AzTrials
AzTrials

Refractory Differentiated Thyroid Gland CarcinomaPhase 3NCT06475989

Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer

A Phase 3 study testing Biospecimen Collection, Cabozantinib and Computed Tomography in people with Refractory Differentiated Thyroid Gland Carcinoma, run by ECOG-ACRIN Cancer Research Group at 307 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial summary

This phase III trial compares the effect of cabozantinib versus combination dabrafenib and trametinib for the treatment of patients with differentiated thyroid cancer that does not respond to treatment (refractory) and which expresses a BRAF V600E mutation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Cabozantinib and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
307 sitesUnited States
Study dates
27 Dec 2024to 30 Sep 2030
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be ≥ 18 years of age
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patient must have differentiated thyroid cancer (DTC) with BRAF V600E mutation as determined by local testing, including the following subtypes (Note: results of a previous biopsy will be accepted):
  • Papillary thyroid carcinoma including histological variants of papillary thyroid carcinoma (PTC) such as follicular variant, tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin-like, trabecular, tumor with nodular fasciitis-like stroma, Hürthle cell variant of papillary carcinoma, poorly differentiated.
  • Follicular thyroid carcinoma including histological variants of follicular thyroid carcinoma (FTC) such as Hürthle cell, clear cell, insular, and poorly differentiated
  • Patient must have been previously treated with or deemed ineligible for treatment with Iodine-131 for DTC, and must be receiving thyroxine suppression therapy
Show all 49Show fewer
  • Patient must have had prior treatment with at least one of the following vascular endothelial growth factor receptors (VEGFR)-targeting tyrosine kinase inhibitor (TKI) agents for DTC: lenvatinib or sorafenib.
  • NOTE: Up to two prior VEGFR-targeting TKI agents are allowed including, but not limited to lenvatinib and sorafenib
  • Patient must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1·1 on chest CT (computed tomography)/abdominal/pelvis CT/MRI (magnetic resonance imaging) performed within 4 weeks prior to randomization
  • Patient must have radiographic progression by RECIST 1.1 over any time interval on or after most recent prior systemic treatment
  • Patient must not have any of the following cardiovascular and thromboembolic disorders or medical conditions:
  • Congestive heart failure class 3 or 4 as defined by the New York Heart Association, unstable angina pectoris, or serious cardiac arrhythmias.
  • Uncontrolled hypertension defined as sustained blood pressure > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment.
  • Stroke, myocardial infarction, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months prior to randomization. Patients with more recent diagnosis of deep venous thrombosis are allowed if stable and treated with therapeutic anticoagulation for at least 6 weeks prior to randomization
  • Patient must not have any clinically significant hematemesis or haemoptysis of > 0·5 teaspoon (> 2·5 mL) of red blood or history of other significant bleeding within 3 months prior to randomization
  • Patient must not have any cavitating pulmonary lesion(s) or lesions invading major pulmonary blood vessels
  • Patient must not be on any concomitant anticoagulation with oral anticoagulants or platelet inhibitors, except for the following allowed agents:
  • Low-dose aspirin for cardioprotection.
  • Therapeutic anticoagulation with any agent in patients (1) without known brain metastases, (2) on a stable dose for at least 6 weeks prior to randomization, and (3) with no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
  • Patient must not have any gastrointestinal (GI) disorders associated with a high risk of perforation or fistula formation:
  • Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction
  • Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months prior to randomization
  • Patient must have completed any prior local therapy (e.g., surgery, radiation, ablation) at least 4 weeks prior to randomization, with complete wound healing and resolution of clinically relevant complications from prior local therapy
  • Patient must not have had major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Complete wound healing from major surgery must have occurred 4 weeks prior to randomization and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days prior to randomization
  • Patient must not have pathologically documented anaplastic histology or transformation on any recurrence specimen collected after initial thyroidectomy/neck dissection
  • Patient must not have had prior treatment with cabozantinib or any prior BRAF targeted therapy for thyroid cancer
  • NOTE: Prior treatment with checkpoint inhibitor (e.g., pembrolizumab) for thyroid cancer is allowed, but must be noted on the eCRF (electronic case report form)
  • 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 someone, regardless of 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)
  • Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 2 weeks after the last dose of dabrafenib and 4 months after the last dose of trametinib or cabozantinib. Patients must also not breastfeed while on study treatment and for 2 weeks after the last dose of dabrafenib and for 4 months after the last dose of trametinib or cabozantinib.
  • NOTE: Patients of childbearing potential who are on hormonal contraceptives may be at risks because dabrafenib may decrease the efficacy of hormonal contraceptives. An effective non-hormonal contraception should be used during therapy and for 2 weeks following discontinuation of dabrafenib and at least 4 months following the last dose of trametinib and cabozantinib
  • 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
  • Hemoglobin (Hgb) ≥ 8 g/dL obtained ≤ 28 days prior to protocol randomization
  • Leukocytes ≥ 3,000/mcL obtained ≤ 28 days prior to protocol randomization
  • Absolute neutrophil count (ANC) ≥ 1,500/mcL obtained ≤ 28 days prior to protocol randomization
  • Platelets ≥ 100,000/mcL obtained ≤ 28 days prior to protocol randomization
  • Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) obtained ≤ 28 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 ULN or < 5.0 x ULN with the presence of hepatic metastasis obtained ≤ 28 days prior to protocol randomization
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² obtained ≤ 28 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 obtained after central nervous system (CNS)-directed therapy (radiotherapy and/or surgery) shows no evidence of progression. CNS disease must be stable for at least 4 weeks prior to randomization; patients must be neurologically asymptomatic and without corticosteroid treatment at time of randomization
  • 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 must have corrected QT interval calculated by the Fridericia formula (QTcF) ≤ 500 ms obtained within 28 days prior to randomization.
  • NOTE: If a single electrocardiogram (ECG) shows a QTcF with an absolute value > 500 ms, two additional ECGs at intervals of approximately 3 minutes (min) must be performed within 30 min after the initial ECG, and the average of these 3 consecutive results for QTcF will be used to determine eligibility
  • Patient must be English or Spanish speaking to be eligible for the quality of life (QOL) component of the study.
  • NOTE: Sites cannot translate the associated QOL forms

