an actionable mutation as defined in EAY191
* GENERAL COMBOMATCH EAY191 REGISTRATION INCLUSION CRITERIA:
* Participants must be enrolled on the ComboMATCH Master Registration Trial EAY191
* Participants must have an activating AKT mutation (a known mutation in AKT1, AKT2, or AKT3, a single nucleotide variant, insertion, or deletion), PTEN mutation (a known mutation in PTEN, a single nucleotide variant, insertion, or deletion), or genomic deletion loss of PTEN as determined by the ComboMATCH screening assessment
* GENERAL COMBOMATCH EAY191 REGISTRATION EXCLUSION CRITERIA:
* Participants must not have an activating KRAS, NRAS, HRAS, or BRAF mutation (a single nucleotide variant, insertion, or deletion) as determined by the ComboMATCH screening assessment
* Participants must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)
* Participants must have a histologically confirmed non-breast solid malignancy
* Participants must have locally advanced, unresectable, or metastatic disease in the opinion of the treating investigator
* Participants must have measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1). Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration
* Participants with known brain metastases must have a CT/MRI scan to evaluate for central nervous system (CNS) disease and show no evidence of progression within 42 days prior to registration
* Participants must have completed any CNS-directed therapy and/or local therapy for spinal cord compression at least 28 days prior to registration
* Participants must not have spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days prior to registration, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to registration
* Participants must not have leptomeningeal disease
* Participants must have progressed on or within 6 months of taxane-based therapy in the neoadjuvant/adjuvant or metastatic setting prior to registration
* Participants must not have received any prior AKT inhibitor (e.g., capivasertib or ipatasertib); prior PI3K/mTOR inhibitor is acceptable
* Participants must not have received cancer-directed therapy prior for at least 14 days prior to initiation of treatment on study
* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic, radiation, or hormonal therapy for cancer treatment while receiving treatment on this study
* Participants must be \>= 18 years of age
* Participants must be able to swallow oral medications whole
* Participants must have a pre-study history and physical exam done within 28 days prior to registration
* Participants must have a Zubrod performance status of 0-2 within 28 days prior to registration
* Participants must have adverse events resolved =\< grade 1 related to any prior therapy, except alopecia within 14 days prior to registration
* Participants with neuropathy must have resolved to \< grade 2 within 14 days prior to registration
* Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to registration)
* Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to registration)
* Platelets \>= 100 x 10\^3/uL (within 28 days prior to registration)
* Total bilirubin =\< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to registration)
* Aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) =\< 3 x institutional ULN (within 28 days prior to registration)
* Participants must have adequate cardiac function, class IIB (2B) or better. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification
* Participants must have a measured OR calculated creatinine clearance \>= 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn within 28 days prior to registration
* Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test results obtained within 6 months prior to registration
* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration
* Participants must have an electrocardiography (ECG) performed (if clinically indicated with a corrected QTc interval of =\< 470 msec) within 28 days prior to registration
* Participants must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ipatasertib and/or paclitaxel
* Participants must not have an active small/large bowel inflammation such as ulcerative colitis or Crohn's disease
* Participants must not have grade 2 or higher uncontrolled intercurrent illness
* NOTE: To receive an agent, participant must not have any uncontrolled intercurrent illness requiring antibiotic/antiviral/antifungal therapy or interventional procedures. Participants with infections unlikely to be resolved within 2 weeks following registration should not be considered for the trial
* Participants must not have a known grade 2 or higher uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia
* Participants must not have any of the following:
* Cirrhosis at a level of Child-Pugh B (or worse),
* Cirrhosis (any degree) and a history of hepatic encephalopathy, or
* Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
* Participants must not be receiving any medications or substances that are inhibitors or inducers of CYP3A. Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug is prohibited.
* NOTE: Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product. The participant wallet card should be presented to the participant
* Participants must not have baseline fasting glucose (after 8-hour fast) \> 160 mg/dL (8.9 mmol/L) within 28 days prior to registration
* Participants with known diabetes mellitus must not require insulin therapy or have a baseline fasting glucose \>150 mg/dL (8.3 mmol/L) or high glycosylated hemoglobin (Hb)A1c, (\>= 8.0%), suggesting poorly controlled diabetes
* Participants who are on a stable dose of oral diabetes medication \>= 2 weeks prior to initiation of study drug treatment are eligible for enrollment
* Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) must not have a potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not have lung disease requiring active systemic therapy or placing participants at increased risk of toxicity related to study-directed therapy including, but not limited to pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia)
* Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is of "reproductive potential". In addition to routine contraceptive methods, "effective contraception" also includes surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
* Participants must not have psychiatric illness/social situations that would limit compliance with study requirements PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, DRUG: Ipatasertib, PROCEDURE: Magnetic Resonance Imaging, DRUG: Paclitaxel
Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | |
| Adena Regional Medical Center Chillicothe, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bryn Mawr Hospital Bryn Mawr, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Carilion Roanoke Memorial Hospital Roanoke, Virginia | |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ctsucontact@westat.com) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Columbus Oncology and Hematology Associates Dublin, Ohio | |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Corewell Health Beaumont Troy Hospital Troy, Michigan | |
| Corewell Health Dearborn Hospital Dearborn, Michigan | |
| Corewell Health Farmington Hills Hospital Farmington Hills, Michigan | |
| Corewell Health William Beaumont University Hospital Royal Oak, Michigan | |
| Dayton Physician LLC - Englewood Dayton, Ohio | |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | |
| Doctors Hospital Columbus, Ohio | |
| Dublin Methodist Hospital Dublin, Ohio | |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairfield Medical Center Lancaster, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Fairview Southdale Hospital Edina, Minnesota | |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesis Healthcare System Cancer Care Center Zanesville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Grady Memorial Hospital Delaware, Ohio | |
| Grant Medical Center Columbus, Ohio | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Schar Cancer Institute Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| Kettering Medical Center Kettering, Ohio | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Knox Community Hospital Mount Vernon, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lankenau Medical Center Wynnewood, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Licking Memorial Hospital Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Memorial Hospital Chattanooga, Tennessee | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Perrysburg Hospital Perrysburg, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mount Carmel East Hospital Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Sinai Hospital New York, New York | |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| National Institutes of Health Clinical Center Bethesda, Maryland | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | |
| OhioHealth Marion General Hospital Marion, Ohio | |
| OhioHealth Westerville Medical Campus/Westerville Cancer Center Westerville, Ohio | |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Paoli Memorial Hospital Paoli, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Puerto Rico Hematology Oncology Group Bayamón, | |
| Rapid City Regional Hospital Rapid City, South Dakota | |
| Regions Hospital Saint Paul, Minnesota | |
| Riddle Memorial Hospital Media, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Riverside Methodist Hospital Columbus, Ohio | |
| Roswell Park Cancer Institute Buffalo, New York | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Ann's Hospital Westerville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Saint John's Cancer Institute Santa Monica, California | |
| Saint Joseph Hospital - Orange Orange, California | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Southern Ohio Medical Center Portsmouth, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Springfield Regional Cancer Center Springfield, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Springfield Regional Medical Center Springfield, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Angeles Clinic and Research Institute - West Los Angeles Office Los Angeles, California | Site Public Contact - (protocols@swog.org) |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UH Seidman Cancer Center at UH Avon Health Center Avon, Ohio | |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| UPMC Altoona Altoona, Pennsylvania | Site Public Contact - (protocols@swog.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Western Maryland Cumberland, Maryland | |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| United Hospital Saint Paul, Minnesota | |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (charlesbaldwin@uabmc.edu) |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of South Alabama Mitchell Cancer Institute Mobile, Alabama | Site Public Contact - (pfrancisco@usouthal.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Virginia Cancer Institute Richmond, Virginia | Site Public Contact - (smoore@vacancer.com) |
| Women and Infants Hospital Providence, Rhode Island |
Enhancing Oral Cancer Awareness Among Minorities
Tamas Gal, Ph.D - Tamas.Gal@vcuhealth.org
NCT06682494
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Inclusion Criteria:
* Identify as African American as defined by the US Census
* Participants must be able to read, speak, and write in English
Exclusion Criteria:
* Individuals who cannot physically or mentally participate in the research project will be excluded
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners BEHAVIORAL: Traditional Education, BEHAVIORAL: AI-powered Chatbox
Oral Cancer, Chatbot, Patient Education, Prevention, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharyngeal Cancers
AI-powered Chatbox, Oral cancer prevention, Socio-economic barriers
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Tamas Gal, Ph.D - (Tamas.Gal@vcuhealth.org) |
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in Men With Opioid Use Disorder Who Are Taking Buprenorphine
Boehringer Ingelheim - clintriage.rdg@boehringer-ingelheim.com
NCT06628622
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Inclusion Criteria:
• Male participants, 18 to 65 years of age, both inclusively, at the time of consent
• Meet current diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) criteria for opioid use disorder, of at least moderate severity within the 12 months prior to screening
• Currently engaged in medications for opioid use disorder (MOUD) treatment with one of the following regimens:
• buprenorphine/naloxone sublingual film total daily dose ranging from 8 mg/2 mg to 24 mg/6 mg for at least 2 weeks at screening OR
• buprenorphine/naloxone sublingual tablet from 5.7 mg/1.4 mg to 17.1 mg/4.3 mg total daily dose for at least 2 weeks at screening OR
• buprenorphine sublingual tablet from 8 mg to 24 mg total daily dose for at least 2 weeks at screening OR
• on a stable dose of depot injectable buprenorphine for at least 5 weeks at screening, with at least 1 week since last depot buprenorphine injection
• Have a current MOUD prescription in accordance with inclusion criterion 4 and a positive urine drug screen for buprenorphine during screening and upon presenting for randomization to document buprenorphine use
• Willingness to abstain from using alcohol for 24 hours (h) and all other drugs of abuse for 72 h prior to Day 1 and through discharge from the trial site on Day 9
• Further inclusion criteria apply
Exclusion Criteria:
• Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, or autism spectrum disorder as confirmed by the mini international neuropsychiatric interview (MINI) at the screening visit
• Moderate or severe substance use disorder other than opioid use disorder (OUD) within the 6 months prior to screening (excluding tobacco, caffeine, and moderate stimulant use)
• Severe stimulant use disorder within the 6 months prior to screening
• Any other psychiatric disorder that is not currently stable in symptoms and treatment. Stable is defined as having no significant changes in symptom acuity or treatment (medication or psychotherapy treatment) in the 8 weeks prior to randomization
• Score of ≥20 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
• Positive results on a urine drug screen for ≥3 drugs (not counting buprenorphine or TCAs) at screening. In the case of a positive drug screen for 1 or 2 agents, if the participant does not meet the exclusion criteria regarding substance use disorder for these compounds, they may be included if the investigator determines that use will not be an impediment to trial participation or accurate data collection
• Any positive result on a urine drug screen (not counting buprenorphine, TCAs, or cannabis) at admission to the trial site on Day -1
• Intoxication at screening or randomization, as determined by clinical exam and breathalyzer
• Further exclusion criteria apply
DRUG: BI 1356225, DRUG: Placebo
Opioid Use Disorder
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| Location | Contacts |
|---|---|
| Collaborative Neuroscience Research, LLC, Los Alamitos Los Alamitos, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| ERG Clinical Research - Houston Houston, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Hassman Research Institute-Marlton-66897 Marlton, New Jersey | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of California Los Angeles Los Angeles, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Virginia Commonwealth University Richmond, Virginia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| iResearch Atlanta Decatur, Georgia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (OMAHA-003)
Toll Free Number - Trialsites@msd.com
NCT06136624
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Inclusion Criteria:
* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI).
* Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
* Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment
* Has ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<1.7 nM)
* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
* Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
* Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment
* Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment
* If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression \>4 weeks since the last flutamide treatment and \>6 weeks since the last bicalutamide or nilutamide treatment
* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization
* Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening.
* Participants who can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom
Exclusion Criteria:
* Has a gastrointestinal disorder that might affect absorption
* Has a history of pituitary dysfunction
* Has poorly controlled diabetes mellitus
* Has clinically significant abnormal serum potassium or sodium level
* Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
* Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization
* Has a history of clinically significant ventricular arrhythmias
* Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization
* Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications
* Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate, citrus pectin polysaccharide) within 4 weeks before the date of randomization
* Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization
* Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
* Has received colony-stimulating factors within 28 days before the date of randomization
* Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
* Has a "superscan" bone scan
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has an active infection requiring systemic therapy
* Has concurrent active HBV or known active HCV infection
* Has a history of long QTc syndrome
* Has any of the following at Screening Visit: hypotension (systolic BP \<110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
* Is unable to swallow capsules/tablets
* Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
* Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle \[Silybum marianum\])
* Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention DRUG: Opevesostat, DRUG: Abiraterone acetate, DRUG: Enzalutamide, DRUG: Hydrocortisone, DRUG: Fludrocortisone acetate, DRUG: Prednisone, DRUG: Dexamethasone
Prostate Cancer Metastatic
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Study Locations
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| Location | Contacts |
|---|---|
| A. C. Camargo Cancer Center ( Site 0310) São Paulo, São Paulo | |
| AHN Allegheny General Hospital ( Site 0001) Pittsburgh, Pennsylvania | |
| Ad-Vance Medical Research-Research ( Site 1353) Ponce, | |
| Addenbrooke's Hospital ( Site 1605) Cambridge, Cambridgeshire | |
| Affiliated hospital of Jiangnan university ( Site 0434) Wuxi, Jiangsu | |
| Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477) Uppsala, Uppsala County | |
| Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227) Lørenskog, Akershus | |
| Akita University Hospital ( Site 0904) Akita, | |
| Aliada-Oncologìa ( Site 1257) Lima, | |
| Amsterdam UMC, locatie VUmc ( Site 1156) Amsterdam, North Holland | |
| Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1552) Ankara, | |
| Anschutz Cancer Pavilion ( Site 0046) Aurora, Colorado | |
| Asahikawa Medical University Hospital ( Site 0901) Asahikawa, Hokkaido | |
| Asan Medical Center-Oncology ( Site 1402) Songpagu, Seoul | |
| Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205) Buenos Aires, Buenos Aires F.D. | |
| Atlantic Health System Morristown Medical Center ( Site 0115) Morristown, New Jersey | |
| Avera Cancer Institute - Pierre ( Site 0118) Pierre, South Dakota | |
| Avera Cancer Institute - Yankton ( Site 0117) Yankton, South Dakota | |
| Avera Cancer Institute- Research ( Site 0094) Sioux Falls, South Dakota | |
| Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 0752) Kecskemét, Bács-Kiskun county | |
| Baltimore Veterans Affairs Medical Center ( Site 0069) Baltimore, Maryland | |
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1554) Adana, | |
| Beijing Cancer hospital-Urinary Surgery ( Site 0395) Beijing, Beijing Municipality | |
| Beijing Friendship Hospital Affiliate of Capital University ( Site 0396) Beijing, Beijing Municipality | |
| Bell Land General Hospital ( Site 0913) Sakai, Osaka | |
| Blue Ridge Cancer Care ( Site 0004) Roanoke, Virginia | |
| Bradford Hill Norte ( Site 0357) Antofagasta, | |
| Bradfordhill-Clinical Area ( Site 0351) Santiago, Region M. de Santiago | |
| Bruce W. Carter Veterans Affairs Medical Center ( Site 0082) Miami, Florida | |
| CIO - Centro de Inmuno-Oncología de Occidente ( Site 1103) Guadalajara, Jalisco | |
| Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0632) Rennes, Ille-et-Vilaine | |
| Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 0630) Nîmes, Gard | |
| Centre Hospitalier de l'Université de Montréal ( Site 0326) Montreal, Quebec | |
| Centre Hospitalier de la Côte Basque ( Site 0633) Bayonne, Pyrenees-Atlantiques | |
| Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0328) Greenfield Park, Quebec | |
| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0629) Clermont-Ferrand, Puy-de-Dome | |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0327) Québec, Quebec | |
| Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0329) Sherbrooke, Quebec | |
| Centro de Investigacion Clinica de Oaxaca ( Site 1109) Oaxaca City, | |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302) Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1504) Taoyuan District, | |
| Charing Cross Hospital-Oncology Research ( Site 1606) London, Hammersmith and Fulham | |
| Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679) Berlin, | |
| China Medical University Hospital-Department of Urology ( Site 1503) Taichung, | |
| Chongqing Three Gorges Central Hospital's ( Site 0426) Chongqing, Chongqing Municipality | |
| Chongqing University Cancer Hospital ( Site 0416) Chongqing, Chongqing Municipality | |
| Chulalongkorn University ( Site 1530) Bangkok, Bangkok | |
| Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0501) Bogotá, Bogota D.C. | |
| Clinica Universidad Catolica del Maule-Oncology ( Site 0355) Talca, Maule Region | |
| Clinical Research Chile SpA ( Site 0358) Valdivia, Los Ríos Region | |
| Clínica Imbanaco S.A.S ( Site 0509) Cali, Valle del Cauca Department | |
| Clínica Sánchez Ferrer ( Site 1261) Trujillo, La Libertad | |
| Clínica de Neoplasias Litoral ( Site 0305) Itajaí, Santa Catarina | |
| Colorado Clinical Research ( Site 0067) Lakewood, Colorado | |
| Complexo Hospitalario Universitario de Ourense ( Site 1426) Ourense, Orense | |
| Comprehensive Cancer Centers of Nevada ( Site 0010) Las Vegas, Nevada | |
| Cross Cancer Institute ( Site 0332) Edmonton, Alberta | |
| Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0758) Debrecen, | |
| Dubbo Hospital ( Site 0235) Dubbo, New South Wales | |
| Dunedin Hospital-Southern Blood and Cancers Service ( Site 1203) Dunedin, Otago | |
| ETZ Elisabeth-Internal Medicine ( Site 1160) Tilburg, North Brabant | |
| Ehime University Hospital ( Site 0918) Tōon, Ehime | |
| Emek Medical Center ( Site 0830) Afula, | |
| FALP ( Site 0353) Santiago, Region M. de Santiago | |
| Faculty of Medicine - Khon Kaen University ( Site 1526) Muang, Changwat Khon Kaen | |
| Faculty of Medicine Siriraj Hospital ( Site 1531) Bangkok, Bangkok | |
| Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555) Olomouc, Olomoucký kraj | |
| Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554) Ostrava, Moravskoslezský kraj | |
| Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0551) Prague, Praha 5 | |
| Filios Alta Medicina ( Site 1106) Monterrey, Nuevo León | |
| First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0436) Huaian, Jiangsu | |
| Florida Cancer Specialists - South ( Site 7003) Fort Myers, Florida | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0877) Milan, Lombardy | |
| Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151) Schiedam, South Holland | |
| Fred Hutchinson Cancer Center ( Site 0013) Seattle, Washington | |
| Fudan University Shanghai Cancer Center-Urology department ( Site 0376) Shanghai, Shanghai Municipality | |
| Fukushima Medical University Hospital ( Site 0933) Fukushima, | |
| Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0204) Mendoza, | |
| Fundación Cardiovascular de Colombia ( Site 0503) Piedecuesta, Santander Department | |
| Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430) Valencia, Valenciana, Comunitat | |
| Fundación Valle del Lili ( Site 0505) Cali, Valle del Cauca Department | |
| Gifu University Hospital ( Site 0910) Gifu, | |
| Greenebaum Comprehensive Cancer Center ( Site 0049) Baltimore, Maryland | |
| Gulhane Egitim Arastirma Hastanesi ( Site 1558) Ankara, | |
| Gustave Roussy ( Site 0626) Villejuif, Val-de-Marne | |
| HELIOS Kliniken Schwerin ( Site 0694) Schwerin, Mecklenburg-Vorpommern | |
| HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1428) Seville, | |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551) Ankara, | |
| Hadassah Medical Center ( Site 0833) Jerusalem, | |
| Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1164) The Hague, South Holland | |
| Henry Ford Hospital ( Site 0015) Detroit, Michigan | |
| Hiroshima University Hospital ( Site 0916) Hiroshima, | |
| Hokkaido University Hospital ( Site 0931) Sapporo, Hokkaido | |
| Hospital Aleman-Oncology ( Site 0207) Buenos Aires, | |
| Hospital Británico de Buenos Aires-Oncology ( Site 0202) Ciudad Autónoma de Buenos Aires, Buenos Aires | |
| Hospital Felicio Rocho ( Site 0317) Belo Horizonte, Minas Gerais | |
| Hospital Jerez de la Frontera ( Site 1427) Jerez de la Frontera, Cadiz | |
| Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1078) Kuala Lumpur, | |
| Hospital Lucus Augusti-Oncology ( Site 1432) Lugo, | |
| Hospital Mario Penna ( Site 0309) Belo Horizonte, Minas Gerais | |
| Hospital Santa Rita de Cassia-Centro de Pesquisa Clínica ( Site 0320) Vitória, Espírito Santo | |
| Hospital Sultan Ismail ( Site 1081) Johor Bahru, Johor | |
| Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1433) Madrid, Madrid, Comunidad de | |
| Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1431) Madrid, Madrid, Comunidad de | |
| Hospital Universitário Evangélico Mackenzie-Centro de Oncologia Mackenzie ( Site 0314) Curitiba, Paraná | |
| Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0308) Bragança Paulista, São Paulo | |
| Hospital of the University of Occupational and Environmental Health, Japan ( Site 0921) Kitakyushu, Fukuoka | |
| Huadong Hospital Affiliated to Fudan University-Urology ( Site 0388) Shanghai, Shanghai Municipality | |
| Hubei Cancer Hospital-Urinary surgery ( Site 0406) Wuhan, Hubei | |
| Hunan Cancer Hospital ( Site 0405) Changsha, Hunan | |
| Hôpital Européen Georges Pompidou ( Site 0628) Paris, | |
| IC La Serena Research ( Site 0356) La Serena, Coquimbo Region | |
| IMAT S.A.S ( Site 0504) Montería, Departamento de Córdoba | |
| INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1256) Lima, | |
| IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1254) Lima, | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 0879) Meldola, Emilia-Romagna | |
| Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0627) Strasbourg, Alsace | |
| Instituto Alexander Fleming-Alexander Fleming ( Site 0206) Buenos Aires, Buenos Aires F.D. | |
| Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 1258) Concepción, Departamento de Junín | |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) Mar del Plata, Buenos Aires | |
| Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555) Istanbul, | |
| James J. Peters VA Medical Center ( Site 0088) The Bronx, New York | |
