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A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
ctrrecruit@vcu.edu
NCT05675410
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Inclusion Criteria:
* Patients must be 5 to 60 years of age at the time of enrollment
* Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \[NOS\]) with stage I or II disease
* Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \>= 1.5 cm)
* Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained
* Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease.
* Note: Pediatric patients who have received both a CT chest and upright PA CXR may meet the definition of bulk through either modality.
* Patients \>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2
* Patients =\< 17 years of age must have a Lansky performance score of \>= 50
* Pediatric patients (age 5-17 years): A serum creatinine based on age/sex as follows (within 28 days prior to enrollment):
* 2 to \< 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female)
* 6 to \< 10 years (age): 1 mg/dL (male), 1 mg/dL (female)
* 10 to \< 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female)
* 13 to \< 16 years (age): 1.5 mg/dL (male), 1.4 mg/dL (female)
* \>= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment). 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 or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility
* For adult patients (age 18 years or older) (within 28 days prior to enrollment): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
* Total bilirubin =\< 2 x upper limit of normal (ULN) (within 28 days prior to enrollment)
* Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
* Aspartate aminotransferase (AST) =\< 3 x ULN (within 28 days prior to enrollment)
* Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
* Alanine aminotransferase (ALT) =\< 3 x ULN (within 28 days prior to enrollment)
* Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
* Shortening fraction of \>= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 28 days prior to enrollment) or ejection fraction of \>= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 28 days prior to enrollment)
* Diffusion capacity of the lung for carbon monoxide (DLCO) \>= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 28 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of \> 92% on room air
* Known 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
Exclusion Criteria:
* Patients with nodular lymphocyte predominant Hodgkin lymphoma
* Patients with a history of active interstitial pneumonitis or interstitial lung disease
* Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients
* Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills
* Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \> 10 mg daily predniSONE for patients \>= 18 years or \> 0.5 mg/kg \[up to 10 mg/day\] for patients \< 18 years) or other immunosuppressive medications within 14 days prior to enrollment
* Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\< 10 mg daily for patients \>= 18 years or =\< 0.5 mg/kg \[up to 10 mg/day\] predniSONE equivalents) are permitted in the absence of active autoimmune disease
* Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1
* Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids.
* Patients with peripheral neuropathy \> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL
* Prior solid organ transplant
* Prior allogeneic stem cell transplantation
* Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette Guerin \[BCG\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment
* Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer
* Men and women of childbearing potential (WOCBP) must use effective contraception during the study and for 2 months for WOCBP and 4 months for men, after last dose of brentuximab vedotin
* WOCBP must continue contraception for a period of at least 5 months after the last dose of nivolumab
* 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 PROCEDURE: Biospecimen Collection, BIOLOGICAL: Bleomycin Sulfate, DRUG: Brentuximab Vedotin, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Dacarbazine, DRUG: Doxorubicin Hydrochloride, DRUG: Etoposide, DRUG: Etoposide Phosphate, OTHER: Fludeoxyglucose F-18, RADIATION: Involved-site Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, PROCEDURE: Positron Emission Tomography, DRUG: Prednisolone, DRUG: Prednisone, DRUG: Procarbazine Hydrochloride, OTHER: Questionnaire Administration, DRUG: Vinblastine Sulfate, DRUG: Vincristine Sulfate
Lugano Classification Limited Stage Hodgkin Lymphoma 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) |
| AdventHealth Orlando Apopka, 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) |
| 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 | |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.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) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Atrium Health Navicent Macon, Georgia | Site Public Contact - (andrew.weatherall@atriumhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| 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 Children's at Desert Mesa, Arizona | |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| 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) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.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) |
| CTCA at Western Regional Medical Center Goodyear, Arizona | |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (ctsucontact@westat.com) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.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 | |
| 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 New Orleans New Orleans, Louisiana | |
| 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) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Antelope Valley Lancaster, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Corona Corona, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Newport Beach Newport Beach, California | |
| City of Hope Seacliff Huntington Beach, California | |
| 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 | |
| City of Hope at Long Beach Elm Long Beach, California | |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| Corewell Health Beaumont Troy Hospital Troy, Michigan | |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Dearborn Hospital Dearborn, Michigan | |
| Corewell Health Farmington Hills Hospital Farmington Hills, Michigan | |
| 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 Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health William Beaumont University Hospital Royal Oak, Michigan | |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| 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) |
| Dayton Children's Hospital Dayton, Ohio | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| 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) |
| 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 | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| Emory Proton Therapy Center Atlanta, Georgia | Site Public Contact - (allyson.anderson@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) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Glens Falls Hospital Glens Falls, New York | |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Grady Health System Atlanta, Georgia | |
| 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) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hematology Oncology Associates of CNY at Camillus Camillus, New York | |
| Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York | |
| 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 Medical Center-Fairlane Dearborn, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Wyandotte Hospital Wyandotte, Michigan | Site Public Contact - (nhay@hfhs.org) |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| Hunterdon Medical Center Flemington, New Jersey | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| 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) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (ctsucontact@westat.com) |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Jim Pattison Children's Hospital Saskatoon, Saskatchewan | Site Public Contact - (Jessica.Marien@saskhealthauthority.ca) |
| 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 Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente- Modesto MOB II Modesto, California | |
| 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-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) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Murrieta, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care Center of York County Sanford, Maine | |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Coastal Cancer Treatment Center Bath, Maine | Site Public Contact - (ctsucontact@westat.com) |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| 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 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 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 Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (OncologyResearch@DignityHealth.org) |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Monmouth Medical Center Long Branch, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| 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) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| 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) |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Naval Medical Center -San Diego San Diego, California | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| 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) |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
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| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
Toll Free Number - Trialsites@msd.com
NCT06079879
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Inclusion Criteria:
* Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms (confirmed by a central pathologist)
* Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
* Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance
* Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
* Has a platelet count \> 450 × 10\^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention
* Has an absolute neutrophil count (ANC) ≥0.75 × 10\^9/L assessed up to 72 hours before first dose of study intervention
* Participants may have received up to 3 prior ET-directed cytoreductive agents including hydroxyurea
Exclusion Criteria:
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation
* History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study
* Evidence at the time of Screening of increased risk of bleeding
* History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease DRUG: Bomedemstat, DRUG: Anagrelide, DRUG: Busulfan, DRUG: Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b, DRUG: Ruxolitinib
Essential Thrombocythemia
essential thrombocythemia, ET, bomedemstat, IMG-7289
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Show 161 locations
Study Locations
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| Location | Contacts |
|---|---|
| Addenbrooke's Hospital ( Site 3303) Cambridge, Cambridgeshire | |
| Affiliated Hospital of Nantong University ( Site 3527) Nantong, Jiangsu | |
| Albert Schweitzer Ziekenhuis, locatie Dordwijk-Internal Medicine ( Site 2302) Dordrecht, South Holland | |
| Anhui Provincial Hospital ( Site 3513) Hefei, Anhui | |
| Ankara Bilkent Şehir Hastanesi ( Site 3201) Ankara, | |
| Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 3210) Ankara, | |
| Antalya Egitim ve Arastırma Hastanesi ( Site 3207) Antalya, | |
| Aotearoa Clinical Trials ( Site 0050) Auckland, | |
| Arcispedale Santa Maria Nuova ( Site 0301) Reggio Emilia, | |
| Asan Medical Center ( Site 0603) Seoul, | |
| Azienda Ospedaliera Universitaria Careggi ( Site 0030) Florence, Tuscany | |
| Azienda Ospedaliero Universitaria Pisana-UO Ematologia UNIV ( Site 0309) Pisa, Tuscany | |
| Azienda Ospedaliero Universitaria delle Marche ( Site 0302) Ancona, | |
| Azienda Ospedaliero Universitaria di Ferrara ( Site 0304) Cona, Ferrara | |
| Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0034) Alessandria, | |
| Boston Pilgrim Hospital ( Site 3301) Boston, Lincolnshire | |
| C.I.C.E. 9 de Julio ( Site 1001) San Miguel de Tucumán, Tucumán Province | |
| CHUS - Hospital Clinico Universitario ( Site 0421) Santiago de Compostela, La Coruna | |
| Calvary Mater Newcastle ( Site 0505) Waratah, New South Wales | |
| Carmel Hospital ( Site 0906) Haifa, | |
| Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois-HEMATOLOGY ( Site 0407) Vandœuvre-lès-Nancy, Lorraine | |
| Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0413) Tours, Indre-et-Loire | |
| Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Hématologie Clinique et Thérapie Cellu ( Site 1701) Limoges, Limousin | |
| Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0417) Rennes, Brittany Region | |
| Centre Hospitalier de Roubaix ( Site 1703) Roubaix, Nord | |
| Chang Gung Medical Foundation-Linkou Branch ( Site 3103) Taoyuan District, | |
| Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 3104) Kaohsiung City, | |
| Chang Gung Memorial Hospital- Chiayi ( Site 3102) Chiayi City, Chiayi | |
| Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0707) Debrecen, | |
| Duke University Health System (DUHS) ( Site 0016) Durham, North Carolina | |
| Ege Universitesi Hastanesi ( Site 3202) Bornova, İzmir | |
| Ehime University Hospital ( Site 3612) Tōon, Ehime | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2201) Milan, Lombardy | |
| Fujita Health University Hospital ( Site 3613) Toyoake, Aichi-ken | |
| Fukushima Medical University Hospital ( Site 3616) Fukushima, | |
| Fundacion Colombiana de Cancerología Clinica Vida ( Site 1403) Medellín, Antioquia | |
| GenesisCare - Windsor ( Site 3309) Windsor, Windsor And Maidenhead | |
| Gloucestershire Royal Hospital ( Site 3302) Gloucester, Gloucestershire | |
| Guy's & St Thomas' NHS Foundation Trust ( Site 3305) London, London, City of | |
| HOSPITAL CLÍNIC DE BARCELONA ( Site 2800) Barcelona, Catalonia | |
| Hacettepe Universite Hastaneleri-Department of Hematology ( Site 3204) Ankara, | |
| Hadassah Medical Center ( Site 0904) Jerusalem, | |
| Henan Cancer Hospital-hematology department ( Site 3504) Zhengzhou, Henan | |
| Henry Ford Hospital ( Site 3413) Detroit, Michigan | |
| Hokkaido University Hospital ( Site 3601) Sapporo, Hokkaido | |
| Hospital Costa del Sol-Hematology Service ( Site 0412) Marbella, Malaga | |
| Hospital General Universitario de Albacete ( Site 0408) Albacete, | |
| Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0409) Badalona, Barcelona | |
| Hospital Italiano de Buenos Aires ( Site 0105) ABB, Buenos Aires F.D. | |
| Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0404) Barcelona, | |
| Hospital Universitario 12 de Octubre ( Site 2806) Madrid, | |
| Hospital Universitario Austral ( Site 0104) Pilar, Buenos Aires | |
| Hospital Universitario Doctor Peset ( Site 0411) Valencia, | |
| Hospital Universitario Ramón y Cajal-Hematology ( Site 2803) Madrid, Madrid, Comunidad de | |
| Hospital Universitario Virgen de la Victoria ( Site 0418) Málaga, | |
| Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 0419) Salamanca, | |
| Hospital del Mar ( Site 2807) Barcelona, Catalonia | |
| Huashan Hospital, Fudan University ( Site 3529) Shanghai, Shanghai Municipality | |
| Hôpital Saint Antoine-Service d'Hématologie et de Thérapie Cellulaire ( Site 1702) Paris, Île-de-France Region | |
| Hôpital Saint-Louis-Centre d'Investigations Cliniques ( Site 0405) Paris, | |
| IMAT S.A.S ( Site 1401) Montería, Departamento de Córdoba | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0308) Meldola, Forli-Cesena | |
| Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 2801) L'Hospitalet Del Llobregat, Barcelona | |
| Institute of hematology&blood disease hospital ( Site 3501) Tianjin, Tianjin Municipality | |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 0414) Porto, | |
| Istituto Oncologico Veneto IRCCS-Oncoematologia ( Site 0306) Castelfranco Veneto, Veneto | |
| Jiangsu Province Hospital ( Site 3507) Nanjing, Jiangsu | |
| Jinan Central Hospital ( Site 3523) Jinan, Shandong | |
| Juntendo University Hospital ( Site 3611) Bunkyo-ku, Tokyo | |
| Kanazawa University Hospital ( Site 3614) Kanazawa, Ishikawa-ken | |
| Kansai Medical University Hospital ( Site 3607) Hirakata, Osaka | |
| Karolinska Universitetssjukhuset Huddinge ( Site 2900) Huddinge, Stockholm County | |
| Kindai University Hospital ( Site 3600) Sakai, Osaka | |
| King's College Hospital ( Site 3308) London, London, City of | |
| Kobe City Medical Center General Hospital ( Site 3603) Kobe, Hyōgo | |
| Kocaeli Üniversitesi-Hematology ( Site 3205) Kocaeli, | |
| Korea University Anam Hospital ( Site 0604) Seoul, | |
| Kyushu University Hospital ( Site 3605) Fukuoka, | |
| Lincoln County Hospital ( Site 3310) Lincoln, Great Britain | |
| Liverpool Hospital-Haematology ( Site 0501) Liverpool, New South Wales | |
| Los Angeles Cancer Network ( Site 3491) Glendale, California | |
| Los Cobos Medical Center ( Site 1404) Bogotá, Bogota D.C. | |
| Martini Ziekenhuis ( Site 2300) Groningen, | |
| Medical University of South Carolina-Hollings Cancer Center ( Site 3426) Charleston, South Carolina | |
| Medipol Mega Universite Hastanesi-oncology ( Site 3203) Istanbul, | |
| Mie University Hospital ( Site 3615) Tsu, Mie-ken | |
| Monash Health-Haematology Research ( Site 0006) Clayton, Victoria | |
| National Cancer Center Hospital East ( Site 3610) Kashiwa, Chiba | |
| National Cheng Kung University Hospital-Clinical Trial Center ( Site 3105) Tainan, | |
| National Hospital Organization Sendai Medical Center ( Site 3617) Sendai, Miyagi | |
| National Taiwan University Hospital ( Site 3101) Taipei, | |
| Nippon Medical School Hospital ( Site 3608) Bunkyo-ku, Tokyo | |
| North Shore Hospital-Department of Haematology ( Site 0051) Auckland, | |
| Okayama University Hospital ( Site 3604) Okayama, | |
| Ondokuz Mayıs Universitesi-hematology ( Site 3206) Samsun, | |
| Optum Care Cancer Center ( Site 3497) Las Vegas, Nevada | |
| Ospedale Mauriziano ( Site 0305) Torino, | |
| Ospedale di Circolo e Fondazione Macchi Varese ( Site 2200) Varese, | |
| Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496) Glendale, Arizona | |
| Peking Union Medical College Hospital ( Site 3531) Beijing, Beijing Municipality | |
| Peking University Third Hospital-Hematology ( Site 3502) Beijing, Beijing Municipality | |
| Petz Aladar Egyetemi Oktato Korhaz ( Site 2000) Győr, Győr-Moson-Sopron | |
| Pratia Onkologia Katowice ( Site 0702) Katowice, Silesian Voivodeship | |
| Queen Mary Hospital ( Site 1901) Hksar, | |
| Rabin Medical Center ( Site 0905) Petah Tikva, | |
| Rambam Health Care Campus ( Site 2102) Haifa, | |
| Roswell Park Cancer Institute ( Site 3421) Buffalo, New York | |
| Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0001) Adelaide, South Australia | |
| Royal Gwent Hospital ( Site 3304) Gwent, Newport | |
| Royal North Shore Hospital ( Site 0003) St Leonards, New South Wales | |
| Royal Perth Hospital-Haematology ( Site 0504) Perth, Western Australia | |
| Royal Prince Alfred Hospital ( Site 1100) Camperdown, New South Wales | |
| Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 0708) Budapest, | |
| Seoul National University Bundang Hospital-Hematology ( Site 0605) Seongnam, Kyonggi-do | |
| Shaanxi provincial people's hospital ( Site 3516) Xi'an, Shaanxi | |
| Sheba Medical Center ( Site 2101) Ramat Gan, | |
| Soroka Medical Center ( Site 2100) Beersheba, | |
| Sourasky Medical Center ( Site 0902) Tel Aviv, | |
| Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 3511) Guangzhou, Guangdong | |
| Spaarne Gasthuis - Hoofddorp-Oncology ( Site 2301) Hoofddorp, North Holland | |
| Stanford Cancer Institute ( Site 0107) Stanford, California | |
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 3524) Guangzhou, Guangdong | |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 2504) Kielce, Świętokrzyskie Voivodeship | |
| Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0706) Nyíregyháza, Szabolcs-Szatmár-Bereg | |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0606) Seoul, | |
| The Christie NHS Foundation Trust ( Site 3307) Manchester, | |
| The First Affiliated hospital of Xiamen University ( Site 3515) Xiamen, Fujian | |
| The First Afflilated Hospital of Bengbu Medical College ( Site 3509) Bengbu, Anhui | |
| The First Hospital of Hebei Medical University ( Site 3510) Shijiazhuang, Hebei | |
| The First Hospital of Jilin University-Hematology ( Site 3526) Changchun, Jilin | |
| The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3505) Nanchang, Jiangxi | |
| The Lundquist Institute ( Site 3423) Torrance, California | |
| The Moncton Hospital-Oncology ( Site 1500) Moncton, New Brunswick | |
| The Second Affiliated Hospital Of Fujian Medical University ( Site 3525) Quanzhou, Fujian | |
| The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3508) Hangzhou, Zhejiang | |
| Trakya University Medical Faculty Hospital-Hematology ( Site 3200) Edirne, | |
| Tufts Medical Center ( Site 3408) Boston, Massachusetts | |
| Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 2600) Lisbon, | |
| Unidade Local de Saude de Braga - Hospital de Braga ( Site 0415) Braga, | |
| Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0402) Dresden, Saxony | |
| Universitetssjukhuset Örebro ( Site 0403) Örebro, Örebro County | |
| University College London Hospital ( Site 3300) London, London, City of | |
| University Medical Center Groningen ( Site 2304) Groningen, | |
| University of Colorado Anschutz Medical Campus ( Site 3425) Aurora, Colorado | |
| University of Michigan ( Site 0008) Ann Arbor, Michigan | |
| University of Miyazaki Hospital ( Site 3609) Miyazaki, | |
| University of Virginia ( Site 3422) Charlottesville, Virginia | |
| University of Yamanashi Hospital ( Site 3606) Chūō, Yamanashi | |
| Universitätsklinikum Aachen ( Site 1801) Aachen, North Rhine-Westphalia | |
| Universitätsklinikum Halle ( Site 0401) Halle, Saxony-Anhalt | |
| VCU Health Adult Outpatient Pavillion ( Site 3416) Richmond, Virginia | |
| VM Medical Park Mersin Hastanesi ( Site 3208) Mersin, | |
| Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400) Winston-Salem, North Carolina | |
| West China Hospital, Sichuan University ( Site 3518) Chengdu, Sichuan | |
| Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0502) Melbourne, Victoria | |
| Wuhan Union Hospital ( Site 3500) Wuhan, Hubei | |
| Yitzhak Shamir Medical Center. ( Site 0901) Ẕerifin, | |
| ZAS Cadix ( Site 1200) Antwerp, | |
| Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 3517) Yiwu, Zhejiang | |
| Zhongshan Hospital,Fudan University-Hematology ( Site 3530) Shanghai, Shanghai Municipality | |
| centre hospitalier lyon sud ( Site 0406) Pierre-Bénite, Rhone |
Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma (CERVINO)
ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com
NCT06158841
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Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
* Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
* Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
* Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
* Urine M-protein \>= 200 mg/24 hours.
* In participants without measurable serum or urine M protein, serum free light chain (FLC) \>= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
* Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
* Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.
Exclusion Criteria:
* Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
* Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
* Central nervous system involvement of MM.
* Has received B-cell maturation antigen (BCMA)-targeted therapy. DRUG: Etentamig, DRUG: Carfilzomib, DRUG: Pomalidomide, DRUG: Elotuzumab, DRUG: Selinexor, DRUG: Bortezomib, DRUG: Dexamethasone
Multiple Myeloma
Cervino, Multiple Myeloma, Etentamig, Carfilzomib, Pomalidomide, Elotuzumab, Selinexor, Bortezomib, Dexamethasone
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Show 166 locations
Study Locations
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| Location | Contacts |
|---|---|
| A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 256808 Turin, Piedmont | |
| AOU Policlinico G. Rodolico - San Marco /ID# 256814 Catania, | |
| ASST Ovest Milanese /ID# 256813 Legnano, Milano | |
| AZ Sint-Jan Brugge /ID# 245345 Bruges, West-Vlaanderen | |
| Addenbrookes Hospital /ID# 261104 Cambridge, Cambridgeshire | |
| Alberts Cellular Therapy /ID# 245725 Pretoria, Gauteng | |
| Alexandra General Hospital /ID# 240591 Athens, Attica | |
| Algemeen Ziekenhuis klina /ID# 260856 Brasschaat, Antwerpen | |
| Alta Bates Summit Medical Center for Research /ID# 261438 Berkeley, California | |
| Anjo Kosei Hospital /ID# 263434 Anjo, Aichi-ken | |
| Antalya Egitim Ve Arastirma Hastanesi /ID# 261674 Antalya, | |
| Atrium Health Levine Cancer Institute /ID# 246199 Charlotte, North Carolina | |
| Auxilio Mutuo Cancer Center /ID# 272565 San Juan, | |
| Azienda Ospedaliero Universitaria delle Marche /ID# 256812 Ancona, | |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 256810 Rome, Roma | |
| Baptist Memorial Hospital /ID# 270910 Memphis, Tennessee | |
| Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891 Lansing, Michigan | |
| Beijing Chaoyang Hospital,Capital Medical University /ID# 245533 Beijing, Beijing Municipality | |
| Beth Israel Deaconess Medical Center /ID# 271535 Boston, Massachusetts | |
| Box Hill Hospital /ID# 262784 Melbourne, Victoria | |
| CH Henri Duffaut /ID# 261844 Avignon, Vaucluse | |
| Calvary Mater Newcastle /ID# 261804 Waratah, New South Wales | |
| Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230 Jacksonville, Florida | |
| Cedars-Sinai Medical Center /ID# 261008 Los Angeles, California | |
| Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637 Bethesda, Maryland | |
| Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 261854 Orléans, | |
| Centre Hospitalier du Mans /ID# 261852 Le Mans, Sarthe | |
| Centrum fuer Haematologie und Onkologie Bethanien /ID# 271982 Frankfurt am Main, | |
| Ch Saint Quentin /Id# 261856 Saint-Quentin, Aisne | |
| Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 260689 Berlin, | |
| Chiba University Hospital /ID# 262006 Chiba, Chiba | |
| China Medical University Hospital /ID# 245483 Taichung, | |
| Chugoku Central Hospital /ID# 263431 Fukuyama, Hiroshima | |
| Cleveland Clinic Main Campus /ID# 246183 Cleveland, Ohio | |
| Complejo Hospitalario Universitario Ourense /ID# 246400 Ourense, Ourense | |
| Constantiaberg Haematology /ID# 261320 Cape Town, Western Cape | |
| Dana-Farber Cancer Institute /ID# 261554 Boston, Massachusetts | |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 261672 Ankara, | |
| Duke University Medical Center /ID# 259694 Durham, North Carolina | |
| Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 262488 London, Greater London | |
| Eastchester Center for Cancer Care /ID# 262952 The Bronx, New York | |
| Fakultni Nemocnice Ostrava /ID# 245686 Ostrava, Ostrava-mesto | |
| Fakultní Nemocnice Brno - Jihlavská /ID# 245689 Brno, Brno-mesto | |
| Fakultní nemocnice Hradec Králové - Sokolská /ID# 245690 Hradec Králové, Hradec Kralove | |
| Falu Lasarett /ID# 262231 Falun, | |
| First Affiliated Hospital of China Medical University /ID# 245547 Shenyang, Liaoning | |
| Fujian Medical University Union Hospital /ID# 245558 Fuzhou, Fujian | |
| Fundacao Champalimaud /ID# 246258 Lisbon, Lisbon District | |
| General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 240596 Athens, | |
| General University Hospital of Thessaloniki AXEPA /ID# 240595 Thessaloniki, | |
| Gifu Municipal Hospital /ID# 263321 Gifu, Gifu | |
| Gunma University Hospital /ID# 262580 Maebashi, Gunma | |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 261648 Győr, Győr-Moson-Sopron | |
| Haemalife Inc. /ID# 245724 Kuils River, Western Cape | |
| Helsingborgs Lasarett /ID# 262513 Helsingborg, Skåne County | |
| Hematology And Oncology Institute /ID# 272531 Manatí, | |
| Henan Cancer Hospital /ID# 245536 Zhengzhou, Henan | |
| Henry Ford Hospital /ID# 262704 Detroit, Michigan | |
| Hospital General Universitario Gregorio Maranon /ID# 246401 Madrid, | |
| Hospital Universitario de Salamanca /ID# 262218 Salamanca, | |
| Hospital Universitario y Politecnico La Fe /ID# 261625 Valencia, | |
| Hospital de Leon /ID# 261624 León, | |
| Hyogo Prefectural Amagasaki General Medical Center /ID# 265696 Amagasaki, Hyōgo | |
| Institute of Hematology and Blood Diseases Hospital /ID# 265702 Tianjin, Tianjin Municipality | |
| Instituto Catalan de Oncologia (ICO) Badalona /ID# 246398 Badalona, Barcelona | |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 246257 Porto, | |
| Istanbul Florence Nightingale Hospital /ID# 271543 Şişli, | |
| Japanese Red Cross Medical Center /ID# 261717 Shibuya-ku, Tokyo | |
| Karmanos Cancer Institute - Detroit /ID# 266298 Detroit, Michigan | |
| Klinik Ottakring /ID# 245829 Vienna, Vienna | |
| Klinikum Chemnitz - Flemmingstraße /ID# 273108 Chemnitz, Saxony | |
| Kyushu University Hospital /ID# 264704 Fukuoka, Fukuoka | |
| Leeds Teaching Hospitals NHS Trust /ID# 261101 Leeds, West Yorkshire | |
| Liverpool Hospital /ID# 262159 Liverpool, New South Wales | |
| Mayo Clinic - Rochester /ID# 246228 Rochester, Minnesota | |
| Mayo Clinic Hospital - Phoenix /ID# 263326 Phoenix, Arizona | |
| Mayo Clinic Hospital Jacksonville /ID# 263324 Jacksonville, Florida | |
| Medical University of South Carolina /ID# 259692 Charleston, South Carolina | |
| Medizinische Universitaet Graz /ID# 261908 Graz, Styria | |
| Miyagi Cancer Center /ID# 265094 Natori-shi, Miyagi | |
| Monash Health - Monash Medical Centre /ID# 262158 Clayton, Victoria | |
| Nagoya City University Hospital /ID# 263320 Nagoya, Aichi-ken | |
| Naha City Hospital /ID# 263972 Naha, Okinawa | |
| Nancy W. Knowles Cancer Center /ID# 271361 Elmhurst, Illinois | |
| National Taiwan University Hospital /ID# 245482 Taipei City, Taipei | |
| Nebraska Cancer Specialists - Omaha - Wright Street /ID# 276772 Omaha, Nebraska | |
| New York Cancer & Blood Specialists - Bay Shore /ID# 261524 Bay Shore, New York | |
| New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953 New Hyde Park, New York | |
| New York Cancer and Blood Specialists - New York /ID# 262951 New York, New York | |
| Northwest Medical Specialties Tacoma /ID# 276281 Tacoma, Washington | |
| Nottingham City Hospital /ID# 261105 Nottingham, Nottinghamshire | |
| Odense University Hospital /ID# 260924 Odense, Region Syddanmark | |
| Oncology Consultants /ID# 276774 Houston, Texas | |
| Ordensklinikum Linz GmbH Elisabethinen /ID# 245609 Linz, Upper Austria | |
| Oregon Medical Research Center /ID# 262335 Portland, Oregon | |
| Our Lady Of The Lake Regional Medical Center /ID# 272780 Baton Rouge, Louisiana | |
| Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 245545 Beijing, Beijing Municipality | |
| People's Hospital of Henan Province /ID# 260918 Zhengzhou, Henan | |
| Princess Alexandra Hospital /ID# 261810 Woolloongabba, Queensland | |
| Providence - St. Jude Medical Center /ID# 262031 Fullerton, California | |
| Rabin Medical Center. /ID# 245498 Petah Tikva, | |
| Regents of the University of Michigan /ID# 261577 Ann Arbor, Michigan | |
| Rocky Mountain Cancer Centers - Lone Tree /ID# 278320 Lone Tree, Colorado | |
| Rush University Medical Center /ID# 265690 Chicago, Illinois | |
| Saitama Prefectural Cancer Center /ID# 262586 Kitaadachi-gun, Saitama | |
| Samsung Medical Center /ID# 245492 Seoul, Seoul Teugbyeolsi | |
| Second Affiliated Hospital of Xian Jiaotong University /ID# 261255 Xi'an, Shaanxi | |
| Semmelweis Egyetem /ID# 261646 Budapest, | |
| Semmelweis Egyetem /ID# 261647 Budapest, | |
| Seoul National University Hospital /ID# 245491 Seoul, Seoul Teugbyeolsi | |
| Shaare Zedek Medical Center /ID# 245681 Jerusalem, Jerusalem | |
| Shanghai Tongji Hospital /ID# 245539 Shanghai, Shanghai Municipality | |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260882 Hangzhou, Zhejiang | |
| Springfield Clinic - First /ID# 262266 Springfield, Illinois | |
| St George Hospital /ID# 261806 Kogarah, New South Wales | |
| St Vincent's Hospital Melbourne /ID# 261808 Fitzroy Melbourne, Victoria | |
| Staedtisches Klinikum Karlsruhe /ID# 272377 Karlsruhe, Baden-Wurttemberg | |
| Sun Yat-Sen University Cancer Center /ID# 245542 Guangzhou, Guangdong | |
| Taichung Veterans General Hospital /ID# 261142 Taichung, | |
| Tel Aviv Sourasky Medical Center /ID# 245495 Tel Aviv, Tel Aviv | |
| Texas Oncology - Northeast Texas /ID# 278304 Tyler, Texas | |
| The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245493 Seoul, Seoul Teugbyeolsi | |
| The Chaim Sheba Medical Center /ID# 245497 Ramat Gan, Tel Aviv | |
| The Christie Hospital /ID# 261102 Manchester, | |
| The First Affiliated Hospital of Nanchang University /ID# 245537 Nanchang, Jiangxi | |
| The First Affiliated Hospital of Soochow University /ID# 245544 Suzhou, Jiangsu | |
| The First Affiliated Hospital of Wenzhou Medical University /ID# 245550 Wenzhou, Zhejiang | |
| The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260883 Hangzhou, Zhejiang | |
| The Royal Marsden NHS Foundation Trust /ID# 262470 London, | |
| The University of Osaka Hospital /ID# 263974 Suita-shi, Osaka | |
| The West Clinic /ID# 262444 Memphis, Tennessee | |
| Tianjin Medical University General Hospital /ID# 260851 Tianjin, Tianjin Municipality | |
| Tokyo Metropolitan Komagome Hospital /ID# 277567 Bunkyo Ku, Tokyo | |
| Trakya University Medical Facu /ID# 261673 Edirne, Istanbul, | |
| Uddevalla sjukhus /ID# 262034 Uddevalla, Västra Götaland County | |
| Ulsan University Hospital /ID# 245490 Ulsan, Ulsan Gwang Yeogsi | |
| Unidade Local de Saude de Santa Maria, EPE /ID# 246255 Lisbon, | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 245549 Wuhan, Hubei | |
| Universitaetsklinikum Freiburg /ID# 262147 Freiburg im Breisgau, Baden-Wurttemberg | |
| Universitaetsklinikum Hamburg-Eppendorf /ID# 260651 Hamburg, | |
| Universitaetsklinikum Krems /ID# 261509 Krems, Lower Austria | |
| University General Hospital Attikon /ID# 240592 Athens, Attica | |
| University Health Network_Princess Margaret Cancer Centre /ID# 261566 Toronto, Ontario | |
| University Hospital Kyoto Prefectural University of Medicine /ID# 262585 Kyoto, Kyoto | |
| University Of Cincinnati Medical Center /ID# 246415 Cincinnati, Ohio | |
| University of Alabama at Birmingham - Main /ID# 261434 Birmingham, Alabama | |
| University of Fukui Hospital /ID# 264222 Yoshida-gun, Fukui | |
| University of Illinois Hospital and Health Sciences System /ID# 246349 Chicago, Illinois | |
| University of Missouri Hospital /ID# 261553 Columbia, Missouri | |
| University of North Carolina /ID# 259854 Chapel Hill, North Carolina | |
| University of Tennessee Health Science Center /ID# 261622 Memphis, Tennessee | |
| University of Yamanashi Hospital /ID# 262912 Chuo-shi, Yamanashi | |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 260168 Lublin, Lublin Voivodeship | |
| Uniwersytecki Szpital Kliniczny We Wroclawiu /ID# 260172 Wroclaw, Lower Silesian Voivodeship | |
| Uniwersyteckie Centrum Kliniczne /ID# 260169 Gdansk, Pomeranian Voivodeship | |
| VA Loma Linda Healthcare System /ID# 261015 Loma Linda, California | |
| VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 261944 Richmond, Virginia | |
| Vanderbilt University Medical Center /ID# 261621 Nashville, Tennessee | |
| Vejle Sygehus /ID# 260923 Vejle, Region Syddanmark | |
| Virginia Cancer Specialists - Fairfax /ID# 262792 Fairfax, Virginia | |
| Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 278314 Norfolk, Virginia | |
| Vseobecna fakultni nemocnice v Praze /ID# 245691 Prague, Praha 17 | |
| Western General Hospital - NHS Lothian /ID# 261106 Edinburgh, Edinburgh, City of | |
| Winship Cancer Institute of Emory University /ID# 262525 Atlanta, Georgia | |
| Yonsei University Health System Severance Hospital /ID# 245489 Seoul, | |
| Zhongda Hospital Southeast University /ID# 245563 Nanjing, Jiangsu |
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)
Study Director - clinicaltrials@beonemed.com
NCT06742996
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Inclusion Criteria:
* Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
* Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis
* Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
* Relapsed or refractory disease after the last line of therapy
* Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
* Adequate organ function
Exclusion Criteria:
* Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
* Prior therapy with BTK degraders
* Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.
* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
* Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
* Known central nervous system involvement by lymphoma
* Clinically significant cardiovascular disease
* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
Note: Other protocol defined Inclusion/Exclusion criteria may apply. DRUG: Sonrotoclax, DRUG: Zanubrutinib, DRUG: Placebo
Mantle Cell Lymphoma, B Cell Lymphoma
mantle cell lymphoma, MCL, relapsed/refractory mantle cell lymphoma, sonrotoclax, BGB-11417
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Show 149 locations
Study Locations
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| Location | Contacts |
|---|---|
| Aichi Cancer Center Hospital Clinical Oncology Nagoya, Aichi-ken | |
| Aidport Sp Z O O Skorzewo, | |
| Antalya Memorial Hospital Dokuma, | |
| Asan Medical Center Seoul, | |
| Atrium Health Levine Cancer Institute (Lci) Charlotte, North Carolina | |
| Atrium Health Wake Forest Baptist Winston-Salem, North Carolina | |
| Auxilio Mutuo Cancer Center San Juan, | |
| Azienda Sanitaria Universitaria Giuliano Isontina Trieste, | |
| Beatson West of Scotland Cancer Centre Glasgow, Scotland | |
| Beijing Cancer Hospital Beijing, | |
| Beijing Hospital Beijing, Beijing Municipality | |
| Box Hill Hospital Clayton, | |
| Centre Hospitalier Universitaire Nantes Hotel Dieu Nantes, | |
| Centroricerche Cliniche Di Verona Srl Verona, | |
| Chiba Cancer Center Chiba, Chiba | |
| Christchurch Hospital Christchurch, | |
| Chu Hopital Lyon Sud PierreBenite, | |
| Chu Montpellier Hopital Saint Eloi Montpellier, | |
| Chu Tours Hopital Bretonneau Tours, | |
| Clatterbridge Cancer Centre Liverpool, | |
| Cleveland Clinic Florida Weston, Florida | |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| Concord Repatriation General Hospital Concord, New South Wales | |
| Dana Farber Cancer Institute Longwood Medical Center Boston, Massachusetts | |
| Dept of Medicine Iii, University Hospitallmu München, | |
| Derriford Hospital Plymouth, | |
| Dokkyo Medical University Saitama Medical Center Saitama, Koshigaya, | |
| Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii Wroclaw, | |
| Duke University Durham, North Carolina | |
| Dunedin Hospital Dunedin, | |
| Etlik City Hospital Ankara, | |
| FUNDALEU Caba, | |
| Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana | |
| Fudan University Shanghai Cancer Center Shanghai, | |
| Fujian Medical University Union Hospital Fuzhou, Fujian | |
| Fundacao Pio Xii Hospital de Amor de Barretos Barretos, São Paulo | |
| Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude Petrópolis, | |
| GenesisCare North Shore St Leonards, New South Wales | |
| H Puerta de Hierro Majadahonda Majadahonda, | |
| Harbin Medical University Cancer Hospital Harbin, Heilongjiang | |
| Hattiesburg Hematology and Oncology Clinic Hattiesburg, Mississippi | |
| Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular São Paulo, | |
| Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital Hiroshima, Hiroshima | |
| Hokkaido University Hospital Sapporo, Hokkaido | |
| Hospital Aleman CABA, | |
| Hospital Clinic de Barcelona Barcelona, | |
| Hospital Do Cancer de Pernambuco Recife, | |
| Hospital Erasto Gaertner Curitiba, | |
| Hospital Felício Rocho Belo Horizonte, Minas Gerais | |
| Hospital Santa Rita de Cassia Afecc Vitória, | |
| Hospital Universitario Fundacion Jimenez Diaz Madrid, | |
| Hospital Universitario de Cordoba Córdoba, | |
| Hospital de Clínicas de Porto Alegre Porto Alegre, | |
| Ico H Duran I Reynals Barcelona, | |
| Institute of Science Tokyo Hospital Tokyo, Bunkyo-ku, | |
| Instituto Joinvilense De Hematologia e Oncologia Joinville, | |
| Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst Meldola, | |
| Jiangsu Province Hospital Nanjing, Jiangsu | |
| Jiangxi Province Cancer Hospital Nanchang, Jiangxi | |
| Kagoshima University Hospital Kagoshima, Kagoshima-ken | |
| Kanagawa Cancer Center Yokohama, Kanagawa | |
| Klinikum Chemnitz gGmbH Chemnitz, | |
| Klinikum der Johann Wolfgang Goethe Universitat Frankfurt am Main, | |
| Kobe City Medical Center General Hospital Kobe, | |
| Kocaeli Universitesi Tip Fakultesi Kocaeli, | |
| Kurashiki Central Hospital Kurashikishi, Okayama-ken | |
| Liaoning Cancer Hospital and Institute Shengyang, Liaoning | |
| Linear Clinical Research Nedlands, Western Australia | |
| Linyi Cancer Hospital Linyi, | |
| MD Anderson Cancer Center Houston, Texas | |
| Matsuyama Red Cross Hospital Ehime, | |
| Mayo Clinic Phoenix Phoenix, Arizona | |
| Mayo Clinic Rochester Rochester, Minnesota | |
| McGlinn Cancer Institute West Reading, Pennsylvania | |
| Medical University Vienna Oncology Vienna, | |
| Memorial Cancer Institute, Memorial Healthcare System Pembroke Pines, Florida | |
| Mission Cancer and Blood Waukee, Iowa | |
| Monash Health Clayton, Victoria | |
| Nanfang Hospital of Southern Medical University Guangzhou, Guangdong | |
| National Hospital Organization Okayama Medical Center Okayama, | |
| Nebraska Cancer Specialists Omaha, Nebraska | |
| Nebraska Cancer Specialists St Francis Grand Island Grand Island, Nebraska | |
| North Shore Hospital Auckland, | |
| Northwest Cancer Specialist, Pc(Us Oncology Research) Vancouver, Washington | |
| Ogaki Municipal Hospital Gifu, | |
| Ohio Health Research Institute Columbus, Ohio | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | |
| One Clinical Research Nedlands, Western Australia | |
| Ordensklinikum Linz GmbH Elisabethinen Linz, | |
| Osaka Metropolitan University Hospital Osaka, | |
| Osaka Red Cross Hospital Osakashi, Osaka | |
| Ospedale Vito Fazzi, Asl Lecce Leece, | |
| Oxford University Hospitals Nhs Trust Churchill Hospital Headington, | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | |
| Perth Blood Institute West Perth, Western Australia | |
| Policlinico Sorsola Malpighi, Aou Di Bologna Bologna, | |
| Pratia MCM Kraków Krakow, | |
| Pusan National University Hospital Busan, | |
| Rockingham Hospital Cooloongup, Western Australia | |
| Rush University Medical Center Chicago, Illinois | |
| Samsung Medical Center Seoul, Gangnam-gu | |
| Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do | |
| Seoul National University Hospital Seoul, Seoul Teugbyeolsi | |
| Severance Hospital Yonsei University Health System SeodaemunGu, Seoul Teugbyeolsi | |
| Shaanxi Provincial Peoples Hospital Xi'an, Shaanxi | |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Chengdu, Sichuan | |
| Stauferklinikum Schwabisch Gmund Kliniken Ostalb Mutlangen, | |
| Sun Yat Sen University Cancer Center Guangzhou, | |
| Sunshine Coast Hospital and Health Service Birtinya, Queensland | |
| Tauranga Hospital Tauranga, | |
| Tennesse Oncology Chattanooga Downtown Chattanooga, Tennessee | |
| Tennessee Oncology Nashville, Tennessee | |
| Texas Oncology Austin Midtown Round Rock, Texas | |
| The Affiliated Hospital of Qingdao University Branch West Coast Qingdao, Shandong | |
| The Affiliated Hospital of Xuzhou Medical University Xuzhou, Jiangsu | |
| The Cancer and Hematology Centers Grand Rapids, Michigan | |
| The Catholic University of Korea, Seoul St Marys Hospital SeochoGu, Seoul Teugbyeolsi | |
| The Catholic University of Korea, Yeouido St Marys Hospital Yeongdeungpo-gu, Seoul Teugbyeolsi | |
| The First Affiliated Hospital of Chongqing Medical University Chongqing, Chongqing Municipality | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan | |
| The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan Hangzhou, Zhejiang | |
| The Royal Bournemouth and Christchurch Hospitals Nhs Foundation Bournemouth, | |
| The Valley Hospital, Inc Paramus, New Jersey | |
| Tohoku University Hospital Sendai, Miyagi | |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan, Hubei | |
| Toyohashi Municipal Hospital Toyohashishi, Aichi-ken | |
| Uk St Poelten Sankt Pölten, | |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei | |
| Universidade de Campinas Centro de Hematologia E Hemoterapia Campinas, | |
| Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg Salzburg, | |
| University College Hospital London, | |
| University Hospitals Cleveland, Ohio | |
| University of Alabama at Birmingham Hospital Birmingham, Alabama | |
| University of Maryland Greenebaum Comprehensive Cancer Center Baltimore, Maryland | |
| University of Michigan Ann Arbor, Michigan | |
| University of Virginia Charlottesville, Virginia | |
| Universitätsklinikum Halle Halle, Saxony-Anhalt | |
| Universitätsklinikum Hamburg Eppendorf Hamburg, | |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Lublin, | |
| VCU Massey Cancer Center Richmond, Virginia | |
| Virgina Cancer Specialists Gainesville, Virginia | |
| Washington University School of Medicine St Louis, Missouri | |
| Wellington Regional Hospital (Ccdhb) Wellington, | |
| Westmead Hospital Westmead, | |
| Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi Lodz, | |
| Yale University, Yale Cancer Center New Haven, Connecticut | |
| Yokohama Municipal Citizens Hospital Yokohama, | |
| hospital Italiano de Buenos Aires Buenos Aires, |
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
Toll Free Number - Trialsites@msd.com
NCT06136650
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
* Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (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 shown by computed tomography (CT)/magnetic resonance imaging (MRI)
* Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer \[mHSPC\] or non-metastatic hormone-sensitive prostate cancer \[nmHSPC\]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer \[mCRPC\] or non-metastatic castration-resistant prostate cancer \[nmCRPC\]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
* Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
* Has ongoing androgen deprivation therapy (ADT) with serum testosterone \<50 ng/dL (\<1.7 nM)
* Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization
* Has adequate organ function
* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
* 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 have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has presence of gastrointestinal condition
* Is unable to swallow capsules/tablets
* Has history of pituitary dysfunction
* Has poorly controlled diabetes mellitus
* Has clinically significant abnormal serum potassium or sodium level
* Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \<110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy
* Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events
* History or family history of long QTc syndrome
* Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment
* Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
* Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)
* Has not adequately recovered from major surgery or have ongoing surgical complications
* Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
* Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention
* Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
* Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
* Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention
* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat
* Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention
* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed
* Active infection requiring systemic therapy
* Has concurrent active Hepatitis B virus and Hepatitis C virus infection DRUG: Opevesostat, DRUG: Dexamethasone, DRUG: Fludrocortisone acetate, DRUG: Hydrocortisone, DRUG: Abiraterone acetate, DRUG: Prednisone acetate, DRUG: Enzalutamide
Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostatic Neoplasms
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Show 323 locations
Study Locations
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| Location | Contacts |
|---|---|
| ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Site 0552) Chaïdári, Attica | |
| Ad-Vance Medical Research-Research ( Site 1177) Ponce, | |
| Addenbrooke's Hospital ( Site 1426) Cambridge, Cambridgeshire | |
| Advance Urology and Laparoscopic Center ( Site 1178) Ponce, | |
| Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1301) Uppsala, Uppsala County | |
| Akita University Hospital ( Site 0728) Akita, | |
| Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0551) Athens, Attica | |
| Aliada-Oncologìa ( Site 1055) Lima, | |
| Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1377) Ankara, | |
| Associated Medical Professionals - Urology ( Site 0081) Syracuse, New York | |
| Auckland City Hospital ( Site 1033) Auckland, | |
| 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 | |
| Azienda Ospedaliera Santa Maria Terni ( Site 1458) Terni, | |
| Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 1456) Foggia, | |
| Baltimore Veterans Affairs Medical Center ( Site 0069) Baltimore, Maryland | |
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1379) Adana, | |
| Beijing Cancer Hospital ( Site 1623) Beijing, Beijing Municipality | |
| Beijing Cancer hospital-Urinary Surgery ( Site 1620) Beijing, Beijing Municipality | |
| Bell Land General Hospital ( Site 0740) Sakai, Osaka | |
| Blue Ridge Cancer Care ( Site 0004) Roanoke, Virginia | |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C ( Site 0630) Miskolc, Borsod-Abauj Zemplen county | |
| Bradfordhill-Clinical Area ( Site 0301) Santiago, Region M. de Santiago | |
| CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 1230) Port Elizabeth, Eastern Cape | |
| CELAN,S.A ( Site 0579) Guatemala City, | |
| CENTRE LEON BERARD ( Site 0459) Lyon Cedex08, Auvergne-Rhône-Alpes | |
| CHU-BREST Cavale Blanche ( Site 0456) Brest, Finistere | |
| CIDO SpA-Oncology ( Site 0302) Temuco, Araucania | |
| CIMCA-Hemato-Oncology ( Site 0380) San José, Provincia de San José | |
| CIO - Centro de Inmuno-Oncología de Occidente ( Site 0928) Guadalajara, Jalisco | |
| CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0256) Fortaleza, Ceará | |
| Cancer and Hematology Centers of Western Michigan ( Site 0005) Grand Rapids, Michigan | |
| Cape Town Oncology Trials ( Site 1233) Cape Town, Western Cape | |
| Cardiomed SRL Cluj-Napoca ( Site 1503) Cluj-Napoca, Cluj | |
| Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0523) Regensburg, Bavaria | |
| Central Ohio Urology Group - Gahanna ( Site 0098) Gahanna, Ohio | |
| Centre Bourgogne ( Site 0464) Lille, Hauts-de-France | |
| Centre Hospitalier de l'Université de Montréal ( Site 0276) Montreal, Quebec | |
| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0454) Clermont-Ferrand, Puy-de-Dome | |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0277) Québec, Quebec | |
| Centro de Investigacion Clinica de Oaxaca ( Site 0934) Oaxaca City, Oaxaca | |
| Centrul de Oncologie "Sfântul Nectarie" ( Site 1501) Craiova, Dolj | |
| Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1334) Taoyuan District, | |
| Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1331) Kaohsiung City, | |
| Charing Cross Hospital-Oncology Research ( Site 1434) London, Hammersmith and Fulham | |
| Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504) Berlin, | |
| Chesapeake Urology ( Site 0009) Towson, Maryland | |
| Chi Mei Medical Center ( Site 1336) Tainan, Tainan | |
| China Medical University Hospital-Department of Urology ( Site 1335) Taichung, | |
| Chongqing University Cancer Hospital ( Site 1603) Chongqing, Chongqing Municipality | |
| Chulalongkorn University ( Site 1355) Bangkok, Bangkok | |
| Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0326) Bogotá, Bogota D.C. | |
| Clinica Universidad Catolica del Maule-Oncology ( Site 0306) Talca, Maule Region | |
| Clínica Imbanaco S.A.S ( Site 0334) Cali, Valle del Cauca Department | |
| Clínica de Neoplasias Litoral ( Site 0269) Itajaí, Santa Catarina | |
| Colorado Clinical Research ( Site 0067) Lakewood, Colorado | |
| Complexo Hospitalario Universitario A Coruna ( Site 1288) A Coruña, La Coruna | |
| Comprehensive Cancer Centers of Nevada ( Site 0010) Las Vegas, Nevada | |
| Cross Cancer Institute (Site 0281) Edmonton, Alberta | Michael Kolinsky - (michael.kolinsky@ahs.ca) |
| Curo Oncology. ( Site 1237) Pretoria, Gauteng | |
| Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0632) Debrecen, | |
| Dunedin Hospital ( Site 1032) Dunedin, Otago | |
| East-Tallinn Central Hospital ( Site 1528) Tallinn, Harju | |
| Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075) Naperville, Illinois | |
| Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074) Elmhurst, Illinois | |
| Ege Universitesi Hastanesi-Medical Oncology ( Site 1380) Izmir, | |
| Emad Ibrahim,MD,INC. ( Site 0012) Redlands, California | |
| Emek Medical Center ( Site 0680) Afula, | |
| Eukarya Pharmasite S.C. ( Site 0939) Monterrey, Nuevo León | |
| FALP ( Site 0303) Santiago, Region M. de Santiago | |
| Faculty of Medicine - Khon Kaen University ( Site 1351) Muang, Changwat Khon Kaen | |
| Faculty of Medicine Siriraj Hospital ( Site 1356) Bangkok, Bangkok | |
| Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0404) Brno, South Moravian | |
| Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0405) Olomouc, | |
| Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0401) Prague, Praha 5 | |
| Filios Alta Medicina ( Site 0931) Monterrey, Nuevo León | |
| First Medical Center of Chinese PLA General Hospital ( Site 1601) Beijing, Beijing Municipality | |
| Florida Cancer Specialists - South ( Site 7003) Fort Myers, Florida | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1452) Milan, Lombardy | |
| Fox Chase Cancer Center ( Site 0076) Philadelphia, Pennsylvania | |
| Fukushima Medical University Hospital ( Site 0758) Fukushima, | |
| Fundación Cardiovascular de Colombia ( Site 0328) Piedecuesta, Santander Department | |
| Fundación Valle del Lili ( Site 0330) Cali, Valle del Cauca Department | |
| Genesis Healthcare System ( Site 0102) Zanesville, Ohio | |
| GenesisCare - Oxford ( Site 1442) Oxford, Oxfordshire | |
| GenesisCare - Windsor ( Site 1443) Windsor, Windsor And Maidenhead | |
| Gifu University Hospital ( Site 0736) Gifu, | |
| Greenebaum Comprehensive Cancer Center ( Site 0049) Baltimore, Maryland | |
| Groupe Hospitalier Paris Saint Joseph ( Site 0465) Paris, | |
| Gustave Roussy ( Site 0452) Villejuif, Val-de-Marne | |
| Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1435) London, London, City of | |
| HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1284) Barcelona, Catalonia | |
| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1283) Pozuelo de Alarcón, Madrid | |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 1376) Ankara, | |
| Hadassah Medical Center ( Site 0683) Jerusalem, | |
| Health Pharma Professional Research S.A. de C.V: ( Site 0929) Mexico City, Mexico City | |
| HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092) Saint Paul, Minnesota | |
| HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072) Saint Louis Park, Minnesota | |
| Henry Ford Hospital ( Site 0015) Detroit, Michigan | |
| Higiea Oncologia ( Site 0938) Mexico City, Mexico City | |
| Hiroshima University Hospital ( Site 0743) Hiroshima, | |
| Hokkaido University Hospital ( Site 0756) Sapporo, Hokkaido | |
| Hong Kong Integrated Oncology Centre ( Site 0603) Central, | |
| Hospital CUF - Tejo ( Site 1157) Lisbon, | |
| Hospital Insular de Gran Canaria-Oncology ( Site 1280) Las Palmas de Gran Canaria, Las Palmas | |
| Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 0903) Kuala Lumpur, | |
| Hospital Mario Penna ( Site 0264) Belo Horizonte, Minas Gerais | |
| Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0379) Santa Ana, Provincia de San José | |
| Hospital Paulistano ( Site 0259) São Paulo, | |
| Hospital Quirón Málaga ( Site 1286) Málaga, | |
| Hospital Santa Rita de Cassia ( Site 0271) Vitória, Espírito Santo | |
| Hospital Sultan Ismail ( Site 0905) Johor Bahru, Johor | |
| Hospital São Domingos ( Site 0258) São Luís, Maranhão | |
| Hospital São Lucas da PUCRS ( Site 0270) Porto Alegre, Rio Grande do Sul | |
| Hospital Universitari Parc Tauli-oncologia ( Site 1282) Sabadell, Barcelona | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0932) Monterrey, Nuevo León | |
| Hospital Universitario de Burgos-Oncología ( Site 1281) Burgos, | |
| Hospital Universitário Evangélico Mackenzie ( Site 0252) Curitiba, Paraná | |
| Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0251) Bragança Paulista, São Paulo | |
| Hospital de Base de São José do Rio Preto ( Site 0275) São José do Rio Preto, São Paulo | |
| Hospital de Cascais Doutor José de Almeida ( Site 1158) Alcabideche, Lisbon District | |
| Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 1576) Kaunas, Kaunas County | |
| Hospital of the University of Occupational and Environmental Health, Japan ( Site 0746) Kitakyushu, Fukuoka | |
| Huadong Hospital Affiliated to Fudan University-Urology ( Site 1613) Shanghai, Shanghai Municipality | |
| Hubei Cancer Hospital-Urinary surgery ( Site 1631) Wuhan, Hubei | |
| Hunan Cancer Hospital ( Site 1630) Changsha, Hunan | |
| Hôpital Foch ( Site 0455) Suresnes, Hauts-de-Seine | |
| ICTRIALS Pesquisa e Desenvolvimento ( Site 0274) Curitiba, Paraná | |
| IMAT S.A.S ( Site 0329) Montería, Departamento de Córdoba | |
| INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1054) Lima, | |
| INTEGRA Cancer Institute-Oncology ( Site 0578) Guatemala City, | |
| IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1052) Lima, | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1454) Meldola, Emilia-Romagna | |
| Illinois Cancer Care ( Site 0104) Peoria, Illinois | |
| Inova Schar Cancer Institute ( Site 0017) Fairfax, Virginia | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0461) Bordeaux, Aquitaine | |
| Institut Català d'Oncologia (ICO) - Girona ( Site 1285) Girona, Gerona | |
| Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0451) Strasbourg, Alsace | |
| Instituto do Câncer Brasil - Unidade Taubaté ( Site 0263) Taubaté, São Paulo | |
| Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1383) Istanbul, | |
| Kagawa University Hospital ( Site 0744) Kita, Kagawa-ken | |
| Kagoshima University Hospital ( Site 0754) Kagoshima, | |
| Kaiser Permanente Riverside Medical Center ( Site 0099) Riverside, California | |
| Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101) Vallejo, California | |
| Kanazawa Medical University Hospital ( Site 0734) Mukai-awagasaki, Ishikawa-ken | |
| Kansai Medical University Hospital ( Site 0739) Hirakata, Osaka | |
| Kaohsiung Veterans General Hospital ( Site 1337) Kaohsiung City, | |
| Karolinska Universitetssjukhuset Solna ( Site 1302) Stockholm, Stockholm County | |
| Kobe University Hospital ( Site 0741) Kobe, Hyōgo | |
| Koc Universitesi Hastanesi ( Site 1384) Istanbul, | |
| Krajská nemocnice Liberec-Department of Urology ( Site 0407) Liberec, Liberec Region | |
| Kyungpook National University Chilgok Hospital-Urology ( Site 1252) Buk-gu, Kyongsangbuk-do | |
| Kyushu University Hospital ( Site 0745) Fukuoka, | |
| LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1236) Pretoria, Gauteng | |
| Liepaja Regional Hospital ( Site 1553) Liepāja, | |
| Los Cobos Medical Center ( Site 0336) Bogotá, Bogota D.C. | |
| MEDI-K ( Site 0576) Guatemala City, | |
| MEDICAL COLLEGE OF WISCONSIN ( Site 0020) Milwaukee, Wisconsin | |
| Macquarie University-MQ Health Clinical Trials Unit ( Site 0214) Macquarie University, New South Wales | |
| Maharaj Nakorn Chiang Mai Hospital ( Site 1353) Muang, Chiang Mai | |
| Marien-Krankenhaus ( Site 0515) Bergisch Gladbach, North Rhine-Westphalia | |
| Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0403) Brno, Brno-mesto | |
| MedStar Washington Hospital Center ( Site 0103) Washington D.C., District of Columbia | |
| Meir Medical Center. ( Site 0682) Kfar Saba, | |
| Memorial Hospital West-Memorial Cancer Institute ( Site 0109) Pembroke Pines, Florida | |
| MidLantic urology ( Site 0022) Bala-Cynwyd, Pennsylvania | |
| Mie University Hospital ( Site 0737) Tsu, Mie-ken | |
| Miyazaki Prefectural Miyazaki Hospital ( Site 0752) Miyazaki, | |
| Monash Health ( Site 0219) Clayton, Victoria | |
| Mount Sinai Cancer Center ( Site 0107) Miami Beach, Florida | |
| Mount Vernon Cancer Centre ( Site 1440) Northwood, England | |
| Nagano Municipal Hospital ( Site 0757) Nagano, | |
| Nanbu Tokushukai Hospital ( Site 0755) Shimajiri, Okinawa | |
| Nanchong Central Hospital-urology ( Site 1647) Nanchong, Sichuan | |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1615) Nanjing, Jiangsu | |
| Nantong Tumor Hospital-Urology ( Site 1609) Nantong, Jiangsu | |
| Nara Medical University Hospital ( Site 0742) Kashihara, Nara | |
| National Cancer Center-Center for Urologic Cancer ( Site 1254) Goyang-si, Kyonggi-do | |
| National Cancer Centre Singapore ( Site 1202) Singapore, Central Singapore | |
| National Cancer Institute ( Site 0904) Putrajaya, Putrajaya | |
| National Cancer Institute ( Site 1577) Vilnius, Vilniaus Miestas | |
| National Hospital Organization Kumamoto Medical Center ( Site 0749) Kumamoto, | |
| National Hospital Organization Nagasaki Medical Center ( Site 0748) Ōmura, Nagasaki | |
| National Hospital Organization Oita Medical Center ( Site 0750) Ōita, | |
| National University Hospital ( Site 1201) Singapore, Central Singapore | |
| Nihon University Itabashi Hospital ( Site 0732) Itabashiku, Tokyo | |
| Ningbo First Hospital-Urology ( Site 1608) Ningbo, Zhejiang | |
| Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0636) Salgótarján, Nógrád megye | |
| North Estonia Medical Centre Foundation ( Site 1526) Tallinn, Harju | |
| Northside Hospital-Northside Hospital Oncology Network ( Site 0100) Atlanta, Georgia | |
| Northwest Cancer Specialists (Compass Oncology) ( Site 8008) Vancouver, Washington | |
| ONCOCENTRO APYS-ACEREY ( Site 0305) Viña del Mar, Valparaiso | |
| Obras Sociais Irma Dulce ( Site 0255) Salvador, Estado de Bahia | |
| Onco Tech, S.A. ( Site 0376) San José, | |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026) Omaha, Nebraska | |
| Oncosalud-Clinical Research ( Site 1057) Lima, | |
| OptumCare Cancer Care-Research Department ( Site 0078) Las Vegas, Nevada | |
| Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0631) Budapest, Pest County | |
| Ospedale Cannizzaro ( Site 1455) Catania, | |
| Ospedale San Raffaele-Oncologia Medica ( Site 1451) Milan, | |
| Pan American Center for Oncology Trials - Ciudadela ( Site 1176) San Juan, | |
| Pauls Stradins Clinical Univeristy Hospital-Urological department ( Site 1551) Riga, | |
| Peking University First Hospital-Urology ( Site 1602) Beijing, Beijing Municipality | |
| Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210) Melbourne, Victoria | |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0304) Santiago, Region M. de Santiago | |
| Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0577) Guatemala City, | |
| Privatna Urologicka Ambulancia ( Site 1478) Trenčín, Trenčín Region | |
| Pusan National University Yangsan Hospital ( Site 1256) Pusan, Kyongsangnam-do | |
| Pärnu Haigla (Site 1550) Pärnu, Pärnumaa | Helis Pokker - (helis.pokker@regionaalhaigla.ee) |
| Queen Mary Hospital ( Site 0602) Hong Kong, | |
| Quemex Medical and Research ( Site 0937) Tlalpan, Mexico City | |
| Rabin Medical Center ( Site 0678) Petah Tikva, | |
| Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083) Charleston, South Carolina | |
| Rambam Health Care Campus-Oncology Division ( Site 0676) Haifa, | |
| Ramsay Santé - Clinical La Croix Du Sud ( Site 0460) Quint-Fonsegrives, Haute-Garonne | |
| Renji Hosp Shanghai Jiaotong U School of Med ( Site 1624) Shanghai, Shanghai Municipality | |
| Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0211) Brisbane, Queensland | |
| Royal Derby Hospital ( Site 1431) Derby, Derbyshire | |
| Rutgers Cancer Institute of New Jersey ( Site 0033) New Brunswick, New Jersey | |
| SC Radiotherapy Center Cluj SRL ( Site 1502) Florești, Cluj | |
| Saga-Ken Medical Centre Koseikan ( Site 0747) Saga, Saga-ken | |
| Sainte Catherine Institut du Cancer Avignon Provence ( Site 0458) Avignon, Vaucluse | |
| Samsun Medical Park Hastanesi-medical oncology ( Site 1382) Samsun, | |
| San Francisco VA Health Care System ( Site 0093) San Francisco, California | |
| Sanatorio Nuestra Senora del Pilar ( Site 0580) Guatemala City, | |
| Sapporo Medical University Hospital ( Site 0726) Sapporo, Hokkaido | |
| Sarawak General Hospital-Radiotherapy Unit ( Site 0901) Kuching, Sarawak | |
| Seoul National University Bundang Hospital-Urology ( Site 1253) Seongnam, Kyonggi-do | |
| Seoul National University Hospital-Urology ( Site 1251) Seoul, | |
| Shaare Zedek Medical Center ( Site 0679) Jerusalem, | |
| Sheba Medical Center ( Site 0677) Ramat Gan, | |
| Singapore General Hospital ( Site 1204) Singapore, Central Singapore | |
| Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0327) Valledupar, Cesar Department | |
| Songklanagarind hospital ( Site 1352) Hat Yai, Changwat Songkhla | |
| Sourasky Medical Center ( Site 0681) Tel Aviv, | |
| Southwest Hospital of Third Military Medical University ( Site 1645) Chongqing, Chongqing Municipality | |
| Spitalul Universitar de Urgență Elias ( Site 1504) Bucharest, Bucharest | |
| Spokane Urology ( Site 0035) Spokane, Washington | |
| St. George's Hospital-Oncology ( Site 1441) London, London, City of | |
| St. Vincent Frontier Cancer Center-Research ( Site 0037) Billings, Montana | |
| St. Vincent's University Hospital ( Site 0652) Dublin, Dublin | |
| Stanford Cancer Center ( Site 0036) Palo Alto, California | |
| Studienpraxis Urologie ( Site 0529) Nürtingen, Baden-Wurttemberg | |
| Sun Yat-sen University Cancer Center-Urology Surgery ( Site 1638) Guangzhou, Guangdong | |
| Sunnybrook Research Institute ( Site 0285) Toronto, Ontario | |
| T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1381) Istanbul, | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1378) Istanbul, | |
| Taichung Veterans General Hospital ( Site 1338) Taichung, | |
| Taipei Veterans General Hospital ( Site 1332) Taipei, | |
| Tallaght University Hospital ( Site 0651) Dublin, | |
| Tan Tock Seng Hospital-Medical Oncology ( Site 1203) Singapore, Central Singapore | |
| Tartu University Hospital-Radiotherapy and oncology ( Site 1527) Tartu, Tartu | |
| Texas Oncology - Central/South Texas ( Site 8003) Austin, Texas | |
| Texas Oncology - DFW ( Site 8001) Dallas, Texas | |
| Texas Oncology - Gulf Coast ( Site 8002) Houston, Texas | |
| The Beatson West of Scotland Cancer Centre ( Site 1428) Glasgow, Glasgow City | |
| The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1255) Seoul, | |
| The Central Hospital of Wuhan ( Site 1635) Wuhan, Hubei | |
| The Christie NHS Foundation Trust ( Site 1436) Manchester, | |
| The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 1639) Fuzhou, Fujian | |
| The First Affiliated Hospital of Wenzhou Medical University ( Site 1604) Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xi'an Jiaotong University-Oncology department ( Site 1618) Xi'an, Shaanxi | |
| The First Hospital of Jiaxing-urology ( Site 1605) Jiaxing, Zhejiang | |
| The Jikei University Hospital ( Site 0731) Minato, Tokyo | |
| The Ottawa Hospital - General Campus ( Site 0286) Ottawa, Ontario | |
| The Royal Cornwall Hospital ( Site 1430) Truro, England | |
| The Second Affiliated Hospital of Xi'an Jiaotong University-Oncology Department ( Site 1619) Xi'an, Shaanxi | |
| The Second Hospital Of Anhui Medical University ( Site 1633) Hefei, Anhui | |
| The Second Hospital of Tianjin Medical University ( Site 1616) Tianjin, Tianjin Municipality | |
| The University of Arizona Cancer Center - North Campus ( Site 0073) Tucson, Arizona | |
| The University of Osaka Hospital ( Site 0738) Suita, Osaka | |
| The West Clinic, PLLC dba West Cancer Center ( Site 0063) Germantown, Tennessee | |
| The first affiliated hospital of Guangzhou medical university ( Site 1637) Guangzhou, Guangdong | |
| Toho University Sakura Medical Center ( Site 0730) Sakura, Chiba | |
| Tongji Hospital Tongji Medical,Science & Technology ( Site 1632) Wuhan, Hubei | |
| Torbay Hospital ( Site 1429) Torquay, Devon | |
| Trillium Health Partners - Credit Valley Hospital ( Site 0289) Mississauga, Ontario | |
| UCHealth Highlands Ranch Hospital ( Site 0111) Highlands Ranch, Colorado | |
| UCLA Hematology/Oncology - Santa Monica ( Site 0044) Los Angeles, California | |
| UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0553) Pátrai, Achaia | |
| UROEXAM ( Site 1479) Nitra, Nitra Region | |
| Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1156) Vila Nova de Gaia, Porto District | |
| Unidade Local de Saude de Braga - Hospital de Braga ( Site 1151) Braga, | |
| Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1153) Lisbon, | |
| Unidade Local de Saude de Santo António - Hospital Santo António ( Site 1152) Porto, | |
| Universidade Federal do Triangulo Mineiro - Hospital de Clinicas ( Site 0262) Uberaba, Minas Gerais | |
| Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0528) Dresden, Saxony | |
| Universitaetsklinikum Freiburg-Klinik für Urologie ( Site 0506) Freiburg im Breisgau, Baden-Wurttemberg | |
| Universitaetsklinikum Heidelberg ( Site 0531) Heidelberg, Baden-Wurttemberg | |
| Universitaetsklinikum Koeln ( Site 0518) Cologne, North Rhine-Westphalia | |
| University College London Hospital ( Site 1437) London, London, City of | |
| University Hospitals Cleveland Medical Center ( Site 0043) Cleveland, Ohio | |
| University Malaya Medical Centre ( Site 0902) Lembah Pantai, Kuala Lumpur | |
| University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114) Sacramento, California | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040) Orange, California | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center (0120) Orange, California | Arash Rezazadeh Kalebasty - (arez@hs.uci.edu) |
| University of Colorado Anschutz Medical Campus ( Site 0046) Aurora, Colorado | |
| University of Colorado Health - Lone Tree Medical Center ( Site 0112) Lone Tree, Colorado | |
| University of Fukui Hospital ( Site 0735) Eiheiji-cho,Yoshida-gun, Fukui | |
| University of Kentucky Chandler Medical Center ( Site 0048) Lexington, Kentucky | |
| University of Miyazaki Hospital ( Site 0751) Miyazaki, | |
| University of Virginia Health System ( Site 0054) Charlottesville, Virginia | |
| Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 0510) Marburg, Hesse | |
| Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Urologie ( Site 0527) Göttingen, Lower Saxony | |
| Urologicum Duisburg (Site 00538) Duisburg, North Rhine-Westphalia | Eva Hellmis - (hellmis@urologicum-duisburg.de) |
| Urology of Indiana - Carmel ( Site 0055) Carmel, Indiana | |
| VCU Health Adult Outpatient Pavillion ( Site 0061) Richmond, Virginia | |
| Virginia Cancer Specialists (VCS) ( Site 8004) Fairfax, Virginia | |
| Vivantes Klinikum Am Urban ( Site 0512) Berlin, | |
| Vseobecna fakultni nemocnice v Praze ( Site 0406) Prague, | |
| West China Hospital, Sichuan University-Urology Surgery ( Site 1642) Chengdu, Sichuan | |
| Westmead Hospital ( Site 0212) Westmead, New South Wales | |
| Wilgers Oncology Centre ( Site 1232) Pretoria, Gauteng | |
| Wits Clinical Research ( Site 1234) Johannesburg, Gauteng | |
| Wuxi People's Hospital ( Site 1612) Wuxi, Jiangsu | |
| Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 1644) Ürümqi, Xinjiang | |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 0064) New Haven, Connecticut | |
| Yantai Yuhuangding Hospital ( Site 1622) Yantai, Shandong | |
| Yokohama City University Medical Center ( Site 0733) Yokohama, Kanagawa | |
| Yunnan Province Cancer Hospital ( Site 1643) Kunming, Yunnan | |
| Zhejiang Provincial People's Hospital-Urology ( Site 1641) Hangzhou, Zhejiang | |
| klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0521) Munich, Bavaria |
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions (ELEMENT-MDS)
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com
NCT05949684
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Inclusion Criteria
* Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and:.
i) \< 5% blasts in bone marrow and \< 1% blasts in peripheral blood.
* Participant is not transfusion dependent (NTD) based on IWG2018 criteria.
* Participant is erythropoiesis-stimulating agent naive. Participants may be randomized at the investigator's discretion if the participant received no more than 2 prior doses of epoetin alfa, epoetin alfa biosimilar, or darbepoetin alfa, with the last dose at least 8 weeks prior to randomization.
* Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L.
* Participant has symptoms of anemia:.
i) Participant records a severity score of "moderate" or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period.
* Participant has a baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. The baseline Hb will be calculated using the mean of the two lowest available Hb measurements within 16 weeks prior to randomization and must include at least one central lab Hb reading done within the screening period (no more than 35 days before randomization). The two Hb measurements must have been performed at least seven days apart. Hb levels less than 21 days following RBC transfusion should not be used. Split samples for local assessments are not required.
Exclusion Criteria
* Participant with secondary MDS (that is, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
* Participant with known history of diagnosis of AML.
* Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to randomization.
* Participant with a history of pure red cell aplasia and/or antibody against erythropoietin.
* Other protocol-defined Inclusion/Exclusion criteria apply.