Who cannot join

None listed.

Trial locations and contacts

307 sites in 1 country. Contact the study team or a site near you to ask about taking part.

300 sites in 1 country

United States300 sites, 282 recruiting
  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

    Site Public Contact, 360-412-8958, deidre.dillon@providence.org

    Alison K. Conlin

    Recruiting
  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Tareq Al baghdadi

    Recruiting
  • MyMichigan Medical Center Gratiot

    Alma, Michigan, 48801

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Tareq Al baghdadi

    Recruiting
  • MyMichigan Medical Center Alpena

    Alpena, Michigan, 49707

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Tareq Al baghdadi

    Recruiting
  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

    Site Public Contact, 618-463-5623

    Jay W. Carlson

    Recruiting
  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting
  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Alison K. Conlin

    Recruiting
  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

    Suspended
  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Alison K. Conlin

    Recruiting
  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Alison K. Conlin

    Recruiting
  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Alison K. Conlin

    Recruiting
  • Katmai Oncology Group

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Alison K. Conlin

    Recruiting
  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Alison K. Conlin

    Recruiting
  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting
  • Trinity Health IHA - Obstetrics and Gynecology West Arbor

    Ann Arbor, Michigan, 48103

    Site Public Contact, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    Francis P. Worden

    Recruiting
  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Dong M. Shin

    Recruiting
  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Site Public Contact, 720-848-0650

    Daniel W. Bowles

    Recruiting
  • Advocate Outpatient Center - Aurora

    Aurora, Illinois, 60506

    Site Public Contact, ncorp@aah.org

    Thomas J. Saphner

    Recruiting
  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Tareq Al baghdadi

    Recruiting
  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting
  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Site Public Contact, 800-888-8823

    Ranee Mehra

    Recruiting
  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

    Site Public Contact, 847-842-4847

    Thomas J. Saphner

    Recruiting
  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

    Site Public Contact, 360-788-8223, achapman1@peacehealth.org

    Alison K. Conlin

    Recruiting
  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

    Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting
  • Saint Charles Health System

    Bend, Oregon, 97701

    Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org

    Alison K. Conlin

    Recruiting
  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Tareq Al baghdadi

