Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study

May 12, 2026 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 is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of the tumor. 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

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 (CLOSED TO ACCRUAL 6/4/2020): 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.

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

United States
- Arizona
  - Kingman, Arizona, United States, 86401
    - Kingman Regional Medical Center
- Arkansas
  - Jonesboro, Arkansas, United States, 72401
    - NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- California
  - Anaheim, California, United States, 92806
    - Kaiser Permanente-Anaheim
  - Baldwin Park, California, United States, 91706
    - Kaiser Permanente-Baldwin Park
  - Bellflower, California, United States, 90706
    - Kaiser Permanente-Bellflower
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Concord, California, United States, 94520
    - John Muir Medical Center-Concord
  - Fontana, California, United States, 92335
    - Kaiser Permanente-Fontana
  - Harbor City, California, United States, 90710
    - Kaiser Permanente South Bay
  - Irvine, California, United States, 92618
    - Kaiser Permanente-Irvine
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90034
    - Kaiser Permanente West Los Angeles
  - Marysville, California, United States, 95901
    - Fremont - Rideout Cancer Center
  - Modesto, California, United States, 95355
    - Memorial Medical Center
  - Ontario, California, United States, 91761
    - Kaiser Permanente-Ontario
  - Orange, California, United States, 92868
    - UC Irvine Health/Chao Family Comprehensive Cancer Center
  - Orange, California, United States, 92868
    - Saint Joseph Hospital - Orange
  - Panorama City, California, United States, 91402
    - Kaiser Permanente - Panorama City
  - Riverside, California, United States, 92505
    - Kaiser Permanente-Riverside
  - Sacramento, California, United States, 95816
    - Sutter Medical Center Sacramento
  - Sacramento, California, United States, 95817
    - University of California Davis Comprehensive Cancer Center
  - Salinas, California, United States, 93901
    - Salinas Valley Memorial
  - San Diego, California, United States, 92120
    - Kaiser Permanente-San Diego Zion
  - San Diego, California, United States, 92108
    - Kaiser Permanente-San Diego Mission
  - San Marcos, California, United States, 92078
    - Kaiser Permanente-San Marcos
  - Walnut Creek, California, United States, 94598
    - John Muir Medical Center-Walnut Creek
  - Whittier, California, United States, 90602
    - Presbyterian Intercommunity Hospital
  - Woodland Hills, California, United States, 91367
    - Kaiser Permanente-Woodland Hills
- Colorado
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers-Aurora
  - Aurora, Colorado, United States, 80045
    - UCHealth University of Colorado Hospital
  - Boulder, Colorado, United States, 80303
    - Boulder Community Foothills Hospital
  - Boulder, Colorado, United States, 80304
    - Rocky Mountain Cancer Centers-Boulder
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80909
    - UCHealth Memorial Hospital Central
  - Colorado Springs, Colorado, United States, 80920
    - Memorial Hospital North
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers-Midtown
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers-Rose
  - Denver, Colorado, United States, 80204
    - Denver Health Medical Center
  - Denver, Colorado, United States, 80206
    - National Jewish Health-Main Campus
  - Denver, Colorado, United States, 80218
    - Saint Joseph Hospital - Cancer Centers of Colorado
  - Denver, Colorado, United States, 80210
    - AdventHealth Porter
  - Englewood, Colorado, United States, 80113
    - Mountain Blue Cancer Care Center - Swedish
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Cancer Care and Hematology-Fort Collins
  - Golden, Colorado, United States, 80401
    - National Jewish Health-Western Hematology Oncology
  - Greeley, Colorado, United States, 80631
    - UCHealth Greeley Hospital
  - Greeley, Colorado, United States, 80631
    - Banner North Colorado Medical Center
  - Littleton, Colorado, United States, 80120
    - Rocky Mountain Cancer Centers-Littleton
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers-Sky Ridge
  - Loveland, Colorado, United States, 80538
    - Medical Center of the Rockies
  - Loveland, Colorado, United States, 80539
    - Banner North Colorado Medical Center - Loveland Campus
  - Thornton, Colorado, United States, 80260