| Jiangxi Cancer Hospital ( Site 0386) Nanchang, Jiangxi | |
| Kagawa University Hospital ( Site 0917) Kita, Kagawa-ken | |
| Kagoshima University Hospital ( Site 0929) Kagoshima, | |
| Kaiser Permanente Riverside Medical Center ( Site 0099) Riverside, California | |
| Kanazawa Medical University Hospital ( Site 0909) Mukai-awagasaki, Ishikawa-ken | |
| Kansai Medical University Hospital ( Site 0912) Hirakata, Osaka | |
| Karolinska Universitetssjukhuset Solna ( Site 1478) Stockholm, Stockholm County | |
| Klinikum Wels-Grieskirchen GmbH ( Site 0279) Wels, Upper Austria | |
| Kobe University Hospital ( Site 0914) Kobe, Hyōgo | |
| Kuopion Yliopistollinen Sairaala ( Site 0603) Kuopio, Northern Savonia | |
| Kurume University Hospital ( Site 0920) Kurume, Fukuoka | |
| Kyushu University Hospital ( Site 0919) Fukuoka, | |
| M Health Fairview Clinics and Surgery Center ( Site 0019) Minneapolis, Minnesota | |
| MEDICAL COLLEGE OF WISCONSIN ( Site 0020) Milwaukee, Wisconsin | |
| Macquarie University-MQ Health Clinical Trials Unit ( Site 0234) Macquarie University, New South Wales | |
| Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0553) Brno, Brno-mesto | |
| Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310) Siedlce, Masovian Voivodeship | |
| Meander Medisch Centrum ( Site 1157) Amersfoort, Utrecht | |
| Medical Care and Research SA de CV ( Site 1108) Mérida, Yucatán | |
| Medische Centrum Leeuwarden ( Site 1172) Leeuwarden, Provincie Friesland | |
| Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0280) Graz, Styria | |
| Meir Medical Center. ( Site 0832) Kfar Saba, | |
| Memorial Ankara Hastanesi-Medical Oncology ( Site 1557) Ankara, | |
| Metro-Minnesota Community Clinical Oncology ( Site 0014) Saint Louis Park, Minnesota | |
| Miyazaki Prefectural Miyazaki Hospital ( Site 0927) Miyazaki, | |
| Nagano Municipal Hospital ( Site 0932) Nagano, | |
| Nanbu Tokushukai Hospital ( Site 0930) Shimajiri, Okinawa | |
| Nanchong Central Hospital-urology ( Site 0422) Nanchong, Sichuan | |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 0377) Nanjing, Jiangsu | |
| Nara Medical University Hospital ( Site 0915) Kashihara, Nara | |
| National Cancer Centre Singapore ( Site 1377) Singapore, Central Singapore | |
| National Cancer Institute ( Site 1079) Putrajaya, Putrajaya | |
| National Cheng Kung University Hospital-Urology ( Site 1502) Tainan, | |
| National Hospital Organization Kumamoto Medical Center ( Site 0924) Kumamoto, | |
| National Hospital Organization Nagasaki Medical Center ( Site 0923) Ōmura, Nagasaki | |
| National Hospital Organization Oita Medical Center ( Site 0925) Ōita, | |
| National Taiwan University Hospital-Urology ( Site 1506) Taipei, | |
| National University Hospital ( Site 1376) Singapore, Central Singapore | |
| Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1153) Amsterdam, North Holland | |
| Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0761) Salgótarján, Nógrád megye | |
| Obras Sociais Irma Dulce ( Site 0302) Salvador, Estado de Bahia | |
| Ochsner Clinic Foundation ( Site 0108) New Orleans, Louisiana | |
| Odense Universitetshospital-Department of oncology ( Site 0579) Odense, Region Syddanmark | |
| Oncosalud-Clinical Research ( Site 1260) Lima, | |
| Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276) Linz, Upper Austria | |
| Oregon Health and Science University ( Site 0028) Portland, Oregon | |
| Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0756) Budapest, Pest County | |
| Ospedale San Raffaele-Oncologia Medica ( Site 0876) Milan, | |
| Pan American Center for Oncology Trials - Ciudadela ( Site 1351) San Juan, | |
| Peking University First Hospital-Urology ( Site 0390) Beijing, Beijing Municipality | |
| Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230) Melbourne, Victoria | |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0354) Santiago, Region M. de Santiago | |
| Prince of Wales Hospital ( Site 0730) Shatin, | |
| Princess Alexandra Hospital-Cancer Care Serices ( Site 0237) Brisbane, Queensland | |
| Princess Margaret Cancer Centre ( Site 0330) Toronto, Ontario | |
| Puerto Rico Medical Research Center LLC ( Site 1354) Hato Rey, | |
| Queen Mary Hospital ( Site 0727) Hong Kong, | |
| Quemex Medical and Research ( Site 1112) Mexico City, Mexico City | |
| Rabin Medical Center ( Site 0828) Petah Tikva, | |
| Radboudumc-Medical Oncology ( Site 1152) Nijmegen, Gelderland | |
| Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083) Charleston, South Carolina | |
| Rambam Health Care Campus-Oncology Division ( Site 0826) Haifa, | |
| Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1316) Grudziądz, Kuyavian-Pomeranian Voivodeship | |
| Rigshospitalet ( Site 0576) Copenhagen, Capital Region | |
| Rutgers Cancer Institute of New Jersey ( Site 0033) New Brunswick, New Jersey | |
| SCRI Oncology Partners ( Site 7000) Nashville, Tennessee | |
| Saga-Ken Medical Centre Koseikan ( Site 0922) Saga, Saga-ken | |
| Sahlgrenska Universitetssjukhuset ( Site 1479) Gothenburg, Västra Götaland County | |
| Samsun Medical Park Hastanesi-medical oncology (1560) Samsun, | Dilek Erdem - (dilekgurgenyatagi@yahoo.com) |
| Samsung Medical Center ( Site 1405) Seoul, | |
| Sanatorio Parque ( Site 0208) Rosario, Santa Fe Province | |
| Sapporo Medical University Hospital ( Site 0902) Sapporo, Hokkaido | |
| Sarawak General Hospital-Radiotherapy Unit ( Site 1076) Kuching, Sarawak | |
| Second Affiliated hospital of Anhui Medical University-Urology ( Site 0408) Hefei, Anhui | |
| Seoul National University Hospital-Oncology ( Site 1401) Seoul, | |
| Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1404) Seoul, | |
| Sheba Medical Center ( Site 0827) Ramat Gan, | |
| Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0502) Valledupar, Cesar Department | |
| Songklanagarind hospital ( Site 1527) Hat Yai, Changwat Songkhla | |
| Southwest Hospital of Third Military Medical University ( Site 0420) Chongqing, Chongqing Municipality | |
| Spaarne Gasthuis - Hoofddorp-Oncology ( Site 1170) Hoofddorp, North Holland | |
| St. Olavs Hospital-Kreftklinikken ( Site 1231) Trondheim, Sor-Trondelag | |
| St. Vincent's University Hospital ( Site 0802) Dublin, Dublin | |
| Stanford Cancer Center ( Site 0036) Palo Alto, California | |
| Suining Central Hospital ( Site 0437) Suining, Sichuan | |
| Sun Yat-sen University Cancer Center-Internal medicine ( Site 0413) Guangzhou, Guangdong | |
| Sunnybrook Research Institute ( Site 0331) Toronto, Ontario | |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1318) Kielce, Świętokrzyskie Voivodeship | |
| Sykehuset Østfold Kalnes ( Site 1228) Sarpsborg, Østfold fylke | |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303) Koszalin, West Pomeranian Voivodeship | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1553) Istanbul, | |
| Taipei Veterans General Hospital ( Site 1505) Taipei, | |
| Tallaght University Hospital ( Site 0801) Dublin, | |
| Tampereen yliopistollinen sairaala ( Site 0604) Tampere, Pirkanmaa | |
| Tan Tock Seng Hospital-Medical Oncology ( Site 1378) Singapore, Central Singapore | |
| Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1201) Tauranga, Bay of Plenty | |
| Texas Oncology - Central/South Texas ( Site 8003) Austin, Texas | |
| Texas Oncology - DFW ( Site 8001) Dallas, Texas | |
| Texas Oncology - Gulf Coast ( Site 8002) The Woodlands, Texas | |
| The Beatson West of Scotland Cancer Centre ( Site 1603) Glasgow, Glasgow City | |
| The Christie NHS Foundation Trust ( Site 1608) Manchester, | |
| The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0414) Fuzhou, Fujian | |
| The First Affiliated Hospital of Chongqing Medical University ( Site 0427) Chongqing, Chongqing Municipality | |
| The First Affiliated Hospital of Guangzhou Medical University ( Site 0412) Guangzhou, Guangdong | |
| The First Affiliated Hospital of Ningbo University ( Site 0383) Ningbo, Zhejiang | |
| The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0379) Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0393) Xi'an, Shaanxi | |
| The First Affiliated hospital of Xiamen University-Urology ( Site 0415) Xiamen, Fujian | |
| The First Hospital of Jiaxing-urology ( Site 0380) Jiaxing, Zhejiang | |
| The Jikei University Hospital ( Site 0907) Minato, Tokyo | |
| The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0336) Ottawa, Ontario | |
| The Royal Cornwall Hospital ( Site 1610) Truro, England | |
| The Second Affiliated Hospital Of Kunming Medical University ( Site 0429) Kunming, Yunnan | |
| The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 0394) Xi'an, Shaanxi | |
| The Second Hospital of Tianjin Medical University ( Site 0391) Tianjin, Tianjin Municipality | |
| The Third People's Hospital of Chengdu (CDTPH) ( Site 0428) Chengdu, Sichuan | |
| The University of Osaka Hospital ( Site 0911) Suita, Osaka | |
| Tianjin Medical University Cancer Institute & Hospital ( Site 0392) Tianjin, Tianjin Municipality | |
| Toho University Sakura Medical Center ( Site 0906) Sakura, Chiba | |
| Tongji Hospital Tongji Medical,Science & Technology ( Site 0407) Wuhan, Hubei | |
| Turku University Hospital-Department of Oncology ( Site 0601) Turku, Southwest Finland | |
| Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0705) Hamburg, | |
| University College London Hospital ( Site 1612) London, London, City of | |
| University Hospitals Cleveland Medical Center ( Site 0043) Cleveland, Ohio | |
| University Malaya Medical Centre ( Site 1077) Lembah Pantai, Kuala Lumpur | |
| University Of Nebraska Medical Center-Oncology/Hematology ( Site 0095) Omaha, Nebraska | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040) Orange, California | |
| University of Chicago Medical Center ( Site 0045) Chicago, Illinois | |
| University of Colorado Health - Highlands Ranch Hospital ( Site 0111) Highlands Ranch, Colorado | |
| University of Colorado Health - Lone Tree Medical Center ( Site 0112) Lone Tree, Colorado | |
| University of Illinois at Chicago ( Site 0105) Chicago, Illinois | |
| University of Iowa ( Site 0047) Iowa City, Iowa | |
| University of Kentucky Chandler Medical Center ( Site 0048) Lexington, Kentucky | |
| University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051) Miami, Florida | |
| University of Miyazaki Hospital ( Site 0926) Miyazaki, | |
| University of Virginia Health System ( Site 0054) Charlottesville, Virginia | |
| Universitätsklinikum Bonn-Klinik und Poliklinik für Urologie und Kinderurologie ( Site 0680) Bonn, North Rhine-Westphalia | |
| Universitätsklinikum Jena-Klinik und Poliklinik für Urologie ( Site 0682) Jena, Thuringia | |
| Universitätsklinikum Münster - Albert Schweitzer Campus-Klinik für Urologie ( Site 0678) Münster, North Rhine-Westphalia | |
| Universitätsklinikum Schleswig-Holstein-Klinik für Urologie ( Site 0691) Lübeck, Schleswig-Holstein | |
| VA Portland Health Care System ( Site 0058) Portland, Oregon | |
| VCU Health Adult Outpatient Pavillion ( Site 0061) Richmond, Virginia | |
| Vejle Sygehus ( Site 0578) Vejle, Region Syddanmark | |
| VieCuri Medisch Centrum ( Site 1173) Venlo, Limburg | |
| Washington University School of Medicine-Internal Medicine/Oncology ( Site 0062) St Louis, Missouri | |
| West China Hospital, Sichuan University-Urology Surgery ( Site 0417) Chengdu, Sichuan | |
| Westmead Hospital ( Site 0232) Westmead, New South Wales | |
| Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 1304) Torun, Kuyavian-Pomeranian Voivodeship | |
| Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 0419) Ürümqi, Xinjiang | |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 0064) New Haven, Connecticut | |
| Yantai Yuhuangding Hospital ( Site 0397) Yantai, Shandong | |
| Yokohama City University Medical Center ( Site 0908) Yokohama, Kanagawa | |
| Yunnan Province Cancer Hospital ( Site 0418) Kunming, Yunnan | |
| Zachodniopomorskie Centrum Onkologii ( Site 1311) Szczecin, West Pomeranian Voivodeship | |
| Zhejiang Cancer Hospital ( Site 0435) Hangzhou, Zhejiang | |
| Zhejiang Provincial People's Hospital-Urology ( Site 0378) Hangzhou, Zhejiang | |
| Zhongshan Hospital of Fudan University (0430) Shanghai, Shangai | Jianming Guo - (guo.jianming@zs-hospital.sh.cn) |
| Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1163) Sittard-Geleen, Limburg | |
| klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0696) Munich, Bavaria |
Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
ctrrecruit@vcu.edu
NCT06096844
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Inclusion Criteria:
* STEP 1 REGISTRATION
* Patient must be ≥ 70 years of age
* Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49%
* Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed
* Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors
* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
* Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Absolute neutrophil count (ANC) ≥ 1,500/uL (obtained within 14 days prior to Step 1 registration)
* Platelets ≥ 75,000/uL (obtained within 14 days prior to Step 1 registration)
* Hemoglobin (Hgb) ≥ 8.0 g/dL (obtained within 14 days prior to Step 1 registration)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to Step 1 registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3.0 × institutional ULN (obtained within 14 days prior to Step 1 registration)
* Creatinine clearance (CrCL) ≥ 45 mL/min (estimated using Cockcroft-Gault method with actual body weight or measured) (obtained within 14 days prior to Step 1 registration)
* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months of Step 1 registration are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have undetectable HCV viral
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patient must be English or Spanish speaking to be eligible for the QOL component of the study
* NOTE: Sites cannot translate the associated GA or QOL forms
* Patient must not have symptomatic central nervous system disease (CNS) metastases. Patients with a clinical history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable for at least 14 days prior to Step 1 registration and off all steroids for at least 24 hours prior to Step 1 registration. Patients with asymptomatic CNS metastases are eligible
* Patient must not have had any prior cytotoxic chemotherapy regimen for metastatic disease. Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration
* Patient must not have had any prior immunotherapy for metastatic disease. Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration
* Patient must not have a history of uncontrolled autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis, lupus, inflammatory bowel disease
* Patient must not be on immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal and/or topical steroids are eligible
* Patient must have baseline imaging done assessing all measurable or non-measurable sites of disease within 45 days prior to Step 1 registration
* Investigator must declare their intended chemotherapy regimen should their patient be randomized to Arm B (doublet versus\[vs\] singlet)
* STEP 2 RANDOMIZATION
* Patient must have completed the baseline Geriatric Assessment (GA) after Step 1 registration and prior to Step 2 randomization DRUG: Carboplatin, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, DRUG: Nab-paclitaxel, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab, DRUG: Pemetrexed, PROCEDURE: Positron Emission Tomography, OTHER: Questionnaire Administration
Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
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Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Adena Regional Medical Center Chillicothe, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Medford Hospital Medford, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Bellin Memorial Hospital Green Bay, Wisconsin | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bryn Mawr Hospital Bryn Mawr, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana Farber-Merrimack Valley Methuen, Massachusetts | |
| Dana-Farber Cancer Institute at Boston Medical Center - Brighton Brighton, Massachusetts | |
| Dana-Farber Cancer Institute at Foxborough Foxborough, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth, Massachusetts | |
| Dartmouth Cancer Center - North Saint Johnsbury, Vermont | Site Public Contact - (cancer.research.nurse@hitchcock.org) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Durham VA Medical Center Durham, North Carolina | Site Public Contact - (VHADURcancertrials@va.gov) |
| ECOG-ACRIN Cancer Research Group Philadelphia, Pennsylvania | Megan A. Baumgart - (megan_baumgart@urmc.rochester.edu) |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesis Healthcare System Cancer Care Center Zanesville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Glens Falls Hospital Glens Falls, New York | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania | |
| HaysMed Hays, Kansas | |
| Highlands Oncology Group Springdale, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Fayetteville Fayetteville, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Rogers Rogers, Arkansas | Site Public Contact - (research@hogonc.com) |
| Holy Cross Hospital Fort Lauderdale, Florida | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Inspira Medical Center Mullica Hill Mullica Hill, New Jersey | |
| Jefferson Cherry Hill Hospital Cherry Hill, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kansas City Veterans Affairs Medical Center Kansas City, Missouri | |
| Knox Community Hospital Mount Vernon, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lancaster General Ann B Barshinger Cancer Institute Lancaster, Pennsylvania | Site Public Contact - (nctn@pennmedicine.upenn.edu) |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Lankenau Medical Center Wynnewood, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Lawrence Memorial Hospital Lawrence, Kansas | |
| Licking Memorial Hospital Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Loyola University Medical Center Maywood, Illinois | |
| Malcom Randall Veterans Administration Medical Center Gainesville, Florida | Site Public Contact - (trials@cancer.ufl.edu) |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mayo Clinic Health System-Eau Claire Clinic Eau Claire, Wisconsin | |
| Mayo Clinic Health Systems-Mankato Mankato, Minnesota | |
| Medical University of South Carolina Charleston, South Carolina | |
| Memorial Hospital Chattanooga, Tennessee | Site Public Contact - (Jeffh@columbusccop.org) |
| Memorial Hospital East Shiloh, Illinois | |
| Mercy Cancer Center-West Lakes Clive, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Health - Perrysburg Hospital Perrysburg, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin | Site Public Contact - (oncologyclinicaltrials@mhemail.org) |
| MetroHealth Medical Center Cleveland, Ohio | Site Public Contact - (ababal@metrohealth.org) |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Moffitt Cancer Center Tampa, Florida | |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | |
| Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Mount Carmel Grove City Hospital Grove City, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northwest Cancer Center - Hobart Hobart, Indiana | |
| Northwest Cancer Center - Main Campus Crown Point, Indiana | |
| Northwest Cancer Center - Valparaiso Valparaiso, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Northwest Oncology LLC Dyer, Indiana | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | |
| Paoli Memorial Hospital Paoli, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Memorial Hospital Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| Penn Medicine Princeton Health Plainsboro, New Jersey | Site Public Contact - (PennCancerTrials@careboxhealth.com) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Premier Blood and Cancer Center Dayton, Ohio | |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| Ralph H Johnson VA Medical Center Charleston, South Carolina | Site Public Contact - (ashley.salvo@va.gov) |
| Rapid City Regional Hospital Rapid City, South Dakota | Site Public Contact - (research@monument.health) |
| Reading Hospital West Reading, Pennsylvania | |
| Reading Hospital McGlinn Cancer Institute at Phoenixville Phoenixville, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riddle Memorial Hospital Media, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SSM Health Good Samaritan Mount Vernon, Illinois | |
| SUNY Upstate Medical Center-Community Campus Syracuse, New York | |
| Sacred Heart Hospital Pensacola, Florida | Site Public Contact - (eebrou@ascension.org) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Catherine Hospital Garden City, Kansas | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | |
| Siteman Cancer Center-South County St Louis, Missouri | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Springfield Regional Cancer Center Springfield, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Stamford Hospital/Bennett Cancer Center Stamford, Connecticut | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Community Hospital Munster, Indiana | |
| The Dana-Farber Cancer Institute at Londonderry Londonderry, New Hampshire | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| ThedaCare Cancer Care - Berlin Berlin, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - New London New London, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Shawano Shawano, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Waupaca Waupaca, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Medical Center - Neenah Neenah, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UH Seidman Cancer Center at UH Avon Health Center Avon, Ohio | |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern Simmons Cancer Center - RedBird Dallas, Texas | Site Public Contact - (canceranswerline@utsouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Illinois Chicago, Illinois | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Clinical Research Center Fairway, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Rochester Rochester, New York | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Upstate Cancer Center at Oswego Oswego, New York | Site Public Contact - (McDowelE@upstate.edu) |
| Upstate Cancer Center at Verona Verona, New York | Site Public Contact - (McDowelE@upstate.edu) |
| VA Palo Alto Health Care System Palo Alto, California | |
| VCU Health Tappahannock Hospital Tappahannock, Virginia | Site Public Contact - (klcampbell@vcu.edu) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven, Connecticut | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Washington University School of Medicine St Louis, Missouri | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| White River Junction Veteran Administration Medical Center White River Junction, Vermont | |
| William E Kahlert Regional Cancer Center/Sinai Hospital Westminster, Maryland | |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Women's Diagnostic Center - Munster Munster, Indiana | Site Public Contact - (mnicholson@comhs.org) |
Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm
ctrrecruit@vcu.edu
NCT05600894
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Inclusion Criteria:
* A diagnosis of an MDS/MPN "overlap" syndrome with \>= 5% marrow blasts (including monocytic blast equivalent in case of CMML). Hydroxyurea may be used to control counts up until the start of therapy
* White blood cell (WBC) \< 25,000/mm\^3. Treatment with hydroxyurea is permitted to lower the WBC to reach this criterion
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of ASTX727 in combination with venetoclax in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) (unless considered due to Gilbert's syndrome)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN OR =\< 5.0 x institutional ULN for patients with liver metastases
* Glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Hormonal therapy for prior or concurrent malignancy is allowed
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and/or family member available will also be eligible
* Ability to swallow pills
Exclusion Criteria:
* Patients with need for emergent disease-directed therapy excluding hydroxyurea
* More than one cycle of previous MDS/MPN-directed therapy, or MDS-directed therapy including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine, excluding hydroxyurea. Prior use of erythropoietin stimulating agents (ESA) and thrombopoietic agents is allowed, but must be discontinued 4 weeks prior to study treatment
* Patients currently or previously receiving an investigational agent or device within 4 weeks of the first dose of treatment
* Patients with symptomatic uncontrolled central nervous system (CNS) disease. Imaging to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
* Patients who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days prior to the initiation of study treatment and are unwilling to discontinue consumption of these throughout the receipt of study drug
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASTX727 or venetoclax
* Patients with uncontrolled intercurrent illness (e.g. requiring intravenous therapy) at the discretion of the investigator
* Pregnant women are excluded from this study because venetoclax and ASTX727 have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax. These potential risks may also apply to other agents used in this study. Patients must be post-menopausal or with evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1
* Post-menopausal is defined as:
* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
* Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50 years of age
* Radiation-induced oophorectomy with last menses \> 1 year ago
* Chemotherapy-induced menopause with \> 1 year interval since last menses
* Surgical sterilization (bilateral oophorectomy or hysterectomy)
* Women of child-bearing potential must agree to use adequate contraception (hormonal birth control or abstinence) prior to study entry and for the duration of study participation, and for 6 months following completion of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception (latex or synthetic condom or abstinence) prior to the study, for the duration of study participation, and 3 months after completion of venetoclax and ASTX727 administration
* Patients with any other medical condition for which the expected survival is below 12 months
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or assessment of the investigational regimen
* Patients with uncontrolled infection at the time of study entry PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Decitabine and Cedazuridine, DRUG: Venetoclax
Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts, Myelodysplastic/Myeloproliferative Neoplasm, Myeloproliferative Neoplasm
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Study Locations
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| Location | Contacts |
|---|---|
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Los Angeles General Medical Center Los Angeles, California | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UC Irvine Health Cancer Center-Newport Costa Mesa, California | |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | Site Public Contact - (ucstudy@uci.edu) |
| UCI Health Laguna Hills Laguna Hills, California | Site Public Contact - (ucstudy@uci.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
ctrrecruit@vcu.edu
NCT03606967
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Inclusion Criteria:
* Patients must have a histologically confirmed diagnosis of metastatic invasive triple negative breast cancer. Patients with clinical and/or radiologic suspicion of metastatic TNBC can be consented prior to this confirmation.
* Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 OR less than 1% positive staining cells in the invasive component of the tumor.
* HER2 negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+.
* PD-L1 negative by a Clinical Laboratory Improvement Act (CLIA) approved laboratory using compatible assays appropriate for treatment decisions.
* Patients may have measurable or evaluable disease.
* Patients must be willing to undergo biopsy and have accessible lesions for a new biopsy, or they must have sufficient tissue available from a biopsy performed for standard of care (specifications below). If patient does not have enough archived tissue available, a new biopsy is required. A tumor specimen obtained from relapsed metastatic or locally advanced disease (if applicable) must be submitted. Acceptable samples include core needle biopsies for deep tumor tissue (minimum 4 cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. Formalin-fixed, paraffin-embedded (FFPE) tumor specimens in paraffin blocks are preferred; FFPE tumor tissue sections on slides may be provided if sufficient material (15 x 10μ- unstained) is available. Fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable.
* No prior therapy for metastatic TNBC. Patients who have received taxane-based adjuvant therapy are required to have a disease-free interval of at least 12 months after completion of taxane therapy.
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of durvalumab (MEDI4736) and tremelimumab in combination with neoantigen vaccine in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 60%).
* Body weight \> 30 kg.
* Must have a life expectancy of at least 12 weeks.
* Absolute neutrophil count \>= 1,500/mcL.
* Platelets \>= 100,000/mcL.
* Hemoglobin \>= 9.0 g/dL.
* Serum bilirubin =\< 1.5 x institutional upper limit of normal.
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =\< 5 x institutional upper limit of normal.
* Calculated creatinine clearance \> 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
* Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
* Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
* The effects of durvalumab (MEDI4736) and tremelimumab and neoantigen vaccine on the developing human fetus are unknown. For this reason and because these agents may be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 180 days after completion of durvalumab (MEDI4736) and tremelimumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
* Human immunodeficiency virus (HIV)-positive patients are eligible provided they have a negative viral load, CD4 count \> 250, and are on a stable antiretroviral regimen.
* Ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity who have a close caregiver or legal guardian are also eligible with the consent of the caregiver/guardian.
Exclusion Criteria:
* Patients who are not considered to be candidates for carboplatin + gemcitabine for first line therapy of their metastatic triple negative breast cancer are not eligible.
* Patients who have had chemotherapy, radiotherapy (to more than 30% of the bone marrow), or biologic therapy within 30 days (42 days for nitrosoureas or mitomycin C) prior to entering the study.
* Patients who have received prior immunotherapy for metastatic disease.
* Patients who have not recovered from grade \>= 2 adverse events due to prior anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
* Patients with grade \>= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician.
* Patients with stable endocrinological adverse events (AEs), (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus), must have been on a stable dose of supplemental therapy for at least 2 weeks before screening to be eligible for this study.
* Patients who are receiving any other investigational agents or who have received an investigational agent within the last 30 days.
* Receipt of live attenuated vaccination within 6 months prior to study entry or within 30 days of receiving durvalumab (MEDI4736) and tremelimumab.
* Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of study treatment.
* Major surgical procedure within 28 days prior to the first dose of durvalumab (MEDI4736) and tremelimumab. Local surgery of isolated lesions for palliative intent is acceptable.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab (MEDI4736) or tremelimumab. The following are exceptions to this criterion:
* Intranasal, inhaled, topical steroids or local steroid injections (e.g. intra-articular injection)
* Systemic corticosteroids at physiological doses which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid
* Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication).
* Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab (MEDI4736) and tremelimumab. Known allergy, or history of serious adverse reaction to vaccines, such as anaphylaxis, hives or respiratory difficulty.
* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) \>= 470 ms calculated from 3 electrocardiograms (ECGs) (within 15 minutes at 5 minutes apart).
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, evidence of any acute or chronic viral illness or disease, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because durvalumab (MEDI4736) and tremelimumab has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with durvalumab (MEDI4736) and tremelimumab, breastfeeding should be discontinued if the mother is treated with durvalumab (MEDI4736) and tremelimumab. These potential risks may also apply to other agents used in this study. A negative serum pregnancy test is required no more than 7 days before study entry.
* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* History of pneumonitis or interstitial lung disease.
* History of active primary immunodeficiency.
* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and tuberculosis \[TB\] testing in line with local practice), hepatitis B (known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
* The patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met:
* Patient has undergone potentially curative therapy for all prior malignancies.
* Patients have been considered disease free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).
* Patients with a strong likelihood of non-adherence (such as difficulties in adhering to follow-up schedule due to geographic distance from the treatment facility) should not be knowingly registered.
* History of allogeneic organ transplantation. PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, PROCEDURE: Computed Tomography, BIOLOGICAL: Durvalumab, DRUG: Gemcitabine Hydrochloride, PROCEDURE: Magnetic Resonance Imaging, DRUG: Nab-paclitaxel, BIOLOGICAL: Personalized Synthetic Long Peptide Vaccine, DRUG: Poly ICLC, BIOLOGICAL: Sacituzumab Govitecan, BIOLOGICAL: Tremelimumab
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma
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Study Locations
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| Location | Contacts |
|---|---|
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut | |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Texas Medical Branch Galveston, Texas | Site Public Contact - (clinical.research@utmb.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Wake Forest University at Clemmons Clemmons, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Yale University New Haven, Connecticut |
Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor Therapy (APPELHUS)
Novartis Pharmaceuticals - novartis.email@novartis.com
NCT04889430
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Main
Inclusion Criteria:
* Adult patients with evidence of active thrombotic microangiopathy (TMA), including thrombocytopenia, evidence of hemolysis, and acute kidney injury
* Vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections are required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations, at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination or before vaccination is given, prophylactic antibiotic treatment must be administered at the start of study treatment and for at least 2 weeks after vaccination
Main Exclusion Criteria:
* Treatment with complement inhibitors, including anti-C5 antibody
* ADAMTS13 deficiency (\<10% activity or \<0.1U/ml), and/or Shiga toxin-related hemolytic uremic syndrome (STx-HUS), and/or Positive direct Coombs test
* Identified drug exposure-related HUS or HUS related to known genetic defects of cobalamin C metabolism or known diacylglycerol kinase ε (DGKE) mediated aHUS
* Receiving PE/PI, for 14 days or longer, prior to the start of screening for the current TMA
* Bone marrow transplantation (BMT)/hematopoietic stem cell transplantation (HSCT), heart, lung, small bowel, pancreas, or liver transplantation
* Patients with sepsis or active severe systemic bacterial, viral (including COVID-19) or fungal infection, systemic infection which confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease, active infection (or history of recurrent invasive infections) caused by encapsulated bacteria
* Kidney disease suggestive of other disease than aHUS or of chronic kidney failure or family history of non-complement mediated genetic kidney disease
* Liver disease or liver injury at screening
* Systemic sclerosis (scleroderma), systemic lupus erythematosus (SLE), or antiphospholipid antibody positivity or syndrome
* Chronic hemo- or peritoneal dialysis
Other protocol-defined inclusion/exclusion criteria may apply DRUG: Iptacopan
Atypical Hemolytic Uremic Syndrome
LNP023, iptacopan, aHUS, atypical hemolytic uremic syndrome, thrombotic microangiopathy
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Study Locations
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| Location | Contacts |
|---|---|
| Baylor Scott and White Research Temple, Texas | Rachel E DeSantis - (Rachel.DeSantis@BSWHealth.org) |
| Brigham and Womens Hospital Boston, Massachusetts | |
| Cleveland Clinic Foundation Cleveland, Ohio | Marina Markovic - (markovm@ccf.org) |
| Comprehensive Transplant Ctr at OSU Columbus, Ohio | Dahlia Najjar - (Dahlia.Najjar@osumc.edu) |
| Duke University Medical Center Durham, North Carolina | |
| Georgetown University Lombardi Cancer Center Washington, District of Columbia | |
| Harbor-UCLA Medical Center . Torrance, California | Katie LaBarbera - (katie.labarbera@lundquist.org) |
| Montefiore Medical Center . Bronx, New York | |
| Novartis Investigative Site London, | |
| Novartis Investigative Site London, | |
| Novartis Investigative Site London, | |
| Novartis Investigative Site London, | |
| Novartis Investigative Site London, | |
| Novartis Investigative Site London, | |
| Novartis Investigative Site London, | |
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| Novartis Investigative Site London, | |
| Novartis Investigative Site London, | |
| Rut Univ for Translational Med Scie New Brunswick, New Jersey | |
| USC Norris Cancer Center Newport Beach, California | Hannah Trey - (hannah.trey@med.usc.edu) |
| UT Southwestern Medical Center Dallas, Texas | Elaine Bonilla - (Elaine.Bonilla@UTSouthwestern.edu) |
| Uni Of Alabama At Birmingham Birmingham, Alabama | Jennifer Newby - (jnewby@uabmc.edu) |
| Univ Cali Irvine ALS Neuromuscular Orange, California | |
| Univ of California at Los Angeles Los Angeles, California | Ahad Qureshi - (ahadqureshi@mednet.ucla.edu) |
| University of Cincinnati Cincinnati, Ohio | Kyra Parker - (beckekd@ucmail.uc.edu) |
| University of Miami Miami, Florida | |
| University of Minnesota Minneapolis, Minnesota | |
| University of New Mexico Albuquerque, New Mexico | |
| Virginia Commonwealth University Richmond, Virginia | Tracy McMullin - (tlmcmullin@vcu.edu) |
| WA Uni School Of Med Saint Louis, Missouri | Elizabeth Reimer - (reimer@wustl.edu) |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com
NCT06003426
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Inclusion Criteria
* Subjects with IPF aged ≥ 40 years at the time of signing the informed consent.
* Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia.
* If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
* If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
* Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
* Men who are sexually active with women of childbearing potential agree to use male barrier contraception.
Exclusion Criteria
* History of stroke or transient ischemic attack within 3 months prior to screening.
* Participants who exhibit symptoms of heart failure at rest.
* Participants who have a current malignancy or a previous malignancy with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
* Other protocol-defined Inclusion/Exclusion criteria apply.
DRUG: BMS-986278, DRUG: BMS-986278 Placebo
Idiopathic Pulmonary Fibrosis
BMS-986278, LPA1 antagonist, IPF, Pulmonary fibrosis
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Study Locations
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| Location | Contacts |
|---|---|
| "Corfu General Hospital ""St. IRINI""" Corfu, | |
| "General Hospital of Thessaloniki ""G. Papanikolaou""" Pylaia-Chortiatis, B | |
| "Ospedale ""Gian Battista Morgagni - Luigi Pierantoni"" di Forli" Forlì, | |
| ACE Hospital & Research Center Pune, Maharashtra | |
| AORN - Ospedali dei Colli Ospedale V. Monaldi Napoli, | |
| Aarhus University Hospital Aarhus N, | |
| Accellacare US Inc. of Wilmington Wilmington, North Carolina | |
| Ajou University Hospital Suwon, Gyeonggi-do | |
| All India Institute of Medical Sciences (AIIMS) - New Delhi New Delhi, National Capital Territory of Delhi | |
| Alliance Pulmonary Group Guaynabo, PR | |
| Amsterdam UMC - Locatie VUMC - Pulmonale Hypertensie (PH) Kenniscentrum Amsterdam, | |
| AnMed Health Oglesby Center - AnMed Health Pulmonary and Sleep Medicine Anderson, South Carolina | |
| Anhui Medical University - Anhui Chest Hospital Hefei, AH | |
| Anhui Medical University - The Second Hospital - Hematological Research Center Hefei, Anhui | |
| Anhui Provincial Hospital Hefei City, Anhui Province, Anhui | |
| Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi Ankara, | |
| Asan Medical Center (AMC) Songpa-gu, Seoul | |
| Aso Iizuka Hospital Iizuka-shi, | |
| Assistance Publique Hopitaux de Marseille - Hopital Nord Marseille, | |
| Asst Papa Giovanni XXIII Bergamo, Lombardy | |
| Asthma Bhawan Jaipur, Rajasthan | |
| Athens Medical Center Marousi, Attica | |
| Avanza Medical Research Center Pensacola, Florida | |
| Azienda Ospedaliera San Paolo Milan, | |
| Azienda Ospedaliera Universitaria - Universita di Sassari Sassari, | |
| Azienda Ospedaliero - Universitaria di Modena Policlinico Modena, Emilia-Romagna | |
| Azienda Ospedaliero Universitaria Pisana Pisa, Tuscany | |
| Azienda Ospedaliero Universitaria delle Marche Ancona, | |
| Azienda Ospedaliero-Universitaria Careggi Florence, Tuscany | |
| Baylor College of Medicine Medical Center - Pulmonary, Critical Care, and Sleep Medicine Houston, Texas | |
| Baylor University Medical Center at Dallas Dallas, Texas | |
| Beijing Chaoyang Hospital, Capital Medical University Beijing, Beijing Municipality | |
| Beijing Friendship Hospital, Capital Medical University Beijing, BJ | |
| Bioreuma Concepción, Bio Bio | |
| Brightshores Health System Owen Sound, Ontario | |
| Burlington Lung Clinic Burlington, Ontario | |
| C.I.C. Joliette Saint-Charles-Borromée, Quebec | |
| C.I.C. Mauricie Inc. Trois-Rivières, Quebec | |
| CEC Centros Estudios Clinicos Santiago, RM | |
| CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo do Campo, São Paulo | |
| CENRESIN - Centro Respiratorio Integral Quillota, Región de Valparaíso | |
| CHRU de Tours - Hôpital Bretonneau Tours, | |
| CHU Dijon - Hôpital François Mitterrand Dijon, | |
| CHU Hopitaux de Bordeaux - Hopital Haut-Leveque Pessac, | |
| CHU UCL Namur - Mont-Godinne Yvoir, Namur | |
| CHU de Brest - Hôpital Cavale Blanche Brest, | |
| CHU de Nantes - Hôpital Nord Laennec Nantes, Pays de la Loire Region | |
| Carmel Medical Center Haifa, | |
| Center Hospital of the National Center for Global Health and Medicine Shinjyu-Ku, | |
| Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) Grenoble, Auvergne-Rhône-Alpes | |
| Centre Hospitalier Universitaire d'Angers Angers, | |
| Centre Hospitalier Universitaire de Liege - Sart Tilman Liège, | |
| Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec | |
| Centro Medico Santa Maria Barra Mansa, Rio de Janeiro | |
| Centro Medico de Enfermedades Respiratorias Florida, B | |
| Centro Respiratorio Quilmes Quilmes, Provincia de Buenos Aires, B | |
| Centro de Estudos de Pneumologia da Faculdade de Medicina do ABC (CEPFMABC) Santo André, São Paulo | |
| Centro de Investigacion Clinica de Oaxaca (CICLO) Oaxaca City, Oaxaca | |
| Centro de Investigacion Curico Curicó, Maule Region | |
| Centro de Investigaciones Metabólicas (CINME) Buenos Aires, | |
| Centro de Investigación Clínica Chapultepec S.A. de C.V. Morelia, Michoacán | |
| Centro de Investigación del Maule Talca, | |
| Centrum Medycyny Oddechowej Bialystok, Podlaskie Voivodeship | |
| Chang Gung Medical Foundation - Kaohsiung Branch Kaohsiung City, Kao-Hsiung | |
| Changhua Christian Hospital Changhua County, | |
| Chiba University Hospital Chiba, Chiba, | |
| China Medical University Hospital Taichung, | |
| Christiana Care Pulmonary Associates - Newark Newark, Delaware | |
| Clinica 25 de Mayo Mar del Plata, B | |
| Clinica Providencia San Miguel, LIM | |
| Clinica Universidad de Navarra Madrid, | |
| Clinica Universidad de los Andes Santiago, RM | |
| Clinical Research Specialists, LLC - Kissimmee Kissimmee, Florida | |
| Cliniques Universitaires Saint-Luc Brussels, | |
| Clínica Universidad de Navarra -Madrid Madrid, | |
| Clínica de día Jockey Salud Lima, LIM | |
| Coastal Pulmonary & Critical Care, P.L.C. St. Petersburg, Florida | |
| Connolly Hospital Blanchardstown Dublin, | |
| Consultorios Médicos del Buen Ayre Caba, B | |
| David Geffen School of Medicine at UCLA Los Angeles, California | |
| Diex Recherche - Trois-Rivieres Trois-Rivières, Quebec | |
| Dokuz Eylul Universitesi Tip Fakultesi Pasaport, | |
| Duke University Medical Center Durham, North Carolina | |
| Ege Universitesi Tip Fakultesi Hastanesi (Ege University Medical Faculty Hospital) Izmir, | |
| Erasmus MC - Centrum voor Interstitiele Longziekten Rotterdam, South Holland | |
| Erciyes University School of Medicine Kayseri, | |
| Escola Paulista de Medicina São Paulo, | |
| Fachkrankenhaus Coswig GmbH Coswig, | |
| Far Eastern Memorial Hospital New Taipei City, | |
| Fiona Stanley Hospital Murdoch, | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, MI | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fondazione IRCCS San Gerardo dei Tintori Monza, | |
| Fondazione Policlinico Universitario Agostino Gemelli Roma, | |
| Fortis Hospital Mohali Mohali, Punjab | |
| Fundacion Enfisema - Instituto Ave Pulmo Mar del Plata, Buenos Aires | |
| Fundacion Respirar Buenos Aires, B | |
| Fundacion Santa Fe de Bogota Bogotá, | |
| Fundacion Scherbovsky Mendoza, M | |
| Gachon University - Gil Medical Center Incheon, | |
