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

May 13, 2026 updated by: ECOG-ACRIN Cancer Research Group

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. 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:

I. 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.

V. 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:

I. 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 per day (BID) and trametinib PO once per day (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.

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99504
        • Suspended
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 98508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital Fort Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 800-378-9373
        • Principal Investigator:
          • Jay W. Carlson
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CARTI Cancer Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • California
      • Burbank, California, United States, 91505
        • Recruiting
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Irvine, California, United States, 92612
        • Recruiting
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Contact:
        • Principal Investigator:
          • Shirin Attarian
      • Napa, California, United States, 94558
        • Recruiting
        • Providence Queen of The Valley
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Shirin Attarian
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute Palo Alto
        • Principal Investigator:
          • Saad A. Khan
        • Contact:
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation - Santa Rosa
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Santa Rosa, California, United States, 95405
        • Recruiting
        • Providence Santa Rosa Memorial Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth University of Colorado Hospital
        • Principal Investigator:
          • Daniel W. Bowles
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
      • Highlands Ranch, Colorado, United States, 80129
        • Recruiting
        • UCHealth Highlands Ranch Hospital
        • Principal Investigator:
          • Daniel W. Bowles
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
    • Connecticut
      • Derby, Connecticut, United States, 06418
        • Recruiting
        • Smilow Cancer Hospital-Derby Care Center
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • Fairfield, Connecticut, United States, 06824
        • Recruiting
        • Smilow Cancer Hospital Care Center-Fairfield
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • Glastonbury, Connecticut, United States, 06033
        • Recruiting
        • Smilow Cancer Hospital Care Center at Glastonbury
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • Greenwich, Connecticut, United States, 06830
        • Recruiting
        • Smilow Cancer Hospital Care Center at Greenwich
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • Guilford, Connecticut, United States, 06437
        • Recruiting
        • Smilow Cancer Hospital Care Center - Guilford
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • Hartford, Connecticut, United States, 06105
        • Recruiting
        • Smilow Cancer Hospital Care Center at Saint Francis
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Smilow Cancer Center/Yale-New Haven Hospital
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • North Haven, Connecticut, United States, 06473
        • Recruiting
        • Yale-New Haven Hospital North Haven Medical Center
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • Stamford, Connecticut, United States, 06902
        • Recruiting
        • Smilow Cancer Hospital Care Center at Long Ridge
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • Torrington, Connecticut, United States, 06790
        • Recruiting
        • Smilow Cancer Hospital-Torrington Care Center
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • Trumbull, Connecticut, United States, 06611
        • Recruiting
        • Smilow Cancer Hospital Care Center-Trumbull
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • Waterbury, Connecticut, United States, 06708
        • Recruiting
        • Smilow Cancer Hospital-Waterbury Care Center
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
      • Waterford, Connecticut, United States, 06385
        • Recruiting
        • Smilow Cancer Hospital Care Center - Waterford
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
        • Principal Investigator:
          • Julie E. Hallanger Johnson
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Principal Investigator:
          • Dong M. Shin
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Emmett, Idaho, United States, 83617
        • Suspended
        • Walter Knox Memorial Hospital
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Idaho Urologic Institute-Meridian
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Clinic Cancer Services - Sandpoint
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Recruiting
        • Saint Luke's Cancer Institute - Twin Falls
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Illinois
      • Alton, Illinois, United States, 62002
        • Recruiting
        • OSF Saint Anthony's Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-463-5623
      • Aurora, Illinois, United States, 60506
        • Recruiting
        • Advocate Outpatient Center - Aurora
        • Principal Investigator:
          • Thomas J. Saphner
        • Contact:
      • Barrington, Illinois, United States, 60010
        • Recruiting
        • Advocate Good Shepherd Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-842-4847
        • Principal Investigator:
          • Thomas J. Saphner
      • Centralia, Illinois, United States, 62801
        • Suspended
        • Saint Mary's Hospital
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Ari J. Rosenberg
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Jochen H. Lorch
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Frank Weinberg
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Advocate Illinois Masonic Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 773-296-5360