    Recruiting
  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

    Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu

    Douglas E. Laux

    Recruiting
  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting
  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting
  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Alison K. Conlin

    Recruiting
  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

    Site Public Contact, 913-948-5588, aroland@kccop.org

    Jay W. Carlson

    Recruiting
  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting
  • Cox Cancer Center Branson

    Branson, Missouri, 65616

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

    Site Public Contact, 800-865-1125

    Francis P. Worden

    Recruiting
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

    Site Public Contact, 818-847-4793, Najee.Boucher@providence.org

    Alison K. Conlin

    Recruiting
  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting
  • Caro Cancer Center

    Caro, Michigan, 48723

    Suspended
  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

    Site Public Contact, 515-689-7658, sbenson@iora.org

    Seema Harichand-Herdt

    Recruiting
  • Duke Cancer Center Cary

    Cary, North Carolina, 27518

    Suspended
  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-365-4673

    Deborah W. Wilbur

    Recruiting
  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-363-2690

    Deborah W. Wilbur

    Recruiting
  • Saint Mary's Hospital

    Centralia, Illinois, 62801

    Suspended
  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

    Site Public Contact, 360-412-8958, deidre.dillon@providence.org

    Alison K. Conlin

    Recruiting
  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Siddharth Sheth

    Recruiting
  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    John M. Kaczmar

    Recruiting
  • Minnesota Oncology Hematology PA-Chaska

    Chaska, Minnesota, 55318

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Memorial Hospital of Laramie County

    Cheyenne, Wyoming, 82001

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    John M. Schallenkamp

    Recruiting
  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Jochen H. Lorch

    Recruiting
  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    Frank Weinberg

    Recruiting
  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Ari J. Rosenberg

    Recruiting
  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Site Public Contact, 773-296-5360

    Thomas J. Saphner

    Recruiting
  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Brendan J. Knapp

    Recruiting
  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting
  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

    Suspended
  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

    Suspended
  • Trinity Health IHA Medical Group - Primary Care - Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 248-858-6215, Emily.Crofts@Trinity-Health.org

    Tareq Al baghdadi

    Recruiting
  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting
  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting
  • Billings Clinic-Cody

    Cody, Wyoming, 82414

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting
  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting
  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Minnesota Oncology - Coon Rapids

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Bay Area Hospital

    Coos Bay, Oregon, 97420

    Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org

    Alison K. Conlin

    Recruiting
  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

    Site Public Contact, 712-322-4136

    Yungpo B. Su

    Recruiting
  • Methodist Jennie Edmundson Hospital

    Council Bluffs, Iowa, 51503

    Site Public Contact, 402-354-7939, kathryn.bartz@nmhs.org

    Yungpo B. Su

    Recruiting
  • Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ

    Council Bluffs, Iowa, 51503

    Site Public Contact, 402-354-5892, Liza.brandes@nmhs.org

    Yungpo B. Su

    Recruiting
  • Greater Regional Medical Center

    Creston, Iowa, 50801

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting
  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Brendan J. Knapp

    Recruiting
  • UChicago Medicine Northwest Indiana

    Crown Point, Indiana, 46307

    Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Ari J. Rosenberg

    Recruiting
  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

    Site Public Contact, 630-929-6129, advocateresearch@advocate.com

    Thomas J. Saphner

    Recruiting
  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Jochen H. Lorch

    Recruiting
  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting
  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

    Site Public Contact, 515-282-2200

    Seema Harichand-Herdt

    Recruiting
  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting
  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting
  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

    Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org

    Tareq Al baghdadi

    Recruiting
  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

    Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com

    Thomas J. Saphner

    Recruiting
  • Duke University Medical Center

    Durham, North Carolina, 27710

    Site Public Contact, 888-275-3853

    Neal E. Ready

    Recruiting
  • Henry Ford River District Hospital

    East China, Michigan, 48054

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Tareq Al baghdadi

    Recruiting
  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Tareq Al baghdadi

    Recruiting
  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Dean A. Delmastro

    Recruiting
  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Minnesota Oncology - Edina