| Gallipoli Medical Research Centre - Clinical Trials Unit (CTU) Greenslopes, Queensland | |
| Gentofte Hospital Hellerup, | |
| Getwell Hospital and Research Institute - Lungs Care Nagpur, Maharashtra | |
| Giromed Institute, SLP Barcelona, | |
| Grant Medical Foundation - Ruby Hall Clinic Pune, | |
| Green City Hospital Bhopal, Madhya Pradesh | |
| Guy's and St Thomas' NHS Foundation Trust - Royal Brompton Hospital London, Greater London | |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Győr, | |
| HELIOS Klinikum Emil von Behring Berlin, State of Berlin | |
| Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem Jerusalem, | |
| Hamamatsu University Hospital Shizuoka, Hamamatsu, | |
| Hangzhou First People's Hospital Hangzhou, | |
| Harmony Medical Research Institute, Inc Hialeah, Florida | |
| Health SURA Calle 100 Bogotá, DC | |
| Health SURA Chipichape Santiago de Cali, VAC | |
| Helsinki University Hospital Heart and Lung Center Helsinki, Etelae-Suomen Laeaeni | |
| Henan provincial people's hospital Zhengzhou, HA | |
| Hiroshima Prefectural Hospital Hiroshima, Hirohima-ken | |
| Hopital Avicenne Bobigny, | |
| Hopitaux Universitaires de Geneve (HUG) Geneva, Canton of Geneva | |
| Hospices Civils de Lyon Bron, Auvergne-Rhône-Alpes | |
| Hospital Alemao Oswaldo Cruz (HAOC) - Centro de Oncologia (Oncology Center) São Paulo, | |
| Hospital CUF Tejo Lisbon, | |
| Hospital Clinic de Barcelona Barcelona, | |
| Hospital Clinico San Carlos Madrid, | |
| Hospital Clinico Universitario Madrid, | |
| Hospital Dia do Pulmão Blumenau, Santa Catarina | |
| Hospital Ernesto Dornelles (HED) Porto Alegre, Rio Grande do Sul | |
| Hospital Madre Teresa Belo Horizonte, Minas Gerais | |
| Hospital Nacional Cayetano Heredia Lima, | |
| Hospital Universitari de Bellvitge (IDIBELL) Barcelona, | |
| Hospital Universitario Central de Asturias Oviedo, Principality of Asturias | |
| Hospital Universitario Fundacion Jimenez Diaz Madrid, | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Marqués de Valdecilla Santander, | |
| Hospital Universitario Puerta De Hierro - Majadahonda Majadahonda, M | |
| Hospital Universitario de La Princesa Madrid, M | |
| Hospital das Clínicas da Universidade Federal de Minas Gerais (UFMG) Belo Horizonte, Minas Gerais | |
| Hospital de Santa Marta Lisbon, | |
| Huadong Hospital Affiliated to Fudan University Shanghai, | |
| Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital Cottingham, Yorkshire and the Humber | |
| Hôpital Bichat - Claude-Bernard Paris, Île-de-France Region | |
| Hôpital Larrey Toulouse, | |
| Ibamedica Santa Fe, | |
| Inje University Busan Paik Hospital BusanjinGu, Busan Gwang'yeogsi | |
| Inje University Haeundae Paik Hospital Busan, | |
| Inje University Ilsan Paik Hospital Goyang-si, Gyeonggi-do | |
| Inselspital - Universitaetsklinik Bern für Pneumologie Bern, Canton of Bern | |
| Inspiration Research Toronto, Ontario | |
| Institute for Respiratory Health Nedlands, Western Australia | |
| Institute of Science Tokyo Hospital Tokyo, Bunkyo-ku, | |
| Instituto De Enfermedades Respiratorias E Investigacion Medica (IERIM) San Juan Bautista, Buenos Aires | |
| Instituto Medico DAMIC Córdoba, Córdoba Province | |
| Instituto Medico INSARES SA Mendoza, M | |
| Instituto Medico de la Fundacion de Estudios Clínicos Rosario, S | |
| Instituto Neumologico del Oriente Floridablanca, Santander Department | |
| Instituto de Seguridad Social del Estado de Mexico y Municipios (ISSEMYM) - Centro Medico Toluca Metepec, Edo De Mexico | |
| Investigaciones en Patologias Respiratorias San Miguel de Tucuman, Tucumán, T | |
| Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi Topkapı, | |
| Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) Palermo, | |
| Jehangir Clinical Development Center Pune, Maharashtra | |
| Jichi Medical University Hospital Shimotsuke, | |
| Jizankai Medical Foundation Tsuboi Cancer Center Hospital Koriyama-shi, Fukushima | |
| Juntendo University Hospital Bunkyo-ku, Tokyo | |
| K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre Belagavi, Karnataka | |
| Kameda Medical Center - Kameda Clinic Kamogawa-shi, Chiba | |
| Kanagawa Cardiovascular and Respiratory Center Kanagawa, Yokohama, | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | |
| Kaplan Medical Center Rehovot, Central District | |
| Kepler Universitatsklinikum Linz, Upper Austria | |
| Kindai University Hospital Sayama, Osaka | |
| King George's Medical University Lucknow, Uttar Pradesh | |
| Klinikum der Universitat Munchen Munich, Bavaria | |
| Kobe City Medical Center General Hospital KobeShi, Hyōgo | |
| Krankenhaus Hietzing Vienna, | |
| Krankenhaus der Augustinerinnen- Klinik fuer Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin Cologne, Northwest | |
| Kurume University Hospital Fukuoka, | |
| Kyorin University Hospital Tokyo, | |
| Kyushu University Hospital Fukuoka, Fukuoka, | |
| Lankenau Medical Center Wynnewood, Pennsylvania | |
| Layrek Clinical Research Tulsa, Oklahoma | |
| Leeds Teaching Hospitals NHS Trust Leeds, West Yorkshire | |
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| Local Institution - 0504 Halle, Saxony-Anhalt | |
| Loyola University Health System Maywood, Illinois | |
| Lungenfachklinik Immenhausen Immenhausen, | |
| MICS Centrum Medyczne Bydgoszcz Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Marengo CIMS Hospital Ahmedabad, Gujarat | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mater Misericordiae Limited South Brisbane, Queensland | |
| Matsusaka Municipal Hospital Matsusaka-shi, Mie-ken | |
| Max Super Specialty Hospital, Saket - West Block - A Unit of Max Healthcare Institute Limited New Delhi, National Capital Territory of Delhi | |
| McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location Houston, Texas | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical University of South Carolina- College of Medicine Charleston, South Carolina | |
| Medicos Internistas de Caldas Manizales, CL | |
| Mercy St. Vincent Medical Center Toledo, Ohio | |
| Meris Clinical Research Brandon, Florida | |
| Metroplex Pulmonary and Sleep Center McKinney, Texas | |
| Midland Healthcare & Research Center Lucknow, | |
| Monteregie Centre de Recherche Greenfield Park, Quebec | |
| Myongji Hospital Goyang-si, Gyeonggi-do | |
| NHS Lothian - Royal Infirmary of Edinburgh Edinburgh, EDH | |
| NHS Tayside Dundee, DND | |
| NZOZ Przychodnia Vitamed Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Nagasaki University Hospital Nagasaki, Nagasaki, | |
| Nagoya University Hospital Aichi, Nagoya, | |
| Nanfang Hospital of Southern Medical University Guangzhou, Guangdong | |
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing, JS | |
| National Hospital Organization - Okinawa National Hospital Ginowan-Shi, Okinawa | |
| National Hospital Organization Himeji Medical Center Himeji-Shi, Hyōgo | |
| National Hospital Organization Ibarakihigashi National Hospital Naka-gun, Gunma | |
| National Hospital Organization Kinki-Chuo Chest Medical Center Osaka, Sakai, | |
| National Hospital Organization Kyushu Medical Center Fukuoka, Fukuoka | |
| National Jewish Health Denver, Colorado | |
| National Taiwan University Hospital - The National Center of Excellence for Clinical Trial Taipei, | |
| National Taiwan University Hospital Yun-Lin Branch Yunlin County, | |
| Nilratan Sircar (NRS) Medical College & Hospital Kolkata, West Bengal | |
| Nippon Medical School Hospital Bunkyo-Ku, Tokyo | |
| North Bristol NHS Trust - Southmead Hospital Bristol Bristol, BST | |
| Northern Westchester Hospital Mount Kisco, New York | |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Norton Pulmonary Specialists Louisville, Kentucky | |
| OSF Saint Francis Medical Center Peoria, Illinois | |
| OU Health Sciences Center - OU Health Physicians - Cardiology, Pulmonary & Vascular Medicine Clinic Oklahoma City, Oklahoma | |
| Ocala Lung & Critical Care Ocala, Florida | |
| Odense Universitetshospital - Svendborg Sygehus Odense C, Region Syddanmark | |
| Omega Research Consultants LLC DeBary, Florida | |
| Oregon Health & Science University - Pulmonary Clinic Portland, Oregon | |
| Ospedale Colonnello D'Avanzo Foggia Foggia, | |
| Ospedale Policlinico di Siena Siena, | |
| Our Lady of Lourdes Hospital - Drogheda Drogheda, LH | |
| Oxford University Hospitals NHS Trust - Churchill Hospital Oxford, Oxfordshire | |
| Papworth Hospital NHS Foundation Trust Cambridge, Cambridgeshire | |
| Peking Union Medical College Hospital Beijing, | |
| Peking University Shenzhen Hospital Shenzhen, | |
| Peninsula Health - Frankston Hospital Frankston, Victoria | |
| Penn Medicine - Perelman Center for Advanced Medicine Philadelphia, Pennsylvania | |
| Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania | |
| Peterborough City Hospital Peterborough, PTE | |
| Policlínica Piquet Carneiro, Universidade do Estado do Rio de Janeiro Rio de Janeiro, Rio de Janeiro | |
| Praxis fur Pneumologie Marburg, HE | |
| Pulmonary Group of Central Florida, LLC - Leesburg Leesburg, Florida | |
| Pulmonary Specialists of the Palm Beaches Loxahatchee Groves, Florida | |
| Pulmonology, Sleep, Asthma & Allergy Center of Dublin Dublin, Georgia | |
| Qilu Hospital of Shandong University Jinan, Shandong | |
| Quebec Heart and Lung Institute Quebec, | |
| Rabin Medical Center - Hasharon Hospital Petah Tikva, | |
| Rambam Health Care Campus - Pulmonology Haifa, | |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine - South Branch Shanghai, SH | |
| Renmin Hospital of Wuhan University Wuhan, | |
| Respira Salud Clinica Integral Godoy Cruz, M | |
| Royal Adelaide Hospital Adelaide, South Australia | |
| Royal Prince Alfred Hospital Camperdown, New South Wales | |
| Rush University Medical Center - Rush Pulmonary and Critical Care Medicine - Professional Building Chicago, Illinois | |
| SALK - Universitatsklinik Fur Pneumologie/ Lungenheilkunde Landeskrankenhaus Salzburg, Salzburger Land | |
| Saiseikai Kumamoto Hospital Kumamoto, | |
| Santa Casa de Misericórdia de Porto Alegre - Hospital Sao Jose Porto Alegre, Rio Grande do Sul | |
| Santiago Clinic Hospital (Hospital Clínico Universitario de Santiago -CHUS) Santiago de Compostela, Galicia | |
| Sapporo Medical University Hospital Sapporo, Hokkaido | |
| Scripps Clinic Torrey Pines La Jolla, California | |
| Semmelweis Egyetem Pulmonologiai Klinika Budapest, | |
| Seoul National University Bundang Hospital Seongnam-si, | |
| Seoul National University Hospital Seoul, | |
| Servicios de Salud IPS Suramericana S.A.S - IPS Sura Industriales Medellín Medellín, ANT | |
| Shanghai Jiao Tong University - Shanghai Chest Hospital Shanghai, SH | |
| Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai, | |
| Shanghai Pulmonary Hospital Shanghai, | |
| Shengjing Hospital of China Medical University Shenyang, Liaoning | |
| Shenyang Chest Hospital Shenyang, Liaoning | |
| Shenzhen People's Hospital Shenzhen, | |
| Shimane University Hospital Izumo-Shi, | |
| Shree Hospital and Critical Care Centre Nagpur, MH | |
| Shri Guru Ram Rai (SGRR) Institute of Medical and Health Sciences - Shri Mahant Indiresh Hospital Dehradun, Uttarakhand | |
| Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital Chengdu, | |
| SoonChunHyang University Bucheon Hospital Bucheon-si, Gyeonggi-do | |
| SoonChunHyang University Seoul Hospital Yongsan-gu, Seoul | |
| South Texas Veterans Health Care System - Audie L. Murphy VA Hospital San Antonio, Texas | |
| Southeastern Research Center Winston-Salem, North Carolina | |
| St Francis Sleep Allergy & Lung Institute Clearwater, Florida | |
| St. Antonius Ziekenhuis Nieuwegein, | |
| St. John's Medical College Bangalore, | |
| St. Joseph's Healthcare Hamilton Hamilton, Ontario | |
| St. Joseph's Hospital and Medical Center Phoenix, Arizona | |
| St. Paul's Hospital Vancouver, British Columbia | |
| St. Vincent's University Hospital Dublin, | |
| Stanford University School of Medicine Stanford, California | |
| Steward St. Elizabeth Medical Center Boston, Massachusetts | |
| Synergy Respiratory & Cardiac Care Sherwood Park, Alberta | |
| T.C.S.B. Süreyyapasa Gögüs Hastaliklari Egitim Ve Arastirma Hastanesi Maltepe, | |
| TC Saglik Bakanlig -Izmir Dr.Suat Seren Gogus Hastaliklari Ve Cerrahisi Egitim Arastirma Hastanesi Izmir, | |
| Taichung Veterans General Hospital Taichung, China | |
| Taipei Veterans General Hospital Taipei, Beitou District / R.o.c. | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| Temple University Hospital (TUH) - Temple Lung Center (TLC) Philadelphia, Pennsylvania | |
| Tenri Hospital Tenri, | |
| The Affiliated Hospital of Inner Mongolia Medical University Hohhot, | |
| The Affiliated Hospital of Xuzhou Medical University Xuzhou, | |
| The Catholic University of Korea, Bucheon St. Mary's Hospital Bucheonsi Weonmigu, | |
| The First Affiliated Hospital of Guangzhou Medical University Guangzhou, | |
| The First Affiliated Hospital of Nanchang University - Xianghu District Nanchang, JX | |
| The First Affiliated Hospital of Ningbo University Ningbo, | |
| The First Affiliated Hospital of Soochow University Suzhou, Jiangsu | |
| The First Affiliated Hospital of Zhengzhou University Zhengzhou, | |
| The First Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong | |
| The First Hospital of China Medical University Shenyang, Liaoning | |
| The Jikei University Hospital Minato-ku, Tokyo | |
| The Lung Centre Vancouver, British Columbia | |
| The Lung Research Center Chesterfield, Missouri | |
| The Ohio State University Wexner Medical Center Columbus, Ohio | |
| The Prince Charles Hospital Chermside, Queensland | |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The Second Hospital of Hebei Medical University Shijiazhuang, Hebi | |
| The Second Xiangya Hospital of Central South University Changsha, | |
| The Third Hospital of Hebei Medical University Shijiazhuang, | |
| The University of Alabama at Birmingham Birmingham, Alabama | |
| The University of Chicago Medicine Chicago, Illinois | |
| Thomas Jefferson University Hospital - Jane and Leonard Korman Lung Center Philadelphia, Pennsylvania | |
| Thoraxklinik-Heidelberg gGmbH Heidelberg, | |
| Thoraxzentrum Bezirk Unterfranken Münnerstadt, Bavaria | |
| Tianjin Chest Hospital Tianjin, TJ | |
| Tianjin Medical University General Hospital Tianjin, | |
| Toho University - Omori Medical Center Tokyo, | |
| Tokyo Medical University Hospital Shinjuku-Ku, Tokyo | |
| Toranomon Hospital Tokyo, Minato-ku, | |
| Tosei General Hospital Seto, | |
| Turun Yliopistollinen Keskussairaala (TYKS) Turku, Laensi-Suomen Laeaeni | |
| UC Irvine Medical Center Orange, California | |
| UPMC - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Diseases (ILD) Pittsburgh, Pennsylvania | |
| UZ Leuven Leuven, | |
| Ulsan University Hospital (UUH) Dong-gu, Ulsan | |
| Uludag Universitesi Tip Fakultesi (Uludag University Faculty of Medicine) Bursa, | |
| Unidade Local de Saude de Gaia/Espinho, EPE Vila Nova de Gaia, | |
| Unidade Local de Saude de Loures - Odivelas, E. P. E. Loures, | |
| Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente Lisbon, | |
| Unidade Local de Saude de Santo Antonio, E.P.E. Porto, | |
| Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao Porto, | |
| Unidade Local de Saúde do Algarve, EPE Faro, | |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei | |
| Unity Hospital Fridley, Minnesota | |
| Universitaetsklinikum Essen - Ruhrlandklinik Essen, North Rhine-Westphalia | |
| Universitaetsklinikum Freiburg - Klinik fuer Pneumologie Freiburg I. Breisgau, Baden-Wurttemberg | |
| Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Pneumologie Leipzig, | |
| University General Hospital Attikon Athens, | |
| University Hospitals Birmingham NHS Foundation Trust - Heartlands Hospital Birmingham, BIR | |
| University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital Birmingham Birmingham, | |
| University of California UC Davis Medical Center Sacramento, California | |
| University of California, San Francisco Medical Center- Pulmonary Practice San Francisco, California | |
| University of Cincinnati College of Medicine Cincinnati, Ohio | |
| University of Colorado Anschutz Medical Campus - Department of Family Medicine Aurora, Colorado | |
| University of Florida (UF) Health Shands Hospital Gainesville, Florida | |
| University of Fukui Hospital Yoshida-gun, Fukui | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| University of Kansas Medical Center (KUMC) Kansas City, Kansas | |
| University of Maryland - Marlene and Stewart Greenebaum Cancer Center Baltimore, Maryland | |
| University of Michigan Ann Arbor, Michigan | |
| University of Patras - Rio Regional University Hospital Rio, | |
| University of South Florida Tampa, Florida | |
| University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic Los Angeles, California | |
| University of Texas Southwestern Medical Center - Pulmonary Specialty Clinic Dallas, Texas | |
| University of Thessaly- General University Hospital of Larissa Larissa, | |
| University of Ulsan College of Medicine - Ulsan University Hospital (UUH) Dong-Gu, | |
| University of Utah, University Hospital Salt Lake City, Utah | |
| University of Washington Medical Center Seattle, Washington | |
| Universitätsklinikum Hamburg-Eppendorf (UKE) Hamburg, | |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz, | |
| Universitätsspital Basel Basel, | |
| Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego Lodz, | |
| Uniwersyteckie Centrum Kliniczne Gdansk, | |
| VCU Medical Center Richmond, Virginia | |
| Vanderbilt Lung Institute - One Hundred Oaks Nashville, Tennessee | |
| Velocity Clinical Research Germany GmbH Ahrensburg, | |
| Vivantes Klinikum Neukolln Berlin, | |
| Vzw Az Groeninge Kortrijk, | |
| WM Clinica Pneumologica Sociedade Simples LTDA Porto Alegre, Rio Grande do Sul | |
| Warminsko-Mazurskie Centrum Chorób Pluc w Olsztynie Olsztyn, Warmian-Masurian Voivodeship | |
| Washington University School of Medicine in St. Louis St Louis, Missouri | |
| West China Hospital, Sichuan University Chengdu, Sichuan | |
| Western Washington Medical Group (WWMG) - Everett - Silver Lake Medical Center Location Everett, Washington | |
| Westmead Hospital Westmead, New South Wales | |
| Wiener Gesundheitsverbund - Klinik Floridsdorf Vienna, | |
| Wonkwang University Hospital Iksansi, | |
| Wuxi People's Hospital Wuxi, | |
| Xi'an International Medical Center Hospital Xi'an, | |
| Yale New Haven Hospital New Haven, Connecticut | |
| Yichang Central People's Hospital - Xiling Campus Yichang Shi, HE | |
| Yonsei University Health System, Severance Hospital Seoul, | |
| Zuyderland Medisch Centrum, Sittard-Geleen Heerlen, | |
| hospital Italiano de Buenos Aires Ciudad Autonoma Buenos Aires, |
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
Iovance Biotherapeutics https://www.tilvance-301.com - Clinical.Inquiries@iovance.com
NCT05727904
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Inclusion Criteria:
• Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
• In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of \> 6 months.
• Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
• Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
• Participants must have adequate organ function.
• Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
• Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
Exclusion Criteria:
• Participant has melanoma of uveal/ocular origin.
• Participant has symptomatic untreated brain metastases.
• Participant received more than 1 prior line of therapy.
• Participant received prior therapy for metastatic disease
• Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
• Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
• Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
• Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)
• Participant has a history of allogeneic cell or organ transplant. Other protocol defined inclusion/exclusion criteria could apply.
BIOLOGICAL: Lifileucel plus Pembrolizumab, BIOLOGICAL: Pembrolizumab with Optional Crossover Period
Metastatic Melanoma, Unresectable Melanoma, Melanoma
Tumor Infiltrating Lymphocytes, TIL, Metastatic Melanoma, Unresectable Melanoma, Cell Therapy, Cellular Immuno-therapy, IL-2, Non-myeloablative lymphodepletion (NMALD), Check point inhibitor, Melanoma, Lifileucel, Stage III Melanoma, Stage IV Melanoma, Skin cancer, Skin cancer types, Malignant melanoma, Autologous Adoptive Cell Therapy, Autologous Adoptive Cell Transfer, LN-144, Pembrolizumab, Pembro, Adjuvant/Neo-adjuvant, BRAF/MEK, ICI, BRAF v600, Immune checkpoint inhibitor, Tumor infiltrating T-cells, TILVANCE, TILVANCE-301
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Show 72 locations
Study Locations
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| Location | Contacts |
|---|---|
| Allegheny Health Network Pittsburgh, Pennsylvania | |
| Azienda Ospedaliera Universitaria Senese Siena, Si | |
| Azienda Ospedaliero Universitaria Pisana Pisa, Tuscany | |
| Baptist Cancer Center Memphis, Tennessee | |
| Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center Detroit, Michigan | |
| Beaston West of Scotland Canter Centre Glasgow, | |
| Bundang Medical Center - CHA University Seongnam-si, Gyeonggi-do | |
| California Pacific Medical Center San Francisco, California | |
| Centre Hospitalier Universitaire Vaudois Lausanne Lausanne, Canton of Vaud | |
| Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu Nantes, | |
| Centre Hospitalier de l'Université de Montréal Montreal, | |
| Centro di Riferimento Oncologico IRCCS Aviano, Friuli-Venezia Giulia | |
| City of Hope Duarte, California | |
| Clinica Universitaria de Navarra Pamplona, | |
| Consorcio Hospital General Universitario de Valencia Valencia, | |
| Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center Lebanon, New Hampshire | |
| Fiona Stanley Hospital Murdoch, | |
| Flinders Medical Centre Bedford PK, South Australia | |
| Freeman Hospital High Heaton, | |
| Greenslopes Private Hospital Greenslopes, Queensland | |
| Guy's Hospital London, | |
| Hadassah Medical Center Jerusalem, | |
| Henry Ford Health Detroit, Michigan | |
| Hopital Saint Louis Paris, | |
| Hospital 12 de Octubre Madrid, | |
| Hospital Clinic de Barcelona Barcelona, | |
| Hospital General Universitario Gregorio Marañon Madrid, | |
| Hospital Regional Universitario de Malaga - Hospital General Malaga, Málaga | |
| Hospital Universitari Vall dHebron Barcelona, | |
| Hospital Universitario Madrid Sanchinarro - CIOCC Madrid, | |
| Hospital Universitario Marqués de Valdecilla Santander, | |
| Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón, | |
| Hospital Universitario Ramon y Cajal Madrid, | |
| Hospital Universitario Virgen Macarena Seville, | |
| ICO l'Hospitalet - Hospital Duran i Reynals Barcelona, | |
| Institut Paoli Calmettes Marseille, | |
| Instituto Oncologico Rosell Barcelona, | |
| Istituto Europeo Di Oncologia Milan, | |
| Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Napoli, | |
| Istituto Romagnolo per lo Studio dei Tumori Meldola, Forli Cesena | |
| Klinikum rechts der Isar der Technischen Universitat Munchen Munich, | |
| MD Anderson Cancer Center at Cooper Camden, New Jersey | |
| National Cancer Institute Bangkok, | |
| Nederlands Kanker Instituut Amsterdam, | |
| Ohio State University Columbus, Ohio | |
| Oncology Hematology Care Cincinnati, Ohio | |
| Orlando Health Cancer Institute Orlando, Florida | |
| Peter MacCallum Cancer Centre Melbourne, Victoria | |
| Princess Margaret Cancer Centre Toronto, Ontario | |
| Queen Elizabeth Hospital Birmingham Birmingham, | |
| Royal Marsden Hospital Chelsea, England | |
| SCRI Oncology Partners Nashville, Tennessee | |
| Sahlgrenska Universitetssjukhuset Gasteborg, | |
| Sarah Cannon Research Institute UK London, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Sheba Medical Center Ramat Gan, | |
| St. Luke's Cancer Center - Anderson Easton, Pennsylvania | |
| Swedish Cancer Institute Seattle, Washington | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| USC Norris Comprehensive Cancer Center Los Angeles, California | |
| Universitair Ziekenhuis Brussel - Oncologisch Centrum Jette, | |
| Universitatsklinikum Hamburg-Eppendorf Hamburg, | |
| University of Alabama at Birmingham: The Kirklin Clinic Birmingham, Alabama | |
| University of Colorado Cancer Center Aurora, Colorado | |
| University of Illinois Hospital & Health Sciences System Chicago, Illinois | |
| University of Kansas Kansas City, Kansas | |
| University of Louisville - James Graham Brown Cancer Center Louisville, Kentucky | |
| Universitätsklinikum Carl Gustav Carus Dresden, | |
| Universitätsklinikum Schleswig-Holstein - Campus Lübeck Lübeck, | |
| Virginia Commonwealth University Richmond, Virginia | |
| Westmead Hospital Westmead, New South Wales |
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
ctrrecruit@vcu.edu
NCT05987241
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Inclusion Criteria:
* PRE-REGISTRATION: Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis
* PRE-REGISTRATION: Variant histology, including neuroendocrine differentiation, sarcomatoid, micropapillary, glandular, trophoblastic, Mullerian, is allowed if urothelial cancer is predominant histology (any amount of squamous differentiation is allowed provided the tumor is not a pure squamous cell cancer)
* PRE-REGISTRATION: Patient must have had radical surgery (i.e., cystectomy and lymph node dissection or nephroureterectomy or ureterectomy) ≥ 3 weeks, but ≤ 12 weeks prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible
* PRE-REGISTRATION: No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., "positive margins") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins
* PRE-REGISTRATION: No evidence of residual cancer or metastasis after radical cystectomy or nephroureterectomy or ureterectomy (imaging is not required prior to pre-registration but is required prior to registration)
* PRE-REGISTRATION: Have undergone a radical cystectomy nephroureterectomy, or ureterectomy with pathological evidence of urothelial carcinoma at high risk of recurrence as described in one of the two scenarios below (i or ii). The 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized.:
* (i) Patients who have not received neoadjuvant systemic therapy: pT3-pT4\* or pT0/x-pT4/N+ on radical surgery (i.e., cystectomy, nephroureterectomy, or ureterectomy) and are not eligible for adjuvant cisplatin chemotherapy
* (i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented:
* (i) Creatinine Clearance (using Cockcroft-Gault): \< 60 mL/min
* (i) Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade \>= 2 audiometric hearing loss
* (i) CTCAE version 5, grade \>= 2 or above peripheral neuropathy
* New York Heart Association Class III heart failure
* (i) Eastern Cooperative Oncology Group (ECOG) performance status = 2
* (i) Patients who are eligible for cisplatin may be candidates if they refuse adjuvant cisplatin-based chemotherapy, despite being informed by the investigator about the treatment options. The patient's refusal must be documented.
* (i) Patients with pT2N0 urothelial cancer on radical surgery specimen (without prior neoadjuvant systemic therapy) with ctDNA(+) Signatera results based on an assay performed post-radical surgery as part of routine care outside of the study may proceed with pre-registration but require confirmation of ctDNA(+) Signatera testing on repeat "central testing" in the context of A032103 testing. Patients with pT2N0 with central testing not confirming ctDNA(+) will not be eligible for A032103 (Note: this is distinct from patients with ypT2N0 who are eligible based on ii).
* (ii) Patients who received neoadjuvant systemic therapy: ypT2-T4a and/or ypN+ on radical surgery (i.e., cystectomy. , nephroureterectomy, or ureterectomy) pathology specimen. Neoadjuvant systemic therapy may have included cisplatin-based chemotherapy, cisplatin-based chemotherapy plus PD-1/PD-L1 blockade, or enfortumab vedotin plus PD-1/PD-L1 blockade
* PRE-REGISTRATION: Available tumor tissue for central Signatera testing to be submitted at pre-registration. Central testing is defined as testing performed as part of the A032103 study prior to registration and is provided by the study and not routine standard commercial testing. Patients who have already had local Signatera testing performed as part of routine care will require repeat central testing as part of the A032103 study to be eligible for registration/randomization. Tumor tissue from the radical surgery specimen is preferred over tissue from prior diagnostic biopsy specimen (e.g., transurethral resection of bladder tumor specimen)
* PRE-REGISTRATION: Age \>= 18 years
* PRE-REGISTRATION: ECOG Performance Status 0-2
* PRE-REGISTRATION: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
* PRE-REGISTRATION: No postoperative/adjuvant systemic therapy after radical surgery
* PRE-REGISTRATION: No adjuvant radiation after radical surgery
* PRE-REGISTRATION: No treatment with any other type of investigational agent =\< 4 weeks before pre-registration
* PRE-REGISTRATION: Not have ever received prior treatment with LAG-3 blockade
* PRE-REGISTRATION: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* PRE-REGISTRATION: Absolute Neutrophil Count (ANC) \>= 1,200/mm\^3
* PRE-REGISTRATION: Platelet count \>= 100,000/mm\^3
* PRE-REGISTRATION: Hemoglobin \>= 8 g/dL
* PRE-REGISTRATION: Creatinine =\< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance \> 30 mL/min (using either Cockcroft-Gault formula or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
* PRE-REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x ULN
* PRE-REGISTRATION: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
* PRE-REGISTRATION: For women of childbearing potential only: A negative urine or serum pregnancy test done =\< 14 days prior to pre-registration is required
* PRE-REGISTRATION: Not currently requiring hemodialysis
* PRE-REGISTRATION: No current or prior history of myocarditis
* PRE-REGISTRATION: No grade ≥ 3 immune related adverse event with prior PD-1/PD-L1 blockade
* PRE-REGISTRATION: No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.
* PRE-REGISTRATION: Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
* PRE-REGISTRATION: Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
* PRE-REGISTRATION: No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years.
* PRE-REGISTRATION: No known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected).
* PRE-REGISTRATION: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* PRE-REGISTRATION: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible.
* PRE-REGISTRATION: No concurrent antineoplastic therapy.
* PRE-REGISTRATION: No current immunosuppressive agents (with the exception of corticosteroids as described below).
* PRE-REGISTRATION: No condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of pre-registration (with the exception of steroid pre-medications for contrast allergies). Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
* REGISTRATION: Patient must have had radical cystectomy and lymph node dissection or nephroureterectomy or ureterectomy =\< 18 weeks prior to registration.
* REGISTRATION: Must have evaluable ctDNA Signatera assay result (i.e., ctDNA\[+\]or ctDNA\[-\]) based on test performed as part of central testing at pre-registration to A032103. Central testing is defined as testing performed as part of the A032103. Local/commercial testing results may not be used for registration to A032103
* Cisplatin-ineligible (or cisplatin-declining) patients with a pT2N0 urothelial cancer on cystectomy or nephroureterectomy or ureterectomy who were pre-registered based on routine standard care ctDNA(+) Signatera testing must have confirmed ctDNA(+) Signatera testing on central testing. If central Signatera testing yields a ctDNA(-) result, these patients are ineligible. NOTE: This is a distinct consideration from patients with ypT2-4 and/or ypN+ urothelial cancer (i.e., patients who had received neoadjuvant cisplatin-based chemotherapy) who are eligible with either ctDNA(+) or ctDNA(-) central Signatera testing
* REGISTRATION: All patients must have confirmed disease-free status defined as no measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or definitive non-measurable radiographic metastatic disease, within 60 days prior to registration. Patients with equivocal nodes less than 15 mm in short axis, or \< 10 mm in long axis for non-lymph node lesions, not considered by the investigator to represent malignant disease will be eligible. Attempts should be made to resolve the etiology of equivocal lesions with complementary imaging (e.g., PET scan) or biopsy.
* REGISTRATION: No major surgery =\< 3 weeks before registration.
* REGISTRATION: No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette- Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines are not live vaccines and are allowed
* REGISTRATION: No change since registration in clinical condition and/or laboratory tests that would impact the safety of nivolumab +/- relatlimab administration in the opinion of the treating investigator
* COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
* Patient must have converted to ctDNA(+) during serial monitoring performed centrally in the setting of the A032103 study
* COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
* No evidence of metastatic disease on the most recent scheduled imaging assessment as outlined in the study calendar (no repeat imaging is necessary specifically at the time of the conversion from ctDNA\[-\] to ctDNA\[+\]).
* COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
* No change in clinical condition and/or laboratory tests that would impact the safety of nivolumab administration in the opinion of the treating investigator
* COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
* =\< 6 weeks from reporting of ctDNA(+) result to site (not from the date sample was drawn). PROCEDURE: Biospecimen Collection, OTHER: cfDNA or ctDNA Measurement, PROCEDURE: Computed Tomography, PROCEDURE: Cystoscopy, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, OTHER: Questionnaire Administration, BIOLOGICAL: Relatlimab
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma, Muscle Invasive Ureter Urothelial Carcinoma, Muscle Invasive Urethral Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma AJCC v6 and v7, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage IV Bladder Urothelial Carcinoma AJCC v7
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Show 467 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Addison Gilbert Hospital Gloucester, Massachusetts | |
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Sherman Hospital Elgin, Illinois | |
| AnMed Health Cancer Center Anderson, South Carolina | Site Public Contact - (rhonda.ballew@anmedhealth.org) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Atrium Health Cleveland/LCI-Cleveland Shelby, North Carolina | |
| Atrium Health Lincoln/LCI-Lincolnton Lincolnton, North Carolina | |
| Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina | |
| Atrium Health Stanly/LCI-Albemarle Albemarle, North Carolina | |
| Atrium Health Union/LCI-Union Monroe, North Carolina | |
| Atrium Health University City/LCI-University Charlotte, North Carolina | |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| BCCA-Vancouver Cancer Centre Vancouver, British Columbia | |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baptist Health Louisville Louisville, Kentucky | Site Public Contact - (Cbcresearch@bhsi.com) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Ben Taub General Hospital Houston, Texas | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care Winchester, Massachusetts | |
| Beverly Hospital Beverly, Massachusetts | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Richmond Community Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont | |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Columbus Oncology and Hematology Associates Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cross Cancer Institute Edmonton, Alberta | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dana-Farber Cancer Institute at Boston Medical Center - Brighton Brighton, Massachusetts | |
| Dana-Farber Cancer Institute at Foxborough Foxborough, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth, Massachusetts | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duke Cancer Center Cary Cary, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke Cancer Center Raleigh Raleigh, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke University Medical Center Durham, North Carolina | |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| Emory Johns Creek Hospital Johns Creek, Georgia | Site Public Contact - (m.lisa.hwang@emory.edu) |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| George Washington University Medical Center Washington D.C., District of Columbia | |
| Glens Falls Hospital Glens Falls, New York | |
| Grady Health System Atlanta, Georgia | |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hartford HealthCare - Saint Vincent's Medical Center Bridgeport, Connecticut | |
| Hartford Healthcare - Fairfield Fairfield, Connecticut | Site Public Contact - (CancerResearchSupport@hhchealth.org) |
| Hartford Hospital Hartford, Connecticut | |
| HaysMed Hays, Kansas | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Highlands Oncology Group Springdale, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Fayetteville Fayetteville, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Rogers Rogers, Arkansas | Site Public Contact - (research@hogonc.com) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Cherry Hill Hospital Cherry Hill, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente South Bay Harbor City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente West Los Angeles Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Baldwin Park Baldwin Park, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Franklin Denver, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Irvine Irvine, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Lone Tree Lone Tree, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Ontario Ontario, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Riverside Riverside, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Rock Creek Lafayette, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kansas City Veterans Affairs Medical Center Kansas City, Missouri | |
| Karmanos Cancer Institute at McLaren Greater Lansing Lansing, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Keck Medicine of USC Koreatown Los Angeles, California | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lahey Hospital and Medical Center Burlington, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lahey Medical Center-Peabody Peabody, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lancaster General Ann B Barshinger Cancer Institute Lancaster, Pennsylvania | Site Public Contact - (nctn@pennmedicine.upenn.edu) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Levine Cancer Institute - Huntersville Huntersville, North Carolina | |
| Levine Cancer Institute - Rutherford Forest City, North Carolina | |
| Levine Cancer Institute - Union West Matthews, North Carolina | |
| Levine Cancer Institute-Ballantyne Charlotte, North Carolina | |
| Levine Cancer Institute-Gaston Gastonia, North Carolina | |
| Levine Cancer Institute-Rock Hill Rock Hill, South Carolina | |
| Levine Cancer Institute-SouthPark Charlotte, North Carolina | |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| London Regional Cancer Program London, Ontario | |
| Los Angeles General Medical Center Los Angeles, California | |
| Louisiana Hematology Oncology Associates LLC Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri | |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| Maimonides Medical Center Brooklyn, New York | |
| Malcom Randall Veterans Administration Medical Center Gainesville, Florida | Site Public Contact - (trials@cancer.ufl.edu) |
| Mary Bird Perkins Cancer Center - Metairie Metairie, Louisiana | |
| Mary Greeley Medical Center Ames, Iowa | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| McLaren Cancer Institute-Bay City Bay City, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Northern Michigan Petoskey, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital West Pembroke Pines, Florida | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Miami Cancer Institute Miami, Florida | |
| Michael E DeBakey VA Medical Center Houston, Texas | |
| Midstate Medical Center Meriden, Connecticut | |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monmouth Medical Center Long Branch, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Monmouth Medical Center Southern Campus Lakewood, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Mount Sinai Chelsea New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Comprehensive Cancer Center at Aventura Aventura, Florida | Site Public Contact - (yenrique@msmc.com) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Medical Center Miami Beach, Florida | Site Public Contact - (yenrique@msmc.com) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northside Hospital Atlanta, Georgia | Site Public Contact - (ClinicalTrials@northside.com) |
| Northside Hospital - Duluth Duluth, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northside Hospital - Gwinnett Lawrenceville, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Marion General Hospital Marion, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth O'Bleness Hospital Athens, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Pickerington Methodist Hospital Pickerington, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Westerville Medical Campus/Westerville Cancer Center Westerville, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma | |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Presbyterian Kaseman Hospital Albuquerque, New Mexico | Site Public Contact - (WBurman@phs.org) |
| Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho, New Mexico | Site Public Contact - (WBurman@phs.org) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Greenville Memorial Hospital Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Reading Hospital West Reading, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Robert Wood Johnson University Hospital Somerset Somerville, New Jersey | Site Public Contact - (Siby.Varughese@rwjbh.org) |
| Rochester General Hospital Rochester, New York | Site Public Contact - (tia.derosa@rochestergeneral.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint John's Cancer Institute Santa Monica, California | |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
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| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
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| Solinsky Center for Cancer Care Manchester, New Hampshire | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southern Ocean County Medical Center Manahawkin, New Jersey | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Swedish Covenant Hospital Chicago, Illinois | |
| The Hospital of Central Connecticut New Britain, Connecticut | |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The New York Hospital Medical Center of Queens Flushing, New York | Site Public Contact - (ctsucontact@westat.com) |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| The West Clinic - Wolf River Germantown, Tennessee | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
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| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado | |
| UCHealth Lone Tree Health Center Lone Tree, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCLA / Jonsson Comprehensive Cancer Center Los Angeles, California | |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UPMC Altoona Altoona, Pennsylvania | Site Public Contact - (protocols@AllianceNCTN.org) |
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| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
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| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
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| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
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| Unity Park Ridge Campus Rochester, New York | Site Public Contact - (protocols@AllianceNCTN.org) |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University Health Truman Medical Center Kansas City, Missouri | |
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| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
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| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
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| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | Site Public Contact - (slusserb@med.umich.edu) |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
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| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial) (LIBELULA)
Debiopharm International S.A - clinicaltrials@debiopharm.com
NCT06129539
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Inclusion Criteria:
• Diagnosis of central precocious puberty.