BIOLOGICAL: Luspatercept, BIOLOGICAL: Epoetin Alfa
Myelodysplastic Syndromes
Luspatercept, BMS-986346, ACE-536, Myelodysplastic Syndrome, Epoetin alfa, Erythropoietin stimulating agent (ESA), Myelodysplastic Syndromes (MDS), Anaemia
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Show 169 locations
Study Locations
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| Location | Contacts |
|---|---|
| ASST Grande Ospedale Metropolitano Niguarda Milan, | |
| Advanced Research Tamarac, Florida | |
| American Oncology Partners, PA Bethesda, Maryland | |
| Arthur J.E. Child Comprehensive Cancer Centre Calgary, Alberta | |
| Austin Health Heidelberg, Victoria | |
| Auxilio Mutuo Cancer Center San Juan, | |
| Azienda Ospedaliera Ordine Mauriziano di Torino Torino, | |
| Azienda Ospedaliera Universitaria Careggi Florence, | |
| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma Verona, | |
| BRCR Global Plantation, Florida | |
| Baptist MD Anderson Cancer Center Jacksonville, Florida | |
| Blacktown Hospital Blacktown, New South Wales | |
| Blue Ridge Cancer Care Roanoke, Virginia | |
| Bradfordhill Santiago, Santiago Metropolitan | |
| CHU Bordeaux Haut-Leveque Pessac, | |
| CHU Grenoble Alpes La Tronche, Isère | |
| Cancer and Blood Specialty Clinic Los Alamitos, California | |
| Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy, | |
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau Tours, Indre-et-Loire | |
| Centre Hospitalier Universitaire d'Angers Angers, | |
| Centre Hospitalier Universitaire de Nice - Hopital L'archet Nice, Alpes-Maritimes | |
| Centro Medico Barrio Parque Buenos Aires, | |
| Centro de Investigacion Clinica de Oaxaca Oaxaca City, | |
| Clínica Inmunocel Santiago, Santiago Metropolitan | |
| Coffs Harbour Health Campus Coffs Harbour, New South Wales | |
| Community Cancer Institute Clovis, California | |
| Compassionate Cancer Care Medical Group Fountain Valley, California | |
| Enroll SpA Santiago, | |
| FALP Santiago, Santiago Metropolitan | |
| Fakultni Nemocnice Ostrava Ostrava, | |
| Fakultní nemocnice Brno Bohunice Brno, Brno-město | |
| Florida Cancer Specialists - North St. Petersburg, Florida | |
| Florida Cancer Specialists - South Fort Myers, Florida | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, | |
| Fondazione Policlinico Tor Vergata Rome, Lazio | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore Roma, | |
| Fundación Cardiovascular de Colombia Piedecuesta, Santander Department | |
| Gemeinschaftspraxis Dres. med. Björn Schöttker & Dominik Pretscher Würzburg, | |
| Gemeinschaftspraxis für Hämatologie und Onkologie Münster Münster, North Rhine-Westphalia | |
| General Hospital of Athens "G. Gennimatas" Athens, Attikí | |
| General Hospital of Athens "Laiko" Goudi, Athens, | |
| Grande Ospedale Metropolitano - Presidio Morelli Reggio Calabria, | |
| Gustave Roussy Villejuif, | |
| Halifax Health Medical Center Daytona Beach, Florida | |
| Hartford Hospital (HH) Hartford, Connecticut | |
| Hattiesburg Clinic Hematology/Oncology Hattiesburg, Mississippi | |
| Hematológica Alta Especialidad SC, consultorio 830 Huixquilucan, | |
| Hemorio Rio de Janeiro, | |
| Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet Eger, Heves County | |
| Hopital Saint-Louis Paris, Île-de-France Region | |
| Hospital Britanico de Buenos Aires Ciudad de Buenos Aires, Buenos Aires | |
| Hospital Clinico de Valencia Valencia, | |
| Hospital La Princesa Madrid, | |
| Hospital Pablo Tobon Uribe Medellín, Antioquia | |
| Hospital Sao Lucas da PUCRS Porto Alegre, Rio Grande do Sul | |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitario Central de Asturias Oviedo, Principality of Asturias | |
| Hospital Universitario Virgen Nieves Granada, | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital Universitario Walter Cantidio Fortaleza, Ceará | |
| Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca Salamanca, | |
| Hospital das Clinicas FMUSP São Paulo, | |
| Humanitas Rozzano, Milano | |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna, | |
| InVO Institut für Versorgungsforschung in der Onkologie Koblenz, Rhineland-Palatinate | |
| Institut Català d'Oncologia - L'Hospitalet L'Hospitalet de Llobregat, Catalunya [Cataluña] | |
| Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE Toulouse, | |
| Instituto Alexander Fleming Buenos Aires, | |
| Instituto Médico de Alta Tecnología S.A.S - IMAT S.A.S Montería, | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City, | |
| John Muir Health - Behring Pavilion Walnut Creek, California | |
| John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey | |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | |
| Kliniken Ostalb, Stauferklinikum Mutlangen, | |
| Local Institution - 0028 Ravenna, Emilia-Romagna | |
| Local Institution - 0029 Parma, | |
| Local Institution - 0030 Beijing, Beijing Municipality | |
| Local Institution - 0031 Orbassano, Piedmont | |
| Local Institution - 0032 Milan, | |
| Local Institution - 0033 Wenzhou, Zhejiang | |
| Local Institution - 0034 Naples, | |
| Local Institution - 0038 Portland, Oregon | |
| Local Institution - 0043 Goyang-si, Kyǒnggi-do | |
| Local Institution - 0048 Shenyang, Liaoning | |
| Local Institution - 0075 Chengdu, Sichuan | |
| Local Institution - 0079 Nanchang, Jiangxi | |
| Local Institution - 0083 Ahmedabad, Gujarat | |
| Local Institution - 0089 Cheongju-si, Chungcheongbuk-do [Chungbuk] | |
| Local Institution - 0095 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0096 Fuzhou Fujian, Fujian | |
| Local Institution - 0097 Nagpur, Maharashtra | |
| Local Institution - 0098 Fort Collins, Colorado | |
| Local Institution - 0103 Drammen, Buskerud | |
| Local Institution - 0108 Wuhan, Hubei | |
| Local Institution - 0109 Hefei, Anhui | |
| Local Institution - 0111 Qingdao, Shandong | |
| Local Institution - 0117 Sapporo, Hokkaido | |
| Local Institution - 0118 Sendai, Miyagi | |
| Local Institution - 0119 Iași, | |
| Local Institution - 0120 Bucharest, Bucharest | |
| Local Institution - 0121 Shimotsuga, Tochigi | |
| Local Institution - 0122 Osaka, | |
| Local Institution - 0123 Bucharest, Bucharest | |
| Local Institution - 0124 Iași, | |
| Local Institution - 0125 Ōsaka-sayama, Osaka | |
| Local Institution - 0126 Amagasaki, Hyōgo | |
| Local Institution - 0177 Barcelona, Catalunya [Cataluña] | |
| Local Institution - 0178 Málaga, | |
| Local Institution - 0185 Montreal, Quebec | |
| Local Institution - 0186 Rochester, New York | |
| Local Institution - 0193 Yokohama, Kanagawa | |
| Local Institution - 0194 Ina-machi, Saitama | |
| Local Institution - 0213 Cologne, North Rhine-Westphalia | |
| Local Institution - 0216 Amsterdam, North Holland | |
| Local Institution - 0217 Sapporo, Hokkaido | |
| Local Institution - 0218 Barcelona, Barcelona [Barcelona] | |
| Local Institution - 0220 Lublin, Lublin Voivodeship | |
| Local Institution - 0223 Mexico City, | |
| Local Institution - 0224 Oaxaca City, Oaxaca | |
| Local Institution - 0230 Daytona Beach, Florida | |
| Local Institution - 0232 Pikeville, Kentucky | |
| Local Institution - 0235 New Delhi, National Capital Territory of Delhi | |
| Local Institution - 0237 San Juan, | |
| Local Institution - 0240 Honolulu, Hawaii | |
| Local Institution - 0242 Hamburg, | |
| Local Institution - 0243 Ahmedabad, Gujarat | |
| Local Institution - 0250 Shanghai, Shanghai Municipality | |
| Local Institution - 0255 Changsha, Hunan | |
| Local Institution - 0261 Luoyang, Henan | |
| Local Institution - 0266 Songkhla, | |
| Local Institution - 0273 Ahmedabad, Gujarat | |
| Local Institution - 0281 Sulton, Surrey, | |
| MTZ Clinical Research powered by Pratia Warsaw, | |
| Metro-Minnesota Community Clinical Oncology Saint Louis Park, Minnesota | |
| Moffitt Cancer Center Tampa, Florida | |
| Monash Health Clayton, Victoria | |
| Northwest Cancer Centers, P.C. Dyer, Indiana | |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Orchard Healthcare Research Inc. Skokie, Illinois | |
| Our Lady of the Lake RMC Baton Rouge, Louisiana | |
| Pindara Private Hospital Benowa, Queensland | |
| Pontchartrain Cancer Center Covington, Louisiana | |
| Pratia Onkologia Katowice Katowice, | |
| Praxis fur Hamatologie und Onkologie Berlin, | |
| Royal Prince Alfred Hospital Camperdown, New South Wales | |
| Semmelweis Egyetem Budapest, | |
| Sociedad De Oncologia Y Hematologia Del Cesar Valledupar, Cesar Department | |
| Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu Wałbrzych, Silesian Voivodeship | |
| St. Joseph Hospital Bethpage, New York | |
| St. Paul's Hospital Vancouver, British Columbia | |
| Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Nyíregyháza, Szabolcs-Szatmár-Bereg | |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus, Ohio | |
| UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) Los Angeles, California | |
| Unidad Médica Onco-Hematológica Puebla City, | |
| Universitaetsklinikum Duesseldorf Düsseldorf, | |
| Universitatsklinikum Jena Jena, | |
| Universitatsklinikum Leipzig Leipzig, | |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Chaïdári, Attikí | |
| University General Hospital of Alexandroupoli Alexandroupoli, Anatolikí Makedonía KAI Thráki | |
| University Hospital of Patras Pátrai, | |
| University of Tennessee Medical Center Knoxville, Tennessee | |
| University of Texas MD Anderson Cancer Center Houston, Texas | |
| Uniwersyteckie Centrum Kliniczne Gdansk, | |
| VCU Health Adult Outpatient Pavillion Richmond, Virginia | |
| Ventura County Hematology Oncology Specialists Oxnard, California | |
| Victoria Hospital & Children's Hospital - London Health Sciences Centre London, Ontario | |
| Vseobecna Fakultni Nemocnice v Praze Prague, | |
| Yale-New Haven Hospital New Haven, Connecticut |
EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
NSABP Department of Site and Study Management Department of Site and Study Management - industry.trials@nsabp.org
NCT06401421
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Inclusion Criteria:
• The participant or a legally authorized representative must provide study-specific informed consent prior to study entry.
• The participant must be ≥ 18 years of age.
• ECOG performance status 0 or 1.
• Histologically confirmed invasive carcinoma of the breast.
• Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
• Tumor size ≥ 2.1 cm in greatest diameter.
• Unifocal or multifocal cancer documented to be the same histologic clinical subtype.
• Clinically node positive or if node negative, any one of the following:
• TNBC or HER2+ subtype
• HR+/HER2-negative with at least one of the following: i. High tumor grade (G3) ii. Ki67 index of 20% or higher iii. High genomic risk (Oncotype DX® (ODX) Breast Recurrence Score of \> 25, MammaPrint® High, etc.)
• Willing and able to comply with the study requirements, which includes the collection of a total of 34 cc (2.5 Tablespoons) of blood for each research blood draw.
• Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay.
Exclusion Criteria:
• Definitive clinical or radiologic evidence of metastatic disease.
• Initiated neoadjuvant therapy for current breast cancer diagnosis.
• Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers.
• Completed all therapy (including endocrine therapy) \<5 years ago for any previous invasive solid organ malignancy (with exception of non-melanoma skin cancers) including prior breast cancer. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment.
• Completed all therapy for any previous hematologic malignancy \< 5 years ago.
• Multicentric or contralateral invasive breast cancers.
• Known pregnancy at time of enrollment.
• Prior solid organ transplant.
• Prior allogeneic hematopoietic stem cell transplant.
DIAGNOSTIC_TEST: ctDNA MRD test
Breast Cancer
Breast Cancer, ctDNA
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Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth East Altamonte Oncology and Hematology Altamonte Springs, Florida | |
| Alan B. Pearson Regional Cancer Center Lynchburg, Virginia | |
| Atrium Health Levine Cancer Institute Charlotte, North Carolina | |
| Atrium Health Wake Forest Baptist Medical Center Winston-Salem, North Carolina | |
| Aultman Timken Family Cancer Center Canton, Ohio | |
| Aurora Cancer Care - Wauwatosa Wauwatosa, Wisconsin | |
| Avera Cancer Institute Sioux Falls, South Dakota | |
| Ballad Health Cancer Center Kingsport, Tennessee | |
| Baptist Cancer Care - Plantation Plantation, Florida | |
| Baptist Health Louisville Louisville, Kentucky | |
| Bon Secours Cancer Institute at St. Francis Midlothian, Virginia | |
| Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec | |
| Cleveland Clinic Main Campus Cleveland, Ohio | |
| Deaconess Chancellor Center for Oncology Newburgh, Indiana | |
| FirstHealth Outpatient Cancer Center Pinehurst, North Carolina | |
| Greater Baltimore Medical Center Baltimore, Maryland | |
| Guthrie Sayre Sayre, Pennsylvania | |
| Harbor-UCLA Medical Center - Hematology / Oncology Torrance, California | |
| Holy Cross Hospital - Silver Spring Silver Spring, Maryland | |
| Hôpital du Saint-Sacrement Québec, Quebec | |
| James M Stockman Cancer Institute Frederick, Maryland | |
| Jewish General Hospital Montreal, Quebec | |
| Joe Arrington Cancer Research & Treatment Center Lubbock, Texas | |
| John Theurer Cancer Center Hackensack, New Jersey | |
| Kaiser Permanente Medical Center Vallejo, California | |
| Katmai Oncology Group - Anchorage Anchorage, Alaska | |
| Lahey Hospital & Medical Center Burlington, Massachusetts | |
| Maisonneuve-Rosemont Hospital (HMR) Montreal, Quebec | |
| McGill University Health - Glen Site Montreal, Quebec | |
| MedStar Georgetown Cancer Institute Baltimore, Maryland | |
| Meritus Center for Clinical Research Hagerstown, Maryland | |
| Metro Minnesota Community Oncology Consortium (MMCORC) Saint Louis Park, Minnesota | |
| Mount Sinai Medical - Comprehensive Cancer Center Miami Beach, Florida | |
| Norton Cancer Institute - Downtown Louisville, Kentucky | |
| Novant Health Cancer Institute - Elizabeth Charlotte, North Carolina | |
| Penn State Cancer Institute Hershey, Pennsylvania | |
| Penn State Health Medical Group - Andrews Patel Harrisburg, Pennsylvania | |
| Rush Cancer Center Chicago, Illinois | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Luke's Hospital of Kansas City Kansas City, Missouri | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Spartanburg Medical Center Spartanburg, South Carolina | |
| St. Elizabeth Edgewood Hospital Edgewood, Kentucky | |
| St. Joseph'S Women'S Hospital Tampa, Florida | |
| Stanford Cancer Institute Palo Alto, California | |
| Stony Brook Medicine Stony Brook, New York | |
| Tate Cancer Center at UM Baltimore Washington Glen Burnie, Maryland | |
| The Center for Cancer and Blood Disorders - Bethesda Bethesda, Maryland | |
| The University of Texas MD Anderson Cancer Center Houston, Texas | |
| UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center Aurora, Colorado | |
| UNC Cancer Care at Nash Rocky Mount, North Carolina | |
| UPMC Magee - Womens Hospital Pittsburgh, Pennsylvania | |
| University of Kansas Cancer Center Kansas City, Kansas | |
| University of Maryland St. Joseph Medical Center Towson, Maryland | |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | |
| WVU Cancer Institute Morgantown, West Virginia | |
| Weinberg Center at Mercy Baltimore, Maryland | |
| Women & Infants Hospital Providence, Rhode Island |
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
ctrrecruit@vcu.edu
NCT04269902
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Inclusion Criteria:
* Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL. Participants must have been diagnosed within 18 months prior to registration
* Participants must have CLL-International Prognostic Index (CLL-IPI) score \>= 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities)
* Cytogenetic AND/OR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accreditation Canada Diagnostics to conduct FISH analyses) laboratory within 18 months prior to registration. At minimum, FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p
* TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) must be obtained within 18 months prior to registration. This sequencing test is distinct from FISH studies for del(17p)
* Note: TP53 gene mutation analysis is recommended but not required if the participant meets disease-related study criteria via a combination of risk factors that totals a score of 4 on the CLL-IPI score and/or has complex cytogenetics completed
* Immunoglobulin heavy chain locus variable (IgVH) gene mutation analysis performed at any CLIA-approved lab (or laboratories accredited under Accreditation Canada Diagnostics) must be obtained prior to registration (at any time prior to registration)
* Serum beta-2 microglobulin level must be obtained within 28 days prior to registration
* Participants must not meet any of the IWCLL specified criteria for active CLL therapy
* Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment
* Steroids used for treatment of conditions other than CLL/SLL must be at a dose of at most 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
* Prior therapy with anti CD20 monoclonal antibodies is not allowed
* Participants must not have received or be currently receiving any prior CLL-directed therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy (with exception of agents approved for emergency access use for the prevention or treatment of COVID-19), or radiotherapy
* Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
* Participants must be \>= 18 years of age
* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Platelet count \>= 100,000/mm\^3 within 28 days prior to registration
* Absolute neutrophil count (ANC) \>= 1,000/mm\^3 within 28 days prior to registration
* Creatinine clearance \>= 30mL/min (by Cockcroft Gault) within 28 days prior to registration
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN) within 28 days prior to registration
* Total bilirubin =\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease), within 28 days prior to registration
* Participants must be able to take oral medications
* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) within 6 months, localized prostate cancer requiring no more than chronic hormonal therapy, or localized breast cancer requiring no more than chronic hormonal therapy
* Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor
* Participants must not have cirrhosis
* Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis during and for 6 months following active protocol therapy with V-O.
* Active infection with hepatitis B or C:
* Active infection is defined as detectable hepatitis B deoxyribonucleic acid (DNA) or hepatitis C ribonucleic acid (RNA) by quantitative polymerase chain reaction (PCR).
* Latent infection with hepatitis B:
* Latent infection is defined as meeting all of the following criteria:
* Hepatitis B surface antigen positive
* Anti-hepatitis B total core antibody positive
* Anti-hepatitis IgM core antibody undetectable
* Hepatitis B PCR undetectable
* Participants with latent hepatitis B infection must agree to take prophylaxis with anti-hepatitis agents during and for 6 months following active protocol therapy with V-O.
* Participants who have received intravenous immunoglobulin (IVIG) therapy within 6 months who are hepatitis B core total antibody positive but PCR undetectable are not mandated to take prophylaxis
* Participants must not have had major surgery within 30 days prior registration or minor surgery within 7 days prior to registration. Examples of major surgery include neurosurgical procedures, joint replacements, and surgeries that occur inside the thoracic or abdomino-pelvic cavities. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. If a participant has had a bone marrow biopsy for diagnosis or evaluation of CLL, this will not exclude the participant from registration to the study. If there is a question about whether a surgery is major or minor, this should be discussed with the Study Chair
* Participants must not have known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
* Participants must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment
* Participants must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5, as venetoclax is extensively metabolized by CYP3A4/5
* Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
* Participants must not have any currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification
* Participants must not have a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
* Participants must not be pregnant or nursing, as there are no safety data available for these drug regimens during pregnancy. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
* Participants must agree to have specimens submitted for translational medicine (MRD) as outlined
* Participants must be offered the opportunity to participate in specimen banking for future research as outlined.
* NOTE: With participant's consent, the site must follow through with specimen submission as outlined
* Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must agree to participate in the quality of life assessments. (Those participants who are unable to read and write in English, Spanish, French, German, Russian or Mandarin may be registered to S1925 without contributing to the quality of life portion of the study.)
* Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, BIOLOGICAL: Obinutuzumab, OTHER: Questionnaire Administration, DRUG: Venetoclax
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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Show 628 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | |
| Adena Regional Medical Center Chillicothe, Ohio | |
| Advanced Breast Care Center PLLC Warren, Michigan | |
| AdventHealth Littleton Littleton, Colorado | |
| AdventHealth Parker Parker, Colorado | |
| AdventHealth Porter Denver, Colorado | |
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | |
| Alaska Women's Cancer Care Anchorage, Alaska | |
| 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 | |
| Allan Blair Cancer Centre Regina, Saskatchewan | |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | |
| Anchorage Oncology Centre Anchorage, Alaska | |
| Anchorage Radiation Therapy Center Anchorage, Alaska | |
| Armes Family Cancer Center Findlay, Ohio | |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Medford Hospital Medford, Wisconsin | |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John, New Brunswick | |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | |
| BCCA-Vancouver Cancer Centre Vancouver, British Columbia | |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Ballad Health Cancer Care - Bristol Bristol, Virginia | Site Public Contact - (charles.mays@balladhealth.org) |
| Ballad Health Cancer Care - Kingsport Kingsport, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Ballad Health Cancer Care - Norton Norton, Virginia | Site Public Contact - (charles.mays@balladhealth.org) |
| Banner North Colorado Medical Center Greeley, Colorado | |
| Banner North Colorado Medical Center - Loveland Campus Loveland, Colorado | |
| 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-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-Union County New Albany, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Bay Area Hospital Coos Bay, Oregon | |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe Medical Center Lewes, Delaware | |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Bellin Memorial Hospital Green Bay, Wisconsin | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| 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 | |
| Blanchard Valley Hospital Findlay, Ohio | |
| Boulder Community Foothills Hospital Boulder, Colorado | |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bristol Regional Medical Center Bristol, Tennessee | |
| Broadlawns Medical Center Des Moines, Iowa | |
| 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 | |
| CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas | |
| Cambridge Medical Center Cambridge, Minnesota | |
| 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 at Saint Joseph's Phoenix, Arizona | |
| Cancer Center of Colorado at Sloan's Lake Denver, Colorado | |
| 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 Partners of Nebraska Lincoln, Nebraska | |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| 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) |
| Caro Cancer Center Caro, Michigan | |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | |
| Central Care Cancer Center - Garden City Garden City, Kansas | |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | |
| Central Ohio Breast and Endocrine Surgery Gahanna, Ohio | |
| Centralia Oncology Clinic Centralia, Illinois | |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Cheyenne Regional Medical Center-West Cheyenne, Wyoming | |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | |
| City of Hope Antelope Valley Lancaster, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Newport Beach Newport Beach, California | |
| City of Hope Seacliff Huntington Beach, California | |
| 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 | |
| City of Hope at Long Beach Elm Long Beach, California | |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.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 | |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Colorado Blood Cancer Institute Denver, Colorado | |
| 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) |
| Community Medical Center Missoula, Montana | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| 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 | |
| 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 | |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| 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 | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| 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 | |
| Delaware Clinical and Laboratory Physicians PA Newark, Delaware | |
| 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) |
| Durham VA Medical Center Durham, North Carolina | |
| ECU Health Oncology Kenansville Kenansville, North Carolina | |
| ECU Health Oncology Kinston Kinston, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| ECU Health Oncology Richlands Richlands, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| 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) |
| 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) |
| FHCC Overlake Bellevue, Washington | |
| FHCC at EvergreenHealth Kirkland, Washington | |
| FHCC at Northwest Hospital Seattle, Washington | |
| Fairbanks Memorial Hospital Fairbanks, Arkansas | |
| Fairfield Medical Center Lancaster, Ohio | |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | |
| Fairview Lakes Medical Center Wyoming, Minnesota | |
| Fairview Northland Medical Center Princeton, Minnesota | |
| Fairview Ridges Hospital Burnsville, Minnesota | |
| Fairview Southdale Hospital Edina, Minnesota | |
| Flaget Memorial Hospital Bardstown, Kentucky | |
| Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Freeman Health System Joplin, Montana | |
| Fremont - Rideout Cancer Center Marysville, California | |
| Geisinger Medical Center Danville, 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 | |
| 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 | |
| Good Samaritan Hospital - Cancer Centers of Colorado Lafayette, Colorado | |
| 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 | |
| Greater Dayton Cancer Center Kettering, Ohio | |
| Greater Regional Medical Center Creston, Iowa | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | |
| HSHS Sacred Heart Hospital Eau Claire, Wisconsin | |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo, Washington | |
| HaysMed Hays, Kansas | |
| Health Partners Inc Minneapolis, Minnesota | |
| Heartland Regional Medical Center Saint Joseph, Missouri | |
| 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) |
| Hematology/Oncology Clinic PLLC Baton Rouge, Louisiana | |
| Hennepin County Medical Center Minneapolis, Minnesota | |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | |
| 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 Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Health Center - Shelby Township Shelby, Michigan | |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Madison Heights Hospital - Breast Warren, Michigan | |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Fairlane Dearborn, Michigan | |
| 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 | |
| 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 | |
| Henry Ford Warren Hospital - GLCMS Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Hickman Cancer Center Adrian, Michigan | |
| 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 | |
| Hope Cancer Clinic Livonia, Michigan | |
| 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) |
| Idaho Urologic Institute-Meridian Meridian, Idaho | |
| Illinois CancerCare - Washington Washington, Illinois | |
| Illinois CancerCare-Bloomington Bloomington, Illinois | |
| Illinois CancerCare-Canton Canton, Illinois | |
| Illinois CancerCare-Carthage Carthage, Illinois | |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | |
| Illinois CancerCare-Galesburg Galesburg, Illinois | |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | |
| Illinois CancerCare-Macomb Macomb, Illinois | |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | |
| Illinois CancerCare-Pekin Pekin, Illinois | |
| Illinois CancerCare-Peoria Peoria, Illinois | |
| Illinois CancerCare-Peru Peru, Illinois | |
| Illinois CancerCare-Princeton Princeton, Illinois | |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Iowa Lutheran Hospital Des Moines, Iowa | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Healthcare Port Townsend, Washington | |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (ctsucontact@westat.com) |
| Jewish General Hospital Montreal, Quebec | |
| Jewish Hospital Louisville, Kentucky | |
| Jewish Hospital Medical Center South Shepherdsville, Kentucky | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@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-Irvine Irvine, California | Site Public Contact - (clinical.trials@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-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Kansas City Veterans Affairs Medical Center Kansas City, Missouri | |
| Katmai Oncology Group Anchorage, Alaska | |
| Kettering Medical Center Kettering, Ohio | |
| Knox Community Hospital Mount Vernon, 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) |
| LSU Health Sciences Center at Shreveport Shreveport, Louisiana | |
| Lakeridge Health Oshawa Oshawa, Ontario | |
| Lakeview Hospital Stillwater, Minnesota | |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | |
| 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) |
| Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania | |
| 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 | |
| Loyola Center for Health at Burr Ridge Burr Ridge, Illinois | |
| Loyola Medicine Homer Glen Homer Glen, Illinois | |
| Loyola University Medical Center Maywood, Illinois | |
| MD Anderson Cancer Center at Cooper-Voorhees Voorhees Township, New Jersey | |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| Macomb Hematology Oncology PC Warren, Michigan | |
| 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 LincolnHealth Hospital Damariscotta, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Margaret R Pardee Memorial Hospital Hendersonville, North Carolina | Site Public Contact - (pardeecancerresearch@unchealth.unc.edu) |
| Marietta Memorial Hospital Marietta, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois | |
| Marshall Cancer Center Cameron Park, California | Site Public Contact - (cancerservices@marshallmedical.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 | |
| 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 | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| 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 Hospital Marysville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Memorial Hospital of Carbondale Carbondale, Illinois | |
| Memorial Medical Center-Las Cruces Las Cruces, New Mexico | Site Public Contact - (Deborah.Brown@LPNT.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 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 - Perrysburg Hospital Perrysburg, Ohio | |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | |
| Mercy Health - Saint Vincent Hospital Toledo, Ohio | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Joplin Joplin, Missouri | |
| 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 Rockville Centre, New York | |
| 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 | |
| Methodist Medical Center of Illinois Peoria, Illinois | |
| Methodist West Hospital West Des Moines, Iowa | |
| Miami Valley Hospital Dayton, Ohio | |
| Miami Valley Hospital North Englewood, Ohio | |
| Miami Valley Hospital South Centerville, Ohio | |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Mid Coast Hospital Brunswick, Maine | Site Public Contact - (ctsucontact@westat.com) |
| Midlands Community Hospital Papillion, Nebraska | |
| Minneapolis VA Medical Center Minneapolis, Minnesota | |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | |
| 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 | |
| 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) |
| Monticello Cancer Center Monticello, Minnesota | |
| Mount Carmel East Hospital Columbus, Ohio | |
| Mount Carmel Grove City Hospital Grove City, Ohio | |
| Mount Carmel Health Center West Columbus, Ohio | |
| Mount Sinai Hospital New York, New York | |
| Mountain Blue Cancer Care Center - Swedish Englewood, Colorado | |
| 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/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | |
| National Jewish Health-Main Campus Denver, Colorado | |
| National Jewish Health-Northern Hematology Oncology Thornton, Colorado | |
| National Jewish Health-Western Hematology Oncology Golden, Colorado | |
| Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska | |
| New Ulm Medical Center New Ulm, Minnesota | |
| Newark Radiation Oncology Newark, Ohio | |
| 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 | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | |
| 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 | |
| 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 University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OSF Saint Anthony's Health Center Alton, Illinois | |
| Ochsner LSU Health Monroe Medical Center Monroe, Louisiana | |
| Ochsner LSU Health Saint Mary's Medical Center Shreveport, Louisiana | |
| 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 | |
| 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) |
| Orion Cancer Care Findlay, Ohio | |
| Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario | |
| 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 | |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | |
| PeaceHealth Southwest Medical Center Vancouver, Washington | |
| PeaceHealth United General Medical Center Sedro-Woolley, Washington | |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Physicians' Clinic of Iowa PC Cedar Rapids, Iowa | |
| Pocono Medical Center East Stroudsburg, Pennsylvania | |
| Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado | |
| Presbyterian Kaseman Hospital Albuquerque, New Mexico | |
| 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) |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | |
| 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 Regional Cancer Partnership Everett, Washington | |
| Providence Regional Cancer System-Aberdeen Aberdeen, Washington | |
| Providence Regional Cancer System-Centralia Centralia, Washington | |
| Providence Regional Cancer System-Lacey Lacey, Washington | |
| 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 | |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | |
| 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) |
| QEII Health Sciences Centre/Nova Scotia Health Authority Halifax, Nova Scotia | |
| Ralph H Johnson VA Medical Center Charleston, South Carolina | Site Public Contact - (ashley.salvo@va.gov) |
| Regions Hospital Saint Paul, Minnesota | |
| Reid Health Richmond, Indiana | |
| Rice Memorial Hospital Willmar, Minnesota | |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riverside Methodist Hospital Columbus, Ohio | |
| Rochester General Hospital Rochester, New York | |
| Rocky Mountain Cancer Centers - Centennial Centennial, Colorado | |
| Rocky Mountain Cancer Centers - Swedish Englewood, Colorado | |
| Rocky Mountain Cancer Centers-Aurora Aurora, Colorado | |
| Rocky Mountain Cancer Centers-Boulder Boulder, Colorado | |
| Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado | |
| Rocky Mountain Cancer Centers-Littleton Littleton, Colorado | |
| Rocky Mountain Cancer Centers-Longmont Longmont, Colorado | |
| Rocky Mountain Cancer Centers-Midtown Denver, Colorado | |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | |
| Rocky Mountain Cancer Centers-Rose Denver, Colorado | |
| Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado | |
| Rocky Mountain Cancer Centers-Thornton Thornton, Colorado | |
| Rose Medical Center Denver, Colorado | |
| 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 | |
| SIH Cancer Institute Carterville, Illinois | |
| 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) |
| SUNY Upstate Medical Center-Community Campus Syracuse, New York | |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon | |
| 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 | |
| Saint Anthony Hospital Lakewood, Colorado | |
| Saint Anthony Regional Hospital Carroll, Iowa | |
| 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 Hospital Greenville, South Carolina | |
| 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 John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital - Cancer Centers of Colorado Denver, Colorado | |
| Saint Joseph Hospital East Lexington, Kentucky | |
| Saint Joseph London London, Kentucky | |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | |
| Saint Joseph Regional Cancer Center Bryan, Texas | |
| Saint Joseph Warren Hospital Warren, Ohio | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | |
| Saint Luke's Hospital Chesterfield, Missouri | |
| Saint Mary Corwin Medical Center Pueblo, Colorado | |
| Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado | |
| Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan | |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Saint Michael Cancer Center Silverdale, Washington | |
| Saint Patrick Hospital - Community Hospital Missoula, Montana | |
| Saint Rita's Medical Center Lima, Ohio | |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| Saint Vincent Healthcare Billings, Montana | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Saints Mary and Elizabeth Hospital Louisville, Kentucky | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sibley Memorial Hospital Washington D.C., District of Columbia | |
| 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 | |
| Sky Ridge Medical Center Lone Tree, Colorado | |
| 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) |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | |
| Springfield Regional Cancer Center Springfield, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Springfield Regional Medical Center Springfield, Ohio | |
| Stanford Cancer Institute Palo Alto Palo Alto, California | |
| State University of New York Upstate Medical University Syracuse, 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 Englewood, Colorado | |
| Swedish Medical Center-Ballard Campus Seattle, Washington | |
| Swedish Medical Center-Cherry Hill Seattle, Washington | |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Carle Foundation Hospital Urbana, Illinois | |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| The Medical Center of Aurora Aurora, Colorado | |
| The Melanoma and Skin Cancer Institute Englewood, Colorado | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| The Women's Imaging Center Denver, Colorado | |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Tibor Rubin VA Medical Center Long Beach, California | |
| TidalHealth Nanticoke / Allen Cancer Center Seaford, Delaware | |
| Toledo Clinic Cancer Centers-Monroe Monroe, Michigan | |
| Toledo Clinic Cancer Centers-Toledo Toledo, Ohio | |
| TriHealth Cancer Institute-Anderson Cincinnati, Ohio | |
| TriHealth Cancer Institute-Westside Cincinnati, Ohio | |
| 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) |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| Tufts Medical Center Cancer Center Stoneham Stoneham, Massachusetts | Site Public Contact - (NCCCR@Tuftsmedicalcenter.org) |
| Tulane University School of Medicine New Orleans, Louisiana | |
| 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) |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.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 | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| United Hospital Saint Paul, Minnesota | |
| Unity Hospital Fridley, Minnesota | |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | |
| 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 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 | |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| 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 Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.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 New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of North Carolina-Hillsborough Campus Hillsborough, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| 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 Rochester Rochester, New York | |
| 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 | |
| Upper Valley Medical Center Troy, Ohio | |
| 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) |
| 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 Radiation Oncology Peru, Illinois | |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Walter Knox Memorial Hospital Emmett, Idaho | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | |
| Wayne Hospital Greenville, Ohio | |
| Welch Cancer Center Sheridan, Wyoming | |
| Wellmont Holston Valley Hospital and Medical Center Kingsport, Tennessee | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Western Illinois Cancer Treatment Center Galesburg, Illinois | |
| Western Surgical Care Denver, Colorado | |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Woodland Memorial Hospital Woodland, California | |
| Wright-Patterson Medical Center Wright-Patterson Air Force Base, Ohio | |
| Zablocki Veterans Administration Medical Center Milwaukee, Wisconsin |
Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma
ctrrecruit@vcu.edu
NCT06337318
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Inclusion Criteria:
* Participants must have a histologically confirmed diagnosis of classic follicular lymphoma (cFL). cFL was previously categorized as grade 1-3A per World Health Organization (WHO)-HAEM4R, but grading of classic follicular lymphoma (FL) is no longer mandatory.
* NOTE: Participants with follicular lymphoma with uncommon features (uFL) are eligible, including FL with diffuse growth pattern (dFL). Diagnosis is as per local pathology. Lymphoma fluorescence in situ hybridization (FISH) is not required. Molecular testing is not required.
* Participants must not have follicular lymphoma with "blastoid" or "large centrocyte" cytological features, or follicular large B-cell lymphoma (FLBL) (previously categorized as follicular lymphoma grade 3B)
* Participants must have low-tumor burden follicular lymphoma defined as:
* Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater diameter
* Involvement of no more than 3 nodal or extra nodal sites with diameter greater than 3 cm.
* Absence of B symptoms which may include unexplained fever, drenching sweats, unintentional weight loss (more than 10% of body weight)
* No symptomatic splenomegaly
* No compression syndrome (ureteral, orbital, gastrointestinal)
* No pleural or peritoneal serous effusion related to follicular lymphoma Participants must have Ann Arbor stage II, III, or IV follicular lymphoma. Participants with stage I disease may be included if they do not wish to undergo radiation or are not candidates for radiation
* Participants must either be experiencing distress due to their disease or would prefer active management of their disease rather than a watch and wait approach
* Participants must have staging imaging performed within 49 days prior to registration, as follows. PET-CT baseline scans are preferred. If a baseline PET-CT scan cannot be obtained, CT scans of the chest, abdomen, and pelvis, along with a bone marrow biopsy, are acceptable. If CT scans are used for staging at baseline, a CT scan of the neck is recommended. All measurable dominant lesions must be assessed within 49 days prior to registration. Tests to assess non-measurable disease must be performed within 49 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form.
* NOTE: if the initial evaluation is insufficient to detect measurable disease, treating investigators may obtain a CT scan with contrast
* Participants must have bi-dimensionally measurable disease (at least one lesion with longest diameter \> 1.5 cm)
* Participants must not have had prior systemic therapy for follicular lymphoma. Radiation therapy for a previous diagnosis of early-stage follicular lymphoma is allowed
* Participant must be ≥ 18 years of age at the time of registration
* Participant must have Zubrod performance status of 0-2
* Participant must have a complete medical history and physical exam within 28 days prior to registration
* Leukocytes ≥ 3 x 10\^3/uL (within 28 days prior to registration)
* Hemoglobin \> 9.0 g/dL (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 ≤ 2 x 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 × institutional ULN (within 28 days prior to registration)
* Participants must have a calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been collected and processed within 28 days prior to registration
* Participants must not have an active or uncontrolled infection before initiation of study treatment in the opinion of the treating investigators
* Participants must not have uncontrolled diabetes within 14 days prior to registration in the opinion of the treating investigators
* Participants must not have uncontrolled blood pressure and hypertension within 14 days prior to registration in the opinion of the treating investigators
* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have 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 while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated. Participants with a positive total hepatitis (Hep) B core antibody and negative hepatitis B virus surface antigen (HBsAg) at screening are at high risk for reactivation and should receive prophylactic antivirals (e.g., entecavir) before and throughout the treatment
* Participants must not have autoimmune disease requiring systemic immunosuppressive therapy
* Participants must not have had undergone organ transplants requiring ongoing systemic immunosuppressive therapy
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated
* Participants must not have known chronic active Epstein Barr Virus infection (CAEBV); testing in asymptomatic participants is not required
* Participants must not have a positive test result for COVID-19 within seven (7) days prior to registration
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not have a history of confirmed progressive multifocal leukoencephalopathy (PML)
* Participants must not have received allogeneic stem cell transplantation
* Participants must not have a history of macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
* 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. Participant must not have significant cardiovascular disease such as class III or IV cardiac disease, myocardial infarction within 6 months prior to registration. Participants with unstable arrhythmias, or unstable angina, should be excluded
* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). 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 considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and 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 registered by participating United States (U.S.) sites must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, BIOLOGICAL: Mosunetuzumab, PROCEDURE: Positron Emission Tomography, BIOLOGICAL: Rituximab, BIOLOGICAL: Rituximab and Hyaluronidase Human
Classic Follicular Lymphoma, Follicular Lymphoma With Unusual Cytological Features
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Study 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) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Atrium Health Cabarrus/LCI-Concord Concord, North Carolina | |
| Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina | |
| Atrium Health University City/LCI-University Charlotte, North Carolina | |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| 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 Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.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) |
| 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@swog.org) |
| 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 | |
| Cedars Sinai Medical Center Los Angeles, California | |
| City of Hope Antelope Valley Lancaster, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| 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 | |
| City of Hope at Long Beach Elm Long Beach, California | |
| 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 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) |
| 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) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| 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 Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute 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 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 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) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Froedtert and MCW Moorland Reserve Health Center New Berlin, Wisconsin | |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| HaysMed Hays, Kansas | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | Site Public Contact - (CTOResearch@hfhs.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 Medical Center-Fairlane Dearborn, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Wyandotte Hospital Wyandotte, Michigan | Site Public Contact - (nhay@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) |
| Hope Cancer Center Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Illinois CancerCare - Washington Washington, Illinois | |
| Illinois CancerCare-Bloomington Bloomington, Illinois | |
| Illinois CancerCare-Canton Canton, Illinois | |
| Illinois CancerCare-Carthage Carthage, Illinois | |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | |
| Illinois CancerCare-Galesburg Galesburg, Illinois | |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | |
| Illinois CancerCare-Macomb Macomb, Illinois | |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | |
| Illinois CancerCare-Pekin Pekin, Illinois | |
| Illinois CancerCare-Peoria Peoria, Illinois | |
| Illinois CancerCare-Peru Peru, Illinois | |
| Illinois CancerCare-Princeton Princeton, Illinois | |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Northwest Portland, Oregon | Site Public Contact - (information@kpchr.org) |
| Kansas City Veterans Affairs Medical Center Kansas City, Missouri | |
| 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) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Levine Cancer Institute-SouthPark Charlotte, North Carolina | |
| 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) |
| 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-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| 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 | 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 | |
| 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) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital West Pembroke Pines, Florida | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| 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) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.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 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 | |
| Novant Health Cancer Institute - Mooresville Mooresville, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Novant Health Forsyth Medical Center Winston-Salem, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| 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) |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Poudre Valley Hospital Fort Collins, Colorado | |
| 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 | |
| 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) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rhode Island Hospital Providence, Rhode Island | |
| 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 Catherine Hospital Indianapolis, Indiana | Site Public Contact - (protocols@swog.org) |
| 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 Luke's Hospital Chesterfield, Missouri | |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sibley Memorial Hospital Washington D.C., District of Columbia | Site Public Contact - (jquiver1@jhmi.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) |
| 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 | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Swedish Covenant Hospital Chicago, Illinois | |
| The Community Hospital Munster, Indiana | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Medical Center - Appleton Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| 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) |
| 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) |
| 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) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (protocols@swog.org) |
| 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) |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.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 Coral Springs Coral Springs, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Doral Doral, Florida | Site Public Contact - (kginnity@med.miami.edu) |
| UM Sylvester Comprehensive Cancer Center at Hollywood Hollywood, 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) |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@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 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 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 Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| 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 Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Miami Sylvester Comprehensive Cancer Center at Sole Mia North Miami, Florida | Site Public Contact - (kginnity@med.miami.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 Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.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) |
| 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) |
| Veteran Administration Eastern Kansas Healthcare Leavenworth, Kansas | Site Public Contact - (protocols@swog.org) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Wake Forest University at Clemmons Clemmons, 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) |
| 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) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| 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) |
Testing the Combination of the Anticancer Drug Durvalumab With Chemotherapy (Gemcitabine and Cisplatin) at Improving Outcomes for High-Risk Resectable Liver Cancer Before Surgery
ctrrecruit@vcu.edu
NCT06050252
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA) that is resectable by imaging evaluation. Choice of staging modality is left up to the discretion of the treatment team; we favor high-quality CT scan of the chest/abdomen/pelvis with liver or biliary protocol. Eligibility will be confirmed through central imaging review.
