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631 Study Matches
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
ctrrecruit@vcu.edu
PHASE2
NCT06317649
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Inclusion Criteria:
* Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of the treating physician are better served by azanucleoside-based therapy rather than intensive, cytarabine-based induction based on clinical status (i.e., performance status, age \> 75 years), organ dysfunction, or disease biology
* Patient must have a morphologically confirmed diagnosis of AML according to the World Health Organization (WHO) 2016 classification excluding acute promyelocytic leukemia (APL) with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11
* Patient must have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible
* Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors
* Patient must have the FLT3-ITD or D835 mutation based on MyeloMATCH Master Screening and Reassessment Protocol (MSRP)
* Patient must be assigned to this protocol by the myeloMATCH MSRP
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
* All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
* A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patient of childbearing potential and/or sexually active patients must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 30 days after the last dose of venetoclax for all patients and for 6 months after the last dose of gilteritinib for patients of childbearing potential and for 4 months after the last dose of gilteritinib for male patients with partners of childbearing potential. Patient must not breastfeed during treatment and for 2 months after treatment ends
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Total bilirubin 2X ≤ institutional upper limit of normal (ULN) (unless thought to be elevated due to disease involvement or Gilbert's syndrome)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN
* Either measured or estimated by Cockcroft-Gault equation
* Creatinine clearance of ≥ 30 mL/min/1.73m\^2
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration/randomization are eligible for this trial
* Patients must not have a baseline corrected QT interval ≥ 480 msec using Fredericia correction (QTcF).
NOTE: Since older patients are at risk for prolonged QTc and many will require supportive care with agents that affect the QTc, an ECG is recommended if clinically indicated. If the QTc is prolonged, they should be treated on tier advancement process (TAP) instead of EA02
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patient must not have the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Patients must not have an active or uncontrolled infection DRUG: Azacitidine, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Gilteritinib, DRUG: Venetoclax
Acute Myeloid Leukemia
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Show 202 locations
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) |
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Ben Taub General Hospital Houston, Texas | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Edward Hines Jr VA Hospital Hines, Illinois | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| George E Wahlen Department of Veterans Affairs Medical Center Salt Lake City, Utah | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Lahey Hospital and Medical Center Burlington, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lahey Medical Center-Peabody Peabody, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Loyola University Medical Center Maywood, Illinois | |
| MaineHealth Cancer Care and IV Therapy - Brunswick Brunswick, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mid Coast Hospital Brunswick, Maine | Site Public Contact - (ctsucontact@westat.com) |
| Mills Health Center San Mateo, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Monmouth Medical Center Long Branch, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| 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) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Our Lady of The Lake Baton Rouge, Louisiana | |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Phoebe Putney Memorial Hospital Albany, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Reading Hospital West Reading, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rhode Island Hospital Providence, Rhode Island | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| San Juan City Hospital San Juan, | |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The Valley Hospital - Luckow Pavilion Paramus, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UCSF Medical Center-Parnassus San Francisco, California | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Clinical Research Center Fairway, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of Tennessee - Knoxville Knoxville, Tennessee | |
| University of Vermont Medical Center Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Health System Ridgewood Campus Ridgewood, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven, Connecticut | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| William S Middleton VA Medical Center Madison, Wisconsin | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
ctrrecruit@vcu.edu
PHASE3
NCT06422806
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Inclusion Criteria:
* Patient must be \>= 18 years of age
* Patient must have a confirmed histopathologic diagnosis of dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma. Because UPS can sometimes exist in a spectrum among related diagnoses, the following additional diagnostic will be allowed, but not limited to:
* Pleomorphic sarcoma with inflammation or with limited areas of differentiation
* Pleomorphic sarcoma with giant cells
* Malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes)
* Myxofibrosarcoma
* Poorly differentiated sarcoma not otherwise specified (NOS)
* Undifferentiated spindle cell sarcoma
* Poorly differentiated spindle cell sarcoma NOS Any of these subtypes may have areas of focal myogenic differentiation
* Patient must have metastatic or unresectable sarcoma
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria:
* Has achieved menarche at some point
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 6 months after the last dose of doxorubicin for patients of child bearing potential and for 3 months after the last dose of doxorubicin for male patients with partners of child bearing potential. Males with pregnant partners should use condoms during doxorubicin treatment and for at least 10 days after the last dose of doxorubicin. Contraception measures must also continue for 4 months after the last dose of pembrolizumab for patients of child bearing potential
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Patient must have a left ventricular ejection fraction (LVEF) \> 50% by either MUGA scan or echocardiogram obtained within 28 days prior to randomization
* Absolute neutrophil count (ANC) ≥ 1,500 cells/uL (must be obtained ≤ 7 days prior to protocol randomization)
* Platelets ≥ 75,000 cells/uL (must be obtained ≤ 7 days prior to protocol randomization)
* Total bilirubin \< 1.2 mg/dL (must be obtained ≤ 7 days prior to protocol randomization)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 × institutional upper limit of normal (ULN) (must be obtained ≤ 7 days prior to protocol randomization)
* Creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (must be obtained ≤ 7 days prior to protocol randomization)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Patient must not have a history of or active interstitial lung disease
* Patient must have measurable disease. Baseline imaging must include a chest computed tomography (CT). Imaging should be inclusive of all measurable and non-measurable disease and must be obtained within 28 days prior to randomization. Imaging must be available for uploading to Transfer of Images and Data (TRIAD)
* NOTE: CT with (w/) contrast preferred, chest CT without contrast is acceptable, CT portion of positron emission tomography (PET) may be acceptable. Magnetic resonance imaging (MRI) is acceptable for measuring other sites of disease
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patient must not have had prior treatment with an anthracycline
* Patient must not have a diagnosis of clinically significant immunodeficiency or an autoimmune disorder requiring the patient to use systemic steroid chronically, or systemic steroids within 7 days prior to randomization
* Patient must not have a known history of active TB (Bacillus Tuberculosis)
* Patient must not have a known hypersensitivity to doxorubicin or pembrolizumab or any of their excipients
* Patients who have received prior chemotherapy, targeted small molecule therapy or radiation therapy must have recovered from the prior therapy at the time of randomization
* Patient must have recovered adequately from any prior major surgery prior to randomization
* Patient must not have had prior pericardial or mediastinal radiation
* Patient must not have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent
* Patient must not have an autoimmune or other disease that requires the use of daily corticosteroids of \> 10 mg of prednisone (or equivalent). Patients who are on an active steroid taper at the time of randomization must finish prior to beginning study treatment. Patients who require inhaled or topical steroids are eligible PROCEDURE: Biospecimen Collection, PROCEDURE: Diagnostic Imaging Testing, DRUG: Doxorubicin, PROCEDURE: Echocardiography Test, PROCEDURE: Multigated Acquisition Scan, BIOLOGICAL: Pembrolizumab
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma, Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Unresectable Dedifferentiated Liposarcoma, Unresectable Undifferentiated Pleomorphic Sarcoma
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Show 223 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Broadlawns Medical Center Des Moines, Iowa | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Cross Cancer Institute Edmonton, Alberta | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Juravinski Cancer Centre at Hamilton Health Sciences Hamilton, Ontario | |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Keck Medicine of USC Koreatown Los Angeles, California | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| Louisiana Hematology Oncology Associates LLC Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario | |
| Pan American Center for Oncology Trials LLC San Juan, PR | Site Public Contact - (marcia.cruzcorrea@panoncologytrials.com) |
| Pennsylvania Hospital Philadelphia, Pennsylvania | Site Public Contact - (PennCancerTrials@careboxhealth.com) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Premier Blood and Cancer Center Dayton, Ohio | |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | |
| 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 | |
| Sidney and Lois Eskenazi Hospital Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UH Seidman Cancer Center at UH Avon Health Center Avon, Ohio | |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| 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 Hollywood Hollywood, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| USC Norris Oncology/Hematology-Newport Beach Newport Beach, California | |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.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 Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | Site Public Contact - (slusserb@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| VA Palo Alto Health Care System Palo Alto, California | |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| 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) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
Reference Study ID Number: CO44657 https://forpatients.roche.com/ - global-roche-genentech-trials@gene.com
PHASE3
NCT06065748
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Inclusion Criteria:
* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
* Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
* Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \>/=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is allowed (if relapse occurred \>/=12 months since completion).
* No prior systemic anti-cancer therapy for advanced disease
* Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment
Exclusion Criteria:
* Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
* Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
* Active cardiac disease or history of cardiac dysfunction
* Clinically significant history of liver disease DRUG: Giredestrant, DRUG: Fulvestrant, DRUG: Abemaciclib, DRUG: Palbociclib, DRUG: Ribociclib, DRUG: LHRH Agonist, DIAGNOSTIC_TEST: FoundationOne Liquid CDx Assay (F1LCDx)
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
oral Selective Estrogen Receptor Degrader (SERD), CDK4/6 inhibitor (CDK4/6i), ESR1 mutation
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Show 348 locations
Study Locations
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| Location | Contacts |
|---|---|
| ?wi?tokrzyskie Centrum Onkologii Kielce, | |
| A.O. Universitaria Di Parma Parma, Emilia-Romagna | |
| A.O. Universitaria S. Maria Della Misericordia Di Udine Udine, Friuli Venezia Giulia | |
| A.O.U. Maggiore della Carità Novara, Piedmont | |
| ASST degli Spedali Civili di Brescia Brescia, Lombardy | |
| AZ St Maarten Campus Leopoldstr Mechelen, | |
| Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit Philadelphia, Pennsylvania | |
| AdventHealth Altamonte Altamonte Springs, Florida | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Allan Blair Cancer Centre Regina, Saskatchewan | |
| Alliance Cancer Specialists Bensalem, Pennsylvania | |
| Amethyst Cluj Cluj County, | |
| Ankara City Hospital Ankara, | |
| Ann B. Barshinger Cancer Institute Lancaster, Pennsylvania | |
| Anticancer Hospital Ag. Savas Athens, | |
| Aretaieio Hospital of Athens Athens, | |
| Asan Medical Center Seoul, | |
| Asante Rogue Regional Medical Center Medford, Oregon | |
| Asst Di Cremona Cremona, Lombardy | |
| Asst Papa Giovanni XXIII Bergamo, Bg | |
| Astera Cancer Care East Brunswick East Brunswick, New Jersey | |
| Aurora BayCare Medical Center Green Bay, Wisconsin | |
| Aurora St Lukes Medical Center Milwaukee, Wisconsin | |
| Avera Cancer Institute Sioux Falls, South Dakota | |
| Avera Cancer Institute - Aberdeen Aberdeen, South Dakota | |
| Azienda Ospedaliera Universitaria Careggi Florence, Tuscany | |
| Azienda Ospedaliera Universitaria Federico II Napoli, Campania | |
| Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati Avellino, Campania | |
| B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház Miskolc, | |
| Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji Bakirkoy / Istanbul, | |
| Baptist Health Hamburg Lexington, Kentucky | |
| Baptist Health Lexington Lexington, Kentucky | |
| Baptist Health Louisville Louisville, Kentucky | |
| Barwon Health Geelong, Victoria | |
| Beijing Cancer Hospital Beijing, Beijing Municipality | |
| Brown University Health Providence, Rhode Island | |
| Brustzentrum Rhein-Ruhr Servicegesellschaft mbH Mönchengladbach, | |
| Bács-Kiskun Vármegyei Oktatókórház Kecskemét, | |
| CEDOES - Diagnóstico e Pesquisa Vitória, Espírito Santo | |
| CENEIT Oncologicos Mexico City, | |
| CHU de Liège (Sart Tilman) Liège, | |
| CHU de Quebec - Hopital du Saint-Sacrement Québec, Quebec | |
| CHVNG/E_Unidade 1 Vila Nova de Gaia, | |
| CISSS Chaudière-Appalaches Lévis, Quebec | |
| CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital Chicoutimi, Quebec | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | |
| Cancer Center, Sun Yat-sen University of Medical Sciences Guangzhou, | |
| Cancer Research SA Adelaide, South Australia | |
| Cancer Specialists of North Florida Jacksonville, Florida | |
| Cancercare Port Elizabeth, | |
| Cancercare Rondebosch Oncology Cape Town, | |
| Capital Health Regional Medical Center Pennington, New Jersey | |
| Celan S.A. Guatemala City, | |
| Centre Cancerologie Grand Montpellier Montpellier, | |
| Centre Eugene Marquis Rennes, | |
| Centre Francois Baclesse Caen, | |
| Centre Hospitalier Regional de Trois-Rivieres Trois-Rivières, Quebec | |
| Centre Hospitalier Saint Louis La Rochelle, | |
| Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec | |
| Centre Jean Perrin Clermont-Ferrand, | |
| Centre Leon Berard Lyon, | |
| Centre Oscar Lambret Lille, | |
| Centro De Cancer Universidad Catolica Santiago, | |
| Centro Medico Dalinde Mexico City, | |
| Centro Medico Integral de Cancerologia CEMIC Salcajá, | |
| Centro Medico monte Carmelo Arequipa, | |
| Centro Oncologico MD Anderson Internacional Madrid, | |
| Centro Oncologico Riojano Integral (CORI) La Rioja, | |
| Centro Oncológico Korben Ciudad Autonoma Buenos Aires, | |
| Centro Oncológico de Excelencia San Juan, | |
| Centro de Investigacion Clinica de Oaxaca Oaxaca City, Oaxaca | |
| Centrul de Oncologie Oncohelp Timișoara, | |
| Centrul de Oncologie Sfantul Nectarie Craiova, | |
| Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli Lublin, | |
| Centrum Onkologii im. Prof. Franciszka ?ukaszczyka Bydgoszcz, | |
| China Medical University Hospital Taichung, | |
| Christchurch Hospital Christchurch, | |
| Chulabhorn Hospital Bangkok, | |
| Chulalongkorn Hospital Bangkok, | |
| Clinica Alivia sucursal Coyoacan Mexico City, | |
| Clinica CIMCA San José, | |
| Clinica Internacional, Sede San Borja Lima, | |
| Clinica Peruana Americana Trujillo, | |
| Clinica San Antonio;Investigaciones Trujillo S.A.C. Trujillo, | |
| Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda São Paulo, São Paulo | |
| Clinique Ste-Elisabeth Namur, | |
| Cliniques Universitaires St-Luc Brussels, | |
| Clínica Puerto Montt Port Montt, | |
| Clínica Santa Beatriz Lima, | |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico Jaén, | |
| Comprehensive Hematology Oncology St. Petersburg, Florida | |
| Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre Mississauga, Ontario | |
| Crio - Centro Regional Integrado de Oncologia Fortaleza, Ceará | |
| Cross Cancer Institute Edmonton, Alberta | |
| DONAU ISAR Klinikum Deggendorf Deggendorf, | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Duke Women Cancer Care Raleigh, North Carolina | |
| European Interbalkan Medical Center Thessaloniki, | |
| Ewha Womans University Mokdong Hospital Seoul, | |
| Florida Cancer Specialists - Broadway Fort Myers, Florida | |
| Florida Cancer Specialists - EAST - SCRI - PPDS West Palm Beach, Florida | |
| Florida Cancer Specialists - Tampa Tampa, Florida | |
| Frederick Health Hospital Frederick, Maryland | |
| Fudan University Shanghai Cancer Center Shanghai, Shanghai Municipality | |
| Fujian Medical University Union Hospital Fuzhou, Fujian | |
| Fundación CENIT para la Investigación en Neurociencias Ciudad Autonoma Buenos Aires, | |
| Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo Bogota, D.C., | |
| GHdC Site Les Viviers Charleroi, | |
| Gangnam Severance Hospital Seoul, | |
| Georgetown University Medical Center Washington D.C., District of Columbia | |
| Goztepe Prof.Dr. Suleyman Yalcin City Hospital Kadiköy, | |
| Grady Health System Atlanta, Georgia | |
| Grant Medical Foundation, Ruby Hall Clinic Pune, Maharashtra | |
| Grupo Angeles Guatemala City, | |
| Guangxi Cancer Hospital of Guangxi Medical University Nanning, | |
| Gustave Roussy Villejuif, | |
| Gynonco Düsseldorf, MVZ Medical Center GmbH Düsseldorf, | |
| HCA Midwest Division Kansas City, Missouri | |
| Hacettepe Uni Medical Faculty Hospital Sihhiye/Ankara, | |
| Hadassah Ein Karem Hospital Jerusalem, | |
| Harbin Medical University Cancer Hospital Harbin, Heilongjiang | |
| HealthCare Global Enterprises Limited Banglore, Karnataka | |
| Henry Ford Hospital Detroit, Michigan | |
| Hopital Jean Minjoz Besançon, | |
| Hopital regional de saint jerome Saint-Jérôme, Quebec | |
| Hospital A. C. Camargo São Paulo, São Paulo | |
| Hospital Aleman Buenos Aires, Buenos Aires F.D. | |
| Hospital Amaral Carvalho Jaú, São Paulo | |
| Hospital Araujo Jorge Goiânia, Goiás | |
| Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia Valencia, | |
| Hospital Goyeneche Arequipa, | |
| Hospital Juan Ramon Jimenez Huelva, | |
| Hospital Moinhos de Vento Porto Alegre, Rio Grande do Sul | |
| Hospital Nacional Arzobispo Loayza Lima, | |
| Hospital Nossa Senhora da Conceicao Porto Alegre, Rio Grande do Sul | |
| Hospital Provincial del Centenario Rosario, | |
| Hospital Quiron de Madrid Pozuelo de Alarcón, Madrid | |
| Hospital Sao Domingos Bequimão, | |
| Hospital Sao Lucas - PUCRS Porto Alegre, Rio Grande do Sul | |
| Hospital Sírio-Libanês São Paulo, | |
| Hospital Sírio-Libanês São Paulo, | |
| Hospital Universitari Dexeus - Grupo Quironsalud Barcelona, | |
| Hospital Universitario Virgen Macarena Seville, Andalusia | |
| Hospital Universitario Virgen de la Arrixaca EL Palmar (EL Palmar), Murcia | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital Zambrano Hellion TecSalud Monterrey, Nuevo León | |
| Hospital da Luz Lisbon, | |
| Hospital de Cancer de Barretos Barretos, São Paulo | |
| Hospital de Jerez de la Frontera Jerez de la Frontera, Cadiz | |
| Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal Madrid, | |
| Hospital de S. Francisco Xavier Lisbon, | |
| Hospital do Cancer de Pernambuco - HCP Recife, Pernambuco | |
| Hospital do Câncer de Londrina Londrina, Paraná | |
| Hospital las Higueras Concepción, Región Bio Bio | |
| Hospital Álvaro Cunqueiro Vigo, Pontevedra | |
| Hsin-Chu Branch of National Taiwan University Hospital Hsinchu, | |
| Hubei Cancer Hospital Wuhan, Hubei | |
| Humanitas Centro Catanese Di Oncologia Misterbianco (CT), Sicily | |
| Hunan Cancer Hospital Changsha, Hunan | |
| I.R.S.T Srl IRCCS Meldola, Emilia-Romagna | |
| ICIMED Instituto de Investigación en Ciencias Médicas San José, | |
| ICO Paul Papin Angers, | |
| INTEGRA Cancer Institute Guatemala City, | |
| IOV - Istituto Oncologico Veneto - IRCCS Padua, Veneto | |
| IPO de Coimbra Coimbra, | |
| IPO do Porto Porto, | |
| IPS Salud SURA Chipichape Cali Santiago de Cali, | |
| IUCT Oncopole Toulouse, | |
| Icegclinic Santiago, | |
| Icon Cancer Centre Gleneagles Singapore, | |
| Inst. de Oncologia Angel H. Roffo Buenos Aires, | |
| Institut Catala d?Oncologia Hospital Germans Trias i Pujol Badalona, Barcelona | |
| Institut Jean Godinot Reims, | |
| Institut Sainte Catherine Avignon, | |
| Institute of Oncology Ljubljana Ljubljana, | |
| Instituto D'Or de Pesquisa e Ensino Rio de Janeiro, | |
| Instituto Nacional Del Cancer Santiago, | |
| Instituto Nacional de Enfermedades Neoplasicas Lima, | |
| Instituto Peruano de Oncología y Radioterapia Lima, | |
| Instituto Regional de Enfermedades Neoplasicas - IREN Norte Trujillo, | |
| Instituto Valenciano Oncologia Valencia, | |
| Instituto de Oncología de Rosario Rosario, | |
| Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucharest, | |
| Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca Cluj-Napoca, | |
| Institutul Regional de Oncologie Iasi Iași, | |
| Instytut "Centrum Zdrowia Matki Polki" ?ód?, | |
| Irccs Istituto Nazionale Dei Tumori (Int) Milan, Lombardy | |
| Istituto Clinico Humanitas Rozzano, | |
| Istituto Nazionale Tumori Irccs Fondazione g. PASCALE Napoli, Campania | |
| JPS Oncology & Infusion Center Fort Worth, Texas | |
| Jinan Central Hospital Jinan, Shandong | |
| Kaiser Permanente - Harbor City Harbor City, California | |
| Katip Celebi University Ataturk Training and Research Hospital Izmir, | |
| Kliniken Essen-Mitte Essen, | |
| Koo Foundation Sun Yat-Sen Cancer Center Taipei, | |
| Korea University Anam Hospital Seoul, | |
| Kuopio Uni Hospital Kuopio, | |
| Kyungpook National University Chilgok Hospital Daegu, | |
| LKH-Univ. Klinikum Graz Graz, | |
| La Hematology Oncology Medical Group Glendale, California | |
| Lakeridge Health Oshawa Oshawa, Ontario | |
| MVR Cancer Centre and Research Institute Kozhikode, Kerala | |
| Maharaj Nakorn Chiang Mai Hospital;Depart of Radiology Muang Chiang MAI Delivery Branch 3, | |
| Marin Cancer Care Inc Greenbrae, California | |
| Maryland Oncology Hematology Columbia, Maryland | |
| Mater Hospital North Sydney, New South Wales | |
| Mater Misericordiae Limited South Brisbane, Queensland | |
| Max Super Speciality Hospital New Delhi, National Capital Territory of Delhi | |
| Mazowiecki Szpital Wojewódzki im. ?w. Jana Paw?a II Siedlce, | |
| McGill University Health Centre - Glen Site Montreal, Quebec | |
| MedStar Washington Hosp Center Washington D.C., District of Columbia | |
| Medi-k Guatemala City, | |
| Medical University Innsbruck Innsbruck, | |
| Medical University of South Carolina Charleston, South Carolina | |
| Medikal Park Samsun Samsun, | |
| Medizinische Universität Wien Vienna, | |
| Mersin City Education and Research Hospital Mersin, | |
| Mission Cancer + Blood - IMMC Des Moines, Iowa | |
| Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad Warsaw, | |
| Narodowy Instytut Onkologii Odzia? w Gliwicach Gliwice, | |
| National Cancer Centre Singapore, | |
| National Cancer Institute Bangkok, | |
| National Taiwan Uni Hospital Taipei, | |
| National University Hospital Singapore, | |
| Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, | |
| Nepean Hospital Kingswood, New South Wales | |
| New England Cancer Specialists Westbrook, Maine | |
| No. 900 Hospital (Fuzhou General Hospital) Fuzhou, | |
| Nograd Varmegyei Szent Lazar Korhaz Salgótarján, | |
| North York General Hospital Toronto, Ontario | |
| Northern Beaches Hospital Frenchs Forest, New South Wales | |
| Northwest Medical Specialties Tacoma, Washington | |
| Obras Sociais Irma Dulce - Osid Salvador, Estado de Bahia | |
| Onco Go, S.A. Guatemala City, | |
| Oncology Hematology Care Cincinnati, Ohio | |
| Oncology Hematology West - Legacy Omaha, Nebraska | |
| Oncomedica Guatemala City, | |
| Oncomedica S.A. Montería, | |
| Oncosalud Sac Lima, | |
| Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda Ijuí, Rio Grande do Sul | |
| Oncovida Providencia, | |
| Oo. Gesundheits- und Spitals-AG/LKH Steyr Steyr, | |
| Opolskie Centrum Onkologii Opole, | |
| Ordensklinikum Linz Barmherzige Schwestern Linz, | |
| Orszagos Onkologiai Intezet Budapest, | |
| Ospedale Di Macerata Macerata, The Marches | |
| Palmerston North Hospital Palmerston North, | |
| Pamela Youde Nethersole Eastern Hospital Chai Wan, | |
| PanAmerican Clinical Research, Querétaro Queréaro, Querétaro | |
| PanOncology Trials San Juan, | |
| Panamerican Clinical Research S.A de C.V. Guadalajara, Jalisco | |
| Policlinico S.Orsola-Malpighi Bologna, Emilia-Romagna | |
| Policlinico Universitario Agostino Gemelli Rome, Lazio | |
| Praxis für Interdisziplinäre Onkologie und Hämatologie GbR Freiburg im Breisgau, | |
| Presidio Ospedaliero di Summa-Perrino Brindisi, Apulia | |
| Princess Margaret Cancer Center Toronto, | |
| Proclinical Pharma San José, | |
| Productos y Servicios Oncologicos Acacias SA de CV Mexico City, Mexico CITY (federal District) | |
| Przychodnia Lekarska KOMED, Roman Karaszewski Konin, | |
| Queen Mary Hospital Hong Kong, | |
| Queens Hospital Cancer Center Jamaica, New York | |
| RCCS - Centro di Riferimento Aviano (PN), Friuli Venezia Giulia | |
| RENATI INNOVATION S.A.P.I. de C.V Guadalajara, Jalisco | |
| Rabin Medical Center Petah Tikva, | |
| Rajavithi Hospital Bangkok, | |
| Regional Cancer Centre Trivandrum, Kerala | |
| Rocky Mountain Cancer Centers Littleton, Colorado | |
| Rotkreuzklinikum München München, | |
| Royal Victoria Regional Health Centre Barrie, Ontario | |
| SCRI Oncology Partners Nashville, Tennessee | |
| Sahyadri Speciality Hospital Pune, Maharashtra | |
| Sakarya Training and Research Hospital Sakarya, | |
| Samsung Medical Center Seoul, | |
| Sanatorio Allende Córdoba, | |
| Sanatorio Parque S.A. Rosario, | |
| Santa Casa de Misericordia de Porto Alegre Porto Alegre, | |
| Saskatoon Cancer Centre Saskatoon, Saskatchewan | |
| Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Shandong Cancer Hospital Jinan, Shandong | |
| Shanxi Province Cancer Hospital Taiyuan, Shanxi | |
| Sheba MC Ramat Gan, | |
| Sichuan Provincial People's Hospital Chengdu, | |
| Sir H. N. Reliance Foundation Hospital and Research Centre Mumbai, | |
| Sociedad de Oncología y hematología del Cesar Ltda Valledupar, | |
| Songklanagarind Hospital Songkhla, | |
| Sourasky Medical Center Tel Aviv, | |
| South West Healthcare Warrnambool, Victoria | |
| Southern Cancer Center Daphne, Alabama | |
| Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie Bamberg, | |
| Spitalul Clinic Filantropia Bucharest, | |
| Springfield Clinic Springfield, Illinois | |
| St. Elisabeth Krankenhaus Köln GmbH Cologne, | |
| Steve Biko Academic Hospital Pretoria, | |
| Sunact Cancer Institute Thāne, Maharashtra | |
| Sunshine Hospital St Albans, Victoria | |
| Sutter Auburn Faith Hospital Auburn, California | |
| Sutter Health Medical Center Sacramento, California | |
| Sutter Medical Group, Roseville Clinic Roseville, California | |
| Szpital Morski im. PCK Gdynia, | |
| Szpital Wojewódzki im. Miko?aja Kopernika Koszalin, | |
| Taizhou Hospital of Zhejiang Province Taizhou, Zhejiang | |
| Tampere University Hospital Tampere, | |
| Texas Oncology - DFW Irving, Texas | |
| Texas Oncology Cancer Center Austin, Texas | |
| The Affiliated Hospital of Xuzhou Medical University Xuzhou, Jiangsu | |
| The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan | |
| The First Affiliated Hospital to Henan University of Science and Technology Luoyang, | |
| The First Affiliated Hospital, Chongqing Medical University Chongqing, | |
| The First People's Hospital of Yunnan Province Kunming, | |
| The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente Torrance, California | |
| The Second Affiliated Hospital of Xi'an Jiao Tong University Xi'an, | |
| The Second Affiliated Hospital of Zhejiang University College Hangzhou, | |
| The Tumor Hospital of Xinjiang Medical University Ürümqi, | |
| Thunder Bay Regional Health Sciences Centre Thunder Bay, Ontario | |
| Tianjin Cancer Hospital Tianjin, Tianjin Municipality | |
| USC Norris Cancer Center Newport Beach, California | |
| USC Norris Comprehensive Cancer Center Los Angeles, California | |
| UZ Gent Ghent, | |
| UZ Leuven Gasthuisberg Leuven, | |
| Ulsan University Hosiptal Ulsan, | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan, Hubei | |
| University Hospital of Larissa Larissa, | |
| University Hospital of Patras Medical Oncology Pátrai, | |
| University of Nairobi - Institute of Tropical and Infectious Diseases Nairobi, | |
| University of the Sunshine Coast Sippy Downs, Queensland | |
| Università Campus Bio-Medico di Roma Rome, Viterbo | |
| Universitätsklinikum Erlangen Erlangen, | |
| Universitätsklinikum des Saarlandes Homburg/Saar, | |
| Vall d'Hebron Institute of Oncology (VHIO), Barcelona Sant Andreu de la Barca, Barcelona | |
| Vencer Oncoclínica - Centro de Pesquisa do Piauí Teresina, Piauí | |
| Veterans General Hospital Taipei, | |
| Veterans General Hospital - Taichung Taichung, | |
| Virginia Cancer Specialists, PC Fairfax, Virginia | |
| Virginia Commonwealth University - Massey Cancer Center Richmond, Virginia | |
| WellSpan Oncology Research York, Pennsylvania | |
| West Cancer Center Germantown, Tennessee | |
| West China Hospital of Sichuan University Chengdu, Sichuan | |
| West Virginia University Hospitals Inc Morgantown, West Virginia | |
| Whangarei Hospital Whangarei, | |
| Winship Cancer Institute of Emory University Atlanta, Georgia | |
| Xi'an International Medical Center Hospital Xi'an, Shan3xi | |
| ZAS Sint Augustinus Wilrijk Wilrijk, | |
| Zachodniopomorskie Centrum Onkologii Szczecin, | |
| Zhejiang Cancer Hospital Hangzhou, Zhejiang | |
| Zhongshan Hospital Fudan University Shanghai, | |
| the First Hospital of Jilin University Changchun, |
Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com
PHASE3
NCT06356129
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Inclusion Criteria:
\- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including:
i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified \[including germinal center B-cell (GCB) and activated B-cell (ABC) types\]
ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas)
iii) High-grade B-cell lymphoma, not otherwise specified
iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)
v) Epstein-Barr virus + DLBCL
* International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) \> 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3.
* Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (\> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
* Must have Ann Arbor Stage II-IV disease.
Exclusion Criteria:
* Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
* Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
* Documented or suspected central nervous system (CNS) involvement by lymphoma.
* Other protocol-defined Inclusion/Exclusion criteria apply. DRUG: Golcadomide, DRUG: Placebo, DRUG: Rituximab, DRUG: Cyclophosphamide, DRUG: Doxorubicin, DRUG: Vincristine, DRUG: Prednisone
Large B-cell Lymphoma
Lymphoma, Large B-Cell, Lymphoma, BMS-986369, CC-99282, DLBCL
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Show 344 locations
Study Locations
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| Location | Contacts |
|---|---|
| A. C. Camargo Cancer Center São Paulo, São Paulo | |
| Affidea Fundeni Bucharest, | |
| Aidport Skórzewo, Greater Poland Voivodeship | |
| Ajou University Hospital Suwon, | |
| Alaska Oncology and Hematology Anchorage, Alaska | |
| All India Institute of Medical Sciences New Delhi, National Capital Territory of Delhi | |
| Allina Health Cancer Institute - Abbott Northwestern Hospital Minneapolis, Minnesota | |
| Ankara University Health Practice and Research Hospitals Ankara, | |
| Aster Medcity Kochi, Kerala | |
| Astera Cancer Care East Brunswick, New Jersey | |
| Atlantic Health System Morristown Medical Center Morristown, New Jersey | |
| Attikon General University Hospital Chaïdári, Attikí | |
| Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO Palermo, Sicily | |
| Azienda Ospedaliero Universitaria Maggiore della Carità Novara, | |
| BC Cancer Victoria Victoria, British Columbia | |
| Bradfordhill Santiago, Santiago Metropolitan | |
| Brooke Army Medical Center Fort Sam Houston, Texas | |
| CHN - Complexo Hospitalar de Niterói Niterói, Rio de Janeiro | |
| CHRU de Brest Brest, Finistère | |
| CHU Grenoble Alpes La Tronche, Isère | |
| CHU Jean Minjoz Besançon, Doubs | |
| CHU de Saint-Etienne Saint Priest En Jarez, Pays de la Loire Region | |
| Cancer Care Specialists Reno, Nevada | |
| Centre Hospitalier Lyon Sud Pierre-Bénite, | |
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau Tours, Indre-et-Loire | |
| Centre Hospitalier Sud Réunion Saint-Pierre, La Réunion | |
| Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre Caen, | |
| Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu Nantes, Pays de la Loire Region | |
| Centre Hospitalier Universitaire de Nice - Hopital L'archet Nice, Alpes-Maritimes | |
| Centre Hospitalier Universitaire de Poitiers Poitiers, Vienne | |
| Centre Hospitalier de la Cote Basque Bayonne, | |
| Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS Sherbrooke, Quebec | |
| Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - Hôpital du Sacré-Coeur Montreal, Quebec | |
| Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa Porto Alegre, Rio Grande do Sul | |
| Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) Buenos Aires, | |
| Centro de Investigacion Clinica Chapultepec Morelia, Michoacán | |
| Centro de Investigacion Clinica de Oaxaca Oaxaca City, Oaxaca | |
| Centro de Investigaciones Viña del Mar, Región de Valparaíso | |
| Centrum Onkologii Ziemi Lubelskiej Lublin, Lublin Voivodeship | |
| Chang Gung Medical Foundation-LinKou Branch Taoyuan District, | |
| Chang Gung Memorial Hospital at Kaohsiung Kaohsiung City, | |
| Chang Gung Memorial Hospital- Chiayi Chiayi City, Chiayi | |
| Chi Mei Medical Center Tainan City, Tainan | |
| China Medical University Hospital Taichung, | |
| Chongqing University Cancer Hospital Chongqing, Chongqing Municipality | |
| Chu Saint Eloi Montpellier, Languedoc-Roussillon | |
| Cleveland Clinic Florida Palm Beach Gardens, Florida | |
| Clínica Alemana de Santiago Santiago, Santiago Metropolitan | |
| Clínica Inmunocel Santiago, Santiago Metropolitan | |
| Clínica Supera Chapecó, Santa Catarina | |
| Clínica UC San Carlos de Apoquindo Santiago, Santiago Metropolitan | |
| Clínica Zabala Buenos Aires, | |
| D&H Cancer Research Center LLC Margate, Florida | |
| Debreceni Egyetem Klinikai Kozpont Debrecen, Hajdú-Bihar | |
| Dong-A University Hospital Busan, | |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi Ankara, | |
| Ege Universitesi Hastanesi Izmir, | |
| Emory University School of Medicine- Grady Campus Atlanta, Georgia | |
| Evangelismos General Hospital of Athens Athens, Attikí | |
| Faculty of Medicine Siriraj Hospital Bangkok, Bangkok | |
| Fakultni nemocnice Hradec Kralove Hradec Králové, | |
| Fakultni nemocnice Kralovske Vinohrady Prague, | |
| Fakultni nemocnice Olomouc Olomouc, | |
| Fakultni nemocnice Plzen Pilsen, | |
| Fakultní nemocnice Brno Bohunice Brno, Brno-město | |
| Florida Cancer Specialists - East West Palm Beach, Florida | |
| Florida Cancer Specialists - North St. Petersburg, Florida | |
| Florida Cancer Specialists - South Fort Myers, Florida | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore Rome, Lazio | |
| Fudan University Shanghai Cancer Center Shanghai, Shanghai Municipality | |
| Fujian Cancer Hospital Fuzhou, | |
| Fundacion Arturo Lopez Perez (FALP) Santiago, Santiago Metropolitan | |
| Fundacion Ctic Centro de Tratamiento E Investigacion Sobre Cancer Luis Carlos Sarmiento Angulo Bogotá, Bogota D.C. | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto Sao Jose Rio Preto, | |
| Fundação Pio XII - Hospital de Câncer de Barretos Barretos, São Paulo | |
| Fundeni Clinical Institute Bucharest, București | |
| Gazi University Health Research and Application Center Gazi Hospital Ankara, | |
| Guangxi Medical University Affiliated Tumor Hospital Nanning, Guangxi | |
| Gustave Roussy Villejuif, | |
| Harbin Medical University Cancer Hospital Harbin, Heilongjiang | |
| Health Pharma Professional Research S.A. de C.V: Mexico City, DIF | |
| Hematology-Oncology Associates of Central New York, PC East Syracuse, New York | |
| Henan Cancer Hospital Zhengzhou, Henan | |
| Henri Mondor Hospital Créteil, Val-de-Marne | |
| Hopital Claude Huriez - CHU de Lille Lille, Nord | |
| Hopital Saint-Louis Paris, | |
| Hospital 9 De Julho São Paulo, | |
| Hospital Aleman Buenos Aires, Buenos Aires F.D. | |
| Hospital Alemão Oswaldo Cruz São Paulo, | |
| Hospital Amaral Carvalho Jaú, São Paulo | |
| Hospital Brasilia Lago Sul, Federal District | |
| Hospital Erasto Gaertner Curitiba, Paraná | |
| Hospital Privado Universitario de Córdoba Córdoba, | |
| Hospital São Lucas de Copacabana Rio de Janeiro, | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey, Nuevo León | |
| Hospital das Clinicas FMUSP São Paulo, | |
| Hunan Cancer Hospital Changsha, Hunan | |
| Hôpital Saint Vincent-de-Paul Lille, Hauts-de-France | |
| Icahn School of Medicine at Mount Sinai New York, New York | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Bordeaux, Aquitaine | |
| Institut Curie - site Saint-Cloud Saint-Cloud, Hauts-de-Seine | |
| Institut Paoli-Calmettes Marseille, Bouches-du-Rhône | |
| Institut de cancérologie Strasbourg Europe (ICANS) Strasbourg, | |
| Instituto Alexander Fleming Buenos Aires, | |
| Instituto D'Or de Pesquisa e Ensino (IDOR) São Paulo, | |
| Instituto Joinvilense De Hematologia e Oncologia Joinville, Santa Catarina | |
| Instituto Nacional De Cancerologia Bogota, Cundinamarca | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City, DIF | |
| Institutul Oncologic Cluj Cluj-Napoca, | |
| Institutul Regional de Oncologie Iași, | |
| Jiangxi Provincial Cancer Hospital Nanchang, Jiangxi | |
| KLES Dr. Prabhakar Kore Hospital & M.R.C Belagavi, Karnataka | |
| Karadeniz Teknik Universitesi Tip Fakultesi Trabzon, | |
| King Abdulaziz Medical City Jeddah, | |
| King Abdulaziz Medical City - National Guard Hospital Riyadh, Riyadh Region | |
| King Fahad Specialist Hospital - Dammam Dammam, Eastern Province | |
| King Faisal Specialist Hospital and Research Center Riyadh, | |
| Koo Foundation Sun Yat-Sen Cancer Center Taipei, | |
| Korea University Anam Hospital Seoul, | |
| Kosin University Gospel Hospital Busan, Pusan-Kwangyǒkshi | |
| Kyungpook National University Chilgok Hospital Daegu, | |
| Leids Universitair Medisch Centrum Leiden, | |
| Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte | |
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| Local Institution - 0516 Houston, Texas | |
| Maharaj Nakorn Chiang Mai Hospital Chiang Mai, | |
| Markusovszky Egyetemi Oktatokorhaz Szombathely, Vas County | |
| Mary Bird Perkins Cancer Center Baton Rouge Baton Rouge, Louisiana | |
| Mayo Clinic in Arizona - Phoenix Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester, Minnesota Rochester, Minnesota | |
| Memorial Hermann Hospital - Texas Medical Center Houston, Texas | |
| Mission Cancer + Blood Waukee, Iowa | |
| Moffitt Cancer Center Tampa, Florida | |
| Mount Sinai Cancer Center Miami Beach, Florida | |
| Narayana Superspecialty Hospital Howrah, West Bengal | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie Warsaw, Masovian Voivodeship | |
| National Cancer Center Goyang-si Gyeonggi-do, | |
| National Taiwan University Hospital Taipei, | |
| Núcleo de Oncologia e Hematologia do Ceará Fortaleza, Ceará | |
| Oklahoma Cancer Specialists and Research Institute Tulsa, Oklahoma | |
| Ondokuz Mayıs Universitesi Samsun, | |
| Orchard Healthcare Research Inc. Skokie, Illinois | |
| Oregon Health and Science University Portland, Oregon | |
| Orszagos Onkologiai Intezet Budapest, | |
| Ospedale Santa Maria delle Croci Ravenna, Emilia-Romagna | |
| Pan American Center for Oncology Trials - Ciudadela San Juan, | |
| Peking University Third Hospital Beijing, | |
| Pratia MCM Kraków Krakow, Malopolska | |
| Pusan National University Hospital Busan, | |
| Qilu Hospital of Shandong University Jinan, Shandong | |
| Rajiv Gandhi Cancer Institute And Research Centre New Delhi, National Capital Territory of Delhi | |
| Ramathibodi Hospital Bangkok, Bangkok | |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai, Shanghai Municipality | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Sacred Heart Medical Oncology Group Pensacola, Florida | |
| Samsung Medical Center Seoul, | |
| Sc Onco Card Srl Brasov, | |
| Semmelweis Egyetem Budapest, | |
| Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do, | |
| Seoul National University Hospital Seoul, | |
| Shandong Cancer Hospital Jinan, Shandong | |
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| Shengjing Hospital of China Medical University Shengyang, | |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo, | |
| Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvár, Somogy County | |
| Southern Medical University Nanfang Hospital Guangzhou, Guangdong | |
| Spital Clinic Judetean de Urgenta Tg.Mures Tg.Mures, Mureș County | |
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| Spitalul Clinic Coltea Bucharest, | |
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| Spitalul Universitar de Urgenta Bucuresti Bucharest, | |
| St. Marys Hospital Center Montreal, Quebec | |
| Sun Yat-sen University Cancer Center Guangzhou, Guangdong | |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Nyíregyháza, Szabolcs-Szatmár-Bereg | |
| Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Taichung Veterans General Hospital Taichung, China | |
| Taipei Veterans General Hospital Taipei, | |
| Tata Medical Center New Town, West Bengal | |
| Tata Memorial Hospital Mumbai, Maharashtra | |
| The Catholic University of Korea, Yeouido St. Mary's Hospital Seoul, | |
| The First Affiliated Hospital of Chongqing Medical University Chongqing, | |
| The First Affiliated Hospital of NanChang University Nanchang, Jiangxi | |
| The First Affiliated Hospital of Soochow University Suzhou, | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xiamen University Xiamen, Fujian | |
| The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The First Hospital of China Medical University Shenyang, Liaoning | |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The University of Kansas Cancer Center - Westwood Westwood, Kansas | |
| Tianjin Medical University Cancer Institute & Hospital Tianjin, Tianjin Municipality | |
| Tongji Hospital Tongji Medical,Science & Technology Wuhan, Hubei | |
| UMHAT 'Sveti Ivan Rilsky' Sofia, | |
| UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | |
| USA Mitchell Cancer Institute Mobile, Alabama | |
| Unidad Médica Onco-Hematológica Puebla City, | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan, Hubei | |
| Universidade Federal de Goias Goiânia, Goiás | |
| University Medical Center Groningen Groningen, | |
| University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD Plovdiv, | |
| University of Michigan Ann Arbor, Michigan | |
| University of Texas MD Anderson Cancer Center Houston, Texas | |
| VM Medical Park Mersin Hastanesi Mersin, | |
| Virginia Commonwealth University (VCU) Medical Center Richmond, Virginia | |
| Vseobecna Fakultni Nemocnice v Praze Prague, | |
| WellSpan Oncology Research York, Pennsylvania | |
| West China Hospital, Sichuan University Chengdu, Sichuan | |
| Winship Cancer Institute, Emory University Atlanta, Georgia | |
| Xinjiang Medical University Cancer Hospital - Urumqi Ürümqi, Xinjiang | |
| the First Hospital of Jilin University Changchun, |
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
ctrrecruit@vcu.edu
PHASE3
NCT05602194
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Inclusion Criteria:
* \>= 15 and \< 40 years at time of diagnosis
* Newly diagnosed B-ALL, T-ALL, lymphoblastic lymphoma (LLy), or mixed-phenotype acute leukemia/lymphoma (MPAL)
* Note: Philadelphia chromosome (PH)+ and PH-like acute leukemia are eligible (use of tyrosine kinase inhibitors \[TKI\] or CRLF2- targeted concomitant medication must be documented, if used)
* Conjugated bilirubin =\< 1.5 x upper limit of normal (ULN) for age, regardless of baseline bilirubin (within 7 days prior to enrollment), and
* Serum glutamate pyruvate transaminase (SGPT) (ALT) =\< 225 U/L (=\< 5x ULN) (within 7 days prior to enrollment), and
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and serum glutamic oxaloacetic transaminase (SGOT) (AST) to 50 U/L regardless of baseline
* SGOT (AST) =\< 250 U/L (=\< 5x ULN) (within 7 days prior to enrollment)
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and SGOT (AST) to 50 U/L regardless of baseline
* For patients receiving ursodiol prior to enrollment, laboratory values must meet above criteria off ursodiol for 7 days
* PEDIATRIC PATIENTS (AGE 15-17 years):
* A 24-hour urine creatinine clearance \>= 30 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR
* A glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2. GFR must be performed using one of the following methods (within 7 days prior to enrollment):
* 1\. Estimated GFR (eGFR) \>= 30 mL/min/1.73 m\^2.
* An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr\_calculatorped
* 2\. Measured GFR \>= 30 mL/min/1.73 m\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard).
* ADULT PATIENTS (AGE 18 YEARS OR OLDER): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection (within 7 days prior to enrollment). Estimated creatinine clearance is based on actual body weight
* An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr\_calculatorcoc
* Berlin-Frankfurt-Munich (BFM), Children's Oncology Group (COG), or C10403-based Induction regimen and must be inclusive of \>= 1 dose of pegaspargase or calaspargase pegol, and
* First dose of asparaginase must be planned within the first week of induction therapy, and
* Dose of pegaspargase or calaspargase pegol must be \>= 1,000 IU/ m\^2 (dose-capping permitted per primary regimen)
* Note: Co-enrollment on a therapeutic consortia trial is not required
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Down syndrome
* Known inherited or autoimmune liver disease impacting conjugated bilirubin (e.g., Alagille syndrome, primary sclerosing cholangitis, other)
* Known biopsy (or imaging) proven severe liver fibrosis (Batts-Ludwig \>= stage 3)
* Unable to tolerate oral formulation of study drug at enrollment
* Patients who received chemotherapy or treatment for a prior malignancy are not eligible
* The following are permitted: steroid prophase, hydroxyurea, or other cytoreduction prior to initiation of Induction chemotherapy (must be documented) and chemotherapy for current diagnosis (i.e. initiation of Induction therapy within enrollment window). Chemotherapy prior to enrollment for treatment of a non-malignancy (e.g., steroid or methotrexate for autoimmune disease) is also permitted and must be documented
* Female patients who are pregnant since fetal toxicities and teratogenic effects in humans are unknown for study drug. A pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation PROCEDURE: Biospecimen Collection, DRUG: Calaspargase Pegol, DIETARY_SUPPLEMENT: Levocarnitine, DRUG: Pegaspargase, OTHER: Quality-of-Life Assessment
B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9,22)(q34.1,q11.2), BCR-ABL1, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Lymphoblastic Lymphoma, Mixed Phenotype Acute Leukemia, T Acute Lymphoblastic Leukemia
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Show 221 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Ann M Wierman MD LTD Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital at Montefiore The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| GenesisCare USA - Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Las Vegas Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Vegas Tenaya Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada | Site Public Contact - (research@sncrf.org) |
| Hospital for Sick Children Toronto, Ontario | |
| IWK Health Centre Halifax, Nova Scotia | |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Mission San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Cathedral Rock Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pebble Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pecos Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Smoke Ranch Las Vegas, Nevada | Site Public Contact - (research@smcrf.org) |
| Las Vegas Urology - Sunset Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Greenville Memorial Hospital Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Radiation Oncology Associates Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (cogbchoak@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | Site Public Contact - (slusserb@med.umich.edu) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Urology Specialists of Nevada - Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus (STRIDE)
Ona Whelove - clinicaltrials@cerevasc.com
NA
NCT06498960
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Inclusion Criteria:
Each subject must meet the following criteria:
• Patients ≥60 years old on the day of study informed consent
• Patient or legally authorized representative is able and willing to provide written informed consent
• History or evidence of gait impairment with a duration ≥3 months
• Clinical presentation consistent with NPH including two or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with all of the following:
• Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index \>0.3) and the absence of severe hippocampal atrophy,
• Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%,
• CSF opening pressure ≥8 cmH2O,
• Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
• Patient is willing and able to attend all scheduled visits and comply with study procedures.
• Confirmation of anatomy suitable for the eShunt procedure, as determined by evaluation of pre-procedure imaging (CT and MRI) and approved by an independent anatomical screening committee.
Exclusion Criteria:
Each subject may not:
• Be unable to walk 10 meters (33 feet) with or without an assistive device
• Be diagnosed with obstructive hydrocephalus
• Have an active systemic infection or infection detected in CSF
• Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
• Demonstrate hypersensitivity or contraindication to heparin or radiographic contrast agents against which the subject cannot be adequately pre-medicated, desensitized or where no alternative is available
• Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS
• Present with venous distension in the neck on physical exam
• Have medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arteriovenous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain
• Have history of bleeding diatheses, coagulopathy or refuse to consent for blood transfusion in cases of emergency
• Have had an ischemic stroke or transient ischemic attack within 180 days of eShunt procedure
• Have documented evidence of a deep vein thrombosis superior to the popliteal vein
• Have intrinsic blood clotting disorder
• Have medical conditions requiring anticoagulation which is unable to be managed to allow for surgical procedure
• Have presence of a posterior fossa tumor or mass
• Have a life expectancy \<1 year
• Be currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study.