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Alison K. Conlin

    Recruiting
  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

    Site Public Contact, 847-429-2907

    Thomas J. Saphner

    Recruiting
  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

    Suspended
  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Dan P. Zandberg

    Recruiting
  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

    Site Public Contact, 425-261-3529, marilyn.birchman@providence.org

    Alison K. Conlin

    Recruiting
  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

    Site Public Contact, 907-458-3043, Veronica.Stevenson@foundationhealth.org

    John M. Schallenkamp

    Recruiting
  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • Sanford South University Medical Center

    Fargo, North Dakota, 58103

    Site Public Contact, 701-234-6161

    Daniel Almquist

    Recruiting
  • Southpointe-Sanford Medical Center Fargo

    Fargo, North Dakota, 58103

    Site Public Contact, 605-312-3320

    Daniel Almquist

    Recruiting
  • Sanford Medical Center Fargo

    Fargo, North Dakota, 58104

    Site Public Contact, 800-437-4010

    Daniel Almquist

    Recruiting
  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting
  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting
  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Tareq Al baghdadi

    Recruiting
  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Tareq Al baghdadi

    Recruiting
  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Tareq Al baghdadi

    Recruiting
  • Hurley Medical Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Tareq Al baghdadi

    Recruiting
  • UI Healthcare Mission Cancer and Blood - Fort Dodge

    Fort Dodge, Iowa, 50501

    Site Public Contact, 515-282-2921, trials@missioncancer.com

    Seema Harichand-Herdt

    Recruiting
  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

    Site Public Contact, eileen.georgi@holy-cross.com

    Tareq Al baghdadi

    Recruiting
  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

    Site Public Contact, 800-378-9373

    Jay W. Carlson

    Recruiting
  • Vanderbilt-Ingram Cancer Center Cool Springs

    Franklin, Tennessee, 37067

    Suspended
  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Alison K. Conlin

    Recruiting
  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

    Site Public Contact, 913-948-5588, aroland@kccop.org

    Jay W. Carlson

    Recruiting
  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Jochen H. Lorch

    Recruiting
  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • MyMichigan Medical Center Gladwin

    Gladwin, Michigan, 48624

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Tareq Al baghdadi

    Recruiting
  • Smilow Cancer Hospital Care Center at Glastonbury

    Glastonbury, Connecticut, 06033

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

    Site Public Contact, 312-695-1102

    Jochen H. Lorch

    Recruiting
  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Tareq Al baghdadi

    Recruiting
  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

    Site Public Contact, 312-695-1102

    Jochen H. Lorch

    Recruiting
  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

    Site Public Contact, 913-948-5588, aroland@kccop.org

    Jay W. Carlson

    Recruiting
  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting
  • Great Falls Clinic

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting
  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • Henry Ford Saint John Hospital - Academic

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Tareq Al baghdadi

    Recruiting
  • Henry Ford Saint John Hospital - Breast

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, karen.forman@ascension.org

    Tareq Al baghdadi

    Recruiting
  • Henry Ford Saint John Hospital - Van Elslander

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Tareq Al baghdadi

    Recruiting
  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • Hi-Line Sletten Cancer Center

    Havre, Montana, 59501

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    John M. Schallenkamp

    Recruiting
  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

    Site Public Contact, 708-799-9995

    Thomas J. Saphner

    Recruiting
  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Tareq Al baghdadi

    Recruiting
  • Benefis Helena Specialty Center

    Helena, Montana, 59601

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting
  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

    Site Public Contact, 720-848-0650

    Daniel W. Bowles

    Recruiting
  • Providence Hood River Memorial Hospital

    Hood River, Oregon, 97031

    Site Public Contact, 503-215-1979, canrsrchstudies@provdience.org

    Alison K. Conlin

    Recruiting
  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Site Public Contact, 800-237-1225

    Douglas E. Laux

    Recruiting
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Shirin Attarian

    Recruiting
  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Alison K. Conlin

    Recruiting
  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Active, not recruiting
  • Freeman Health System

    Joplin, Missouri, 64804

    Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com

    Jay W. Carlson

    Recruiting
  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

    Site Public Contact, 417-556-3074, esmeralda.carrillo@mercy.net

    Jay W. Carlson

    Recruiting
  • Logan Health Medical Center

    Kalispell, Montana, 59901

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting
  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