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 10 mm (\>= 1 cm) with CT scan, MRI, or calipers by clinical exam.
* Patients must be an acceptable risk surgical candidate at the time of enrollment, as determined by a board-certified surgeon with expertise in hepatobiliary surgery.
* High-risk iCCA is defined as the presence of any of these factors:
* Tumor size \> 5 cm.
* Multifocality or satellitosis limited to the same lobe.
* Vascular invasion.
* Suspected or confirmed (via biopsy) regional lymph node metastases.
* Suspected is defined as lymph nodes that are deemed suspicious for metastasis based on large size (criteria vary per anatomical location; 6-10 mm for abdominal and 8-10 mm for pelvic), enhancement pattern, and shape. These may also include lymph nodes that display fludeoxyglucose F 18 (FDG)-avidity on positron emission tomography (PET) scan, if obtained, in the course of disease work-up (not mandatory).
* CA 19-9 \> 200 U/mL.
* Patients are treatment naïve for iCCA.
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of durvalumab (MEDI4736) in combination with cisplatin and gemcitabine in patients \< 18 years of age, children are excluded from this study.
* Body weight \> 30 kg.
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%).
* Leukocytes \>= 3,000/mcL.
* Hemoglobin \>= 9.0 g/dL.
* Absolute neutrophil count \>= 1,500/mcL.
* Platelets \>= 100,000/mcL.
* Neuropathy grade =\< 1 by CTCAE.
* Albumin \>= 2.8 g/dL.
* Serum bilirubin =\< 1.5 x institutional upper limit of normal (ULN).
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 × institutional ULN.
* Serum creatinine =\< 1.5 x institutional ULN.
* Measured creatinine clearance \> 60 mL/min or glomerular filtration rate (GFR) \>= 60 mL/min/1.73 m\^2 (by the Cockcroft-Gault equation).
* 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).
* Life expectancy \>= 12 weeks.
* 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 treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
* 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. If non-protocol anticancer agents for non-study indications is required concurrently with the protocol therapy, the case should be discussed and approved by the study chair and the sponsor (Cancer Therapy Evaluation Program \[CTEP\]).
* 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. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion Criteria:
* Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment.
* Major surgical procedure (as defined by the Investigator) within 14 days prior to the first dose of durvalumab. Note: Local surgery of isolated lesions for palliative intent or biliary stents is acceptable.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
* Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).
* Systemic corticosteroids at physiologic doses not to exceed \<\<10 mg/day\>\> of prednisone or its equivalent.
* Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
* Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of durvalumab.
* Patients who are receiving any other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab, gemcitabine, cisplatin, or other platinum-containing compounds.
* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous.
* Pregnant women are excluded from this study because durvalumab (MEDI4736) is an anti-PD-L1 monoclonal antibody agent with 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, breastfeeding should be discontinued if the mother is treated with durvalumab. These potential risks may also apply to other agents used in this study. Women of child-bearing potential and men 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 for 6 months after durvalumab administration. 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 prior to the study, for the duration of study participation, and 6 months after completion of durvalumab.
* Patients with active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). The following are exceptions to this criterion:
* Patients with vitiligo or alopecia.
* Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement.
* Any chronic skin condition that does not require systemic therapy.
* Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
* Patients with celiac disease controlled by diet alone.
* 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 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 RNA.
* History of allogenic organ transplantation.
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, DRUG: Cisplatin, PROCEDURE: Computed Tomography, BIOLOGICAL: Durvalumab, DRUG: Gemcitabine, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Resection
Resectable Intrahepatic Cholangiocarcinoma
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Study Locations
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| Location | Contacts |
|---|---|
| Boston Medical Center Boston, Massachusetts | |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Los Angeles General Medical Center Los Angeles, California | |
| 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) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| 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 - 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-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) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | |
| 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 Cancer Center - Briarcliff Kansas City, Missouri | |
| 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 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 Texas Health Science Center at San Antonio San Antonio, Texas | |
| 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 Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| 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) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
Toll Free Number - Trialsites@msd.com
NCT06074588
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The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
* Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
* Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
* Measurable disease per RECIST 1.1 as assessed by the local site investigator.
* Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
* Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
* Have an ECOG performance status of 0 or 1 within 3 days before randomization.
Exclusion Criteria:
* Has predominantly squamous cell histology NSCLC.
* Has mixed tumor(s) with small cell elements.
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
* Has Grade ≥2 peripheral neuropathy.
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
* Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
* Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
* Received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of study intervention.
* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
* Received prior treatment with a topoisomerase I-containing ADC.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Active infection requiring systemic therapy.
* History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
* Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable, radiologically stable for at least 4 weeks and do not require glucocorticoids for at least 14 days prior to randomization.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. BIOLOGICAL: Sacituzumab tirumotecan, DRUG: Docetaxel, DRUG: Pemetrexed
Non-small Cell Lung Cancer (NSCLC)
Anaplastic lymphoma kinase (ALK), Antibody-drug conjugate (ADC), Epidermal growth factor receptor (EGFR), Trophoblast cell-surface antigen 2 (TROP2)
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Study Locations
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| Location | Contacts |
|---|---|
| "Theagenio" Cancer Hospital of Thessaloniki ( Site 2703) Thessaloniki, Central Macedonia | |
| A. C. Camargo Cancer Center-CAPEC ( Site 0442) São Paulo, | |
| ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 2704) Chaidari, Athens, Attica | |
| Adana Medical Park Seyhan Hastanesi ( Site 2506) Adana, | |
| Aichi Cancer Center ( Site 3400) Nagoya, Aichi-ken | |
| Anhui Provincial Cancer Hospital ( Site 2830) Hefei, Anhui | |
| Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2501) Ankara, | |
| Aretaieio Hospital ( Site 2702) Athens, Attica | |
| Asan Medical Center ( Site 3801) Seoul, | |
| Asian Hospital and Medical Center ( Site 3605) Muntinlupa, National Capital Region | |
| Asklepios Klinik Harburg ( Site 1403) Hamburg, | |
| Atlantic Health System Morristown Medical Center ( Site 0031) Morristown, New Jersey | |
| Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2810) Beijing, Beijing Municipality | |
| Beijing Peking Union Medical College Hospital-pneumology department ( Site 2815) Beijing, Beijing Municipality | |
| Bradfordhill-Clinical Area ( Site 0507) Santiago, Region M. de Santiago | |
| CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3602) San Juan City, Metro Manila, National Capital Region | |
| CENTRE LEON BERARD ( Site 1305) Lyon Cedex08, Auvergne-Rhône-Alpes | |
| CHU Charles Nicolle-pneumology, intensive care and thoracic oncology ( Site 1300) Rouen, Haute-Normandie | |
| CIO - Centro de Inmuno-Oncología de Occidente ( Site 0706) Guadalajara, Jalisco | |
| Cancer Institute Hospital of JFCR ( Site 3402) Koto, Tokyo | |
| Capital Health Medical Center - Hopewell ( Site 0006) Pennington, New Jersey | |
| Centro Investigacion Cancer James Lind ( Site 0513) Temuco, Región de la Araucanía | |
| Centro de Estudios Clínicos SAGA ( Site 0517) Santiago, Region M. de Santiago | |
| Centro de Investigacion Clinica de Oaxaca ( Site 0701) Oaxaca City, Oaxaca | |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003) Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Chang Gung Memorial Hospital at Kaohsiung ( Site 3906) Kaohsiung City, | |
| Changhua Christian Hospital ( Site 3908) Changhua, | |
| Chi Mei Medical Center ( Site 3910) Tainan, Tainan | |
| Chiba University Hospital ( Site 3411) Chiba, | |
| Chongqing University Cancer Hospital-Medical Oncology ( Site 2814) Chongqing, Chongqing Municipality | |
| Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807) Hwasun, Jeonranamdo | |
| Chungbuk National University Hospital-Internal medicine ( Site 3809) Cheongju-si, North Chungcheong | |
| Chungnam national university hospital ( Site 3808) Junggu, Taejon-Kwangyokshi | |
| Clinica Integral Internacional de Oncología ( Site 0705) Puebla City, | |
| Clinica Universidad Catolica del Maule-Oncology ( Site 0501) Talca, Maule Region | |
| Clinica Universidad de Navarra-Medical Oncology ( Site 2306) Madrid, | |
| Clínica RedSalud Vitacura ( Site 0511) Santiago, Region M. de Santiago | |
| E-Da hospital ( Site 3911) Kaohsiung City, | |
| Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2504) Bornova, İzmir | |
| Englewood Hospital and Medical Center ( Site 0033) Englewood, New Jersey | |
| Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 2705) Athens, Attica | |
| FALP-UIDO ( Site 0509) Santiago, Region M. de Santiago | |
| Faculty of Medicine - Khon Kaen University ( Site 4004) Khon Kaen, | |
| Faculty of Medicine Siriraj Hospital ( Site 4000) Bangkok, Bangkok | |
| Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102) Olomouc, | |
| Fakultni nemocnice Plzen ( Site 1104) Pilsen, Plzeň Region | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800) Milan, Lombardy | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802) Rome, Lazio | |
| Fudan University Shanghai Cancer Center-Oncology ( Site 2811) Shanghai, Shanghai Municipality | |
| Fujian Cancer Hospital ( Site 2819) Fuzhou, Fujian | |
| Fujita Health University Hospital ( Site 3419) Toyoake, Aichi-ken | |
| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444) Barretos, São Paulo | |
| Groupe hospitalier Paris saint Joseph. ( Site 1307) Paris, | |
| Guangxi Medical University Cancer Hospital-Respiratory Oncology ( Site 2816) Nanning, Guangxi | |
| Gunma Prefectural Cancer Center ( Site 3418) Otashi, Gunma | |
| Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2603) London, London, City of | |
| H.R.U Málaga - Hospital General-Oncology ( Site 2302) Málaga, Malaga | |
| HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2304) Barcelona, Catalonia | |
| HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2303) Madrid, Madrid, Comunidad de | |
| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2301) Pozuelo de Alarcón, Madrid | |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500) Ankara, | |
| Hanoi Oncology Hospital ( Site 4102) Hanoi, Hanoi | |
| Harbin Medical University Cancer Hospital-oncology of department ( Site 2807) Harbin, Heilongjiang | |
| Hattiesburg Clinic Hematology/Oncology ( Site 0010) Hattiesburg, Mississippi | |
| Henan Cancer Hospital-henan cancer hospital ( Site 2813) Zhengzhou, Henan | |
| Hong Kong Integrated Oncology Centre ( Site 3200) Central, | |
| Hospital Insular de Gran Canaria-Oncology ( Site 2305) Las Palmas de Gran Canaria, Las Palmas | |
| Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440) Porto Alegre, Rio Grande do Sul | |
| Hospital Paulistano-Americas Oncologia ( Site 0441) São Paulo, | |
| Hospital Raja Perempuan Zainab II-Medical Department ( Site 3502) Kota Bharu, Kelantan | |
| Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2300) Barcelona, | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 0704) Monterrey, Nuevo León | |
| Hubei Cancer Hospital ( Site 2809) Wuhan, Hubei | |
| Hunan Cancer Hospital-thoracic oncology II ( Site 2808) Changsha, Hunan | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1806) Meldola, Emilia-Romagna | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1303) Bordeaux, Aquitaine | |
| Institut Curie-Thorax Institute ( Site 1304) Paris, | |
| Instytut Gruźlicy i Chorób Płuc w Warszawie ( Site 2011) Warsaw, Masovian Voivodeship | |
| Istituto Clinico Humanitas ( Site 1803) Rozzano, Lombardy | |
| Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1805) Rome, Roma | |
| Jilin Province Tumor Hospital-clinical research ( Site 2803) Changchun, Jilin | |
| Jinan Central Hospital-oncology department ( Site 2802) Jinan, Shandong | |
| K Hospital - National Cancer Hospital ( Site 4105) Hanoi, Hanoi | |
| K2 Oncology ( Site 0514) Santiago, Region M. de Santiago | |
| Kanagawa Cancer Center ( Site 3404) Yokohama, Kanagawa | |
| Kanazawa University Hospital ( Site 3414) Kanazawa, Ishikawa-ken | |
| Kangbuk Samsung Hospital ( Site 3813) Seoul, | |
| Kansai Medical University Hospital ( Site 3410) Hirakata, Osaka | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3912) Kaohsiung City, | |
| Karmanos Cancer Institute ( Site 0018) Detroit, Michigan | |
| Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1400) Essen, North Rhine-Westphalia | |
| Klinikum Chemnitz - Flemmingstraße ( Site 1401) Chemnitz, Saxony | |
| Konkuk University Medical Center ( Site 3812) Seoul, | |
| Korea University Guro Hospital-Internal Medicine ( Site 3800) Seoul, | |
| Kyushu University Hospital ( Site 3407) Fukuoka, | |
| Lampang Cancer Hospital ( Site 4005) Muang, Changwat Lampang | |
| Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447) Natal, Rio Grande do Norte | |
| LinYi Cancer Hospital ( Site 2804) Linyi, Shandong | |
| Mackay Memorial Hospital-Chest Medicine ( Site 3902) Taipei, | |
| Maharaj Nakorn Chiang Mai Hospital ( Site 4003) Muang, Chiang Mai | |
| Manila Doctors Hospital-Clinical Trial Office ( Site 3604) Manila, National Capital Region | |
| Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1100) Brno, Brno-mesto | |
| Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001) Jacksonville, Florida | |
| Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027) Rochester, Minnesota | |
| Medipol Mega Universite Hastanesi-oncology ( Site 2505) Stanbul, Istanbul | |
| Mid Florida Hematology and Oncology Center ( Site 0005) Orange City, Florida | |
| Miyagi Cancer Center ( Site 3416) Natori-shi, Miyagi | |
| Monash Health-Oncology Research ( Site 3001) Clayton, Victoria | |
| Nanjing Drum Tower Hospital ( Site 2812) Nangjing, Jiangsu | |
| Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002) Gliwice, Silesian Voivodeship | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000) Warsaw, Masovian Voivodeship | |
| National Cancer Center Hospital East ( Site 3406) Kashiwa, Chiba | |
| National Cancer Center-Lung Cancer Center ( Site 3810) Goyang-si, Kyonggi-do | |
| National Cancer Institute-Radiotherapy and Oncology ( Site 3504) Putrajaya, Kuala Lumpur | |
| National Cheng Kung University Hospital ( Site 3909) Tainan, | |
| National Hospital Organization Kyushu Medical Center ( Site 3412) Fukuoka, | |
| National Hospital Organization Shikoku Cancer Center ( Site 3415) Matsuyama, Ehime | |
| National Lung Hospital-Oncology Department ( Site 4104) Hanoi, Hanoi | |
| National Taiwan University Cancer Center (NTUCC) ( Site 3903) Taipei City, Taipei | |
| National Taiwan University Hospital - Hsinchu branch ( Site 3907) Hsinchu, | |
| National Taiwan University Hospital-Oncology ( Site 3904) Taipei, | |
| Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni odd ( Site 1103) Ostrava, Ostrava Mesto | |
| Niigata Cancer Center Hospital ( Site 3405) Niigata, Niigata | |
| Nippon Medical School Hospital ( Site 3408) Tokyo, | |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003) Marietta, Georgia | |
| Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0446) São Paulo, | |
| ONCOCENTRO APYS-ACEREY ( Site 0500) Viña del Mar, Región de Valparaíso | |
| Okayama University Hospital ( Site 3417) Okayama, | |
| Orlandi Oncologia-Oncology ( Site 0504) Santiago, Region M. de Santiago | |
| Osaka International Cancer Institute ( Site 3413) Osaka, | |
| Papageorgiou General Hospital of Thessaloniki ( Site 2701) Thessaloniki, | |
| Pontificia Universidad Catolica de Chile ( Site 0502) Santiago, Region M. de Santiago | |
| Princess Margaret Cancer Centre ( Site 0204) Toronto, Ontario | |
| Princess Margaret Hospital-Department of Oncology ( Site 3201) Lai Chi Kok, | |
| Pusan National University Hospital ( Site 3805) Busan, Pusan-Kwangyokshi | |
| Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3811) Yangsan, Kyongsangnam-do | |
| Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204) Kowloon, | |
| Queen Mary Hospital ( Site 3203) Hksar, | |
| ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2606) London, Kensington and Chelsea | |
| Rabin Medical Center ( Site 1703) Petah Tikva, | |
| Rambam Health Care Campus-Oncology Division ( Site 1702) Haifa, | |
| Royal Marsden Hospital (Sutton) ( Site 2605) Sutton, Surrey | |
| ST. LUKE'S MEDICAL CENTER ( Site 3601) Quezon City, National Capital Region | |
| Samsung Medical Center-Division of Hematology/Oncology ( Site 3802) Seoul, | |
| Sarawak General Hospital-Radiotherapy Unit ( Site 3500) Kuching, Sarawak | |
| Sendai Kousei Hospital ( Site 3401) Sendai, Miyagi | |
| Seoul National University Bundang Hospital ( Site 3806) Seongnam, Kyonggi-do | |
| Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 3804) Seoul, | |
| Shaare Zedek Medical Center ( Site 1700) Jerusalem, | |
| Shanghai Chest Hospital-Oncology department ( Site 2800) Shanghai, Shanghai Municipality | |
| Shizuoka Cancer Center ( Site 3403) Nagaizumi-cho,Sunto-gun, Shizuoka | |
| Sichuan Cancer hospital. ( Site 2822) Chengdu, Sichuan | |
| Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 2828) Hangzhou, Zhejiang | |
| Songklanagarind hospital ( Site 4001) Hat Yai, Changwat Songkhla | |
| Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2818) Guangzhou, Guangdong | |
| St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2600) London, London, City of | |
| St. George Private Hospital ( Site 3004) Kogarah, New South Wales | |
| Sunpasitthiprasong Hospital-Oncology ( Site 4002) Ubon Ratchathani, | |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2005) Kielce, Świętokrzyskie Voivodeship | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502) Istanbul, | |
| THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 3600) Iloilo City, Iloilo | |
| THE MEDICAL CITY-Cancer Research Center ( Site 3603) Pasig, National Capital Region | |
| THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2700) Athens, Attica | |
| Taipei Medical University Hospital ( Site 3900) Taipei, | |
| Takarazuka City Hospital ( Site 3409) Takarazuka, Hyōgo | |
| Tennessee Oncology (0036) Nashville, Tennessee | Tamjeed Ahmed - (tahmed@tnonc.com) |
| The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3803) Suwon, Kyonggi-do | |
| The Christie NHS Foundation Trust ( Site 2604) Manchester, | |
| The Clatterbridge Cancer Centre ( Site 2602) Metropolitan Borough of Wirral, | |
| The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2817) Xi'an, Shaanxi | |
| The First Affiliated hospital of Xiamen University ( Site 2820) Xiamen, Fujian | |
| The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2821) Nanchang, Jiangxi | |
| The Second Xiangya Hospital of Central South University ( Site 2827) Changsha, Hunan | |
| Tongji Hospital Tongji Medical,Science & Technology ( Site 2805) Wuhan, Hubei | |
| UCLA Hematology/Oncology - Santa Monica ( Site 0023) Los Angeles, California | |
| Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1402) Dresden, Saxony | |
| Universitaetsklinikum Freiburg ( Site 1405) Freiburg, Brandenburg | |
| University Of Nebraska Medical Center ( Site 0011) Omaha, Nebraska | |
| University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015) Cincinnati, Ohio | |
| University of Texas MD Anderson (0037) Houston, Texas | Yasir Elamin - (yyelamin@mdanderson.org) |
| Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Hämatologie und Medizinische On ( Site 1407) Göttingen, Lower Saxony | |
| VCU Health Adult Outpatient Pavillion ( Site 0026) Richmond, Virginia | |
| Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1105) Prague, | |
| West China Hospital, Sichuan University-Lung cancer center ( Site 2826) Chengdu, Sichuan | |
| Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003) Melbourne, Victoria | |
| Westmead Hospital ( Site 3000) Westmead, New South Wales | |
| William Osler Health System ( Site 0205) Brampton, Ontario | |
| Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2009) Torun, Kuyavian-Pomeranian Voivodeship | |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001) Przemyśl, Podkarpackie Voivodeship | |
| Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2806) Wuhan, Hubei | |
| Yunnan Province Cancer Hospital ( Site 2824) Kunming, Yunnan | |
| Zhejiang Cancer Hospital ( Site 2829) Hangzhou, Zhejiang |
Pancreatic Cancer Early Detection Consortium (PRECEDE)
Naveen Fawas, BS - naveen.fawaz@arborresearch.org
NCT04970056
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Inclusion Criteria:
Individuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE database:
Cohort 1
Individuals without history of PDAC meeting any of the following criteria:
• 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis.
• 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
• BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family
• Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
• Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
• Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+ Cohort 2 Individuals without history of PDAC meeting any of the following criteria:
• ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
• 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family
• 1 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member Cohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2) Cohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort. Cohort 5 Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort. Cohort 6a Individuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria:
• Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
• Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11 Cohort 6b Individuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria:
• Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
• Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
• Diagnosed ≤ age 45 Cohort 6c Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b. Cohort 6d Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c. Cyst Cohort Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)
Exclusion Criteria:
* Individuals not meeting the criteria above. Pancreas Cancer, Pancreas Cyst, Pancreatic Ductal Adenocarcinoma, Genetic Predisposition
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Study Locations
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| Location | Contacts |
|---|---|
| Azienda Ospedaliera Universitaria Integrata Verona Verona, | Salvatore Paiella - (salvatore.paiella@univr.it) Erica Secchettin - (erica.secchettin@univr.it) |
| Beaumont/Corewell Health Royal Oak, Michigan | Tara Rangarajan - (tara.rangarajan@corewellhealth.org) |
| British Columbia Cancer Agency Vancouver, British Columbia | Eugene Cheung - (eugene.cheung1@bccancer.bc.ca) |
| Cedars-Sinai Medical Center Beverly Hills, California | Liliana Bancila - (liliana.bancila@cshs.org) |
| City of Hope Duarte, California | Diamond Ward - (diward@coh.org) |
| Columbia University Irving Medical Center New York, New York | Katharine Godfrey - (kb3217@cumc.columbia.edu) |
| Emory University Hospital Atlanta, Georgia | Halley Fowler - (halley.fowler@emory.edu) |
| Epworth Healthcare Melbourne, Victoria | Ashleigh Poh - (ashleigh.poh@epworth.org.au) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | Eberechukwu Muoneke - (eberechukwu.muoneke@fccc.edu) |
| Hackensack Meridian Health Hackensack, New Jersey | Christianna Torres - (christianna.torres@hmhn.org) |
| Hoag Newport Beach, California | Alexandria Adams - (alexandria.adams@hoag.org) Zulma Loera - (zulma.loera@hoag.org) |
| Honor Health Research Institute Scottsdale, Arizona | Jeanette Dupree - (jdupree@honorhealth.com) |
| Hospital Clinic de Barcelona Barcelona, | Eva Vaquero - (evaquero@clinic.cat) |
| Hospital Universitari Arnau de Vilanova Lleida, Lerida | Xavier Molero - (xmolero@gss.cat) |
| Huntsman Cancer Institute Salt Lake City, Utah | Jo Lyman - (jo.anson@hci.utah.edu) |
| Icahn School of Medicine at Mount Sinai New York, New York | Joyce Serebrenik - (joyce.serebrenik@mountsinai.org) Storey Harbison - (storey.harbison@mssm.edu) |
| Illinois CancerCare Peoria, Illinois | Carrie Geoffroy - (cgeoffroy@illinoiscancercare.com) |
| Inova Schar Cancer Institute Fairfax, Virginia | Stephanie Van Bebber - (Stephanie.VanBebber@inova.org) |
| Intermountain Health Murray, Utah | Maricel Purcell - (hrcancerprevention@imail.org) |
| Landspitali University Hospital Reykjavik, | Jóhanna Stefansdottir - (johanste@landspitali.is) |
| MD Anderson Center Houston, Texas | |
| Massachusetts General Hospital Boston, Massachusetts | Danielle Lynch - (dlynch22@mgh.harvard.edu) |
| Mayo Clinic Arizona Phoenix, Arizona | Michele Richardson - (richardson.michele@mayo.edu) |
| Mayo Clinic Jacksonville Jacksonville, Florida | Christian Glover - (glover.christian@mayo.edu) |
| McGill University Health Centre Montreal, Quebec | Adeline Cuggia - (pancreas.surveillance@muhc.mcgill.ca) |
| Memorial Sloan Kettering Cancer Center New York, New York | Jeffin Naduparambil - (naduparj@mskcc.org) |
| Moffitt Cancer Center Tampa, Florida | Toni Basinski - (Toni.Basinski@Moffitt.Org) |
| National Cancer Centre Singapore Singapore, | Caitlin Nicole - (caitlin.nicole.s.v@nccs.com.sg) Meggie Huang Mochao - (meggie.huang.m.c@nccs.com.sg) |
| National Cheng Kung University Hospital (NCKUH) Tainan, Taiwan T.o.c. | Yung-Yeh Su - (yysu@nhri.edu.tw) |
| National Taiwan University Hospital Taipei, | Wei-Chih David Liao - (david.ntuh@gmail.com) |
| NorthShore University Healthsystem Evanston, Illinois | Aram Rojas - (arojas@northshore.org) |
| Oregon Health & Science University Portland, Oregon | Dove Keith - (keithd@ohsu.edu) |
| Providence Health and Services Burbank, California | Taridu Ekanayake - (emtaridu.ekanayake@providence.org) |
| Ramón y Cajal University Hospital Madrid, | Julie Earl - (julie.earl@live.co.uk) |
| Semmelweis University, Institute of Pancreatic Diseases Budapest, | Zoltán Hajnády - (hajnady.zoltan@semmelweis.hu) |
| Sheba Medical Center Ramat Gan, | Maria Raitses - (Maria.RaitsesGurevich@sheba.health.gov.il) |
| The Ohio State University Columbus, Ohio | Angela Lontoc - (angela.lontoc@osumc.edu) |
| The University of Texas Southwestern Medical Center Dallas, Texas | |
| UC Davis Sacramento, California | Anthony Martinez - (axmartinez@ucdavis.edu) |
| UC Irvine Health Orange, California | Luong Vy - (vyl8@hs.uci.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Emma Vail - (e2brooks@health.ucsd.edu) |
| UCLA Health Los Angeles, California | Aletta Deranteriassian - (aderanteriassian@mednet.ucla.edu) |
| UMass Memorial Medical Center Worcester, Massachusetts | Paige Malone - (paige.malone@umassmed.edu) |
| University Health Network Toronto, Ontario | Spring Holter - (spring.holter@uhn.ca) |
| University of California, San Francisco (UCSF) San Francisco, California | Kurt Giles - (PancreasCRC@ucsf.edu) |
| University of Chicago Medicine Chicago, Illinois | Nia Howard - (nia.howard@bsd.uchicago.edu) |
| University of Kansas Medical Center Kansas City, Kansas | Na Yu - (nyu3@kumc.edu) |
| University of Liverpool Liverpool, | Annabelle Boughey - (europac@liverpool.ac.uk) |
| University of Miami Miami, Florida | Casper Ruiz Ruiz - (cxr1353@med.miami.edu) |
| University of Michigan Ann Arbor, Michigan | Sarah Volk - (stomanic@med.umich.edu) Erika Koeppe - (eskoeppe@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Suzanne Wessling - (suzanne.wessling@unmc.edu) |
| University of Pennsylvania Philadelphia, Pennsylvania | Danny Clay - (Daniel.Clay@Pennmedicine.upenn.edu) |
| University of Pittsburgh Medical Center (UPMC) Pittsburgh, Pennsylvania | Beth Dudley - (dudleyre@upmc.edu) |
| University of Rochester Medical Center Rochester, New York | Soha Shabooti - (soha_shabooti@urmc.rochester.edu) |
| University of Tennessee Graduate School of Medicine Knoxville, Tennessee | Tiffany Johnson - (thjohnson@utmck.edu) |
| University of Virginia Charlottesville, Virginia | Evelyn Garcia - (ev4pd@uvahealth.org) |
| University of Washington Seattle, Washington | Lisa Ann Lai - (LLai@medicine.washington.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Tyler Phillips - (phillipst5@vcu.edu) |
| White Plains Hospital White Plains, New York | Griselda Cruz - (grcruz@wphospital.org) |
| Yale University New Haven, Connecticut | Scott Merenda - (scott.merenda@yale.edu) |
Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation
Massey IIT Research Operations - masseyepd@vcu.edu
NCT06966388
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Inclusion Criteria:
Age ≥ 18 years
* Self-reports as Black, Asian, Hispanic/Latin, ethnically originating from the Mediterranean rim or Pacific rim, or she/he tans easily in the sun
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 1, Section 18)
* Attestation by the patient that she/he is not pregnant, lactating, or planning to become pregnant, or planning to father a baby during the study period
* Histologic confirmation of breast malignancy (with TNM staging) If the patient did not receive adjuvant chemotherapy, adjuvant radiation must start within 180 days of lumpectomy or mastectomy. If the patient received adjuvant chemotherapy, adjuvant radiation should start within 60 days of the last dose of chemotherapy
* Treatment plan includes one of the following:
* Conventionally fractionated whole breast radiation (45-50 Gray in 25 fractions)
* Moderately hypofractionated whole breast radiation (42.56 Gray in 16 fractions or 40 Gray in 15 fractions)
* Conventionally fractionated chest wall radiation (45-50 Gray in 25 fractions)
* Partial breast radiation (42.56 Gray in 16 fractions, 40 Gray in 15 fractions, or 30 Gray in 5 fractions) if using 3D conformal radiation or if the tumor is located close to the skin surface
* Treatment of the regional lymph nodes, a tumor bed boost (4-8 fractions), and use of tissue-equivalent bolus on the chest wall may be included at the discretion of the treating physician.
* Radiation will be photon-based. Note: If the patient receives a boost, photons and/or electrons may be used at the discretion of the treating physician.
Exclusion Criteria:
* Prior radiotherapy to any portion of the planned treatment site
* Current inflammatory breast cancer or gross dermal involvement at initiation of radiotherapy
* Concomitant immunotherapy or cytotoxic chemotherapy. Concomitant HER2 directed therapy or concomitant endocrine therapy is allowed
* Active rash or dermatitis within the treatment field, or a history of any rash or dermatologic condition within the treatment field
* Active collagen vascular diseases (ie lupus erythematosus, scleroderma, dermatomyositis)
* History of organ transplant or bone marrow transplant
* History of hypersensitivity or allergic reaction to any ingredients in the topical azelaic acid formulation
* Has used within 28 days prior to baseline:
* topical retinoids to the breast
* oral retinoids
* systemic (oral or injectable) antibiotics known to have an impact on the severity of skin rash or sun-sensitivity (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim)
* systemic corticosteroids or immunosuppressive drugs, except as part of standard chemotherapy treatment or used for an IV contrast allergy
* Has used on treated breast within 2 weeks prior to baseline:
* topical corticosteroids
* topical antibiotics
* topical medications for skin rash (eg, metronidazole, azelaic acid)
* Radiation therapy will be proton therapy or carbon therapy
* External beam partial breast irradiation, brachytherapy partial breast irradiation, or intraoperative radiation are included in the treatment plan Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements DRUG: Azelaic Acid
Breast Cancer
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Massey CTO CPC Team - (MasseyCPC@vcu.edu) |
Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial
ctrrecruit@vcu.edu
NCT05554328
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Inclusion Criteria:
* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N4 based on the presence of an actionable mutation as defined in EAY191
* Patients must be enrolled on the ComboMATCH Master Registration Trial EAY191
* Patients must have RAS pathway mutations as determined by the ComboMATCH screening assessment
* Cohort 1: Patients with histologically confirmed RAS pathway mutant ovarian, primary peritoneal, or fallopian tube ("ovarian") cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1)
* Cohort 2: Patients with histologically confirmed RAS pathway mutant endometrial cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1)
* Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)
* Patients must have progressed after first-line treatment for recurrent or persistent disease
* Patients with ovarian cancer should not be eligible for further platinum-based therapy
* Patients with endometrial cancer must have received or been offered an immune oncology agent (alone or in combination with lenvatinib) unless there are existing contraindications for immune oncology agents or lenvatinib
* Patients may have received unlimited prior therapy
* Patients must have measurable and biopsiable disease. Measurable disease is defined by RECIST 1.1 as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \> 10 mm when measured by CT, magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \> 20 mm when measured by chest x-ray. Lymph nodes must be \> 15 mm in short axis when measured by CT or MRI
* Patients must have at least one "target lesion" separate from the lesion to be biopsied to be used to assess response on this protocol as defined by RECIST version 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
* Prior therapy must have been completed at least four weeks prior to registration
* Age \>= 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* Hemoglobin (Hgb) \>= 9.5 g/dL with no blood transfusion in the past 28 days (within 14 days prior to registration)
* Platelets \>= 100,000/mcl (within 14 days prior to registration)
* Absolute neutrophil count (ANC) \>= 1,500/mcl (within 14 days prior to registration)
* Patients must have creatinine clearance estimated of \>= 50 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test (within 14 days prior to registration)
* Total bilirubin level =\< 1.5 x institutional upper limit of normal (ULN) or =\< 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) (within 14 days prior to registration)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN (within 14 days prior to registration)
* Patients must be able to swallow and retain oral medications and be without gastrointestinal illnesses that would preclude absorption of selumetinib or olaparib
* 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
* Women of childbearing potential (WOCBP) must agree to use two forms of birth control (hormonal or barrier method of birth control; abstinence) during the study and for 6 months after completing treatment
* Non-sterilized male partners of WOCBP (including males sterilized by a method other than bilateral orchidectomy e.g., vasectomy) who intend to be sexually active with a female partner must be using an acceptable method of contraception such as male condom plus spermicide (condom alone in countries where spermicides are not approved) from the time of screening throughout the total duration of the study and the drug washout period (at least 6 months after the last dose of study intervention) to prevent pregnancy in a partner. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Vasectomized (i.e., sterile) males are considered fertile and should still use a male condom plus spermicide as indicated above during the clinical study
* 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
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
* Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load 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 new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy
* Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression
* Extra caution should be taken with olaparib, as it crosses the blood brain barrier and can cause edema in brain metastases
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Exclusion Criteria:
* Patients who have received any MEK inhibitors
* Patients who have progressed while receiving a PARP inhibitor
* Patients who have received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
* Patients with uncontrolled intercurrent illness
* Patients with \>= grade 2 neuropathy within 14 days of registration
* Patients with severe (Child-Pugh C) liver dysfunction
* Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib and selumetinib or any excipients thereof
* Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents
* Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E
* Vitamin E must not be taken in the 7 days prior to initiation of treatment with selumetinib
* Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or known moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, Fluconazole, verapamil). The required washout period prior to starting olaparib is at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication
* Concomitant use of strong CYP2C19 inhibitors (e.g., ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole). The required washout period prior to starting selumetinib is at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication
* Have received or are receiving an investigational medicinal product (IMP) or other systemic anti-cancer treatment (including chemotherapy, immunotherapy, targeted therapy, biologic therapy, tumor embolization, or monoclonal antibodies) within 4 weeks prior to registration, or within a period during which the IMP or systemic target treatment has not been cleared from the body (e.g., a period of 5 'half-lives'), whichever is longer
* Known myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
* Patients who have had previous organ transplant, allogenic bone marrow transplant or double umbilical cord blood transplantation
* Patients who have had whole blood transfusion within 28 days prior to registration
* Patients with ophthalmological conditions as follows:
* Current or past history of retinal pigment epithelial detachment/central serous retinopathy or retinal vein occlusion.