        • Principal Investigator:
          • Thomas J. Saphner
      • Crystal Lake, Illinois, United States, 60014
        • Recruiting
        • AMG Crystal Lake - Oncology
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contact:
        • Principal Investigator:
          • Jochen H. Lorch
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Advocate Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Advocate Sherman Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-429-2907
        • Principal Investigator:
          • Thomas J. Saphner
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Contact:
        • Principal Investigator:
          • Jochen H. Lorch
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • Northwestern Medicine Glenview Outpatient Center
        • Principal Investigator:
          • Jochen H. Lorch
        • Contact:
          • Site Public Contact
          • Phone Number: 312-695-1102
      • Grayslake, Illinois, United States, 60030
        • Recruiting
        • Northwestern Medicine Grayslake Outpatient Center
        • Principal Investigator:
          • Jochen H. Lorch
        • Contact:
          • Site Public Contact
          • Phone Number: 312-695-1102
      • Hazel Crest, Illinois, United States, 60429
        • Recruiting
        • Advocate South Suburban Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 708-799-9995
        • Principal Investigator:
          • Thomas J. Saphner
      • Lake Forest, Illinois, United States, 60045
        • Recruiting
        • Northwestern Medicine Lake Forest Hospital
        • Contact:
        • Principal Investigator:
          • Jochen H. Lorch
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • AMG Libertyville - Oncology
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • Condell Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • SSM Health Good Samaritan
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • New Lenox, Illinois, United States, 60451
        • Recruiting
        • UC Comprehensive Cancer Center at Silver Cross
        • Contact:
        • Principal Investigator:
          • Ari J. Rosenberg
      • Oak Lawn, Illinois, United States, 60453-2699
        • Recruiting
        • Advocate Christ Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-323-8622
        • Principal Investigator:
          • Thomas J. Saphner
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Outpatient Center - Oak Lawn
        • Principal Investigator:
          • Thomas J. Saphner
        • Contact:
      • Orland Park, Illinois, United States, 60462
        • Recruiting
        • University of Chicago Medicine-Orland Park
        • Contact:
        • Principal Investigator:
          • Ari J. Rosenberg
      • Orland Park, Illinois, United States, 60462
      • Palos Heights, Illinois, United States, 60463
        • Recruiting
        • Advocate High Tech Medical Park
        • Principal Investigator:
          • Thomas J. Saphner
        • Contact:
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Lutheran General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-384-3621
        • Principal Investigator:
          • Thomas J. Saphner
      • Shiloh, Illinois, United States, 62269
        • Recruiting
        • Memorial Hospital East
        • Contact:
        • Principal Investigator:
          • Brendan J. Knapp
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Jochen H. Lorch
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Recruiting
        • UChicago Medicine Northwest Indiana
        • Principal Investigator:
          • Ari J. Rosenberg
        • Contact:
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Bettendorf, Iowa, United States, 52722
        • Recruiting
        • University of Iowa Healthcare Cancer Services Quad Cities
        • Contact:
        • Principal Investigator:
          • Douglas E. Laux
      • Carroll, Iowa, United States, 51401
        • Recruiting
        • Saint Anthony Regional Hospital
        • Contact:
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Mercy Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 319-365-4673
        • Principal Investigator:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Oncology Associates at Mercy Medical Center
        • Principal Investigator:
          • Deborah W. Wilbur
        • Contact:
          • Site Public Contact
          • Phone Number: 319-363-2690
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Mercy Cancer Center-West Lakes
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Clive, Iowa, United States, 50325
        • Recruiting
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Council Bluffs, Iowa, United States, 51503
        • Recruiting
        • Heartland Oncology and Hematology LLP
        • Contact:
          • Site Public Contact
          • Phone Number: 712-322-4136
        • Principal Investigator:
          • Yungpo B. Su
      • Council Bluffs, Iowa, United States, 51503
        • Recruiting
        • Methodist Jennie Edmundson Hospital
        • Principal Investigator:
          • Yungpo B. Su
        • Contact:
      • Council Bluffs, Iowa, United States, 51503
        • Recruiting
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
        • Principal Investigator:
          • Yungpo B. Su
        • Contact:
      • Creston, Iowa, United States, 50801
        • Recruiting
        • Greater Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Broadlawns Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2200
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
        • Principal Investigator:
          • Seema Harichand-Herdt
        • Contact:
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
        • Principal Investigator:
          • Douglas E. Laux
      • Pella, Iowa, United States, 50219
        • Recruiting
        • UI Healthcare Mission Cancer and Blood - Pella
        • Principal Investigator:
          • Seema Harichand-Herdt
        • Contact:
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Mercy Medical Center-West Lakes
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • The Iowa Clinic PC
        • Principal Investigator:
          • Seema Harichand-Herdt
        • Contact:
          • Site Public Contact
          • Phone Number: 515-875-9815
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Recruiting
        • Central Care Cancer Center - Garden City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Great Bend, Kansas, United States, 67530
        • Recruiting
        • Central Care Cancer Center - Great Bend
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Pittsburg, Kansas, United States, 66762
        • Recruiting
        • Mercy Hospital Pittsburg
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
        • Principal Investigator:
          • Omar M. El Kawkgi
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland/Greenebaum Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-888-8823
        • Principal Investigator:
          • Ranee Mehra
    • Michigan
      • Alma, Michigan, United States, 48801
        • Recruiting
        • MyMichigan Medical Center Gratiot
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Alpena, Michigan, United States, 49707
        • Recruiting
        • MyMichigan Medical Center Alpena
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Rogel Cancer Center
        • Principal Investigator:
          • Francis P. Worden
        • Contact:
      • Ann Arbor, Michigan, United States, 48106
        • Recruiting
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Ann Arbor, Michigan, United States, 48103
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Brighton, Michigan, United States, 48116
        • Recruiting
        • University of Michigan - Brighton Center for Specialty Care
        • Principal Investigator:
          • Francis P. Worden
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health Medical Center - Brighton
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health Medical Center - Canton
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Caro, Michigan, United States, 48723
        • Suspended
        • Caro Cancer Center
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Chelsea, Michigan, United States, 48118
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Hematology Oncology Consultants-Clarkston
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Clarkston, Michigan, United States, 48346
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Health Saint John Hospital
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • East China Township, Michigan, United States, 48054
        • Recruiting
        • Henry Ford River District Hospital
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Hematology Oncology PC
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Cancer Hematology Centers - Flint
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Gladwin, Michigan, United States, 48624
        • Recruiting
        • MyMichigan Medical Center Gladwin
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Saint John Hospital - Breast
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Saint John Hospital - Academic
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Saint John Hospital - Van Elslander
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • Henry Ford Warren Hospital - Breast Macomb
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • Henry Ford Saint John Hospital - Macomb Medical
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • Marlette, Michigan, United States, 48453
        • Suspended
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Midland, Michigan, United States, 48670
        • Recruiting
        • MyMichigan Medical Center Midland
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Mount Pleasant, Michigan, United States, 48858
        • Recruiting
        • MyMichigan Medical Center Mount Pleasant
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Pontiac, Michigan, United States, 48341
      • Pontiac, Michigan, United States, 48341
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Michigan Healthcare Professionals Pontiac
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • Saginaw, Michigan, United States, 48604
        • Suspended
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, United States, 48601
      • Tawas City, Michigan, United States, 48764
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Henry Ford Madison Heights Hospital - Breast
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Henry Ford Health Warren Hospital
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Henry Ford Warren Hospital - GLCMS
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • West Branch, Michigan, United States, 48661
        • Suspended
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Ypsilanti, Michigan, United States, 48106
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology - Burnsville
        • Contact:
        • Principal Investigator:
          • David M. King
      • Cambridge, Minnesota, United States, 55008
        • Recruiting
        • Cambridge Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Chaska, Minnesota, United States, 55318
        • Recruiting
        • Minnesota Oncology Hematology PA-Chaska
        • Contact:
        • Principal Investigator:
          • David M. King
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Minnesota Oncology - Coon Rapids
        • Contact:
        • Principal Investigator:
          • David M. King
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Minnesota Oncology - Edina
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Minnesota Oncology - Maple Grove
        • Principal Investigator:
          • David M. King
        • Contact:
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • Health Partners Inc
        • Contact:
        • Principal Investigator:
          • David M. King
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • New Ulm, Minnesota, United States, 56073
        • Recruiting
        • New Ulm Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Princeton, Minnesota, United States, 55371
        • Recruiting
        • Fairview Northland Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Julie E. Hallanger Johnson
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Shakopee, Minnesota, United States, 55379