• Have established diagnosis of neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia
• Be diagnosed with schizophrenia or any psychiatric diagnosis (including depression) that may complicate outcome evaluation
• Need an intracranial neurosurgical procedure within 180 days of study index procedure
• Be unwilling or unable to comply with follow-up requirements
• Have mRS of 0, 5, or 6
DEVICE: CereVasc eShunt System, DEVICE: VP Shunt
Normal Pressure Hydrocephalus
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Show 28 locations
Study Locations
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| Location | Contacts |
|---|---|
| Advocate Lutheran General Hospital Park Ridge, Illinois | Gina Littlejohn, BSN, RN, CCRC - (Gina.Littlejohn@aah.org) |
| Albany Medical Center Albany, New York | Julia Zajaceskowski - (zajacej@amc.edu) |
| Baptist Medical Center - Jacksonville Jacksonville, Florida | Jefferson Atillo, RN, BSN - (jefferson.atillo@bmcjax.com) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | Mark Rotondo, MS - (mrotondo@bidmc.harvard.edu) |
| Brigham and Women's Hospital Boston, Massachusetts | Odysseas Nikas - (onikas@bwh.harvard.edu) |
| Cleveland Clinic Cleveland, Ohio | Joyce Barmen - (BARMENJ2@ccf.org) |
| Clinica La Sagrada Familia Buenos Aires, | Carlos Toranzo - (ctoranzo@lylyk.com.ar) |
| Cooper Neurological Institute Camden, New Jersey | Sean Behnke - (Behnke-sean@cooperhealth.edu) |
| Henry Ford Health Detroit, Michigan | Rehnuma Newaz - (rnewaz1@hfhs.org) |
| Icahn School of Medicine at Mount Sinai New York, New York | Kevin Buttet - (kevin.buttet@mountsinai.org) |
| Indiana University Indianapolis, Indiana | Lauren Snyder, RN, BSN, CCRC - (lmillar@iu.edu) |
| Lenox Hill Hospital New York, New York | Faith Singh - (fsingh3@northwell.edu) |
| Massachusetts General Hospital Boston, Massachusetts | Shayna Hollander - (sdhollander@mgh.harvard.edu) |
| Montefiore Medical Center The Bronx, New York | Lyanna Gomez, MD - (lygomez@montefiore.org) |
| NYU Langone Health Brooklyn, New York | Michelle Sclafani - (michelle.sclafani@nyulangone.org) |
| Northwell Health Manhasset, New York | Ajith Vellat - (avellat1@northwell.edu) |
| Northwestern University Chicago, Illinois | Pouya Nazari - (pouya.nazari@northwestern.edu) |
| Rhode Island Hospital Providence, Rhode Island | Wendy Smith, BS, RTRCV, CCRP - (wsmith@brownhealth.org) |
| St. Michael's Hospital Toronto, Ontario | Eileen Liu - (Eileen.liu@unityhealth.to) |
| Thomas Jefferson University Philadelphia, Pennsylvania | Sha'Mere Herder - (shamere.herder@jefferson.edu) |
| University at Buffalo Neurosurgery Buffalo, New York | Ellen Carl - (ecarl@ubns.com) |
| University of Kansas Medical Center Kansas City, Kansas | Max Hardenbrook - (mhardenbrook@kumc.edu) |
| University of Kentucky Research Foundation Lexington, Kentucky | Rachel Norris - (rachel.norris@uky.edu) |
| University of Rochester Medical Center Rochester, New York | Tilor Hallquist - (Tilor_Hallquist@URMC.Rochester.edu) |
| University of South Florida Tampa, Florida | Shalini Nampally - (snampally@tgh.org) |
| University of Southern California Los Angeles, California | Kelly Hu - (kelly.hu@med.usc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Amy Erickson - (amy.e.stout@vcuhealth.org) |
| Yale University New Haven, Connecticut | Lindsey Fraczkiewicz - (lindsey.fraczkiewicz@yale.edu) |
MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Trial Manager at Intellia - medicalinformation@intelliatx.com
PHASE3
NCT06128629
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Inclusion Criteria:
* Documented diagnosis of ATTR amyloidosis with cardiomyopathy
* Medical history of heart failure (HF)
* Symptoms of HF are optimally managed and clinically stable within 28 days prior to administration of study intervention
* Screening NT-proBNP, a blood marker of HF severity, greater than or equal to 600 pg/mL and less than 10,000 pg/mL
Exclusion Criteria:
* New York Heart Association (NYHA) Class IV HF
* Polyneuropathy Disability score of IV (confined to wheelchair or bed)
* Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
* History of active malignancy within 3 years prior to screening
* RNA silencer therapy (patisiran, inotersen and/or eplontersen) within 12 months prior to dosing. Any prior vutrisiran use is not allowed
* Initiation of tafamidis or acoramidis within 56 days prior to study dosing
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2
* Liver failure
* Uncontrolled blood pressure
* Unable or unwilling to take vitamin A supplementation for the duration of the study BIOLOGICAL: NTLA-2001, DRUG: Placebo
Transthyretin Amyloidosis (ATTR) with Cardiomyopathy
TTR, Amyloidosis, Cardiomyopathy, NTLA-2001, ATTR-CM, Transthyretin, ATTR, TTR-mediated amyloidosis, Amyloidosis, Hereditary, Amyloidosis, Hereditary, Transthyretin-Related Amyloidosis, Transthyretin amyloid cardiomyopathy, TTR cardiomyopathy, Wild-type TTR, V122I, Amyloidosis, Wild Type
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Show 132 locations
Study Locations
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| Location | Contacts |
|---|---|
| AP-HM - Hopital de la Timone Marseille, | |
| AP-HP Hopital Bichat - Claude Bernard Paris, | |
| AP-HP Hopital Henri Mondor Créteil, | |
| AZ Sint-Jan Brugge Bruges, | |
| Aarhus University Hospital Aarhus, | |
| Alberta Health Services - University of Calgary Calgary, Alberta | |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Antwerp University Hospital Edegem, Antwerp | |
| Azienda Ospedaliero-Universitaria Careggi Florence, FI | |
| Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna Cona, | |
| Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara Trieste, | |
| Barbara Ann Karmanos Cancer Institute Detroit, Michigan | |
| Baylor College of Medicine Houston, Texas | |
| Baylor Scott & White Research Institute Forth Worth, Texas | |
| Baylor Scott and White - The Heart Hospital Baylor Plano Plano, Texas | |
| Boston University School of Medicine Boston, Massachusetts | |
| Brigham and Women's Hospital Boston, Massachusetts | |
| CAPED - Centro Avancado de Pesquisa Ribeirão Preto, | |
| CHU de Toulouse - Hopital Rangueil Toulouse, | |
| Cairns Hospital Cairns, Queensland | |
| Cardiopulmonar da Bahia S. A. (Hospital Cardio Pulmonar) Salvador, | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Regional de la Citadelle Liège, | |
| Centro Hospitalar Universitario de Lisboa Norte Lisbon, | |
| Centro Hospitalar Universitario do Porto Porto, | |
| Centro de Pesquisa NUPEC - Instituto Orizonti em Belo Horizonte Belo Horizonte, | |
| Charite Universitaetsmedizin Berlin Berlin, | |
| Chonnam National University Hospital Gwangju, | |
| Chu Rennes - Hopital Pontchaillou Rennes, Ille Et Vilaine | |
| Cleveland Clinic Cleveland, Ohio | |
| Cleveland Clinic of Florida Weston, Florida | |
| Columbia University Medical Center New York, New York | |
| Complexo Hospitalar de Niterói (CHN-DASA) Niterói, | |
| Duke University Medical Center Durham, North Carolina | |
| Eastern Health - Box Hill Hospital Box Hill, Victoria | |
| Emory University School Of Medicine Atlanta, Georgia | |
| Erasmus MC Rotterdam, South Holland | |
| Fakultni nemocnice u sv. Anny v Brne Brno, | |
| Far Eastern Memorial Hospital New Taipei City, | |
| Fiona Stanley Hospital Murdoch, | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fondazione Toscana Gabriele Monasterio per la Ricerca Medica Pisa, | |
| Fundacion Favaloro CABA, Buenos Aires, Argentina | |
| Fundacion Favalro Buenos Aires, | |
| HCFMRP - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto Ribeirão Preto, | |
| Hadassah University Hospital, Ein Karem Jerusalem, | |
| Hospital Israelita Albert Einstein Morumbi, São Paulo | |
| Hospital Privado de Rosario Rosario, | |
| Hospital Universitari de Bellvitge Barcelona, | |
| Hospital Universitario Puerta de Hierro Majadahonda, | |
| Hospital Universitario Son Llatzer Palma de Mallorca, | |
| Hospital Universitario Vall d'Hebron Horta-Guinardó, Barcelona | |
| Hospital Universitario Virgen de la Victoria Málaga, | |
| Hospital Universitario de A Coruna A Coruña, | |
| Houston Methodist Hospital Houston, Texas | |
| ICBA Buenos Aires, | |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola Bologna, | |
| Indiana University Health Indianapolis, Indiana | |
| Inova Fairfax Hospital Falls Church, Virginia | |
| Instituto Dante Pazzanese de Cardiologia São Paulo, São Paulo | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City, DIF | |
| Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP São Paulo, | |
| Johns Hopkins University Baltimore, Maryland | |
| Karolinska University Hospital Stockholm, | |
| Kumamoto University Hospital Kumamoto, | |
| Mayo Clinic Rochester, Minnesota | |
| Mayo Clinic - Jacksonville Jacksonville, Florida | |
| McGill University Health Centre Montreal, Quebec | |
| MedStar Washington Hospital Center - MedStar Heart and Vascular Institute Washington D.C., District of Columbia | |
| Medical University of South Carolina Charleston, South Carolina | |
| Medizinische Universitaet Innsbruck Innsbruck, | |
| National Cerebral and Cardiovascular Center Osaka, | |
| National Heart Centre Singapore, | |
| National Taiwan University Hospital Taipei, | |
| National University Hospital Singapore, | |
| New York University (NYU) School of Medicine - Langone Medical Center New York, New York | |
| New Zealand Clinical Research Christchurch, | |
| New Zealand Clinical Research Christchurch, | |
| Northwestern University Chicago, Illinois | |
| Ohio Health Research Institute Columbus, Ohio | |
| Oregon Health and Science University (OHSU) Portland, Oregon | |
| Oslo University Hospital - Rikshospitalet Oslo, | |
| Ospedale Policlinico San Martino IRCCS Genova, | |
| PSEG Centro de Pesquisa Clinica S.A. São Paulo, | |
| Penn Presbyterian Medical Center Philadelphia, Pennsylvania | |
| Princess Alexandra Hospital Woolloongabba, | |
| Rambam Health Care Campus Haifa, Haifa District | |
| Richmond Pharmacology London, | |
| Rigshospitalet Copenhagen, | |
| Royal Adelaide Hospital Adelaide, South Australia | |
| Samsung Medical Center Seoul, | |
| Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika Budapest, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Sheba Medical Center Ramat Gan, | |
| St. Luke's Hospital Kansas City, Missouri | |
| Stanford University Palo Alto, California | |
| Synexus Hexham Clinical Research Centre Hexham, | |
| Synexus Manchester Clinical Research Centre Manchester, | |
| Synexus Merseyside Clinical Research Centre Liverpool, | |
| Synexus Midlands Clinical Research Centre Birmingham, | |
| Synexus Scotland Clinical Research Centre Glasgow, | |
| Synexus Wales Clinical Research Centre Cardiff, | |
| Taipai Veterans General Hospital Taipei, | |
| The Alfred Hospital Melbourne, Victoria | |
| The Canberra Hospital Garran, Australian Capital Territory | |
| The University of Tokyo Hospital Bunkyo-ku, Tokyo | |
| Toyama University Hospital Toyama, | |
| UZ Leuven Leuven, | |
| Universitaesklinikum St. Poelten Sankt Pölten, | |
| UniversitaetsKlinikum Heidelberg Heidelberg, | |
| Universitaetsklinikum Essen Essen, | |
| Universitaetsklinikum Wuerzburg Würzburg, | |
| Universitair Medisch Centrum Utrecht Utrecht, | |
| University Health Network - Toronto General Hospital Toronto, Ontario | |
| University Hospital of Umea Umeå, | |
| University Medical Center Groningen, | |
| University of Arizona Tucson, Arizona | |
| University of California, San Diego (UCSD) - Medical Center La Jolla, California | |
| University of Colorado Denver Aurora, Colorado | |
| University of Kentucky Gill Heart Institute Lexington, Kentucky | |
| University of Michigan Ann Arbor, Michigan | |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| Université libre de Bruxelles (ULB) - Hôpital Erasme Brussels, | |
| Vancouver Coastal Health Research Institute Vancouver, British Columbia | |
| Virginia Commonwealth University - Department of Internal Medicine Richmond, Virginia | |
| Western Greater Los Angeles VA Medical Center Los Angeles, California | |
| Westmead Hospital Sydney, New South Wales | |
| Yale University School of Medicine New Haven, Connecticut | |
| hospital Italiano de Buenos Aires CABA, | |
| hospital Italiano de Buenos Aires CABA, |
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) (Shamrock)
Sabine Coppieters, MD - clinicaltrials@argenx.com
PHASE2
NCT06503731
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Inclusion Criteria:
* The participant is within the ages of 18 and 80 years old
* The participant had a kidney transplant (living or deceased donor) at least 6 months before the study
* The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study
* A participant may be allowed into the study if they receive the following medications:
• Received mycophenolate mofetil for at least 20 weeks before the study
• Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study
• Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study
• Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for at least 4 weeks before being allowed to participate in the study
Exclusion Criteria:
* Confirmed T-cell or mixed rejection at time of the study
* Recent change in immunosuppressive therapy agents
* Any other medical condition that, in the investigator's opinion, would interfere with the results of the study or put the participant at undue risk
* Pregnant or lactating state or intention to become pregnant during the study
The complete list of criteria can be found in the protocol COMBINATION_PRODUCT: Efgartigimod PH20 SC - prefilled syringe, OTHER: Placebo PH20 SC - prefilled syringe
Antibody-mediated Rejection
Active AMR, Chronic active AMR, Late AMR
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Study Locations
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| Location | Contacts |
|---|---|
| Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus Wien, | Georg A. Boehmig, MD - (clinicaltrials@argenx.com) |
| Cedars-Sinai Medical Center Los Angeles, California | Stanley Jordan, MD - (clinicaltrials@argenx.com) |
| Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin Bordeaux, | Lionel Couzi, MD - (clinicaltrials@argenx.com) |
| Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon La Tronche, | Paolo Malvezzi, MD - (clinicaltrials@argenx.com) |
| Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil Toulouse, | Nassim Kamar, MD - (clinicaltrials@argenx.com) |
| Charite - Universitatsmedizin Berlin Berlin, | Eva Schrezenmeier, MD - (clinicaltrials@argenx.com) |
| Duke University Hospital Durham, North Carolina | Goni Katz-Greenberg, MD - (clinicaltrials@argenx.com) |
| Hospital Del Mar Barcelona, Catalonia | Marta Crespo, MD - (clinicaltrials@argenx.com) |
| Hospital Universitario Vall d'Hebron Horta-Guinardó, Barcelona | Francesc Moreso, MD - (clinicaltrials@argenx.com) |
| Hospital Universitario de Bellvitge Barcelona, | Edoardo Melilli, MD - (clinicaltrials@argenx.com) |
| Institut klinicke a experimentalni mediciny (IKEM) Praha, | Ondrej Viklický, MD - (clinicaltrials@argenx.com) |
| London Health Sciences Centre London, Ontario | Lakshman Gunaratnam, MD - (clinicaltrials@argenx.com) |
| The Ohio State University Wexner Medical Center Columbus, Ohio | Todd Pesavento, MD - (clinicaltrials@argenx.com) |
| Universitaetsklinikum Carl Gustav Carus Dresden Dresden, | Christian Hugo, MD - (clinicaltrials@argenx.com) |
| Universitair Ziekenhuis (UZ) Gent Gent, | Steven Van Laecke, MD - (clinicaltrials@argenx.com) |
| Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg Leuven, | Dirk Kuypers, MD - (clinicaltrials@argenx.com) |
| Universitatsklinikum Hamburg-Eppendorf Hamburg, | Florian Grahammer, MD - (clinicaltrials@argenx.com) |
| University of Alabama at Birmingham (UAB) Hospital Birmingham, Alabama | Navya Eleti, MD - (clinicaltrials@argenx.com) |
| University of Washington Medical Center Seattle, Washington | Nicolae Leca, MD - (clinicaltrials@argenx.com) |
| Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center Richmond, Virginia | Gaurav Gupta, MD - (clinicaltrials@argenx.com) |
Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
LumaBridge CRO - contact@lumabridge.com
PHASE1
NCT06028074
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Inclusion Criteria:
General
* Written informed consent
* ECOG performance status 0-1.
* Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions
* Recommended Double methods of contraception 90-days post treatment Cancer Specific
* Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor
* Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
* Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation
* No other lines of therapy that are available
Exclusion Criteria:
General
* Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy
* Women who are pregnant or breastfeeding
* History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
* Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific
* Current second malignancy at other sites
* Leptomeningeal disease
* Spinal cord compression
* Symptomatic or new or enlarging central nervous system (CNS) metastases
Treatment-specific Exclusion Criteria
* Ongoing toxicity \> Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
* Has undergone a major surgery \< 1 month prior to administration of GIM-122
* Has received radiation therapy within 2 weeks prior to administration of GIM-122
* Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time
* Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122
* Prior treatment with other immune modulating agents within \< 4 weeks prior to the first dose of GIM-122.
* Has a diagnosis of immunodeficiency, either primary or acquired
* Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122
* Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.
* Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any of the study medications, or excipients in the various formulations of any agent.
* Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date \> 30 days prior to administration of GIM-122). DRUG: GIM122
Advanced Solid Malignancies
solid tumor, advanced malignancies, GIM-122
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Study Locations
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| Location | Contacts |
|---|---|
| Florida Cancer Specialists West Palm Beach, Florida | |
| NEXT Oncology Dallas Irving, Texas | |
| Norton Cancer Institute Louisville, Kentucky | Juanita Dwingelo, MS, PhD, ACRP-CP - (juanita.vondwingelo@nortonhealthcare.org) |
| Rutgers Cancer Institute of Nj New Brunswick, New Jersey | Taryn Bollaro - (tb509@cinj.rutgers.edu) |
| Tennessee Oncology, PLLC Nashville, Tennessee | Amber Hilyard - (ahilyard@tnonc.com) |
| Texas Oncology - Baylor Sammons Cancer Center Dallas, Texas | |
| The Angeles Clinic and Research Institute Los Angeles, California | |
| UCLA Hematology/Oncology Los Angeles, California | Thu Ly - (tply@mednet.ucla.edu) |
| UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California | Markee Micu - (markee.micu@ucsf.edu) |
| USC/Norris Comprehensive Cancer Center Los Angeles, California | Thomas Won - (thomas.won@med.usc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Faith McFadden - (mcfaddenfr@vcu.edu) |
EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation (EXCLAMATORY)
Pamela Grizzard - pamela.grizzard@vcuhealth.org
NCT06212791
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Inclusion Criteria:
* Age ≥18 years
* Diagnosis of paroxysmal AF
* Left ventricular ejection fraction ≥50%
* Scheduled for catheter ablation
* Able to speak, hear, and read English
* Willing and able to provide informed consent
Exclusion Criteria:
* Persistent or permanent AF
* Prior ablation (catheter based or surgical) for AF
* Significant sinus node dysfunction
* Implanted pacemaker or defibrillator
* Contraindication to or inability to complete cardiovascular magnetic resonance study
* Contraindication to or inability to complete exercise testing
* Chronic kidney disease with estimated glomerular filtration rate \<30 mL/min/1.73m2
* Severe left ventricular hypertrophy
* Unrelated cardiomyopathy that is expected to limit exercise capacity, including but not limited to:
* Hypertrophic cardiomyopathy
* Cardiac amyloidosis
* Constrictive pericarditis
* Pulmonary arterial hypertension
* Prior cardiac surgery
* Active pregnancy BEHAVIORAL: Self- Report Evaluation-Duke Activity Status Index, BEHAVIORAL: Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire, DIAGNOSTIC_TEST: Cardiopulmonary exercise test (CPET), DIAGNOSTIC_TEST: Transthoracic echocardiogram, DIAGNOSTIC_TEST: Ambulatory cardiac rhythm assessment, DIAGNOSTIC_TEST: Cardiovascular magnetic resonance (CMR)
Paroxysmal Atrial Fibrillation
Catheter ablation, Exercise capacity
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Pamela Grizzard - (pamela.grizzard@vcuhealth.org) Melissa Sears - (melissa.sears@vcuhealth.org) |
Targeting Trimethylamine N-Oxide for Cardiovascular Health In Liver Transplant Recipients
Patrice Wiecek - wiecekpj@vcu.edu
NA
NCT06043531
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Inclusion Criteria:
* Aged \> 18 years
* Speak and understand English
* Have received and LT
Exclusion Criteria:
* Acute cellular or chronic rejection within 3 months
* Post-LT liver or non-liver related malignancy
* Active viral hepatitis (B or C) or autoimmune hepatitis
* Untreated biliary strictures or vascular complications (e.g. hepatic artery thrombosis)
* Poorly controlled diabetes (HbA1c \>8.5%)
* Relapse of alcohol use after LT
* Follow a vegetarian or vegan diet
* Current pregnancy
* Unable to provide informed consent OTHER: Experimental: EVOO
Liver Transplant
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Danielle Kirkman - (dlkirkman@vcu.edu) Patrice Wiecek - (wiecekpj@vcu.edu) |
Effect of Clear Aligner Attachment Size on Extrusion of Maxillary Lateral Incisors
Alexis Catalano - catalanoam2@vcu.edu
NA
NCT06814262
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Inclusion Criteria:
* Patients treated with either Comprehensive Invisalign or Invisalign Teen treatment
* The maxillary arch has less than 6 mm of crowding or spacing
* Maxillary lateral incisors have a minimum of 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck for the first set of aligners
* Maxillary lateral incisors within a normal range of bucco-lingual inclination
* Patients 12 years of age or older and either the patient or legal guardian are able to give consent
* Patients confirm good compliance throughout the study period
Exclusion Criteria:
* Patients do not complete all aligners in the first phase as prescribed
* Poor compliance recorded for aligner wear
* Restorations placed or oral surgery completed prior to final scan
* Midcourse intervention to improve tracking such as a bootstrap
* Maxillary lateral incisors not tracking and noted by minimum of 1 mm of aligner material incisally displaced when aligner fully seated
* Treatment plans include surgery or extractions
* Maxillary lateral incisors with pathology and restorations
* Missing teeth other than third molars
* Patients with anterior crossbite DEVICE: Corresponding treatment order in the prescription with Align Technology, DEVICE: Superimposition of final and initial positions of lateral incisors: Predicted model, DEVICE: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners, DEVICE: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm aligners, DEVICE: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm aligners
Orthodontic Appliance Complication
Extrusion of Maxillary Lateral Incisors, Clear Aligner Attachment
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Alexis Catalano - (catalanoam2@vcu.edu) Steven Lindauer - (sjlindau@vcu.edu) |
An Observational Research Study to Uncover Subtypes of Cancer Cachexia (LOTUS-CC)
Ashley Mack, MS - URCC_22063@urmc.rochester.edu
NCT06073431
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Inclusion Criteria:
* Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer
* Note: Patients do not need to have cachexia to be eligible
* Plan to start first-line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, interventional clinical trial) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.