    - National Jewish Health-Northern Hematology Oncology
  - Wheat Ridge, Colorado, United States, 80401
    - Intermountain Health Lutheran Hospital
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Danbury Hospital
  - Hartford, Connecticut, United States, 06102
    - Hartford Hospital
  - Meriden, Connecticut, United States, 06451
    - Midstate Medical Center
  - New Britain, Connecticut, United States, 06050
    - The Hospital of Central Connecticut
  - Norwich, Connecticut, United States, 06360
    - William Backus Hospital
- Delaware
  - Millville, Delaware, United States, 19967
    - Beebe South Coastal Health Campus
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20002
    - Kaiser Permanente-Capitol Hill Medical Center
- Florida
  - Fort Lauderdale, Florida, United States, 33316
    - Broward Health Medical Center
  - Fort Myers, Florida, United States, 33905
    - Regional Cancer Center-Lee Memorial Health System
  - Gainesville, Florida, United States, 32610
    - UF Health Cancer Institute - Gainesville
  - Jacksonville, Florida, United States, 32207
    - Baptist MD Anderson Cancer Center
  - Orlando, Florida, United States, 32803
    - AdventHealth Orlando
- Georgia
  - Albany, Georgia, United States, 31701
    - Phoebe Putney Memorial Hospital
  - Athens, Georgia, United States, 30607
    - University Cancer and Blood Center LLC
  - Augusta, Georgia, United States, 30912
    - Augusta University Medical Center
  - Augusta, Georgia, United States, 30901
    - Augusta Oncology Associates PC-D'Antignac
  - Augusta, Georgia, United States, 30909
    - Augusta Oncology Associates PC-Wheeler
  - Newnan, Georgia, United States, 30265
    - CTCA at Southeastern Regional Medical Center
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, United States, 83712
    - Saint Luke's Cancer Institute - Boise
  - Caldwell, Idaho, United States, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Health - Coeur d'Alene
  - Fruitland, Idaho, United States, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, United States, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, United States, 83687
    - Saint Alphonsus Cancer Care Center-Nampa
  - Nampa, Idaho, United States, 83687
    - Saint Luke's Cancer Institute - Nampa
  - Post Falls, Idaho, United States, 83854
    - Kootenai Clinic Cancer Services - Post Falls
  - Sandpoint, Idaho, United States, 83864
    - Kootenai Clinic Cancer Services - Sandpoint
  - Twin Falls, Idaho, United States, 83301
    - Saint Luke's Cancer Institute - Twin Falls
- Illinois
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60612
    - University of Illinois
  - Chicago, Illinois, United States, 60612
    - Rush MD Anderson Cancer Center
  - Danville, Illinois, United States, 61832
    - Carle at The Riverfront
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Dixon, Illinois, United States, 61021
    - Illinois CancerCare-Dixon
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Evanston, Illinois, United States, 60201
    - NorthShore University HealthSystem-Evanston Hospital
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg
  - Glenview, Illinois, United States, 60026
    - NorthShore University HealthSystem-Glenbrook Hospital
  - Highland Park, Illinois, United States, 60035
    - NorthShore University HealthSystem-Highland Park Hospital
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Mount Vernon, Illinois, United States, 62864
    - SSM Health Good Samaritan
  - O'Fallon, Illinois, United States, 62269
    - Cancer Care Center of O'Fallon
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Springfield, Illinois, United States, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, United States, 62702
    - Springfield Clinic
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Washington, Illinois, United States, 61571
    - Illinois CancerCare - Washington
- Indiana
  - Indianapolis, Indiana, United States, 46237
    - Franciscan Health Indianapolis
  - Indianapolis, Indiana, United States, 46202
    - Indiana University/Melvin and Bren Simon Cancer Center
  - Indianapolis, Indiana, United States, 46219
    - Community Cancer Center East
  - Indianapolis, Indiana, United States, 46227
    - Community Cancer Center South
  - Indianapolis, Indiana, United States, 46256
    - Community Cancer Center North
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - Lafayette, Indiana, United States, 47905
    - Franciscan Saint Elizabeth Health - Lafayette East
  - Michigan City, Indiana, United States, 46360
    - Woodland Cancer Care Center
  - Mooresville, Indiana, United States, 46158
    - Franciscan Health Mooresville