        • Recruiting
        • Saint Francis Regional Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Thief River Falls, Minnesota, United States, 56701
        • Recruiting
        • Sanford Thief River Falls Medical Center
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 605-312-3320
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Principal Investigator:
          • David M. King
      • Worthington, Minnesota, United States, 56187
        • Recruiting
        • Sanford Cancer Center Worthington
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 605-312-3320
      • Wyoming, Minnesota, United States, 55092
        • Recruiting
        • Fairview Lakes Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Mercy Oncology and Hematology - Clayton-Clarkson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Central Care Cancer Center - Bolivar
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Branson, Missouri, United States, 65616
        • Recruiting
        • Cox Cancer Center Branson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Mercy Cancer Center - Cape Girardeau
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Brendan J. Knapp
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Brendan J. Knapp
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 573-458-6379
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Phelps Health Delbert Day Cancer Institute
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • CoxHealth South Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Brendan J. Knapp
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Contact:
        • Principal Investigator:
          • Brendan J. Knapp
      • St Louis, Missouri, United States, 63136
        • Recruiting
        • Siteman Cancer Center at Christian Hospital
        • Contact:
        • Principal Investigator:
          • Brendan J. Knapp
      • St Louis, Missouri, United States, 63109
        • Recruiting
        • Mercy Infusion Center - Chippewa
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • Washington, Missouri, United States, 63090
        • Recruiting
        • Mercy Hospital Washington
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 636-390-1600
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Health Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Great Falls Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Havre, Montana, United States, 59501
        • Recruiting
        • Hi-Line Sletten Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Helena, Montana, United States, 59601
        • Recruiting
        • Benefis Helena Specialty Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Logan Health Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59802
        • Recruiting
        • Saint Patrick Hospital - Community Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
        • Contact:
          • Site Public Contact
          • Phone Number: 402-334-4773
        • Principal Investigator:
          • Yungpo B. Su
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 402-354-5144
        • Principal Investigator:
          • Yungpo B. Su
      • Omaha, Nebraska, United States, 68114
        • Suspended
        • Oncology Associates PC
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Suspended
        • Duke Cancer Center Cary
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Siddharth Sheth
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
        • Principal Investigator:
          • Neal E. Ready
      • Raleigh, North Carolina, United States, 27609
        • Suspended
        • Duke Cancer Center Raleigh
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Sanford South University Medical Center
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 701-234-6161
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Southpointe-Sanford Medical Center Fargo
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 605-312-3320
      • Fargo, North Dakota, United States, 58104
        • Recruiting
        • Sanford Medical Center Fargo
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 800-437-4010
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Recruiting
        • Cancer Centers of Southwest Oklahoma Research
        • Contact:
          • Site Public Contact
          • Phone Number: 877-231-4440
        • Principal Investigator:
          • Minh Phan
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Minh Phan
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Baker City
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Saint Charles Health System
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Clackamas, Oregon, United States, 97015
        • Suspended
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, United States, 97420
        • Recruiting
        • Bay Area Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Hood River, Oregon, United States, 97031
        • Recruiting
        • Providence Hood River Memorial Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Ontario, Oregon, United States, 97914
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Ontario
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Chetan Vakkalagadda
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Redmond, Oregon, United States, 97756
        • Recruiting
        • Saint Charles Health System-Redmond
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 541-706-2909
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Recruiting
        • Pocono Medical Center
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • UPMC Hillman Cancer Center Erie
        • Principal Investigator:
          • Dan P. Zandberg
        • Contact:
      • Hazleton, Pennsylvania, United States, 18201
        • Recruiting
        • Lehigh Valley Hospital-Hazleton
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania/Abramson Cancer Center
        • Principal Investigator:
          • Lova Sun
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
        • Principal Investigator:
          • Dan P. Zandberg
    • Rhode Island
      • Westerly, Rhode Island, United States, 02891
        • Recruiting
        • Smilow Cancer Hospital Care Center - Westerly