* Intraocular pressure \> 21 mmHg (or ULN adjusted by age) or uncontrolled glaucoma (irrespective of intraocular pressure \[IOP\]). Subjects with known glaucoma and increased IOP who do not have meaningful vision (light perception only or no light perception) and are not experiencing pain related to the glaucoma, may be eligible after discussion with the study chair
* Patients with any other significant abnormality on ophthalmic examination should be discussed with the study chair for potential eligibility
* Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN) (such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study
* Patients with severe, active co-morbidity defined as any of the following:
* History and/or confirmed pneumonitis
* Uncontrolled hypertension (blood pressure \[BP\] \>= 150/90 mmHg despite medical therapy)
* Acute coronary syndrome within 6 months prior to registration
* Uncontrolled atrial fibrillation
* Known family history of long QT syndrome
* Women who are pregnant or unwilling to discontinue nursing PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration and Biopsy, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, PROCEDURE: Multigated Acquisition Scan, DRUG: Olaparib, DRUG: Selumetinib Sulfate
Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
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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 | |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Annie Penn Memorial Hospital Reidsville, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| 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) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.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) |
| CTCA at Western Regional Medical Center Goodyear, Arizona | |
| 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) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Carilion Roanoke Memorial Hospital Roanoke, Virginia | |
| 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) |
| 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) |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (Roster@nrgoncology.org) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.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) |
| Cone Health Cancer Center Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health Cancer Center at Alamance Regional Burlington, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health Cancer Center at Drawbridge Parkway Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health MedCenter Asheboro Asheboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.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 | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dayton Physician LLC - Englewood Dayton, Ohio | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| 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) |
| 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 Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| 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) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| Henrico Doctor's Hospital Richmond, Virginia | |
| Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Hope Women's Cancer Centers-Asheville Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.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) |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (Roster@nrgoncology.org) |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| 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) |
| Licking Memorial Hospital Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.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) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marietta Memorial Hospital Marietta, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Memorial Hospital Marysville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| 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 Westchester Harrison, New York | |
| 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 | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Medical Center - Des Moines 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 Englewood, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| 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) |
| Mount Carmel East Hospital Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| National Institutes of Health Clinical Center Bethesda, Maryland | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Ochsner Baptist Medical Center New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| 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 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) |
| 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) |
| 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 | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Pennsylvania Hospital Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Presbyterian Intercommunity Hospital Whittier, California | |
| 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 System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@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 Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Puerto Rico Hematology Oncology Group Bayamón, | |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Rapid City Regional Hospital Rapid City, South Dakota | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riddle Memorial Hospital Media, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| 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 Ann's Hospital Westerville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| 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 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 | |
| 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 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) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southern Ohio Medical Center Portsmouth, Ohio | Site Public Contact - (Jeffh@columbusccop.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) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| State University of New York Upstate Medical University Syracuse, 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 Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | Site Public Contact - (rohta@queens.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) |
| Tufts Medical Center Cancer Center Stoneham Stoneham, Massachusetts | Site Public Contact - (NCCCR@Tuftsmedicalcenter.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UH Seidman Cancer Center at Saint John Medical Center Westlake, 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 | |
| UPMC Altoona Altoona, 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 - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@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 | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@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 Hawaii Cancer Center Honolulu, Hawaii | |
| University of Illinois Chicago, Illinois | |
| 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 Miami Sylvester Comprehensive Cancer Center at Sole Mia North Miami, Florida | Site Public Contact - (kginnity@med.miami.edu) |
| University of Michigan - Brighton Center for Specialty Care Brighton, Michigan | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.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 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) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.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) |
| 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) |
| 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 Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Women and Infants Hospital Providence, Rhode Island |
Trial Readiness and Endpoint Assessment in Pediatric Myotonic Dystrophy Extension (TREAT-EXT)
Ruby Langeslay, MPH - Ruby.Langeslay@vcuhealth.org
NCT06747884
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Inclusion Criteria (Congenital Myotonic Dystrophy Group):
* Age 5-17 years, 11 months at enrollment. Lower age limit not applicable for participants who have completed ASPIRE-DM1 protocol. Upper age limit not applicable for participants who previously participated in TREAT-01-001 (TREAT-CDM) study
* A diagnosis of CDM, defined as: children having symptoms of myotonic dystrophy in the newborn period (\<30 days), such as hypotonia, feeding or respiratory difficulty, requiring hospitalization to a ward or to the neonatal intensive care unit for more than 72 hours; and a genetic test confirming an expanded trinucleotide (CTG) repeat in the DMPK gene in the child or mother. An expanded CTG repeat size in the child is considered greater than 200 repeats or E1-E4 classification (E1= 200-500, E2=500-1,000, E3=1,000-1,500, E4\>1,500).
* Written, voluntary informed consent must be obtained before any study related procedures are conducted.
Inclusion Criteria (Childhood Myotonic Dystrophy Group):
* Age 3-17 years, 11 months at enrollment. Upper age limit not applicable for participants who previously participated in TREAT-01-001 (TREAT-CDM) study.
* A diagnosis of ChDM, defined as: children having cognitive deficits, muscle weakness, myotonia that developed after age 1 and prior to age 10 and a genetic test confirming an expanded trinucleotide (CTG) repeat in the DMPK gene in the child or mother. An expanded CTG repeat size in the child is considered greater than 200 repeats or E1-E4 classification (E1= 200-500, E2=500-1,000, E3=1,000-1,500, E4\>1,500).
* Written, voluntary informed consent must be obtained before any study related procedures are conducted.
Exclusion Criteria:
* Any other non-DM1 illness that would interfere with the ability to undergo safe testing or would affect the interpretation of the results, in the opinion of the site investigator
* Significant trauma within the past month
* Internal metal or devices (exclusion for DEXA component)
* Use of anticoagulants, such as warfarin or a direct oral anticoagulant (e.g., dabigatran) due to the increased risk of bleeding with biopsy
* Platelet count \<50,000
* History of a bleeding disorder
* Participation in a clinical trial involving an investigational product
* History of adverse reaction to lidocaine (if participating in muscle biopsy) Congenital Myotonic Dystrophy, Childhood Myotonic Dystrophy, Myotonic Dystrophy
DM1, Childhood Myotonic Dystrophy, Congenital Myotonic Dystrophy, Myotonic Dystrophy, Myotonia, Dystrophy Myotonic, DMCRN, TREAT-EXT, TREAT CDM
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Shantel Kyles - (shantel.brown@vcuhealth.org) Levi Headrick - (levi.headrick@vcuhealth.org) |
Improving Traumatic Brain Injury Rehab Care With Comm Health Services: a Research Project Within the TBI Model System
Katherine Abbasi - katherine.walker@vcuhealth.org
NCT06188364
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Inclusion Criteria:
* Participants must be adults (age 18 or older).
* Must be primary person responsible for supervision/care needs of person with TBI post-IRF discharge.
* The person with TBI must have been admitted to the Brain Injury Service Unit at SAI.
* If the care partner does not live in the same residence as the person with TBI, they must provide multiple daily check-ins on day-to-day care.
* Must agree to use mHealth (texts, calls) and possess or be eligible to acquire a smart phone.
Exclusion Criteria:
* Any severe cognitive impairment that precludes the ability to provide informed consent or safely function as the care partner for a vulnerable adult with TBI. OTHER: Standard of Care, OTHER: Experimental
Traumatic Brain Injury
Community Health Services, Rehabilitation Care Transitions, Caregiver Supports
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Katherine Abbasi - (katherine.walker@vcuhealth.org) Daniel Klyce - (daniel.klyce@vcuhealth.org) |
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
Patient Advocacy - Duchenne@regenxbio.com
NCT05693142
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Part 1 - Key
Inclusion Criteria:
* The participant's legal guardian(s) is (are) willing and able to provide written, signed informed consent prior to any study-related procedures; and, where applicable, the minor participant has provided written or verbal assent according to local requirements.
* Is a male at least 4 years of age and less than 12 years of age at consent or 1 to \<4 years of age at the time of dosing and ≥ 10 kg at the time of screening.
* Must meet any of the following criteria:
* DMD gene mutation in exons 18 and above, and a clinical picture consistent with typical DMD with the exception of a participant (Cohort 1b) with DMD gene mutation in exons 12-17.
* Participant is able to walk 100 meters independently without assistive devices. Cohort 2c participant must be able to walk 10 meters independently without assistive devices. Cohort 1b participant must be able to walk with or without assistive devices.
* Participant is able to complete the TTSTAND per protocol-specific criteria.
* Participant has been on a stable dose of systemic glucocorticoids according to the standard of care for at least 12 weeks. Cohort 2c participants must be consistently on or off a stable dose of systemic glucocorticoids according to the standard of care for at least 12 weeks.
* Clinical laboratory test results, including hepatic and renal function, are within the normal range during screening, or if abnormal, are not clinically significant, in the opinion of the investigator.
* Documentation is provided at screening visit for participant's adherence to the local country's vaccination schedule. The parent(s) or legal guardian(s) must be willing to have their child receive a meningococcal vaccine, if not already vaccinated.
* Participant and parent(s)/legal guardian(s) are willing and able to comply with scheduled visits, study intervention administration plan, and study procedures.
Part 2 and 3 Inclusion Criteria:
* The participant's legal guardian(s) is (are) willing and able to provide written, signed informed consent prior to any study-related procedures; and, where applicable, the minor participant has provided written or verbal assent according to local requirements.
* DMD gene mutation with any mutation except for those with deletions or point mutations in exons 8, 9 and/or 10.
* Participant is able to complete the TTSTAND per protocol-specific criteria.
* Clinical laboratory test results, including hepatic and renal function, are within the normal range during screening, or if abnormal, are not clinically significant, in the opinion of the investigator.
* Documentation is provided at screening visit for participant's adherence to the local country's vaccination schedule. The parent(s) or legal guardian(s) must be willing to have their child receive a meningococcal vaccine, if not already vaccinated.
* Participant and parent(s)/legal guardian(s) are willing and able to comply with scheduled visits, study intervention administration plan, and study procedures.
* Is a male at least 1 year of age and ≥ 10 kg at the time of screening.
* Participants 1 to \<4 years of age must meet the following criteria:
* is able to walk 10 meters independently without assistive devices.
* must be consistently on or off a stable dose of systemic glucocorticoids according to the standard of care for at least 12 weeks.
* Participants 4 years and older must meet the following criteria:
* are able to walk 100 meters independently without assistive devices.
* have been on a stable dose of systemic glucocorticoids according to the standard of care for at least 12 weeks.
* have a NSAA total score ≥16.
Part 1 Exclusion Criteria:
* Participant has any condition that would contraindicate treatment with immunosuppression.
* Participant has received ataluren (a protein restoration therapy) or an exon-skipping therapy for the treatment of DMD within 6 months of study entry or is unable to refrain from taking ataluren or exon-skipping therapy for a duration of 5 years from the time of RGX-202 administration.
* Participant has received any investigational or commercial gene therapy product over his lifetime.
* Participant is currently taking any other investigational intervention (other than corticosteroids) or has taken any other investigational intervention (other than corticosteroids) within 3 months prior to the scheduled Day 1 intervention. If your corticosteroid is vamorolone, the participant will be asked to temporarily convert his daily dosing to prednisolone/prednisone during a short period of time around RGX-202 administration. He will be allowed to revert back to his baseline vamorolone regimen at the original per kilogram dose at which he entered the study and should remain on this for 24 months unless the investigator determines that this is not clinically indicated or possible.
* Participant has impaired cardiac function defined as a left ventricular ejection fraction of \< 55% on screening cardiac assessments (echocardiogram or MRI).
* Participant is not a good candidate for the study, in the opinion of the investigator.
Part 2 and 3 Exclusion Criteria:
* Participant has any condition that would contraindicate treatment with immunosuppression.
* Participant has received givinostat within 3 months of study entry or has received ataluren (a protein restoration therapy) or an exon-skipping therapy for the treatment of DMD within 6 months of study entry or is unable to refrain from taking ataluren or exon-skipping therapy for a duration of 5 years from the time of RGX-202 administration.
* Participant has received any investigational or commercial gene therapy product over his lifetime.
* Participant is currently taking any other investigational intervention (other than corticosteroids) or has taken any other investigational intervention (other than corticosteroids) within 3 months prior to the scheduled Day 1 intervention. If your corticosteroid is vamorolone, the participant will be asked to temporarily convert his daily dosing to prednisolone/prednisone during a short period of time around RGX-202 administration. He will be allowed to revert back to his baseline vamorolone regimen at the original per kilogram dose at which he entered the study and should remain on this for 24 months unless the investigator determines that this is not clinically indicated or possible.
* Participant has detectable AAV8 total binding antibodies in serum.
* Participant has impaired cardiac function defined as a left ventricular ejection fraction of \< 55% on screening cardiac assessments echocardiogram or MRI).
* Participant is not a good candidate for the study, in the opinion of the investigator. GENETIC: RGX-202
Duchenne Muscular Dystrophy
Gene therapy, DMD, Duchenne Muscular Dystrophy, Duchenne
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| Location | Contacts |
|---|---|
| Alberta Children's Hospital Calgary, Alberta | Israt Yasmeen, MBT - (Israt.Yasmeen@ahs.ca) |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | Nicole Geanous - (ngeanous@luriechildrens.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | Amber Evans - (evansa17@archildrens.org) |
| BC Children's Hospital Vancouver, British Columbia | Nela Martic - (NMartic3@cw.bc.ca) |
| Children's Hospital Colorado Aurora, Colorado | Michele Yang - (Michele.Yang@childrenscolorado.org) Hannah Kleiner - (Hannah.Kleiner@childrenscolorado.org) |
| Children's Hospital London Health Science Centre London, Ontario | Rhiannon Hicks - (rhiannon.hicks@lhsc.on.ca) |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | Laura Thompson - (lathompson@cheo.on.ca) |
| Children's Hospital of Richmond at Virginia Commonwealth University Richmond, Virginia | Falgun Patel - (Falgun.Patel@vcuhealth.org) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Erika Paradiso - (proud.research@chkd.org) |
| Cincinnati Children's Cincinnati, Ohio | Angela Edmondson - (Angela.Edmondson@cchmc.org) |
| Oregon Health & Science University Portland, Oregon | Beata Dyar - (dyar@ohsu.edu) |
| Rare Disease Research Atlanta, Georgia | Lily Goggans - (lily.goggans@rarediseaseresearch.com) Maureen Ikpeoha - (maureen.ikpeoha@rarediseaseresearch.com) |
| Stanford School of Medicine /Division of Neuromuscular Medicine Palo Alto, California | - (neuromuscularresearch@stanford.edu) |
| The University of Texas Southwestern Medical Center Dallas, Texas | Elaine Most - (elaine.most@utsouthwestern.edu) |
| University of Florida Gainesville, Florida | Melissa Lewis - (melissa.lewis@peds.ufl.edu) |
| University of Iowa Iowa City, Iowa | Laura Knosp - (laura-knosp@uiowa.edu) |
| University of Massachusetts Chan Medical School Worcester, Massachusetts | Tyler Mola - (tyler.mola@umassmed.edu) |
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Clinical Trial Disclosure & Transparency - ClinicalTrialDisclosure@JazzPharma.com
NCT06282575
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Inclusion Criteria
• Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC).
• Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.
• Received no more than 2 cycles of systemic therapy which is limited to Cisplatin and Gemcitabine (CisGem) with or without a PD-1/L1 inhibitor (physician's choice of durvalumab or pembrolizumab, where approved under local regulations) for advanced unresectable or metastatic disease.
• HER2-positive disease (defined as IHC 3+; or IHC 2+/ ISH+) by IHC and in situ Hybridization (ISH) assay (in participants with IHC 2+ tumors) at a central laboratory on new biopsy tissue or archival tissue from the most recent biopsy.
• Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.
• Male or female ≥ 18 years or age (or the legal age of adulthood per country-specific regulations).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function
• Females of childbearing potential must have a negative pregnancy test result.
• Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control. Exclusion Criteria
• Prior treatment with a HER2-targeted agent
• Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
• The following BTC histologic subtypes are excluded: small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and mucinous cystic neoplasms detected in the biliary tract region.
• Use of systemic corticosteroids.
• Brain metastases
• Severe chronic or active infections
• History of allogeneic organ transplantation.
• Active or prior autoimmune inflammatory conditions
• History of interstitial lung disease or non-infectious pneumonitis.
• Participation in another clinical trial with an investigational medicinal product within the last 3 months.
• Females who are breastfeeding
• Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
• Use of phenytoin
• Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC).
• Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.
• Received no more than 2 cycles of systemic therapy which is limited to Cisplatin and Gemcitabine (CisGem) with or without a PD-1/L1 inhibitor (physician's choice of durvalumab or pembrolizumab, where approved under local regulations) for advanced unresectable or metastatic disease.
• HER2-positive disease (defined as IHC 3+; or IHC 2+/ ISH+) by IHC and in situ Hybridization (ISH) assay (in participants with IHC 2+ tumors) at a central laboratory on new biopsy tissue or archival tissue from the most recent biopsy.
• Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.
• Male or female ≥ 18 years or age (or the legal age of adulthood per country-specific regulations).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function
• Females of childbearing potential must have a negative pregnancy test result.
• Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control. Exclusion Criteria
• Prior treatment with a HER2-targeted agent
• Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
• The following BTC histologic subtypes are excluded: small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and mucinous cystic neoplasms detected in the biliary tract region.
• Use of systemic corticosteroids.
• Brain metastases
• Severe chronic or active infections
• History of allogeneic organ transplantation.
• Active or prior autoimmune inflammatory conditions
• History of interstitial lung disease or non-infectious pneumonitis.
• Participation in another clinical trial with an investigational medicinal product within the last 3 months.
• Females who are breastfeeding
• Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
• Use of phenytoin
DRUG: Zanidatamab, DRUG: Cisplatin, DRUG: Gemcitabine, DRUG: Pembrolizumab, DRUG: Durvalumab
Biliary Tract Cancer
JZP598, ZW25, HER-2 positive BIliary Tract cancer, Gallbladder Cancer, Intrahepatic Cholangiocarcinoma (ICC), Extrahepatic Cholangiocarcinoma (ECC), Zanidatamab, HER-2 overexpression, HER-2 amplification
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| Location | Contacts |
|---|---|
| AIG Hospitals (A Unit of Asian Institute of Gastroenterology) Hyderabad, Telangana | |
| AOU dell'Universit~ degli Studi della Campania Luigi Vanvitelli Naples, | |
| AdventHealth Hematology and Oncology Orlando, Florida | |
| Aichi Cancer Center Nagoya, | |
| Akdeniz University Medical Faculty Hospital Antalya, | |
| Asan Medical Center Seoul, | |
| Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona - Onkologie und Palliativmedizin mit Sektionen Hamatologie und Rheumatologie Hamburg, | |
| Atlantic Health System/Morristown Medical Center Morristown, New Jersey | |
| Azienda Ospedaliera Universitaria Integrata Verona Verona, | |
| Azienda Ospedaliero - Universitaria Pisana Pisa, | |
| Azienda Ospedaliero Universitaria di Cagliari Presidio Ospedaliero Duilio Casula Monserrato, Cagliari | |
| Azienda Sanitaria Universitaria Friuli Centrale - P.O. S. Maria della Misericordia Udine, | |
| Beijing Cancer Hospital Beijing, | |
| Biocinetic Ltda Santiago, | |
| CAIPO Centro para la Atención Integral del Paciente Oncológico San Miguel de Tucumán, Tucumán Province | |
| CHA Bundang Medical Center, CHA University Seongnam-si, | |
| CHU Besancon Besançon, Cedex | |
| CHU Brest Hôpital de la Cavale Blanche Brest, | |
| CHU Estaing Clermont-Ferrand, | |
| CHU Montepellier - Hôpital Saint Eloi Montpellier, | |
| CHU Poitiers Poitiers, | |
| CHU de Bordeaux - Hopital Haut Leveque Pessac, Cedex | |
| CHU de Toulouse- (Toulouse University Hospital Center) Toulouse, Cedex 9 | |
| Cancerstudieenheten Huddinge, Karolinska Universitetssjukhuset Huddinge Huddinge, | |
| Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec | |
| Centro Médico Privado CEMAIC Córdoba, | |
| Centro Médico en Oncología Clínica EXELSUS S.R.L San Miguel de Tucumán, Tucumán Province | |
| Centro de Investigacion y Especialidades Medicas (CDIEM) Santiago, Santiago Metropolitan | |
| Centro de Investigaciónes Clínicas - Clínica Viedma Viedma, Río Negro Province | |
| Centrul De Oncologie "SF. Nectarie" S.R.L. Craiova, Dolj | |
| Centrul de Oncologie Euroclinic SRL Iași, | |
| Champalimaud Clinical Center Lisbon, | |
| Chang Gung Memorial Hospital Kaohsiung Branch of the Chang Gung Medical Foundation Kaohsiung City, | |
| Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation Taoyuan District, | |
| Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie und Tumorimmunologie Berlin, | |
| Chiba Cancer Center Chiba, Chiba | |
| Chopda Medicare & Research Centre Pvt. Ltd - Magnum Heart Institute Nashik, Maharashtra | |
| City of Hope(City of Hope National Medical Center, City of Hope Medical Center) Duarte, California | |
| Clinica Universidad de Navarra Pamplona, | |
| Clínica Puerto Montt Port Montt, | |
| Complejo Hospitalario Universitario de Santiago -Hospital Clinico Universitario de Santiago Santiago de Compostela, A Coruna | |
| Comprehensive Cancer Center, Helsinki University Hospital Helsinki, | |
| Docrates Cancer Center Helsinki, | |
| Fakultni nemocnice Hradec Kralove, Klinika onkologie a radioterapie Hradec Králové, | |
| Fakultni nemocnice v Motole, Onkologicka klinika Prague, | |
| Fakultní nemocnice Brno, Interní hematologická a onkologická klinika Brno, | |
| Fondazione IRCCS Istituto Nazionale per lo studio e la cura dei Tumori Milan, | |
| Fondazione Policlinico Universitario Gemelli-IRCCS Roma, | |
| Fundacao Pio Xii Hospital de Amor de Barretos Barretos, São Paulo | |
| Fundacion Arturo Lopez Perez (FALP) Santiago, Santiago Metropolitan | |
| Fundación Ars Medica San Salvador de Jujuy, Jujuy Province | |
| Fundação Doutor Amaral Carvalho - Hospital Amaral Carvalho Jaú, São Paulo | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto (FUNFARME) São José do Rio Preto, São Paulo | |
| Gustave Roussy Villejuif, | |
| Hacettepe University Cancer Institute Ankara, Sihhiye | |
| Hanyang University Seoul Hospital Seoul, | |
| Harbin Medical University Cancer Hospital Harbin, Heilongjiang | |
| Henry Ford Health System Detroit, Michigan | |
| Hokkaido University Hospital Sapporo, Hokkaido | |
| Hopital Henri Mondor Créteil, | |
| Hospital Beaujon University Clichy, | |
| Hospital Clinico Universidad de Chile Santiago, | |
| Hospital Nossa Senhora Da Conceição/Centro Integrado de Pesquisa em Oncologia CIPO-GHC Porto Alegre, | |
| Hospital Oncologico, Puerto Rico Medical Center Rio Piedras, | |
| Hospital Provincial del Centenario Rosario, | |
| Hospital Regional Universitario de Malaga Málaga, | |
| Hospital Universitario 12 de Octubre Madrid, | |
| Hospital Universitario Fundacion Jimenez Diaz Madrid, | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Miguel Servet Zaragoza, | |
| Hospital Universitario Reina Sofia Córdoba, Andalusia | |
| Hospital Universitario Virgen Macarena Seville, | |
| Hospital Universitario y Politécnico La Fe Valencia, Valencia | |
| Hospital de Clinicas de Porto Alegre - HCPA Porto Alegre, Rio Grande do Sul | |
| Hunan Provincial People's Hospital Changsha, Hunan | |
| IRCCS Ospedale Policlinico San Martino Genova, | |
| Imelda VZW Bonheiden, Antwerpen | |
| Instituo di Candiolo, Fondazione del Piemonte per l'Oncologia (IRCCS) Candiolo, Torino | |
| Institut de Cancerologie de l'Ouest Saint-Herblain, | |
| Instituto Medico de la Fundacion Estudios Clinicos Rosario, | |
| Instituto Nacional de Cancer - INCA Rio de Janeiro, | |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE Porto, | |
| Institutul Clinic Fundeni Bucharest, | |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre - ISCMPA Porto Alegrev, Rio Grande do Sul | |
| Istanbul University Cerrahpasa Medical Faculty Hospital/Clinical Research Center Istanbul, Fatih | |
| Istituto Clinico Humanitas Rozzano (MI), | |
| James Lind Centro de Investigación Del Cáncer Temuco, Región de la Araucanía | |
| Jilin Cancer Hospital Changchun, | |
| KLES Dr Prabhakar Kore Hospital and Medical Research Centre Belagavi, Karnataka | |
| Kagoshima University Hospital Kagoshima, Kagoshima-ken | |
| Kanagawa Cancer Center Yokohama, Kanagawa | |
| Kanazawa University Hospital Kanazawa-shi, Ishikawa, | |
| Kaohsiung Medical University - Chung-Ho Memorial Hospital Kaohsiung City, | |
| Korea University Anam Hospital Seoul, Seoul-teukbyeolsi [seoul] | |
| Korea University Guro Hospital Seoul, | |
| Krankenhaus Nordwest - Institut für Klinisch-Onkologische Forschung (IFK) Frankfurt am Main, Hesse | |
| Kuopio University Hospital Kuopio, | |
| Kyorin University Hospital Mitaka, Tokyo | |
| Kyoto University Hospital Kyoto, | |
| LMU Universitätsklinikum München, Campus Großhadern, Medizinische Klinik und Poliklinik III - Hämatologie und Onkologie München, Bavaria | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center New York, New York | |
| Liga Norte Riograndense Contra O Cancer Natal, | |
| London Health Sciences Centre London, Ontario | |
| Mahamana Pandit Madan Mohan Malviya Cancer Centre Varanasi, | |
| Max Super Speciality Hospital - Saket (a unit of Devki Devi foundation) New Delhi, | |
| Medizinische Hochschule Hannover - Klinik Fur Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie Hanover, Nieder-Sachsen | |
| Memorial Sloan Kettering Cancer Centers New York, New York | |
| Mie University Hospital Tsu, Mie-ken | |
| Military Medical Academy, Clinic for Gastroenterology and Hepatology Belgrade, | |
| Minnesota Oncology Hematology, P.A. Maple Grove, Minnesota | |
| Mount Vernon Cancer Centre Northwood, | |
| NHS Foundation Trust Royal Marsden Hospital London, England | |
| National Cancer Center Goyang-si, | |
| National Cancer Center Hospital ChuoKu, Tokyo | |
| National Cancer Center Hospital East Kashiwa, Chiba | |
| National Cheng Kung University Hospital Tainan, | |
| National Hospital Organization Kyushu Cancer Center Fukuoka, | |
| National Hospital Organization Shikoku Cancer Center Matsuyama, | |
| National Taiwan University Cancer Center Taipei, | |
| Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg Heidelberg, Baden-Wurttemberg | |
| Niigata University Medical and Dental Hospital Niigata, Niigata, | |
| Norton Cancer Institute - Audubon Louisville, Kentucky | |
| Ochsner Clinic Foundation New Orleans, Louisiana | |
| Oncology Institute of Vojvodina, Internal Oncology Clinic Kamenitz, | |
| Oncovida Providencia, | |
| Onkologiska mottagningen, Sahlgrenska Universitetssjukhuset Gothenburg, | |
| Onkologiska mottagningen, Skånes Universitetssjukhus Malmö Malmo, | |
| Oregon Health and Science University Portland, Oregon | |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute Osaka, | |
| Osaka University Hospital Osaka, | |
| Pi Health Cancer Hospital Hyderabad, Telangana | |
| Princess Margaret Cancer Centre - University Health Network Toronto, Ontario | |
| Pusan National University Hospital Busan, | |
| Rabin Medical Center, Bellinson Hospital Petah Tikva, | |
| Rajiv Gandhi Cancer Institute And Research Centre Delhi, | |
| Rambam Health Care Campus Haifa, | |
| Rocky Mountain Cancer Centers, LLP Denver, Colorado | |
| Royal Marsden Hospital NHS Foundation Trust Surrey, England | |
| SCRI Oncology Partners Nashville, Tennessee | |
| Saint Francis Cancer Center Greenville, South Carolina | |
| Samsung Medical Center Seoul, Gangnam-gu | |
| Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do | |
| Seoul National University Hospital Seoul, Seoul Teugbyeolsi | |
| Servicios Médicos URUMED SpA Rancagua, Libertador Gen Bernardo O Higgins | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Shandong Provincial Third Hospital Jinan, Shandong | |
| Sichuan Cancer Hospital Chengdu, | |
| Spital Clinic Judetean de Urgenta Bihor Oradea, Bihor County | |
| Tata Memorial Hospital Mumbai, | |
| Technische Universität Dresden Medizinische Fakultät Carl Gustav Carus Dresden, Saxony | |
| Tel Aviv Sourasky Medical Center (Ichilov) Tel Aviv, | |
| Texas Oncology - DFW Irving, Texas | |
| The Cancer Institute Hospital of Japanese Foundation For Cancer Research Koto-Ku, Tokyo | |
| The Chaim Sheba Medical Center, Tel Hashomer Ramat Gan, HaMerkaz, | |
| The Christie NHS Foundation Trust Manchester, England | |
| The First Affiliated Hospital of USTC(Anhui Provincial Hospital) Hefei, Anhui | |
| The First Hospital of Lanzhou University Lanzhou, Gansu | |
| The Hadassah University Medical Center, Ein Kerem Hospital Jerusalem, | |
| The Univerrsity of Texas MD Anderson Cancer Center Houston, Texas | |
| The University of Kansas Cancer Center - Westwood Westwood, Kansas | |
| The University of Tokyo Hospital Tokyo, | |
| Tohoku University Hospital Sendai, Miyagi | |
| Trakya University Faculty of Medicine Edirne, | |
| Tufts Medical Center Boston, Massachusetts | |
| UZ Antwerpen Edegem, | |
| UZ Leuven Leuven, | |
| Unidade Local de Saude de Almada-Seixal, E.P.E. - Hospital Garcia de Orta Almada, | |
| Unidade Local de Saude de Coimbra, EPE - Hospitais da Universidade de Coimbra Coimbra, | |
| Unidade Local de Saúde de São José - Hospital de Santo António dos Capuchos Lisbon, | |
| University Clinical Center of Serbia, Clinic for Gastroenterohepatology Belgrade, | |
| University of Michigan Hospital Ann Arbor, Michigan | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| Universitätsklinikum Freiburg - Klinik für Innere Medizin II, Freiburg im Breisgau, Baden-Wurttemberg | |
| Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Medizinische Klinik I (MKI) Lübeck, Schleswig-Holstein | |
| Universitätsklinikum Tübingen - Medizinische Universitätsklinik, Innere Medizin I Tübingen, Baden-Wuttemberg | |
| Vall d'Hebron Institute of Oncology/Hospital Universitari de Vall d'Hebron Barcelona, | |
| Veneto Institute of Oncology IOV - I.R.C.C.S. Padua, | |
| Virginia Commonwealth University, VCU Health Richmond, Virginia | |
| West China Hospital Sichuan University Chengdu, Sichuan | |
| Western General Hospital, Edinburgh Cancer Centre Edinburgh, Scotland | |
| Winship Cancer Institute Atlanta, Georgia | |
| Yamaguchi University Hospital Ube, Yamaguchi | |
| Zhongshan Hospital Fudan University Shanghai, | |
| hospital Italiano de Buenos Aires Buenos Aires, |
Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
Wendy Parulekar - wparulekar@ctg.queensu.ca
NCT05640999
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Inclusion Criteria:
* Patients must have had surgery consisting of hysterectomy and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards. There must be no macroscopic residual disease after surgery.
* Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
* Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Patients' age must be ≥ 18 years.
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
* Patient is able (i.e. sufficiently fluent) and willing to complete the patient-reported outcomes (PRO) questionnaires in either English, French or a validated language
* Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre
* Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy
Exclusion Criteria:
* Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
* Prior pelvic radiation.
* Patients with a history of other malignancies, except: carcinoma in-situ without evidence of invasive disease when resected, adequately treated non-melanoma skin cancer, or other tumours curatively treated with no evidence of disease for ≥ 5 years.
* Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)
* Patients with a documented positive surgical margin.
* Patients with a documented positive peritoneal washings, if performed. RADIATION: Vaginal brachytherapy, RADIATION: Adjuvant radiotherapy (EBRT +/- brachytherapy), OTHER: Observation
Endometrial Cancer
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Show 105 locations
Study Locations
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| Location | Contacts |
|---|---|
| ASST Lecco Lecco, | |
| ASST Spedali Civili Brescia Brescia, | |
| AdventHealth Porter Denver, Colorado | |
| Alaska Womens Cancer Care Anchorage, Alaska | |
| Arthur J.E. Child Comprehensive Cancer Centre Calgary, Alberta | |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | |
| Auckland City Hospital Auckland, | |
| BCCA - Kelowna Kelowna, British Columbia | |
| BCCA - Prince George Prince George, British Columbia | |
| BCCA - Vancouver Vancouver, British Columbia | |
| BCCA - Victoria Victoria, British Columbia | |
| Baystate Medical Center Springfield, Massachusetts | |
| CHUM-Centre Hospitalier de l'Universite de Montreal Montreal, Quebec | |
| CIUSSS de l'Estrie - Centre hospitalier Sherbrooke, Quebec | |
| Calvary Mater Newcastle Hospital Waratah, New South Wales | |
| Canberra Hospital Garran, Australian Capital Territory | |
| Case Western Reserve University Cleveland, Ohio | |
| Catharina Ziekenhuis Eindhoven, North Brabant | |
| Cedars-Sinai Medical Center Beverly Hills, California | |
| Centre Leon Berard Lyon, | |
| Christchurch Hospital Christchurch, | |
| Cross Cancer Institute Edmonton, Alberta | |
| Duke University Medical Center Durham, North Carolina | |
| Duke Womens Cancer Care Raleigh Raleigh, North Carolina | |
| Emory Decatur Hospital Decatur, Georgia | |
| Emory Saint Josephs Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital Winship Cancer Institute Atlanta, Georgia | |
| Erasmus Medical Center (EMC) Rotterdam, The Netherlands | |
| European Institute of Oncology Milan, | |
| Farmington Health Centre Farmington, Utah | |
| First Physicians Group-Sarasota Sarasota, Florida | |
| Florida Cancer Specialists - Sarasota Downtown Sarasota, Florida | |
| Florida Cancer Specialists - Venice Pinebrook Venice, Florida | |
| Frankston Hospital Frankston, Victoria | |
| Grady Health System Atlanta, Georgia | |
| Groupe Hospitalier Diaconesses Croix Saint-Simon Paris, | |
| Huntington Memorial Hospital Pasadena, California | |
| Huntsman Cancer Institute University of Utah Salt Lake City, Utah | |
| Institut Gustave-Roussy Villejuif, FR | |
| Institut Universitaire du Cancer de Toulouse - IUCT Toulouse, Occitanie | |
| Leiden University Medical Center (LUMC) Leiden, | |
| London Health Sciences Centre Research Inc. London, Ontario | |
| M.D. Anderson Cancer Center Houston, Texas | |
| MC Haaglanden The Hague, South Holland | |
| Maastro clinic (Maastricht UMC) Maastricht, Limburg | |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mater Research Institute South Brisbane South Brisbane, Queensland | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Monash Medical Centre Clayton, Victoria | |
| Mount Sinai Chelsea New York, New York | |
| Mount Sinai Hospital New York, New York | |
| Nebraska Methodist Hospital Omaha, Nebraska | |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | |
| Northwestern Medicine Orland Park Orland Park, Illinois | |
| Northwestern University Chicago, Illinois | |
| Norton Hospital Pavilion and Medical Campus Louisville, Kentucky | |
| Norton Suburban Hospital and Medical Campus Louisville, Kentucky | |
| Odette Cancer Centre Toronto, Ontario | |
| Ohio State University Comprehensive Columbus, Ohio | |
| Oslo University Hospital Oslo, Ullernchausseen 70 | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | |
| Piedmont Hospital Atlanta, Georgia | |
| Policlinico Umberto I, Universita Sapienza Rome, | |
| Providence Portland Medical Centre Portland, Oregon | |
| Providence Saint Vincent Medical Center Portland, Oregon | |
| Radiotherapiegroep Arnhem, Gelderland | |
| Royal Brisbane and Womens Hospital Herston, | |
| Royal North Shore Hospital St Leonards, New South Wales | |
| Royal Victoria Regional Health Centre Barrie, Ontario | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | |
| Sarasota Memorial Health Care Centre Sarasota, Florida | |
| Sarasota Memorial Hospital Sarasota, Florida | |
| Sarasota Memorial Hospital - Venice N. Venice, Florida | |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | |
| South Western Sydney Local Health District Liverpool, New South Wales | |
| State University Of New York Syracuse, New York | |
| Sutter Medical Center Sacramento Sacramento, California | |
| Swedish Medical Center First Hill Seattle, Washington | |
| The Jewish General Hospital Montreal, Quebec | |
| The Royal Women's Hospital Parkville, Victoria | |
| Thomas Jefferson University Philadelphia, Pennsylvania | |
| Trillium Health Partners - Credit Valley Hospital Mississauga, Ontario | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UH Seidman Cancer Center Mentor, Ohio | |
| UMass Memorial Medical Centre Worcester, Massachusetts | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | |
| University Health Network Toronto, Ontario | |
| University Medical Center New Orleans New Orleans, Louisiana | |
| University Of Miami School Of Medicine Miami, Florida | |
| University of Arizona Cancer Center Tucson, Arizona | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| University of Utah Sugarhouse Health Centre Salt Lake City, Utah | |
| University of Vermont Medical Center Burlington, Vermont | |
| University of Vermont and State Agricultural College Burlington, Vermont | |
| University of Virginia Cancer Center Charlottesville, Virginia | |
| Upstate Cancer Center Radiation Oncology at Oswego Oswego, New York | |
| Upstate Cancer Center at Hill Radiation Oncology Syracuse, New York | |
| Upstate Cancer Center at Verona Verona, New York | |
| Virginia Commonwealth University Richmond, Virginia | |
| Washington University School of Medicine St Louis, Missouri | |
| Westmead Hospital Westmead, | |
| Women and Infants Hospital Providence, Rhode Island | |
| Womens Cancer Center of Nevada Las Vegas, Nevada |
A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)
ctrrecruit@vcu.edu
NCT06064097
Show full eligibility criteria
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Inclusion Criteria:
* Patients must be ≤ 21 years of age at the time of study enrollment
* Newly diagnosed American Joint Committee on Cancer (AJCC) stage II-IV nasopharyngeal carcinoma (NPC)
* Patients must have had histologic verification of the malignancy at original diagnosis
* Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended
* Patients must have had histologic verification of the malignancy at original diagnosis
* Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended
* Patients must have a Lansky (for patients ≤ 16 years of age) or Karnofsky (for patients \> 16 years of age) performance status score of ≥ 60%
* Peripheral absolute neutrophil count (ANC) ≥ 1000/uL (within 7 days prior to start of protocol therapy)
* Platelet count ≥ 100,000/uL (transfusion independent) (within 7 days prior to start of protocol therapy)
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2 or (within 7 days prior to start of protocol therapy)
* A serum creatinine based on age/sex (within 7 days prior to start of protocol therapy) Age: Maximum serum creatinine (mg/dL)
1 month to \< 6 months: 0.4 mg/dL (male); 0.4 mg/dL (female) 6 months to \< 1 year: 0.5 mg/dL (male); 0.5 mg/dL (female)
1 to \< 2 years: 0.6 mg/dL (male); 0.6 mg/dL (female) 2 to \< 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female) 6 to \< 10 years 1 mg/dL (male); 1 mg/dL (female) 10 to \<13 years: 1.2 mg/dL (male); 1.2 mg/dL (female) 13 to \< 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
≥ 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and (within 7 days prior to start of protocol therapy)
* Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) ≤ 135 U/L\* (within 7 days prior to start of protocol therapy)
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
* Shortening fraction of ≥ 27% by echocardiogram, or
* Ejection fraction of ≥ 50% by radionuclide angiogram
* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and T-cell count above the lower limit of normal 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
Exclusion Criteria:
* Patients who received prior radiotherapy to the head or neck
* Patients who received prior chemotherapy or radiation for the treatment of any cancer in the last 3 years. These patients must also be in remission
* Patients with a diagnosis of immunodeficiency
* Patients with an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive agents). 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.