  - Terre Haute, Indiana, United States, 47804
    - Union Hospital
- Iowa
  - Ames, Iowa, United States, 50010
    - Mary Greeley Medical Center
  - Ames, Iowa, United States, 50010
    - McFarland Clinic - Ames
  - Bettendorf, Iowa, United States, 52722
    - University of Iowa Healthcare Cancer Services Quad Cities
  - Boone, Iowa, United States, 50036
    - McFarland Clinic - Boone
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, United States, 50325
    - UI Health Care Mission Cancer and Blood - West Des Moines Clinic
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50314
    - Broadlawns Medical Center
  - Des Moines, Iowa, United States, 50309
    - UI Health Care Mission Cancer and Blood - Des Moines Clinic
  - Des Moines, Iowa, United States, 50314
    - UI Health Care Mission Cancer and Blood - Laurel Clinic
  - Fort Dodge, Iowa, United States, 50501
    - McFarland Clinic - Trinity Cancer Center
  - Fort Dodge, Iowa, United States, 50501
    - UI Healthcare Mission Cancer and Blood - Fort Dodge
  - Iowa City, Iowa, United States, 52242
    - University of Iowa/Holden Comprehensive Cancer Center
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic - Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic - Marshalltown
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Hays, Kansas, United States, 67601
    - HaysMed
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Olathe, Kansas, United States, 66061
    - The University of Kansas Cancer Center - Olathe
  - Salina, Kansas, United States, 67401
    - Salina Regional Health Center
  - Topeka, Kansas, United States, 66606
    - University of Kansas Health System Saint Francis Campus
  - Westwood, Kansas, United States, 66205
    - University of Kansas Hospital-Westwood Cancer Center
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Wichita
- Kentucky
  - Bardstown, Kentucky, United States, 40004
    - Flaget Memorial Hospital
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky/Markey Cancer Center
  - Lexington, Kentucky, United States, 40509
    - Saint Joseph Hospital East
  - Lexington, Kentucky, United States, 40503
    - Baptist Health Lexington
  - Louisville, Kentucky, United States, 40202
    - Norton Hospital Pavilion and Medical Campus
  - Louisville, Kentucky, United States, 40241
    - Norton Brownsboro Hospital and Medical Campus
  - Louisville, Kentucky, United States, 40217
    - Norton Audubon Hospital and Medical Campus
- Louisiana
  - Kenner, Louisiana, United States, 70065
    - Ochsner Medical Center Kenner
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
- Maine
  - Augusta, Maine, United States, 04330
    - Harold Alfond Center for Cancer Care
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
  - Belfast, Maine, United States, 04915
    - MaineHealth Waldo Hospital
  - Biddeford, Maine, United States, 04005
    - MaineHealth Maine Medical Center - Biddeford
  - Brewer, Maine, United States, 04412
    - Lafayette Family Cancer Center-EMMC
  - Rockport, Maine, United States, 04856
    - Penobscot Bay Medical Center
  - Sanford, Maine, United States, 04073
    - MaineHealth Cancer Care and IV Therapy - Sanford
  - South Portland, Maine, United States, 04106
    - MaineHealth Cancer Care and IV Therapy - South Portland
- Maryland
  - Baltimore, Maryland, United States, 21244
    - Kaiser Permanente-Woodlawn Medical Center
  - Easton, Maryland, United States, 21601
    - University of Maryland Shore Medical Center at Easton
  - Gaithersburg, Maryland, United States, 20879
    - Kaiser Permanente-Gaithersburg Medical Center
  - Largo, Maryland, United States, 20774
    - Kaiser Permanente - Largo Medical Center
  - Lutherville, Maryland, United States, 21093
    - Kaiser Permanente Lutherville - Timonium Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute
  - Lowell, Massachusetts, United States, 01854
    - Lowell General Hospital
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - Trinity Health Saint Joseph Mercy Hospital Ann Arbor
  - Bay City, Michigan, United States, 48706
    - McLaren Cancer Institute-Bay City
  - Bloomfield, Michigan, United States, 48302
    - McLaren Cancer Institute-Bloomfield
  - Brighton, Michigan, United States, 48114
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Brighton, Michigan, United States, 48114
    - Trinity Health Medical Center - Brighton
  - Brownstown, Michigan, United States, 48183
    - Henry Ford Cancer Institute-Downriver
  - Canton, Michigan, United States, 48188
    - Trinity Health IHA Medical Group Hematology Oncology - Canton
  - Canton, Michigan, United States, 48188
    - Trinity Health Medical Center - Canton
