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ACTIVE NOT RECRUITING
NCT05308446
PHASE2

Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with encorafenib and cetuximab may be more effective than encorafenib and cetuximab alone at stopping tumor growth and spreading in patients with metastatic or unresectable BRAF-mutant colorectal cancer.

Official title: Randomized Phase II Trial of Encorafenib and Cetuximab With or Without Nivolumab (NSC #748726) for Patients With Previously Treated, Microsatellite Stable, BRAFV600E Metastatic and/or Unresectable Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2022-07-19

Completion Date

2026-09-30

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

BIOLOGICAL

Cetuximab

Given IV

DRUG

Encorafenib

Given PO

BIOLOGICAL

Nivolumab

Given IV

Locations (286)

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Woodland Memorial Hospital

Woodland, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Memorial Hospital North

Colorado Springs, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, United States

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Rush-Copley Medical Center

Aurora, Illinois, United States

Advocate Good Shepherd Hospital

Barrington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Advocate Sherman Hospital

Elgin, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

AMG Libertyville - Oncology

Libertyville, Illinois, United States

Condell Memorial Hospital

Libertyville, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Illinois CancerCare - Washington

Washington, Illinois, United States

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

Northwest Cancer Center - Main Campus

Crown Point, Indiana, United States

Northwest Oncology LLC

Dyer, Indiana, United States

Northwest Cancer Center - Hobart

Hobart, Indiana, United States

Saint Mary Medical Center

Hobart, Indiana, United States

Franciscan Health Indianapolis

Indianapolis, Indiana, United States

Saint Catherine Hospital

Indianapolis, Indiana, United States

Franciscan Saint Elizabeth Health - Lafayette East

Lafayette, Indiana, United States

Woodland Cancer Care Center

Michigan City, Indiana, United States

Franciscan Health Mooresville

Mooresville, Indiana, United States

The Community Hospital

Munster, Indiana, United States

Women's Diagnostic Center - Munster

Munster, Indiana, United States

Northwest Cancer Center - Valparaiso

Valparaiso, Indiana, United States

Mary Greeley Medical Center

Ames, Iowa, United States

McFarland Clinic - Ames

Ames, Iowa, United States

McFarland Clinic - Boone

Boone, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, United States

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, United States

Ochsner Hematology Oncology North Shore - Covington (West Region)

Covington, Louisiana, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Bronson Battle Creek

Battle Creek, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Chelsea Hospital

Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Henry Ford River District Hospital

East China Township, Michigan, United States

Cancer Hematology Centers - Flint

Flint, Michigan, United States

Genesee Hematology Oncology PC

Flint, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Henry Ford Saint John Hospital - Academic

Grosse Pointe Woods, Michigan, United States

Henry Ford Saint John Hospital - Van Elslander

Grosse Pointe Woods, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Beacon Kalamazoo Cancer Center

Kalamazoo, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States

Henry Ford Health Providence Novi Hospital

Novi, Michigan, United States

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

Corewell Health Reed City Hospital

Reed City, Michigan, United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, United States

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, Michigan, United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

Henry Ford Health Warren Hospital

Warren, Michigan, United States

Henry Ford Warren Hospital - GLCMS

Warren, Michigan, United States

Macomb Hematology Oncology PC

Warren, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

University of Michigan Health - West

Wyoming, Michigan, United States

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Community Hospital of Anaconda

Anaconda, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Logan Health Medical Center

Kalispell, Montana, United States

Community Medical Center

Missoula, Montana, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Hunterdon Medical Center

Flemington, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, United States

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Miami Valley Hospital South

Centerville, Ohio, United States

Adena Regional Medical Center

Chillicothe, Ohio, United States

Mount Carmel East Hospital

Columbus, Ohio, United States

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Grant Medical Center

Columbus, Ohio, United States

The Mark H Zangmeister Center

Columbus, Ohio, United States

Doctors Hospital

Columbus, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

Premier Blood and Cancer Center

Dayton, Ohio, United States

Dayton Physician LLC - Englewood

Dayton, Ohio, United States

Miami Valley Hospital North

Dayton, Ohio, United States

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, United States

Grady Memorial Hospital

Delaware, Ohio, United States

Columbus Oncology and Hematology Associates

Dublin, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Dayton Physicians LLC-Atrium

Franklin, Ohio, United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, United States

Mount Carmel Grove City Hospital

Grove City, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Fairfield Medical Center

Lancaster, Ohio, United States

OhioHealth Mansfield Hospital

Mansfield, Ohio, United States

OhioHealth Marion General Hospital

Marion, Ohio, United States

Memorial Hospital

Marysville, Ohio, United States

Knox Community Hospital

Mount Vernon, Ohio, United States

Licking Memorial Hospital

Newark, Ohio, United States

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Springfield Regional Cancer Center

Springfield, Ohio, United States

Springfield Regional Medical Center

Springfield, Ohio, United States

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, United States

Upper Valley Medical Center

Troy, Ohio, United States

Saint Ann's Hospital

Westerville, Ohio, United States

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Reading Hospital

West Reading, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Prisma Health Cancer Institute - Easley

Easley, South Carolina, United States

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, United States

UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Swedish Medical Center-First Hill

Seattle, Washington, United States

United Hospital Center

Bridgeport, West Virginia, United States

West Virginia University Healthcare

Morgantown, West Virginia, United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, United States

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Aurora Cancer Care-Racine

Racine, Wisconsin, United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Puerto Rico Hematology Oncology Group

Bayamón, Puerto Rico

Centro Comprensivo de Cancer de UPR

San Juan, Puerto Rico

PROncology

San Juan, Puerto Rico

San Juan City Hospital

San Juan, Puerto Rico