• Onset of development of sex characteristics (i.e., breast development in girls or testicular enlargement in boys according to the Tanner method) before the age of 8 years in girls and 9 years in boys.
• Initially, only participants aged (a) 5 to 8 years inclusive (i.e., \<9 years) are eligible. The Sponsor will determine based on the recommendation of the DMC following the interim analysis whether participants aged (b) 2 to 4 years inclusive (i.e., \<5 years) and/or (c) 9 to 10 years inclusive (i.e., \<11 years) may be recruited.
• Participant to receive at least 1 year of gonadotropin-releasing hormone agonist (GnRHa) therapy from study treatment start.
• (a) Pre-treated participants: Start of initial GnRHa therapy no later than 18 months after onset of the first signs of CPP. (b) Treatment-naive participants: Start of Debio 4326 treatment no later than 18 months after onset of the first signs of CPP.
• (a) Pre-treated participants: Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year based on historical values at the initiation of the GnRHa therapy. (b) Treatment-naive participants: Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year.
• (a) Pre-treated participants: Pubertal-type LH response (LH ≥6 IU/L) following a GnRH/GnRHa stimulation test, or random non-stimulated serum LH \>0.5 IU/L (if considered local standard of care), based on historical values prior to the initiation of GnRHa therapy. (b) Treatment-naive participants: Pubertal-type LH response (≥6 IU/L) 30 minutes following a GnRHa \[leuprolide acetate 20 micrograms per kilogram (μg/kg) subcutaneous injection (SC)\] stimulation test before treatment initiation.
• (a) Pre-treated participants: Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 milliliter (mL) (cubic centimeter \[cc\]) for boys, prior to the initiation of GnRHa therapy. (b) Treatment-naive participants: Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 mL (cc) for boys.
Exclusion Criteria:
• Gonadotropin-independent (peripheral) precocious puberty: gonadotropin-independent gonadal or adrenal sex steroid secretion.
• (a) Pre-treated participants: Non-progressing, isolated premature thelarche prior to the initial GnRHa therapy. (b) Treatment-naive participants: Non-progressing, isolated premature thelarche.
• Presence of an unstable intracranial tumor or an intracranial tumor potentially requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible.
• Any other condition or chronic illness possibly interfering with growth (e.g., renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor).
• Other than GnRHa therapy in pre-treated participants, any ongoing treatment with a potential effect on serum levels of gonadotropins or sex steroids, or possibly interfering with growth, opioids, central nervous system \[CNS\] stimulants).
• Prior or current therapy with medroxyprogesterone acetate, growth hormone, or Insulin-like growth factor-1 (IGF-1).
• Diagnosis of short stature, i.e., more than 2.25 standard deviations (SD) below the mean height-for-age.
• Known history of seizures, epilepsy, and/or central nervous system disorders that may have been associated with seizures or convulsions.
• Prior (within 2 months of study treatment start) or current use of medications that have been associated with seizures or convulsions.
• Use of anticoagulants (heparin or coumarin derivatives). Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
DRUG: Debio 4326
Central Precocious Puberty
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Study Locations
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| Location | Contacts |
|---|---|
| Akron Children's Hospital Akron, Ohio | |
| Ann and Robert H.Lurie Children's Hospital of Chicago Chicago, Illinois | |
| Atlanta Diabetes Associates Atlanta, Georgia | |
| CETI - Centro de Estudos em Terapias Inovadoras Ltda Curitiba, | |
| CPCLIN - Centro de Pesquisas Clínicas Ltda. São Paulo, | |
| CPQuali Pesquisa Clinica São Paulo, | |
| Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada Buenos Aires, | |
| Centro de Investigaciones Medicas Mar del Plata Mar del Plata, | |
| Children's Hospital at Montefiore The Bronx, New York | |
| Christus Latam Hub Center of Excellence and Innovation S C Monterrey, | |
| Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L San Miguel de Tucumán, | |
| Clínica de Endocrinologia e Metabologia Ltda Lago Sul, | |
| ENDOMET Antofagasta, | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto, São Paulo | |
| Hospital Clinico San Borja Arriaran (HCSBA) Santiago, | |
| Hospital Da Criança de Brasília Jose Alencar Brasília, | |
| Hospital Universitario Walter Cantidio Fortaleza, | |
| Icahn School of Medicine at Mount Sinai New York, New York | |
| Indiana University/Riley Hospital for Children Indianapolis, Indiana | |
| Instituto de Investigaciones Metabolicas (IDIM) Buenos Aires, | |
| Integral Pesquisa e Ensino Votuporanga, | |
| Investigational Drug Service, The Children's Hospital of Philadelphia Philadelphia, Pennsylvania | |
| Irmandade Santa Casa de São Paulo São Paulo, | |
| Nemours Children's Health Pensacola, Florida | |
| Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS Porto Alegre, | |
| Prisma Health Pediatric Endocrinology Columbia, South Carolina | |
| Rady Children's Hospital - San Diego San Diego, California | |
| Research Institute of Dallas Dallas, Texas | |
| TMC HealthCare Tucson, Arizona | |
| Texas Children's Hospital Houston, Texas | |
| University of California San Francisco-Benioff Children's Hospital San Francisco, California | |
| University of Michigan Ann Arbor, Michigan | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| Virginia Commonwealth University Health System Richmond, Virginia | |
| Washington University St Louis, Missouri | |
| Wolfson's Children's Hospital Jacksonville, Florida |
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
ctrrecruit@vcu.edu
NCT06317649
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Inclusion Criteria:
* Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of the treating physician are better served by azanucleoside-based therapy rather than intensive, cytarabine-based induction based on clinical status (i.e., performance status, age \> 75 years), organ dysfunction, or disease biology
* Patient must have a morphologically confirmed diagnosis of AML according to the World Health Organization (WHO) 2016 classification excluding acute promyelocytic leukemia (APL) with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11
* Patient must have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible
* Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors
* Patient must have the FLT3-ITD or D835 mutation based on MyeloMATCH Master Screening and Reassessment Protocol (MSRP)
* Patient must be assigned to this protocol by the myeloMATCH MSRP
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
* All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
* A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patient of childbearing potential and/or sexually active patients must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 30 days after the last dose of venetoclax for all patients and for 6 months after the last dose of gilteritinib for patients of childbearing potential and for 4 months after the last dose of gilteritinib for male patients with partners of childbearing potential. Patient must not breastfeed during treatment and for 2 months after treatment ends
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Total bilirubin 2X ≤ institutional upper limit of normal (ULN) (unless thought to be elevated due to disease involvement or Gilbert's syndrome)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN
* Either measured or estimated by Cockcroft-Gault equation
* Creatinine clearance of ≥ 30 mL/min/1.73m\^2
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration/randomization are eligible for this trial
* Patients must not have a baseline corrected QT interval ≥ 480 msec using Fredericia correction (QTcF).
NOTE: Since older patients are at risk for prolonged QTc and many will require supportive care with agents that affect the QTc, an ECG is recommended if clinically indicated. If the QTc is prolonged, they should be treated on tier advancement process (TAP) instead of EA02
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patient must not have the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Patients must not have an active or uncontrolled infection DRUG: Azacitidine, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Gilteritinib, DRUG: Venetoclax
Acute Myeloid Leukemia
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Show 207 locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Ben Taub General Hospital Houston, Texas | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Edward Hines Jr VA Hospital Hines, Illinois | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| George E Wahlen Department of Veterans Affairs Medical Center Salt Lake City, Utah | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Lahey Hospital and Medical Center Burlington, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lahey Medical Center-Peabody Peabody, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Loyola University Medical Center Maywood, Illinois | |
| MaineHealth Cancer Care and IV Therapy - Brunswick Brunswick, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mid Coast Hospital Brunswick, Maine | Site Public Contact - (ctsucontact@westat.com) |
| Mills Health Center San Mateo, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Monmouth Medical Center Long Branch, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| North Shore University Hospital Manhasset, New York | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Our Lady of The Lake Baton Rouge, Louisiana | |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Phoebe Putney Memorial Hospital Albany, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Reading Hospital West Reading, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rhode Island Hospital Providence, Rhode Island | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| San Juan City Hospital San Juan, | |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The Valley Hospital - Luckow Pavilion Paramus, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UCSF Medical Center-Parnassus San Francisco, California | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Clinical Research Center Fairway, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of Tennessee - Knoxville Knoxville, Tennessee | |
| University of Vermont Medical Center Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Health System Ridgewood Campus Ridgewood, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven, Connecticut | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| William S Middleton VA Medical Center Madison, Wisconsin | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
ctrrecruit@vcu.edu
NCT06422806
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Inclusion Criteria:
* Patient must be \>= 18 years of age
* Patient must have a confirmed histopathologic diagnosis of dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma. Because UPS can sometimes exist in a spectrum among related diagnoses, the following additional diagnostic will be allowed, but not limited to:
* Pleomorphic sarcoma with inflammation or with limited areas of differentiation
* Pleomorphic sarcoma with giant cells
* Malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes)
* Myxofibrosarcoma
* Poorly differentiated sarcoma not otherwise specified (NOS)
* Undifferentiated spindle cell sarcoma
* Poorly differentiated spindle cell sarcoma NOS Any of these subtypes may have areas of focal myogenic differentiation
* Patient must have metastatic or unresectable sarcoma
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria:
* Has achieved menarche at some point
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 6 months after the last dose of doxorubicin for patients of child bearing potential and for 3 months after the last dose of doxorubicin for male patients with partners of child bearing potential. Males with pregnant partners should use condoms during doxorubicin treatment and for at least 10 days after the last dose of doxorubicin. Contraception measures must also continue for 4 months after the last dose of pembrolizumab for patients of child bearing potential
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Patient must have a left ventricular ejection fraction (LVEF) \> 50% by either MUGA scan or echocardiogram obtained within 28 days prior to randomization
* Absolute neutrophil count (ANC) ≥ 1,500 cells/uL (must be obtained ≤ 7 days prior to protocol randomization)
* Platelets ≥ 75,000 cells/uL (must be obtained ≤ 7 days prior to protocol randomization)
* Total bilirubin \< 1.2 mg/dL (must be obtained ≤ 7 days prior to protocol randomization)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 × institutional upper limit of normal (ULN) (must be obtained ≤ 7 days prior to protocol randomization)
* Creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (must be obtained ≤ 7 days prior to protocol randomization)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Patient must not have a history of or active interstitial lung disease
* Patient must have measurable disease. Baseline imaging must include a chest computed tomography (CT). Imaging should be inclusive of all measurable and non-measurable disease and must be obtained within 28 days prior to randomization. Imaging must be available for uploading to Transfer of Images and Data (TRIAD)
* NOTE: CT with (w/) contrast preferred, chest CT without contrast is acceptable, CT portion of positron emission tomography (PET) may be acceptable. Magnetic resonance imaging (MRI) is acceptable for measuring other sites of disease
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patient must not have had prior treatment with an anthracycline
* Patient must not have a diagnosis of clinically significant immunodeficiency or an autoimmune disorder requiring the patient to use systemic steroid chronically, or systemic steroids within 7 days prior to randomization
* Patient must not have a known history of active TB (Bacillus Tuberculosis)
* Patient must not have a known hypersensitivity to doxorubicin or pembrolizumab or any of their excipients
* Patients who have received prior chemotherapy, targeted small molecule therapy or radiation therapy must have recovered from the prior therapy at the time of randomization
* Patient must have recovered adequately from any prior major surgery prior to randomization
* Patient must not have had prior pericardial or mediastinal radiation
* Patient must not have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent
* Patient must not have an autoimmune or other disease that requires the use of daily corticosteroids of \> 10 mg of prednisone (or equivalent). Patients who are on an active steroid taper at the time of randomization must finish prior to beginning study treatment. Patients who require inhaled or topical steroids are eligible PROCEDURE: Biospecimen Collection, PROCEDURE: Diagnostic Imaging Testing, DRUG: Doxorubicin, PROCEDURE: Echocardiography Test, PROCEDURE: Multigated Acquisition Scan, BIOLOGICAL: Pembrolizumab
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma, Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Unresectable Dedifferentiated Liposarcoma, Unresectable Undifferentiated Pleomorphic Sarcoma
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Show 228 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | Site Public Contact - (ctsucontact@westat.com) |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Broadlawns Medical Center Des Moines, Iowa | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Cross Cancer Institute Edmonton, Alberta | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
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| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
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| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
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| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Juravinski Cancer Centre at Hamilton Health Sciences Hamilton, Ontario | |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
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| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Keck Medicine of USC Koreatown Los Angeles, California | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| Louisiana Hematology Oncology Associates LLC Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario | |
| Pan American Center for Oncology Trials LLC San Juan, | Site Public Contact - (marcia.cruzcorrea@panoncologytrials.com) |
| Pennsylvania Hospital Philadelphia, Pennsylvania | Site Public Contact - (PennCancerTrials@careboxhealth.com) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Premier Blood and Cancer Center Dayton, Ohio | |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sidney and Lois Eskenazi Hospital Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UH Seidman Cancer Center at UH Avon Health Center Avon, Ohio | |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
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| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| USC Norris Oncology/Hematology-Newport Beach Newport Beach, California | |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
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| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | Site Public Contact - (slusserb@med.umich.edu) |
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| VA Palo Alto Health Care System Palo Alto, California | |
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| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
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| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
Reference Study ID Number: CO44657 https://forpatients.roche.com/ - global-roche-genentech-trials@gene.com
NCT06065748
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Inclusion Criteria:
* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
* Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
* Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \>/=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is allowed (if relapse occurred \>/=12 months since completion).
* No prior systemic anti-cancer therapy for advanced disease
* Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment
Exclusion Criteria:
* Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
* Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
* Active cardiac disease or history of cardiac dysfunction
* Clinically significant history of liver disease DRUG: Giredestrant, DRUG: Fulvestrant, DRUG: Abemaciclib, DRUG: Palbociclib, DRUG: Ribociclib, DRUG: LHRH Agonist, DIAGNOSTIC_TEST: FoundationOne Liquid CDx Assay (F1LCDx)
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
oral Selective Estrogen Receptor Degrader (SERD), CDK4/6 inhibitor (CDK4/6i), ESR1 mutation
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Show 350 locations
Study Locations
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| Location | Contacts |
|---|---|
| ?wi?tokrzyskie Centrum Onkologii Kielce, | |
| A.O. Universitaria Di Parma Parma, Emilia-Romagna | |
| A.O. Universitaria S. Maria Della Misericordia Di Udine Udine, Friuli Venezia Giulia | |
| A.O.U. Maggiore della Carità Novara, Piedmont | |
| ASST degli Spedali Civili di Brescia Brescia, Lombardy | |
| AZ St Maarten Campus Leopoldstr Mechelen, | |
| Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit Philadelphia, Pennsylvania | |
| AdventHealth Altamonte Altamonte Springs, Florida | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Allan Blair Cancer Centre Regina, Saskatchewan | |
| Alliance Cancer Specialists Bensalem, Pennsylvania | |
| Amethyst Cluj Cluj County, | |
| Ankara City Hospital Ankara, | |
| Ann B. Barshinger Cancer Institute Lancaster, Pennsylvania | |
| Anticancer Hospital Ag. Savas Athens, | |
| Aretaieio Hospital of Athens Athens, | |
| Asan Medical Center Seoul, | |
| Asante Rogue Regional Medical Center Medford, Oregon | |
| Asst Di Cremona Cremona, Lombardy | |
| Asst Papa Giovanni XXIII Bergamo, Lombardy | |
| Astera Cancer Care East Brunswick East Brunswick, New Jersey | |
| Aurora BayCare Medical Center Green Bay, Wisconsin | |
| Aurora St Lukes Medical Center Milwaukee, Wisconsin | |
| Avera Cancer Institute Sioux Falls, South Dakota | |
| Avera Cancer Institute - Aberdeen Aberdeen, South Dakota | |
| Azienda Ospedaliera Universitaria Careggi Florence, Tuscany | |
| Azienda Ospedaliera Universitaria Federico II Napoli, Campania | |
| Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati Avellino, Campania | |
| B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház Miskolc, | |
| Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji Bakirkoy / Istanbul, | |
| Baptist Health Hamburg Lexington, Kentucky | |
| Baptist Health Lexington Lexington, Kentucky | |
| Baptist Health Louisville Louisville, Kentucky | |
| Barwon Health Geelong, Victoria | |
| Beijing Cancer Hospital Beijing, | |
| Brown University Health Providence, Rhode Island | |
| Brustzentrum Rhein-Ruhr Servicegesellschaft mbH Mönchengladbach, | |
| Bács-Kiskun Vármegyei Oktatókórház Kecskemét, | |
| CEDOES - Diagnóstico e Pesquisa Vitória, Espírito Santo | |
| CENEIT Oncologicos Mexico City, | |
| CHU de Liège (Sart Tilman) Liège, | |
| CHU de Quebec - Hopital du Saint-Sacrement Québec, Quebec | |
| CHVNG/E_Unidade 1 Vila Nova de Gaia, | |
| CISSS Chaudière-Appalaches Lévis, Quebec | |
| CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital Chicoutimi, Quebec | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | |
| Cancer Center, Sun Yat-sen University of Medical Sciences Guangzhou, | |
| Cancer Research SA Adelaide, South Australia | |
| Cancer Specialists of North Florida Jacksonville, Florida | |
| Cancercare Port Elizabeth, | |
| Cancercare Rondebosch Oncology Cape Town, | |
| Capital Health Regional Medical Center Pennington, New Jersey | |
| Celan S.A. Guatemala City, | |
| Centre Cancerologie Grand Montpellier Montpellier, | |
| Centre Eugene Marquis Rennes, | |
| Centre Francois Baclesse Caen, | |
| Centre Hospitalier Regional de Trois-Rivieres Trois-Rivières, Quebec | |
| Centre Hospitalier Saint Louis La Rochelle, | |
| Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec | |
| Centre Jean Perrin Clermont-Ferrand, | |
| Centre Leon Berard Lyon, | |
| Centre Oscar Lambret Lille, | |
| Centro De Cancer Universidad Catolica Santiago, | |
| Centro Medico Integral de Cancerologia CEMIC Salcajá, | |
| Centro Medico monte Carmelo Arequipa, | |
| Centro Oncologico MD Anderson Internacional Madrid, | |
| Centro Oncologico Riojano Integral (CORI) La Rioja, | |
| Centro Oncológico Korben Ciudad Autonoma Buenos Aires, | |
| Centro Oncológico de Excelencia San Juan, | |
| Centro de Atencion Oncologica Viva S de RL de CV Mexico City, Mexico CITY (federal District) | |
| Centro de Investigacion Clinica de Oaxaca Oaxaca City, Oaxaca | |
| Centrul de Oncologie Oncohelp Timișoara, | |
| Centrul de Oncologie Sfantul Nectarie Craiova, | |
| Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli Lublin, | |
| Centrum Onkologii im. Prof. Franciszka ?ukaszczyka Bydgoszcz, | |
| China Medical University Hospital Taichung, | |
| Christchurch Hospital Christchurch, | |
| Chulabhorn Hospital Lak Si, | |
| Chulalongkorn Hospital Bangkok, | |
| Clinica Alivia sucursal Coyoacan Mexico City, | |
| Clinica CIMCA San José, | |
| Clinica Colsanitas S.A. sede Clinica Universitaria Colombia Bogotá D.C., | |
| Clinica Internacional, Sede San Borja Lima, | |
| Clinica Peruana Americana Trujillo, | |
| Clinica San Antonio;Investigaciones Trujillo S.A.C. Trujillo, | |
| Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda São Paulo, São Paulo | |
| Clinique Ste-Elisabeth Namur, | |
| Cliniques Universitaires St-Luc Brussels, | |
| Clínica Puerto Montt Port Montt, | |
| Clínica Santa Beatriz Lima, | |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico Jaén, | |
| Comprehensive Hematology Oncology St. Petersburg, Florida | |
| Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre Mississauga, Ontario | |
| Crio - Centro Regional Integrado de Oncologia Fortaleza, Ceará | |
| Cross Cancer Institute Edmonton, Alberta | |
| DONAU ISAR Klinikum Deggendorf Deggendorf, | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Duke Women Cancer Care Raleigh, North Carolina | |
| European Interbalkan Medical Center Thessaloniki, | |
| Ewha Womans University Mokdong Hospital Seoul, | |
| Florida Cancer Specialists - Broadway Fort Myers, Florida | |
| Florida Cancer Specialists - EAST - SCRI - PPDS West Palm Beach, Florida | |
| Florida Cancer Specialists - Tampa Tampa, Florida | |
| Frederick Health Hospital Frederick, Maryland | |
| Fudan University Shanghai Cancer Center Shanghai, Shanghai Municipality | |
| Fujian Medical University Union Hospital Fuzhou, | |
| Fundación CENIT para la Investigación en Neurociencias Ciudad Autonoma Buenos Aires, | |
| Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo Bogota, D.C., | |
| GHdC Site Les Viviers Charleroi, | |
| Gangnam Severance Hospital Seoul, | |
| Georgetown University Medical Center Washington D.C., District of Columbia | |
| Goztepe Prof.Dr. Suleyman Yalcin City Hospital Kadiköy, | |
| Grady Health System Atlanta, Georgia | |
| Grant Medical Foundation, Ruby Hall Clinic Pune, Maharashtra | |
| Grupo Angeles Guatemala City, | |
| Guangxi Cancer Hospital of Guangxi Medical University Nanning, | |
| Gustave Roussy Villejuif, | |
| Gynonco Düsseldorf, MVZ Medical Center GmbH Düsseldorf, | |
| HCA Midwest Division Kansas City, Missouri | |
| Hacettepe Uni Medical Faculty Hospital Sihhiye/Ankara, | |
| Hadassah Ein Karem Hospital Jerusalem, | |
| Harbin Medical University Cancer Hospital Harbin, Heilongjiang | |
| HealthCare Global Enterprises Limited Banglore, Karnataka | |
| Henry Ford Hospital Detroit, Michigan | |
| Hopital Jean Minjoz Besançon, | |
| Hopital regional de saint jerome Saint-Jérôme, Quebec | |
| Hospital A. C. Camargo São Paulo, São Paulo | |
| Hospital Aleman CABA, | |
| Hospital Amaral Carvalho Jaú, São Paulo | |
| Hospital Araujo Jorge Goiânia, Goiás | |
| Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia Valencia, | |
| Hospital Goyeneche Arequipa, | |
| Hospital Juan Ramon Jimenez Huelva, | |
| Hospital Moinhos de Vento Porto Alegre, Rio Grande do Sul | |
| Hospital Nacional Arzobispo Loayza Lima, | |
| Hospital Nossa Senhora da Conceicao Porto Alegre, Rio Grande do Sul | |
| Hospital Provincial del Centenario Rosario, | |
| Hospital Quiron de Madrid Pozuelo de Alarcón, Madrid | |
| Hospital Sao Domingos São Luís, Maranhão | |
| Hospital Sao Lucas - PUCRS Porto Alegre, Rio Grande do Sul | |
| Hospital Sírio-Libanês São Paulo, São Paulo | |
| Hospital Sírio-Libanês São Paulo, São Paulo | |
| Hospital Universitari Dexeus - Grupo Quironsalud Barcelona, | |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitario Virgen Macarena Seville, | |
| Hospital Universitario Virgen de la Arrixaca El Palmar, | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital Zambrano Hellion TecSalud Monterrey, Nuevo León | |
| Hospital da Luz Lisbon, | |
| Hospital de Cancer de Barretos Barretos, São Paulo | |
| Hospital de Jerez de la Frontera Jerez de la Frontera, Cadiz | |
| Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal Madrid, | |
| Hospital de S. Francisco Xavier Lisbon, | |
| Hospital do Cancer de Pernambuco - HCP Recife, Pernambuco | |
| Hospital do Câncer de Londrina Londrina, Paraná | |
| Hospital las Higueras Concepción, Región Bio Bio | |
| Hospital Álvaro Cunqueiro Vigo, Pontevedra | |
| Hsin-Chu Branch of National Taiwan University Hospital Hsinchu, | |
| Hubei Cancer Hospital Wuhan, | |
| Humanitas Centro Catanese Di Oncologia Misterbianco (CT), Sicily | |
| Hunan Cancer Hospital Changsha, Hunan | |
| I.R.S.T Srl IRCCS Meldola, Emilia-Romagna | |
| ICIMED Instituto de Investigación en Ciencias Médicas San José, | |
| ICO Paul Papin Angers, | |
| INTEGRA Cancer Institute Guatemala City, | |
| IOV - Istituto Oncologico Veneto - IRCCS Padua, Veneto | |
| IPO de Coimbra Coimbra, | |
| IPO do Porto Porto, | |
| IPS Salud SURA Chipichape Cali Cali, | |
| IUCT Oncopole Toulouse, | |
| Icegclinic Santiago, | |
| Icon Cancer Centre Gleneagles Singapore, | |
| Inst. de Oncologia Angel H. Roffo Buenos Aires, | |
| Institut Catala d?Oncologia Hospital Germans Trias i Pujol Badalona, Barcelona | |
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| Korea University Anam Hospital Seoul, | |
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| La Hematology Oncology Medical Group Glendale, California | |
| Lakeridge Health Oshawa Oshawa, Ontario | |
| MVR Cancer Centre and Research Institute Kozhikode, Kerala | |
| Maharaj Nakorn Chiang Mai Hospital;Depart of Radiology Muang Chiang MAI Delivery Branch 3, | |
| Marin Cancer Care Inc Greenbrae, California | |
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| Mater Hospital North Sydney, New South Wales | |
| Mater Misericordiae Limited South Brisbane, Queensland | |
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| Ospedale Di Macerata Macerata, The Marches | |
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| Zhongshan Hospital Fudan University Shanghai, | |
| the First Hospital of Jilin University Changchun, Jilin |
Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com
NCT06356129
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Inclusion Criteria
\- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including:
i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified \[including germinal center B-cell (GCB) and activated B-cell (ABC) types\]
ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas)
iii) High-grade B-cell lymphoma, not otherwise specified
iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)
v) Epstein-Barr virus + DLBCL
* International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) \> 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3.
* Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (\> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
* Must have Ann Arbor Stage II-IV disease.
Exclusion Criteria
* Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
* Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
* Documented or suspected central nervous system (CNS) involvement by lymphoma.
* Other protocol-defined Inclusion/Exclusion criteria apply.
DRUG: Golcadomide, DRUG: Placebo, DRUG: Rituximab, DRUG: Cyclophosphamide, DRUG: Doxorubicin, DRUG: Vincristine, DRUG: Prednisone
Large B-cell Lymphoma
Lymphoma, Large B-Cell, Lymphoma, BMS-986369, CC-99282, DLBCL
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Study Locations
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| Location | Contacts |
|---|---|
| A. C. Camargo Cancer Center São Paulo, São Paulo | |
| Affidea Fundeni Bucharest, | |
| Aidport Skórzewo, Greater Poland Voivodeship | |
| Alaska Oncology and Hematology Anchorage, Alaska | |
| All India Institute of Medical Sciences New Delhi, National Capital Territory of Delhi | |
| Allina Health Cancer Institute - Abbott Northwestern Hospital Minneapolis, Minnesota | |
| Ankara University Health Practice and Research Hospitals Ankara, | |
| Aster Medcity Kochi, Kerala | |
| Astera Cancer Care East Brunswick, New Jersey | |
| Atlantic Health System Morristown Medical Center Morristown, New Jersey | |
| Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO Palermo, Sicily | |
| Azienda Ospedaliero Universitaria Maggiore della Carità Novara, | |
| Brooke Army Medical Center Fort Sam Houston, Texas | |
| CHN - Complexo Hospitalar de Niterói Niterói, Rio de Janeiro | |
| Cancer Care Specialists Reno, Nevada | |
| Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa Porto Alegre, Rio Grande do Sul | |
| Centro de Investigacion Clinica Chapultepec Morelia, Michoacán | |
| Centro de Investigacion Clinica de Oaxaca Oaxaca City, Oaxaca | |
| Centrum Onkologii Ziemi Lubelskiej Lublin, Lublin Voivodeship | |
| Chang Gung Medical Foundation-LinKou Branch Taoyuan District, | |
| Chang Gung Memorial Hospital at Kaohsiung Kaohsiung City, | |
| Chang Gung Memorial Hospital- Chiayi Chiayi City, Chiayi | |
| Chi Mei Medical Center Tainan, Tainan | |
| China Medical University Hospital Taichung, | |
| Chongqing University Cancer Hospital Chongqing, Chongqing Municipality | |
| Cleveland Clinic Florida Stuart, Florida | |
| Clínica Supera Chapecó, Santa Catarina | |
| Debreceni Egyetem Klinikai Kozpont Debrecen, Hajdú-Bihar | |
| Dong-A University Hospital Busan, Pusan-Kwangyǒkshi | |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi Ankara, | |
| Ege Universitesi Hastanesi Izmir, | |
| Emory University School of Medicine- Grady Campus Atlanta, Georgia | |
| Faculty of Medicine Siriraj Hospital Bangkok, Bangkok | |
| Fakultni nemocnice Hradec Kralove Hradec Králové, Hradec Králové | |
| Fakultni nemocnice Kralovske Vinohrady Prague, Praha 10 | |
| Fakultni nemocnice Olomouc Olomouc, Olomoucký kraj | |
| Fakultni nemocnice Plzen Pilsen, Plzeň Region | |
| Fakultní nemocnice Brno Bohunice Brno, Brno-město | |
| Florida Cancer Specialists - East West Palm Beach, Florida | |
| Florida Cancer Specialists - North St. Petersburg, Florida | |
| Florida Cancer Specialists - South Fort Myers, Florida | |
| Fudan University Shanghai Cancer Center Shanghai, Shanghai Municipality | |
| Fujian Cancer Hospital Fuzhou, Fujian | |
| Fundacion Ctic Centro de Tratamiento E Investigacion Sobre Cancer Luis Carlos Sarmiento Angulo Bogotá, Bogota D.C. | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto, São Paulo | |
| Fundação Pio XII - Hospital de Câncer de Barretos Barretos, São Paulo | |
| Fundeni Clinical Institute Bucharest, București | |
| Gazi University Health Research and Application Center Gazi Hospital Ankara, | |
| Guangxi Medical University Affiliated Tumor Hospital Nanning, Guangxi | |
| Harbin Medical University Cancer Hospital Harbin, Heilongjiang | |
| Health Pharma Professional Research S.A. de C.V: Mexico City, DIF | |
| Hematology-Oncology Associates of Central New York, PC East Syracuse, New York | |
| Henan Cancer Hospital Zhengzhou, Henan | |
| Hospital 9 De Julho São Paulo, | |
| Hospital Alemão Oswaldo Cruz São Paulo, São Paulo | |
| Hospital Amaral Carvalho Jaú, São Paulo | |
| Hospital Brasilia Lago Sul, Federal District | |
| Hospital Erasto Gaertner Curitiba, Paraná | |
| Hospital São Lucas de Copacabana Rio de Janeiro, | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey, Nuevo León | |
| Hospital das Clinicas FMUSP São Paulo, | |
| Hunan Cancer Hospital Changsha, Hunan | |
| Icahn School of Medicine at Mount Sinai New York, New York | |
| Instituto D'Or de Pesquisa e Ensino (IDOR) São Paulo, | |
| Instituto Joinvilense De Hematologia e Oncologia Joinville, Santa Catarina | |
| Instituto Nacional De Cancerologia Bogota, Cundinamarca | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City, DIF | |
| Institutul Oncologic Cluj Cluj-Napoca, | |
| Institutul Regional de Oncologie Iași, | |
| Jiangxi Provincial Cancer Hospital Nanchang, Jiangxi | |
| KLES Dr. Prabhakar Kore Hospital & M.R.C Belagavi, Karnataka | |
| Karadeniz Teknik Universitesi Tip Fakultesi Trabzon, | |
| Koo Foundation Sun Yat-Sen Cancer Center Taipei, | |
| Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte | |
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| Local Institution - 0444 Hermosillo, Sonora | |
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| Local Institution - 0459 Santiago, Santiago Metropolitan | |
| Local Institution - 0462 Auckland, | |
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| Local Institution - 0475 Eiheiji-cho,Yoshida-gun, Fukui | |
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| Local Institution - 0486 Besançon, Doubs | |
| Local Institution - 0487 Solna, Stockholms Län [se-01] | |
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| Local Institution - 0491 Badalona, Barcelona [Barcelona] | |
| Local Institution - 0492 Edmonton, Alberta | |
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| Local Institution - 0500 Leiden, South Holland | |
| Local Institution - 0503 Cottbus, | |
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| Local Institution - 0505 Erlangen, Bavaria | |
| Local Institution - 0506 Lübeck, Schleswig-Holstein | |
| Local Institution - 0507 Langen, Hesse | |
| Local Institution - 0508 Berlin, | |
| Local Institution - 0510 Dresden, | |
| Local Institution - 0511 Ulm, Baden-Wurttemberg | |
| Local Institution - 0512 Bayreuth, Bavaria | |
| Local Institution - 0513 Hanover, Lower Saxony | |
| Local Institution - 0516 Houston, Texas | |
| Maharaj Nakorn Chiang Mai Hospital Chiang Mai, | |
| Markusovszky Egyetemi Oktatokorhaz Szombathely, Vas County | |
| Mary Bird Perkins Cancer Center Baton Rouge Baton Rouge, Louisiana | |
| Mayo Clinic in Arizona - Phoenix Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester, Minnesota Rochester, Minnesota | |
| Memorial Hermann Hospital - Texas Medical Center Houston, Texas | |
| Mission Cancer + Blood Waukee, Iowa | |
| Moffitt Cancer Center Tampa, Florida | |
| Mount Sinai Cancer Center Miami Beach, Florida | |
| Narayana Superspecialty Hospital Howrah, West Bengal | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie Warsaw, Masovian Voivodeship | |
| National Taiwan University Hospital Taipei, | |
| Núcleo de Oncologia e Hematologia do Ceará Fortaleza, Ceará | |
| Ondokuz Mayıs Universitesi Samsun, | |
| Orchard Healthcare Research Inc. Skokie, Illinois | |
| Oregon Health and Science University Portland, Oregon | |
| Orszagos Onkologiai Intezet Budapest, | |
| Ospedale Santa Maria delle Croci Ravenna, Emilia-Romagna | |
| Pan American Center for Oncology Trials - Ciudadela San Juan, | |
| Peking University Third Hospital Beijing, Beijing Municipality | |
| Pratia MCM Kraków Krakow, Lesser Poland Voivodeship | |
| Qilu Hospital of Shandong University Jinan, Shandong | |
| Rajiv Gandhi Cancer Institute And Research Centre New Delhi, National Capital Territory of Delhi | |
| Ramathibodi Hospital Bangkok, Bangkok | |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai, Shanghai Municipality | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Sacred Heart Medical Oncology Group Pensacola, Florida | |
| Sc Onco Card Srl Brasov, | |
| Semmelweis Egyetem Budapest, | |
| Shandong Cancer Hospital Jinan, Shandong | |
| Shanxi Bethune Hospital Taiyuan, Shanxi | |
| Shengjing Hospital of China Medical University Shenyang, Liaoning | |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo, | |
| Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvár, Somogy County | |
| Southern Medical University Nanfang Hospital Guangzhou, Guangdong | |
| Spital Clinic Judetean de Urgenta Tg.Mures Tg.Mures, Mureș County | |
| Spitalul Clinic Coltea Bucharest, | |
| Spitalul Clinic Coltea Bucharest, | |
| Spitalul Clinic Județean de Urgență Sibiu Sibiu, | |
| Spitalul Universitar de Urgenta Bucuresti Bucharest, | |
| Sun Yat-sen University Cancer Center Guangzhou, Guangdong | |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Nyíregyháza, Szabolcs-Szatmár-Bereg | |
| Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Taichung Veterans General Hospital Taichung, China | |
| Taipei Veterans General Hospital Taipei, Beitou District / R.o.c. | |
| Tata Medical Center New Town, West Bengal | |
| Tata Memorial Hospital Mumbai, Maharashtra | |
| The First Affiliated Hospital of Chongqing Medical University Chongqing, Chongqing Municipality | |
| The First Affiliated Hospital of NanChang University Nanchang, Jiangxi | |
| The First Affiliated Hospital of Soochow University Suzhou, Jiangsu | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xiamen University Xiamen, Fujian | |
| The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The First Hospital of China Medical University Shenyang, Liaoning | |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The University of Kansas Cancer Center - Westwood Westwood, Kansas | |
| Tianjin Medical University Cancer Institute & Hospital Tianjin, Tianjin Municipality | |
| Tongji Hospital Tongji Medical,Science & Technology Wuhan, Hubei | |
| UMHAT 'Sveti Ivan Rilsky' Sofia, | |
| USA Mitchell Cancer Institute Mobile, Alabama | |
| Unidad Médica Onco-Hematológica Puebla City, | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan, Hubei | |
| Universidade Federal de Goias Goiânia, Goiás | |
| University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD Plovdiv, | |
| University of Michigan Ann Arbor, Michigan | |
| University of Texas MD Anderson Cancer Center Houston, Texas | |
| VM Medical Park Mersin Hastanesi Mersin, | |
| Virginia Commonwealth University (VCU) Medical Center Richmond, Virginia | |
| Vseobecna Fakultni Nemocnice v Praze Prague, | |
| WellSpan Oncology Research York, Pennsylvania | |
| West China Hospital, Sichuan University Chengdu, Sichuan | |
| Winship Cancer Institute, Emory University Atlanta, Georgia | |
| Xinjiang Medical University Cancer Hospital - Urumqi Ürümqi, Xinjiang | |
| the First Hospital of Jilin University Changchun, Jilin |
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
ctrrecruit@vcu.edu
NCT05602194
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Inclusion Criteria:
* \>= 15 and \< 40 years at time of diagnosis
* Newly diagnosed B-ALL, T-ALL, lymphoblastic lymphoma (LLy), or mixed-phenotype acute leukemia/lymphoma (MPAL)
* Note: Philadelphia chromosome (PH)+ and PH-like acute leukemia are eligible (use of tyrosine kinase inhibitors \[TKI\] or CRLF2- targeted concomitant medication must be documented, if used)
* Conjugated bilirubin =\< 1.5 x upper limit of normal (ULN) for age, regardless of baseline bilirubin (within 7 days prior to enrollment), and
* Serum glutamate pyruvate transaminase (SGPT) (ALT) =\< 225 U/L (=\< 5x ULN) (within 7 days prior to enrollment), and
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and serum glutamic oxaloacetic transaminase (SGOT) (AST) to 50 U/L regardless of baseline
* SGOT (AST) =\< 250 U/L (=\< 5x ULN) (within 7 days prior to enrollment)
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and SGOT (AST) to 50 U/L regardless of baseline
* For patients receiving ursodiol prior to enrollment, laboratory values must meet above criteria off ursodiol for 7 days
* PEDIATRIC PATIENTS (AGE 15-17 years):
* A 24-hour urine creatinine clearance \>= 30 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR
* A glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2. GFR must be performed using one of the following methods (within 7 days prior to enrollment):
* 1\. Estimated GFR (eGFR) \>= 30 mL/min/1.73 m\^2.
* An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr\_calculatorped
* 2\. Measured GFR \>= 30 mL/min/1.73 m\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard).
* ADULT PATIENTS (AGE 18 YEARS OR OLDER): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection (within 7 days prior to enrollment). Estimated creatinine clearance is based on actual body weight
* An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr\_calculatorcoc
* Berlin-Frankfurt-Munich (BFM), Children's Oncology Group (COG), or C10403-based Induction regimen and must be inclusive of \>= 1 dose of pegaspargase or calaspargase pegol, and
* First dose of asparaginase must be planned within the first week of induction therapy, and
* Dose of pegaspargase or calaspargase pegol must be \>= 1,000 IU/ m\^2 (dose-capping permitted per primary regimen)
* Note: Co-enrollment on a therapeutic consortia trial is not required
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Down syndrome
* Known inherited or autoimmune liver disease impacting conjugated bilirubin (e.g., Alagille syndrome, primary sclerosing cholangitis, other)
* Known biopsy (or imaging) proven severe liver fibrosis (Batts-Ludwig \>= stage 3)
* Unable to tolerate oral formulation of study drug at enrollment
* Patients who received chemotherapy or treatment for a prior malignancy are not eligible
* The following are permitted: steroid prophase, hydroxyurea, or other cytoreduction prior to initiation of Induction chemotherapy (must be documented) and chemotherapy for current diagnosis (i.e. initiation of Induction therapy within enrollment window). Chemotherapy prior to enrollment for treatment of a non-malignancy (e.g., steroid or methotrexate for autoimmune disease) is also permitted and must be documented
* Female patients who are pregnant since fetal toxicities and teratogenic effects in humans are unknown for study drug. A pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation PROCEDURE: Biospecimen Collection, DRUG: Calaspargase Pegol, DIETARY_SUPPLEMENT: Levocarnitine, DRUG: Pegaspargase, OTHER: Quality-of-Life Assessment
B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9,22)(q34.1,q11.2), BCR-ABL1, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Lymphoblastic Lymphoma, Mixed Phenotype Acute Leukemia, T Acute Lymphoblastic Leukemia
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Show 221 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Ann M Wierman MD LTD Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital at Montefiore The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| GenesisCare USA - Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Las Vegas Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada | Site Public Contact - (research@sncrf.org) |
| Hospital for Sick Children Toronto, Ontario | |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Mission San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Cathedral Rock Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pebble Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pecos Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Smoke Ranch Las Vegas, Nevada | Site Public Contact - (research@smcrf.org) |
| Las Vegas Urology - Sunset Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oncology Las Vegas - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oncology Las Vegas - Tenaya Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Greenville Memorial Hospital Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Radiation Oncology Associates Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Federal Way, Washington | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | Site Public Contact - (slusserb@med.umich.edu) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Urology Specialists of Nevada - Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus (STRIDE)
Ona Whelove - clinicaltrials@cerevasc.com
NCT06498960
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Inclusion Criteria:
Each subject must meet the following criteria:
• Patients ≥60 years old on the day of study informed consent
• Patient or legally authorized representative is able and willing to provide written informed consent
• History or evidence of gait impairment with a duration ≥3 months
• Clinical presentation consistent with NPH including two or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with all of the following:
• Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index \>0.3) and the absence of severe hippocampal atrophy,
• Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%,
• CSF opening pressure ≥8 cmH2O,
• Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
• Patient is willing and able to attend all scheduled visits and comply with study procedures.