  - Chelsea, Michigan, United States, 48118
    - Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  - Chelsea, Michigan, United States, 48118
    - Chelsea Hospital
  - Clarkston, Michigan, United States, 48346
    - McLaren Cancer Institute-Clarkston
  - Clarkston, Michigan, United States, 48346
    - Hematology Oncology Consultants-Clarkston
  - Clarkston, Michigan, United States, 48346
    - Newland Medical Associates-Clarkston
  - Clinton Township, Michigan, United States, 48038
    - Henry Ford Macomb Hospital-Clinton Township
  - Dearborn, Michigan, United States, 48126
    - Henry Ford Medical Center-Fairlane
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Farmington Hills, Michigan, United States, 48334
    - Weisberg Cancer Treatment Center
  - Flint, Michigan, United States, 48532
    - McLaren Cancer Institute-Flint
  - Flint, Michigan, United States, 48532
    - Singh and Arora Hematology Oncology PC
  - Grand Rapids, Michigan, United States, 49503
    - Corewell Health Grand Rapids Hospitals - Butterworth Hospital
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Lansing, Michigan, United States, 48910
    - Karmanos Cancer Institute at McLaren Greater Lansing
  - Lansing, Michigan, United States, 48912
    - University of Michigan Health - Sparrow Lansing
  - Lapeer, Michigan, United States, 48446
    - McLaren Cancer Institute-Lapeer Region
  - Livonia, Michigan, United States, 48154
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Livonia, Michigan, United States, 48154
    - Hope Cancer Clinic
  - Mount Clemens, Michigan, United States, 48043
    - McLaren Cancer Institute-Macomb
  - Mount Pleasant, Michigan, United States, 48858
    - McLaren Cancer Institute-Central Michigan
  - Novi, Michigan, United States, 48377
    - Henry Ford Medical Center-Columbus
  - Petoskey, Michigan, United States, 49770
    - McLaren Cancer Institute-Northern Michigan
  - Pontiac, Michigan, United States, 48341
    - Newland Medical Associates-Pontiac
  - Pontiac, Michigan, United States, 48341
    - Trinity Health Saint Joseph Mercy Oakland Hospital
  - Port Huron, Michigan, United States, 48060
    - McLaren-Port Huron
  - Saginaw, Michigan, United States, 48604
    - Oncology Hematology Associates of Saginaw Valley PC
  - Saginaw, Michigan, United States, 48601
    - MyMichigan Medical Center Saginaw
  - Tawas City, Michigan, United States, 48764
    - MyMichigan Medical Center Tawas
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - West Bloomfield, Michigan, United States, 48322
    - Henry Ford West Bloomfield Hospital
  - West Branch, Michigan, United States, 48661
    - Saint Mary's Oncology/Hematology Associates of West Branch
  - Ypsilanti, Michigan, United States, 48197
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Sanford Joe Lueken Cancer Center
  - Burnsville, Minnesota, United States, 55337
    - Minnesota Oncology - Burnsville
  - Deer River, Minnesota, United States, 56636
    - Essentia Health - Deer River Clinic
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Hibbing, Minnesota, United States, 55746
    - Essentia Health Hibbing Clinic
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55454
    - Health Partners Inc
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Sandstone, Minnesota, United States, 55072
    - Essentia Health Sandstone
  - Virginia, Minnesota, United States, 55792
    - Essentia Health Virginia Clinic
- Mississippi
  - Grenada, Mississippi, United States, 38901
    - Baptist Cancer Center-Grenada
  - New Albany, Mississippi, United States, 38652
    - Baptist Memorial Hospital and Cancer Center-Union County
  - Oxford, Mississippi, United States, 38655
    - Baptist Memorial Hospital and Cancer Center-Oxford
  - Southhaven, Mississippi, United States, 38671
    - Baptist Memorial Hospital and Cancer Center-Desoto
- Missouri
  - Ballwin, Missouri, United States, 63011
    - Mercy Oncology and Hematology - Clayton-Clarkson
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Columbia, Missouri, United States, 65212
    - MU Health - University Hospital/Ellis Fischel Cancer Center
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital Joplin
  - Kansas City, Missouri, United States, 64108
    - University Health Truman Medical Center
  - St Louis, Missouri, United States, 63109
    - Mercy Infusion Center - Chippewa
  - St Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
- Montana
  - Anaconda, Montana, United States, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Health Deaconess Hospital
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Benefis Sletten Cancer Institute
