Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study

March 27, 2024 updated by: National Cancer Institute (NCI)

Colorectal Cancer Metastatic dMMR/MSI-H Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab/Atezolizumab Combination Versus Single Agent Atezolizumab in the First-Line Treatment of Patients With Deficient DNA Mismatch Repair (dMMR)/Microsatellite Instability-High (MSI-H) Metastatic Colorectal Cancer

This phase III trial studies how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating patients with deficient deoxyribonucleic acid (DNA) mismatch repair colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may stop or slow colorectal cancer by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with colorectal cancer.

Study Overview

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the efficacy, based on progression-free survival (PFS), of fluorouracil, oxaliplatin, and leucovorin calcium (modified [m]FOLFOX6)/bevacizumab plus atezolizumab (combination) as compared to single agent atezolizumab.

SECONDARY OBJECTIVES:

I. To compare the overall survival. II. To compare the objective response rates (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

III. To determine the safety profiles of single agent atezolizumab and the combination of mFOLFOX6/bevacizumab/atezolizumab in patients with mismatch-repair deficient (dMMR)/microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC).

IV. To determine the duration of response. V. To determine the duration of stable disease. VI. To determine the rate of progression-free survival (PFS) at 12 months. VII. To evaluate the disease control rate (complete response [CR] + partial response [PR] + stable disease [SD]) at 12 months.

TRANSLATIONAL OBJECTIVE:

I. To bank tissue and blood samples for other future correlative studies from patients enrolled on the study.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 of cycles 1-10, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1 and 2. Treatment with oxaliplatin repeats every 2 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Treatment of bevacizumab, leucovorin calcium, and fluorouracil repeat every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) with or without positron emission tomography (PET) or magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo collection of optional blood samples throughout the trial. (CLOSED TO ACCRUAL)

ARM II: Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with or without PET or MRI throughout the trial. Patients may also undergo collection of optional blood samples throughout the trial.

ARM III: Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive bevacizumab IV over 30-90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 cycles 1-10, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on day 1. Treatment with oxaliplatin repeats every 2 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Treatment of bevacizumab, leucovorin calcium, and fluorouracil repeat every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with or without PET or MRI throughout the trial. Patients may also undergo collection of optional blood samples throughout the trial.

After completion of study treatment, patients are followed up every 8 weeks for 18 months, and then every 12 weeks for up to 5 years.

Study Type

Interventional

Enrollment (Estimated)