    Site Public Contact, 509-783-4637, research@kadlecmed.org

    Alison K. Conlin

    Recruiting
  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

    Site Public Contact, 360-412-8958, deidre.dillon@providence.org

    Alison K. Conlin

    Recruiting
  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Site Public Contact, cancertrials@northwestern.edu

    Jochen H. Lorch

    Recruiting
  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    Tareq Al baghdadi

    Recruiting
  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

    Site Public Contact, 877-231-4440

    Minh Phan

    Recruiting
  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    Omar M. El Kawkgi

    Recruiting
  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

    Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com

    Thomas J. Saphner

    Recruiting
  • Condell Memorial Hospital

    Libertyville, Illinois, 60048

    Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com

    Thomas J. Saphner

    Recruiting
  • CARTI Cancer Center

    Little Rock, Arkansas, 72205

    Site Public Contact, 501-906-4199, Research@CARTI.com

    Jay W. Carlson

    Recruiting
  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

    Site Public Contact, 360-514-2016, kmakin-bond@peacehealth.org

    Alison K. Conlin

    Recruiting
  • Henry Ford Saint John Hospital - Macomb Medical

    Macomb, Michigan, 48044

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Tareq Al baghdadi

    Recruiting
  • Henry Ford Warren Hospital - Breast Macomb

    Macomb, Michigan, 48044

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Tareq Al baghdadi

    Recruiting
  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Minnesota Oncology - Maple Grove

    Maple Grove, Minnesota, 55369

    Site Public Contact, 952-993-1572, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

    Suspended
  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Dean A. Delmastro

    Recruiting
  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Alison K. Conlin

    Recruiting
  • MyMichigan Medical Center Midland

    Midland, Michigan, 48670

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Tareq Al baghdadi

    Recruiting
  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Health Partners Inc

    Minneapolis, Minnesota, 55454

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Dean A. Delmastro

    Recruiting
  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

    Site Public Contact, 406-327-3118, amy.hanneman@providence.org

    Alison K. Conlin

    Recruiting
  • Community Medical Center

    Missoula, Montana, 59804

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting
  • Monticello Cancer Center

    Monticello, Minnesota, 55362

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • MyMichigan Medical Center Mount Pleasant

    Mount Pleasant, Michigan, 48858

    Site Public Contact, 989-631-2469, CVResearch@mymichigan.org

    Tareq Al baghdadi

    Recruiting
  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

    Site Public Contact, 618-899-1894, gayla.hall@ssmhealth.com

    Jay W. Carlson

    Recruiting
  • Skagit Regional Health Cancer Care Center

    Mount Vernon, Washington, 98274

    Site Public Contact, 360-814-2182, rcccclinicalresearch@skagitvalleyhospital.org

    Alison K. Conlin

    Recruiting
  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Tareq Al baghdadi

    Recruiting
  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Tareq Al baghdadi

    Recruiting
  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Alison K. Conlin

    Recruiting
  • Providence Queen of The Valley

    Napa, California, 94558

    Site Public Contact, 707-521-3830

    Alison K. Conlin

    Recruiting
  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204

    Site Public Contact, 800-811-8480

    Jennifer H. Choe

    Recruiting
  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

    Site Public Contact, 800-811-8480

    Jennifer H. Choe

    Recruiting
  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut, 06510

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • Yale University

    New Haven, Connecticut, 06520

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Ari J. Rosenberg

    Recruiting
  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting
  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444

    Site Public Contact, 616-391-1230, connie.szczepanek@crcwm.org

    Tareq Al baghdadi

    Recruiting
  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

    Site Public Contact, 800-323-8622

    Thomas J. Saphner

    Recruiting
  • Advocate Outpatient Center - Oak Lawn

    Oak Lawn, Illinois, 60453

    Site Public Contact, ncorp@aah.org

    Thomas J. Saphner

    Recruiting
  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Minh Phan

    Recruiting
  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

    Site Public Contact, 405-752-3402

    Jay W. Carlson

    Recruiting
  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

    Omaha, Nebraska, 68114

    Site Public Contact, 402-334-4773

    Yungpo B. Su

    Recruiting
  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Site Public Contact, 402-354-5144