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Logan Health Medical Center
  - Missoula, Montana, United States, 59804
    - Community Medical Center
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - OptumCare Cancer Care at Charleston
  - Las Vegas, Nevada, United States, 89128
    - OptumCare Cancer Care at MountainView
  - Las Vegas, Nevada, United States, 89183
    - OptumCare Cancer Care at Fort Apache
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
  - Manchester, New Hampshire, United States, 03104
    - Dartmouth Cancer Center - Manchester/ DCC Manchester
  - Nashua, New Hampshire, United States, 03063
    - Dartmouth Cancer Center - Nashua
- New Jersey
  - Hamilton, New Jersey, United States, 08690
    - The Cancer Institute of New Jersey Hamilton
  - Morristown, New Jersey, United States, 07960
    - Morristown Medical Center
  - New Brunswick, New Jersey, United States, 08903
    - Rutgers Cancer Institute of New Jersey
  - Paramus, New Jersey, United States, 07652
    - The Valley Hospital - Luckow Pavilion
  - Ridgewood, New Jersey, United States, 07450
    - Valley Health System Ridgewood Campus
  - Somerville, New Jersey, United States, 08876
    - Robert Wood Johnson University Hospital Somerset
  - Summit, New Jersey, United States, 07902
    - Overlook Hospital
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, United States, 87110
    - Presbyterian Kaseman Hospital
  - Las Cruces, New Mexico, United States, 88011
    - Memorial Medical Center-Las Cruces
  - Rio Rancho, New Mexico, United States, 87124
    - Presbyterian Rust Medical Center/Jorgensen Cancer Center
- New York
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - Elmira, New York, United States, 14905
    - Arnot Ogden Medical Center/Falck Cancer Center
  - Lake Success, New York, United States, 11042
    - Northwell Health/Center for Advanced Medicine
  - New York, New York, United States, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
  - Rochester, New York, United States, 14642
    - University of Rochester
  - White Plains, New York, United States, 10601
    - Dickstein Cancer Treatment Center
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Lineberger Comprehensive Cancer Center
  - Clinton, North Carolina, United States, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Goldsboro, North Carolina, United States, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Hendersonville, North Carolina, United States, 28791
    - Margaret R Pardee Memorial Hospital
  - Jacksonville, North Carolina, United States, 28546
    - Southeastern Medical Oncology Center-Jacksonville
  - Kenansville, North Carolina, United States, 28349
    - ECU Health Oncology Kenansville
  - Kinston, North Carolina, United States, 28501
    - ECU Health Oncology Kinston
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth of the Carolinas-Moore Regional Hospital
  - Richlands, North Carolina, United States, 28574
    - ECU Health Oncology Richlands
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Broadway Medical Center
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center
- Ohio
  - Akron, Ohio, United States, 44307
    - Cleveland Clinic Akron General
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Centerville, Ohio, United States, 45459
    - Miami Valley Hospital South
  - Centerville, Ohio, United States, 45459
    - Dayton Physicians LLC-Miami Valley South
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45219
    - University of Cincinnati Cancer Center-UC Medical Center
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43210
    - Ohio State University Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43213
    - Mount Carmel East Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Kettering, Ohio, United States, 45409
    - Greater Dayton Cancer Center
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Mansfield, Ohio, United States, 44906
    - Cleveland Clinic Cancer Center Mansfield
  - Mansfield, Ohio, United States, 44903
    - OhioHealth Mansfield Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Marion, Ohio, United States, 43302
    - OhioHealth Marion General Hospital
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Hospital Cancer Center
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care
  - Sylvania, Ohio, United States, 43560
    - ProMedica Flower Hospital
  - Warrensville Heights, Ohio, United States, 44122
    - South Pointe Hospital
  - West Chester, Ohio, United States, 45069
    - University of Cincinnati Cancer Center-West Chester
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cancer Centers of Southwest Oklahoma Research