* NOTE: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant treatment and have since recurred are still eligible if such treatment ended \> 6 months prior to enrollment. Patients receiving concurrent radiation with systemic therapy or received local therapy alone (surgery, radiation therapy \[RT\]) prior to first line therapy remain eligible. Patients receiving maintenance treatment after first line therapy are not eligible
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Be able to understand, speak and read English
* Be 18 years of age or older
Exclusion Criteria:
* Have contraindications to physical function assessments (30-second arm curl, Timed-Up-And-Go test, or 30-second chair-stand test) per the treating provider or their designee
* Have any planned major surgeries within the next 3 months
* Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer
* Be pregnant PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, OTHER: Electronic Medical Record, OTHER: Medical Device Usage and Evaluation, OTHER: Physical Performance Testing, PROCEDURE: Positron Emission Tomography, OTHER: Survey Administration
Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Pancreatic Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Colorectal Carcinoma, Unresectable Lung Non-Small Cell Carcinoma, Unresectable Pancreatic Adenocarcinoma
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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) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Oak Lawn Oak Lawn, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Armes Family Cancer Center Findlay, 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 Health Center - Greenfield Greenfield, Wisconsin | Site Public Contact - (ncorp@aah.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 | |
| 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) |
| Blanchard Valley Hospital Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Boulder Community Foothills Hospital Boulder, Colorado | Site Public Contact - (info@westernstatesncorp.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 Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Christiana Care - Union Hospital Elkton, Maryland | Site Public Contact - (frank.crum@christianacare.org) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Colorado Blood Cancer Institute Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dayton Physician LLC - Englewood Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC - Troy Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Atrium Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dickinson County Healthcare System Iron Mountain, Michigan | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Northland Medical Center Princeton, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Greater Dayton Cancer Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| HSHS Sacred Heart Hospital Eau Claire, Wisconsin | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| 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) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| John B Amos Cancer Center Columbus, Georgia | Site Public Contact - (cdean@iacthealth.com) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kettering Medical Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia | Site Public Contact - (underberga@sjchs.org) |
| Marietta Memorial Hospital Marietta, Ohio | Site Public Contact - (Jeffh@columbusccop.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) |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northeast Georgia Medical Center Braselton Braselton, Georgia | Site Public Contact - (cancerpatient.navigator@nghs.com) |
| Northeast Georgia Medical Center-Gainesville Gainesville, Georgia | Site Public Contact - (cancerpatient.navigator@nghs.com) |
| Northside Hospital Atlanta, Georgia | Site Public Contact - (ClinicalTrials@northside.com) |
| Northside Hospital - Duluth Duluth, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northside Hospital - Gwinnett Lawrenceville, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| PeaceHealth Saint John Medical Center Longview, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | |
| PeaceHealth Southwest Medical Center Vancouver, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Cancer Center - Pearlridge ‘Aiea, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reid Health Richmond, Indiana | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rocky Mountain Cancer Centers - Centennial Centennial, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers - Swedish Englewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Aurora Aurora, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Boulder Boulder, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Littleton Littleton, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Midtown Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Rose Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Thornton Thornton, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Saint Elizabeth Boardman Hospital Boardman, Ohio | |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
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| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Warren Hospital Warren, Ohio | |
| Saint Joseph's/Candler - Bluffton Campus Bluffton, South Carolina | Site Public Contact - (underberga@sjchs.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 Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Shenandoah Oncology PC Winchester, Virginia | Site Public Contact - (William.Houck@usoncology.com) |
| South Carolina Cancer Specialists PC Hilton Head Island, South Carolina | Site Public Contact - (underberga@sjchs.org) |
| South Georgia Medical Center/Pearlman Cancer Center Valdosta, Georgia | Site Public Contact - (maryann.heddon@sgmc.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
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| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
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| The Longstreet Clinic - Gainesville Gainesville, Georgia | |
| The Melanoma and Skin Cancer Institute Englewood, Colorado | Site Public Contact - (ryan.weight@theskincancerinstitute.com) |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | Site Public Contact - (rohta@queens.org) |
| The Women's Imaging Center Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Tift Regional Medical Center Tifton, Georgia | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Valley Radiation Oncology Peru, Illinois | |
| 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) |
| Wayne Hospital Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
Toll Free Number - Trialsites@msd.com
PHASE3
NCT03486873
Show full eligibility criteria
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Inclusion Criteria:
* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.
* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.
Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:
* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Demonstrates adequate organ function.
* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \>30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.
Additional eligibility criteria for participants who enter dosing with Lenvatinib:
* Adequately controlled blood pressure (BP) to \<150/90 mmHg, with or without antihypertensive medications.
* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.
* Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.
Exclusion Criteria:
-There are no exclusion criteria to participate in MK-3475-587.
Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:
* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.
* Has a 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 to the Cycle 1 Day 1 of Second Course Phase.
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
* Has known active central nervous system metastases and/or carcinomatous meningitis.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., 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) is not considered a form of systemic treatment and is allowed.
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.
* Has an active infection requiring systemic therapy.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
* Has hepatic decompensation (Child-Pugh score \>6 \[class B and C\]).
* Has uncontrolled thyroid dysfunction.
* Has uncontrolled diabetes mellitus.
* Has had an allogeneic tissue/solid organ transplant.
* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
Additional exclusion criteria for participants who enter dosing with Lenvatinib:
* Has had major surgery within 3 weeks prior to first dose of study intervention(s).
* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
* Has urine protein ≥1 g/24 hours.
* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.
* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \>480 ms.
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib. DRUG: Pembrolizumab, DRUG: Standard of Care (SOC), DRUG: Lenvatinib, DRUG: Olaparib, DRUG: MK-4280, BIOLOGICAL: MK-4280A
Solid Tumors, Hematologic Malignancies
PD1, PD-1, PDL1, PD-L1
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Show 675 locations
Study Locations
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| Location | Contacts |
|---|---|
| A. C. Camargo Cancer Center ( Site 1002) São Paulo, | |
| AO Santa Maria della Misericordia-Oncology Department ( Site 1971) Perugia, Umbria | |
| AZ Maria Middelares ( Site 2908) Ghent, Oost-Vlaanderen | |
| AZ Sint-Maarten ( Site 2904) Mechelen, Antwerpen | |
| Aberdeen Royal Infirmary-Department of Oncology ( Site 0521) Aberdeen, Aberdeen City | |
| Acibadem Adana Hospital-Pediatric Hematology-Oncology ( Site 1312) Adana, | |
| Acibadem Altunizade Hospital-Oncology ( Site 1317) Üsküdar /Istanbul, Istanbul | |
| Acibadem Universitesi Atakent Hastanesi ( Site 1319) Istanbul, | |
| Acıbadem Maslak Hastanesi-Medical Oncology ( Site 1321) Istanbul, | |
| Ad-Vance Medical Research-Research ( Site 1151) Ponce, | |
| Adana Sehir Egitim ve Arastirma Hastanesi ( Site 1324) Adana, | |
| Addenbrookes Hospital ( Site 0522) Cambridge, Cambridgeshire | |
| Administradora Country S.A. ( Site 2701) Bogotá, Bogota D.C. | |
| Aichi Cancer Center ( Site 3101) Nagoya, Aichi-ken | |
| Akdeniz Universitesi Hastanesi-Medical Onkology ( Site 1318) Antalya, | |
| Almazov National Medical Research Centre ( Site 1233) Saint Petersburg, Sankt-Peterburg | |
| Altai Regional Clinical Oncology Center ( Site 1229) Barnaul, Altayskiy Kray | |
| Ambroise Pare Hopital ( Site 2503) Boulogne, Hauts-de-Seine | |
| Amsterdam UMC, locatie VUmc ( Site 1555) Amsterdam, North Holland | |
| Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 3480) Hefei, Anhui | |
| Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 3487) Hefei, Anhui | |
| Ankara City Hospital-Medical Oncology ( Site 1311) Ankara, | |
| Ankara University Hospital Cebeci ( Site 1306) Ankara, | |
| Antoni van Leeuwenhoek Ziekenhuis ( Site 1551) Amsterdam, North Holland | |
| Arizona Cancer Center at UMC North ( Site 0018) Tucson, Arizona | |
| Army Medical Center of People's Liberation Army-Oncology Department ( Site 3477) Chongqing, Chongqing Municipality | |
| Arthur J.E. Child Comprehensive Cancer Centre ( Site 2815) Calgary, Alberta | |
| Asan Medical Center ( Site 0952) Songpagu, Seoul | |
| Asklepion Medical Center ( Site 3667) Khodosovka, Kyivska Oblast | |
| Auckland City Hospital ( Site 1503) Auckland, | |
| Augusta University ( Site 0077) Augusta, Georgia | |
| Austin Health-Austin Hospital ( Site 3004) Heidelberg, Victoria | |
| Avix Investigación Clinica, S.C.-Oncology ( Site 1104) Monterrey, Nuevo León | |
| Azienda Ospedaliera San Camillo Forlanini ( Site 1958) Roma, | |
| Azienda Ospedaliera San Gerardo ( Site 1980) Monza, Lombardy | |
| Azienda Ospedaliera Santa Maria ( Site 1962) Terni, | |
| Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 1972) Brescia, | |
| Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 1964) Parma, | |
| Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1974) Torino, | |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-UOC Oncologia ( Site 1967) Bergamo, | |
| BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 1030) São Paulo, | |
| Ballarat Oncology & Haematology Services ( Site 3022) Wendouree, Victoria | |
| Baptist MD Anderson Cancer Center ( Site 0083) Jacksonville, Florida | |
| Barts Health NHS Trust ( Site 0512) London, London, City of | |
| Bashkir State Medical University ( Site 1221) Ufa, Baskortostan, Respublika | |
| Baskent Universitesi Ankara Hastanesi ( Site 1303) Ankara, | |
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1307) Adana, | |
| Beijing Cancer Hospital ( Site 3451) Beijing, Beijing Municipality | |
| Beijing Cancer Hospital ( Site 3499) Beijing, Beijing Municipality | |
| Beijing Cancer Hospital ( Site 3500) Beijing, Beijing Municipality | |
| Beijing Cancer hospital-Thoracic Cancer Department A ( Site 3454) Beijing, Beijing Municipality | |
| Belfast City Hospital ( Site 0508) Belfast, Northern Ireland | |
| Belgorod Oncology Dispensary ( Site 1213) Belgorod, Belgorod Oblast | |
| Bezmialem Vakf Üniversitesi-Oncology ( Site 1308) Istanbul, | |
| Bialostockie Centrum Onkologii ( Site 1610) Bialystok, Podlaskie Voivodeship | |
| Blod och Tumorssjukdomar. Akademiska sjukhuset ( Site 0801) Uppsala, Uppsala County | |
| Blue Ridge Cancer Care ( Site 0067) Roanoke, Virginia | |
| Bnai Zion Medical Center ( Site 2060) Haifa, | |
| Bon Secours St. Francis Medical Center-Oncology Research ( Site 0075) Midlothian, Virginia | |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 1409) Miskolc, Borsod-Abauj Zemplen county | |
| Bradfordhill-Clinical Area ( Site 2756) Santiago, Region M. de Santiago | |
| Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1405) Gyula, Bekes County | |
| C.H.U. Pontchaillou ( Site 2511) Pierre-Bénite, Rhone | |
| C.H.U. de Tours - Hopital Bretonneau ( Site 2515) Tours, Indre-et-Loire | |
| CEPON ( Site 1012) Florianópolis, Santa Catarina | |
| CH Lyon Sud Hospices Civils de Lyon ( Site 2521) Pierre-Bénite, Rhone-Alpes | |
| CHA Bundang Medical Center CHA University ( Site 0957) Seongnam-si, Kyonggi-do | |
| CHRU Brest - Hopital Cavale Blanche ( Site 2504) Brest, Finistere | |
| CHRU Lille Hospital Claude Huriez ( Site 2506) Lille, Nord | |
| CHU Bordeaux Haut-Leveque ( Site 2534) Pessac, Aquitaine | |
| CHU Hopital Saint Antoine ( Site 2517) Paris, | |
| CHU Jean Minjoz ( Site 2520) Besançon, Doubs | |
| CHU La Timone ( Site 2508) Marseille, Bouches-du-Rhone | |
| CHU Toulouse - Hopital Rangueil ( Site 2518) Toulouse, Haute-Garonne | |
| CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 2526) Toulouse, Haute-Garonne | |
| CHU-Jean Minjoz ( Site 2550) Besançon, Doubs | |
| CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0876) Santiago de Compostela, La Coruna | |
| CIMCA ( Site 3900) San José, | |
| CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1024) Fortaleza, Ceará | |
| California Cancer Associates for Research & Excellence ( Site 0016) Fresno, California | |
| Calvary Mater Newcastle ( Site 3005) Waratah, New South Wales | |
| Cancer Institute Hospital of JFCR ( Site 3108) Tokyo, | |
| Cancer Institute Hospital of JFCR ( Site 3146) Koto, Tokyo | |
| Cancer Institute Hospital of JFCR ( Site 3164) Koto, Tokyo | |
| Cancer Institute of New Jersey ( Site 0025) New Brunswick, New Jersey | |
| CancerCare Manitoba ( Site 2814) Winnipeg, Manitoba | |
| Canterbury Regional Cancer & Blood Service ( Site 1500) Christchurch, Canterbury | |
| Cape Town Oncology Trials ( Site 2007) Cape Town, Western Cape | |
| Capital & Coast District Health Board - Wellington Hospital ( Site 1501) Wellington, | |
| Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2525) Rennes, Ille-et-Vilaine | |
| Centre Georges François Leclerc-Centre de recherche clinique ( Site 2536) Dijon, Cote-d Or | |
| Centre Henri Becquerel ( Site 2547) Rouen, Seine-Maritime | |
| Centre Hopitalar Leon-Berard ( Site 2519) Lyon, Auvergne | |
| Centre Hopitalier Intercommunal Creteil ( Site 2514) Créteil, Val-de-Marne | |
| Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 2539) Nice, Alpes-Maritimes | |
| Centre Hospitalier Universitaire de Poitiers-Dermatologie ( Site 2544) Poitiers, Vienne | |
| Centre Hospitalier de l Universite de Montreal - CHUM ( Site 2807) Montreal, Quebec | |
| Centre Hospitalier du Mans-Pneumologie ( Site 2527) Le Mans, Sarthe | |
| Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava ( Site 2810) Laval, Quebec | |
| Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre-Oncology ( Site 2809) Greenfield Park, Quebec | |
| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 2542) Clermont-Ferrand, Puy-de-Dome | |
| Centre Oscar Lambret ( Site 2551) Lille, Hauts-de-France | |
| Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 2816) Trois-Rivières, Quebec | |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 2805) Québec, Quebec | |
| Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 2812) Sherbrooke, Quebec | |
| Centro Hospitalar de Sao Joao - Hospital de Sao Joao ( Site 1752) Porto, | |
| Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, ( Site 0869) Madrid, | |
| Centro Medico Privado CEMAIC ( Site 1371) Córdoba, | |
| Centro Medico San Roque-Oncology ( Site 1352) San Miguel de Tucumán, | |
| Centro de Investigaciones ( Site 2755) Viña del Mar, Región de Valparaíso | |
| Centro de Oncología e Investigación de Buenos Aires ( Site 1357) Berazategui, Buenos Aires | |
| Centro de Pesquisa Clínica do Instituto do Câncer do Ceará ( Site 1016) Fortaleza, Ceará | |
| Centro de Urologa Avanzada del Noreste ( Site 1110) San Pedro Garza García, Nuevo León | |
| Centrul de Oncologie "Sfântul Nectarie" ( Site 3552) Craiova, Dolj | |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1612) Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Chaim Sheba Medical Center ( Site 2055) Ramat Gan, | |
| Chaim Sheba Medical Center. ( Site 2052) Ramat Gan, | |
| Champalimaud Foundation ( Site 1751) Lisbon, Lisbon District | |
| Chang Gung Medical Foundation-Linkou Branch ( Site 3206) Taoyuan District, | |
| Chiba Cancer Center ( Site 3117) Chiba, | |
| China Medical University Hospital ( Site 3204) Taichung, | |
| Chinese Academy of medical science, Peking Union Medical College Hospital(Dongdan) ( Site 3466) Beijing, Beijing Municipality | |
| Chonnam National University Hwasun Hospital-Hemato-Oncology ( Site 0959) Hwasun, Jeonranamdo | |
| Chris OBrien Lifehouse ( Site 3003) Camperdown, New South Wales | |
| Chulalongkorn University ( Site 2363) Bangkok, Bangkok | |
| Chungbuk National University Hospital ( Site 0961) Cheongju-si, North Chungcheong | |
| Chungnam national university hospital-Department of Internal Medicine ( Site 0958) Daejeon, Taejon-Kwangyokshi | |
| City Clinical Oncology Center ( Site 1237) Saint Petersburg, Sankt-Peterburg | |
| Clinica Universitaria de Navarra ( Site 0855) Madrid, | |
| Clinica Viedma ( Site 1353) Viedma, Río Negro Province | |
| Clinica Viver ( Site 1021) Santa Maria, Rio Grande do Sul | |
| Clinica de la Costa S.A.S. ( Site 2705) Barranquilla, Atlántico | |
| Clinical Research Center of specialized types medical care-Oncology ( Site 1205) Saint Petersburg, Sankt-Peterburg | |
| Clinique de L'Europe ( Site 2548) Amiens, Somme | |
| Cliniques Universitaires de Bruxelles - CUB - Hopital Erasme ( Site 2905) Brussels, Bruxelles-Capitale, Region de | |
| Cliniques universitaires Saint-Luc-Medical Oncology ( Site 2911) Brussels, Bruxelles-Capitale, Region de | |
| Clínica Imbanaco S.A.S ( Site 2708) Santiago de Cali, Valle del Cauca Department | |
| Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA ( Site 1017) São Paulo, São Paulo | |
| Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 3663) Ivano-Frankivsk, Ivano-Frankivsk Oblast | |
| Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 3662) Vinnytsia, Vinnytsia Oblast | |
| Complejo Hospitalario de Jaén-Servicio de Oncología Médica ( Site 0879) Jaén, | |
| Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 0054) Bakersfield, California | |
| Comprehensive Cancer Centers of Nevada ( Site 0043) Las Vegas, Nevada | |
| Cross Cancer Institute ( Site 2804) Edmonton, Alberta | |
| Dana-Farber Cancer Institute ( Site 0006) Boston, Massachusetts | |
| Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 1415) Debrecen, | |
| Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1412) Debrecen, | |
| Dokkyo Medical University Saitama Medical Center ( Site 3152) Koshigaya, Saitama | |
| Dokuz Eylul Universitesi Hastanesi ( Site 1323) Izmir, | |
| Duke Cancer Center ( Site 0028) Durham, North Carolina | |
| Ege Universitesi Tip Fakultesi Hastanesi ( Site 1300) Izmir, | |
| Ehime University Hospital ( Site 3158) Tōon, Ehime | |
| Elbe Klinikum Buxtehude ( Site 2400) Buxtehude, Lower Saxony | |
| Emory School of Medicine ( Site 0013) Atlanta, Georgia | |
| Erasmus MC ( Site 1553) Rotterdam, South Holland | |
| EuroCityClinic ( Site 1230) Saint Petersburg, Sankt-Peterburg | |
| European Interbalkan Medical Center ( Site 1855) Thessaloniki, | |
| FDI Clinical Research ( Site 1152) San Juan, | |
| FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 1208) Moscow, Moscow | |
| FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 1234) Moscow, Moscow | |
| Facharztzentrum Eppendorf ( Site 2415) Hamburg, | |
| Faculty of Medicine - Khon Kaen University ( Site 2366) Muang, Changwat Khon Kaen | |
| Faculty of Medicine Siriraj Hospital ( Site 2365) Bangkok, Bangkok | |
| Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0702) Prague, Praha 4 | |
| Fakultni nemocnice Olomouc ( Site 0701) Olomouc, | |
| Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0704) Olomouc, Olomoucký kraj | |
| Fakultni nemocnice v Motole ( Site 0700) Prague, | |
| Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0705) Prague, Praha 5 | |
| Farkasgyepui Tudogyogyintezet-Pulmonologia ( Site 1414) Farkasgyepű, Veszprém megye | |
| Fejér Megyei Szent György Egyetemi Oktató Kórház-l.Pulmonologia ( Site 1407) Székesfehérvár, Fejér | |
| First Pavlov State Medical University of Saint Petersburg ( Site 1232) Saint Petersburg, Sankt-Peterburg | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1977) Milan, Lombardy | |
| Fondazione IRCCS Policlinico San Matteo ( Site 1982) Pavia, | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1975) Rome, Lazio | |
| Fox Chase Cancer Center ( Site 0042) Philadelphia, Pennsylvania | |
| Fred Hutchinson Cancer Center ( Site 0024) Seattle, Washington | |
| Fudan University Shanghai Cancer Center ( Site 3467) Shanghai, Shanghai Municipality | |
| Fujian Provincial Cancer Hospital ( Site 3461) Fuzhou, Fujian | |
| Fundacion Arturo Lopez Perez FALP ( Site 2750) Santiago, Region M. de Santiago | |
| Fundacion Colombiana de Cancerología Clinica Vida ( Site 2707) Medellín, Antioquia | |
| Fundacion Estudios Clinicos ( Site 1369) Rosario, Santa Fe Province | |
| Fundacion Favaloro ( Site 1367) CABA, Buenos Aires | |
| Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1358) La Rioja, | |
| Fundación Valle del Lili ( Site 2700) Santiago de Cali, Valle del Cauca Department | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site 1003) São José do Rio Preto, São Paulo | |
| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1010) Barretos, São Paulo | |
| GBUZ LOKB ( Site 1218) Saint-Petersburg, Leningradskaya Oblast' | |
| GBUZ LOKB-Oncology department #1 ( Site 1222) Saint-Petersburg, Leningradskaya Oblast' | |
| GBUZ SK Pyatigorsk Interdistrict Oncology dispensary ( Site 1223) Pyatigorsk, Stavropol Kray | |
| GVI Oncology ( Site 2008) George, Western Cape | |
| Gachon University Gil Medical Center ( Site 0967) Inceon, Incheon | |
| Gallipoli Medical Research Ltd ( Site 3011) Brisbane, Queensland | |
| Gangnam Severance Hospital, Yonsei University Health System ( Site 0966) Gangnam-gu, Seoul | |
| Gazi University Health Research and Application Center Gazi Hospital ( Site 1325) Ankara, | |
| General Hospital of Athens "Laiko"-Hematology Department ( Site 1851) Athens, Attica | |
| Georgetown University Medical Center ( Site 0023) Washington D.C., District of Columbia | |
| Gifu University Hospital ( Site 3161) Gifu, | |
| Gleneagles Penang ( Site 0625) George Town, Pulau Pinang | |
| Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 2545) Paris, | |