    Yungpo B. Su

    Recruiting
  • Oncology Associates PC

    Omaha, Nebraska, 68114

    Suspended
  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Tareq Al baghdadi

    Recruiting
  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Shirin Attarian

    Recruiting
  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting
  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Jochen H. Lorch

    Recruiting
  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Ari J. Rosenberg

    Recruiting
  • Lake Regional Hospital

    Osage Beach, Missouri, 65065

    Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com

    Jay W. Carlson

    Recruiting
  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

    Site Public Contact, 650-498-7061, cancertrialsinfo@stanford.edu

    Saad A. Khan

    Recruiting
  • Advocate High Tech Medical Park

    Palos Heights, Illinois, 60463

    Site Public Contact, ncorp@aah.org

    Thomas J. Saphner

    Recruiting
  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Site Public Contact, 847-384-3621

    Thomas J. Saphner

    Recruiting
  • UI Healthcare Mission Cancer and Blood - Pella

    Pella, Iowa, 50219

    Site Public Contact, 515-282-2921, trials@missioncancer.com

    Seema Harichand-Herdt

    Recruiting
  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

    Site Public Contact, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu

    Lova Sun

    Recruiting
  • Mercy Hospital Pittsburg

    Pittsburg, Kansas, 66762

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting
  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Dan P. Zandberg

    Recruiting
  • Hope Cancer Center

    Pontiac, Michigan, 48341

    Suspended
  • Michigan Healthcare Professionals Pontiac

    Pontiac, Michigan, 48341

    Site Public Contact, 248-858-6215, Emily.Crofts@trinity-health.org

    Tareq Al baghdadi

    Recruiting
  • Newland Medical Associates-Pontiac

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting
  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting
  • Oregon Health and Science University

    Portland, Oregon, 97239

    Active, not recruiting
  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting
  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Duke Cancer Center Raleigh

    Raleigh, North Carolina, 27609

    Suspended
  • Saint Charles Health System-Redmond

    Redmond, Oregon, 97756

    Site Public Contact, 541-706-2909

    Alison K. Conlin

    Recruiting
  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Dean A. Delmastro

    Recruiting
  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Active, not recruiting
  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

    Site Public Contact, 573-458-6379

    Jay W. Carlson

    Recruiting
  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

    Site Public Contact, 573-458-7504, research@phelpshealth.org

    Jay W. Carlson

    Recruiting
  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

    Suspended
  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

    Site Public Contact, 816-271-7937, Trisha.England2@mymlc.com

    Jay W. Carlson

    Recruiting
  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Regions Hospital

    Saint Paul, Minnesota, 55101

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • United Hospital

    Saint Paul, Minnesota, 55102

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

    Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu

    Kathleen C. Kerrigan

    Recruiting
  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting
  • Providence Medical Foundation - Santa Rosa

    Santa Rosa, California, 95403

    Site Public Contact, 707-521-3830

    Alison K. Conlin

    Recruiting
  • Providence Santa Rosa Memorial Hospital

    Santa Rosa, California, 95405

    Site Public Contact, 707-521-3830

    Alison K. Conlin

    Recruiting
  • Swedish Medical Center-Ballard Campus

    Seattle, Washington, 98107

    Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org

    Alison K. Conlin

    Recruiting
  • Swedish Medical Center-Cherry Hill

    Seattle, Washington, 98122-5711

    Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org

    Alison K. Conlin

    Recruiting
  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Alison K. Conlin

    Recruiting
  • PeaceHealth United General Medical Center

    Sedro-Woolley, Washington, 98284

    Site Public Contact, 360-788-8239, achapman1@peacehealth.org

    Alison K. Conlin

    Recruiting
  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Welch Cancer Center

    Sheridan, Wyoming, 82801

    Suspended
  • Memorial Hospital East

    Shiloh, Illinois, 62269

    Site Public Contact, 314-747-9912, dschwab@wustl.edu

    Brendan J. Knapp

    Recruiting
  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

    Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org

    Daniel Almquist

    Recruiting
  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

    Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org

    Daniel Almquist

    Recruiting
  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

    Site Public Contact, 509-228-1680, research@ccnw.net

    Alison K. Conlin

    Recruiting
  • Cancer Care Northwest-Valley

    Spokane, Washington, 99216

    Site Public Contact, 509-228-1680, research@ccnw.net

    Alison K. Conlin

    Recruiting
  • Cancer Care Northwest-North Spokane

    Spokane, Washington, 99218

    Site Public Contact, 509-228-1680, research@ccnw.net

    Alison K. Conlin

    Recruiting
  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting
  • CoxHealth South Hospital