        • Principal Investigator:
          • Hari A. Deshpande
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • John M. Kaczmar
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Michael K. Gibson
      • Nashville, Tennessee, United States, 37204
        • Suspended
        • Vanderbilt Breast Center at One Hundred Oaks
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Principal Investigator:
          • Kathleen C. Kerrigan
        • Contact:
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Recruiting
        • Providence Regional Cancer System-Aberdeen
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Bellingham, Washington, United States, 98225
        • Recruiting
        • PeaceHealth Saint Joseph Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Centralia, Washington, United States, 98531
        • Recruiting
        • Providence Regional Cancer System-Centralia
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Everett, Washington, United States, 98201
        • Recruiting
        • Providence Regional Cancer Partnership
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Lacey, Washington, United States, 98503
        • Recruiting
        • Providence Regional Cancer System-Lacey
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Longview, Washington, United States, 98632
        • Recruiting
        • PeaceHealth Saint John Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Mount Vernon, Washington, United States, 98274
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, United States, 98107
        • Recruiting
        • Swedish Medical Center-Ballard Campus
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, United States, 98122-5711
        • Recruiting
        • Swedish Medical Center-Cherry Hill
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Sedro-Woolley, Washington, United States, 98284
        • Recruiting
        • PeaceHealth United General Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Cancer Care Northwest - Spokane South
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Spokane, Washington, United States, 99216
        • Recruiting
        • Cancer Care Northwest-Valley
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Spokane, Washington, United States, 99218
        • Recruiting
        • Cancer Care Northwest-North Spokane
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Walla Walla, Washington, United States, 99362
        • Recruiting
        • Providence Saint Mary Regional Cancer Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Wisconsin
      • Burlington, Wisconsin, United States, 53105
        • Recruiting
        • Aurora Cancer Care-Southern Lakes VLCC
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Cudahy, Wisconsin, United States, 53110
        • Recruiting
        • Aurora Saint Luke's South Shore
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Eau Claire, Wisconsin, United States, 54701
      • Germantown, Wisconsin, United States, 53022
        • Recruiting
        • Aurora Health Care Germantown Health Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Grafton, Wisconsin, United States, 53024
        • Recruiting
        • Aurora Cancer Care-Grafton
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Green Bay, Wisconsin, United States, 54311
        • Recruiting
        • Aurora BayCare Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Kenosha, Wisconsin, United States, 53142
        • Recruiting
        • Aurora Cancer Care-Kenosha South
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Marinette, Wisconsin, United States, 54143
        • Recruiting
        • Aurora Bay Area Medical Group-Marinette
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53209
        • Recruiting
        • Aurora Cancer Care-Milwaukee
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Saint Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Aurora Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Minocqua, Wisconsin, United States, 54548
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • David M. King
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Vince Lombardi Cancer Clinic - Oshkosh
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Racine, Wisconsin, United States, 53406
        • Recruiting
        • Aurora Cancer Care-Racine
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Rice Lake, Wisconsin, United States, 54868
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Vince Lombardi Cancer Clinic-Sheboygan
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Stevens Point, Wisconsin, United States, 54482
      • Summit, Wisconsin, United States, 53066
        • Recruiting
        • Aurora Medical Center in Summit
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Two Rivers, Wisconsin, United States, 54241
        • Recruiting
        • Vince Lombardi Cancer Clinic-Two Rivers
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Aurora Cancer Care-Milwaukee West
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • West Allis, Wisconsin, United States, 53227
        • Recruiting
        • Aurora West Allis Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Weston, Wisconsin, United States, 54476
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Recruiting
        • Memorial Hospital of Laramie County
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Cody, Wyoming, United States, 82414
        • Recruiting
        • Billings Clinic-Cody
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sheridan, Wyoming, United States, 82801
        • Suspended
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

  • 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 Response Evaluation Criteria in Solid Tumors (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 any lesion(s) with ≥ 2cm growth within 3 months or ≥ 1.5cm growth within 2 months prior to randomization, and must not have documented anaplastic histology at or following cancer recurrence
  • Patient must not have had prior treatment with cabozantinib or any prior BRAF targeted therapy for thyroid cancer
  • 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 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).