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Tulsa, Oklahoma, United States, 74146
    - Oklahoma Cancer Specialists and Research Institute-Tulsa
  - Tulsa, Oklahoma, United States, 74133
    - Cancer Treatment Centers of America
- Oregon
  - Bend, Oregon, United States, 97701
    - Saint Charles Health System
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Clackamas, Oregon, United States, 97015
    - Providence Cancer Institute Clackamas Clinic
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Ontario, Oregon, United States, 97914
    - Saint Alphonsus Cancer Care Center-Ontario
  - Oregon City, Oregon, United States, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Allentown, Pennsylvania, United States, 18104
    - Saint Luke's Cancer Center - Allentown
  - Bethlehem, Pennsylvania, United States, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - Bethlehem, Pennsylvania, United States, 18015
    - Saint Luke's University Hospital-Bethlehem Campus
  - Easton, Pennsylvania, United States, 18045
    - Saint Luke's Hospital-Anderson Campus
  - Erie, Pennsylvania, United States, 16544
    - Saint Vincent Hospital
  - Harrisburg, Pennsylvania, United States, 17109
    - UPMC Pinnacle Cancer Center/Community Osteopathic Campus
  - Jefferson Hills, Pennsylvania, United States, 15025
    - Jefferson Hospital
  - Monroeville, Pennsylvania, United States, 15146
    - Forbes Hospital
  - Natrona Heights, Pennsylvania, United States, 15065
    - Allegheny Valley Hospital
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, United States, 15224
    - West Penn Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute (UPCI)
  - Quakertown, Pennsylvania, United States, 18951
    - Saint Luke's Hospital-Quakertown Campus
  - West Reading, Pennsylvania, United States, 19611
    - Reading Hospital
  - Wexford, Pennsylvania, United States, 15090
    - Wexford Health and Wellness Pavilion
  - Willow Grove, Pennsylvania, United States, 19090
    - Asplundh Cancer Pavilion
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Cancer Center
  - Beaufort, South Carolina, United States, 29902
    - Beaufort Memorial Hospital
  - Boiling Springs, South Carolina, United States, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Easley, South Carolina, United States, 29640
    - Prisma Health Cancer Institute - Easley
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29607
    - Saint Francis Cancer Center
  - Greenville, South Carolina, United States, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greenville, South Carolina, United States, 29601
    - Saint Francis Hospital
  - Greer, South Carolina, United States, 29650
    - Prisma Health Cancer Institute - Greer
  - Seneca, South Carolina, United States, 29672
    - Prisma Health Cancer Institute - Seneca
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Medical Center
- South Dakota
  - Aberdeen, South Dakota, United States, 57401
    - Avera Cancer Institute-Aberdeen
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Bristol Regional Medical Center
  - Collierville, Tennessee, United States, 38017
    - Baptist Memorial Hospital and Cancer Center-Collierville
  - Cookeville, Tennessee, United States, 38501
    - Cookeville Regional Medical Center
  - Johnson City, Tennessee, United States, 37604
    - Wellmont Medical Associates Oncology and Hematology-Johnson City
  - Kingsport, Tennessee, United States, 37660
    - Ballad Health Cancer Care - Kingsport
  - Kingsport, Tennessee, United States, 37660
    - Wellmont Holston Valley Hospital and Medical Center
  - Memphis, Tennessee, United States, 38120
    - Baptist Memorial Hospital and Cancer Center-Memphis
- Texas
  - Amarillo, Texas, United States, 79106
    - The Don and Sybil Harrington Cancer Center
  - Beaumont, Texas, United States, 77701
    - Baptist Hospitals of Southeast Texas Cancer Center
  - Conroe, Texas, United States, 77384
    - MD Anderson in The Woodlands
  - Dallas, Texas, United States, 75235
    - Parkland Memorial Hospital
  - Dallas, Texas, United States, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Edinburg, Texas, United States, 78539
    - STCC at DHR Health Institute for Research and Development
  - Houston, Texas, United States, 77030
    - M D Anderson Cancer Center
  - Houston, Texas, United States, 77026-1967
    - Lyndon Baines Johnson General Hospital
  - Houston, Texas, United States, 77030
    - Houston Methodist Hospital
  - Houston, Texas, United States, 77079
    - MD Anderson West Houston
  - League City, Texas, United States, 77573
    - MD Anderson League City
  - Port Arthur, Texas, United States, 77642