    Springfield, Missouri, 65807

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting
  • Mercy Infusion Center - Chippewa

    St Louis, Missouri, 63109

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting
  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Brendan J. Knapp

    Recruiting
  • Mercy Hospital South

    St Louis, Missouri, 63128

    Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net

    Jay W. Carlson

    Recruiting
  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Brendan J. Knapp

    Recruiting
  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Brendan J. Knapp

    Recruiting
  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

    Site Public Contact, 314-251-7066

    Jay W. Carlson

    Recruiting
  • Smilow Cancer Hospital Care Center at Long Ridge

    Stamford, Connecticut, 06902

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Dean A. Delmastro

    Recruiting
  • Lakeview Hospital

    Stillwater, Minnesota, 55082

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • MyMichigan Medical Center Tawas

    Tawas City, Michigan, 48764

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Tareq Al baghdadi

    Recruiting
  • Sanford Thief River Falls Medical Center

    Thief River Falls, Minnesota, 56701

    Site Public Contact, 605-312-3320

    Daniel Almquist

    Recruiting
  • Smilow Cancer Hospital-Torrington Care Center

    Torrington, Connecticut, 06790

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Alison K. Conlin

    Recruiting
  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

    Site Public Contact, 360-514-3940, kmakin-bond@peacehealth.org

    Alison K. Conlin

    Recruiting
  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting
  • Providence Saint Mary Regional Cancer Center

    Walla Walla, Washington, 99362

    Site Public Contact, 509-897-5993, Cheryl.Dodd@providence.org

    Alison K. Conlin

    Recruiting
  • Henry Ford Health Warren Hospital

    Warren, Michigan, 48093

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Tareq Al baghdadi

    Recruiting
  • Henry Ford Madison Heights Hospital - Breast

    Warren, Michigan, 48093

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Tareq Al baghdadi

    Recruiting
  • Henry Ford Warren Hospital - GLCMS

    Warren, Michigan, 48093

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Tareq Al baghdadi

    Recruiting
  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Jochen H. Lorch

    Recruiting
  • Mercy Hospital Washington

    Washington, Missouri, 63090

    Site Public Contact, 636-390-1600

    Jay W. Carlson

    Recruiting
  • Smilow Cancer Hospital-Waterbury Care Center

    Waterbury, Connecticut, 06708

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • Smilow Cancer Hospital Care Center - Waterford

    Waterford, Connecticut, 06385

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting
  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting
  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting
  • Saint Mary's Oncology/Hematology Associates of West Branch

    West Branch, Michigan, 48661

    Suspended
  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting
  • The Iowa Clinic PC

    West Des Moines, Iowa, 50266

    Site Public Contact, 515-875-9815

    Seema Harichand-Herdt

    Recruiting
  • Smilow Cancer Hospital Care Center - Westerly

    Westerly, Rhode Island, 02891

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Phase III Study of BRAF-Targeted Therapy vs Cabozantinib in RAI-Refractory Differentiated Thyroid Cancer With BRAF V600Em

This phase III trial compares the effect of cabozantinib versus combination dabrafenib and trametinib for the treatment of patients with differentiated thyroid cancer that does not respond to treatment (refractory) and which expresses a BRAF V600E mutation. Cabozantinib is in a class of medications called receptor tyrosine kinase inhibitors. It binds to and blocks the action of several enzymes which are often over-expressed in a variety of tumor cell types. This may help stop or slow the growth of tumor cells and blood vessels the tumor needs to survive. Dabrafenib is an enzyme inhibitor that binds to and inhibits the activity of a protein called B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. Trametinib is also an enzyme inhibitor. It binds to and inhibits the activity of proteins called MEK 1 and 2, which play a key role in activating pathways that regulate cell growth. This may inhibit the growth of tumor cells mediated by these pathways. The usual approach for patients with thyroid cancer is targeted therapy with dabrafenib and trametinib. This trial may help researchers decide which treatment option (cabozantinib alone or dabrafenib in combination with trametinib) is safer and/or more effective in treating patients with refractory BRAF V600E-mutated differentiated thyroid cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare progression-free survival (PFS) in patients with BRAF V600Em differentiated thyroid cancer who progressed on frontline multikinase inhibitor treated with dabrafenib/trametinib or cabozantinib.