  • 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
  • Hemoglobulin (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])/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
  • Urine protein/creatinine (UPC) ratio ≥ 1 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A (Dabrafenib and trametinib)
Patients 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.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Drug: Trametinib
Given PO
Other Names:
  • GSK1120212
  • JTP-74057
  • MEK Inhibitor GSK1120212
  • GSK 1120212
  • GSK-1120212
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Dabrafenib
Given PO
Other Names:
  • GSK2118436
  • BRAF Inhibitor GSK2118436
  • GSK-2118436
  • GSK-2118436A
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Other: Questionnaire Administration
Ancillary study
Experimental: Arm B (Cabozantinib)
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.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Cabozantinib
Given PO
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Other: Questionnaire Administration
Ancillary study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response
Time Frame: Up to 5 years
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.
Up to 5 years
Overall survival
Time Frame: From randomization to death from any cause, up to 5 years
Median and 95% CI will be estimated in each arm using the Kaplan-Meier method.
From randomization to death from any cause, up to 5 years
Duration of response
Time Frame: From confirmed response (complete response or partial response) to progression among patients who achieve a response, up to 5 years
Median and 95% CI will be estimated in each arm using the Kaplan-Meier method.
From confirmed response (complete response or partial response) to progression among patients who achieve a response, up to 5 years
PFS2 - the time from randomization to progression on subsequent therapy or death from any cause (whichever occurs first)
Time Frame: From randomization to progression on subsequent therapy or death from any cause, up to 5 years
Median and 95% CI will be estimated in each arm using the Kaplan-Meier method. PFS2 will be measured for every patient. For patients who receive a next line of therapy, PFS2 will be measured from the time of randomization to radiographic progression on the next line of therapy after the protocol-assigned therapy, or death from any cause, whichever occurs first. If patients are alive and have not had progression on the next of line therapy, they will be censored at the last assessment on the next line of therapy, and PFS2 will be measured from the time of randomization to the last assessment. For patients who do not receive the next line of therapy, PFS2 will be measured from the time of randomization to last assessed on the protocol-assigned therapy and will be censored unless death occurs, in which case death will count as an event.
From randomization to progression on subsequent therapy or death from any cause, up to 5 years
Incidence of adverse events
Time Frame: at 2 weeks, 4 weeks, 8 weeks, 16 weeks, and then every 12 weeks after the 16-week confirmatory scan
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.
at 2 weeks, 4 weeks, 8 weeks, 16 weeks, and then every 12 weeks after the 16-week confirmatory scan

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient tolerability
Time Frame: At baseline, 4, 8, 16, and 28 weeks
Will assess patients tolerability of treatment using the Functional Assessment of Cancer Therapy-General (FACT G)7.
At baseline, 4, 8, 16, and 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lova Sun, ECOG-ACRIN Cancer Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2024

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA3231 (Other Identifier: CTEP)
  • U10CA180820 (U.S. NIH Grant/Contract)
  • NCI-2024-03023 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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