    - Baptist Regional Cancer Network-Cancer Center of Southeast Texas
  - Sugar Land, Texas, United States, 77478
    - MD Anderson in Sugar Land
  - Temple, Texas, United States, 76508
    - Scott and White Memorial Hospital
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute/University of Utah
- Vermont
  - Saint Johnsbury, Vermont, United States, 05819
    - Dartmouth Cancer Center - North
- Virginia
  - Bristol, Virginia, United States, 24201
    - Ballad Health Cancer Care - Bristol
  - Burke, Virginia, United States, 22015
    - Kaiser Permanente-Burke Medical Center
  - Fishersville, Virginia, United States, 22939
    - Augusta Health Center for Cancer and Blood Disorders
  - Lynchburg, Virginia, United States, 24501
    - Centra Alan B Pearson Regional Cancer Center
  - McLean, Virginia, United States, 22102
    - Kaiser Permanente Tysons Corner Medical Center
  - Norton, Virginia, United States, 24273
    - Ballad Health Cancer Care - Norton
  - Richmond, Virginia, United States, 23235
    - VCU Massey Cancer Center at Stony Point
  - Richmond, Virginia, United States, 23229
    - Virginia Cancer Institute
  - Richmond, Virginia, United States, 23298
    - VCU Massey Comprehensive Cancer Center
  - South Hill, Virginia, United States, 23970
    - VCU Community Memorial Health Center
  - Woodbridge, Virginia, United States, 22192
    - Kaiser Permanente-Caton Hill Medical Center
- Washington
  - Edmonds, Washington, United States, 98026
    - Swedish Cancer Institute-Edmonds
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute-Issaquah
  - Port Townsend, Washington, United States, 98368
    - Jefferson Healthcare
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center-First Hill
  - Spokane, Washington, United States, 99204
    - MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
  - Spokane, Washington, United States, 99218
    - MultiCare Deaconess Cancer and Blood Specialty Center - North
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - West Virginia University Charleston Division
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Healthcare
  - Parkersburg, West Virginia, United States, 26101
    - Camden Clark Medical Center
- Wisconsin
  - Antigo, Wisconsin, United States, 54409
    - Langlade Hospital and Cancer Center
  - Appleton, Wisconsin, United States, 54911
    - ThedaCare Regional Cancer Center
  - Appleton, Wisconsin, United States, 54915
    - Ascension Saint Elizabeth Hospital
  - Ashland, Wisconsin, United States, 54806
    - Duluth Clinic Ashland
  - Brookfield, Wisconsin, United States, 53045
    - Ascension Southeast Wisconsin Hospital - Elmbrook Campus
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Medical Center-EC Cancer Center
  - Franklin, Wisconsin, United States, 53132
    - Ascension Saint Francis - Reiman Cancer Center
  - Green Bay, Wisconsin, United States, 54301
    - Bellin Memorial Hospital
  - Janesville, Wisconsin, United States, 53548
    - Mercyhealth Hospital and Cancer Center - Janesville
  - Johnson Creek, Wisconsin, United States, 53038
    - University of Wisconsin Carbone Cancer Center - Johnson Creek
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Carbone Cancer Center - University Hospital
  - Madison, Wisconsin, United States, 53718
    - University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center-Marshfield
  - Medford, Wisconsin, United States, 54451
    - Aspirus Medford Hospital
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Medical Center - Minocqua
  - Mukwonago, Wisconsin, United States, 53149
    - ProHealth D N Greenwald Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oconomowoc, Wisconsin, United States, 53066
    - ProHealth Oconomowoc Memorial Hospital
  - Oshkosh, Wisconsin, United States, 54904
    - Ascension Mercy Hospital
  - Racine, Wisconsin, United States, 53405
    - Ascension All Saints Hospital
  - Rhinelander, Wisconsin, United States, 54501
    - Aspirus Cancer Care - James Beck Cancer Center
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Medical Center-Rice Lake
  - Stevens Point, Wisconsin, United States, 54482
    - Marshfield Medical Center-River Region at Stevens Point
  - Waukesha, Wisconsin, United States, 53188
    - UW Cancer Center at ProHealth Care
  - Waukesha, Wisconsin, United States, 53188
    - ProHealth Waukesha Memorial Hospital
  - Wausau, Wisconsin, United States, 54401
    - Aspirus Regional Cancer Center
  - Wauwatosa, Wisconsin, United States, 53226
    - Ascension Medical Group Southeast Wisconsin - Mayfair Road
  - Weston, Wisconsin, United States, 54476
    - Marshfield Medical Center - Weston