SECONDARY OBJECTIVES:

  1. To compare the objective response rate in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenib/trametinib or cabozantinib.

II. To compare the duration of response in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenib/trametinib or cabozantinib.

III. To compare the overall survival in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenib/trametinib or cabozantinib.

IV. To compare the PFS2 in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenib/trametinib or cabozantinib.

  1. To compare the safety/tolerability in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenib/trametinib or cabozantinib.

QUALITY OF LIFE OBJECTIVE:

  1. To assess patient tolerability of treatment using the Functional Assessment Cancer Therapy General (FACT G) P5 and general quality of life using the FACT-G7.

OUTLINE: Patients are randomized to 1 of 2 arms. Patients may crossover to other treatment arm at the time of progression.

ARM A: Patients receive dabrafenib orally (PO) twice daily (BID) and trametinib PO once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan, blood sample collection and may undergo magnetic resonance imaging (MRI) throughout the study.

ARM B: Patients receive cabozantinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, blood sample collection and may undergo MRI throughout the study.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter up to 5 years.

Being tested
Biospecimen Collection, Cabozantinib, Computed Tomography, Dabrafenib, Magnetic Resonance Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • CabozantinibDrug

    Given PO

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • DabrafenibDrug

    Also called BRAF Inhibitor GSK2118436, GSK 2118436, GSK 2118436A, GSK-2118436

    Given PO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Questionnaire AdministrationOther

    Ancillary study

  • TrametinibDrug

    Also called GSK 1120212, GSK 212, GSK-1120212, GSK-212

    Given PO

Study groups in NCT06475989
Study groupRoleWhat they receive
Arm A (Dabrafenib and trametinib)Active comparatorPatients receive dabrafenib PO BID and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, blood sample collection and may undergo MRI throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Dabrafenib; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Drug: Trametinib
Arm B (Cabozantinib)ExperimentalPatients receive cabozantinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, blood sample collection and may undergo MRI throughout the study.
Receives: Procedure: Biospecimen Collection; Drug: Cabozantinib; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    PFS will be compared between the two groups using a stratified log-rank test with one-sided type I error of 0.05. Median PFS and 95% confidence interval (CI) for each treatment arm will be estimated using the Kaplan-Meier method. The stratified hazard ratio and 95% CI will be estimated using a Cox proportional hazard model with treatment group as the independent variable.

    Measured: From randomization to radiographic progression of disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, up to 5 years

Secondary outcomes (5)
  1. Objective response

    Will be assessed based on international criteria proposed by the RECIST 1.1 guideline. Response (complete and partial responses) rate will be estimated. Will be compared using the Fisher's exact test.

    Measured: Up to 5 years

  2. Overall survival

    Median and 95% CI will be estimated in each arm using the Kaplan-Meier method.

    Measured: From randomization to death from any cause, up to 5 years

  3. Duration of response

    Median and 95% CI will be estimated in each arm using the Kaplan-Meier method.

    Measured: From confirmed response (complete response or partial response) to progression among patients who achieve a response, up to 5 years

  4. PFS2

    Median and 95% CI will be estimated in each arm using the Kaplan-Meier method.

    Measured: From randomization to progression on subsequent therapy or death from any cause, up to 5 years

  5. Incidence of adverse events

    Using the National Cancer Institute's Common Terminology Criteria for Adverse Events. Response rate and grade 3 or higher toxicity rates will be compared using the Fisher's exact test between the two arms.

    Measured: Up to the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start27 Dec 2024
  3. Primary completion30 Sep 2030 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06475989
Sponsor's protocol ID
EA3231
Other IDs
NCI-2024-03023, EA3231, EA3231, U10CA180820
Status last verified
Sep 2026
First submitted
17 May 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in