| Groupe hospitalier Paris saint Joseph-Service de Pneumologie-Allergologie -Oncologie Thoracique ( Site 2533) Paris, Île-de-France Region | |
| Grupo Medico Angeles ( Site 3402) Guatemala City, | |
| Guangdong Provincial People's Hospital-Cancer Center ( Site 3462) Guangzhou, Guangdong | |
| H. Marques de Valdecilla ( Site 0865) Santander, Cantabria | |
| H.R.U Malaga - Hospital General ( Site 0884) Málaga, Malaga | |
| H.U. Vall de Hebron ( Site 0850) Barcelona, | |
| HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0872) Seville, | |
| Hacettepe Universitesi-oncology hospital ( Site 1304) Ankara, | |
| Hadassah Ein Kerem Medical Center ( Site 2051) Jerusalem, | |
| Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2801) Hamilton, Ontario | |
| Hangzhou Cancer Hospital-Medical Oncology ( Site 3468) Hangzhou, Zhejiang | |
| Harbin Medical University Cancer Hospital ( Site 3506) Harbin, Heilongjiang | |
| Harbin Medical University Cancer Hospital-Harbin Medical University Cancer Hospital ( Site 3475) Harbin, Heilongjiang | |
| Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 2418) Berlin, | |
| Helse Bergen Haukeland universitetssykehus ( Site 1451) Bergen, Vestfold | |
| Henan Cancer Hospital ( Site 3488) Zhengzhou, Henan | |
| Hiroshima City Hiroshima Citizens Hospital ( Site 3119) Hiroshima, | |
| Hiroshima University Hospital ( Site 3154) Hiroshima, | |
| Hokkaido University Hospital ( Site 3165) Sapporo, Hokkaido | |
| Holy Cross Hospital, Michael & Dianne Bienes Comp Cancer Ctr ( Site 0022) Fort Lauderdale, Florida | |
| Hopital Cochin ( Site 2509) Paris, | |
| Hopital Nord ( Site 2516) Marseille, Bouches-du-Rhone | |
| Hopital Saint Louis ( Site 2510) Paris, | |
| Hopital Trousseau ( Site 2512) Chambray-lès-Tours, Indre-et-Loire | |
| Hospital Aleman-Oncology ( Site 1351) Buenos Aires, | |
| Hospital Amaral Carvalho ( Site 1023) Jaú, São Paulo | |
| Hospital Arnau de Vilanova ( Site 0866) Valencia, Valenciana, Comunitat | |
| Hospital Cayetano Heredia-Oncology ( Site 0675) Lima, | |
| Hospital Clinic de Barcelona ( Site 0852) Barcelona, Catalonia | |
| Hospital Clinico San Carlos ( Site 0857) Madrid, | |
| Hospital Clinico Universitario Lozano Blesa ( Site 0859) Zaragoza, | |
| Hospital Clinico de Valencia ( Site 0858) Valencia, Valenciana, Comunitat | |
| Hospital General Universitario 12 de Octubre ( Site 0856) Madrid, | |
| Hospital General Universitario de Alicante-Oncologia ( Site 0881) Alicante, | |
| Hospital General Universitario de Valencia ( Site 0854) Valencia, Valenciana, Comunitat | |
| Hospital Nossa Senhora da Conceição ( Site 1011) Porto Alegre, Rio Grande do Sul | |
| Hospital Privado Universitario de Córdoba ( Site 1354) Córdoba, | |
| Hospital Provincial del Centenario ( Site 1359) Rosario, Santa Fe Province | |
| Hospital Son Llatzer ( Site 0886) Palma de Mallorca, Balearic Islands | |
| Hospital São Carlos-Oncocentro Ce ( Site 1029) Fortaleza, Ceará | |
| Hospital São Lucas da PUCRS-Centro de Pesquisa em Oncologia ( Site 1006) Porto Alegre, Rio Grande do Sul | |
| Hospital Tengku Ampuan Afzan ( Site 0627) Kuantan, Pahang | |
| Hospital Universitari Sant Joan de Reus-Oncology ( Site 0874) Reus, Tarragona | |
| Hospital Universitari Son Espases-Oncologia ( Site 0883) Palma, Balearic Islands | |
| Hospital Universitari i Politecnic La Fe ( Site 0875) Valencia, Valencia | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 1113) Monterrey, Nuevo León | |
| Hospital Universitario Central de Asturias-Medical Oncology ( Site 0870) Oviedo, Principality of Asturias | |
| Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0871) Madrid, | |
| Hospital Universitario Gregorio Maranon ( Site 0864) Madrid, | |
| Hospital Universitario Insular de Gran Canaria ( Site 0867) Las Palmas de Gran Canaria, Las Palmas | |
| Hospital Universitario La Paz ( Site 0853) Madrid, | |
| Hospital Universitario Puerta de Hierro-Majadahonda ( Site 0861) Majadahonda, Madrid | |
| Hospital Universitario Quiron Madrid ( Site 0868) Pozuelo de Alarcón, Madrid | |
| Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0877) Madrid, Madrid, Comunidad de | |
| Hospital Universitario Reina Sofia ( Site 0885) Córdoba, | |
| Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 0880) Seville, | |
| Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 0882) Seville, | |
| Hospital Universitario Virgen de la Victoria ( Site 0878) Málaga, Andalusia | |
| Hospital de Clinicas de Porto Alegre ( Site 1000) Porto Alegre, Rio Grande do Sul | |
| Hospital de Clínicas de Passo Fundo ( Site 1025) Passo Fundo, Rio Grande do Sul | |
| Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 0862) Barcelona, Catalonia | |
| Humanitas Gavazzeni ( Site 1954) Bergamo, | |
| Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1968) Rozzano, Milano | |
| Hunan Cancer Hospital ( Site 3485) Changsha, Hunan | |
| Hunan Cancer Hospital ( Site 3501) Changsha, Hunan | |
| Hyogo Cancer Center ( Site 3131) Akashi, Hyōgo | |
| Hyogo Medical University Hospital ( Site 3100) Nishinomiya, Hyōgo | |
| Hôpital Avicenne-Dermatologie ( Site 2538) Bobigny, Seine-Saint-Denis | |
| Hôpital Beaujon ( Site 2524) Clichy, Île-de-France Region | |
| Hôpital Foch ( Site 2543) Suresnes, Hauts-de-Seine | |
| Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes-lung oncology ( Site 2546) Saint-Herblain, Loire-Atlantique | |
| Hôpital Privé Clairval ( Site 2549) Marseille, Bouches-du-Rhone | |
| Hôpital Tenon ( Site 2530) Paris, | |
| Hôpital Universitaire Paul Brousse ( Site 2541) Villejuif, Val-de-Marne | |
| Hôpitaux Universitaires de Genève (HUG) ( Site 0753) Geneva, Canton of Geneva | |
| I.E.U. Medical Point Hastanesi-Oncology ( Site 1310) Izmir, | |
| IDIM - Instituto de Investigaciones Metabólicas ( Site 1362) Ciudad de Buenos Aires, Buenos Aires | |
| IMAT S.A.S ( Site 2703) Montería, Departamento de Córdoba | |
| INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1102) Mexico City, Mexico City | |
| INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0681) Lima, | |
| IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0678) Lima, | |
| IRCCS A.O.U. San Martino - IST ( Site 1961) Genova, | |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1978) Bologna, Emilia-Romagna | |
| IRCCS CRO Aviano, Hematology/Oncology ( Site 1957) Aviano, Pordenone | |
| Ibaraki Prefectural Central Hospital ( Site 3180) Kasama, Ibaraki | |
| Inonu Universitesi ( Site 1309) Malatya, | |
| Institut Bergonie ( Site 2502) Bordeaux, Gironde | |
| Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0851) Badalona, Catalonia | |
| Institut Gustave Roussy ( Site 2513) Villejuif, Île-de-France Region | |
| Institut Jules Bordet ( Site 2903) Anderlecht, Bruxelles-Capitale, Region de | |
| Institut de Cancérologie de Lorraine Alexis Vautrin ( Site 2532) Vandœuvre-lès-Nancy, Lorraine | |
| Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 2522) Saint-Herblain, Loire-Atlantique | |
| Institute of Science Tokyo Hospital ( Site 3149) Bunkyō, Tokyo | |
| Instituto Alexander Fleming ( Site 1364) Ciudad Autónoma de Buenos Aires, Buenos Aires | |
| Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0860) L'Hospitalet de Llobregat, Barcelona | |
| Instituto Nacional De Cancerologia-Oncología Clínica ( Site 2706) Bogota, Cundinamarca | |
| Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 1020) Rio de Janeiro, | |
| Instituto Nacional del Cancer-CR Investigación ( Site 2753) Santiago, Region M. de Santiago | |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE-Oncologia Médica ( Site 1753) Porto, | |
| Instituto San Marcos ( Site 1366) San Juan, | |
| Instituto Valenciano de Oncologia - IVO ( Site 0863) Valencia, Valenciana, Comunitat | |
| Instituto de Cancerología-Oncology ( Site 2702) Medellín, Antioquia | |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 1363) Mar del Plata, Buenos Aires | |
| Instituto de Oncologia de Rosario ( Site 1350) Rosario, Santa Fe Province | |
| Instituto de de Educação, pesquisa e Gestão em Saúde ( Site 1014) Rio de Janeiro, | |
| Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1001) São Paulo, | |
| Institutul Oncologic "Prof. Dr. Ioan Chiricuta" ( Site 3551) Cluj-Napoca, | |
| Instytut Centrum Zdrowia Matki Polki-Klinika Onkologii ( Site 1609) Lodz, Łódź Voivodeship | |
| Investigación Oncofarmacéutica-Investigación clínica ( Site 1114) La Paz, Baja California Sur | |
| Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302) Istanbul, | |
| Istanbul University Capa Campus ( Site 1314) Istanbul, | |
| Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 1963) Rome, Lazio | |
| Istituto Europeo di Oncologia ( Site 1952) Milan, | |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1955) Napoli, | |
| Istituto Oncologico Veneto IRCCS ( Site 1976) Padua, Veneto | |
| Istituto di Candiolo - IRCCS ( Site 1960) Candiolo, Torino | |
| Iwate Medical University Hospital ( Site 3157) Shiwa-gun, Iwate | |
| James Graham Brown Cancer Center ( Site 0058) Louisville, Kentucky | |
| James Lind Centro de Investigacion del Cancer ( Site 2757) Temuco, Región de la Araucanía | |
| Jewish General Hospital ( Site 2800) Montreal, Quebec | |
| Jiangsu Cancer Hospital-Medical Oncotherapy ( Site 3469) Nanjing, Jiangsu | |
| Jichi Medical University Hospital ( Site 3141) Shimotsuke, Tochigi | |
| Jilin Province Tumor Hospital ( Site 3484) Changchun, Jilin | |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0038) Hackensack, New Jersey | |
| Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1401) Szolnok, Jász-Nagykun-Szolnok | |
| Kagawa University Hospital ( Site 3171) Kita, Kagawa-ken | |
| Kaiser Permanente Moanalua Medical Center ( Site 0063) Honolulu, Hawaii | |
| Kanagawa Cancer Center ( Site 3137) Yokohama, Kanagawa | |
| Kanazawa University Hospital ( Site 3140) Kanazawa, Ishikawa-ken | |
| Kansai Medical University Hospital ( Site 3126) Hirakata, Osaka | |
| Kaohsiung Chang Gung Memorial Hospital ( Site 3203) Kaohsiung City, | |
| Karmanos Cancer Institute ( Site 0047) Detroit, Michigan | |
| Karolinska Universitetssjukhuset Solna ( Site 0802) Stockholm, Stockholm County | |
| Keimyung University Dongsan Hospital CRC room 1 ( Site 0960) Daegu, Taegu-Kwangyokshi | |
| Keio University Hospital ( Site 3127) Tokyo, | |
| Kepler Universitätsklinikum ( Site 2955) Linz, Upper Austria | |
| Kindai University Hospital ( Site 3102) Sayama, Osaka | |
| Kindai University Hospital ( Site 3135) Sayama, Osaka | |
| Kindai University Hospital ( Site 3166) Sayama, Osaka | |
| Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2808) Kingston, Ontario | |
| Kitasato University Hospital ( Site 3142) Sagamihara, Kanagawa | |
| Klaipeda University Hospital-Oncology chemotherapy ( Site 3302) Klaipėda, Klaipedos Miestas | |
| Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2954) Vienna, | |
| Kobe City Medical Center General Hospital ( Site 3144) Kobe, Hyōgo | |
| Kocaeli Üniversitesi ( Site 1313) Kocaeli, | |
| Kochi Health Sciences Center ( Site 3145) Kochi, | |
| Koo Foundation Sun Yat-Sen Cancer Center-Gynecology, Obstetrics, and women's health ( Site 3207) Taipei, | |
| Korea University Anam Hospital ( Site 0956) Seoul, | |
| Korea University Guro Hospital ( Site 0963) Seoul, | |
| Krankenhaus Nordwest ( Site 2409) Frankfurt am Main, Hesse | |
| Kumamoto University Hospital ( Site 3179) Kumamoto, | |
| Kurashiki Central Hospital ( Site 3132) Kurashiki, Okayama-ken | |
| Kurume University Hospital ( Site 3105) Kurume, Fukuoka | |
| Kyorin University Hospital ( Site 3103) Mitaka, Tokyo | |
| Kyorin University Hospital ( Site 3147) Mitaka-shi, Tokyo | |
| Kyoto University Hospital ( Site 3181) Kyoto, | |
| Kyungpook National University Chilgok Hospital ( Site 0964) Deagu, Taegu-Kwangyokshi | |
| Kyushu University Hospital ( Site 3143) Fukuoka, | |
| Kyushu University Hospital ( Site 3185) Fukuoka, | |
| LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2005) Pretoria, Gauteng | |
| Lacks - Oncologia E Hematologia ( Site 1026) Pelotas, Rio Grande do Sul | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0032) New York, New York | |
| Levine Cancer Institute ( Site 0034) Charlotte, North Carolina | |
| Liepjas reionl slimnca ( Site 3851) Liepāja, | |
| Liverpool Hospital-Medical Oncology ( Site 3021) Liverpool, New South Wales | |
| London Regional Cancer Program - LHSC ( Site 2806) London, Ontario | |
| Lung Center of the Philippines ( Site 1705) Quezon City, National Capital Region | |
| LungenClinic Grosshansdorf GmbH ( Site 2412) Großhansdorf, Schleswig-Holstein | |
| Luxmed Onkologia sp. z o. o. ( Site 1621) Warsaw, Masovian Voivodeship | |
| ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 3668) Dnipro, Dnipropetrovsk Oblast | |
| MEDI-K ( Site 3403) Guatemala City, | |
| MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 3657) Kryvyi Rih, Dnipropetrovsk Oblast | |
| MNPE Regional Center of Oncology ( Site 3665) Kharkiv, Kharkivs’ka Oblast’ | |
| Mackay Memorial Hospital ( Site 3205) Taipei, | |
| Macquarie University ( Site 3010) Macquarie University, New South Wales | |
| Makati Medical Center ( Site 1702) Makati City, National Capital Region | |
| Markusovszky Egyetemi Oktatokorhaz-Onkológiai Osztály ( Site 1410) Szombathely, Vas County | |
| Marmara Universitesi Pendik Egitim Arastirma Hastanesi-Medical Oncology ( Site 1305) Istanbul, | |
| Maryland Oncology Hematology (MOH) ( Site 8000) Columbia, Maryland | |
| Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0703) Brno, Brno-mesto | |
| Massachusetts General Hospital ( Site 0041) Boston, Massachusetts | |
| Mater Hospital Sydney ( Site 3007) North Sydney, New South Wales | |
| Mater Misercordiae University Hospital ( Site 1800) Dublin, Leinster | |
| Mater Misericordiae Limited-Medical Oncology ( Site 3019) Brisbane, Queensland | |
| Mayo Clinic in Rochester, Minnesota ( Site 0002) Rochester, Minnesota | |
| McGill University Health Centre ( Site 2818) Montreal, Quebec | |
| Med-Polonia Sp. z o. o. ( Site 1605) Poznan, Greater Poland Voivodeship | |
| MedStar Franklin Square Medical Center ( Site 0046) Baltimore, Maryland | |
| Medical Care and Research SA de CV ( Site 1103) Mérida, Yucatán | |
| Medical University of Graz ( Site 2952) Graz, Styria | |
| Medizinische Hochschule Hannover ( Site 2402) Hanover, Lower Saxony | |
| Medizinische Universitaet Innsbruck ( Site 2951) Innsbruck, Tyrol | |
| Medizinische Universität Wien ( Site 2953) Vienna, | |
| Melanoma Institute Australia ( Site 3001) Wollstonecraft, New South Wales | |
| Memorial Antalya Hospital-Oncology ( Site 1315) Antalya, | |
| Memorial Sloan Kettering Cancer Center ( Site 0012) New York, New York | |
| Mercy Health-Paducah Cancer Center ( Site 0084) Paducah, Kentucky | |
| Mid Essex Hospitals Service Trust. Broomfield Hospital ( Site 0503) Broomfield, Essex | |
| Miyagi Cancer Center ( Site 3122) Natori-shi, Miyagi | |
| Moffitt Cancer Center ( Site 0011) Tampa, Florida | |
| Monash Health ( Site 3015) Clayton, Victoria | |
| Mount Sinai Hospital ( Site 2811) Toronto, Ontario | |
| Mount Sinai Medical Center Comprehensive Cancer Center ( Site 0031) Miami Beach, Florida | |
| Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council ( Site 3650) Dnipro, Dnipropetrovsk Oblast | |
| Municipal institution of Lviv regional council Lviv Oncology-Chemotherapy ( Site 3653) Lviv, Lviv Oblast | |
| Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City ( Site 3651) Kyiv, Kyivska Oblast | |
| Municipal non-profit enterprise "Zaporizhzhia regional clinical hospital" of Zaporizhzhia regional c ( Site 3664) Zaporizhzhia, Zaporizhzhia Oblast | |
| N.N. Blokhin NMRCO ( Site 1209) Moscow, Moscow | |
| N.N.Petrov Research Institute of Oncology-Department of Preclinical and Clinical Research ( Site 1211) Saint Petersburg, Sankt-Peterburg | |
| Nagoya University Hospital ( Site 3151) Nagoya, Aichi-ken | |
| Nara Medical University Hospital ( Site 3110) Kashihara, Nara | |
| Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1620) Gliwice, Silesian Voivodeship | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 1608) Krakow, Lesser Poland Voivodeship | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1604) Warsaw, Masovian Voivodeship | |
| National Cancer Center ( Site 0955) Goyang-si, Kyonggi-do | |
| National Cancer Center Hospital ( Site 3130) Tokyo, | |
| National Cancer Center Hospital East ( Site 3121) Kashiwa, Chiba | |
| National Cancer Centre Singapore ( Site 2200) Singapore, Central Singapore | |
| National Cancer Institute-Department of Minimally Invasive and Endoscopic Surgery, Interventional R ( Site 3658) Kyiv, Kyivska Oblast | |
| National Cheng Kung University Hospital ( Site 3201) Tainan City, | |
| National Defense Medical College Hospital ( Site 3177) Tokorozawa, Saitama | |
| National Hospital Organization Himeji Medical Center ( Site 3111) Himeji, Hyōgo | |
| National Hospital Organization Hokkaido Cancer Center ( Site 3160) Sapporo, Hokkaido | |
| National Hospital Organization Kyushu Cancer Center ( Site 3169) Fukuoka, | |
| National Hospital Organization Kyushu Medical Center ( Site 3136) Fukuoka, | |
| National Hospital Organization Nagoya Medical Center ( Site 3109) Nagoya, Aichi-ken | |
| National Hospital Organization Osaka National Hospital ( Site 3162) Osaka, | |
| National Hospital Organization Shikoku Cancer Center ( Site 3116) Matsuyama, Ehime | |
| National Hospital Organization Yamaguchi Ube Medical Center ( Site 3123) Ube, Yamaguchi | |
| National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1210) Saint Petersburg, Sankt-Peterburg | |
| National Taiwan University Hospital ( Site 3200) Taipei, | |
| National University Hospital-Haematology -Oncology Research Group ( Site 2201) Singapore, South West | |
| New Cross Hospital-Department of Oncology ( Site 0517) Wolverhampton, | |
| Niigata Cancer Center Hospital ( Site 3173) Niigata, Niigata | |
| Niigata University Medical & Dental Hospital ( Site 3174) Niigata, | |
| Nippon Medical School Hospital ( Site 3139) Tokyo, | |
| Nippon Medical School Musashi Kosugi Hospital ( Site 3178) Kawasaki, Kanagawa | |
| Norrlands Universitetssjukhus ( Site 0800) Umeå, Västerbotten County | |
| Northern Jiangsu People's Hospital-General Surgery Department ( Site 3474) Yangzhou, Jiangsu | |
| Northwest Georgia Oncology Centers PC ( Site 0061) Marietta, Georgia | |
| Nottingham University Hospitals NHS Trust ( Site 0510) Nottingham, Nottinghamshire | |
| Nouvel Hôpital Civil (NHC) ( Site 2529) Strasbourg, Alsace | |
| ONCOCENTRO APYS-ACEREY ( Site 2758) Viña del Mar, Región de Valparaíso | |
| ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1008) Ijuí, Rio Grande do Sul | |
| Oaxaca Site Management Organization ( Site 1106) Oaxaca City, Oaxaca | |
| Obstetrics & Gynecology Hospital of Fudan University ( Site 3494) Shanghai, Shanghai Municipality | |
| Odense Universitetshospital ( Site 0650) Odense, Region Syddanmark | |
| Odessa Regional Oncology Center ( Site 3655) Odesa, Odesa Oblast | |
| Ogarev Mordovia State University ( Site 1206) Saransk, Mordoviya, Respublika | |
| Okayama University Hospital ( Site 3107) Okayama, | |
| Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0082) Tulsa, Oklahoma | |
| Oncare Viaducto Napoles ( Site 1107) Mexico City, | |
| Oncomedica ( Site 3401) Guatemala City, | |
| Oncovida ( Site 2759) Santiago, Region M. de Santiago | |
| Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Kosza-Klinika Onkologii z Odcinkiem Dziennym ( Site 1616) Opole, Opole Voivodeship | |
| Orange Hospital-Clinical Trials Unit ( Site 3027) Orange, New South Wales | |
| Orlandi Oncologia-Oncology ( Site 2752) Santiago, Region M. de Santiago | |
| Orszagos Koranyi Pulmonologiai Intezet ( Site 1403) Budapest, | |
| Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1411) Budapest, Pest County | |
| Osaka City General Hospital ( Site 3125) Osaka, | |
| Osaka General Medical Center ( Site 3184) Osaka, | |
| Osaka Habikino Medical Center ( Site 3138) Habikino, Osaka | |
| Osaka International Cancer Institute ( Site 3129) Chuo-ku, Osaka | |
| Osaka Medical and Pharmaceutical University Hospital ( Site 3167) Takatsuki, Osaka | |
| Osaka Rosai Hospital ( Site 3148) Sakai, Osaka | |
| Oslo Universitetssykehus Radiumhospitalet ( Site 1450) Oslo, | |
| Oslo universitetssykehus, Radiumhospitalet ( Site 1452) Oslo, | |
| Ospedale Cannizzaro ( Site 1981) Catania, Sicily | |
| Ospedale San Luigi Gonzaga ( Site 1956) Orbassano, Torino | |
| Ospedale San Raffaele. ( Site 1979) Milan, | |
| P. A. Hertsen Moscow Oncology Research Center ( Site 1214) Moscow, Moscow | |
| Pantai Hospital Kuala Lumpur ( Site 0628) Kuala Lumpur, | |
| Parc de Salut Mar - Hospital del Mar-Oncologia ( Site 0873) Barcelona, | |
| Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3008) Melbourne, Victoria | |
| Policlinico Universitario Agostino Gemelli ( Site 1965) Roma, | |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 2751) Santiago, Region M. de Santiago | |
| Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3020) Port Macquarie, New South Wales | |
| Powiatowe Centrum Zdrowia w Brzezinach Sp. z o. o. Oddział Dziennej Chemioterapii ( Site 1611) Brzeziny, Łódź Voivodeship | |
| Princess Alexandra Hospital ( Site 3002) Woolloongabba, Queensland | |
| Princess Margaret Cancer Centre ( Site 2803) Toronto, Ontario | |
| Princess Margaret Hospital ( Site 1903) Hong Kong, | |
| Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 3656) Kropyvnytskyi, Kirovohrad Oblast | |
| Providence Medical Foundation ( Site 0087) Fullerton, California | |
| Providence Portland Medical Center ( Site 0051) Portland, Oregon | |
| Providence Saint John's Health Center ( Site 0059) Santa Monica, California | |
| Przychodnia Lekarska KOMED ( Site 1603) Konin, Greater Poland Voivodeship | |
| Queen Mary Hospital ( Site 1902) Hksar, | |
| Queen Mary Hospital-Department of Medicine (Respiratory) ( Site 1900) Hksar, | |
| RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia-Out-patient and Day patient facility of Ch ( Site 3850) Riga, | |
| Rabin Medical Center ( Site 2059) Petah Tikva, | |
| Radboud University Medical Center ( Site 1554) Nijmegen, Gelderland | |
| Ramathibodi Hospital ( Site 2364) Bangkok, Bangkok | |
| Rambam Health Care Campus-Oncology Division ( Site 2053) Haifa, | |
| Regional Budgetary Healthcare Institution 'Ivanovo Regional Oncology Dispensary'-Urology ( Site 1219) Ivanovo, Ivanovo Oblast | |
| Republican Clinical Oncology Dispensary ( Site 1228) Kazan', Tatarstan, Respublika | |
| Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1204) Ufa, Baskortostan, Respublika | |
| Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 1203) Kazan', Tatarstan, Respublika | |
| Royal Adelaide Hospital ( Site 3014) Adelaide, South Australia | |
| Royal Brisbane and Women's Hospital ( Site 3009) Herston, Queensland | |
| Royal Free Hospital ( Site 0507) London, London, City of | |
| Royal Marsden Hospital ( Site 0505) London, London, City of | |
| Royal North Shore Hospital-Medical Oncology Clinical Trials ( Site 3025) St Leonards, New South Wales | |
| Royal Preston Hospital ( Site 0518) Preston, Lancashire | |
| Royal Prince Alfred Hospital-A.W. Morrow Gastroenterology and Liver Centre ( Site 3016) Camperdown, New South Wales | |
| Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1201) Moscow, Moscow | |
| Russian Scientific Center of Roentgenoradiology ( Site 1215) Moscow, Moscow | |
| Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 1224) Saint Petersburg, Sankt-Peterburg | |
| SAIH of the Tyumen region, Multidisciplinary Clinical Medical Center "Medical town" ( Site 1220) Tyumen, Tyumen Oblast | |
| SO"Grigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine" ( Site 3666) Kharlkiv, Kharkivs’ka Oblast’ | |
| SRH Wald-Klinikum Gera GmbH ( Site 2403) Gera, Thuringia | |
| SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 3452) Guangzhou, Guangdong | |
| Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 0803) Gothenburg, Västra Götaland County | |
| Saint Francis Health System ( Site 0089) Greenville, South Carolina | |
| Saitama Medical University International Medical Center ( Site 3118) Hidaka, Saitama | |
| Saitama Prefectural Cancer Center ( Site 3112) Kitaadachi-gun, Saitama | |
| Samsung Medical Center ( Site 0950) Seoul, | |
| Sanatorio Parque ( Site 1355) Rosario, Santa Fe Province | |
| Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2004) Sandton, Gauteng | |
| Sanford Cancer Center ( Site 0066) Sioux Falls, South Dakota | |
| Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0065) Fargo, North Dakota | |