120

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

    • Arizona
      • Kingman, Arizona, United States, 86401
        • Recruiting
        • Kingman Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Active, not recruiting
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    • California
      • Anaheim, California, United States, 92806
        • Recruiting
        • Kaiser Permanente-Anaheim
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Baldwin Park, California, United States, 91706
        • Recruiting
        • Kaiser Permanente-Baldwin Park
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Bellflower, California, United States, 90706
        • Recruiting
        • Kaiser Permanente-Bellflower
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Berkeley, California, United States, 94704
        • Recruiting
        • Alta Bates Summit Medical Center-Herrick Campus
        • Principal Investigator:
          • Kristie A. Bobolis
        • Contact:
      • Concord, California, United States, 94520
        • Active, not recruiting
        • John Muir Medical Center-Concord Campus
      • Fontana, California, United States, 92335
        • Recruiting
        • Kaiser Permanente-Fontana
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Harbor City, California, United States, 90710
        • Recruiting
        • Kaiser Permanente - Harbor City
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Irvine, California, United States, 92618
        • Recruiting
        • Kaiser Permanente-Irvine
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles Medical Center
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Los Angeles, California, United States, 90034
        • Recruiting
        • Kaiser Permanente West Los Angeles
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Marysville, California, United States, 95901
        • Recruiting
        • Fremont - Rideout Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 530-749-4400
        • Principal Investigator:
          • Edward J. Kim
      • Modesto, California, United States, 95355
      • Ontario, California, United States, 91761
        • Recruiting
        • Kaiser Permanente-Ontario
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Orange, California, United States, 92868
        • Recruiting
        • Saint Joseph Hospital - Orange
        • Contact:
          • Site Public Contact
          • Phone Number: 714-734-6220
        • Principal Investigator:
          • Timothy E. Byun
      • Orange, California, United States, 92868
        • Active, not recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Panorama City, California, United States, 91402
        • Recruiting
        • Kaiser Permanente - Panorama City
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Riverside, California, United States, 92505
        • Recruiting
        • Kaiser Permanente-Riverside
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Sacramento, California, United States, 95816
      • Sacramento, California, United States, 95817
        • Active, not recruiting
        • University of California Davis Comprehensive Cancer Center
      • Salinas, California, United States, 93901
        • Active, not recruiting
        • Salinas Valley Memorial
      • San Diego, California, United States, 92108
        • Recruiting
        • Kaiser Permanente-San Diego Mission
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • San Diego, California, United States, 92120
        • Recruiting
        • Kaiser Permanente-San Diego Zion
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • San Marcos, California, United States, 92078
        • Recruiting
        • Kaiser Permanente-San Marcos
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
      • Walnut Creek, California, United States, 94598
        • Active, not recruiting
        • John Muir Medical Center-Walnut Creek
      • Whittier, California, United States, 90602
        • Active, not recruiting
        • Presbyterian Intercommunity Hospital
      • Woodland Hills, California, United States, 91367
        • Recruiting
        • Kaiser Permanente-Woodland Hills
        • Contact:
        • Principal Investigator:
          • Gary L. Buchschacher
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers-Aurora
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth University of Colorado Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
        • Principal Investigator:
          • Alexis D. Leal
      • Boulder, Colorado, United States, 80301
        • Suspended
        • Boulder Community Hospital
      • Boulder, Colorado, United States, 80304
        • Recruiting
        • Rocky Mountain Cancer Centers-Boulder
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Penrose-Saint Francis Healthcare
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • UCHealth Memorial Hospital Central
        • Contact:
          • Site Public Contact
          • Phone Number: 719-365-2406
        • Principal Investigator:
          • Alexis D. Leal
      • Colorado Springs, Colorado, United States, 80920
        • Recruiting
        • Memorial Hospital North
        • Contact:
          • Site Public Contact
          • Phone Number: 719-364-6700
        • Principal Investigator:
          • Alexis D. Leal
      • Denver, Colorado, United States, 80210
        • Suspended
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers-Midtown
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80220
        • Recruiting
        • Rocky Mountain Cancer Centers-Rose
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80204
        • Suspended
        • Denver Health Medical Center
      • Denver, Colorado, United States, 80206
        • Active, not recruiting
        • National Jewish Health-Main Campus
      • Denver, Colorado, United States, 80218
        • Active, not recruiting
        • SCL Health Saint Joseph Hospital
      • Englewood, Colorado, United States, 80113
        • Suspended
        • Swedish Medical Center
      • Englewood, Colorado, United States, 80113
        • Suspended
        • Mountain Blue Cancer Care Center - Swedish
      • Fort Collins, Colorado, United States, 80524
        • Recruiting
        • Poudre Valley Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 970-297-6150
        • Principal Investigator:
          • Alexis D. Leal
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Cancer Care and Hematology-Fort Collins
        • Principal Investigator:
          • Alexis D. Leal
        • Contact:
      • Golden, Colorado, United States, 80401
        • Active, not recruiting
        • National Jewish Health-Western Hematology Oncology
      • Greeley, Colorado, United States, 80631
        • Recruiting
        • UCHealth Greeley Hospital
        • Principal Investigator:
          • Alexis D. Leal
        • Contact:
      • Greeley, Colorado, United States, 80631
        • Suspended
        • North Colorado Medical Center
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • Rocky Mountain Cancer Centers-Littleton
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Rocky Mountain Cancer Centers-Sky Ridge
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • Medical Center of the Rockies
        • Contact:
          • Site Public Contact
          • Phone Number: 970-203-7083
        • Principal Investigator:
          • Alexis D. Leal
      • Loveland, Colorado, United States, 80539
        • Suspended
        • McKee Medical Center
      • Thornton, Colorado, United States, 80260
        • Active, not recruiting
        • National Jewish Health-Northern Hematology Oncology
      • Wheat Ridge, Colorado, United States, 80033
        • Active, not recruiting
        • SCL Health Lutheran Medical Center
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Active, not recruiting
        • Danbury Hospital
      • Hartford, Connecticut, United States, 06102
        • Active, not recruiting
        • Hartford Hospital
      • Meriden, Connecticut, United States, 06451
        • Active, not recruiting
        • Midstate Medical Center
      • New Britain, Connecticut, United States, 06050
        • Active, not recruiting
        • The Hospital of Central Connecticut
      • Norwich, Connecticut, United States, 06360
        • Active, not recruiting
        • William Backus Hospital
    • Delaware
      • Frankford, Delaware, United States, 19945
        • Active, not recruiting
        • Beebe South Coastal Health Campus
      • Newark, Delaware, United States, 19713
        • Active, not recruiting
        • Helen F Graham Cancer Center
      • Newark, Delaware, United States, 19713
        • Active, not recruiting
        • Medical Oncology Hematology Consultants PA
      • Rehoboth Beach, Delaware, United States, 19971
        • Active, not recruiting
        • Beebe Health Campus
    • District of Columbia
      • Washington, District of Columbia, United States, 20002
        • Recruiting
        • Kaiser Permanente-Capitol Hill Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 301-548-5743
        • Principal Investigator:
          • Leon C. Hwang
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Active, not recruiting
        • Broward Health Medical Center
      • Fort Myers, Florida, United States, 33905
        • Suspended
        • Regional Cancer Center-Lee Memorial Health System
      • Gainesville, Florida, United States, 32610
        • Active, not recruiting
        • University of Florida Health Science Center - Gainesville
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 904-202-7468
        • Principal Investigator:
          • Robert A. Zaiden
      • Orlando, Florida, United States, 32803
        • Active, not recruiting
        • AdventHealth Orlando
    • Georgia
      • Albany, Georgia, United States, 31701
        • Recruiting
        • Phoebe Putney Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Sharad A. Ghamande
      • Athens, Georgia, United States, 30607
        • Suspended
        • University Cancer and Blood Center LLC
      • Augusta, Georgia, United States, 30901
        • Recruiting
        • Augusta Oncology Associates PC-D'Antignac
        • Principal Investigator:
          • Sharad A. Ghamande
        • Contact:
          • Site Public Contact
          • Phone Number: 706-821-2944
      • Augusta, Georgia, United States, 30909
        • Recruiting
        • Augusta Oncology Associates PC-Wheeler
        • Principal Investigator:
          • Sharad A. Ghamande
        • Contact:
          • Site Public Contact
          • Phone Number: 706-736-1830
      • Augusta, Georgia, United States, 30912
        • Suspended
        • Augusta University Medical Center
      • Newnan, Georgia, United States, 30265
        • Active, not recruiting
        • CTCA at Southeastern Regional Medical Center
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Nampa, Idaho, United States, 83686
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Nampa
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • 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 Cancer Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Recruiting
        • Saint Luke's Cancer Institute - Twin Falls
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Active, not recruiting
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Active, not recruiting
        • Illinois CancerCare-Canton
      • Carthage, Illinois, United States, 62321
        • Active, not recruiting
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • William T. Leslie
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Shikha Jain
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Principal Investigator:
          • Suparna Mantha
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, United States, 61021
        • Active, not recruiting
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Principal Investigator:
          • Suparna Mantha
        • Contact:
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Eureka, Illinois, United States, 61530
        • Active, not recruiting
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University HealthSystem-Evanston Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • Robert d. Marsh
      • Galesburg, Illinois, United States, 61401
        • Active, not recruiting
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • Robert d. Marsh
      • Highland Park, Illinois, United States, 60035
        • Recruiting
        • NorthShore University HealthSystem-Highland Park Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • Robert d. Marsh
      • Kewanee, Illinois, United States, 61443
        • Active, not recruiting
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Active, not recruiting
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Principal Investigator:
          • Suparna Mantha
        • Contact:
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
        • Principal Investigator:
          • Asha R. Dhanarajan
      • Mount Vernon, Illinois, United States, 62864
        • Suspended
        • Good Samaritan Regional Health Center
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Ottawa, Illinois, United States, 61350
        • Active, not recruiting
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Active, not recruiting
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61615
        • Active, not recruiting
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Active, not recruiting
        • Illinois CancerCare-Peru
      • Princeton, Illinois, United States, 61356
        • Active, not recruiting
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Principal Investigator:
          • Suparna Mantha
        • Contact:
      • Washington, Illinois, United States, 61571
        • Active, not recruiting
        • Illinois CancerCare - Washington
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Franciscan Health Indianapolis
        • Contact:
          • Site Public Contact
          • Phone Number: 317-528-7060
        • Principal Investigator:
          • Meghana Raghavendra
      • Indianapolis, Indiana, United States, 46202
        • Active, not recruiting
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46219
        • Active, not recruiting
        • Community Cancer Center East
      • Indianapolis, Indiana, United States, 46227
        • Active, not recruiting
        • Community Cancer Center South
      • Indianapolis, Indiana, United States, 46256
        • Active, not recruiting
        • Community Cancer Center North
      • Kokomo, Indiana, United States, 46904
        • Active, not recruiting
        • Community Howard Regional Health
      • Lafayette, Indiana, United States, 47905
        • Recruiting
        • Franciscan Saint Elizabeth Health - Lafayette East
        • Contact:
        • Principal Investigator:
          • Meghana Raghavendra
      • Michigan City, Indiana, United States, 46360
        • Recruiting
        • Woodland Cancer Care Center
        • Principal Investigator:
          • Meghana Raghavendra
        • Contact:
      • Mooresville, Indiana, United States, 46158
        • Recruiting
        • Franciscan Health Mooresville
        • Contact:
          • Site Public Contact
          • Phone Number: 317-834-3603
        • Principal Investigator:
          • Meghana Raghavendra
      • Terre Haute, Indiana, United States, 47804
        • Recruiting
        • Union Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 812-238-7394
        • Principal Investigator:
          • Meghana Raghavendra
    • Iowa
      • Ames, Iowa, United States, 50010
        • Suspended
        • Mary Greeley Medical Center
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Bettendorf, Iowa, United States, 52722
        • Active, not recruiting
        • University of Iowa Healthcare Cancer Services Quad Cities
      • Boone, Iowa, United States, 50036
        • Suspended
        • McFarland Clinic - Boone
      • 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
        • Medical Oncology and Hematology Associates-West Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Mercy Cancer Center-West Lakes
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mission Cancer and Blood - Laurel
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50314
        • Active, not recruiting
        • Broadlawns Medical Center
      • Des Moines, Iowa, United States, 50309
        • Active, not recruiting
        • Medical Oncology and Hematology Associates-Des Moines
      • Fort Dodge, Iowa, United States, 50501
        • Active, not recruiting
        • Trinity Regional Medical Center
      • Fort Dodge, Iowa, United States, 50501
        • Suspended
        • McFarland Clinic - Trinity Cancer Center
      • Iowa City, Iowa, United States, 52242
        • Active, not recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
      • Jefferson, Iowa, United States, 50129
        • Suspended
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, United States, 50158
        • Suspended
        • McFarland Clinic - Marshalltown
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Mercy Medical Center-West Lakes
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
    • Kansas
      • Hays, Kansas, United States, 67601
        • Active, not recruiting
        • HaysMed University of Kansas Health System
      • Lawrence, Kansas, United States, 66044
        • Recruiting
        • Lawrence Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Weijing Sun
      • Olathe, Kansas, United States, 66061
        • Recruiting
        • Olathe Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Weijing Sun
      • Salina, Kansas, United States, 67401
        • Recruiting
        • Salina Regional Health Center
        • Contact:
        • Principal Investigator:
          • Weijing Sun
      • Topeka, Kansas, United States, 66606
        • Active, not recruiting
        • University of Kansas Health System Saint Francis Campus
      • Westwood, Kansas, United States, 66205
        • Active, not recruiting
        • University of Kansas Hospital-Westwood Cancer Center
      • Wichita, Kansas, United States, 67208
        • Recruiting
        • Cancer Center of Kansas-Wichita Medical Arts Tower
        • Contact:
        • Principal Investigator:
          • Dennis F. Moore
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Cancer Center of Kansas - Wichita
        • Contact:
        • Principal Investigator:
          • Dennis F. Moore