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Aspirus Cancer Care - Wisconsin Rapids
- Wyoming
  - Cheyenne, Wyoming, United States, 82001
    - Cheyenne Regional Medical Center-West
  - Cody, Wyoming, United States, 82414
    - 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

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)

Number of Arms

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)	Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Procedure: Biospecimen Collection Undergo collection of blood samples Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Sample Collection Procedure: Magnetic Resonance Imaging Undergo MRI Other Names: MRI Magnetic Resonance Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Magnetic Resonance Imaging (MRI) sMRI Magnetic resonance imaging (procedure) MRIs Structural MRI Biological: Bevacizumab 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 Alymsys ABP-215 ABP215 Aybintio Bevacizumab-aybi Bevacizumab-equi Bevacizumab-maly Bevacizumab-onbe CT P16 CTP16 Equidacent Onbevzi Avzivi Bevacizumab Biosimilar MB02 Bevacizumab-tnjn FKB 238 FKB-238 FKB238 MB 02 MB-02 MB02 Oyavas PF 06439535 PF-06439535 PF06439535 Drug: Fluorouracil 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 Drug: Leucovorin Given IV Other Names: Folinic acid Drug: Oxaliplatin 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 SR96669 Elplat JM 83 JM83 RP54780 SR 96669 Procedure: Computed Tomography 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 Diagnostic CAT Scan Diagnostic CAT Scan Service Type Procedure: Positron Emission Tomography Undergo CT/PET Other Names: Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography 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.	Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Procedure: Biospecimen Collection Undergo collection of blood samples Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Sample Collection Procedure: Magnetic Resonance Imaging Undergo MRI Other Names: MRI Magnetic Resonance Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Magnetic Resonance Imaging (MRI) sMRI Magnetic resonance imaging (procedure) MRIs Structural MRI Drug: Atezolizumab Given IV Other Names: Tecentriq MPDL3280A RO5541267 RG7446 MPDL 3280A MPDL 328OA MPDL-3280A MPDL328OA RG-7446 RG 7446 RO 5541267 RO-5541267 Procedure: Computed Tomography 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 Diagnostic CAT Scan Diagnostic CAT Scan Service Type Procedure: Positron Emission Tomography Undergo CT/PET Other Names: Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography 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.	Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Procedure: Biospecimen Collection Undergo collection of blood samples Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Sample Collection Procedure: Magnetic Resonance Imaging Undergo MRI Other Names: MRI Magnetic Resonance Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Magnetic Resonance Imaging (MRI) sMRI Magnetic resonance imaging (procedure) MRIs Structural MRI Biological: Bevacizumab 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 Alymsys ABP-215 ABP215 Aybintio Bevacizumab-aybi Bevacizumab-equi Bevacizumab-maly Bevacizumab-onbe CT P16 CTP16 Equidacent Onbevzi Avzivi Bevacizumab Biosimilar MB02 Bevacizumab-tnjn FKB 238 FKB-238 FKB238 MB 02 MB-02 MB02 Oyavas PF 06439535 PF-06439535 PF06439535 Drug: Atezolizumab Given IV Other Names: Tecentriq MPDL3280A RO5541267 RG7446 MPDL 3280A MPDL 328OA MPDL-3280A MPDL328OA RG-7446 RG 7446 RO 5541267 RO-5541267 Drug: Fluorouracil 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 Drug: Leucovorin Given IV Other Names: Folinic acid Drug: Oxaliplatin 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 SR96669 Elplat JM 83 JM83 RP54780 SR 96669 Procedure: Computed Tomography 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 Diagnostic CAT Scan Diagnostic CAT Scan Service Type Procedure: Positron Emission Tomography Undergo CT/PET Other Names: Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography 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.

Sponsor

National Cancer Institute (NCI)

Collaborators

NRG Oncology

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)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

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 (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NCI-2016-01961 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
U10CA180868 (U.S. NIH Grant/Contract)
NRG-GI004/S1610
NRG-GI004 (Other Identifier: CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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