| Sapporo Kosei General Hospital ( Site 3172) Sapporo, Hokkaido | |
| Sapporo Medical University Hospital ( Site 3113) Sapporo, Hokkaido | |
| Sarah Cannon Research UK ( Site 0504) London, London, City of | |
| Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 1406) Budapest, | |
| Sendai Kousei Hospital ( Site 3115) Sendai, Miyagi | |
| Seoul National University Bundang Hospital ( Site 0951) Seongnam-si, Kyonggi-do | |
| Seoul National University Hospital ( Site 0953) Seoul, | |
| Severance Hospital ( Site 0954) Seoul, | |
| Severance Hospital, Yonsei University Health System ( Site 0962) Seoul, | |
| Shaare Zedek Medical Center ( Site 2068) Jerusalem, | |
| Shamir Medical Center Assaf Harofeh ( Site 2058) Ẕerifin, | |
| Shanghai Pulmonary Hospital ( Site 3470) Shanghai, Shanghai Municipality | |
| Sheba Medical Center ( Site 2062) Ramat Gan, | |
| Sheba Medical Center ( Site 2065) Ramat Gan, | |
| Shizuoka Cancer Center ( Site 3128) Nakatogari, Shizuoka | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0056) Baltimore, Maryland | |
| Sir Charles Gairdner Hospital ( Site 3006) Nedlands, Western Australia | |
| Sir Run Run Shaw Hospital ( Site 3505) Hangzhou, Zhejiang | |
| Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2704) Valledupar, Cesar Department | |
| Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1402) Kaposvár, | |
| Sotiria Regional Chest Diseases Hospital of Athens ( Site 1850) Athens, Attica | |
| Sourasky Medical Center ( Site 2054) Tel Aviv, | |
| South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001) San Antonio, Texas | |
| Southern medical university Nangfang Hospital ( Site 3490) Guanghzou, Guangdong | |
| Spitalul Județean Sfântul Ioan cel Nou Suceava-Oncology ( Site 3550) Suceava, | |
| St James University Hospital ( Site 0509) Leeds, | |
| St John of God Subiaco Hospital ( Site 3013) Subiaco, Western Australia | |
| St Vincent's Hospital-Oncology Clinical Trials ( Site 3018) Melbourne, Victoria | |
| St. James s Hospital ( Site 1801) Dublin, | |
| St. Luke s Medical Center ( Site 1700) Quezon City, National Capital Region | |
| St. Luke's University Health Network ( Site 0017) Bethlehem, Pennsylvania | |
| St. Marianna University Hospital ( Site 3182) Kawasaki, Kanagawa | |
| St. Petersburg Clinical Hospital of Russian Academy Of Sciences ( Site 1235) Saint Petersburg, Sankt-Peterburg | |
| St.Luke's International Hospital ( Site 3120) Tokyo, | |
| Stanford Cancer Center ( Site 0086) Palo Alto, California | |
| Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 3661) Sumy, Sumska Oblast | |
| Sun Yat-sen University Cancer Center-melanoma ( Site 3482) Guangzhou, Guangdong | |
| Sunnybrook Research Institute ( Site 2802) Toronto, Ontario | |
| Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna ( Site 1601) Poznan, Greater Poland Voivodeship | |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1618) Krakow, Lesser Poland Voivodeship | |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1614) Koszalin, West Pomeranian Voivodeship | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1316) Istanbul, | |
| Taipei Veterans General Hospital ( Site 3202) Taipei, | |
| Tallaght University Hospital ( Site 1803) Dublin, | |
| Tampere University Hospital [Tampere Finland] ( Site 0600) Tampere, Pirkanmaa | |
| Tangdu Hospital of Fourth Military Medical University of Chi-department of radiotherapy ( Site 3455) Xi'an, Shaanxi | |
| Tartu University Hospital-Radiotherapy and oncology ( Site 3800) Tartu, Tartu | |
| Tasman Oncology Research Pty Ltd ( Site 3012) Southport, Queensland | |
| Teikyo University Hospital ( Site 3104) Tokyo, | |
| Texas Oncology - Central/South Texas ( Site 8001) Austin, Texas | |
| Texas Oncology-Baylor Sammons Cancer Center ( Site 0062) Dallas, Texas | |
| The Affiliated Cancer Hospital of Guizhou Medical University ( Site 3498) Guiyang, Guizhou | |
| The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 3502) Ürümqi, Xinjiang | |
| The Angeles Clinic and Research Institute ( Site 0005) Los Angeles, California | |
| The Beatson West of Scotland Cancer Centre ( Site 0506) Glasgow, Glasgow City | |
| The Catholic University Of Korea St. Vincent's Hospital ( Site 0968) Suwon, Kyonggi-do | |
| The Christie ( Site 0516) Manchester, England | |
| The Fifth Medical Center Of The Chinese PLA General Hospital (South) ( Site 3465) Beijing, Beijing Municipality | |
| The First Affiliated Hospital of Guangzhou Medical University-thoracic surgery department ( Site 3460) Guangzhou, Guangdong | |
| The First Affiliated Hospital of Xi an Jiaotong University ( Site 3489) XiAn, Shanxi | |
| The First Affiliated Hospital, Sun Yat-sen University-pneumology department ( Site 3459) Guangzhou, Guangdong | |
| The First Hospital of Jilin University-Oncology ( Site 3464) Changchun, Jilin | |
| The Jikei University Hospital ( Site 3156) Tokyo, | |
| The National Medico-Surgical Center N.I. Pirogov ( Site 1225) Moscow, Moscow | |
| The Oncology Centre ( Site 2000) Durban, KwaZulu-Natal | |
| The Ottawa Hospital - General Campus ( Site 2813) Ottawa, Ontario | |
| The Queen Elizabeth Hospital ( Site 3026) Woodville, South Australia | |
| The Royal Marsden NHS Foundation Trust. ( Site 0513) Sutton, | |
| The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3491) Guangzhou, Guangdong | |
| The Townsville Hospital ( Site 3017) Townsville, Queensland | |
| The University of Chicago ( Site 0020) Chicago, Illinois | |
| The University of Osaka Hospital ( Site 3168) Suita, Osaka | |
| Tianjin Medical University Cancer Institute and Hospital ( Site 3456) Tianjin, Tianjin Municipality | |
| Tohoku University Hospital ( Site 3175) Sendai, Miyagi | |
| Tokyo Medical University Hospital ( Site 3170) Shinjuku-ku, Tokyo | |
| Tokyo Metropolitan Komagome Hospital ( Site 3133) Tokyo, | |
| Tomsk Scientific Research Institute of Oncology ( Site 1227) Tomsk, Tomsk Oblast | |
| Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 3476) Wuhan, Hubei | |
| Toranomon Hospital ( Site 3134) Minato-ku, Tokyo | |
| Toranomon Hospital ( Site 3153) Minato-ku, Tokyo | |
| Toyama Prefectural Central Hospital ( Site 3183) Toyama, | |
| Trakya Universitesi Tip Fakultesi ( Site 1301) Edirne, | |
| Transcarpathian Regional Clinical Oncology Center-Chemotherapy dept. ( Site 3652) Uzhhorod, Zakarpattia Oblast | |
| Turku University Hospital ( Site 0601) Turku, Southwest Finland | |
| UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0009) Los Angeles, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004) San Francisco, California | |
| UPMC Hillman Cancer Center ( Site 0008) Pittsburgh, Pennsylvania | |
| UPR Comprehensive Cancer Center ( Site 1150) San Juan, | |
| UZ Brussel ( Site 2900) Brussels, Bruxelles-Capitale, Region de | |
| UZ Leuven ( Site 2901) Leuven, Vlaams-Brabant | |
| UZ Leuven - Campus Gasthuisberg ( Site 2906) Leuven, Vlaams-Brabant | |
| UZ Leuven Gasthuisberg, Gynaecologie-Verloskunde ( Site 2907) Leuven, Vlaams-Brabant | |
| Udmurtian Republican Clinical Oncology Center ( Site 1212) Izhevsk, Udmurtiya Republic | |
| Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 1750) Lisbon, | |
| Uniklinikum Salzburg ( Site 2956) Salzburg, | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3492) Wuhan, Hubei | |
| Universitaetsklinik Muenchen ( Site 2406) Munich, Bavaria | |
| Universitaetsklinikum Essen ( Site 2404) Essen, North Rhine-Westphalia | |
| Universitaetsklinikum Tuebingen ( Site 2405) Tübingen, Baden-Wurttemberg | |
| Universitaetsklinikum des Saarlandes-Klinik für Innere Medizin V-Pneumologie, Allergologie, Beatmun ( Site 2411) Homburg, Saarland | |
| Universitaetsspital Zuerich ( Site 0750) Zürich-Flughafen, Canton of Zurich | |
| Universitair Medisch Centrum Groningen ( Site 1550) Groningen, | |
| Universitatsklinikum Carl Gustav Carus ( Site 2407) Dresden, Saxony | |
| University College London Hospital-Cancer Clinical Trials Unit ( Site 0520) London, London, City of | |
| University Hospital Basel ( Site 0752) Basel, Canton of Basel-City | |
| University Hospital Coventry & Warwickshire ( Site 0524) Coventry, | |
| University Hospitals ( Site 0044) Cleveland, Ohio | |
| University Malaya Medical Centre ( Site 0626) Kuala Lumpur, | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0076) Orange, California | |
| University of Colorado Cancer Center ( Site 0021) Aurora, Colorado | |
| University of Iowa Hospital and Clinics ( Site 0026) Iowa City, Iowa | |
| University of North Carolina at Chapel Hill ( Site 0040) Chapel Hill, North Carolina | |
| University of Pennsylvania ( Site 0010) Philadelphia, Pennsylvania | |
| University of Texas MD Anderson Cancer Center ( Site 0007) Houston, Texas | |
| University of Tsukuba Hospital ( Site 3176) Tsukuba, Ibaraki | |
| University of Virginia Health System ( Site 0035) Charlottesville, Virginia | |
| University of the Ryukyus Hospital ( Site 3155) Ginowan, Okinawa | |
| Universitätsklinikum Erlangen ( Site 2408) Erlangen, Bavaria | |
| Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 2909) Namur, | |
| Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1413) Budapest, | |
| VCU Health Adult Outpatient Pavillion ( Site 0080) Richmond, Virginia | |
| Vanderbilt Health One Hundred Oaks Diagnostic ( Site 0060) Nashville, Tennessee | |
| Vanderbilt Ingram Cancer Center ( Site 0015) Nashville, Tennessee | |
| Vejle Sygehus ( Site 0653) Vejle, Region Syddanmark | |
| Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 3300) Vilnius, | |
| Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 3301) Vilnius, | |
| WCR Office ( Site 2002) Johannesburg, Gauteng | |
| Waikato Hospital ( Site 1502) Hamilton, Waikato Region | |
| Wakayama Medical University Hospital ( Site 3124) Wakayama, | |
| WakeMed Cancer Care - Waverly Hematology & Medical Oncology ( Site 0074) Cary, North Carolina | |
| West Cancer Center and Research Institute ( Site 0055) Germantown, Tennessee | |
| West China Hospital Sichuan University-respiratory ( Site 3473) Chengdu, Sichuan | |
| Western General Hospital ( Site 0502) Edinburgh, Edinburgh, City of | |
| Western Health-Sunshine & Footscray Hospitals ( Site 3023) St Albans, Victoria | |
| Westmead Hospital ( Site 3000) Westmead, New South Wales | |
| Weston Park Hospital ( Site 0519) Sheffield, England | |
| White Plains Hospital-Center for Cancer Care ( Site 0069) White Plains, New York | |
| Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1619) Poznan, Greater Poland Voivodeship | |
| Wilgers Oncology Centre ( Site 2006) Pretoria, Gauteng | |
| Wojskowy Instytut Medyczny-Klinika Onkologii ( Site 1606) Warsaw, Masovian Voivodeship | |
| Women s Hospital School of Medicine Zhejiang University ( Site 3493) Hangzhou, Zhejiang | |
| Women's Cancer Care ( Site 0088) Covington, Louisiana | |
| Xiangya Hospital Central South University-Gynecology ( Site 3497) Changsha, Hunan | |
| Xiangya Hospital Central South University-Respiratory ( Site 3479) Changsha, Hunan | |
| Xinjiang Medical University Cancer Hospital - Urumqi-galactophore department ( Site 3486) Ürümqi, Xinjiang | |
| Yale Cancer Center ( Site 0014) New Haven, Connecticut | |
| Yamaguchi University Hospital ( Site 3114) Ube, Yamaguchi | |
| Yancheng First People s Hospital ( Site 3504) Yancheng, Jiangsu | |
| Yokohama City University Hospital ( Site 3163) Yokohama, Kanagawa | |
| Yokosuka Kyosai Hospital ( Site 3150) Yokosuka, Kanagawa | |
| ZIV Medical Center-Hematology Institute ( Site 2061) Safed, | |
| Zala Megyei Szent Rafael Korhaz ( Site 1400) Zalaegerszeg, | |
| Zhejiang Cancer Hospital ( Site 3481) Hangzhou, Zhejiang | |
| Zhejiang Cancer Hospital ( Site 3495) Hangzhou, Zhejiang | |
| Zhongshan Hospital of Fudan University ( Site 3503) Shanghai, Shanghai Municipality | |
| ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 1969) Siena, |
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
ctrrecruit@vcu.edu
PHASE2
NCT06126276
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Inclusion Criteria:
* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191
* Patients must have a HER2 amplified solid tumor except breast cancer. Patient's cancer must have HER2 amplification as defined with ≥ 7 copies by next generation sequencing (NGS) testing
* Patients must have recurrent or persistent disease
* No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation
* 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 measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required
* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression for 3 months or more and patient is not on steroids and is asymptomatic
* No known leptomeningeal disease
* Patients may have received up to 5 prior lines of systemic therapy
* Prior therapy with trastuzumab or pertuzumab, either alone or in combination, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed
* Prior therapy with tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib is not allowed
* No prior therapy with CDK4/6 inhibition
* No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug. No HER2 targeting ADCs within 30 days prior to registration
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
* Not pregnant and not nursing
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
* Platelets ≥ 100,000 cells/mm\^3
* Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 9 g/dl is acceptable)
* Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
* Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN)
* 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
* No active infection requiring parenteral antibiotics
* No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
* No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy
* No lung disease causing dyspnea at rest
* No interstitial lung disease with ongoing signs and symptoms at the time of registration
* No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan, DRUG: Neratinib Maleate, DRUG: Palbociclib
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm
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Show 153 locations
Study Locations
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| Location | Contacts |
|---|---|
| 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) |
| 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) |
| 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) |
| Bristol Regional Medical Center Bristol, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| 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) |
| 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) |
| 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) |
| 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) |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.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) |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (Roster@nrgoncology.org) |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| Kettering Medical Center Kettering, Ohio | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| 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 in Rochester Rochester, Minnesota | |
| Mercyhealth Cancer Institute - Rockford Rockford, Illinois | Site Public Contact - (oncologyclinicaltrials@mhemail.org) |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| 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) |
| National Institutes of Health Clinical Center Bethesda, Maryland | |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Premier Blood and Cancer Center Dayton, Ohio | |
| 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) |
| Regional Cancer Center at Johnson City Medical Center Johnson City, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| 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) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| 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) |
| 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 | |
| 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 - (ctsucontact@westat.com) |
| 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 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) |
| UC San Diego Health System - Encinitas Encinitas, California | |
| UC San Diego Medical Center - Hillcrest San Diego, California | Site Public Contact - (rhabbaba@health.ucsd.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| 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 | |
| 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 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 - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Western Maryland Cumberland, Maryland | |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (tmyrick@uab.edu) |
| 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 Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of South Alabama Mitchell Cancer Institute Mobile, Alabama | Site Public Contact - (pfrancisco@usouthal.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wellmont Holston Valley Hospital and Medical Center Kingsport, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Woodland Cancer Care Center Michigan City, Indiana |
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
ctrrecruit@vcu.edu
PHASE3
NCT06589804
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Inclusion Criteria:
* Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC).
* Previously untreated for recurrent and/or metastatic disease incurable by local therapies.
* Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx.
* Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair.
* Measurable disease.
* Must have platinum-refractory disease defined as disease progression during or ≤ 6 months after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy.
* Patient must have a combined positive score PD-L1 positive (CPS \>/= 1) tumor.
* Any radiation therapy must be completed \>= 10 days prior to registration.
* Patients should not have received any prior treatment in the recurrent or metastatic setting.
* Prior therapy with anti PD-1/PD-L1 monoclonal antibody or cetuximab in the curative setting is allowed if last treatment dose was \>= 6 months prior to registration without evidence of disease progression during that treatment period.
* Patient has not received a live vaccine within 30 days prior to registration.
* Patient does not have a history of any contraindication or has a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3).
* Patient has not received chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.
* Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and/or HPV in situ hybridization (ISH).
* Note: A Clinical Laboratory Improvement Act (CLIA) certified circulating tumor HPV deoxyribonucleic acid (ctHPVDNA) assay can be used if tissue sample is not available.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3.
* Platelet count ≥ 100,000/mm\^3.
* Hemoglobin (Hgb) ≥ 9 g/dL (if \< 9 g/dL, then transfusions are acceptable to increase hemoglobin above 9 g/dL).
* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula for participant with creatinine levels \> 1.5 x institutional ULN.
* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin \< ULN for participant with total bilirubin \> 1.5 x institutional ULN.
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 3.0 x ULN unless liver metastases are present in which case \< 5.0 x ULN.
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
* Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.
* 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 should be included.
* For treated/stable brain metastases: 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.
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
* Patients does not have a history of active myocarditis.
* Patients does not have a history of any form of pneumonitis or diffuse idiopathic or immune mediated interstitial pulmonary disease.
* Patient does not have a history of solid organ transplantation. PROCEDURE: Biospecimen Collection, BIOLOGICAL: Cetuximab, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Pembrolizumab, PROCEDURE: Positron Emission Tomography
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Oral Cavity Squamous Cell Carcinoma, Metastatic Oropharyngeal Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Neck Squamous Cell Carcinoma of Unknown Primary, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Refractory Head and Neck Squamous Cell Carcinoma, Refractory Hypopharyngeal Squamous Cell Carcinoma, Refractory Laryngeal Squamous Cell Carcinoma, Refractory Oral Cavity Squamous Cell Carcinoma, Refractory Oropharyngeal Squamous Cell Carcinoma, Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
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Show 152 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) |
| 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 High Tech Medical Park Palos Heights, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Oak Lawn Oak Lawn, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Avera Cancer Institute Sioux Falls, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute - Mitchell Mitchell, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Pierre Pierre, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Yankton Yankton, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Fremont - Rideout Cancer Center Marysville, California | |
| 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 | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| HaysMed Hays, Kansas | |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Jefferson Cherry Hill Hospital Cherry Hill, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| 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) |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| 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) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Lutheran Hospital - Cancer Centers of Colorado Golden, Colorado | Site Public Contact - (peaksresearch@imail.org) |
| Margaret R Pardee Memorial Hospital Hendersonville, North Carolina | Site Public Contact - (pardeecancerresearch@unchealth.unc.edu) |
| 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 | |
| Medical Center of the Rockies Loveland, Colorado | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital North Colorado Springs, Colorado | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| 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 | |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| SUNY Upstate Medical Center-Community Campus Syracuse, New York | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.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 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) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| 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) |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of 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 Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| Upstate Cancer Center at Verona Verona, New York | Site Public Contact - (McDowelE@upstate.edu) |
| VA Palo Alto Health Care System Palo Alto, California | |
| 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) |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Charleston Division Charleston, West Virginia |
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
ctrrecruit@vcu.edu
PHASE2
NCT05828069
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Inclusion Criteria:
* 180 days- \< 22 years (at time of study enrollment)
* Patient must have a body surface area of ≥ 0.3 m\^2
* Patients with progressive, relapsed, or recurrent LCH with measurable disease at study entry
* Patients must have had histologic verification of LCH (from either original diagnosis or relapse/progression) at the time of study entry (must be obtained within 28 days prior to enrollment and start of protocol therapy) (repeat if necessary)
* Tissue confirmation of relapse is recommended but not required
* Pathology report must be submitted for central confirmation of diagnosis within 7 days of enrollment.
* Formalin-fixed paraffin-embedded (FFPE) blocks or unstained slides (initial diagnosis and/or subsequent biopsies) will be required for retrospective central confirmation of diagnosis and molecular studies
* Patients with mixed histiocytic disorders (e.g. LCH with juvenile xanthogranuloma) may be included
* Patients must have measurable disease, documented by radiographic imaging (LCH- specific response criteria (must be obtained within 28 days prior to enrollment and start of protocol therapy) (repeat if necessary).