* Note: Patients with well-controlled asthma and no need for systemic steroids for the treatment of asthma in the last 12 months will not be excluded
* Patients with a condition requiring systemic treatment with either corticosteroids (\> 0.25 mg/kg (10 mg) daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 0.25 mg/kg (10 mg) daily prednisone equivalent, are permitted in the absence of active autoimmune disease
* Patients with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
* Patients with detectable viral load of human immunodeficiency virus (HIV), hepatitis B or hepatitis C, or active tuberculosis
* Patients who have undergone solid organ or allogeneic hematopoietic transplant at any time
* Due to risks of fetal and teratogenic adverse events as seen in animal studies, a negative pregnancy test must be obtained in females of childbearing potential, defined as females who are post-menarchal. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Females of childbearing potential that are sexually active must agree to either practice 2 medically accepted highly-effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 5 months after the last dose of nivolumab, 6 months after the last dose of gemcitabine, and 14 months after the last dose of cisplatin, whichever is longer
* Males of childbearing potential that are sexually active must agree to either practice a medically accepted highly-effective methods of contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 3 months after the last dose of gemcitabine, and 11 months after the last dose of cisplatin, whichever is longer
* Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy through 5 months after the last dose of nivolumab
* 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 PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Chest Radiography, DRUG: Cisplatin, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, OTHER: Electronic Health Record Review, OTHER: Fluciclovine F18, DRUG: Gemcitabine, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan, BIOLOGICAL: Nivolumab, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy, PROCEDURE: X-Ray Imaging
Stage II Nasopharyngeal Carcinoma AJCC v8, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage IV Nasopharyngeal Carcinoma AJCC v8
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Show 84 locations
Study Locations
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| Location | Contacts |
|---|---|
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| 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 | |
| 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 New Orleans New Orleans, Louisiana | |
| 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 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 - (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) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.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) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| 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) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Murrieta, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| 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) |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.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 | |
| Starship Children's Hospital Grafton, Auckland | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| 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) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Pediatric Hospital San Juan, | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| 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 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) |
| 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 | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
ctrrecruit@vcu.edu
NCT06058377
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Inclusion Criteria:
* STEP 1: REGISTRATION (SCREENING): Participants must have histologically confirmed estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (hormone receptor positive) and HER2 negative breast cancer, as per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines
* NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP guidelines that do not receive HER2 targeted therapy are eligible
* STEP 1: REGISTRATION (SCREENING): Participants must have clinical stage II or III breast cancer
* NOTE: Participants with inflammatory breast cancer are eligible
* NOTE: Participants with occult (i.e. undetectable) primary breast cancer with axillary nodal involvement are not eligible, as MammaPrint testing has not been validated on tissue obtained from an axillary lymph node
* STEP 1: REGISTRATION (SCREENING): Participants must not have metastatic disease (i.e., must be clinically M0 or Mx) Systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network (NCCN) and ASCO guidelines
* STEP 1: REGISTRATION (SCREENING): Participants must not have locally recurrent breast cancer
* STEP 1: REGISTRATION (SCREENING): Participants with multifocal disease in the same breast or synchronous bilateral primary tumors are eligible, however, all tumors that are biopsied must be hormone receptor positive and HER2 negative per ASCO CAP guidelines and at least one of the tumors must be MammaPrint High-2. MammaPrint can be performed sequentially on biopsies as it is sufficient to have MammaPrint High 2 status on at least one of the lesions
* NOTE: Biopsy of multiple lesions in the same breast is not required if the clinical presentation is consistent with a single disease process that is multifocal in nature. However, if there is clinical suspicion of two distinct primary breast malignancies, additional biopsies should be pursued
* STEP 1: REGISTRATION (SCREENING): Participants must have either adequate tissue available to submit on-study or a prior known MammaPrint Index Score that is MP2 status
* Submitting tissue for on-study MammaPrint testing:
* Participants must have a minimum of ten, unstained formalin-fixed paraffin-embedded (FFPE) slides (4-5 micron thickness) available from initial tumor biopsy for MammaPrint assessment
* NOTE: Participants must agree to have this tissue submitted to Agendia for MammaPrint Index Scoring and to have subsequent results disclosed to Southwest Oncology Group (SWOG) Cancer Research Network OR
* Submitting prior known MammaPrint Index Score:
* If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy
* NOTE: Participants must agree to have their commercial MammaPrint Index Score disclosed to SWOG Cancer Research Network
* NOTE: Participants with prior known MammaPrint result that is not MP2 status should not be enrolled to either step of this study
* NOTE: Participants enrolling with known MP2 status (i.e. MP already obtained as routine care) must only sign the treatment informed consent form. Screening consent is not required when MP2 status is known prior to study enrollment
* STEP 1: REGISTRATION (SCREENING): Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy
* STEP 1: REGISTRATION (SCREENING): Participants must be \>= 18 years old at the time of registration
* STEP 1: REGISTRATION (SCREENING): Participants must have body weight \> 30 kg
* STEP 1: REGISTRATION (SCREENING): Participants must have Zubrod Performance Status of 0-2
* STEP 1: REGISTRATION (SCREENING): Participants 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
* STEP 1: REGISTRATION (SCREENING): Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed
* STEP 1: REGISTRATION (SCREENING): NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
* STEP 2: RANDOMIZATION: Participants must have met all eligibility criteria for Step 1 Registration
* STEP 2: RANDOMIZATION: Participants must have MammaPrint High Risk 2 result
* For participants submitting tissue for on-study MammaPrint testing:
* Participants must be registered to Step 2: Randomization within 84 calendar days (12 weeks) after receiving an MP2 status from the MammaPrint Index score. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) from initial tumor biopsy OR
* Submitting commercial MammaPrint Index Score:
* If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy
* NOTE: Participants without a MammaPrint High-Risk 2 score must not be registered to Step 2 Randomization
* STEP 2: RANDOMIZATION: Participants must not have received live vaccines within 28 days prior to study Step 2: Randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines and coronavirus disease 2019 (COVID-19) vaccines are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed
* STEP 2: RANDOMIZATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
* STEP 2: RANDOMIZATION: Participant must have Zubrod Performance Status of 0-2
* STEP 2: RANDOMIZATION: Participants must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis within two years prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Participants must not have active autoimmune disease that has required systemic treatment in the past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) prior to Step 2: Randomization. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed
* STEP 2: RANDOMIZATION: Participant must have a complete medical history and physical exam within 28 days prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Platelets \>= 100 x 10\^3/uL (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: 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 Step 2: Randomization)
* STEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 × institutional ULN (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Participants must have a calculated creatinine clearance \>= 50 mL/min using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Participants must have adequate cardiac function. 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. To be eligible for this trial, participants must be class 2B or better
* STEP 2: RANDOMIZATION: Participants must not have uncontrolled diabetes defined as hemoglobin A1c of 9.0% or greater, within 28 days prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Participants with history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have an undetectable viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Participants with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained while on suppressive therapy within 6 months prior to Step 2: Randomization, if indicated
* STEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization, if indicated
* STEP 2: RANDOMIZATION: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process and must have a negative pregnancy test at screening. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and 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 should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy
* STEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System
* STEP 2: RANDOMIZATION: Participants who can complete questionnaires in English, or Spanish must be offered the opportunity to participate in the Quality of Life study
* STEP 2: RANDOMIZATION: NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* STEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines PROCEDURE: Biospecimen Collection, DRUG: Cyclophosphamide, DRUG: Doxorubicin, BIOLOGICAL: Durvalumab, OTHER: Genetic Testing, PROCEDURE: Mammography, DRUG: Paclitaxel, OTHER: Quality-of-Life Assessment
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma
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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) |
| Addison Gilbert Hospital Gloucester, Massachusetts | |
| 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 | |
| Allegheny General Hospital Natrona Heights, Pennsylvania | |
| 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) |
| Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| 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) |
| 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 Corbin Corbin, 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) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.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) |
| Bellin Memorial Hospital Green Bay, Wisconsin | |
| Ben Taub General Hospital Houston, Texas | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| 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 Saint Francis Hospital Charleston, South Carolina | Site Public Contact - (Julia.Johnson@rsfh.com) |
| 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) |
| Broadlawns Medical Center Des Moines, Iowa | |
| 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) |
| 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 Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (protocols@swog.org) |
| 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 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 | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Cedars-Sinai Cancer - Tarzana Tarzana, California | |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ctsucontact@westat.com) |
| 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) |
| City of Hope Antelope Valley Lancaster, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Newport Beach Newport Beach, California | |
| 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 | |
| City of Hope at Long Beach Elm Long Beach, California | |
| 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) |
| Community Medical Center Missoula, Montana | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| 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 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) |
| Corewell Health William Beaumont University Hospital Royal Oak, Michigan | |
| Covenant Health Cancer Centers Knoxville, Tennessee | |
| Covenant Health Cancer Centers - West Knoxville, Tennessee | |
| Covenant Health Oncology Group - Oak Ridge Oak Ridge, Tennessee | |
| CoxHealth South Hospital Springfield, Missouri | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| 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) |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Desert Regional Medical Center Palm Springs, California | |
| Dickstein Cancer Treatment Center White Plains, New York | Site Public Contact - (mcortese@wphospital.org) |
| Divine Providence Hospital Williamsport, Pennsylvania | Site Public Contact - (protocols@swog.org) |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Emory Decatur Hospital Decatur, Georgia | Site Public Contact - (clinicaltrialsoncology@dekalbmedical.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 | |
| 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 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 Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health-Spooner Clinic Spooner, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Forbes Hospital Monroeville, Pennsylvania | |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Geisinger Cancer Center Dickson City Dickson City, Pennsylvania | Site Public Contact - (hemoncctrials@geisinger.edu) |
| 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) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| 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) |
| HaysMed Hays, Kansas | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hematology Oncology Associates of Fredericksburg Inc Fredericksburg, Virginia | Site Public Contact - (cvaughn@hoafredericksburg.com) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| 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 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 Medical Center-Fairlane Dearborn, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford River District Hospital East China Township, Michigan | Site Public Contact - (kforman1@hfhs.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 - GLCMS Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Wyandotte Hospital Wyandotte, Michigan | Site Public Contact - (nhay@hfhs.org) |
| Huntington Memorial Hospital Pasadena, California | |
| 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) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Hospital Jefferson Hills, Pennsylvania | Site Public Contact - (ddefazio@wpahs.org) |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (ctsucontact@westat.com) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Jupiter Medical Center Jupiter, Florida | |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Karmanos Cancer Institute at McLaren Greater Lansing Lansing, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Katmai Oncology Group Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.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 Sciences Center at Shreveport Shreveport, Louisiana | Site Public Contact - (LPost@lsuhsc.edu) |
| 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) |
| Lankenau Medical Center Wynnewood, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| 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) |
| 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 | |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia | Site Public Contact - (underberga@sjchs.org) |
| Loma Linda University Medical Center Murrieta, California | |
| Loyola University Medical Center Maywood, Illinois | |
| 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 | |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| 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) |
| Mease Countryside Hospital Safety Harbor, Florida | Site Public Contact - (research.cto@baycare.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) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital West Pembroke Pines, Florida | |
| Memorial Medical Center Modesto, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| 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 Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Medical Center Rockville Centre, New York | Site Public Contact - (acline@mdmercy.com) |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| 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 Englewood, 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) |
| 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 | |
| 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) |
| Morristown Medical Center Morristown, New Jersey | |
| Morton Plant Hospital Clearwater, Florida | |
| Mount Sinai Chelsea New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| 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) |
| 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) |
| NYU Langone Hospital - Brooklyn Brooklyn, New York | Site Public Contact - (david.wallach@nyulangone.org) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northern Westchester Hospital Mount Kisco, New York | Site Public Contact - (AMellor@northwell.edu) |
| 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 Medical Specialties PLLC Tacoma, Washington | Site Public Contact - (research@southsoundcare.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 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 LSU Health - Cancer Treatment Center Shreveport, Louisiana | |
| Ochsner LSU Health Monroe Medical Center Monroe, Louisiana | Site Public Contact - (LPost@lsuhsc.edu) |
| 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 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 Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| 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) |
| Overlook Hospital Summit, New Jersey | |
| PROncology San Juan, | Site Public Contact - (info@PRoncology.com) |
| 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) |
| 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 Health Center - Farmington Farmington, Missouri | |
| Phelps Memorial Hospital Center Sleepy Hollow, New York | |
| 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 | |
| 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) |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Hood River Memorial Hospital Hood River, Oregon | Site Public Contact - (canrsrchstudies@provdience.org) |
| Providence Medical Foundation - Santa Rosa Santa Rosa, California | |
| 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 System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Santa Rosa Memorial Hospital Santa Rosa, California | |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Regional Cancer Center-Lee Memorial Health System Fort Myers, Florida | Site Public Contact - (protocols@swog.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Riddle Memorial Hospital Media, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Ridgeview Medical Center Waconia, 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) |
| Roper Hospital Charleston, South Carolina | Site Public Contact - (Julia.Johnson@rsfh.com) |
| 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) |
| SSM Health Good Samaritan Mount Vernon, Illinois | |
| SUNY Upstate Medical Center-Community Campus Syracuse, New York | |
| SWOG Sacramento, California | Erin F. Cobain - (ecobain@med.umich.edu) |
| 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 Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Catherine Hospital Indianapolis, Indiana | Site Public Contact - (protocols@swog.org) |
| Saint Charles Health System Bend, Oregon | Site Public Contact - (nosall@stcharleshealthcare.org) |
| 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 John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's/Candler - Bluffton Campus Bluffton, South Carolina | Site Public Contact - (underberga@sjchs.org) |
| Saint Luke's Cancer Center - Allentown Allentown, Pennsylvania | |
| 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 Hospital - Monroe Campus Stroudsburg, Pennsylvania | Site Public Contact - (ctsucontact@westat.com) |
| Saint Luke's Hospital - Upper Bucks Campus Quakertown, Pennsylvania | |
| Saint Luke's Hospital of Duluth Duluth, Minnesota | Site Public Contact - (kdean@slhduluth.com) |
| Saint Luke's Hospital-Anderson Campus Easton, Pennsylvania | Site Public Contact - (ctsucontact@westat.com) |
| Saint Luke's University Hospital-Bethlehem Campus Bethlehem, Pennsylvania | |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| 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 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) |
| Schulze Family Foundation Cancer Clinic - Bonita Health Center Bonita Springs, Florida | Site Public Contact - (RCCR@leehealth.org) |
| Shaw Cancer Center Edwards, Colorado | |
| Sibley Memorial Hospital Washington D.C., District of Columbia | Site Public Contact - (jquiver1@jhmi.edu) |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| 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 - 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-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) |
| South Carolina Cancer Specialists PC Hilton Head Island, South Carolina | Site Public Contact - (underberga@sjchs.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 | |
| 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 | |
| Staten Island University Hospital Staten Island, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| 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) |
| 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 Cancer Institute of New Jersey Hamilton Hamilton, New Jersey | |
| The Community Hospital Munster, Indiana | |
| The Philips Family Cancer Center Southampton, New York | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| 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) |
| Tidelands Georgetown Memorial Hospital Georgetown, South Carolina | Site Public Contact - (broe@tidelandshealth.org) |
| 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) |
| 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 | |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UCHealth - Cherry Creek Denver, Colorado | Site Public Contact - (protocols@swog.org) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (protocols@swog.org) |
| UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado | |
| UCHealth Lone Tree Health Center Lone Tree, Colorado | Site Public Contact - (protocols@swog.org) |
| 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 - Yorba Linda Yorba Linda, California | Site Public Contact - (ucstudy@uci.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 | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | Site Public Contact - (trials@missioncancer.com) |
| 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 Health Cancer Care Cary Cary, North Carolina | Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu) |
| UNC Health Cancer Care Garner Garner, North Carolina | Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu) |
| UNC Health Cancer Care Raleigh Raleigh, North Carolina | Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu) |
| UNC Health Cancer Care Wakefield Raleigh, North Carolina | Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania | |
| UPMC Cancer Center-Natrona Heights Natrona Heights, Pennsylvania | |
| UPMC Cancer Center-Washington Washington, 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 - (ClinicalResearchServices@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 - (ClinicalResearchServices@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 West Mifflin-Cancer Center Jefferson West Mifflin, Pennsylvania | |
| 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-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| 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 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 - (gingerreeves@uabmc.edu) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of Arizona Cancer Center-Orange Grove Campus Tucson, Arizona | |
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The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
Boehringer Ingelheim - clintriage.rdg@boehringer-ingelheim.com
NCT06872892
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Inclusion criteria:
* Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the participant information.
* Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.
* Age of participants when signing the informed consent/assent ≥12 years.
\-- Adolescents need to weigh at least 35 kg at Visit 1.
* Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist.
Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.
* Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.
* History of documented pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:
* at least 2 exacerbations, or
* at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \>40 at screening Visit 1 (adults only)
* at least 1 exacerbation and high symptom burden according to the investigator's judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.
Exclusion criteria:
* Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
* Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
* Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
* Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial.
* Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.
* Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.
* Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.
* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.
* Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).
* estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) \<30 mL/min at Visit 1.
* Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply.
DRUG: BI 1291583, DRUG: Placebo matching BI 1291583
Bronchiectasis
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Show 495 locations
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| Location | Contacts |
|---|---|
| A.O. dei Colli Naples, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| A.O.U.Policlinico G.Martino Messina, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| APRILLUS-Asistencia e Investigacion Ciudad Autonoma Buenos Aires, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Aalborg Sygehus Syd Aalborg, | Boehringer Ingelheim - (danmark@bitrialsupport.com) |
| Aarhus University Hospital Aarhus N, | Boehringer Ingelheim - (danmark@bitrialsupport.com) |
| Addington Hospital Durban, | Boehringer Ingelheim - (southafrica@bitrialsupport.com) |
| Adnan Menderes Üniversitesi Aydin, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Affiliated Hospital of Nantong University Nantong, Jiangsu | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Affiliated Hospital, Xuzhou Medical college Xuzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Ain Shams University Clinical Research Center (MASRI) Cairo, | Boehringer Ingelheim - (support@bitrialsupport.com) |
| Air Force Specialized Hospital Cairo, | Boehringer Ingelheim - (support@bitrialsupport.com) |
| Akdeniz Universitesi Tip Fakultesi Antalya, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Akron Children's Hospital Akron, Ohio | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Alfred Hospital Melbourne, Victoria | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski Warsaw, | Boehringer Ingelheim - (polska@bitrialsupport.com) |
| Amsterdam UMC Locatie VUMC Amsterdam, | Boehringer Ingelheim - (nederland@bitrialsupport.com) |
| Ankara University Medical Faculty Ankara, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Arke SMO S.A. de C.V. Veracruz de Ignacio de La Llave, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Asan Medical Center Seoul, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Asklepios Fachkliniken München-Gauting Gauting, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Aso Co.,Ltd Iizuka Hospital Fukuoka, Iizuka, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Asociación Mexicana para la Investigacion Clínica, A.C(AMIC) Pachuca, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Augusta University Augusta, Georgia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Augustiner Krankenhäuser GmbH Cologne, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Azienda Ospedaliera San Martino Genova, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Azienda Ospedaliera Universitaria Integrata Verona Verona, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Azienda Ospedaliera Universitaria di Padova Padova, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Azienda Ospedaliero Universitaria delle Marche Ancona, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Azienda Socio Sanitaria Territoriale Di Monza Monza (MB), | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| B. P. Poddar Hospital and Medical Research Limited Kolkata, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| BAG Wiesbaden Wiesbaden, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| BKS Research Ltd Hatvan, | Boehringer Ingelheim - (magyarorszag@bitrialsupport.com) |
| BLC Clinical Research Burlington, Ontario | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| Baylor College of Medicine Houston, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Baylor University Medical Center Dallas, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Beijing Children's Hospital, Capital Medical University Beijing, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Belfast City Hospital Belfast, Northern Ireland | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Blackpool Victoria Hospital Blackpool, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Bradford Royal Infirmary Bradford, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| CAPRISA Offices on the King DinuZulu Hospital Complex Springfield, | Boehringer Ingelheim - (southafrica@bitrialsupport.com) |
| CEC- Centro de Especialidades Cardiovasculares Bahía Blanca, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| CEDIC - Centro de Investigacion Clinica CABA, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| CHU Amiens-Picardie Amiens, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| CHUC - Centro Hospitalar e Universitário de Coimbra, EPE Coimbra, | Boehringer Ingelheim - (portugal@bitrialsupport.com) |
| CIMS Studienzentrum Bamberg GmbH Bamberg, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| CRC-Alexandria University Alexandria, | Boehringer Ingelheim - (support@bitrialsupport.com) |
| CTC Clinical Trial Consultants AB Uppsala, | Boehringer Ingelheim - (sverige@bitrialsupport.com) |
| Canberra Hospital Garran, Australian Capital Territory | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Cardio 1 Medical Clinic Winnipeg, Manitoba | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| Caritas-Krankenhaus St. Maria gGmbH Donaustauf, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Central Florida Pulmonary Group Altamonte Springs, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| Centro Dr. Lazaro Langer S.R.L Alberdi Sur, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Centro Hospitalar Universitário São João,EPE Porto, | Boehringer Ingelheim - (portugal@bitrialsupport.com) |
| Centro Respiratorio de Quilmes Quilmes, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Centro de Estudios Clínicos CEC Santiago, | Boehringer Ingelheim - (chile@bitrialsupport.com) |
| Centro de Investigacion Farmacologica del Bajío, S.C. León, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Centro de Investigacion Integral MEDIVEST S.C Chihuahua City, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Centro de Investigación Clinica Belgrano CABA, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Centro de Investigación del Maule Talca, | Boehringer Ingelheim - (chile@bitrialsupport.com) |
| Chang Gung Memorial Hospital, Linkou Taoyuan, | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| Changi General Hospital Singapore, | Boehringer Ingelheim - (singapore@bitrialsupport.com) |
| Charite - Universitatsmedizin Berlin Berlin, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Charite - Universitatsmedizin Berlin Berlin, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Chiba University Hospital Chiba, Chiba, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| China-Japan Friendship Hospital Beijing, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Christchurch Hospital Christchurch, | Boehringer Ingelheim - (newzealand@bitrialsupport.com) |
| Chronos Pesquisa Clinica Brasília, | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| Chungbuk National University Hospital Cheongju-si, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Cleveland Clinic Florida Weston, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Clinical Hospital Centar Sestre Milosrdnice Zagreb, | |
| Clinical Hospital Centre Zagreb Zagreb, | |
| Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara Timișoara, | Boehringer Ingelheim - (romania@bitrialsupport.com) |
| Clinical Hospital of Pneumophysiology Leon Daniello Cluj-Napoca, | Boehringer Ingelheim - (romania@bitrialsupport.com) |
| Clinical Research Associates of Central PA DuBois, Pennsylvania | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Clinical Research Institute S.C. Tlalnepantla, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Clinical Research of Rock Hill Rock Hill, South Carolina | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Cliniques Universitaires Saint-Luc Brussels, | Boehringer Ingelheim - (belgique@bitrialsupport.com) |
| Columbia University Medical Center-New York Presbyterian Hospital New York, New York | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Complejo Hospitalario Universitario A Coruna A Coruña, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Complejo Hospitalario de Navarra Pamplona, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Complexo Hospitalario Universitario De Santiago Santiago de Compostela, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Connolly Hospital Blanchardstown Dublin, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Copenhagen University Hospital, Rigshospitalet København Ø, | Boehringer Ingelheim - (danmark@bitrialsupport.com) |
| Cork University Hospital Cork, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Craigavon Area Hospital Portadown, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Da Vinci Private Clinic Pécs, | Boehringer Ingelheim - (magyarorszag@bitrialsupport.com) |
| Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Daugavpils Regional Hospital LTD Centre Outpatient Clinic Daugavpils, | |
| Diagnostics And Consultation Center Convex Ltd. Sofia, | Boehringer Ingelheim - (balgariya@bitrialsupport.com) |
| Diagnostics And Consultation Center Convex Ltd. Sofia, | |
| Diex Recherche (Sherbrooke Est) Sherbrooke, Quebec | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| Diex Recherche (Trois-Rivieres) Trois-Rivières, Quebec | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| Dignity Health, St. Joseph's Hospital and Medical Center Phoenix, Arizona | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Dr Ismail Abdullah Cape Town, | Boehringer Ingelheim - (southafrica@bitrialsupport.com) |
| EMED, Center of Medical Services,Private Prac,Rzeszow Rzeszów, | |
| Eastern Health-Box Hill Hospital Box Hill, Victoria | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| El Paso Pulmonary Association El Paso, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Element Research Group San Antonio, Texas | |
| Emory University Atlanta, Georgia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Enhancing Care Foundation NPC Mount Edgecombe, | Boehringer Ingelheim - (southafrica@bitrialsupport.com) |
| Equipo Ciencia CABA, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Erasmus Medisch Centrum-ROTTERDAM-50697 Rotterdam, | Boehringer Ingelheim - (nederland@bitrialsupport.com) |
| Essence MD Research Naples, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Evangelische Lungenklinik Berlin Berlin, | |
| Faculdade de Medicina de Botucatu - UNESP Botucatu, | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| First Affiliated Hospital of Guangzhou Medical University Guangzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| First Affiliated Hospital of Xi'an JiaoTong University Xi'an, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico Milan, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Fondazione IRCCS Policlinico S. Matteo Pavia, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Fondazione Policlinico Universitario Agostino Gemelli Irccs Roma, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Freeman Hospital Newcastle upon Tyne, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Froedtert and The Medical College of Wisconsin Milwaukee, Wisconsin | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Fukujuji Hospital Tokyo, Kiyose, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Fukuoka Children's Hospital Fukuoka, Fukuoka, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Fukuoka University Hospital Fukuoka, Fukuoka, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Gelre Ziekenhuis Zutphen Zutphen, | Boehringer Ingelheim - (nederland@bitrialsupport.com) |
| Georgetown University Washington D.C., District of Columbia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Government Hospital for Chest and Communicable Diseases (GHCCD) Visakhapatnam, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| Greenslopes Private Hospital Greenslopes, Queensland | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Guangdong Provincial People's Hospital Guangzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Guizhou People's Hospital Guiyang, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás Goiânia, | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| HOP Arnaud de Villeneuve Montpellier, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| HOP Haut-Lévêque Pessac, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| HOP Intercommunal Créteil, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| HOP Nord Laennec Saint-Herblain, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| HOP Pontchaillou Rennes, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| Hadassah Medical Center, Ein-Karem Jerusalem, | Boehringer Ingelheim - (israel@bitrialsupport.com) |
| Hadassah Medical Center, Ein-Karem Jerusalem, | Boehringer Ingelheim - (israel@bitrialsupport.com) |
| Haga Ziekenhuis The Hague, | Boehringer Ingelheim - (nederland@bitrialsupport.com) |
| Hallym University Kangnam Sacred Heart Hospital Seoul, Seoul-teukbyeolsi [seoul] | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Hallym University Sacred Heart Hospital Anyang, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Hamamatsu University Hospital Hamamatsu, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Hangzhou First People's Hospital Hangzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Hanyang University Medical Center Seoul, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Health Cube Medical Clinics Mandaluyong, | Boehringer Ingelheim - (pilipinas@bitrialsupport.com) |
| Health Partners Specialty Saint Paul, Minnesota | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Heart of Australia Research Institute Chelmer, Queensland | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Heartlands Hospital Birmingham, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Helios Hanseklinikum Stralsund Stralstund, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Helsinki University Hospital Helsinki, | Boehringer Ingelheim - (suomi@bitrialsupport.com) |
| Hirosaki University Hospital Aomori, Hirosaki, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Hokkaido University Hospital Sapporo, Hokkaido | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Hopital Cochin Paris, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| Hopital Pasteur Nice, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| Hopital de la Croix-Rousse Lyon, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| Horizon Clinical Research Group Cypress, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Hospital Aleman CABA, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Hospital Central de Asturias Oviedo, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Clinic de Barcelona Barcelona, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Germans Trias I Pujol Badalona, Barcelona [barcelona] | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Infanta Elena Huelva, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Jerez de la Frontera Jerez de la Frontera, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Quirónsalud Madrid Pozuelo de Alarcón, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Raja Perempuan Zainab II Kelantan, | Boehringer Ingelheim - (malaysia@bitrialsupport.com) |
| Hospital Son Espases Palma de Mallorca, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Sultan Idris Shah Serdang Kajang, | Boehringer Ingelheim - (malaysia@bitrialsupport.com) |
| Hospital Sultanah Bahiyah Alor Setar, Kedah, | Boehringer Ingelheim - (malaysia@bitrialsupport.com) |
| Hospital Universitari Vall d'Hebron Barcelona, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Universitari de Bellvitge L'Hospitalet Del Llobregat, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Universitari de Girona Doctor Josep Trueta Girona, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Universitari i Politécnic La Fe Valencia, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Universitario Dr Jose Eleuterio Gonzalez Nuevo León, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Hospital Universitario Dr Jose Eleuterio Gonzalez Nuevo León, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Hospital Universitario La Paz Madrid, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Universitario Marqués de Valdecilla Santander, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Universitario Puerto Real Puerto Real, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Universitario Virgen De La Macarena Seville, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Universitario Virgen de la Arrixaca El Palmar, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital Virgen del Rocio Seville, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital de Mérida Mérida, | Boehringer Ingelheim - (espana@bitrialsupport.com) |
| Hospital of Lithuanian University of Health Sciences Kauno Klinikos Kaunas, | Boehringer Ingelheim - (lithuania@bitrialsupport.com) |
| Huadong Hospital Affiliated to Fudan University Shanghai, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Huzhou Central Hospital Huzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Hvidovre Hospital Hvidovre, | Boehringer Ingelheim - (danmark@bitrialsupport.com) |
| Hôpital Larrey - CHU de Toulouse Toulouse, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| IKF Pneumologie GmbH & Co. KG Frankfurt, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| INCOR e Hospital das Clínicas da Universidade de São Paulo São Paulo, | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| INS Coeur Poumon Lille, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| Iatros International Bloemfontein, | Boehringer Ingelheim - (southafrica@bitrialsupport.com) |
| Ibamedica Santa Fe, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Icahn School of Medicine at Mount Sinai New York, New York | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Iloilo Doctors Hospital Iloilo City, | Boehringer Ingelheim - (pilipinas@bitrialsupport.com) |
| Indiana University Indianapolis, Indiana | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Inova Fairfax Medical Campus Falls Church, Virginia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Institut Perubatan Respiratori Kuala Lumpur, | Boehringer Ingelheim - (malaysia@bitrialsupport.com) |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) Québec, | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| Institute for Respiratory Health Nedlands, Western Australia | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Institute of Science Tokyo Hospital Tokyo, Bunkyo-ku, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Instituto Ave Pulmo - Fundacion Enfisema Mar del Plata, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Instituto de Especialidades de la Salud Rosario Rosario, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Intermountain Healthcare Salt Lake City, Utah | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre, Rio Grande do Sul | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| Istanbul University Medical Faculty Capa Hospital Istanbul, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Istituto Clinico Humanitas Rozzano (MI), | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Istituto G. Gaslini Genova, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Jawahar Lal Nehru Medical College Ajmer, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| Jefferson Health Honickman Center Philadelphia, Pennsylvania | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Jeonbuk National University Hospital Seoul, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Jiangmen Central Hospital Jiangmen, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Johns Hopkins Hospital Baltimore, Maryland | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Kagoshima University Hospital Kagoshima, Kagoshima-ken | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Kameda Clinic Chiba, Kamogawa, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Kanagawa Cardiovascular and Respiratory Center Kanagawa, Yokohama, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Kangdong Sacred Heart Hospital Seoul, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Kaohsiung Chang Gung Memorial Hospital Kaohsiung City, | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| Karolinska University Hospital Stockholm, | Boehringer Ingelheim - (sverige@bitrialsupport.com) |
| Kasr Al Aini, Cairo University Cairo, | Boehringer Ingelheim - (support@bitrialsupport.com) |
| Katholisches Klinikum Bochum gGmbH Bochum, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Keio University Hospital Shinjuku-Ku, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| King Chulalongkorn Memorial Hospital Thailand, | Boehringer Ingelheim - (thai@bitrialsupport.com) |
| King's College Hospital London, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Klinikum Dortmund gGmbH Dortmund, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Klinikum Ernst von Bergmann Potsdam, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Klinikum der Universität München AÖR München, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Konkuk University Medical Center Seoul, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Koranyi National Institute For Pulmonolgy Budapest, | Boehringer Ingelheim - (magyarorszag@bitrialsupport.com) |
| Korea University Guro Hospital Seoul, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Krankenhaus Martha-Maria Halle-Dölau gGmbH Halle, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Kurashiki Central Hospital Kurashikishi, Okayama-ken | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Kyoto University Hospital Kyoto, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Kyushu University Hospital Fukuoka, Fukuoka, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| LUMPII Doctors practice Riga, | |