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
      • Lexington, Kentucky, United States, 40509
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health Lexington
        • Principal Investigator:
          • Lee G. Hicks
        • Contact:
          • Site Public Contact
          • Phone Number: 859-260-6425
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, United States, 40202
        • Active, not recruiting
        • Norton Hospital Pavilion and Medical Campus
      • Louisville, Kentucky, United States, 40217
        • Active, not recruiting
        • Norton Audubon Hospital and Medical Campus
      • Louisville, Kentucky, United States, 40241
        • Active, not recruiting
        • Norton Brownsboro Hospital and Medical Campus
    • Louisiana
      • Kenner, Louisiana, United States, 70065
        • Active, not recruiting
        • Ochsner Medical Center Kenner
      • New Orleans, Louisiana, United States, 70121
        • Active, not recruiting
        • Ochsner Medical Center Jefferson
    • Maine
      • Augusta, Maine, United States, 04330
        • Recruiting
        • Harold Alfond Center for Cancer Care
        • Contact:
          • Site Public Contact
          • Phone Number: 207-626-4855
        • Principal Investigator:
          • Scot C. Remick
      • Bangor, Maine, United States, 04401
        • Recruiting
        • Eastern Maine Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 207-973-4274
        • Principal Investigator:
          • Sarah J. Sinclair
      • Belfast, Maine, United States, 04915
        • Recruiting
        • Waldo County General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 207-338-2500
        • Principal Investigator:
          • Scot C. Remick
      • Biddeford, Maine, United States, 04005
        • Recruiting
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
        • Contact:
        • Principal Investigator:
          • Scot C. Remick
      • Brewer, Maine, United States, 04412
        • Recruiting
        • Lafayette Family Cancer Center-EMMC
        • Principal Investigator:
          • Sarah J. Sinclair
        • Contact:
          • Site Public Contact
          • Phone Number: 800-987-3005
      • Rockport, Maine, United States, 04856
        • Recruiting
        • Penobscot Bay Medical Center
        • Contact:
        • Principal Investigator:
          • Scot C. Remick
      • Sanford, Maine, United States, 04073
        • Recruiting
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
        • Contact:
        • Principal Investigator:
          • Scot C. Remick
      • South Portland, Maine, United States, 04106
        • Recruiting
        • Maine Medical Partners - South Portland
        • Contact:
        • Principal Investigator:
          • Scot C. Remick
    • Maryland
      • Baltimore, Maryland, United States, 21244
        • Recruiting
        • Kaiser Permanente-Woodlawn Medical Center
        • Principal Investigator:
          • Leon C. Hwang
        • Contact:
          • Site Public Contact
          • Phone Number: 301-816-7218
      • Easton, Maryland, United States, 21601
        • Recruiting
        • University of Maryland Shore Medical Center at Easton
        • Contact:
        • Principal Investigator:
          • Adam J. Goldrich
      • Gaithersburg, Maryland, United States, 20879
        • Recruiting
        • Kaiser Permanente-Gaithersburg Medical Center
        • Principal Investigator:
          • Leon C. Hwang
        • Contact:
          • Site Public Contact
          • Phone Number: 301-816-7218
      • Largo, Maryland, United States, 20774
        • Recruiting
        • Kaiser Permanente - Largo Medical Center
        • Principal Investigator:
          • Leon C. Hwang
        • Contact:
          • Site Public Contact
          • Phone Number: 301-816-7446
      • Lutherville, Maryland, United States, 21093
        • Recruiting
        • Kaiser Permanente Lutherville - Timonium Medical Center
        • Principal Investigator:
          • Leon C. Hwang
        • Contact:
          • Site Public Contact
          • Phone Number: 410-847-3000
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Active, not recruiting
        • Dana-Farber Cancer Institute
      • Lowell, Massachusetts, United States, 01854
        • Active, not recruiting
        • Lowell General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
      • Bay City, Michigan, United States, 48706
        • Recruiting
        • McLaren Cancer Institute-Bay City
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Bloomfield, Michigan, United States, 48302
        • Suspended
        • McLaren Cancer Institute-Bloomfield
      • Brighton, Michigan, United States, 48114
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Brownstown, Michigan, United States, 48183
        • Suspended
        • Henry Ford Cancer Institute-Downriver
      • Canton, Michigan, United States, 48188
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Chelsea, Michigan, United States, 48118
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Hematology Oncology Consultants-Clarkston
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Clarkston, Michigan, United States, 48346
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • McLaren Cancer Institute-Clarkston
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Clinton Township, Michigan, United States, 48038
        • Suspended
        • Henry Ford Macomb Hospital-Clinton Township
      • Dearborn, Michigan, United States, 48126
        • Suspended
        • Henry Ford Medical Center-Fairlane
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University/Karmanos Cancer Institute
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Detroit, Michigan, United States, 48202
        • Suspended
        • Henry Ford Hospital
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Weisberg Cancer Treatment Center
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Flint, Michigan, United States, 48532
        • Suspended
        • Singh and Arora Hematology Oncology PC
      • Flint, Michigan, United States, 48532
        • Recruiting
        • McLaren Cancer Institute-Flint
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Jackson, Michigan, United States, 49201
        • Suspended
        • Allegiance Health
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Sparrow Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 517-364-9400
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Lansing, Michigan, United States, 48910
        • Recruiting
        • Karmanos Cancer Institute at McLaren Greater Lansing
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Lapeer, Michigan, United States, 48446
        • Recruiting
        • McLaren Cancer Institute-Lapeer Region
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Livonia, Michigan, United States, 48154
        • Suspended
        • Hope Cancer Clinic
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Mount Clemens, Michigan, United States, 48043
        • Recruiting
        • McLaren Cancer Institute-Macomb
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Mount Pleasant, Michigan, United States, 48858
        • Recruiting
        • McLaren Cancer Institute-Central Michigan
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Novi, Michigan, United States, 48377
        • Suspended
        • Henry Ford Medical Center-Columbus
      • Petoskey, Michigan, United States, 49770
        • Recruiting
        • McLaren Cancer Institute-Northern Michigan
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Pontiac, Michigan, United States, 48341
      • Pontiac, Michigan, United States, 48341
      • Port Huron, Michigan, United States, 48060
        • Recruiting
        • McLaren-Port Huron
        • Contact:
        • Principal Investigator:
          • Mohammed N. Al Hallak
      • Saginaw, Michigan, United States, 48601
        • Recruiting
        • Ascension Saint Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Saginaw, Michigan, United States, 48604
        • Recruiting
        • Oncology Hematology Associates of Saginaw Valley PC
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Tawas City, Michigan, United States, 48764
        • Recruiting
        • Ascension Saint Joseph Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • West Bloomfield, Michigan, United States, 48322
        • Suspended
        • Henry Ford West Bloomfield Hospital
      • West Branch, Michigan, United States, 48661
        • Recruiting
        • Saint Mary's Oncology/Hematology Associates of West Branch
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • 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:
          • Yan Ji
      • Deer River, Minnesota, United States, 56636
        • Recruiting
        • Essentia Health - Deer River Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Hibbing, Minnesota, United States, 55746
        • Recruiting
        • Essentia Health Hibbing Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-786-3308
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Minneapolis, Minnesota, United States, 55454
        • Active, not recruiting
        • Health Partners Inc
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Sandstone, Minnesota, United States, 55072
        • Recruiting
        • Essentia Health Sandstone
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Virginia, Minnesota, United States, 55792
        • Recruiting
        • Essentia Health Virginia Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
    • Mississippi
      • Grenada, Mississippi, United States, 38901
        • Active, not recruiting
        • Baptist Cancer Center-Grenada
      • New Albany, Mississippi, United States, 38652
        • Active, not recruiting
        • Baptist Memorial Hospital and Cancer Center-Union County
      • Oxford, Mississippi, United States, 38655
        • Active, not recruiting
        • Baptist Memorial Hospital and Cancer Center-Oxford
      • Southhaven, Mississippi, United States, 38671
        • Active, not recruiting
        • Baptist Memorial Hospital and Cancer Center-Desoto
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Saint Louis Cancer and Breast Institute-Ballwin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7058
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Columbia, Missouri, United States, 65212
        • Active, not recruiting
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Joplin, Missouri, United States, 64804
        • Suspended
        • Freeman Health System
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Truman Medical Centers
        • Contact:
          • Site Public Contact
          • Phone Number: 816-404-4375
        • Principal Investigator:
          • Weijing Sun
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • Saint Louis, Missouri, United States, 63109
        • Recruiting
        • Saint Louis Cancer and Breast Institute-South City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-353-1870
    • 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 Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Suspended
        • Great Falls Clinic
      • Helena, Montana, United States, 59601
        • Suspended
        • Saint Peter's Community Hospital
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Kalispell Regional Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 402-354-5144
        • Principal Investigator:
          • Timothy Huyck
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • OptumCare Cancer Care at Seven Hills
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • OptumCare Cancer Care at Charleston
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • OptumCare Cancer Care at MountainView
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • OptumCare Cancer Care at Fort Apache
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathryn C. Hourdequin
      • Manchester, New Hampshire, United States, 03102
        • Recruiting
        • Norris Cotton Cancer Center-Manchester
        • Contact:
        • Principal Investigator:
          • Kathryn C. Hourdequin
      • Nashua, New Hampshire, United States, 03063
        • Recruiting
        • Dartmouth Cancer Center - Nashua
        • Contact:
        • Principal Investigator:
          • Kathryn C. Hourdequin
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • Recruiting
        • The Cancer Institute of New Jersey Hamilton
        • Contact:
          • Site Public Contact
          • Phone Number: 609-631-6946
        • Principal Investigator:
          • Howard S. Hochster
      • Morristown, New Jersey, United States, 07960
        • Active, not recruiting
        • Morristown Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
        • Principal Investigator:
          • Howard S. Hochster
      • Paramus, New Jersey, United States, 07652
        • Recruiting
        • The Valley Hospital-Luckow Pavilion
        • Contact:
          • Site Public Contact
          • Phone Number: 201-634-5792
        • Principal Investigator:
          • Kevin C. Wood
      • Ridgewood, New Jersey, United States, 07450
        • Recruiting
        • Valley Hospital
        • Contact:
        • Principal Investigator:
          • Kevin C. Wood
      • Somerville, New Jersey, United States, 08876
        • Active, not recruiting
        • Robert Wood Johnson University Hospital Somerset
      • Summit, New Jersey, United States, 07902
        • Active, not recruiting
        • Overlook Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Jessica Belmonte
      • Albuquerque, New Mexico, United States, 87110
        • Recruiting
        • Presbyterian Kaseman Hospital
        • Contact:
        • Principal Investigator:
          • Jessica Belmonte
      • Las Cruces, New Mexico, United States, 88011
        • Recruiting
        • Memorial Medical Center - Las Cruces
        • Contact:
        • Principal Investigator:
          • Jessica Belmonte
      • Rio Rancho, New Mexico, United States, 87124
        • Recruiting
        • Presbyterian Rust Medical Center/Jorgensen Cancer Center
        • Contact:
        • Principal Investigator:
          • Jessica Belmonte
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Sarbajit Mukherjee
      • Elmira, New York, United States, 14905
        • Active, not recruiting
        • Arnot Ogden Medical Center/Falck Cancer Center
      • Lake Success, New York, United States, 11042
        • Active, not recruiting
        • Northwell Health/Center for Advanced Medicine
      • New York, New York, United States, 10016
        • Active, not recruiting
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Paul M. Barr
      • White Plains, New York, United States, 10601
        • Active, not recruiting
        • Dickstein Cancer Treatment Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Hanna K. Sanoff
      • Clinton, North Carolina, United States, 28328
        • Recruiting
        • Southeastern Medical Oncology Center-Clinton
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Goldsboro, North Carolina, United States, 27534
        • Recruiting
        • Southeastern Medical Oncology Center-Goldsboro
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Hendersonville, North Carolina, United States, 28791
        • Recruiting
        • Margaret R Pardee Memorial Hospital
        • Principal Investigator:
          • Praveen Vashist
        • Contact:
      • Jacksonville, North Carolina, United States, 28546
        • Recruiting
        • Southeastern Medical Oncology Center-Jacksonville
        • Principal Investigator:
          • Samer S. Kasbari
        • Contact:
      • Kenansville, North Carolina, United States, 28349
        • Recruiting
        • Vidant Oncology-Kenansville
        • Contact:
        • Principal Investigator:
          • Misbah U. Qadir
      • Kinston, North Carolina, United States, 28501
        • Recruiting
        • Vidant Oncology-Kinston
        • Contact:
        • Principal Investigator:
          • Misbah U. Qadir
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • FirstHealth of the Carolinas-Moore Regional Hospital
        • Contact:
        • Principal Investigator:
          • Charles S. Kuzma
      • Richlands, North Carolina, United States, 28574
        • Suspended
        • Vidant Oncology-Richlands
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
        • Principal Investigator:
          • Caio Max S. Rocha Lima
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58122
      • Grand Forks, North Dakota, United States, 58201
        • Active, not recruiting
        • Altru Cancer Center
    • Ohio
      • Akron, Ohio, United States, 44307
        • Recruiting
        • Cleveland Clinic Akron General
        • Contact:
        • Principal Investigator:
          • Judy Peih-Ying Tsai
      • Belpre, Ohio, United States, 45714
        • Recruiting
        • Strecker Cancer Center-Belpre
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Dayton Physicians LLC-Miami Valley South
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Centerville, Ohio, United States, 45459
        • Active, not recruiting
        • Miami Valley Hospital South
      • Chillicothe, Ohio, United States, 45601
        • Recruiting
        • Adena Regional Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Cincinnati, Ohio, United States, 45219
        • Active, not recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cleveland, Ohio, United States, 44111
        • Active, not recruiting
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Mount Carmel East Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43219
        • Recruiting
        • The Mark H Zangmeister Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43222
        • Recruiting
        • Mount Carmel Health Center West
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • John L. Hays
      • Columbus, Ohio, United States, 43214
        • Suspended
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43215
        • Suspended
        • Grant Medical Center
      • Columbus, Ohio, United States, 43228
        • Suspended
        • Doctors Hospital
      • Columbus, Ohio, United States, 43214
        • Suspended
        • Columbus Oncology and Hematology Associates Inc
      • Dayton, Ohio, United States, 45409
        • Active, not recruiting
        • Miami Valley Hospital
      • Delaware, Ohio, United States, 43015
        • Suspended