* Patients must have progressive or refractory disease or experience relapse after at least one previous systemic treatment strategy
* Pathogenic somatic mutation detected in genes encoding tyrosine kinase receptors (CSFR1, ERBB3 or ALK), RAS or RAF (may be from original or subsequent biopsy or peripheral blood/bone marrow aspirate). Clinical mutation reports may include quantitative polymerase chain reaction (PCR) (e.g. BRAFV600E) and/or Sanger or next generation sequencing. Immunohistochemistry (e.g. VE1 antibody for BRAFV600E) alone is not sufficient
* Participant must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet, which may be taken by mouth or other enteral route such as nasogastric, jejunostomy, or gastric tube
* Karnofsky \>= 50% for patients \> 16 years of age and Lansky \>= 50% for patients =\< 16 years of age
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Myelosuppressive chemotherapy: Patients must not have received within 14 days of entry onto this study
* Investigational agent or any other anticancer therapy not defined above: Patients must not have received any investigational agent or any other anticancer therapy (including MAPK pathway inhibitor) for at least 14 days prior to planned start of tovorafenib (DAY101)
* Radiation therapy (RT): Patient must not have received RT within 2 weeks after the last dose fraction of RT
* Patients must have fully recovered from any prior surgery
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, targeted inhibitor, and/or radiotherapy with toxicities reduced to grade 1 or less (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0)
* Steroids: =\< 0.5 mg/kg/day of prednisone equivalent (maximum 20 mg/day) averaged during the month prior to study enrollment is permissible
* Strong inducers or inhibitors of CYP2C8 are prohibited for 14 days before the first dose of tovorafenib (DAY101) and from planned administration for the duration of study participation
* Medications that are breast cancer resistant protein (BCRP) substrates that have a narrow therapeutic index are prohibited for 14 days before the first dose of tovorafenib (DAY101) and for the duration of study participation
* Peripheral absolute neutrophil count (ANC) \>= 750/uL unless secondary to bone marrow involvement, in such cases bone marrow involvement must be documented (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Platelet count \>= 75,000/uL (unsupported/without transfusion within the past 7 days) (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Patients with marrow disease must have platelet count of \>= 75,000/uL (transfusion support allowed) and must not be refractory to platelet transfusions. Bone marrow involvement must be documented
* Hemoglobin \>= 8 g/dL (unsupported/without transfusion within the past 7 days). Patients with marrow disease must have hemoglobin \>= 8 g/dL (transfusion support allowed). Bone marrow involvement must be documented
* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g., Neulasta \[registered trademark\]) or 7 days for short-acting growth factor
* A serum creatinine based on age/sex as follows (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Age: 6 months to \< 1 year; Maximum Serum Creatinine (mg/dL):= 0.5 mg/dl (male and female)
* Age: 1 to \< 2 years; Maximum Serum Creatinine (mg/dL): = 0.6 mg/dl (male and female)
* Age: 2 to \< 6 years; Maximum Serum Creatinine (mg/dL): = 0.8 mg/dl (male and female)
* Age: 6 to \< 10 years; Maximum Serum Creatinine (mg/dL): = 1.0 mg/dl (male and female)
* Age: 10 to \< 13 years; Maximum Serum Creatinine (mg/dL): = 1.2 mg/dl (male and female)
* 13 to \< 16 years; Maximum Serum Creatinine (mg/dL): = 1.5 mg/dl (male) and 1.4 mg/dl (female)
* Age: \>= 16 years; Maximum Serum Creatinine (mg/dL): = 1.7 mg/dl (male) and 1.4 mg/dl (female)
* OR- a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2
* OR- a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
* Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility
* Bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Alanine aminotransferase (ALT) =\< 3 x ULN for age (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Serum albumin \>= 2 g/dl must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* For patients with liver disease caused by their histiocytic disorder (as evaluated on radiographic imaging or biopsy): patients may be enrolled with abnormal bilirubin, aspartate aminotransferase (AST), ALT and albumin with documentation of histiocytic liver disease
* Fractional shortening (FS) of \>= 25% or ejection fraction of \>= 50%, as determined by echocardiography or multigated acquisition scan (MUGA) within 28 days prior to study enrollment. Depending on institutional standard, either FS or left ventricular ejection fraction (LVEF) is adequate for enrollment if only one value is measured; if both values are measured, then both values must meet criteria above (must be obtained within 28 days prior to enrollment and start of protocol therapy) (repeat if necessary)
* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination; unless it is due to underlying pulmonary LCH
* Central Nervous System Function Defined As:
* Patients with seizure disorder may be enrolled if well controlled
* Central nervous system (CNS) toxicity =\< Grade 2
* Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial unless antiretroviral therapy interacts with the metabolism of tovorafenib (DAY101) and cannot safely be changed to antivirals that do not interact with study medication
Exclusion Criteria:
* LCH arising along with other hematologic malignancy (e.g. mixed LCH with acute lymphoblastic leukemia) or any history of non-histiocytic malignancy
* Disease scenarios as below will be excluded
* Skin-limited disease
* Gastrointestinal (GI) tract involvement only (those that have disease that can be determined by endoscopic biopsies only)
* LCH-associated neurodegeneration (LCH-ND) without parenchymal lesions or other systemic lesions
* Patients with activating mutations in MAP2K1 are not eligible for this study due to drug target specificity. Mutation status will be submitted to study team within 7 days of enrollment
* Refractory nausea and vomiting, malabsorption, or external biliary shunt that would preclude adequate absorption of tovorafenib (DAY101)
* Uncontrolled systemic bacterial, viral, or fungal infection
* Major surgical procedure or significant traumatic injury within 14 days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study. Placement of a vascular access device or minor surgery is permitted within fourteen (14) days of study enrollment (provided that the wound has healed)
* History of significant bowel resection that would preclude adequate absorption or other significant malabsorptive disease
* Ophthalmologic considerations: Patients with known significant ophthalmologic conditions or known risk factors for retinal vein occlusion (RVO) or central serous retinopathy (CSR) are not eligible
* History of solid organ or hematopoietic bone marrow transplantation
* Clinically significant active cardiovascular disease, or history of myocardial infarction, or deep vein thrombosis/pulmonary embolism within 6 months prior to enrollment, ongoing cardiomyopathy, or current prolonged QT interval \> 440 ms based on triplicate electrocardiogram (ECG) average
* History of Grade \>= 2 CNS hemorrhage or history of any CNS hemorrhage within 28 days of study entry
* History of any drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome or Stevens Johnsons syndrome (SJS) or who are allergic to tovorafenib (DAY101) or any of its components
* CTCAE version (V). 5.0 Grade 3 symptomatic creatinine kinase (CPK) elevation ( \> 5 x ULN)
* Female patients who are pregnant are ineligible. A pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants are ineligible
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation are ineligible. Women of childbearing potential must use non-hormonal contraception during tovorafenib treatment and for at least 28 days after the last dose. Men should use effective contraception and must not father a child while taking tovorafenib and for 14 days after the last dose PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, PROCEDURE: FDG-Positron Emission Tomography and Computed Tomography Scan, PROCEDURE: Lumbar Puncture, PROCEDURE: Multigated Acquisition Scan, DRUG: Tovorafenib
Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis
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Show 106 locations
Study Locations
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| Location | Contacts |
|---|---|
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| 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) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| 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 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 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 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 National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| 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) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Maimonides Medical Center Brooklyn, New York | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Michigan State University East Lansing, Michigan | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.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 | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Nicklaus Children's Hospital Miami, Florida | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sydney Children's Hospital Randwick, New South Wales | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (cogbchoak@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| 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 Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of 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 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) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
ctrrecruit@vcu.edu
PHASE2
NCT05112601
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Inclusion Criteria:
* Patients with measurable or non-measurable (detectable) recurrent endometrial cancer
* Measurable disease will be defined and monitored by RECIST v 1.1. Measurable disease is defined per RECIST 1.1 criteria 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 computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
* Non-measurable (detectable) disease in a patient is defined in this protocol per RECIST 1.1 criteria as one who does not have measurable disease but has at least one of the following conditions:
* All other lesions (or sites of disease), including small lesions (longest diameter \<10 mm or pathological lymph nodes with \>= 10 to \< 15 mm short axis), are considered non-measurable disease
* Ascites and/or pleural effusion attributed to tumor
* Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
* Patients must have endometrial cancer with deficient mismatch repair system. All patients must have institutional immunohistochemistry (IHC) and/or microsatellite instability (MSI) testing to determine mismatch repair (MMR) status. MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry and/or presence of microsatellite instability high using the National Cancer Institute (NCI)-5plex and Promega v1.2 assays, or institutional standards (e.g. next-generation sequencing \[NGS\] panel)
* Method(s) of detection of MMR deficiency will be recorded for each patient. An institutional pathology report, and additional reports if available, documenting these results must be submitted. Patients with "equivocal" results on MMR testing by immunohistochemistry may be eligible if they have documented evidence of microsatellite instability by MSI testing or by next generation sequencing assays. MMR testing by IHC may be used to resolve equivocal/indeterminate MSI results
* Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, mucinous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)
* Patients may have received 1-2 prior lines of systemic therapy:
* Prior anti-PD1/PD-L1 therapy is allowed if given in combination with chemotherapy or radiation therapy in adjuvant or primary metastatic/recurrent settings. Patients must have had a complete response and have disease progression/relapse with treatment-free interval of 12 months or more from last dose of therapy with immune check inhibition
* Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration
* Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to registration
* Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C)
* Age \>= 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Platelets \>= 100,000/mcl
* Absolute neutrophil count (ANC) \>= 1,500/mcl
* Creatinine =\< 1.5 x institutional/laboratory upper limit of normal (ULN)
* Total serum bilirubin level =\< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =\<3 x ULN may be enrolled)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN
* Adequate oxygen saturation via pulse oximeter (CTCAE v.5.0 hypoxia \< grade 2 within 28 days prior to registration)
* Thyroid-stimulating hormone (TSH) within normal limits (TSH \< ULN allowed in euthyroid patients on thyroid replacement therapy). TSH testing is only required if clinically indicated
* Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy. At least 4 weeks must have elapsed since major surgery
* As clinically indicated, 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 and have a corrected QT (QTc) interval \< 450 msec
* The effects of nivolumab, and ipilimumab on the developing human fetus are unknown. For this reason and because nivolumab and ipilimumab are known to be teratogenic, women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 5 months after the last dose of investigational drug. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception
* WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
* 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 treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and the patient is stable off steroids for at least one month
* 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
* Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible
* Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Exclusion Criteria:
* Patients with a diagnosis of endometrial serous carcinoma or carcinosarcoma
* Patients who received prior anti-PD1/PD-L1 therapy and had grade 3-4 or recurring grade 2 immune-related toxicities that led to dose delay or discontinuation of immunotherapy due to those toxicities
* Patients who received anti-CTLA-4 therapy or other immunotherapeutic agents
* Patients on chronic steroid therapy except those on replacement therapy at a daily dose of 10mg or less prednisone or equivalent
* Patients on immunosuppressive therapy, with the exception of:
* Intra-nasal, inhaled, topical or local steroid injections
* Premedication for hypersensitivity reaction
* Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease
* Patients with known immune impairment who may be unable to respond to anti-CTLA-4 antibody
* Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Women who are pregnant or unwilling to discontinue nursing
* Prior therapy with CTLA-4 inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, and/or ipilimumab including severe hypersensitivity reactions to any monoclonal antibody PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, BIOLOGICAL: Ipilimumab, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma, Endometrial Mucinous Adenocarcinoma, Endometrial Undifferentiated Carcinoma, Endometrioid Adenocarcinoma, Recurrent Endometrial Carcinoma
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Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| 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) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| 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) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| 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) |
| 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 Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Geauga Hospital Chardon, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Henrico Doctor's Hospital Richmond, Virginia | |
| Hillcrest Hospital Cancer Center Mayfield Heights, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| IRMC Cancer Center Indiana, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| IU Health North Hospital Carmel, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Intermountain Health West End Clinic Billings, Montana | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Nebraska Methodist Hospital Omaha, Nebraska | |
| 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 | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma | |
| Parkland Memorial Hospital Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| 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) |
| Roswell Park Cancer Institute Buffalo, New York | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | |
| Saint Catherine Hospital Indianapolis, Indiana | Site Public Contact - (Roster@nrgoncology.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| State University of New York Upstate Medical University Syracuse, New York | |
| The Community Hospital Munster, Indiana | |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| 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) |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center at UPMC McKeesport McKeesport, Pennsylvania | |
| UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania | |
| UPMC Cancer Center-Natrona Heights Natrona Heights, Pennsylvania | |
| UPMC Cancer Center-Washington Washington, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center - New Castle New Castle, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center - Part of Frick Hospital Mount Pleasant, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center - Passavant - Cranberry Cranberry Township, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center at Butler Health System Butler, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center in Coraopolis Moon Township, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC West Mifflin-Cancer Center Jefferson West Mifflin, Pennsylvania | |
| 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-Mercy Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Cancer and Blood Center LLC Athens, Georgia | Site Public Contact - (research@universitycancer.com) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (tmyrick@uab.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| 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 Rochester Rochester, New York | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Women and Infants Hospital Providence, Rhode Island | |
| Women's Cancer Center of Nevada Las Vegas, Nevada | |
| Women's Diagnostic Center - Munster Munster, Indiana | Site Public Contact - (mnicholson@comhs.org) |
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
ctrrecruit@vcu.edu
PHASE3
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/gender 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 must continue contraception for a period of 6 months after last dose of brentuximab vedotin
* Women of child-bearing potential (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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Show 356 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) |
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| 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 | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| 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) |
| 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) |
| 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 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 - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope 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 Toms River, New Jersey | 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 Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Hospital for Sick Children Toronto, Ontario | |
| 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 | |
| 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 | |
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| 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 Loma Linda, 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) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
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| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
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| Mercy Hospital Saint Louis St Louis, Missouri | |
| 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 | |
| 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) |
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| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
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| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| 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 | |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
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| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Cancer Institute - Eastside Greenville, 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 | |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
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| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
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| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
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| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
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| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
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| Saint Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.org) |
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| 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) |
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| Saint Jude Midwest Affiliate Peoria, Illinois | |
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| 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) |
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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 Medical Center West Palm Beach, Florida | |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Vincent Hospital Cancer Center Green Bay 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) |
| 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) |
| Santa Barbara Cottage Hospital Santa Barbara, California | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| 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) |
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| Southern Illinois University School of Medicine Springfield, Illinois | |
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| Stony Brook University Medical Center Stony Brook, New York | |
| T C Thompson Children's Hospital Chattanooga, Tennessee | |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| 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 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 Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
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| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
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| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
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| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| 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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| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
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| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
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| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
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| 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) |
| Wesley Medical Center Wichita, Kansas | Site Public Contact - (WesleyResearch@wesleymc.com) |
| 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) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study 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
PHASE3
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 159 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, Ancona | |
| 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, Ille-et-Vilaine | |
| 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) Izmir, | |
| 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) Sayama, 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 City, | |
| 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, | |
| Ospedale Mauriziano ( Site 0305) Torino, | |
| Ospedale di Circolo e Fondazione Macchi Varese ( Site 2200) Varese, | |
| 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
PHASE3
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 162 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, | |
| 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 | |
| Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 261646 Budapest, | |
| 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, | |
| 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 | |
| Levine Cancer Institute /ID# 246199 Charlotte, North Carolina | |
| 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 | |
| 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 | |
| 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# 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 First Hospital of China Medical University /ID# 245547 Shenyang, Liaoning | |
| 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 | |
| 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 | |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 260168 Lublin, Lublin Voivodeship | |
| Uniwersytecki Szpital Kliniczny We Wrocławiu /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
Study Director - clinicaltrials@beigene.com
PHASE3
NCT06742996
Show full eligibility criteria
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Inclusion Criteria:
* Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
* 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
* 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
* 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
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Show 148 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, Lanarkshire | |
| Beijing Cancer Hospital Beijing, Beijing Municipality | |
| Beijing Hospital Beijing, Beijing Municipality | |
| Birmingham Heartlands Hospital Birmingham, | |
| Box Hill Hospital Box Hill, | |
| 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, | |
| Churchill Hospital Oxford University Hospital Nhs Trust Headington, | |
| Clatterbridge Cancer Centre Metropolitan Borough of Wirral, | |
| Cleveland Clinic Florida Palm Beach Gardens, Florida | |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| Concord Repatriation General Hospital Concord, | |
| 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 Koshigaya, Saitama | |
| 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, Shanghai Municipality | |
| Fujian Medical University Union Hospital Fuzhou, Fujian | |
| Fundacao Pio Xii Hospital de Amor de Barretos Barretos, | |
| 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 Buenos Aires, Buenos Aires F.D. | |
| Hospital Clinic de Barcelona Barcelona, | |
| Hospital Do Cancer de Pernambuco Recife, | |
| Hospital Erasto Gaertner Curitiba, Paraná | |
| 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, Rio Grande do Sul | |
| Ico H Duran I Reynals Barcelona, | |
| Institute of Science Tokyo Hospital Bunkyo-Ku, Tokyo | |
| Instituto Joinvilense De Hematologia e Oncologia Joinville, Santa Catarina | |
| 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, | |
| 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 Okayama, | |
| Liaoning Cancer Hospital and Institute Shenyang, Liaoning | |
| Linear Clinical Research Nedlands, Western Australia | |
| Linyi Cancer Hospital Linyi, Shandong | |
| 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, | |
| North Shore Hospital Auckland, | |
| Northwest Cancer Specialist, Pc(Us Oncology Research) Vancouver, Washington | |
| Ogaki Municipal Hospital Ōgaki, 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, | |
| 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, Malopolska | |
| Pusan National University Hospital Busan, | |
| Rockingham Hospital Cooloongup, Western Australia | |
| Rush University Medical Center Chicago, Illinois | |
| Samsung Medical Center Seoul, | |
| Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital Yonsei University Health System Seoul, | |
| Shaanxi Provincial Peoples Hospital Xi'an, Shaanxi | |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Chengdu, | |
| Stauferklinikum Schwabisch Gmund Kliniken Ostalb Mutlangen, | |
| Sun Yat Sen University Cancer Center Guangzhou, Guangdong | |
| 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, | |
| 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 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 Ibadan, | |
| 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 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 Sydney, New South Wales | |
| 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 CABA, |
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
PHASE3
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 | |
| All India Institute of Medical Sciences New Delhi, National Capital Territory of Delhi | |
| American Oncology Partners, PA Bethesda, Maryland | |
| Arthur J.E. Child Comprehensive Cancer Centre Calgary, Alberta | |
| Attikon General University Hospital Chaïdári, Attikí | |
| Austin Health Heidelberg, Victoria | |
| Auxilio Mutuo Cancer Center San Juan, | |
| Azienda Ospedaliera Ordine Mauriziano di Torino Torino, | |
| Azienda Ospedaliera Universitaria Careggi Florence, Tuscany | |
| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma Verona, | |
| BRCR Global Plantation, Florida | |
| Baptist MD Anderson Cancer Center Jacksonville, Florida | |
| Beijing Peking Union Medical College Hospital Beijing, Beijing Municipality | |
| 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, Lorraine | |
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau Tours, Indre-et-Loire | |
| Centre Hospitalier Universitaire d'Angers Angers, Pays de la Loire Region | |
| 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, Oaxaca | |
| 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 | |
| D&H Cancer Research Center LLC Margate, Florida | |
| Enroll SpA Santiago, | |
| FALP Santiago, | |
| Fakultni Nemocnice Ostrava Poruba, | |
| 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 Rome, Lazio | |
| 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 | |
| Hemato Oncology Clinic Ahmedabad, | |
| 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, | |
| 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, | |
| 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, | |
| 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, | |
| Institute of Medical Sciences and Sum Hospital Bhubaneswar, Odisha | |
| Institute of hematology&blood disease hospital Tianjin, Tianjin Municipality | |
| Instituto Alexander Fleming Buenos Aires, | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City, DIF | |
| Jiangsu Province Hospital Nanjing, Jiangsu | |
| 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 Salt Lake City, Utah | |
| Local Institution - 0031 Guangzhou, Guangdong | |
| Local Institution - 0034 Chicago, Illinois | |
| Local Institution - 0043 Changchun, Jilin | |
| Local Institution - 0075 Chengdu, Sichuan | |
| Local Institution - 0095 Cáceres, | |
| Local Institution - 0096 Majadahonda, Madrid, Comunidad de | |
| Local Institution - 0097 New Orleans, Louisiana | |
| Local Institution - 0098 Porto, | |
| Local Institution - 0109 Chile, Santiago Metropolitan | |
| Local Institution - 0117 Seongnam, Kyǒnggi-do | |
| Local Institution - 0118 Sendai, Miyagi | |
| Local Institution - 0119 Tokyo, | |
| Local Institution - 0120 Sagamihara, Kanagawa | |
| Local Institution - 0121 Shimotsuga, Tochigi | |
| Local Institution - 0122 Osaka, | |
| Local Institution - 0123 Huixquilucan, | |
| Local Institution - 0124 Nagasaki, | |
| Local Institution - 0125 Ōsaka-sayama, Osaka | |
| Local Institution - 0126 Mexico City, Mexico City | |
| Local Institution - 0177 Bengaluru, Karnataka | |
| Local Institution - 0185 Hyderabad, | |
| Local Institution - 0186 New Delhi, | |
| Local Institution - 0213 Seattle, Washington | |
| Local Institution - 0220 Xiamen, Fujian | |
| Local Institution - 0223 Chongqing, Chongqing Municipality | |
| Local Institution - 0230 Daytona Beach, Florida | |
| Local Institution - 0232 Pikeville, Kentucky | |
| Local Institution - 0237 San Juan, | |
| Local Institution - 0240 Honolulu, Hawaii | |
| Local Institution - 0242 Pátrai, Achaḯa | |
| Local Institution - 0250 Kempten (Allgäu), Bavaria | |
| Local Institution - 0255 Lübeck, | |
| Local Institution - 0273 Amagasaki, Hyōgo | |
| Local Institution - 0281 Oulu, North Ostrobothnia | |
| 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 | |
| Oncomédica S.A.S Montería, | |
| Onkologie Erding Erding, Bavaria | |
| Orchard Healthcare Research Inc. Skokie, Illinois | |
| Our Lady of the Lake RMC Baton Rouge, Louisiana | |
| Peking University People's Hospital Beijing, | |
| People's Hospital of Henan Province Zhengzhou, Henan | |
| Pindara Private Hospital Gold Coast, Queensland | |
| Pontchartrain Cancer Center Covington, Louisiana | |
| Pratia Onkologia Katowice Katowice, Silesian Voivodeship | |
| Praxis fur Hamatologie und Onkologie Berlin, | |
| Rajiv Gandhi Cancer Institute And Research Centre New Delhi, National Capital Territory of Delhi | |
| Royal Prince Alfred Hospital Camperdown, New South Wales | |
| Semmelweis Egyetem Budapest, | |
| Shaanxi Provincial People's Hospital Xi’an, Shanxi | |
| Shanghai Sixth People's Hospital Shanghai, Shanghai Municipality | |
| 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 Affiliated Hospital of Qingdao University Qingdao, | |
| The First Affiliated Hospital of NanChang University Nanchang, Jiangxi | |
| The First Affiliated Hospital of Soochow University Suzhou, | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang | |
| The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The First Hospital of China Medical University Shenyang, Liaoning | |
| The First Hospital of Harbin Harbin, Heilongjiang | |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus, Ohio | |
| The Second Afilliated Hospital of Hebei Medical University Shijiazhuang, Hebei | |
| UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) Los Angeles, California | |
| Unidad Médica Onco-Hematológica Puebla City, | |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei | |
| Universitaetsklinikum Duesseldorf Düsseldorf, | |
| Universitatsklinikum Jena Jena, Thuringia | |
| Universitatsklinikum Leipzig Leipzig, Saxony | |
| 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, Pomeranian Voivodeship | |
| 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, | |
| Xiangya Hospital Central South University Changsha, | |
| 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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Show 44 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth East Altamonte Oncology and Hematology Altamonte Springs, Florida | |
| Atrium Health Levine Cancer Institute Charlotte, 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 | |
| FirstHealth Outpatient Cancer Center Pinehurst, North Carolina | |
| Greater Baltimore Medical Center Baltimore, Maryland | |
| Holy Cross Hospital - Silver Spring Silver Spring, Maryland | |
| Hôpital du Saint-Sacrement Québec City, Quebec | |
| Jewish General Hospital Montreal, Quebec | |
| Joe Arrington Cancer Research & Treatment Center Lubbock, Texas | |
| Kaiser Permanente Medical Center Riverside, California | |
| Katmai Oncology Group - Anchorage Anchorage, Alaska | |
| Lahey Hospital & Medical Center Burlington, Massachusetts | |
| Maisonneuve-Rosemont Hospital (HMR) Montréal, Quebec | |
| McGill University Health - Glen Site Montréal, Quebec | |
| MedStar Georgetown Cancer Institute Baltimore, 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 | |
| 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 | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| St. Elizabeth Edgewood Hospital Edgewood, Kentucky | |
| St. Joseph'S Women'S Hospital Tampa, Florida | |
| Stanford Cancer Institute Stanford, 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 | |
| UNC Cancer Care at Nash Rocky Mount, North Carolina | |
| UPMC Magee - Womens Hospital Pittsburgh, Pennsylvania | |
| University of Maryland St. Joseph Medical Center Towson, Maryland | |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | |
| WVU Cancer Institute Morgantown, West Virginia | |
| 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
PHASE3
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 621 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 McKee Medical Center Loveland, Colorado | |
| Banner North Colorado Medical Center Greeley, 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 | Site Public Contact - (info@westernstatesncorp.org) |
| 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 Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | 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 | |
| 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, Alaska | Site Public Contact - (Veronica.Stevenson@foundationhealth.org) |
| 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, Missouri | |
| 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 Atlanta, Georgia | |
| 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) |
| 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 - South Portland South Portland, 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 | |
| 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) |
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Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative
ctrrecruit@vcu.edu
PHASE2
NCT04929041
Show full eligibility criteria
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Inclusion Criteria:
* Histologic or cytologic diagnosis of stage IV NSCLC using version American Joint Committee on Cancer (AJCC) 8th edition (includes M1a, M1b, and M1c stage disease). Patients with stage IIIB and IIIC disease are eligible if they are not a candidate for combined chemotherapy and radiation
* PD-L1 expression tumor proportion score (TPS) \< 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed patients are not eligible. The assay must have been performed locally by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory. The type of assay will be recorded
* For non-squamous patients only (adenocarcinoma or adenosquamous): EGFR, ALK and ROS1 testing must be done locally. No patients with known actionable EGFR mutations (except exon 20 insertion), ALK or ROS1 mutations that can be treated with oral tyrosine inhibitors
* Measurable disease based on RECIST 1.1, including at least two cancerous deposits. At least one deposit must be RECIST measurable (and not to be irradiated) while at least one OTHER deposit (measurable or non-measurable) must meet criteria for three 8 gray (Gy) doses of radiation
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* No more than three weeks of treatment with systemic chemotherapy or immunotherapy for advanced NSCLC
* No more than three weeks of treatment with checkpoint inhibitors for metastatic lung cancer
* No treatment with chemotherapy or immunotherapy for non-metastatic disease (e.g., adjuvant therapy) within 6 months prior to registration
* No systemic immunostimulatory or immunosuppressive drugs, including \> 10 mg prednisone equivalent per day, within 2 weeks or 5 half-live of the drug, whichever is shorter. Steroid premedication per local standard is allowed
* \>= 1 week prior to registration since palliative (including central nervous system \[CNS\]) radiotherapy to any tumor site
* No prior allogeneic tissue/solid organ transplant
* No uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements
* No current pneumonitis or history of non-infectious pneumonitis that required steroids
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration
* No active auto-immune disease that requires systemic therapy within 2 years prior to registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* No known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection
* No patients with symptomatic central nervous system metastases and/or carcinomatous meningitis. Patients with small asymptomatic brain metastases are eligible as are patients with treated brain metastases that require no steroids
* Not pregnant and not nursing, because this study involves radiation as well as potentially chemotherapy which have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 7 days prior to registration is required
* No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 2 years. Participants with non-melanoma skin cancers or carcinoma in-situ (e.g., breast carcinoma, urothelial carcinoma or cervical cancer in situ) or localized prostate cancer (T1-3, N0, M0) that have undergone potentially curative therapy are eligible
* No hypersensitivity (\>= grade 3) to immunotherapy and/or any of its excipients
* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed. COVID-19 vaccine is allowed
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Calculated (Calc.) creatinine clearance \>= 45 mL/min
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, BIOLOGICAL: Ipilimumab, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, RADIATION: Radiation Therapy
Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
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Show 167 locations
Study Locations
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| Location | Contacts |
|---|---|
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| 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) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| 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) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.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 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 | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duke Cancer Center Raleigh Raleigh, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke University Medical Center Durham, North Carolina | |
| Fremont - Rideout Cancer Center Marysville, California | |
| 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) |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Greater Regional Medical Center Creston, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.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 | |
| 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) |
| 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 Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| 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) |
| Mary Greeley Medical Center Ames, Iowa | |
| Mayo Clinic Health System-Franciscan Healthcare La Crosse, Wisconsin | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hospital North Colorado Springs, Colorado | |
| Memorial Medical Center Modesto, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Mercy Cancer Center-West Lakes Clive, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| 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 Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Morton Plant Hospital Clearwater, Florida | |
| Mount Sinai Chelsea New York, New York | |
| Mount Sinai Hospital New York, New York | |
| Mount Sinai West New York, New York | |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| 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) |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Penn State Health Saint Joseph Medical Center Reading, Pennsylvania | Site Public Contact - (dward1@pennstatehealth.psu.edu) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| 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 | |
| Providence Queen of The Valley Napa, California | |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Roswell Park Cancer Institute Buffalo, New York | |
| SUNY Upstate Medical Center-Community Campus Syracuse, New York | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| 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 Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Summa Health System - Akron Campus Akron, Ohio | Site Public Contact - (cancerresearch@summahealth.org) |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | Site Public Contact - (Gina.Cravey@bsahs.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 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) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| 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 Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| Upstate Cancer Center Radiation Oncology at Oswego Oswego, New York | Site Public Contact - (BinghamE@upstate.edu) |
| Upstate Cancer Center at Hill Radiation Oncology Syracuse, New York | Site Public Contact - (BinghamE@upstate.edu) |
| Upstate Cancer Center at 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) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Winter Haven Hospital Winter Haven, Florida | Site Public Contact - (Research.CTO@baycare.org) |
Testing the Combination of Two Anticancer Drugs M1774 (Tuvusertib) and Avelumab to Evaluate Their Safety and Effectiveness in Treating Merkel Cell Skin Cancer, MATRiX Trial
ctrrecruit@vcu.edu
PHASE2
NCT05947500
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Inclusion Criteria:
* REGISTRATION ELIGIBILITY: Patients must have a history of pathologically confirmed locally advanced/unresectable Merkel cell carcinoma or metastatic Merkel cell carcinoma
* REGISTRATION ELIGIBILITY: Patients must have evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
* REGISTRATION ELIGIBILITY: Patients must have had prior treatment with anti-PD-1 or anti-PD-L-1 antibody (e.g., pembrolizumab, avelumab, etc.) and have experienced progressive disease during treatment or within 120 days from the last dose of anti-PD-(L)1 therapy. Anti-PD-(L)1 therapy administered in combination with other agent(s) including ipilimumab is also allowed as prior therapy, if patients experienced progressive disease during treatment or within 120 days from the last dose of anti-PD-(L)1 therapy. The last dose of anti-PD-(L)1 antibody must be ≥ 14 days prior to planned C1D1. If participants are receiving or received cytotoxic chemotherapy as most recent therapy prior to screening for this trial, there must be clinically and/or radiologically documented progressive disease on or after chemotherapy prior to being eligible for this study. If the patient is receiving bridging chemotherapy, the most recent administration must be ≥ 14 days prior to planned cycle 1 day 1 (C1D1) of the clinical trial to be eligible
* REGISTRATION ELIGIBILITY: Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of M1774/tuvusertib in combination with avelumab in patients \< 18 years of age, children are excluded from this study
* REGISTRATION ELIGIBILITY: Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* REGISTRATION ELIGIBILITY: Absolute neutrophil count \>= 1,000/mcL
* REGISTRATION ELIGIBILITY: Platelets \>= 100,000/mcL
* REGISTRATION ELIGIBILITY: Total bilirubin =\< institutional upper limit of normal (ULN) or ≤ 1.5 x ULN for subjects with Gilbert's disease
* REGISTRATION ELIGIBILITY: Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN
* REGISTRATION ELIGIBILITY: Serum creatinine =\< 1.5 x institutional ULN
* (If serum creatinine is \> 1.5 x ULN, creatinine clearance needs to be ≥ 50 mL/min by Cockcroft-Gault calculation or by a measured 24-hour urine collection for the participant to be eligible.)