• Confirmation of anatomy suitable for the eShunt procedure, as determined by evaluation of pre-procedure imaging (CT and MRI) and approved by an independent anatomical screening committee.
Exclusion Criteria:
Each subject may not:
• Be unable to walk 10 meters (33 feet) with or without an assistive device
• Be diagnosed with obstructive hydrocephalus
• Have an active systemic infection or infection detected in CSF
• Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
• Demonstrate hypersensitivity or contraindication to heparin or radiographic contrast agents against which the subject cannot be adequately pre-medicated, desensitized or where no alternative is available
• Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS
• Present with venous distension in the neck on physical exam
• Have medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arteriovenous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain
• Have history of bleeding diatheses, coagulopathy or refuse to consent for blood transfusion in cases of emergency
• Have had an ischemic stroke or transient ischemic attack within 180 days of eShunt procedure
• Have documented evidence of a deep vein thrombosis superior to the popliteal vein
• Have intrinsic blood clotting disorder
• Have medical conditions requiring anticoagulation which is unable to be managed to allow for surgical procedure
• Have presence of a posterior fossa tumor or mass
• Have a life expectancy \<1 year
• Be currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study.
• Have established diagnosis of neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia
• Be diagnosed with schizophrenia or any psychiatric diagnosis (including depression) that may complicate outcome evaluation
• Need an intracranial neurosurgical procedure within 180 days of study index procedure
• Be unwilling or unable to comply with follow-up requirements
• Have mRS of 0, 5, or 6
DEVICE: CereVasc eShunt System, DEVICE: VP Shunt
Normal Pressure Hydrocephalus
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Show 28 locations
Study Locations
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| Location | Contacts |
|---|---|
| Advocate Lutheran General Hospital Park Ridge, Illinois | Gina Littlejohn, BSN, RN, CCRC - (Gina.Littlejohn@aah.org) |
| Albany Medical Center Albany, New York | Julia Zajaceskowski - (zajacej@amc.edu) |
| Baptist Medical Center - Jacksonville Jacksonville, Florida | Jefferson Atillo, RN, BSN - (jefferson.atillo@bmcjax.com) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | Mark Rotondo, MS - (mrotondo@bidmc.harvard.edu) |
| Brigham and Women's Hospital Boston, Massachusetts | Odysseas Nikas - (onikas@bwh.harvard.edu) |
| Cleveland Clinic Cleveland, Ohio | Joyce Barmen - (BARMENJ2@ccf.org) |
| Clinica La Sagrada Familia Buenos Aires, | Carlos Toranzo - (ctoranzo@lylyk.com.ar) |
| Cooper Neurological Institute Camden, New Jersey | Sean Behnke - (Behnke-sean@cooperhealth.edu) |
| Henry Ford Health Detroit, Michigan | Rehnuma Newaz - (rnewaz1@hfhs.org) |
| Icahn School of Medicine at Mount Sinai New York, New York | Kevin Buttet - (kevin.buttet@mountsinai.org) |
| Indiana University Indianapolis, Indiana | Lauren Snyder, RN, BSN, CCRC - (lmillar@iu.edu) |
| Lenox Hill Hospital New York, New York | Faith Singh - (fsingh3@northwell.edu) |
| Massachusetts General Hospital Boston, Massachusetts | Shayna Hollander - (sdhollander@mgh.harvard.edu) |
| Montefiore Medical Center The Bronx, New York | Lyanna Gomez, MD - (lygomez@montefiore.org) |
| NYU Langone Health New York, New York | Michelle Sclafani - (michelle.sclafani@nyulangone.org) |
| Northwell Health New Hyde Park, New York | Ajith Vellat - (avellat1@northwell.edu) |
| Northwestern University Chicago, Illinois | Pouya Nazari - (pouya.nazari@northwestern.edu) |
| Rhode Island Hospital Providence, Rhode Island | Wendy Smith, BS, RTRCV, CCRP - (wsmith@brownhealth.org) |
| St. Michael's Hospital Toronto, Ontario | Eileen Liu - (Eileen.liu@unityhealth.to) |
| Thomas Jefferson University Philadelphia, Pennsylvania | Sha'Mere Herder - (shamere.herder@jefferson.edu) |
| University at Buffalo Neurosurgery Buffalo, New York | Ellen Carl - (ecarl@ubns.com) |
| University of Kansas Medical Center Kansas City, Kansas | Max Hardenbrook - (mhardenbrook@kumc.edu) |
| University of Kentucky Research Foundation Lexington, Kentucky | Rachel Norris - (rachel.norris@uky.edu) |
| University of Rochester Medical Center Rochester, New York | Tilor Hallquist - (Tilor_Hallquist@URMC.Rochester.edu) |
| University of South Florida Tampa, Florida | Shalini Nampally - (snampally@tgh.org) |
| University of Southern California Los Angeles, California | Kelly Hu - (kelly.hu@med.usc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Amy Erickson - (amy.e.stout@vcuhealth.org) |
| Yale University New Haven, Connecticut | Lindsey Fraczkiewicz - (lindsey.fraczkiewicz@yale.edu) |
MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Trial Manager at Intellia - medicalinformation@intelliatx.com
NCT06128629
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Inclusion Criteria:
* Documented diagnosis of ATTR amyloidosis with cardiomyopathy
* Medical history of heart failure (HF)
* Symptoms of HF are optimally managed and clinically stable within 28 days prior to administration of study intervention
* Screening NT-proBNP, a blood marker of HF severity, greater than or equal to 600 pg/mL and less than 10,000 pg/mL
Exclusion Criteria:
* New York Heart Association (NYHA) Class IV HF
* Polyneuropathy Disability score of IV (confined to wheelchair or bed)
* Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
* History of active malignancy within 3 years prior to screening
* RNA silencer therapy (patisiran, inotersen and/or eplontersen) within 12 months prior to dosing. Any prior vutrisiran use is not allowed
* Initiation of tafamidis or acoramidis within 56 days prior to study dosing
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2
* Liver failure
* Uncontrolled blood pressure
* Unable or unwilling to take vitamin A supplementation for the duration of the study BIOLOGICAL: NTLA-2001, DRUG: Placebo
Transthyretin Amyloidosis (ATTR) with Cardiomyopathy
TTR, Amyloidosis, Cardiomyopathy, NTLA-2001, ATTR-CM, Transthyretin, ATTR, TTR-mediated amyloidosis, Amyloidosis, Hereditary, Amyloidosis, Hereditary, Transthyretin-Related Amyloidosis, Transthyretin amyloid cardiomyopathy, TTR cardiomyopathy, Wild-type TTR, V122I, Amyloidosis, Wild Type
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Show 132 locations
Study Locations
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| Location | Contacts |
|---|---|
| AP-HM - Hopital de la Timone Marseille, | |
| AP-HP Hopital Bichat - Claude Bernard Paris, | |
| AP-HP Hopital Henri Mondor Paris, | |
| AZ Sint-Jan Brugge Bruges, | |
| Aarhus University Hospital Aarhus N, | |
| Alberta Health Services - University of Calgary Calgary, Alberta | |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Antwerp University Hospital Edegem, Antwerp | |
| Azienda Ospedaliero-Universitaria Careggi Florence, Tuscany | |
| Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna Cona, | |
| Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara Trieste, | |
| Barbara Ann Karmanos Cancer Institute Detroit, Michigan | |
| Baylor College of Medicine Houston, Texas | |
| Baylor Scott & White Research Institute Dallas, Texas | |
| Baylor Scott and White - The Heart Hospital Baylor Plano Plano, Texas | |
| Boston University School of Medicine Boston, Massachusetts | |
| Brigham and Women's Hospital Boston, Massachusetts | |
| CAPED - Centro Avancado de Pesquisa Ribeirão Preto, | |
| CHU de Toulouse - Hopital Rangueil Toulouse, | |
| Cairns Hospital Cairns, Queensland | |
| Cardiopulmonar da Bahia S. A. (Hospital Cardio Pulmonar) Salvador, | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Regional de la Citadelle Liége, | |
| Centro Hospitalar Universitario de Lisboa Norte Lisbon, | |
| Centro Hospitalar Universitario do Porto Porto, | |
| Centro de Pesquisa NUPEC - Instituto Orizonti em Belo Horizonte Belo Horizonte, | |
| Charite Universitaetsmedizin Berlin Berlin, | |
| Chonnam National University Hospital Gwangju, | |
| Chu Rennes - Hopital Pontchaillou Rennes, | |
| Cleveland Clinic Cleveland, Ohio | |
| Cleveland Clinic of Florida Weston, Florida | |
| Columbia University Medical Center New York, New York | |
| Complexo Hospitalar de Niterói (CHN-DASA) Niterói, | |
| Duke University Medical Center Durham, North Carolina | |
| Eastern Health - Box Hill Hospital Box Hill, Victoria | |
| Emory University School Of Medicine Atlanta, Georgia | |
| Erasmus MC Rotterdam, | |
| Fakultni nemocnice u sv. Anny v Brne Brno, | |
| Far Eastern Memorial Hospital New Taipei City, | |
| Fiona Stanley Hospital Murdoch, | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fondazione Toscana Gabriele Monasterio per la Ricerca Medica Pisa, | |
| Fundacion Favaloro CABA, Buenos Aires, Argentina | |
| Fundacion Favalro Buenos Aires, | |
| HCFMRP - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto Ribeirão Preto, | |
| Hadassah University Hospital, Ein Karem Jerusalem, | |
| Hospital Israelita Albert Einstein Morumbi, São Paulo | |
| Hospital Privado de Rosario Rosario, | |
| Hospital Universitari de Bellvitge L'Hospitalet de Llobregat, | |
| Hospital Universitario Puerta de Hierro Majadahonda, | |
| Hospital Universitario Son Llatzer Palma de Mallorca, | |
| Hospital Universitario Vall d'Hebron Horta-Guinardó, Barcelona | |
| Hospital Universitario Virgen de la Victoria Málaga, | |
| Hospital Universitario de A Coruna A Coruña, | |
| Houston Methodist Hospital Houston, Texas | |
| ICBA Buenos Aires, | |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola Bologna, | |
| Indiana University Health Indianapolis, Indiana | |
| Inova Fairfax Hospital Falls Church, Virginia | |
| Instituto Dante Pazzanese de Cardiologia São Paulo, | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City, DIF | |
| Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP São Paulo, | |
| Johns Hopkins University Baltimore, Maryland | |
| Karolinska University Hospital Stockholm, | |
| Kumamoto University Hospital Kumamoto, | |
| Mayo Clinic Jacksonville, Florida | |
| Mayo Clinic - Jacksonville Jacksonville, Florida | |
| McGill University Health Centre Montreal, Quebec | |
| MedStar Washington Hospital Center - MedStar Heart and Vascular Institute Washington D.C., District of Columbia | |
| Medical University of South Carolina Charleston, South Carolina | |
| Medizinische Universitaet Innsbruck Innsbruck, | |
| National Cerebral and Cardiovascular Center Suita, Osaka | |
| National Heart Centre Singapore, | |
| National Taiwan University Hospital Taipei, | |
| National University Hospital Singapore, | |
| New York University (NYU) School of Medicine - Langone Medical Center New York, New York | |
| New Zealand Clinical Research Christchurch, | |
| New Zealand Clinical Research Christchurch, | |
| Northwestern University Chicago, Illinois | |
| Ohio Health Research Institute Columbus, Ohio | |
| Oregon Health and Science University (OHSU) Portland, Oregon | |
| Oslo University Hospital - Rikshospitalet Oslo, | |
| Ospedale Policlinico San Martino IRCCS Genova, | |
| PSEG Centro de Pesquisa Clinica S.A. São Paulo, | |
| Penn Presbyterian Medical Center Philadelphia, Pennsylvania | |
| Princess Alexandra Hospital Queensland, Queensland | |
| Rambam Health Care Campus Haifa, | |
| Richmond Pharmacology London, | |
| Rigshospitalet Copenhagen, | |
| Royal Adelaide Hospital Adelaide, South Australia | |
| Samsung Medical Center Seoul, | |
| Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika Budapest, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Sheba Medical Center Ramat Gan, | |
| St. Luke's Hospital Kansas City, Missouri | |
| Stanford University Stanford, California | |
| Synexus Hexham Clinical Research Centre Hexham, | |
| Synexus Manchester Clinical Research Centre Manchester, Greater Manchester | |
| Synexus Merseyside Clinical Research Centre Liverpool, | |
| Synexus Midlands Clinical Research Centre Birmingham, West Midlands | |
| Synexus Scotland Clinical Research Centre Bellshill, Lanarkshire | |
| Synexus Wales Clinical Research Centre Cardiff, | |
| Taipai Veterans General Hospital Taipei, | |
| The Alfred Hospital Melbourne, Victoria | |
| The Canberra Hospital Garran, Australian Capital Territory | |
| The University of Tokyo Hospital Tokyo, | |
| Toyama University Hospital Toyama, | |
| UZ Leuven Leuven, | |
| Universitaesklinikum St. Poelten Sankt Pölten, | |
| UniversitaetsKlinikum Heidelberg Heidelberg, | |
| Universitaetsklinikum Essen Essen, | |
| Universitaetsklinikum Wuerzburg Würzburg, | |
| Universitair Medisch Centrum Utrecht Utrecht, | |
| University Health Network - Toronto General Hospital Toronto, Ontario | |
| University Hospital of Umea Umeå, | |
| University Medical Center New Orleans, Louisiana | |
| University of Arizona Tucson, Arizona | |
| University of California, San Diego (UCSD) - Medical Center La Jolla, California | |
| University of Colorado Denver Aurora, Colorado | |
| University of Kentucky Gill Heart Institute Lexington, Kentucky | |
| University of Michigan Ann Arbor, Michigan | |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| Université libre de Bruxelles (ULB) - Hôpital Erasme Brussels, | |
| Vancouver Coastal Health Research Institute Vancouver, British Columbia | |
| Virginia Commonwealth University - Department of Internal Medicine Richmond, Virginia | |
| Western Greater Los Angeles VA Medical Center Los Angeles, California | |
| Westmead Hospital Westmead, New South Wales | |
| Yale University School of Medicine North Haven, Connecticut | |
| hospital Italiano de Buenos Aires Ciudad Autonoma Buenos Aires, | |
| hospital Italiano de Buenos Aires Ciudad Autonoma Buenos Aires, |
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) (Shamrock)
Sabine Coppieters, MD - clinicaltrials@argenx.com
NCT06503731
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Inclusion Criteria:
* The participant is within the ages of 18 and 80 years old
* The participant had a kidney transplant (living or deceased donor) at least 6 months before the study
* The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study
* A participant may be allowed into the study if they receive the following medications:
• Received mycophenolate mofetil for at least 20 weeks before the study
• Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study
• Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study
• Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for at least 4 weeks before being allowed to participate in the study
Exclusion Criteria:
* Confirmed T-cell or mixed rejection at time of the study
* Recent change in immunosuppressive therapy agents
* Any other medical condition that, in the investigator's opinion, would interfere with the results of the study or put the participant at undue risk
* Pregnant or lactating state or intention to become pregnant during the study
The complete list of criteria can be found in the protocol COMBINATION_PRODUCT: Efgartigimod PH20 SC - prefilled syringe, OTHER: Placebo PH20 SC - prefilled syringe
Antibody-mediated Rejection
Active AMR, Chronic active AMR, Late AMR
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Study Locations
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| Location | Contacts |
|---|---|
| Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus Wien, | Georg A. Boehmig, MD - (clinicaltrials@argenx.com) |
| Cedars-Sinai Medical Center Los Angeles, California | Stanley Jordan, MD - (clinicaltrials@argenx.com) |
| Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin Bordeaux, | Lionel Couzi, MD - (clinicaltrials@argenx.com) |
| Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon La Tronche, | Paolo Malvezzi, MD - (clinicaltrials@argenx.com) |
| Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil Toulouse, | Nassim Kamar, MD - (clinicaltrials@argenx.com) |
| Charite - Universitatsmedizin Berlin Berlin, | Eva Schrezenmeier, MD - (clinicaltrials@argenx.com) |
| Duke University Hospital Durham, North Carolina | Goni Katz-Greenberg, MD - (clinicaltrials@argenx.com) |
| Hospital Del Mar Barcelona, | Marta Crespo, MD - (clinicaltrials@argenx.com) |
| Hospital Universitario Vall d'Hebron Horta-Guinardó, Barcelona | Francesc Moreso, MD - (clinicaltrials@argenx.com) |
| Hospital Universitario de Bellvitge Barcelona, | Edoardo Melilli, MD - (clinicaltrials@argenx.com) |
| Institut klinicke a experimentalni mediciny (IKEM) Praha, | Ondrej Viklický, MD - (clinicaltrials@argenx.com) |
| London Health Sciences Centre London, | Lakshman Gunaratnam, MD - (clinicaltrials@argenx.com) |
| The Ohio State University Wexner Medical Center Columbus, Ohio | Todd Pesavento, MD - (clinicaltrials@argenx.com) |
| Universitaetsklinikum Carl Gustav Carus Dresden Dresden, | Christian Hugo, MD - (clinicaltrials@argenx.com) |
| Universitair Ziekenhuis (UZ) Gent Gent, | Steven Van Laecke, MD - (clinicaltrials@argenx.com) |
| Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg Leuven, | Dirk Kuypers, MD - (clinicaltrials@argenx.com) |
| Universitatsklinikum Hamburg-Eppendorf Hamburg, | Florian Grahammer, MD - (clinicaltrials@argenx.com) |
| University of Alabama at Birmingham (UAB) Hospital Birmingham, Alabama | Navya Eleti, MD - (clinicaltrials@argenx.com) |
| University of Washington Medical Center Seattle, Washington | Nicolae Leca, MD - (clinicaltrials@argenx.com) |
| Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center Richmond, Virginia | Gaurav Gupta, MD - (clinicaltrials@argenx.com) |
Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
LumaBridge CRO - contact@lumabridge.com
NCT06028074
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Inclusion Criteria:
General
* Written informed consent
* ECOG performance status 0-1.
* Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions
* Recommended Double methods of contraception 90-days post treatment Cancer Specific
* Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor
* Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
* Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation
* No other lines of therapy that are available
Exclusion Criteria:
General
* Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy
* Women who are pregnant or breastfeeding
* History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
* Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific
* Current second malignancy at other sites
* Leptomeningeal disease
* Spinal cord compression
* Symptomatic or new or enlarging central nervous system (CNS) metastases
Treatment-specific Exclusion Criteria
* Ongoing toxicity \> Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
* Has undergone a major surgery \< 1 month prior to administration of GIM-122
* Has received radiation therapy within 2 weeks prior to administration of GIM-122
* Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time
* Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122
* Prior treatment with other immune modulating agents within \< 4 weeks prior to the first dose of GIM-122.
* Has a diagnosis of immunodeficiency, either primary or acquired
* Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122
* Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.
* Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any of the study medications, or excipients in the various formulations of any agent.
* Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date \> 30 days prior to administration of GIM-122). DRUG: GIM122
Advanced Solid Malignancies
solid tumor, advanced malignancies, GIM-122
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Study Locations
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| Location | Contacts |
|---|---|
| Florida Cancer Specialists West Palm Beach, Florida | |
| NEXT Oncology Dallas Irving, Texas | |
| Norton Cancer Institute Louisville, Kentucky | Juanita Dwingelo, MS, PhD, ACRP-CP - (juanita.vondwingelo@nortonhealthcare.org) |
| Rutgers Cancer Institute of Nj New Brunswick, New Jersey | Taryn Bollaro - (tb509@cinj.rutgers.edu) |
| Tennessee Oncology, PLLC Nashville, Tennessee | Amber Hilyard - (ahilyard@tnonc.com) |
| Texas Oncology - Baylor Sammons Cancer Center Dallas, Texas | |
| The Angeles Clinic and Research Institute Los Angeles, California | |
| UCLA Hematology/Oncology Los Angeles, California | Thu Ly - (tply@mednet.ucla.edu) |
| UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California | Markee Micu - (markee.micu@ucsf.edu) |
| USC/Norris Comprehensive Cancer Center Los Angeles, California | Thomas Won - (thomas.won@med.usc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Faith McFadden - (mcfaddenfr@vcu.edu) |