        • Grady Memorial Hospital
      • Delaware, Ohio, United States, 43015
        • Suspended
        • Delaware Health Center-Grady Cancer Center
      • Kettering, Ohio, United States, 45409
        • Recruiting
        • Greater Dayton Cancer Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Lancaster, Ohio, United States, 43130
        • Recruiting
        • Fairfield Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Mansfield, Ohio, United States, 44903
        • Suspended
        • OhioHealth Mansfield Hospital
      • Mansfield, Ohio, United States, 44906
        • Active, not recruiting
        • Cleveland Clinic Cancer Center Mansfield
      • Marietta, Ohio, United States, 45750
        • Recruiting
        • Marietta Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Marion, Ohio, United States, 43302
        • Suspended
        • OhioHealth Marion General Hospital
      • Mayfield Heights, Ohio, United States, 44124
        • Active, not recruiting
        • Hillcrest Hospital Cancer Center
      • Mount Vernon, Ohio, United States, 43050
        • Recruiting
        • Knox Community Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Newark, Ohio, United States, 43055
        • Recruiting
        • Licking Memorial Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Portsmouth, Ohio, United States, 45662
        • Recruiting
        • Southern Ohio Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Sandusky, Ohio, United States, 44870
        • Active, not recruiting
        • North Coast Cancer Care
      • Sylvania, Ohio, United States, 43560
        • Recruiting
        • ProMedica Flower Hospital
        • Contact:
        • Principal Investigator:
          • Feng Jiang
      • Warrensville Heights, Ohio, United States, 44122
        • Active, not recruiting
        • South Pointe Hospital
      • West Chester, Ohio, United States, 45069
        • Active, not recruiting
        • University of Cincinnati Cancer Center-West Chester
      • Westerville, Ohio, United States, 43081
        • Recruiting
        • Saint Ann's Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis Healthcare System Cancer Care Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Recruiting
        • Cancer Centers of Southwest Oklahoma Research
        • Contact:
          • Site Public Contact
          • Phone Number: 877-231-4440
        • Principal Investigator:
          • Susanna V. Ulahannan
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Susanna V. Ulahannan
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
        • Principal Investigator:
          • Susanna V. Ulahannan
        • Contact:
          • Site Public Contact
          • Phone Number: 918-505-3200
      • Tulsa, Oklahoma, United States, 74133
        • Active, not recruiting
        • Cancer Treatment Centers of America
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Saint Charles Health System
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Clackamas, Oregon, United States, 97015
        • Suspended
        • Providence Cancer Institute Clackamas Clinic
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Ontario, Oregon, United States, 97914
        • Recruiting
        • Saint Alphonsus Medical Center-Ontario
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Allentown, Pennsylvania, United States, 18104
        • Active, not recruiting
        • Saint Luke's Cancer Center - Allentown
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Bethlehem, Pennsylvania, United States, 18015
        • Active, not recruiting
        • Saint Luke's University Hospital-Bethlehem Campus
      • Easton, Pennsylvania, United States, 18045
        • Active, not recruiting
        • Saint Luke's Hospital-Anderson Campus
      • Erie, Pennsylvania, United States, 16544
        • Recruiting
        • Saint Vincent Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 814-452-5000
        • Principal Investigator:
          • Amjad Jalil
      • Harrisburg, Pennsylvania, United States, 17109
        • Recruiting
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
        • Contact:
        • Principal Investigator:
          • Dennis Hsu
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Recruiting
        • Jefferson Hospital
        • Contact:
        • Principal Investigator:
          • Amjad Jalil
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • Forbes Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-858-7746
        • Principal Investigator:
          • Amjad Jalil
      • Natrona Heights, Pennsylvania, United States, 15065
        • Recruiting
        • Allegheny Valley Hospital
        • Contact:
        • Principal Investigator:
          • Amjad Jalil
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
        • Principal Investigator:
          • Dennis Hsu
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • West Penn Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-578-5000
        • Principal Investigator:
          • Amjad Jalil
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 877-284-2000
        • Principal Investigator:
          • Amjad Jalil
      • Quakertown, Pennsylvania, United States, 18951
        • Active, not recruiting
        • Saint Luke's Hospital-Quakertown Campus
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 610-988-9323
        • Principal Investigator:
          • Terrence P. Cescon
      • Wexford, Pennsylvania, United States, 15090
        • Recruiting
        • Wexford Health and Wellness Pavilion
        • Contact:
        • Principal Investigator:
          • Amjad Jalil
      • Willow Grove, Pennsylvania, United States, 19090
        • Active, not recruiting
        • Asplundh Cancer Pavilion
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • AnMed Health Cancer Center
        • Contact:
        • Principal Investigator:
          • John E. Doster
      • Beaufort, South Carolina, United States, 29902
        • Active, not recruiting
        • Beaufort Memorial Hospital
      • Boiling Springs, South Carolina, United States, 29316
        • Recruiting
        • Prisma Health Cancer Institute - Spartanburg
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Easley, South Carolina, United States, 29640
        • Recruiting
        • Prisma Health Cancer Institute - Easley
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Greenville, South Carolina, United States, 29601
        • Active, not recruiting
        • Saint Francis Hospital
      • Greenville, South Carolina, United States, 29607
        • Active, not recruiting
        • Saint Francis Cancer Center
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Faris
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Butternut
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Cancer Institute - Eastside
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Greer, South Carolina, United States, 29650
        • Recruiting
        • Prisma Health Cancer Institute - Greer
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Seneca, South Carolina, United States, 29672
        • Recruiting
        • Prisma Health Cancer Institute - Seneca
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Spartanburg, South Carolina, United States, 29303
        • Active, not recruiting
        • Spartanburg Medical Center
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Active, not recruiting
        • Avera Cancer Institute-Aberdeen
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
      • Sioux Falls, South Dakota, United States, 57105
        • Active, not recruiting
        • Avera Cancer Institute
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Recruiting
        • Bristol Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Asheesh Shipstone
      • Collierville, Tennessee, United States, 38017
        • Active, not recruiting
        • Baptist Memorial Hospital and Cancer Center-Collierville
      • Cookeville, Tennessee, United States, 38501
        • Suspended
        • Cookeville Regional Medical Center
      • Johnson City, Tennessee, United States, 37604
        • Suspended
        • Wellmont Medical Associates Oncology and Hematology-Johnson City
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Ballad Health Cancer Care - Kingsport
        • Principal Investigator:
          • Asheesh Shipstone
        • Contact:
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Wellmont Holston Valley Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Asheesh Shipstone
      • Memphis, Tennessee, United States, 38120
        • Active, not recruiting
        • Baptist Memorial Hospital and Cancer Center-Memphis
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • The Don and Sybil Harrington Cancer Center
        • Contact:
        • Principal Investigator:
          • Anita Ravipati
      • Beaumont, Texas, United States, 77701
        • Active, not recruiting
        • Baptist Hospitals of Southeast Texas Cancer Center
      • Conroe, Texas, United States, 77384
        • Recruiting
        • MD Anderson in The Woodlands
        • Contact:
        • Principal Investigator:
          • Michael J. Overman
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • Syed M. Kazmi
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Parkland Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Syed M. Kazmi
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • STCC at DHR Health Institute for Research and Development
        • Contact:
        • Principal Investigator:
          • Shravan K. Narmala
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Michael J. Overman
      • Houston, Texas, United States, 77079
        • Recruiting
        • MD Anderson West Houston
        • Contact:
        • Principal Investigator:
          • Michael J. Overman
      • Houston, Texas, United States, 77026-1967
        • Recruiting
        • Lyndon Baines Johnson General Hospital
        • Principal Investigator:
          • Michael J. Overman
        • Contact:
          • Site Public Contact
          • Phone Number: 713-566-5000
      • Houston, Texas, United States, 77030
        • Suspended
        • Houston Methodist Hospital
      • League City, Texas, United States, 77573
        • Recruiting
        • MD Anderson League City
        • Contact:
        • Principal Investigator:
          • Michael J. Overman
      • Port Arthur, Texas, United States, 77642
        • Active, not recruiting
        • Baptist Regional Cancer Network-Cancer Center of Southeast Texas
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • MD Anderson in Sugar Land
        • Contact:
        • Principal Investigator:
          • Michael J. Overman
      • Temple, Texas, United States, 76508
        • Active, not recruiting
        • Scott and White Memorial Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Heloisa P. Soares
    • Vermont
      • Saint Johnsbury, Vermont, United States, 05819
        • Recruiting
        • Norris Cotton Cancer Center-North
        • Contact:
        • Principal Investigator:
          • Kathryn C. Hourdequin
    • Virginia
      • Bristol, Virginia, United States, 24201
        • Recruiting
        • Wellmont Medical Associates-Bristol
        • Contact:
        • Principal Investigator:
          • Asheesh Shipstone
      • Burke, Virginia, United States, 22015
        • Recruiting
        • Kaiser Permanente-Burke Medical Center
        • Principal Investigator:
          • Leon C. Hwang
        • Contact:
      • Fishersville, Virginia, United States, 22939
        • Recruiting
        • Augusta Health Center for Cancer and Blood Disorders
        • Contact:
          • Site Public Contact
          • Phone Number: 540-332-5960
        • Principal Investigator:
          • Robert M. Kyler
      • Lynchburg, Virginia, United States, 24501
        • Suspended
        • Centra Lynchburg Hematology-Oncology Clinic Inc
      • McLean, Virginia, United States, 22102
        • Recruiting
        • Kaiser Permanente Tysons Corner Medical Center
        • Principal Investigator:
          • Leon C. Hwang
        • Contact:
          • Site Public Contact
          • Phone Number: 240-632-4284
      • Norton, Virginia, United States, 24273
        • Recruiting
        • Southwest VA Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Asheesh Shipstone
      • Richmond, Virginia, United States, 23229
        • Recruiting
        • Virginia Cancer Institute
        • Contact:
        • Principal Investigator:
          • Khalid Matin
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University/Massey Cancer Center
        • Contact:
        • Principal Investigator:
          • Khalid Matin
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • VCU Massey Cancer Center at Stony Point
        • Contact:
        • Principal Investigator:
          • Khalid Matin
      • South Hill, Virginia, United States, 23970
        • Recruiting
        • VCU Community Memorial Health Center
        • Contact:
        • Principal Investigator:
          • Khalid Matin
      • Woodbridge, Virginia, United States, 22192
        • Recruiting
        • Kaiser Permanente-Caton Hill Medical Center
        • Principal Investigator:
          • Leon C. Hwang
        • Contact:
    • Washington
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Port Townsend, Washington, United States, 98368
        • Recruiting
        • Jefferson Healthcare
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
          • Site Public Contact
          • Phone Number: 360-344-3091
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Spokane, Washington, United States, 99204
        • Recruiting
        • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
        • Principal Investigator:
          • Jennifer Slim
        • Contact:
      • Spokane, Washington, United States, 99218
        • Recruiting
        • MultiCare Deaconess Cancer and Blood Specialty Center - North
        • Principal Investigator:
          • Jennifer Slim
        • Contact:
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • West Virginia University Charleston Division
        • Contact:
          • Site Public Contact
          • Phone Number: 304-388-9944
        • Principal Investigator:
          • Ahmed A. Khalid
      • Morgantown, West Virginia, United States, 26506
        • Active, not recruiting
        • West Virginia University Healthcare
      • Parkersburg, West Virginia, United States, 26101
        • Active, not recruiting
        • Camden Clark Medical Center
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Recruiting
        • Langlade Hospital and Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew J. Huang
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Matthias Weiss
      • Appleton, Wisconsin, United States, 54915
        • Recruiting
        • Ascension Saint Elizabeth Hospital
        • Contact:
        • Principal Investigator:
          • Francis J. Cuevas
      • Ashland, Wisconsin, United States, 54806
        • Recruiting
        • Duluth Clinic Ashland
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Brookfield, Wisconsin, United States, 53045
        • Recruiting
        • Ascension Southeast Wisconsin Hospital - Elmbrook Campus
        • Contact:
        • Principal Investigator:
          • Francis J. Cuevas
      • Eau Claire, Wisconsin, United States, 54701
      • Franklin, Wisconsin, United States, 53132
        • Recruiting
        • Ascension Saint Francis - Reiman Cancer Center
        • Contact:
        • Principal Investigator:
          • Francis J. Cuevas
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Bellin Memorial Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 920-435-8326
        • Principal Investigator:
          • Kevin L. Mortara
      • Janesville, Wisconsin, United States, 53548
        • Recruiting
        • Mercyhealth Hospital and Cancer Center - Janesville
        • Contact:
        • Principal Investigator:
          • Emily G. Robinson
      • Johnson Creek, Wisconsin, United States, 53038
        • Recruiting
        • UW Cancer Center Johnson Creek
        • Contact:
        • Principal Investigator:
          • Dustin A. Deming
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Kurt Oettel
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-622-8922
        • Principal Investigator:
          • Dustin A. Deming
      • Marshfield, Wisconsin, United States, 54449
      • Medford, Wisconsin, United States, 54451
        • Recruiting
        • Aspirus Medford Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Minocqua, Wisconsin, United States, 54548
      • Mukwonago, Wisconsin, United States, 53149
        • Recruiting
        • ProHealth D N Greenwald Center
        • Contact:
        • Principal Investigator:
          • Timothy R. Wassenaar
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Oconomowoc, Wisconsin, United States, 53066
        • Recruiting
        • ProHealth Oconomowoc Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7878
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Ascension Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Francis J. Cuevas
      • Racine, Wisconsin, United States, 53405
        • Recruiting
        • Ascension All Saints Hospital
        • Contact:
        • Principal Investigator:
          • Francis J. Cuevas
      • Rhinelander, Wisconsin, United States, 54501
        • Recruiting
        • Ascension Saint Mary's Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Rice Lake, Wisconsin, United States, 54868
      • Stevens Point, Wisconsin, United States, 54482
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • ProHealth Waukesha Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7632
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • UW Cancer Center at ProHealth Care
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Regional Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Ascension Medical Group Southeast Wisconsin - Mayfair Road
        • Contact:
        • Principal Investigator:
          • Francis J. Cuevas
      • Weston, Wisconsin, United States, 54476
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Recruiting
        • Aspirus Cancer Care - Wisconsin Rapids
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 715-422-7718
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Suspended
        • Cheyenne Regional Medical Center-West
      • Cody, Wyoming, United States, 82414
        • Suspended
        • Billings Clinic-Cody