| Lady Davis Carmel Medical Center Haifa, | Boehringer Ingelheim - (israel@bitrialsupport.com) |
| Liverpool Heart & Chest Hospital Liverpool, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Lung Research Queensland Chermside, Queensland | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Lungenfachklinik Immenhausen Immenhausen, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| M. S. Ramaiah Institute of Health Science Bengaluru, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| M2M Med Sp. z o.o. Chorzów, | Boehringer Ingelheim - (polska@bitrialsupport.com) |
| MHAT Rahila Angelova AD Pernik, | |
| Macquarie University North Ryde, New South Wales | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Manisa Celal Bayar Üniversitesi Tıp Fakültesi Manisa, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Marius Nasta Institute of Pneumophthisiology Bucharest, | Boehringer Ingelheim - (romania@bitrialsupport.com) |
| Marmara University Pendik Training and Research Hospital Istanbul, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Martin-Luther-Universität Halle-Wittenberg Halle, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Massachusetts General Hospital Boston, Massachusetts | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Mater Hospital Brisbane South Brisbane, Queensland | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Matsue Medical Center Shimane, Matsue, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Matsusaka City Hospital Mie, Matsusaka, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Mautalen- Salud e Investigacion CABA, | Boehringer Ingelheim - (argentina@bitrialsupport.com) |
| Mayo Clinic - Florida Jacksonville, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Mayo Clinic, Rochester Rochester, Minnesota | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Mecas Servicos Educacionais e Administrativos LTDA João Pessoa, | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| Med.Center OLVI Health Center Assotiation,Private Practice Daugavpils, | |
| MediTrial s.r.o. Jindřichův Hradec, | |
| Mediadvance Clinical S.A.P.I de C.V. Chihuahua City, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Medical Center "Pulmovision" Sofia, | Boehringer Ingelheim - (balgariya@bitrialsupport.com) |
| Medical Center "Sveti Ivan Rilski" Vidin, | Boehringer Ingelheim - (balgariya@bitrialsupport.com) |
| Medical Center K2J2 Wołomin, | |
| Medical Center Tara Veliko Tarnovo, | Boehringer Ingelheim - (balgariya@bitrialsupport.com) |
| Medical Center Unimed Plovdiv, | |
| Medical University Graz Graz, | Boehringer Ingelheim - (oesterreich@bitrialsupport.com) |
| Medical University of Innsbruck Innsbruck, | Boehringer Ingelheim - (oesterreich@bitrialsupport.com) |
| Medizinische Hochschule hannover Hanover, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Meris Clinical Research-Brandon-69466 Brandon, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Mersin University Research and Training Hospital Chest Diseases Department Yenişehir, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Methodist Heart and Lung Institute San Antonio, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Metroplex Pulmonary & Sleep Center McKinney, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Middlemore Clinical Trials Papatoetoe, | Boehringer Ingelheim - (newzealand@bitrialsupport.com) |
| Midland Healthcare & Research Center Lucknow, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| Minami Kyoto Hospital Kyoto, Joyo, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Momentum Clinical Research Mount Cook, Wellington Region | Boehringer Ingelheim - (newzealand@bitrialsupport.com) |
| Momentum Clinical Research Dunedin Dunedin, Otago | Boehringer Ingelheim - (newzealand@bitrialsupport.com) |
| Momentum clinical Research Tauranga Tauranga, Bay of Plenty | Boehringer Ingelheim - (newzealand@bitrialsupport.com) |
| Multidisciplinary City Hospital №1 of the Akimat of Astana Astana, | Boehringer Ingelheim - (kazakhstan@bitrialsupport.com) |
| Multiprofile Hospital MHATEM 'Pirogov', Sofia Sofia, | Boehringer Ingelheim - (balgariya@bitrialsupport.com) |
| NZ Respiratory and Sleep Institute Greenlane East, Auckland | Boehringer Ingelheim - (newzealand@bitrialsupport.com) |
| Nagasaki University Hospital Nagasaki, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Nagoya University Hospital Nagoya, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Nanjing Drum Tower Hospital Nanjing, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Nanjing First Hospital Nanjing, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Narayana Health - Mazumdar Shaw Medical Center Bengaluru, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| National Center for Child Health and Development Tokyo, Setagaya-ku, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| National Hospital Organization Kinki-Chuo Chest Medical Center Osaka, Sakai, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| National Jewish Health Denver, Colorado | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| National Taiwan University Hospital Taipei, | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| National Taiwan University Hospital Yun-Lin Branch Yunlin County, | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| National University Hospital-Singapore-42005 Singapore, | Boehringer Ingelheim - (singapore@bitrialsupport.com) |
| Netspiro Clinica Medica Ltda - Respsono São Bernardo do Campo, | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| New York Medical College - Hawthorne Hawthorne, New York | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| New York University Langone Medical Center New York, New York | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| NewYork-Presbyterian/Weill Cornell Medical Center New York, New York | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Newport Native MD, Inc Newport Beach, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Nihon University Itabashi Hospital Tokyo, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Niigata University Medical and Dental Hospital Niigata, Niigata, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Ninewells Hospital & Medical School Dundee, Scotland, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Ningbo Medical Center Lihuili Hospital Ningbo, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Noordwest Ziekenhuisgroep Alkmaar, | Boehringer Ingelheim - (nederland@bitrialsupport.com) |
| North Florida/South Georgia Veterans Health System Gainesville, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Northern General Hospital Sheffield, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Northern Jiangsu People's Hospital Yangzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Northwell Health New Hyde Park, New York | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Northwestern University Chicago, Illinois | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Oaxaca Site Management Organization, S.C. Oaxaca City, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Oita University Hospital Yufu, Oita Prefecture | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Oregon Health and Sciences University Portland, Oregon | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Osaka Toneyama Medical Center Osaka, Toyonaka, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Osp. Pediatrico Bambin Gesù Roma, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Oulun yliopistollinen keskussairaala Oulu, | Boehringer Ingelheim - (suomi@bitrialsupport.com) |
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| Paradigm Clinical Research - Redding Redding, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Pauls Stradins Clinical University Hospital Riga, | |
| Peking Union Medical College Hospital Beijing, Beijing Municipality | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Peking University People's Hospital Beijing, Beijing Municipality | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Peking University Third Hospital Beijing, Beijing Municipality | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Peninsula Health Frankston, Victoria | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| People's Hospital of Sichuan Province Chengdu, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Philippine General Hospital Taft, Manila, | Boehringer Ingelheim - (pilipinas@bitrialsupport.com) |
| Pinehurst Medical Clinic, Inc. - East Pinehurst, North Carolina | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| PingXiang People's Hospital Pingxiang, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Plucna ambulancia Hrebenar s.r.o. Spišská Nová Ves, | Boehringer Ingelheim - (slovensko@bitrialsupport.com) |
| Pneumologisches Studienzentrum München-West München, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Policlinico "Paolo Giaccone" Palermo, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Policlinico S. Orsola-Malpighi Bologna, | Boehringer Ingelheim - (italia@bitrialsupport.com) |
| Premier Medical Associates The Villages, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Prince of Wales Hospital-Hong Kong-20715 Hong Kong, | Boehringer Ingelheim - (hongkong@bitrialsupport.com) |
| ProMedica Physicians Pulmonary and Sleep Medicine - Toledo Toledo, Ohio | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Providence Medical Group Alaska Anchorage, Alaska | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Providence Medical Research Center Spokane, Washington | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Puerto Rico Consortium for Clinical Investigation San Juan, | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| QEII Health Sciences Centre Halifax, Nova Scotia | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| QingDao Municipal Hospital Qingdao, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University Shanghai, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Queen Mary Hospital Hong Kong, | Boehringer Ingelheim - (hongkong@bitrialsupport.com) |
| Queensland Children's Hospital South Brisbane, Queensland | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Quirino Memorial Medical Center Quezon City, | Boehringer Ingelheim - (pilipinas@bitrialsupport.com) |
| Rabin Medical Center Beilinson Petah Tikva, | Boehringer Ingelheim - (israel@bitrialsupport.com) |
| Ramathibodi Hospital Bangkok, | Boehringer Ingelheim - (thai@bitrialsupport.com) |
| Regional Clinical Hospital of the Health Department of the Karaganda Region Karaganda, | Boehringer Ingelheim - (kazakhstan@bitrialsupport.com) |
| Republic Klaipeda Hospital Klaipėda, | |
| Respiratory Medicine Centre, private prac., Bialystok Bialystok, | Boehringer Ingelheim - (polska@bitrialsupport.com) |
| Riga 1st Hospital Riga, | |
| Riga East University Hospital Upeslejas, | Boehringer Ingelheim - (latvia@bitrialsupport.com) |
| Royal Brompton Hospital London, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Royal Hospital for Children and Young People Edinburgh, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Royal Infirmary of Edinburgh Edinburgh, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Royal Lancaster Infirmary Lancaster, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Royal Papworth Hospital Cambridge, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Royal Prince Alfred Hospital Camperdown, New South Wales | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Royal Stoke University Hospital Stoke-on-Trent, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Royal University Hospital (Saskatoon) Saskatoon, Saskatchewan | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH Essen, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Rutgers Robert Wood Johnson Medical School New Brunswick, New Jersey | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| SC Medlife S.A Cluj-Napoca, | Boehringer Ingelheim - (romania@bitrialsupport.com) |
| SHATPPD "Dr. Dimitar Gramatikov" Rousse, | |
| SMG-SNU Boramae Medical Center Seoul, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| SSM Health Cardinal Glennon Children's Hospital St Louis, Missouri | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Saga University Hospital Saga, Saga, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Saitama Cardiovascular and Respiratory Center Saitama, Kumagaya, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Samsung Medical Center Seoul, Gangnam-gu | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| San Juan Bautista School of Medicine Caguas, | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Sarawak General Hospital Kuching, | Boehringer Ingelheim - (malaysia@bitrialsupport.com) |
| Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi Ankara, | Boehringer Ingelheim - (turkiye@bitrialsupport.com) |
| Sbalpfz-Vratsa Vratsa, | |
| Screenmed Sp. z o.o. Piaseczno, | Boehringer Ingelheim - (polska@bitrialsupport.com) |
| Serviços Medicos Respirar Sul Fluminense Barra Mansa, | Boehringer Ingelheim - (brasil@bitrialsupport.com) |
| Severance Hospital Seoul, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Shanghai Fifth People's Hospital affiliated to Fudan University Shanghai, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Shanghai General Hospital Shanghai, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Shanghai Pulmonary Hospital Shanghai, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Shenzhen People's Hospital Shenzhen, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Shiga University of Medical Science Hospital Shiga, Otsu, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Siddhi Hospital, C/o Dr. Mutha Hospital Nashik, | Boehringer Ingelheim - (india@bitrialsupport.com) |
| Singapore General Hospital Singapore, | Boehringer Ingelheim - (singapore@bitrialsupport.com) |
| Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Hangzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Siriraj Hospital Bangkok, | Boehringer Ingelheim - (thai@bitrialsupport.com) |
| Soluciones terapeuticas medico quirurgicas S de RL de CV Mexico City, | Boehringer Ingelheim - (mexico@bitrialsupport.com) |
| Songklanagarind Hospital Songkhla, | Boehringer Ingelheim - (thai@bitrialsupport.com) |
| Sourasky Medical Center Tel Aviv, | Boehringer Ingelheim - (israel@bitrialsupport.com) |
| Southampton General Hospital Southampton, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Srinagarind Hospital Khon Kaen, | Boehringer Ingelheim - (thai@bitrialsupport.com) |
| St James's University Hospital Leeds, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| St. Francis Medical Institute Clearwater, Florida | |
| St. Paul's Hospital (Vancouver) Vancouver, British Columbia | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| St. Vincent's University Hospital Dublin, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Stern Research Partners, LLC Huntersville, North Carolina | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Taichung Veterans General Hospital Taichung, | Boehringer Ingelheim - (taiwan@bitrialsupport.com) |
| Tampere University Hospital Tampere, | Boehringer Ingelheim - (suomi@bitrialsupport.com) |
| Tan Tock Seng Hospital Singapore, | Boehringer Ingelheim - (singapore@bitrialsupport.com) |
| Technische Universitat Dresden Dresden, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Tenryu Hospital Shizuoka, Hamamatsu, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Terada Clinic, Respiratory Medicine & General practice Hyogo, Himeji, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul, Seoul-teukbyeolsi [seoul] | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| The Catholic University of Korea, Incheon St. Mary's Hospital Incheon, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| The Catholic University of Korea, Seoul St.Mary's Hospital Seoul, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| The Children's Hospital of Fudan University Shanghai, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The First Affiliated Hospital of Anhui Medical University Hefei, Anhui | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The First Affiliated Hospital of NanChang University Nanchang, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The First Affiliated Hospital of Ningbo University Ningbo, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The First Affiliated Hospital of Soochow University Suzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The First Affiliated Hospital, Zhejiang University Hangzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The First Pulmonary Private Practice Prague, | |
| The Lung Research Center, LLC Chesterfield, Missouri | |
| The Prince Charles Hospital Chermside, Queensland | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| The Royal Children's Hospital Parkville, Victoria | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The Second Affiliated Hospital of Fujian Medical University Quanzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The Second Affiliated Hospital to Nanchang University Nanchang, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The Second Hospital of Jilin University Changchun, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The Second Xiangya Hospital of Central South University Changsha, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| The University of North Carolina at Chapel Hill Chapel Hill, North Carolina | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg Heidelberg, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Tianjin Medical University General Hospital Tianjin, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Tohoku University Hospital Sendai, Miyagi | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Tokushima University Hospital Tokushima, Tokushima, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Tokyo Women's Medical University Hospital Tokyo, Shinjuku-ku, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Tongji Hospital, Tongji University Shanghai, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Toranomon Hospital Tokyo, Minato-ku, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Torbay Hospital Torquay, Devon | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Trialswest Spearwood, Western Australia | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Turku University Hospital / TYKS Turku, | Boehringer Ingelheim - (suomi@bitrialsupport.com) |
| ULS Braga Braga, | Boehringer Ingelheim - (portugal@bitrialsupport.com) |
| ULS da Região de Aveiro Aveiro, | Boehringer Ingelheim - (portugal@bitrialsupport.com) |
| ULS da Região de Leiria, E.P.E. Leiria, | Boehringer Ingelheim - (portugal@bitrialsupport.com) |
| ULS de Santa Maria, E.P.E Lisbon, | Boehringer Ingelheim - (portugal@bitrialsupport.com) |
| ULS do Alto Ave Guimarães, | Boehringer Ingelheim - (portugal@bitrialsupport.com) |
| UMC Utrecht Utrecht, | Boehringer Ingelheim - (nederland@bitrialsupport.com) |
| UMass Memorial Medical Center Worcester, Massachusetts | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| UZ Leuven Leuven, | Boehringer Ingelheim - (belgique@bitrialsupport.com) |
| Ulsan University Hospital Dong-gu Ulsan, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Univ. Hospital Martin Martin, | Boehringer Ingelheim - (slovensko@bitrialsupport.com) |
| Universitair Ziekenhuis Gent Ghent, | Boehringer Ingelheim - (belgique@bitrialsupport.com) |
| Universitatsklinikum Freiburg Freiburg im Breisgau, Baden-Wurttemberg | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Universitatsklinikum Jena Jena, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Universitatsklinikum Schleswig-Holstein, Campus Kiel Kiel, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Universitetssjukhuset, Örebro Örebro, | Boehringer Ingelheim - (sverige@bitrialsupport.com) |
| University Hospital Hairmyres East Kilbride, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| University Hospital Llandough Cardiff, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| University Hospital Motol Prague, | |
| University Hospital of Lausanne Lausanne, | Boehringer Ingelheim - (suisse@bitrialsupport.com) |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University Malaya Medical Centre Lembah Pantai, | Boehringer Ingelheim - (malaysia@bitrialsupport.com) |
| University of Alabama at Birmingham Birmingham, Alabama | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Arizona Tucson, Arizona | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Calgary Calgary, Alberta | Boehringer Ingelheim - (canada@bitrialsupport.com) |
| University of California Davis Sacramento, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of California San Francisco San Francisco, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Cincinnati Cincinnati, Ohio | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Florida College of Medicine Jacksonville, Florida | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Kansas Medical Center Kansas City, Kansas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Maryland St. Joseph Medical Group Pulmonary Care and Sleep Medicine Towson, Maryland | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Miami Miami, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Michigan Ann Arbor, Michigan | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Mississippi Medical Center Jackson, Mississippi | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Nebraska Medical Center Omaha, Nebraska | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Pennsylvania Philadelphia, Pennsylvania | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Texas Health Science Center at Tyler Tyler, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Texas Medical Branch at Galveston Galveston, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Texas Southwestern Medical Center Dallas, Texas | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of Tsukuba Hospital Ibaraki, Tsukuba, | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| University of Vermont Burlington, Vermont | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
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| Universitätsklinikum Aachen, AöR Aachen, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Universitätsklinikum Bonn AöR Bonn, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Universitätsklinikum Frankfurt Frankfurt, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Universitätsklinikum Köln (AöR) Cologne, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Universitätsklinikum Münster Münster, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
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| VA Caribbean Healthcare System San Juan, | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| VCA Dubultu Medical center Jūrmala, | |
| Vejle University Hospital Vejle, | Boehringer Ingelheim - (danmark@bitrialsupport.com) |
| Velocity Clinical Research Germany GmbH, Ahrensburg Ahrensburg, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Velocity Clinical Research, Bristol Bristol, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Ventura County Medical Center Ventura, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Vilnius University Hospital, Santariskiu Vilnius, | |
| Virginia Commonwealth University Health Systems Richmond, Virginia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Vitaz - Campus Sint-Niklaas Sint-Niklaas, | Boehringer Ingelheim - (belgique@bitrialsupport.com) |
| Vivantes Netzwerk für Gesundheit GmbH Berlin, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Waikato Hospital Hamilton, Waikato Region | Boehringer Ingelheim - (newzealand@bitrialsupport.com) |
| Washington University School of Medicine St Louis, Missouri | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Washington University School of Medicine St Louis, Missouri | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Wenzhou People's Hospital Wenzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| West China Hospital, Sichuan University Chengdu, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| West Visayas State University Medical Center Iloilo City, | Boehringer Ingelheim - (pilipinas@bitrialsupport.com) |
| Western General Hospital Edinburgh, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Westmead Hospital Westmead, | Boehringer Ingelheim - (australia@bitrialsupport.com) |
| Wuhan Union Hospital Wuhan, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Wuxi People's Hospital Wuxi, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Yale University School of Medicine North Haven, Connecticut | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Yamaguchi University Hospital Ube, Yamaguchi | Boehringer Ingelheim - (nippon@bitrialsupport.com) |
| Yeongnam University Hospital Daegu, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Yixing People'S Hospital Yixing, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Yonsei University Wonju Severance Christian Hospital Wŏnju, | Boehringer Ingelheim - (namhan@bitrialsupport.com) |
| Zhejiang Hospital Hangzhou, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| Zhongshan Hospital Affiliated to Fudan University Shanghai, | Boehringer Ingelheim - (china@bitrialsupport.com) |
| the First Hospital of Jilin University Changchun, Jilin | Boehringer Ingelheim - (china@bitrialsupport.com) |
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Clinical Trials Administrator - clinicaltrials@regeneron.com
NCT06246916
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Key
• Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
• Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
• Measurable disease per RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
• Adequate bone marrow, hepatic, and kidney function
• Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol Key
• Uveal, acral or mucosal melanoma.
• Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
• Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed. Prior/Concomitant Therapy:
• Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
• Systemic immune suppression as described in the protocol. Other Comorbidities:
• Participants with a history of myocarditis.
• Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
• Active or untreated brain metastases or spinal cord compression as described in the protocol. Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
Inclusion Criteria:
• Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
• Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
• Measurable disease per RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
• Adequate bone marrow, hepatic, and kidney function
• Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol Key
Exclusion Criteria:
Medical Conditions:
• Uveal, acral or mucosal melanoma.
• Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
• Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed. Prior/Concomitant Therapy:
• Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
• Systemic immune suppression as described in the protocol. Other Comorbidities:
• Participants with a history of myocarditis.
• Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
• Active or untreated brain metastases or spinal cord compression as described in the protocol. Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
DRUG: fianlimab, DRUG: cemiplimab, DRUG: relatlimab+nivolumab
Melanoma
Unresectable Melanoma, Metastatic Melanoma, Advanced Melanoma, Stage III, Stage IV
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Study Locations
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| Location | Contacts |
|---|---|
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Allina Health Cancer Institute Minneapolis, Minnesota | |
| Arizona Oncology Associates Tucson, Arizona | |
| Banner MD Anderson Cancer Center Gilbert, Arizona | |
| Beacon Clinic Coeur d'Alene, Idaho | |
| Boca Raton Clinical Research (BRCR) Global Tamarac, Florida | |
| Cancer Specialist of North Florida Jacksonville, Florida | |
| Cancer and Blood Specialty Clinic Los Alamitos, California | |
| Center For Disease And Blood Disorder Fort Worth, Texas | |
| Centre Hospitalier Universitaire de Quebec (CHUQ) - Centre Hospitalier de l'Universite Laval (CHUL) Québec, | |
| Clermont Oncology Center Clermont, Florida | |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Duke Health System Durham, North Carolina | |
| Eisenhower Medical Center Rancho Mirage, California | |
| Emad Ibrahim, MD, Inc. Redlands, California | |
| Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| H. Lee Moffitt Cancer Center Tampa, Florida | |
| Henry Ford Cancer Institute/Henry Ford Health System Detroit, Michigan | |
| Hope and Healing Cancer Services Hinsdale, Illinois | |
| Illinois CancerCare Peoria, Illinois | |
| Inova Schar Cancer Institute Fairfax, Virginia | |
| Ironwood Cancer & Research Centers Chandler, Arizona | |
| Jewish General Hospital - Main Address Montreal, Quebec | |
| Joe Arrington Cancer Research & Treatment Center Lubbock, Texas | |
| John B. Amos Cancer Center Columbus, Georgia | |
| John Theurer Cancer Center Hackensack, New Jersey | |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | |
| Kaiser Foundation Hospitals Portland, Oregon | |
| Karmanos Cancer Institute Detroit, Michigan | |
| Levine Cancer Institute Charlotte, North Carolina | |
| Lifespan Cancer Institute Providence, Rhode Island | |
| London Regional Cancer Centre London, Ontario | |
| Markey Cancer Center Clinical Research Organization Lexington, Kentucky | |
| Mary Bird Perkins Cancer Center Baton Rouge, Louisiana | |
| Maryland Oncology Hematology, P.A. Columbia, Maryland | |
| Mayo Clinic Florida Jacksonville, Florida | |
| Mercy South St Louis, Missouri | |
| Messino Cancer Center Asheville, North Carolina | |
| Minnesota Oncology Hematology, P.A Saint Paul, Minnesota | |
| New York Oncology Hematology Albany, New York | |
| Novant Health Cancer Institute Charlotte, North Carolina | |
| Novant Health Weisiger Cancer Institute - Charlotte Charlotte, North Carolina | |
| Novant Health Zimmer Cancer Institute - Wilmington Wilmington, North Carolina | |
| Oklahoma Cancer Specialists and Research Institute, LLC Tulsa, Oklahoma | |
| Oncology & Hematology Associates of Southwest Virginia, Inc. Wytheville, Virginia | |
| Oncology Associates of Oregon PC Eugene, Oregon | |
| Oncology Hematology Care Clinical Trials Cincinnati, Ohio | |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha, Nebraska | |
| Oregon Health and Science University Portland, Oregon | |
| Princess Margaret Cancer Centre Toronto, | |
| Providence Medical Foundation Santa Rosa, California | |
| Rocky Mountain Regional VA Medical Center Aurora, Colorado | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Francis Cancer Center Greenville, South Carolina | |
| Sansum Clinic Santa Barbara, California | |
| Sarah Cannon Research Institute (SCRI) Oncology Partners Nashville, Tennessee | |
| Seidman Cancer Center Cleveland, Ohio | |
| St John's Cancer Institute Santa Monica, California | |
| St. Joseph Hospital Orange Orange, California | |
| St. Luke's University Health Network Bethlehem, Pennsylvania | |
| St. Vincent Healthcare Billings, Montana | |
| Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Sutter Health Sacramento, California | |
| Swedish Cancer Institute Seattle, Washington | |
| Swedish Cancer Institute - Edmonds Campus Edmonds, Washington | |
| Swedish Cancer Institute - Issaquah Campus Issaquah, Washington | |
| Tennessee Oncology Nashville, Tennessee | |
| Tennessee Oncology - Chattanooga Chattanooga, Tennessee | |
| Texas Oncology Dallas, Texas | |
| Texas Oncology - Austin Central, Central Austin Cancer Center Austin, Texas | |
| Texas Oncology - Austin Midtown, Midtown Medical Center I Austin, Texas | |
| Texas Oncology - Bedford Bedford, Texas | |
| Texas Oncology - Fort Worth Fort Worth, Texas | |
| Texas Oncology - Grapevine Grapevine, Texas | |
| Texas Oncology - Harlingen, Medical Arts Pavillion Harlingen, Texas | |
| Texas Oncology - Longview Longview, Texas | |
| Texas Oncology - McAllen McAllen, Texas | |
| Texas Oncology - Medical City Dallas, Texas | |
| Texas Oncology - Weslaco, Knapp Medical Plaza Weslaco, Texas | |
| Texas Oncology-Palestine Cancer Center Palestine, Texas | |
| Texas Oncology-Tyler, Northeast Texas Cancer Institute Tyler, Texas | |
| The Melanoma and Skin Cancer Institute Englewood, Colorado | |
| The Ohio State University Wexner Medical Center Columbus, Ohio | |
| The University of Kansas Cancer Center Westwood, Kansas | |
| The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center Tyler, Texas | |
| The University of Texas MD Anderson Cancer Center Houston, Texas | |
| The Valley Hospital Inc. Paramus, New Jersey | |
| UCHealth Fort Collins, Colorado | |
| University Cancer & Blood Center Athens, Georgia | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Los Angeles Los Angeles, California | |
| University of California San Francisco (UCSF) San Francisco, California | |
| University of Colorado Cancer Center Aurora, Colorado | |
| University of Michigan Ann Arbor, Michigan | |
| University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center Pittsburgh, Pennsylvania | |
| University of Tennessee Medical Center Knoxville, Tennessee | |
| University of Utah Huntsman Cancer Institute Salt Lake City, Utah | |
| University of Virginia Charlottesville, Virginia | |
| University of Wisconsin Carbone Cancer Center Madison, Wisconsin | |
| VA St. Louis Healthcare System St Louis, Missouri | |
| Virginia Cancer Specialists, PC Fairfax, Virginia | |
| Virginia Commonwealth University Massey Cancer Center Richmond, Virginia | |
| Virginia Oncology Associates Norfolk, Virginia | |
| Washington University St Louis, Missouri | |
| West Virginia University Morgantown, West Virginia | |
| Yale Cancer Center New Haven, Connecticut |
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
ctrrecruit@vcu.edu
NCT05564377
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Inclusion Criteria:
* Patient must have measurable disease
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \>= 50% or Karnofsky performance status of \>= 50%
* Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider
* All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)
* Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria:
* Patients must have progressed on at least one line of standard systemic therapy OR
* Patients whose disease has no standard treatment that has been shown to prolong overall survival
* Patient must meet one of the following requirements:
* Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR
* Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
* Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial
* Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response \[CR\] or partial response \[PR\]) to any intervening therapy after collection of the tissue
* Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR
* Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
* Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available
* NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only
* NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial DRUG: Alpelisib, DRUG: Binimetinib, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, DRUG: Fluorouracil, DRUG: Fulvestrant, DRUG: Ipatasertib, DRUG: Leucovorin, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mutation Carrier Screening, DRUG: Neratinib Maleate, DRUG: Nilotinib Hydrochloride Monohydrate, DRUG: Olaparib, DRUG: Oxaliplatin, DRUG: Paclitaxel, DRUG: Palbociclib, BIOLOGICAL: Panitumumab, PROCEDURE: Positron Emission Tomography, DRUG: Selumetinib Sulfate, DRUG: Sotorasib
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm, Malignant Female Reproductive System Neoplasm, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Unresectable HER2-Negative Breast Carcinoma, Unresectable Malignant Solid Neoplasm
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Show 480 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) |
| 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) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Annie Penn Memorial Hospital Reidsville, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Armes Family Cancer Center Findlay, Ohio | |
| 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 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) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Ballad Health Cancer Care - Kingsport Kingsport, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| 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) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| 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) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Bryn Mawr Hospital Bryn Mawr, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| CTCA at Western Regional Medical Center Goodyear, Arizona | |
| 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) |
| 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 Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Capital Health Medical Center-Hopewell Pennington, New Jersey | |
| Carilion Roanoke Memorial Hospital Roanoke, Virginia | |
| 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) |
| 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) |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | |
| 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) |
| 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) |
| Cone Health Cancer Center Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health Cancer Center at Alamance Regional Burlington, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health Cancer Center at Drawbridge Parkway Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health MedCenter Asheboro Asheboro, 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 Children's Royal Oak, Michigan | |
| Corewell Health Dearborn Hospital Dearborn, Michigan | |
| Corewell Health Farmington Hills Hospital Farmington Hills, 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 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) |
| Corewell Health William Beaumont University Hospital Royal Oak, Michigan | |
| Covenant Medical Center-Lakeside Lubbock, Texas | |
| 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-Atrium Franklin, Ohio | |
| 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 Cancer Center Manati, | |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| East Jefferson General Hospital Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| Epic Care Cyberknife Center Walnut Creek, California | |
| Epic Care-Dublin Dublin, California | |
| 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 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) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| 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) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Greater Dayton Cancer Center Kettering, Ohio | |
| Gulfport Memorial Hospital Gulfport, Mississippi | Site Public Contact - (emede1@lsuhsc.edu) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania | |
| 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) |
| Hayworth Cancer Center High Point, North Carolina | |
| 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) |
| Hendrick Medical Center Abilene, Texas | |
| Henrico Doctor's Hospital Richmond, Virginia | |
| Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Hillcrest Hospital Cancer Center Mayfield Heights, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Houston Methodist Hospital Houston, Texas | |
| Houston Methodist Saint John Hospital Nassau Bay, Texas | |
| Houston Methodist Sugar Land Hospital Sugar Land, Texas | |
| Houston Methodist The Woodlands Hospital Shenandoah, Texas | |
| Houston Methodist West Hospital Houston, Texas | |
| 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) |
| 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) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.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 | |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kettering Medical Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| 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) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.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) |
| Loyola University Medical Center Maywood, Illinois | |
| Lyndon Baines Johnson General Hospital Houston, Texas | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.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) |
| 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 Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Hospital Marysville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital of South Bend South Bend, Indiana | |
| 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 Westchester Harrison, New York | |
| 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 Health - Paducah Cancer Center Paducah, Kentucky | |
| 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 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 | |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (OncologyResearch@DignityHealth.org) |
| Mercyhealth Cancer Institute - Rockford Rockford, Illinois | Site Public Contact - (oncologyclinicaltrials@mhemail.org) |
| Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin | Site Public Contact - (oncologyclinicaltrials@mhemail.org) |
| Methodist Willowbrook Hospital Houston, Texas | |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Englewood, 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) |
| Midwestern Regional Medical Center Zion, Illinois | |
| 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 - 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) |
| Mount Carmel East Hospital Columbus, 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) |
| 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) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| National Institutes of Health Clinical Center Bethesda, Maryland | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| 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) |
| 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) |
| 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) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| 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) |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| PROncology San Juan, | Site Public Contact - (info@PRoncology.com) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| 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 Health Center - Farmington Farmington, Missouri | |
| Pennsylvania Hospital Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Pluta Cancer Center Rochester, New York | |
| 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 Intercommunity Hospital Whittier, California | |
| 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 Richland Hospital Columbia, 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 | |
| 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 System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@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 Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Puerto Rico Hematology Oncology Group Bayamón, | |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Rapid City Regional Hospital Rapid City, South Dakota | Site Public Contact - (research@monument.health) |
| Regional Cancer Center at Johnson City Medical Center Johnson City, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| 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) |
| Riddle Memorial Hospital Media, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| 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) |
| 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) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| 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 Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.org) |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint John's Cancer Institute Santa Monica, California | |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital - Orange Orange, California | |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.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) |
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| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Hospital Chesterfield, Missouri | |
| 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 | |
| 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) |
| Scott and White Memorial Hospital Temple, Texas | |
| Sharp Memorial Hospital San Diego, California | Site Public Contact - (cathy.wood@sharp.com) |
| 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) |
| 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) |
| 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) |
| 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) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| 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) |
| 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 - (ecog.rss@jimmy.harvard.edu) |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | Site Public Contact - (rohta@queens.org) |
| 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 - Appleton 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) |
| Toledo Clinic Cancer Centers-Toledo Toledo, Ohio | |
| 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) |
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| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| Tufts Medical Center Cancer Center Stoneham Stoneham, Massachusetts | Site Public Contact - (NCCCR@Tuftsmedicalcenter.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
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| UC San Diego Medical Center - Hillcrest San Diego, California | Site Public Contact - (rhabbaba@health.ucsd.edu) |
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| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights, Ohio | |
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| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
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| UI Health Care Mission Cancer and Blood - Laurel 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 - (ecog.rss@jimmy.harvard.edu) |
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| 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 | |
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| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
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| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@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 Hawaii Cancer Center Honolulu, Hawaii | |
| University of Illinois Chicago, Illinois | |
| 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 Miami Sylvester Comprehensive Cancer Center at Sole Mia North Miami, Florida | Site Public Contact - (kginnity@med.miami.edu) |
| University of Michigan - Brighton Center for Specialty Care Brighton, Michigan | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
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| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | |
| 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 Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of South Alabama Mitchell Cancer Institute Mobile, Alabama | Site Public Contact - (pfrancisco@usouthal.edu) |
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| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
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| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| VA Palo Alto Health Care System Palo Alto, California | |
| 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) |
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| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Vanderbilt Breast Center at One Hundred Oaks Nashville, Tennessee | |
| 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 | |
| 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 Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Women and Infants Hospital Providence, Rhode Island | |
| Woodland Cancer Care Center Michigan City, Indiana | |
| Woodland Memorial Hospital Woodland, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Zangmeister Center Grove City Grove City, Ohio |
Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
Emily Federmann - Emily.Federmann@vcuhealth.org
NCT06874192
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Inclusion Criteria:
* History of statin intolerance (As defined by the NLA 2023 guidelines) Patients who have experienced one or more adverse effects associated with statin therapy, which resolves or improves with dose continuation or reduction
* Stable dose of lipid-lowering regimen (statin or non-statin) for at least one month
* Patients able to provide informed consent.
* Aged 18 to 80 will be enrolled in the study.
Exclusion Criteria:
* Known hypersensitivity to colchicine, current use of colchicine or other anti-inflammatory medications.