* REGISTRATION ELIGIBILITY: Hemoglobin \>= 9.0 g/dL
* REGISTRATION ELIGIBILITY: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* REGISTRATION ELIGIBILITY: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* REGISTRATION ELIGIBILITY: 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
* REGISTRATION ELIGIBILITY: Patients with treated brain metastases are eligible if follow-up brain imaging during screening shows no evidence of progressive brain metastases and it has been at least 4 weeks since central nervous system (CNS) directed therapy
* REGISTRATION ELIGIBILITY: 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
* REGISTRATION ELIGIBILITY: 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
* REGISTRATION ELIGIBILITY: The effects of M1774(tuvusertib) on the developing human fetus are unknown. For this reason and because ATR inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and, for the duration of study participation, and 6 months after completion of M1774 (tuvusertib) and avelumab 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 3 months after completion of M1774 (tuvusertib) and avelumab administration
* REGISTRATION ELIGIBILITY: 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
* CROSSOVER ELIGIBILITY: Patient was initially assigned to arm 1 (M1774/tuvusertib monotherapy) and completed at least 21 of 28 possible doses of M1774/ tuvusertib
* CROSSOVER ELIGIBILITY: Patients must have documented progressive disease per RECIST v 1.1
* CROSSOVER ELIGIBILITY: ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
* CROSSOVER ELIGIBILITY: Absolute neutrophil count ≥ 1,000/mcL (within 14 days of crossover registration)
* CROSSOVER ELIGIBILITY: Platelets ≥ 100,000/mcL (within 14 days of crossover registration)
* CROSSOVER ELIGIBILITY: Total bilirubin ≤ institutional upper limit of normal (ULN) or ≤ 1.5 x ULN for subjects with Gilbert's disease (within 14 days of crossover registration)
* CROSSOVER ELIGIBILITY: AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN (within 14 days of crossover registration)
* CROSSOVER ELIGIBILITY: Serum creatinine ≤ 1.5 x institutional ULN (within 14 days of crossover registration)
* (If serum creatinine is \> 1.5 x ULN, creatinine clearance needs to be ≥ 50 mL/min by Cockcroft-Gault calculation or by a measured 24-hour urine collection for the participant to be eligible.)
* CROSSOVER ELIGIBILITY: Hemoglobin ≥ 9.0 g/dL (within 14 days of crossover registration)
* CROSSOVER ELIGIBILITY: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* CROSSOVER ELIGIBILITY: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* CROSSOVER ELIGIBILITY: 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
* CROSSOVER ELIGIBILITY: Patients with treated brain metastases are eligible if follow-up brain imaging during screening shows no evidence of progressive brain metastases and it has been at least 4 weeks since central nervous system (CNS) directed therapy
* CROSSOVER ELIGIBILITY: 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
* CROSSOVER ELIGIBILITY: 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
* CROSSOVER ELIGIBILITY: The effects of M1774 (tuvusertib) on the developing human fetus are unknown. For this reason and because ATR inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and, for the duration of study participation, and 6 months after completion of M1774 (tuvusertib) and avelumab 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 3 months after completion of M1774 (tuvusertib) and avelumab administration
Exclusion Criteria:
* REGISTRATION EXCLUSION: Patients with life-threatening immune-related adverse events (IRAEs) related to prior anti-PD-(L)1 antibody. Patients with a history of IRAE of grade 4 (G4) severity (excluding thyroid or endocrine disorders now controlled) or IRAE of any severity that required permanent treatment discontinuation with prior immune checkpoint inhibitor (ICI) therapy due to toxicity
* REGISTRATION EXCLUSION: Patients with a prior history of ataxia telangiectasia
* REGISTRATION EXCLUSION: Patients who are receiving any other investigational agents
* REGISTRATION EXCLUSION: History of allergic reactions attributed to compounds of similar chemical or biologic composition to M1774/tuvusertib or avelumab
* REGISTRATION EXCLUSION: Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
* REGISTRATION EXCLUSION: Pregnant women are excluded from this study because M1774 (tuvusertib) and avelumab have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M1774 (tuvusertib) and avelumab breastfeeding should be discontinued if the mother is treated with M1774 (tuvusertib) or avelumab and for at least 1 month after the last dose of study medications. These potential risks may also apply to other agents used in this study
* REGISTRATION EXCLUSION: Patients who are not able to swallow orally administered medication or have gastrointestinal disorders likely to interfere with absorption of the study medication
* REGISTRATION EXCLUSION: Patients who cannot discontinue proton-pump inhibitors (PPIs)
* REGISTRATION EXCLUSION: 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 and neuropathy, which may be =\< grade 2. Patients with endocrinopathies requiring hormone replacement (such as hypothyroidism, autoimmune diabetes mellitus, adrenal insufficiency) will be allowed
* REGISTRATION EXCLUSION: M1774/ tuvusertib is primarily metabolized by aldehyde oxidase and to a lesser extent CYP3A4 and CYP1A2; therefore, concomitant administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir and saquinavir) and CYP1A2 or inducers of CYP3A4 (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) and CYP1A2 are prohibited. M1774/ tuvusertib is an inhibitor of MATE1 and MATE2K and substrates of these transporters are also prohibited. These include metformin, acyclovir, estrone sulfate, ciprofloxacin and cephalexin. Patients who are taking such medications who cannot discontinue or switch them to an acceptable alternative are not eligible
* Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of. One example of such a reference is here (https://go.drugbank.com/categories/DBCAT003956)
* 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
* REGISTRATION EXCLUSION: Patients who are on chronic corticosteroid treatment exceeding 10 mg prednisone daily (or equivalent) are excluded. Chronic corticosteroid use lower than this range is permitted
* REGISTRATION EXCLUSION: Patients with a QTcF (using the Fridericia correction calculation) of \> 470 msec
* CROSSOVER EXCLUSION: Patients with life-threatening immune-related adverse events (IRAEs) related to prior anti-PD-(L)1 antibody. Patients with a history of IRAE of G4 severity (excluding thyroid or endocrine disorders now controlled) or IRAE of any severity that required permanent treatment discontinuation with prior ICI therapy due to toxicity
* CROSSOVER EXCLUSION: Patients with a prior history of ataxia telangiectasia.
* CROSSOVER EXCLUSION: Patients who are receiving any other investigational agents
* CROSSOVER EXCLUSION: History of allergic reactions attributed to compounds of similar chemical or biologic composition to M1774/tuvusertib or avelumab
* CROSSOVER EXCLUSION: Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
* CROSSOVER EXCLUSION: Pregnant women are excluded from this study because M1774 (tuvusertib) and avelumab have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M1774 (tuvusertib) and avelumab breastfeeding should be discontinued if the mother is treated with M1774 (tuvusertib) or avelumab and for at least 1 month after the last dose of study medications. These potential risks may also apply to other agents used in this study
* CROSSOVER EXCLUSION: Patients who are not able to swallow orally administered medication or have gastrointestinal disorders likely to interfere with absorption of the study medication
* CROSSOVER EXCLUSION: Patients who cannot discontinue proton-pump inhibitors (PPIs)
* CROSSOVER EXCLUSION: 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 and neuropathy which may be ≤ grade 2. Additionally, anemia felt related to M1774/tuvusertib may be grade 2 as long as it exceeds requirement of hemoglobin \> 9 g/dL. Patients with endocrinopathies requiring hormone replacement (such as hypothyroidism, autoimmune diabetes mellitus, adrenal insufficiency) will be allowed
* CROSSOVER EXCLUSION: M1774/ tuvusertib is primarily metabolized by aldehyde oxidase and to a lesser extent CYP3A4 and CYP1A2; therefore, concomitant administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir and saquinavir) and CYP1A2 or inducers of CYP3A4 (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) and CYP1A2 are prohibited. M1774/ tuvusertib is an inhibitor of MATE1 and MATE2K and substrates of these transporters are also prohibited. These include metformin, acyclovir, estrone sulfate, ciprofloxacin and cephalexin. Patients who are taking such medications who cannot discontinue or switch them to an acceptable alternative are not eligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of. One example of such a reference is here (https://go.drugbank.com/categories/DBCAT003956). Patient Drug Information Handout and Wallet Card) should be provided to patients. 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
* CROSSOVER EXCLUSION: Patients who are on chronic corticosteroid treatment exceeding 10 mg prednisone daily (or equivalent) are excluded. Chronic corticosteroid use lower than this range is permitted
* CROSSOVER EXCLUSION: Patients with a QTcF (using the Fridericia correction calculation) of \> 470 msec DRUG: Avelumab, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, DRUG: Tuvusertib
Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Locally Advanced Merkel Cell Carcinoma, Metastatic Merkel Cell Carcinoma, Refractory Merkel Cell Carcinoma, Unresectable Merkel Cell Carcinoma
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Show 52 locations
Study Locations
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| Location | Contacts |
|---|---|
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| HaysMed Hays, Kansas | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Keck Medicine of USC Koreatown Los Angeles, California | |
| 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) |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| 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) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.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) |
| 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 | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| USC Norris Oncology/Hematology-Newport Beach Newport Beach, California | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| 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) |
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab (DeLLphi-305)
Amgen Call Center - medinfo@amgen.com
PHASE3
NCT06211036
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Inclusion:
* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Age \>= 18 years (or \>= legal adult age within the country if it is older than 18 years).
* Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
* Minimum life expectancy \> 12 weeks.
* Toxicities attributed to prior anti-cancer therapy resolved to grade ≤ 1, unless otherwise specified, excluding alopecia or fatigue.
* Adequate organ function.
* Histologically or cytologically documented extensive-stage disease (American Joint Committee on Cancer, 2017, IV small-cell lung cancer (SCLC) \[T any, N any, M1 a/b/c\]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Participants with prior limited-stage (LS)-SCLC are allowed if the interval is \> 6 months since the end of previous therapy and progression, in discussion with the medical monitor.
Exclusion
* Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. Participants with treated brain metastases are eligible as per protocol.
* Prior history of severe or life-threatening events from any immune-mediated therapy.
* History of other malignancy within the past 2 years, with some exceptions as per protocol.
* Active or prior documented autoimmune or inflammatory disorders as per protocol.
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months of first dose of study treatment.
* History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months of first dose of study treatment.
* Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
* History of solid organ transplant.
* Major surgical procedures within 28 days of first dose of study treatment.
* Known human immunodeficiency virus (HIV) infection (participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study), hepatitis C infection (participants with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (participants with hepatitis B surface antigen \[HBsAg\] or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study).
* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
* History of allergic reactions or acute hypersensitivity reaction to antibody therapies, platinum chemotherapy, or etoposide.
* Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.
* Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.
* Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for Monkeypox infection) within 30 days prior to first dose of study treatment.
* Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
* Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
* Treatment in an alternative investigational trial within 28 days prior to enrollment.
* Has received or is planning to receive consolidative chest radiation for extensive stage disease.
* Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment as per protocol.
* Female participants who are breastfeeding or who plan to breastfeed while on study as per protocol.
* Female participants planning to become pregnant or donate eggs while on study as per protocol.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment as per protocol.
* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment as per protocol.
* Male participants unwilling to abstain from donating sperm during treatment as per protocol.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or physician if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator's knowledge. Participants who are unable to complete clinical outcome assessments are eligible.
DRUG: Tarlatamab, DRUG: Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
Extensive-Stage Small-Cell Lung Cancer, ES-SCLC, Platinum, Etoposide, Durvalumab, Tarlatamab, AMG 757
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Show 219 locations
Study Locations
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| Location | Contacts |
|---|---|
| Affiliated Cancer Hospital of Xinjiang Medical University Ürümqi, Xinjiang | |
| Affiliated Hospital of Guilin Medical University Guilin, Guangxi | |
| Aichi Cancer Center Nagoya, Aichi-ken | |
| Algemeen Ziekenhuis Maria Middelares Ghent, | |
| Allegheny Health Network Pittsburgh, Pennsylvania | |
| Allina Health System dba Allina Health Cancer Institute Saint Paul, Minnesota | |
| Ankara Bilkent Sehir Hastanesi Ankara, | |
| Asan Medical Center Seoul, | |
| Asklepios Fachkliniken Muenchen Gauting Gauting, | |
| Astera Cancer Care East Brunswick, New Jersey | |
| Attikon University Hospital Athens, | |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milan, Milan | |
| Azorg Campus Aalst - Moorselbaan Aalst, | |
| Bagcilar Medipol Mega Universite Hastanesi Istanbul, | |
| Baptist Cancer Center Memphis Thoracic Memphis, Tennessee | |
| Beaumont Hospital Dublin, | |
| Beijing Cancer Hospital Beijing, Beijing Municipality | |
| Beijing Cancer Hospital Beijing, Beijing Municipality | |
| Beijing Chaoyang Hospital, Capital Medical University Beijing, Beijing Municipality | |
| CHU de Quebec Hopital de l Enfant Jesus Québec, Quebec | |
| Cancer Research South Australia Adelaide, South Australia | |
| Cancer and Hematology Centers of Western Michigan Grand Rapids, Michigan | |
| Cangzhou Peoples Hospital Cangzhou, Hebei | |
| Cenantron Centro Avançado de Tratamento Oncologico Ltda Belo Horizonte, Minas Gerais | |
| Centre Hospitalier - Le Mans Le Mans, | |
| Centre Hospitalier Intercommunal de Creteil Créteil, | |
| Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan Brest, | |
| Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec Saint-Herblain, | |
| Centre Hospitalier Universitaire Nord Marseille, | |
| Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil Strasbourg, | |
| Centre Hospitalier Universitaire de Toulouse - Hopital Larrey Toulouse, | |
| Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne Yvoir, | |
| Centre Leon Berard Lyon, | |
| Centres Hospitaliers Universitaires - Helora - Hopital de Mons - Site Kennedy Mons, | |
| Centro Ricerche Cliniche Di Verona Societa responsabilita limitata Verona, | |
| Chris Obrien Lifehouse Camperdown, New South Wales | |
| Chungbuk National University Hospital Cheongju Chungbuk, | |
| Clinica Universidad de Navarra Pamplona, Navarre | |
| Clinique Teissier Valenciennes, | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii Wroclaw, | |
| Duke University Durham, North Carolina | |
| Emory University Atlanta, Georgia | |
| Erasmus Medisch Centrum Rotterdam, | |
| European Interbalkan Medical Center Thessaloniki, | |
| Exelsus Oncologia Clinica San Miguel de Tucumán, Tucumán Province | |
| Fakultni nemocnice Brno Brno, | |
| Fakultni nemocnice Olomouc Olomouc, | |
| Fakultni nemocnice v Motole Prague, | |
| Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz Székesfehérvár, | |
| Franciscan Health Indianapolis Indianapolis, Indiana | |
| Fujian Cancer Hospital Fuzhou, | |
| Fundacao Antonio Prudente AC Camargo Cancer Center São Paulo, São Paulo | |
| Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer La Rioja, | |
| Fundacion Medica de Rio Negro y Neuquen Cipolletti, Río Negro Province | |
| Greenslopes Private Hospital Greenslopes, Queensland | |
| Guangxi Medical University Affiliated Tumor Hospital Nanning, Guangxi | |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz Győr, | |
| Health Pharma Professional Research SA de CV Mexico City, Mexico City | |
| Henan Cancer Hospital Zhengzhou, Henan | |
| Henry Dunant Hospital Center Athens, | |
| Hopital Cochin Paris, Île-de-France Region | |
| Hospital Britanico de Buenos Aires Ciudad de Buenos Aires, Buenos Aires | |
| Hospital CUF Descobertas Lisbon, | |
| Hospital Clinic i Provincial de Barcelona Barcelona, | |
| Hospital Cuf porto Porto, | |
| Hospital De La Santa Creu I Sant Pau Barcelona, Catalonia | |
| Hospital Israelita Albert Einstein Morumbi, São Paulo | |
| Hospital Regional Universitario de Malaga Málaga, Andalusia | |
| Hospital Sao Rafael-Idor Salvador, Estado de Bahia | |
| Hospital Universitari Vall d Hebron Barcelona, Catalonia | |
| Hospital Universitari i Politécnic La Fe Valencia, | |
| Hospital Universitario Ramon y Cajal Madrid, | |
| Hospital Universitario Virgen Macarena Seville, Andalusia | |
| Hospital Uopeccan Cascavel, Paraná | |
| Hospital da Luz, SA Lisbon, | |
| Hospital de Clinicas de Ijui Ijuí, Rio Grande do Sul | |
| Hospital de Clinicas de Passo Fundo Passo Fundo, | |
| Hubei Cancer Hospital Wuhan, Hubei | |
| Hyogo Cancer Center Akashi, Hyōgo | |
| IRCCS Istituto Oncologico Europeo Milan, | |
| IRCCS Istituto Tumori Giovanni Paolo II Bari, | |
| Infirmary Cancer Center Mobile, Alabama | |
| Inselspital Bern Bern, | |
| Institut Bergonie Bordeaux, Aquitaine | |
| Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals L'Hospitalet de Llobregat, Catalonia | |
| Institut Jules Bordet Anderlecht, | |
| Institut regional du Cancer Montpellier Montpellier, | |
| Instituto Alexander Fleming Buenos Aires, | |
| Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca Cluj-Napoca, | |
| Instytut Gruzlicy i Chorob Pluc Warsaw, | |
| Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre, Rio Grande do Sul | |
| Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi Izmir, | |
| Jiamusi Cancer Hospital Jiamusi, Heilongjiang | |
| Jiangxi Cancer Hospital Nanchang, Jiangxi | |
| Jilin Cancer Hospital Changchun, Jilin | |
| Juntendo University Hospital Bunkyo-ku, Tokyo | |
| Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center Yokohama, Kanagawa | |
| Kansai Medical University Hospital Hirakata-shi, Osaka | |
| Kantonsspital Sankt Gallen Sankt Gallen, | |
| Kaohsiung Chang Gung Memorial Hospital Kaohsiung City, | |
| Kindai University Hospital Osakasayama-shi, Osaka | |
| Kliniken der Stadt Koeln gGmbH Cologne, | |
| Kurume University Hospital Kurume-shi, Fukuoka | |
| Kyushu University Hospital Fukuoka, | |
| Landeskrankenhaus Feldkirch Rankweil, | |
| Linyi Cancer Hospital Linyi, Shandong | |
| London Health Sciences Centre London, Ontario | |
| LungenClinic Grosshansdorf GmbH Großhansdorf, | |
| Maastricht Universitair Medisch Centrum Maastricht, | |
| Matrai Gyogyintezet Gyöngyös, | |
| Mayo Clinic Rochester, Minnesota | |
| Medical Park Seyhan Hastanesi Mersin, | |
| Medical University of South Carolina Charleston, South Carolina | |
| Medizinische Universitaet Graz Graz, | |
| Meir Medical Center Kfar Saba, | |
| Metropolitan General Athens, | |
| Metropolitan Hospital Athens, | |
| Monash Medical Centre Clayton, Victoria | |
| Montefiore Medical Center - Bronx The Bronx, New York | |
| Nanjing Chest Hospital Nanjing, Jiangsu | |
| National Cancer Center Goyang-si Gyeonggi-do, | |
| National Cancer Center Hospital Tokyo, | |
| National Cancer Center Hospital East Kashiwa-shi, Chiba | |
| National Cheng Kung University Hospital Tainan City, | |
| National Hospital Organization Hokkaido Cancer Center Sapporo, Hokkaido | |
| National Hospital Organization Shikoku Cancer Center Matsuyama, Ehime | |
| National Taiwan University Hospital Taipei, | |
| Nebraska Cancer Specialists Omaha, Nebraska | |
| Nemocnice Agel Ostrava-Vitkovice as Ostrava-Vitkovice, | |
| Niigata Cancer Center Hospital Niigata, Niigata | |
| Northeast Georgia Medical Center Gainesville, Georgia | |
| Odense Universitetshospital Odense C, | |
| Okayama University Hospital Okayama, Okayama-ken | |
| Oncare Mexico City, Mexico City | |
| Oncoclinicas Rio de Janeiro S A Rio de Janeiro, | |
| Oncology Associates of Oregon, PC Eugene, Oregon | |
| Oncology Hematology Associates Springfield, Missouri | |
| Oncology Hematology Care Incorporated Cincinnati, Ohio | |
| Oregon Health and Science University Portland, Oregon | |
| Orszagos Koranyi Pulmonologiai Intezet Budapest, | |
| Osaka International Cancer Institute Osaka, Osaka | |
| Ospedale Regionale di Bellinzona e Vali Mendrisio, | |
| Our Lady of the Lake Cancer Institute Baton Rouge, Louisiana | |
| Prince of Wales Hospital, Chinese University of Hong Kong Shatin, New Territories, | |
| Princess Margaret Hospital Kowloon, | |
| Rabin Medical Center Petah Tikva, | |
| Rambam Medical Center Haifa, | |
| Reformatus Pulmonologiai Centrum Törökbálint, | |
| Regionshospitalet Godstrup Herning, | |
| Rigshospitalet Copenhagen, | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Lukes Hospital SA Thessaloniki, | |
| Saitama Medical University International Medical Center Saitama, | |
| Sakarya Egitim ve Arastirma Hastanesi Sakarya, | |
| Samsung Medical Center Seoul, | |
| Santa Casa de Misericordia de Passos Passos, Minas Gerais | |
| Sarah Cannon Research Institute Nashville, Tennessee | |
| Semmelweis Egyetem Budapest, | |
| Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital Yonsei University Health System Seoul, | |
| Shaare Zedek Medical Center Jerusalem, | |
| Shanghai Chest Hospital Shanghai, Shanghai Municipality | |
| Shanghai Pulmonary Hospital Shanghai, Shanghai Municipality | |
| Shanxi Provincial Cancer Hospital Taiyuan, Shanxi | |
| Shizuoka Cancer Center Sunto-gun, Shizuoka | |
| Sir Charles Gairdner Hospital Perth, | |
| Sotiria General Hospital Athens, | |
| Spitalul Municipal Ploiesti Ploieşti, | |
| Sun Yat-sen University Cancer Center Guangzhou, Guangdong | |
| Swedish Cancer Institute Seattle, Washington | |
| Taipei Veterans General Hospital Taipei, | |
| Texas Oncology - Dallas Fort Worth Dallas, Texas | |
| The Affiliated Cancer Hospital of Shandong First Medical University Jinan, Shandong | |
| The Affiliated Hospital of Inner Mongolia Medical University Hohhot, Inner Mongolia | |
| The Cancer Institute Hospital of Japanese Foundation For Cancer Research Koto-ku, Tokyo | |
| The First Affiliated Hospital of Ningbo University Ningbo, Zhejiang | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xian Jiaotong University Xi’an, Shanxi | |
| The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan | |
| The Medical College of Wisconsin Milwaukee, Wisconsin | |
| The Ohio State University Columbus, Ohio | |
| The Second Attached Hospital Of Fujian Medical University Quanzhou, Fujian | |
| Tianjin Peoples Hospital Tianjin, | |
| US Oncology Research Investigational Products Center Dallas, Texas | |
| Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano Matosinhos Municipality, | |
| UniversitaetsKlinikum Heidelberg Heidelberg, | |
| Universitaetsklinikum Dresden Dresden, | |
| Universitaetsklinikum Essen Essen, | |
| Universitaetsklinikum Krems Krems, | |
| Universitaetsklinikum Wuerzburg Würzburg, | |
| Universitaetsspital Basel Basel, | |
| Universitair Medisch Centrum Groningen Groningen, | |
| Universitair Ziekenhuis Antwerpen Edegem, Brussels Capital | |
| Universitair Ziekenhuis Brussel Brussels, | |
| Universite Catholique de Louvain Cliniques Universitaires Saint Luc Brussels, | |
| University Cancer and Blood Center LLC Athens, Georgia | |
| University Hospital Muenster Münster, | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of Illinois Chicago Chicago, Illinois | |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | |
| University of Southern California Los Angeles, California | |
| University of Texas MD Anderson Cancer Center Houston, Texas | |
| Uniwersyteckie Centrum Kliniczne Gdansk, Pomeranian Voivodeship | |
| VM Medical Park Mersin Hastanesi Mersin, | |
| Virginia Commonwealth University Massey Cancer Center Richmond, Virginia | |
| Virginia Oncology Associates Newport News, Virginia | |
| Vseobecna Fakultni Nemocnice v Praze Prague, | |
| Wakayama Medical University Hospital Wakayama, Wakayama | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| West China Hospital of Sichuan University Chengdu, Sichuan | |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow Poznan, | |
| Wollongong Hospital Wollongong, New South Wales | |
| Xinqiao Hospital Chongqing, Chongqing Municipality | |
| Xuzhou Central Hospital Xuzhou, Jiangsu | |
| Yale New Haven Hospital New Haven, Connecticut | |
| Ziekenhuis Oost-Limburg Genk, | |
| the First Affiliated Hospital Zhejiang University School of Medicine Hangzhou, Zhejiang |
Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma
ctrrecruit@vcu.edu
PHASE3
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
* 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)
* Lactate dehydrogenase (LDH) \< 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 active autoimmune disease requiring systemic 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 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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Show 228 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| 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 Toms River, New Jersey | 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 Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| 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 | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | |
| 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 | |
| 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) |
| 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) |
| 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 | |
| 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) |
| 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) |
| 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 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 Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, 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 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) |
| 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) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| 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 | |
| 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 - (tmyrick@uab.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 - 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 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 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) |
| 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) |
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
PHASE3
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 City, 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 City, | |
| 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 | |
| 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 | |
| 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 |