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer except for one cycle of FOLFOX or capecitabine and oxaliplatin (CAPOX), either with or without bevacizumab prior to enrollment. Upon enrollment, the preceding single cycle of FOLFOX or FOLFOX + bevacizumab, if the patient received one, will not count towards patients' assessments per protocol. Cycle 1 day 1 (C1D1) of atezolizumab or C1D1 of mFOLFOX6/bevacizumab + atezolizumab will correspond to the first day the patient received therapy on trial
  • Tumor determined to be mismatch-repair deficient (dMMR) by Clinical Laboratory Improvement Act (CLIA)-certified immunohistochemical (IHC) assay with a panel of all four IHC markers, including MLH1, MSH2, PMS2, and MSH6; alternatively, MSI-H diagnosed by polymerase chain reaction (PCR)-based assessment of microsatellite alterations (either Bethesda markers or Pentaplex panel) or by next-generation sequencing (NGS) are eligible
  • Documentation by PET/CT scan, CT scan, or MRI that the patient has measurable metastatic disease per RECIST 1.1
  • No immediate need for surgical intervention for the primary tumor or palliative diversion/bypass
  • Absolute neutrophil count (ANC) must be >= 1500/mm^3 (obtained within 28 days prior randomization)
  • Platelet count must be >= 100,000/mm^3 (obtained within 28 days prior randomization)
  • Hemoglobin must be >= 8 g/dL (obtained within 28 days prior randomization)
  • Total bilirubin must be =< 4 x ULN (upper limit of normal) (obtained within 28 days prior randomization); and
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be =< 3 x ULN for the lab with the following exception: for patients with documented liver metastases, AST and ALT must be =< 5 x ULN (obtained within 28 days prior randomization)
  • Calculated creatinine clearance >= 30 mL/min (obtained within 28 days prior randomization)
  • A urine sample tested for proteinuria by either the dipstick method, urinalysis (UA), or a urine protein creatinine (UPC) ratio:

    • The dipstick method must indicate 0-1+ protein; if dipstick reading is >= 2+, a 24-hour urine must be done and it must demonstrate < 1.0 g of protein per 24 hours or a UPC ratio < 1.0
    • A urine protein creatinine (UPC) ratio must be < 1.0; if the UPC ratio is >= 1.0 a 24-hour urine must be done and it must demonstrate < 1.0 g of protein per 24 hours
    • Urinalysis must indicate < 30 mg/dl. If urinalysis >= 30 mg/dl, a 24-hour urine must be done and it must demonstrate < 1.0 g of protein per 24 hours or a UPC ratio < 1.0
  • International normalized ratio of prothrombin time (INR) and prothrombin time (PT) must be =< 1.5 x ULN for the lab within 28 days before randomization; patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history, regardless of PT/INR results
  • Pregnancy test done within 28 days prior randomization must be negative (for women of childbearing potential only); pregnancy testing should be performed according to institutional standards; administration of atezolizumab or mFOLFOX6/bevacizumab/atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Women of child-bearing potential and men must agree to use adequate contraception methods that result in a failure rate of < 1% per year during the treatment period (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, and 6 months after the last dose of mFOLFOX6; a woman is considered to be of childbearing potential if she is not postmenopausal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus); examples of contraceptive methods with a failure rate of < 1% per year include: bilateral tubal ligation; male partner sterilization; intrauterine devices; the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception; men must refrain from donating sperm during this same period