* Renal impairment (eGFR \<45 mL/min/1.73 m2)
* Transaminitis (ALT or AST \>3 times upper limit of normal)
* Cirrhosis
* Severe Heart Failure
* Active cancer or currently on chemotherapy
* Irritable Bowel Syndrome, Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis) or other diarrheal related GI pathologies
* Active infection
* Autoimmune or inflammatory condition
* Pregnancy or breastfeeding. DRUG: Low-dose colchicine at 0.5mg daily, OTHER: Placebo
Statin Adverse Reaction
statin intolerance
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Pamela Alebna - (pamela.alebna@vcuhealth.org) Anurag Mehta - (anurag.mehta@vcuhealth.org) |
Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer
ctrrecruit@vcu.edu
NCT06102902
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Inclusion Criteria:
* Patients must have histologically confirmed and radiographically measurable metastatic colorectal adenocarcinoma with known BRAF V600E mutation, confirmed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory with at least one tumor measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and for which standard curative or palliative measures do not exist or are no longer effective
* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ZEN003694 in combination with cetuximab and encorafenib in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Hemoglobin (Hb) ≥ 9 mg/dl
* Total bilirubin ≤ 1.5 mg/dl (excluding Gilbert's disease)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 x institutional upper limit of normal (ULN)
* Creatinine clearance (CrCL) glomerular filtration rate (GFR) ≥ 50 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 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. Patients should be New York Heart Association Functional Classification of class II or better
* Patients must have progressed after at least 1 prior systemic treatment for incurable advanced or metastatic disease
* Patients must have received prior treatment with the combination of encorafenib and cetuximab. They must have tolerated the combination at doses planned for the study
* The effects of ZEN003694 on the developing human fetus are unknown. For this reason and because BRD and BET inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men 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 for at least 4 months following the last dose of study drug. Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 72 hours prior to the start of investigational product. 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
* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
Exclusion Criteria:
* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
* Patients who are receiving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 or other agents used in study
* Patients with uncontrolled intercurrent illness including, but not limited to, active bleeding diatheses, poorly controlled infection/disorders, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694. As proton pump inhibitors (PPIs), H2 receptor antagonists, and antacids may alter the pharmacokinetics of ZEN003694 by reducing ZEN003694 exposure, patients receiving proton pump inhibitors are ineligible. If H2 blockers or other acid reducing agents are used concomitantly with ZEN003694, a staggered dosing schedule should be used, either dose ZEN003694 2 hours before the H2 blocker or 10-12 hours after an H2 blocker. 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 patient 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 patient is considering a new over-the-counter medicine or herbal product
* Pregnant women are excluded from this study because ZEN003694 is BRD and BET inhibitor agent with 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 ZEN003694, breastfeeding should be discontinued if the mother is treated with ZEN003694. These potential risks may also apply to other agents used in this study DRUG: BET Bromodomain Inhibitor ZEN-3694, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, BIOLOGICAL: Cetuximab, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, DRUG: Encorafenib, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan
Metastatic Colorectal Adenocarcinoma, Recurrent Colorectal Adenocarcinoma, Refractory Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
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| Location | Contacts |
|---|---|
| Los Angeles General Medical Center Los Angeles, California | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| 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) |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| 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 Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| 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) |
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
Toll Free Number - Trialsites@msd.com
NCT06312176
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Inclusion Criteria:
* Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
* Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
* Is a chemotherapy candidate
* Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
* Has adequate organ function
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion Criteria:
* Has breast cancer amenable to treatment with curative intent
* Has experienced an early recurrence (\<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
* Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
* Active autoimmune disease that has required systemic treatment in the past 2 years
* History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy DRUG: Sacituzumab tirumotecan, BIOLOGICAL: Pembrolizumab, DRUG: Paclitaxel, DRUG: Nab-paclitaxel, DRUG: Capecitabine, DRUG: Liposomal doxorubicin
Breast Neoplasms
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
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Study Locations
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| Location | Contacts |
|---|---|
| AZ Maria Middelares-IKG ( Site 1106) Ghent, Oost-Vlaanderen | |
| Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1876) Adana, | |
| AdventHealth Altamonte Springs ( Site 0021) Altamonte Springs, Florida | |
| Agios Loukas Clinic ( Site 1347) Thessaloniki, | |
| Akademiska sjukhuset ( Site 1802) Uppsala, Uppsala County | |
| All India Institute of Medical Sciences ( Site 2051) New Delhi, National Capital Territory of Delhi | |
| Amphia Ziekenhuis, locatie Breda Molengracht-oncologie ( Site 1523) Breda, North Brabant | |
| Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1871) Ankara, | |
| Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032) Thomasville, Georgia | |
| Aretaieio Hospital Oncology Unit ( Site 1345) Athens, Attica | |
| Asan Medical Center-Department of Oncology ( Site 2352) Seoul, | |
| Auckland City Hospital ( Site 2031) Auckland, | |
| BC Cancer Surrey ( Site 0315) Surrey, British Columbia | |
| Banner MD Anderson Cancer Center-Oncology ( Site 0004) Gilbert, Arizona | |
| Bialostockie Centrum Onkologii ( Site 1585) Bialystok, Podlaskie Voivodeship | |
| Blackpool Victoria Hospital ( Site 1941) Blackpool, | |
| Bon Secours Cork Hospital ( Site 1422) Cork, | |
| Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015) Midlothian, Virginia | |
| Bradford Hill Norte ( Site 0456) Antofagasta, | |
| Bradfordhill ( Site 0452) Santiago, Region M. de Santiago | |
| Brust-Zentrum ( Site 1841) Zurich, Canton of Zurich | |
| Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1373) Budapest, | |
| CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2905) Port Elizabeth, Eastern Cape | |
| CENTRO MEDICO ZAMBRANO HELLION-Centro de Cáncer de Mama ( Site 0595) San Pedro Garza García, Nuevo León | |
| CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0302) Québec, Quebec | |
| CIMCA ( Site 0551) San José, Provincia de San José | |
| CIO - Centro de Inmuno-Oncología de Occidente ( Site 0592) Guadalajara, Jalisco | |
| CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301) Montreal, Quebec | |
| CRO-IRCCS ( Site 1478) Aviano, Friuli Venezia Giulia | |
| Cancer Institute Hospital of JFCR ( Site 2464) Koto, Tokyo | |
| Cancer and Blood Specialty Clinic ( Site 0001) Los Alamitos, California | |
| Cancercare Rondebosch Oncology-Clinical trials ( Site 2904) Cape Town, Western Cape | |
| CaritasKlinikum Saarbruecken St. Theresia ( Site 1304) Saarbrücken, Saarland | |
| Catharina Ziekenhuis ( Site 1526) Eindhoven, North Brabant | |
| Centre François Baclesse ( Site 1250) Caen, Calvados | |
| Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1243) Poitiers, Vienne | |
| Centre de Cancérologie du Grand Montpellier ( Site 1244) Montpellier, Languedoc-Roussillon | |
| Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0308) Rimouski, Quebec | |
| Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0383) Buenos Aires, | |
| Centrul Medical Neolife- Baneasa ( Site 1704) Bucharest, | |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1582) Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Chang Gung Medical Foundation-Linkou Branch-General Surgery ( Site 2414) Taoyuan District, | |
| Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2413) Kaohsiung City, | |
| Changhua Christian Hospital ( Site 2410) Changhua, | |
| City Hospital, Nottingham University Hospitals NHS Trust ( Site 1945) Nottingham, | |
| Clinica Vallesur - AUNA ( Site 0652) Arequipa, Ariqipa | |
| Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1103) Brussels, Bruxelles-Capitale, Region de | |
| Clínica RedSalud Vitacura ( Site 0455) Santiago, Region M. de Santiago | |
| Curo Oncology ( Site 2908) Pretoria, Gauteng | |
| Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037) Boston, Massachusetts | |
| Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1375) Debrecen, | |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1878) Yenimahalle, Ankara | |
| Errikos Dunant Hospital Center ( Site 1348) Athens, Attica | |
| European Interbalkan Medical Center ( Site 1341) Thessaloniki, | |
| FALP-UIDO ( Site 0451) Santiago, Region M. de Santiago | |
| FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0507) Bogotá, Bogota D.C. | |
| Fakultni nemocnice Kralovske Vinohrady-Onkologická klinika ( Site 1135) Prague, | |
| Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1132) Olomouc, Olomoucký kraj | |
| Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 1134) Ostrava-Poruba, Moravskoslezský kraj | |
| Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1136) Prague, Praha 5 | |
| Fiona Stanley Hospital-Medical Oncology ( Site 2004) Murdoch, Western Australia | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1472) Milan, Lombardy | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1477) Roma, | |
| Frankston Hospital-Oncology and Haematology ( Site 2003) Frankston, Victoria | |
| Franziskus-Hospital Harderberg ( Site 1308) Georgsmarienhütte, Lower Saxony | |
| Fukushima Medical University Hospital ( Site 2461) Fukushima, | |
| Fundacion Colombiana de Cancerología Clinica Vida ( Site 0506) Medellín, Antioquia | |
| Fundacion Estudios Clinicos-Oncology ( Site 0384) Rosario, Santa Fe Province | |
| Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0387) La Rioja, | |
| Fundación Valle del Lili ( Site 0508) Cali, Valle del Cauca Department | |
| Gifu University Hospital ( Site 2486) Gifu, | |
| Greenebaum Comprehensive Cancer Center ( Site 0036) Baltimore, Maryland | |
| Grupo Médico ASSET-Clinical Research ( Site 0596) Mexico City, Mexico City | |
| HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 1752) Valencia, Valenciana, Comunitat | |
| HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 1756) Madrid, | |
| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1758) Pozuelo de Alarcón, Madrid | |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 1870) Ankara, | |
| Hadassah Medical Center ( Site 1451) Jerusalem, | |
| Health Pharma Professional Research S.A. de C.V: ( Site 0598) Mexico City, Mexico City | |
| Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1314) Berlin, | |
| Hematology Oncology Associates of Rockland ( Site 0054) Nyack, New York | |
| Henry Ford Health ( Site 0002) Detroit, Michigan | |
| Hiroshima City Hiroshima Citizens Hospital ( Site 2478) Hiroshima, | |
| Hokkaido University Hospital ( Site 2460) Sapporo, Hokkaido | |
| Holy Cross Hospital ( Site 0073) Silver Spring, Maryland | |
| Hopital Prive Jean Mermoz-Oncology ( Site 1246) Lyon, Auvergne-Rhône-Alpes | |
| Hospital Aleman-Oncology ( Site 0386) Buenos Aires, | |
| Hospital Beata María Ana-oncology ( Site 1755) Madrid, | |
| Hospital Italiano de Córdoba ( Site 0385) Córdoba, | |
| Hospital Metropolitano - Sede Lindora ( Site 0550) Santa Ana, Provincia de San José | |
| Hospital Militar Central Luis Arias Schereiber ( Site 0651) Jesús María, Lima | |
| Hospital Moinhos de Vento ( Site 0403) Porto Alegre, Rio Grande do Sul | |
| Hospital Sultan Ismail ( Site 2153) Johor Bahru, Johor | |
| Hospital Universitari Vall d'Hebron-Oncology ( Site 1750) Barcelona, | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0590) Monterrey, Nuevo León | |
| Hospital Universitario Reina Sofia-Oncologia Medica ( Site 1754) Córdoba, | |
| Hospital Universitario Virgen Macarena ( Site 1757) Seville, | |
| Hospital do Câncer Mãe de Deus ( Site 0404) Porto Alegre, Rio Grande do Sul | |
| Hygeia Hospital ( Site 1346) Marousi, Attica | |
| Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 1242) Nantes, Loire-Atlantique | |
| IBCC - Núcleo de Pesquisa e Ensino ( Site 0401) São Paulo, | |
| ICIMED ( Site 0552) San José, | |
| IMAT S.A.S ( Site 0502) Montería, Departamento de Córdoba | |
| INCAN-TUMORES MAMARIOS ( Site 0597) Mexico City, Mexico City | |
| IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0653) Lima, | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1480) Meldola, Forli-Cesena | |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1474) Bologna, | |
| Inova Schar Cancer Institute ( Site 0025) Fairfax, Virginia | |
| Institut Curie-Oncology medical Department ( Site 1240) Paris, | |
| Institut Jules Bordet-Medicine Oncology ( Site 1104) Anderlecht, Bruxelles-Capitale, Region de | |
| Instituto Alexander Fleming-Alexander Fleming ( Site 0382) Buenos Aires, Buenos Aires F.D. | |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1662) Porto, | |
| Instituto de Oncologia Saint Gallen ( Site 0412) Santa Cruz do Sul, Rio Grande do Sul | |
| Instituto do Câncer Brasil - Unidade Taubaté ( Site 0408) Taubaté, São Paulo | |
| Institutul Oncologic Cluj ( Site 1701) Cluj-Napoca, | |
| Ironwood Cancer & Research Centers ( Site 0066) Chandler, Arizona | |
| Isala, locatie Zwolle ( Site 1525) Zwolle, Overijssel | |
| Istituto Clinico Humanitas ( Site 1476) Rozzano, Milano | |
| Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1475) Milan, Lombardy | |
| Jessa Ziekenhuis-Limburgs Oncologisch Centrum ( Site 1105) Hasselt, Limburg | |
| Jewish General Hospital ( Site 0303) Montreal, Quebec | |
| Juntendo University Hospital ( Site 2468) Bunkyo, Tokyo | |
| Kanagawa Cancer Center ( Site 2472) Yokohama, Kanagawa | |
| Karolinska Universitetssjukhuset Solna ( Site 1801) Stockholm, Stockholm County | |
| Kitasato University Hospital ( Site 2471) Sagamihara, Kanagawa | |
| Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1300) Essen, North Rhine-Westphalia | |
| Klinikum Ernst von Bergmann-Frauenklinik ( Site 1305) Potsdam, Brandenburg | |
| Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute-Centre for cancer ( Site 2056) Mumbai, Maharashtra | |
| Kumamoto University Hospital ( Site 2480) Kumamoto, | |
| Kyoto University Hospital ( Site 2475) Kyoto, | |
| Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068) New York, New York | |
| Levine Cancer Institute ( Site 0014) Charlotte, North Carolina | |
| Maastricht UMC+-Medical Oncology ( Site 1522) Maastricht, Limburg | |
| Mackay Memorial Hospital ( Site 2412) Taipei, | |
| Macquarie University-MQ Health Clinical Trials Unit ( Site 2002) Macquarie University, New South Wales | |
| Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042) Baton Rouge, Louisiana | |
| Mater Misericordiae University Hospital-Clinical Trials Research Unit ( Site 1423) Dublin, | |
| Mazowiecki Szpital Onkologiczny ( Site 1581) Wieliszew, Masovian Voivodeship | |
| Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1584) Siedlce, Masovian Voivodeship | |
| Meander Medisch Centrum ( Site 1521) Amersfoort, Utrecht | |
| Medipol Mega Universite Hastanesi-oncology ( Site 1875) Stanbul, Istanbul | |
| Memorial Ankara Hastanesi-Medical Oncology ( Site 1874) Ankara, | |
| Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028) Baltimore, Maryland | |
| Metro Davao Medical and Research Center ( Site 2202) Davao City, Davao Del Sur | |
| Mie University Hospital ( Site 2483) Tsu, Mie-ken | |
| Moores Cancer Center ( Site 0059) La Jolla, California | |
| Mount Alvernia ICON Cancer Center ( Site 2251) Singapore, North East | |
| Mrukmed-Mrukmed ( Site 1592) Rzeszów, Podkarpackie Voivodeship | |
| NYU Langone Health - Brooklyn ( Site 0089) Brooklyn, New York | |
| NYU Langone Hospital - Long Island ( Site 0090) Mineola, New York | |
| Nagoya City University Hospital ( Site 2474) Nagoya, Aichi-ken | |
| Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 1590) Gliwice, Silesian Voivodeship | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 1580) Warsaw, Masovian Voivodeship | |
| National Cancer Center Hospital East ( Site 2463) Kashiwa, Chiba | |
| National Center for Global Health and Medicine ( Site 2469) Shinjuku, Tokyo | |
| National Cheng Kung University Hospital-Surgery ( Site 2411) Tainan, | |
| National Taiwan University Hospital-Oncology ( Site 2415) Taipei, | |
| National University Hospital ( Site 2250) Singapore, Central Singapore | |
| Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 1520) Amsterdam, North Holland | |
| Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1138) České Budějovice, Jihočeský kraj | |
| Nordsjællands Hospital - Hillerød ( Site 1184) Hillerød, Capital Region | |
| North West Cancer Centre ( Site 1944) Londonderry, Derry and Strabane | |
| Næstved Sygehus ( Site 1182) Næstved, Region Sjælland | |
| Odense Universitetshospital ( Site 1181) Odense, Region Syddanmark | |
| Okayama University Hospital ( Site 2485) Okayama, | |
| Oncoclínica Oncologistas Associados-Clinical Research ( Site 0407) Teresina, Piauí | |
| Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001) Roanoke, Virginia | |
| Oncosalud ( Site 0650) Lima, Muni Metro de Lima | |
| Oncovida ( Site 0453) Santiago, Region M. de Santiago | |
| Orlando Health Cancer Institute ( Site 0011) Orlando, Florida | |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2477) Osaka, | |
| Ospedale San Martino ( Site 1479) Genova, | |
| Ospedale San Raffaele-Oncologia Medica ( Site 1471) Milan, | |
| Pantai Hospital Kuala Lumpur ( Site 2151) Kuala Lumpur, | |
| Parkland Health and Hospital System ( Site 0069) Dallas, Texas | |
| Pitie Salpetriere University Hospital ( Site 1249) Paris, | |
| Pontificia Universidad Catolica de Chile ( Site 0454) Santiago, Region M. de Santiago | |
| Prince of Wales Hospital ( Site 2041) Shatin, | |
| Princess Margaret Cancer Centre ( Site 0310) Toronto, Ontario | |
| Providence Medical Foundation-Oncology ( Site 0020) Fullerton, California | |
| Providence Portland Medical Center ( Site 0044) Portland, Oregon | |
| Providence St. Vincent Medical Center ( Site 0081) Portland, Oregon | |
| Puerto Rico Medical Research Center LLC ( Site 0675) Hato Rey, | |
| Queen Mary Hospital ( Site 2040) Hksar, | |
| Rabin Medical Center ( Site 1453) Petah Tikva, | |
| Rajiv Gandhi Cancer Institute And Research Centre-Department of Clinical Research ( Site 2052) New Delhi, National Capital Territory of Delhi | |
| Rambam Health Care Campus-Oncology Division ( Site 1452) Haifa, | |
| Rigshospitalet ( Site 1180) Copenhagen, Capital Region | |
| Rush University Medical Center ( Site 0079) Chicago, Illinois | |
| SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1702) Florești, Cluj | |
| SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1315) Gera, Thuringia | |
| ST. LUKE'S MEDICAL CENTER-Medicine ( Site 2200) Quezon City, National Capital Region | |
| Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053) Edgewood, Kentucky | |
| Saint Luke's Cancer Institute ( Site 0027) Kansas City, Missouri | |
| Saitama Medical University International Medical Center ( Site 2462) Hidaka, Saitama | |
| Samsun Medical Park Hastanesi-medical oncology ( Site 1873) Samsun, | |
| Samsung Medical Center-Division of Hematology/Oncology ( Site 2351) Seoul, | |
| Sandton Oncology Medical Group (Pty) Ltd ( Site 2911) Sandton, Gauteng | |
| Sarawak General Hospital ( Site 2154) Kuching, Sarawak | |
| Semmelweis Egyetem-Belgyógyászati és Onkológiai Klinika ( Site 1381) Budapest, | |
| Seoul National University Hospital-Internal Medicine ( Site 2353) Seoul, | |
| Severance Hospital, Yonsei University Health System-Medical oncology ( Site 2350) Seoul, | |
| Sheba Medical Center ( Site 1450) Ramat Gan, | |
| Showa Medical University Hospital ( Site 2466) Shinagawa, Tokyo | |
| Social medical corporation Hakuaikai Sagara Hospital ( Site 2481) Kagoshima, | |
| Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501) Valledupar, Cesar Department | |
| Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1371) Kaposvár, Somogy County | |
| Southlake Health ( Site 0311) Newmarket, Ontario | |
| Spital Thun ( Site 1840) Thun, Canton of Bern | |
| Spitalul Clinic Filantropia ( Site 1703) Bucharest, București | |
| St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940) London, London, City of | |
| St. Marianna University Hospital ( Site 2465) Kawasaki, Kanagawa | |
| St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1420) Dublin, | |
| Stamford Hospital ( Site 0049) Stamford, Connecticut | |
| Stony Brook University-Cancer Center ( Site 0034) Stony Brook, New York | |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1595) Kielce, Świętokrzyskie Voivodeship | |
| Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterápiás Klinika ( Site 1379) Szeged, Csongrád megye | |
| Szpital Wojewódzki w Koszalinie. ( Site 1583) Poland, West Pomeranian Voivodeship | |
| Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 1593) Gdynia, Pomeranian Voivodeship | |
| Södra Älvsborgs Sjukhus Borås ( Site 1803) Borås, Västra Götaland County | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1872) Istanbul, | |
| Tata Memorial Hospital-Medical Oncology ( Site 2053) Mumbai, Maharashtra | |
| Texas Oncology - San Antonio ( Site 8002) San Antonio, Texas | |
| Texas Oncology-Dallas Presbyterian Hospital ( Site 8000) Dallas, Texas | |
| The Center for Cancer and Blood Disorders ( Site 0041) Fort Worth, Texas | |
| The Royal Cornwall Hospital ( Site 1943) Truro, England | |
| The University of Osaka Hospital ( Site 2476) Suita, Osaka | |
| The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057) Tyler, Texas | |
| Thomas Jefferson University - Clinical Research Institute ( Site 0056) Philadelphia, Pennsylvania | |
| Tohoku University Hospital ( Site 2482) Sendai, Miyagi | |
| Tokai University Hospital ( Site 2473) Isehara, Kanagawa | |
| Tokyo Medical University Hospital ( Site 2467) Shinjuku, Tokyo | |
| UCHealth Cherry Creek Medical Center ( Site 0094) Denver, Colorado | |
| UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0677) San Juan, | |
| UT Southwestern Medical Center ( Site 0050) Dallas, Texas | |
| Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 1663) Lisbon, Lisbon District | |
| Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1661) Lisbon, | |
| Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1311) Düsseldorf, North Rhine-Westphalia | |
| Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1301) Erlangen, Bavaria | |
| University College London Hospital-Cancer Clinical Trials Unit ( Site 1942) London, London, City of | |
| University General Hospital of Larissa ( Site 1343) Larissa, Thessaly | |
| University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 1844) Basel, Canton of Basel-City | |
| University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040) Madison, Wisconsin | |
| University of Chicago Medical Center ( Site 0067) Chicago, Illinois | |
| University of Colorado Anschutz Medical Campus ( Site 0061) Aurora, Colorado | |
| University of Colorado Health - Highlands Ranch Hospital ( Site 0095) Highlands Ranch, Colorado | |
| University of Florida College of Medicine ( Site 0063) Gainesville, Florida | |
| Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1107) Namur, | |
| VCU Health Adult Outpatient Pavillion ( Site 0070) Richmond, Virginia | |
| Vejle Sygehus ( Site 1183) Vejle, Region Syddanmark | |
| Washington University School of Medicine ( Site 0076) St Louis, Missouri | |
| Westmead Hospital ( Site 2000) Westmead, New South Wales | |
| Wits Clinical Research ( Site 2903) Johannesburg, Gauteng | |
| Yale Cancer Center ( Site 0060) New Haven, Connecticut | |
| Zachodniopomorskie Centrum Onkologii ( Site 1588) Szczecin, West Pomeranian Voivodeship | |
| Zala Vármegyei Szent Rafael Kórház-Onkológiai osztály ( Site 1372) Zalaegerszeg, Zala County | |
| Zangmeister Cancer Center ( Site 7000) Columbus, Ohio | |
| Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 1524) Arnhem, Gelderland |
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Toll Free Number - Trialsites@msd.com
NCT06456346
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Inclusion Criteria:
* Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status
* Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
* Has received no prior cytoreductive treatment for their ET
* Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy
* 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
* Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion Criteria:
* History of any illness/impairment of gastrointestinal function that might interfere with drug absorption
* History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has an active infection requiring systemic therapy
* Has had a major surgery \<4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery \>4 weeks prior to first dose DRUG: Bomedemstat, DRUG: Hydroxyurea, DRUG: Bomedemstat placebo, DRUG: Hydroxyurea placebo
Essential Thrombocythemia
essential thrombocythemia, ET, bomedemstat, IMG-7289
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Show 166 locations
Study Locations
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| Location | Contacts |
|---|---|
| Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0324) Aarhus, Central Jutland | |
| Akademiska sjukhuset ( Site 0545) Uppsala, Uppsala County | |
| Anhui Provincial Hospital ( Site 0657) Hefei, Anhui | |
| Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0502) Ankara, | |
| Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 0511) Ankara, | |
| Antalya Egitim ve Arastırma Hastanesi ( Site 0508) Antalya, | |
| Arthur J.E. Child Comprehensive Cancer Centre ( Site 0038) Calgary, Alberta | |
| Austin Health-Cancer Clinical Trials Centre ( Site 0206) Heidelberg, Victoria | |
| Azienda Ospedaliera Universitaria Careggi ( Site 0441) Florence, Tuscany | |
| Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0443) Alessandria, | |
| Biocenter ( Site 0149) Concepción, Biobio | |
| Boston Pilgrim Hospital ( Site 0525) Boston, Lincolnshire | |
| Bradfordhill-Clinical Area ( Site 0142) Santiago, Region M. de Santiago | |
| C.I.C.E. 9 de Julio ( Site 0104) San Miguel de Tucumán, Tucumán Province | |
| CHU Bordeaux Haut-Leveque-service de mèdecine interne et maladies infectieuses ( Site 0346) Pessac, Aquitaine | |
| Carmel Hospital ( Site 0426) Haifa, | |
| Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0342) Tours, Indre-et-Loire | |
| Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0344) Limoges, Haute-Vienne | |
| Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0347) Nantes, Pays de la Loire Region | |
| Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology ( Site 0349) Nice, Alpes-Maritimes | |
| Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0037) Greenfield Park, Quebec | |
| Centro de Investigacion Clinica de Oaxaca ( Site 0181) Oaxaca City, Oaxaca | |
| Chang Gung Medical Foundation-Linkou Branch ( Site 0243) Taoyuan District, | |
| Chang Gung Memorial Hospital- Chiayi ( Site 0242) Chiayi City, Chiayi | |
| Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0369) Berlin, | |
| Chinese Academy of medical science, Peking Union Medical College Hospital(Dongdan) ( Site 0675) Beijing, Beijing Municipality | |
| Chongqing University Cancer Hospital ( Site 0666) Chongqing, Chongqing Municipality | |
| Clinica Universidad de Navarra-Hematology Department ( Site 0485) Madrid, Madrid, Comunidad de | |
| Clínica Alemana de Santiago ( Site 0143) Santiago, Region M. de Santiago | |
| Clínica Inmunocel ( Site 0147) Santiago, Region M. de Santiago | |
| Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0105) Santa Fe, | |
| Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402) Debrecen, | |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-Hemotology ( Site 0510) Ankara, | |
| Duke University Health System (DUHS) ( Site 0012) Durham, North Carolina | |
| Ege Universitesi Hastanesi ( Site 0503) Bornova, İzmir | |
| Ehime University Hospital ( Site 0612) Tōon, Ehime | |
| Exempla Lutheran Medical Center ( Site 0014) Golden, Colorado | |
| FALP-UIDO ( Site 0148) Santiago, Region M. de Santiago | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0447) Milan, | |
| Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0444) Pavia, | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0445) Roma, | |
| Freeman Hospital ( Site 0532) Newcastle upon Tyne, | |
| Fujita Health University Hospital ( Site 0613) Toyoake, Aichi-ken | |
| Fukushima Medical University Hospital ( Site 0616) Fukushima, | |
| Fundacion Colombiana de Cancerología Clinica Vida ( Site 0164) Medellín, Antioquia | |
| Galilee Medical Center ( Site 0431) Nahariya, | |
| Glan Clwyd Hospital ( Site 0528) Bodelwyddan, Denbighshire | |
| Gloucestershire Royal Hospital ( Site 0521) Gloucester, Gloucestershire | |
| Guy's & St Thomas' NHS Foundation Trust ( Site 0523) London, London, City of | |
| HENRI MONDOR HOSPITAL ( Site 0348) Créteil, Val-de-Marne | |
| HOSPITAL CLÍNIC DE BARCELONA ( Site 0481) Barcelona, Catalonia | |
| Hacettepe Universite Hastaneleri-Department of Hematology ( Site 0505) Ankara, | |
| Hadassah Medical Center ( Site 0424) Jerusalem, | |
| Hammersmith Hospital ( Site 0533) London, London, City of | |
| Henan Cancer Hospital-hematology department ( Site 0644) Zhengzhou, Henan | |
| Higiea Oncologia ( Site 0184) Mexico City, Mexico City | |
| Hokkaido University Hospital ( Site 0601) Sapporo, Hokkaido | |
| Hopital Saint-Louis ( Site 0341) Paris, | |
| Hospital Costa del Sol-Hematology Service ( Site 0493) Marbella, Malaga | |
| Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0490) Badalona, Barcelona | |
| Hospital Italiano de Buenos Aires ( Site 0102) ABB, Buenos Aires F.D. | |
| Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0489) Barcelona, | |
| Hospital Universitario 12 de Octubre ( Site 0494) Madrid, | |
| Hospital Universitario Austral ( Site 0101) Pilar, Buenos Aires | |
| Hospital Universitario Marqués de Valdecilla-Haematology ( Site 0486) Santander, Cantabria | |
| Hospital Universitario Ramón y Cajal-Hematology ( Site 0484) Madrid, Madrid, Comunidad de | |
| Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 0488) Salamanca, | |
| Huashan Hospital, Fudan University ( Site 0669) Shanghai, Shanghai Municipality | |
| Hôpital de la Conception ( Site 0351) Marseille, Bouches-du-Rhone | |
| IC La Serena Research ( Site 0150) La Serena, Coquimbo Region | |
| IMAT S.A.S ( Site 0162) Montería, Departamento de Córdoba | |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0446) Bologna, | |
| Institut Català d'Oncologia - L'Hospitalet ( Site 0482) L'Hospitalet de Llobregat, Catalonia | |
| Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0352) Toulouse, Haute-Garonne | |
| Institute of hematology&blood disease hospital-Hematology ( Site 0641) Tianjin, Tianjin Municipality | |
| Jinan Central Hospital ( Site 0667) Jinan, Shandong | |
| Juntendo University Hospital ( Site 0611) Bunkyo-ku, Tokyo | |
| Kanazawa University Hospital ( Site 0614) Kanazawa, Ishikawa-ken | |
| Kansai Medical University Hospital ( Site 0607) Hirakata, Osaka | |
| Karolinska Universitetssjukhuset Huddinge ( Site 0541) Huddinge, Stockholm County | |
| Kindai University Hospital ( Site 0600) Sakai, Osaka | |
| Kobe City Medical Center General Hospital ( Site 0603) Kobe, Hyōgo | |
| Kocaeli Üniversitesi-Hematology ( Site 0506) Kocaeli, | |
| Kyushu University Hospital ( Site 0605) Fukuoka, | |
| Levine Cancer Institute ( Site 0009) Charlotte, North Carolina | |
| Lincoln County Hospital ( Site 0535) Lincoln, Great Britain | |
| Los Angeles Cancer Network ( Site 0025) Glendale, California | |
| Los Cobos Medical Center ( Site 0165) Bogotá, Bogota D.C. | |
| Medipol Mega Universite Hastanesi ( Site 0504) Istanbul, | |
| Medivest Centro de Investigación Integral ( Site 0183) Chihuahua City, Chihuahua | |
| Medizinische Hochschule Hannover ( Site 0371) Hanover, Lower Saxony | |
| Mie University Hospital ( Site 0615) Tsu, Mie-ken | |
| Monash Health-Haematology Research ( Site 0202) Clayton, Victoria | |
| National Cheng Kung University Hospital-Clinical Trial Center ( Site 0245) Tainan, | |
| National Hospital Organization Sendai Medical Center ( Site 0617) Sendai, Miyagi | |
| National Taiwan University Hospital ( Site 0241) Taipei, | |
| Nippon Medical School Hospital ( Site 0608) Tokyo, | |
| Odense Universitetshospital-Department of Hematology ( Site 0325) Odense C, Region Syddanmark | |
| Okayama University Hospital ( Site 0604) Okayama, | |
| Ondokuz Mayıs Universitesi-hematology ( Site 0507) Samsun, | |
| Optum Care Cancer Center ( Site 0053) Las Vegas, Nevada | |
| Ordensklinikum Linz GmbH Elisabethinen ( Site 0562) Linz, Upper Austria | |
| Oregon Health & Science University ( Site 0018) Portland, Oregon | |
| Ospedale di Circolo e Fondazione Macchi Varese ( Site 0442) Varese, | |
| Palo Verde Cancer Specialists ( Site 0052) Glendale, Arizona | |
| Parkview Research Center at Parkview Regional Medical Center ( Site 0006) Fort Wayne, Indiana | |
| Peking University Third Hospital-Hematology ( Site 0659) Beijing, Beijing Municipality | |
| Petz Aladar Egyetemi Oktato Korhaz-Hematológia ( Site 0405) Győr, Győr-Moson-Sopron | |
| Pratia Onkologia Katowice ( Site 0461) Katowice, Silesian Voivodeship | |
| Queen Mary Hospital ( Site 0221) Hksar, | |
| Rabin Medical Center ( Site 0425) Petah Tikva, | |
| Rambam Health Care Campus ( Site 0429) Haifa, | |
| Rigshospitalet-Hematology - CTU ( Site 0321) Copenhagen, Capital Region | |
| Roskilde Sygehus-Department of Hematology ( Site 0323) Roskilde, Region Sjælland | |
| Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0203) Adelaide, South Australia | |
| Royal Gwent Hospital ( Site 0524) Newport, | |
| Royal Perth Hospital-Haematology ( Site 0204) Perth, Western Australia | |
| Sahlgrenska Universitetssjukhuset-Department of hematology and coagulation ( Site 0543) Gothenburg, Västra Götaland County | |
| Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii, Transplantacji Szp ( Site 0463) Lublin, Lublin Voivodeship | |
| Shaanxi provincial people's hospital ( Site 0652) Xi'an, Shaanxi | |
| Sheba Medical Center ( Site 0428) Ramat Gan, | |
| Skånes Universitetssjukhus Lund-Department of Hematology ( Site 0544) Lund, Skåne County | |
| Somogy Vármegyei Kaposi Mór Oktató Kórház-Haematológiai osztály ( Site 0406) Kaposvár, Somogy County | |
| Soroka Medical Center ( Site 0427) Beersheba, | |
| Sourasky Medical Center ( Site 0422) Tel Aviv, | |
| Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 0655) Guangzhou, Guangdong | |
| Stanford Cancer Center ( Site 0024) Palo Alto, California | |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University-hematology department ( Site 0668) Guangzhou, Guangdong | |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 0466) Kielce, Świętokrzyskie Voivodeship | |
| Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0404) Nyíregyháza, Szabolcs-Szatmár-Bereg | |
| Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 0407) Szeged, Csongrád megye | |
| The First Affiliated Hospital of Soochow University ( Site 0676) Suzhou, Jiangsu | |
| The First Affiliated hospital of Xiamen University ( Site 0658) Xiamen, Fujian | |
| The First Afflilated Hospital of Bengbu Medical College ( Site 0651) Bengbu, Anhui | |
| The First Hospital of Hebei Medical University ( Site 0649) Shijiazhuang, Hebei | |
| The First Hospital of Jilin University-Hematology ( Site 0672) Changchun, Jilin | |
| The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0645) Nanchang, Jiangxi | |
| The Ohio State University Wexner Medical Center ( Site 0028) Columbus, Ohio | |
| The Second Affiliated Hospital of Fujian Medical University ( Site 0671) Quanzhou, Fujian | |
| The Second Afilliated Hospital of Hebei Medical University ( Site 0650) Shijiazhuang, Hebei | |
| The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 0646) Hangzhou, Zhejiang | |
| Trakya University Medical Faculty Hospital-Hematology ( Site 0501) Edirne, | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0642) Wuhan, Hubei | |
| Universitaetsklinikum Essen ( Site 0366) Essen, North Rhine-Westphalia | |
| Universitetssjukhuset Örebro ( Site 0542) Örebro, Örebro County | |
| University College London Hospital ( Site 0527) London, London, City of | |
| University of Michigan ( Site 0003) Ann Arbor, Michigan | |
| University of Miyazaki Hospital ( Site 0609) Miyazaki, | |
| University of Texas Health Science Center at San Antonio ( Site 0021) San Antonio, Texas | |
| University of Texas MD Anderson Cancer Center ( Site 0026) Houston, Texas | |
| University of Virginia ( Site 0020) Charlottesville, Virginia | |
| University of Yamanashi Hospital ( Site 0606) Chūō, Yamanashi | |
| Universitätsklinikum Aachen ( Site 0367) Aachen, North Rhine-Westphalia | |
| Universitätsklinikum Halle ( Site 0361) Halle, Saxony-Anhalt | |
| Universitätsklinikum Jena-Klinik für Innere Medizin II, Abt. Hämatologie und Internistische Onkolog ( Site 0364) Jena, Thuringia | |
| Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Site 0365) Mainz, Rhineland-Palatinate | |
| VCU Health Adult Outpatient Pavillion ( Site 0008) Richmond, Virginia | |
| VK&K Studien GbR ( Site 0370) Landshut, Bavaria | |
| Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013) Winston-Salem, North Carolina | |
| West China Hospital, Sichuan University ( Site 0661) Chengdu, Sichuan | |
| Westmead Hospital ( Site 0201) Westmead, New South Wales | |
| Yale University School of Medicine ( Site 0051) New Haven, Connecticut | |
| Yitzhak Shamir Medical Center. ( Site 0421) Ẕerifin, | |
| Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 0662) Yiwu, Zhejiang | |
| Zhongshan Hospital,Fudan University-Hematology ( Site 0674) Shanghai, Shanghai Municipality | |
| centre hospitalier lyon sud ( Site 0343) Pierre-Bénite, Rhone |
Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer
ctrrecruit@vcu.edu
NCT05673200
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Inclusion Criteria:
* Patients must have histologically confirmed triple-negative breast cancer (TNBC) (estrogen receptor \[ER\] and progesterone receptor \[PR\] =\< 10%, human epidermal growth factor receptor-2 \[HER2\]-negative per American Society of Clinical Oncology \[ASCO\]/College of American Pathologists \[CAP\] guidelines) that is metastatic or unresectable
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of ASTX727 in combination with pembrolizumab (MK-3475) and paclitaxel in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (or Karnofsky \>= 60%)
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 (within 14 days prior to registration)
* Platelets \>= 100,000/mm\^3 (within 14 days prior to registration)
* Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L (within 14 days prior to registration)
* Criteria must be met without packed red blood cell (pRBC) transfusion within the prior 14 days of registration. Participants can be on stable dose of erythropoietin (90 days or more prior to registration)
* Creatinine clearance (CrCl) \>= 30 mL/min (within 14 days prior to registration)
* Glomerular filtration rate (GFR) can also be used in place of CrCl
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) OR direct bilirubin =\< ULN for patients with total bilirubin levels \> 1.5 × ULN (within 14 days prior to registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) =\< 3 x institutional ULN (within 14 days prior to 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
* Patients with treated brain metastases are eligible if there is evidence of measurable extracranial disease, and if follow-up brain imaging 4 weeks after central nervous system (CNS)-direct therapy shows no evidence of progression. Patients with carcinomatous meningitis are not eligible.
* Patients with a prior malignancy whose natural history does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Concurrent use of other antineoplastic treatments is not allowed.
* Patients should be New York Heart Association Functional Classification of class II or better.
* Patients who have received live attenuated vaccines within the 30 days prior to registration are not eligible. Seasonal flu vaccines that do not contain live virus, and coronavirus disease 2019 (COVID-19) vaccinations and boosters are permitted.
* Patients with prior history of peripheral neuropathy are allowed if it has recovered to grade 1 or less.
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
* Patients who have received 0-3 prior lines of chemotherapy in the metastatic setting. Patients who have received prior PD-1/PD-L1 monoclonal antibodies in any disease setting are eligible.
* For enrollment to Dose Finding Cohort: Availability and willingness to provide archival tumor tissue as required per protocol.
* For enrollment to Dose Expansion Cohort: (i) Willingness to provide baseline and 3-week tumor tissue biopsy specimens. (ii) Patients must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* The effects of ASTX727 and pembrolizumab (MK-3475) on the developing human fetus are unknown. For this reason and because these agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men 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 180 days after the last dose 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. Pregnant women are excluded from this study because pembrolizumab (MK-3475) is an anti PD-1 monoclonal antibody agent, ASTX727 is a hypomethylating agent, and paclitaxel is a class D agent with 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 pembrolizumab (MK-3475), breastfeeding should be discontinued if the mother is treated with pembrolizumab (MK-3475). These potential risks may also apply to other agents used in this study. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 180 days after completion of study treatment.
* Ability to understand and the willingness to sign a written informed consent document (or have legally acceptable representative sign, if applicable).
* Patients who have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia.
* Note: If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
* Has not received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor \[GM-CSF\], or recombinant erythropoietin) within 4 weeks prior to registration.
Exclusion Criteria:
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within the 7 days prior to registration.
* Has a known additional malignancy that is progressing or requires active treatment.
* Has an active autoimmune disease that has required systemic treatment within 2 years prior to registration (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. Current treatment with systemic steroids up to 10 mg of prednisone daily or equivalent is allowed.
* Patients with uncontrolled intercurrent illness (including but not limited to interstitial lung disease or active, non-infectious pneumonitis) or a history of (non-infectious) pneumonitis that required steroids.
* History of grade 3-4 immediate hypersensitivity reaction to paclitaxel or other drugs formulated in polyoxyl 35 castor oil.
* Patients who are receiving any other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASTX727, pembrolizumab (MK-3475), and/or paclitaxel.
* Has a known history of active tuberculosis (TB).
* Gastrointestinal disorder that may impact absorption of oral medications.
* History of solid organ or bone marrow transplantation. PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, DRUG: Decitabine and Cedazuridine, PROCEDURE: Magnetic Resonance Imaging, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Unresectable Triple-Negative Breast Carcinoma
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Study Locations
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| Location | Contacts |
|---|---|
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.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) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| 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 | |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)
ctrrecruit@vcu.edu
NCT06611540
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Inclusion Criteria:
* Willingness and ability to provide a documented informed consent.
* Is 25 years or older.
* Has an intact cervix.
* Has had a referral for colposcopy and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance \[ASC-US\] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit.
* Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable.
Exclusion Criteria:
* Is pregnant when presenting for the referral visit or gave birth within the past 3 months.
* Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure \[LEEP\], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit.
* Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records.
* Known medical conditions that, in the opinion of the investigator, preclude study participation.
* Previous participation in the SHIP Trial. Participation is defined as completing the self-collection.
* Is experiencing unusual bleeding or pelvic pain. PROCEDURE: Biospecimen Collection, PROCEDURE: Cervical Biopsy, PROCEDURE: Colposcopy, OTHER: Electronic Health Record Review, PROCEDURE: Endocervical Curettage, PROCEDURE: Excision, PROCEDURE: HPV Self-Collection, PROCEDURE: Human Papillomavirus Test, OTHER: Questionnaire Administration
Cervical Carcinoma, Human Papillomavirus Infection
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Show 25 locations
Study Locations
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| Location | Contacts |
|---|---|
| Cleveland Clinic Foundation Cleveland, Ohio | Miriam Cremer - (cremerm@ccf.org) |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | Lisa C. Flowers - (lflowe2@emory.edu) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Deanna L. Kepka - (deanna.kepka@hci.utah.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Jenell S. Coleman - (colemanj@jhmi.edu) |
| Louisiana State University Health Science Center New Orleans, Louisiana | Michael E. Hagensee - (mhagen@lsuhsc.edu) |
| M D Anderson Cancer Center Houston, Texas | Elizabeth Y. Chiao - (eychiao@mdanderson.org) |
| Minneapolis VA Medical Center Minneapolis, Minnesota | Elisheva Danan - (elizabeth.danan@va.gov) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Mark H. Einstein - (mark.einstein@rutgers.edu) |
| NYP/Weill Cornell Medical Center New York, New York | Denise A. Howard - (deh3002@med.cornell.edu) |
| UCSF Medical Center-Parnassus San Francisco, California | George Sawaya - (george.sawaya@ucsf.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Lisa Rahangdale - (lisa_rahangdale@med.unc.edu) |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | Harold C. Wiesenfeld - (wieshc@upmc.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Warner K. Huh - (whuh@uabmc.edu) |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Leeya F. Pinder - (pinderl@ucmail.uc.edu) |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | Erin Kobetz-Kerman - (ekobetz@med.miami.edu) |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | Diane M. Harper - (harperdi@med.umich.edu) |
| University of Mississippi Medical Center Jackson, Mississippi | Carolann Risley - (crisley@umc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Cosette M. Wheeler - (cwheeler@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Joan L. Walker - (joan-walker@ouhsc.edu) |
| University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Carmen Guerra - (carmen.guerra@pennmedicine.upenn.edu) |
| University of Puerto Rico Rio Piedras, | Ana P. Ortiz - (ana.ortiz7@upr.edu) |
| University of Washington Medical Center - Northwest Seattle, Washington | Rachel L. Winer - (RLW@UW.EDU) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Tanya E. Franklin - (tanya.franklin@louisville.edu) |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Nicole W. Karjane - (nicole.karjane@vcuhealth.org) |
| Yale University New Haven, Connecticut | Sangini Sheth - (sangini.sheth@yale.edu) |