Exclusion Criteria:

  • Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies, fluoropyrimidines, folic acid derivatives or oxaliplatin
  • Uncontrolled high blood pressure defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP > 100 mmHg with or without anti-hypertensive medication; patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria
  • Documented New York Heart Association (NYHA) class III or IV congestive heart failure
  • Serious or non-healing wound, skin ulcer, or bone fracture
  • History of inherited bleeding diathesis, gastrointestinal (GI) perforation, significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis or symptomatic peripheral ischemia, transient ischemic attack [TIA], cerebrovascular accident [CVA] or arterial thrombotic event), abdominal fistula, intra-abdominal abscess, or active GI bleeding (with cause not addressed) within 6 months prior to randomization, or other medical condition in the opinion of the treating oncologist that makes the risk of cardiovascular or bleeding complications with bevacizumab use unacceptably high
  • Other malignancies are excluded unless the patient has completed therapy for the malignancy >= 12 months prior to randomization and is considered disease-free; patients with the following cancers are eligible if diagnosed and treated within the past 12 months: in situ carcinomas or basal cell and squamous cell carcinoma of the skin
  • Known DPD (dihydro pyrimidine dehydrogenase) deficiency
  • Symptomatic peripheral sensory neuropathy >= grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0)
  • Prior treatment with oxaliplatin chemotherapy within 6 months prior to randomization
  • History of grade 2 hemoptysis (defined as 2.5 mL of bright red blood per episode) within 1 month prior to screening
  • Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents; patients who have received prior treatment with anti-CTLA-4 may be enrolled provided the following requirements are met:

    • Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose to randomization
    • No history of severe immune-related adverse effects (CTCAE grade 3 and 4) from anti-CTLA-4
  • Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization; however,

    • Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea; or chronic daily treatment with corticosteroids with a dose of =< 10 mg/day methylprednisolone equivalent) may be enrolled
    • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease; however,

    • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HbsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible if polymerase chain reaction (PCR) for hepatits B virus (HBV) ribonucleic acid (RNA) is negative per local guidelines
    • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA per local guidelines
  • History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; however,

    • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible
    • Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible
    • Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:

      • Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
      • Rash must cover less than 10% of body surface area (BSA)
      • Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)
      • No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or active or recently active (within 90 days of randomization) pneumonitis (including drug induced) that required systemic immunosuppressive therapy (i.e. corticosteroids, etc.). History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Patients with known active tuberculosis (TB) are excluded
  • Severe infections within 28 days prior to randomization, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Signs or symptoms of infection within 14 days prior to randomization
  • Received oral or intravenous (IV) antibiotics within 14 days prior to randomization; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
  • The administration of a live, attenuated vaccine within 28 days prior to randomization
  • Pregnant women are excluded from this study because atezolizumab is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding should be discontinued if the mother is treated with atezolizumab; these potential risks may also apply to other agents used in this study; (Note: pregnancy testing should be performed within 28 days prior to randomization according to institutional standards for women of childbearing potential)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation

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 I (bevacizumab, mFOLFOX6)
Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 of cycles 1-10, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1 and 2. Treatment with oxaliplatin repeats every 2 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Treatment of bevacizumab, leucovorin calcium, and fluorouracil repeat every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with or without PET or MRI throughout the trial. Patients may also undergo collection of optional blood samples throughout the trial. (CLOSED TO ACCRUAL)
Ancillary studies
Other Names:
  • Quality of Life Assessment
Ancillary studies
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
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
Given IV
Other Names:
  • Avastin
  • ABP 215
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF Monoclonal Antibody SIBP04
  • Anti-VEGF rhuMAb
  • Bevacizumab awwb
  • Bevacizumab Biosimilar ABP 215
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar CBT 124
  • Bevacizumab Biosimilar CT-P16
  • Bevacizumab Biosimilar FKB238
  • Bevacizumab Biosimilar GB-222
  • Bevacizumab Biosimilar HD204
  • Bevacizumab Biosimilar HLX04
  • Bevacizumab Biosimilar IBI305
  • Bevacizumab Biosimilar LY01008
  • Bevacizumab Biosimilar MIL60
  • Bevacizumab Biosimilar Mvasi
  • Bevacizumab Biosimilar MYL-1402O
  • Bevacizumab Biosimilar QL 1101
  • Bevacizumab Biosimilar RPH-001
  • Bevacizumab Biosimilar SCT501
  • Bevacizumab Biosimilar Zirabev
  • Bevacizumab-awwb
  • Bevacizumab-bvzr
  • BP102
  • BP102 Biosimilar
  • HD204
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Mvasi
  • MYL-1402O
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
  • SCT501
  • SIBP 04
  • SIBP-04
  • SIBP04
  • Zirabev
  • QL1101
  • Bevacizumab Biosimilar QL1101
  • BAT1706
  • BAT 1706
  • BAT-1706
  • BAT1706 Biosimilar
  • Bevacizumab Biosimilar BAT1706
  • Bevacizumab-adcd
  • CT-P16
  • Vegzelma
Given IV
Other Names:
  • 5-Fluracil
  • Fluracil
  • 5 Fluorouracil
  • 5 Fluorouracilum
  • 5 FU
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Given IV
Other Names:
  • Folinic acid
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • Ai Heng
  • Aiheng
  • Diaminocyclohexane Oxalatoplatinum
  • Eloxatine
  • JM-83
  • Oxalatoplatin
  • Oxalatoplatinum
  • RP 54780
  • RP-54780
  • SR-96669
Undergo CT or CT/PET
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
Undergo CT/PET
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Experimental: Arm II (atezolizumab)
Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with or without PET or MRI throughout the trial. Patients may also undergo collection of optional blood samples throughout the trial.
Ancillary studies
Other Names:
  • Quality of Life Assessment
Ancillary studies
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
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
Given IV
Other Names:
  • Tecentriq
  • MPDL3280A
  • RO5541267
  • RG7446
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL328OA
Undergo CT or CT/PET
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
Undergo CT/PET
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Experimental: Arm III (atezolizumab, bevacizumab, mFOLFOX6)
Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive bevacizumab IV over 30-90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 cycles 1-10, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on day 1. Treatment with oxaliplatin repeats every 2 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Treatment of bevacizumab, leucovorin calcium, and fluorouracil repeat every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with or without PET or MRI throughout the trial. Patients may also undergo collection of optional blood samples throughout the trial.
Ancillary studies
Other Names:
  • Quality of Life Assessment
Ancillary studies
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
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
Given IV
Other Names:
  • Avastin
  • ABP 215
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF Monoclonal Antibody SIBP04
  • Anti-VEGF rhuMAb
  • Bevacizumab awwb
  • Bevacizumab Biosimilar ABP 215
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar CBT 124
  • Bevacizumab Biosimilar CT-P16
  • Bevacizumab Biosimilar FKB238
  • Bevacizumab Biosimilar GB-222
  • Bevacizumab Biosimilar HD204
  • Bevacizumab Biosimilar HLX04
  • Bevacizumab Biosimilar IBI305
  • Bevacizumab Biosimilar LY01008
  • Bevacizumab Biosimilar MIL60
  • Bevacizumab Biosimilar Mvasi
  • Bevacizumab Biosimilar MYL-1402O
  • Bevacizumab Biosimilar QL 1101
  • Bevacizumab Biosimilar RPH-001
  • Bevacizumab Biosimilar SCT501
  • Bevacizumab Biosimilar Zirabev
  • Bevacizumab-awwb
  • Bevacizumab-bvzr
  • BP102
  • BP102 Biosimilar
  • HD204
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Mvasi
  • MYL-1402O
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
  • SCT501
  • SIBP 04
  • SIBP-04
  • SIBP04
  • Zirabev
  • QL1101
  • Bevacizumab Biosimilar QL1101
  • BAT1706
  • BAT 1706
  • BAT-1706
  • BAT1706 Biosimilar
  • Bevacizumab Biosimilar BAT1706
  • Bevacizumab-adcd
  • CT-P16
  • Vegzelma
Given IV
Other Names:
  • Tecentriq
  • MPDL3280A
  • RO5541267
  • RG7446
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL328OA
Given IV
Other Names:
  • 5-Fluracil
  • Fluracil
  • 5 Fluorouracil
  • 5 Fluorouracilum
  • 5 FU
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Given IV
Other Names:
  • Folinic acid
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • Ai Heng
  • Aiheng
  • Diaminocyclohexane Oxalatoplatinum
  • Eloxatine
  • JM-83
  • Oxalatoplatin
  • Oxalatoplatinum
  • RP 54780
  • RP-54780
  • SR-96669
Undergo CT or CT/PET
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
Undergo CT/PET
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: From the time from randomization until first confirmed progression or death from any cause, assessed up to 5 years
The analysis set is intent-to-treat (ITT). The experimental arms will be compared to the control arm by the log-rank test stratified by BRAF status (V600E mutation or not), metastatic disease: (liver-only, extra-hepatic), and prior adjuvant therapy for colon cancer (yes, no). Hazard ratios and associated confidence intervals from a stratified Cox regression model will also be reported along with estimates of the distributions of time to PFS event by the method of Kaplan and Meier. Sensitivity analyses accounting for 2 or more consecutively missed scheduled tumor imaging scans before progression/death will also be conducted.
From the time from randomization until first confirmed progression or death from any cause, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: The time from randomization to death from any cause, assessed up to 5 years
Will be analyzed using the stratified log rank test and the ITT population. Kaplan-Meier plots will illustrate the distribution of these endpoints by treatment. Stratified Cox regression models will be used to estimate hazard ratios and associated confidence intervals.
The time from randomization to death from any cause, assessed up to 5 years
Objective response rate (ORR) (complete response [CR] or partial response [PR])
Time Frame: Up to 5 years
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be analyzed by a logistic regression models that control for the stratification factors (BRAF status, liver involvement, and adjuvant chemotherapy [chemo]) using the ITT population. Observed proportions along with confidence intervals will be presented by treatment.
Up to 5 years
Incidence of adverse events
Time Frame: Up to 30 days after last cycle
Defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The safety profile will be described by tabulating the maximum observed grade of adverse event for each individual adverse event, for each system organ class, and overall using the Safety population.
Up to 30 days after last cycle
Rate of PFS
Time Frame: At 12 months
At 12 months
Disease control rate (CR + PR + stable disease [SD])
Time Frame: At 12 months
Assessed by RECIST 1.1. Will be analyzed by a logistic regression models that control for the stratification factors (BRAF status, liver involvement, and adjuvant chemo) using the ITT population. Observed proportions along with confidence intervals will be presented by treatment.
At 12 months
Duration of overall response (CR or PR)
Time Frame: From the time of first response to first confirmed progression by the study investigator or death from any cause, assessed up to 5 years
Assessed by RECIST 1.1. Will be analyzed using the stratified log rank test and the ITT population. Kaplan-Meier plots will illustrate the distribution of these endpoints by treatment. Stratified Cox regression models will be used to estimate hazard ratios and associated confidence intervals.
From the time of first response to first confirmed progression by the study investigator or death from any cause, assessed up to 5 years
Duration of SD
Time Frame: From the time of first on-study assessment of SD to first progression by the study investigator or death from any cause, assessed up to 5 years
Assessed per RECIST 1.1. Will be analyzed using the stratified log rank test and the ITT population. Kaplan-Meier plots will illustrate the distribution of these endpoints by treatment. Stratified Cox regression models will be used to estimate hazard ratios and associated confidence intervals.
From the time of first on-study assessment of SD to first progression by the study investigator or death from any cause, assessed up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of fatigue
Time Frame: At 16 weeks
Will use the ITT population. Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue questionnaire. Will be compared between the control arm (Chemo-bevacizumab [Bev]) and the experimental arm by means of ordinal logistic regression with adjustment for the corresponding baseline measurement and stratification variables. The comparison will be performed at the significance level of 0.05 (two-sided) and the clinical meaningfulness of the comparison will be considered.
At 16 weeks
Physical functioning
Time Frame: At 16 weeks
Will use the ITT population. Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire (QLQ)-C30 physical functioning scale. Will be compared between the control arm (Chemo-Bev) and the experimental arm by means of ordinal logistic regression with adjustment for the corresponding baseline measurement and stratification variables. The comparison will be performed at the significance level of 0.05 (two-sided) and the clinical meaningfulness of the comparison will be considered.
At 16 weeks
Health utility scores
Time Frame: Up to 5 years
Will use the ITT population. Will be measured using the EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire.
Up to 5 years
Proportion of patients reporting each response option at each assessment timepoint by treatment arm for item GP5 from the Functional Assessment of Cancer Therapy - General (FACT-G)
Time Frame: Up to 5 years
Will use the ITT population.
Up to 5 years
Intratumoral lymphocyte PD-L1+ expression (>= 1 % is positive) by immunohistochemistry (IHC) as a predictive biomarker of efficacy
Time Frame: Up to 5 years
Will use the ITT population.
Up to 5 years
Efficacy dependent on the number of somatic mutations
Time Frame: Up to 5 years
Will use the ITT population.
Up to 5 years
Efficacy in tumors with MLH1 silencing
Time Frame: Up to 5 years
Will use the ITT population.
Up to 5 years
Change in quantification of cell free deoxyribonucleic acid (cfDNA) mutations
Time Frame: Baseline up to 5 years
Will use the ITT population.
Baseline up to 5 years
Development of progression or relapse to treatment in cfDNA
Time Frame: Up to 5 years
Will use the ITT population.
Up to 5 years
Changes in T-cell repertoire diversity as a predictive biomarker of efficacy
Time Frame: Baseline up to 5 years
Will use the ITT population.
Baseline up to 5 years
PFS of patients with high levels of diversity
Time Frame: Up to 5 years
Compared to patients with low levels of diversity. Will use the ITT population.
Up to 5 years
Change in T-cell diversity
Time Frame: Baseline to first restaging between immunotherapy arms and the standard of care arm
Will use the ITT population.
Baseline to first restaging between immunotherapy arms and the standard of care arm
Mechanism of immune resistance to PD-1 blockade in mismatch repair deficient (dMMR)/microsatellite instability-high metastatic colorectal cancer (mCRC) by comparative analysis of tumor samples collected
Time Frame: Baseline up to 5 years
Will use the ITT population.
Baseline up to 5 years

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Caio Max S Rocha Lima, NRG Oncology

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)

January 19, 2018

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

December 19, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (Estimated)

December 20, 2016

Study Record Updates

Last Update Posted (Estimated)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

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.

Clinical Trials on Metastatic Colorectal Adenocarcinoma

Clinical Trials on Quality-of-Life Assessment

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