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

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Trial Identification

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

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

Study ID: NCT05308446

Study Description

Brief 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.

Detailed Description: PRIMARY OBJECTIVE: I. To compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in patients with microsatellite stable (MSS), BRAF\^V600E metastatic and/or unresectable colorectal cancer (CRC) randomized to treatment with nivolumab + encorafenib + cetuximab compared to encorafenib + cetuximab. SECONDARY OBJECTIVES: I. To compare overall response rate (ORR), including confirmed and unconfirmed, complete and partial response, according to RECIST 1.1 criteria between the two arms. II. To compare overall survival (OS) between the two arms. III. To compare duration of response between the two arms. IV. To compare safety and tolerability between the two arms. V. To assess immune-related PFS using modified response criteria adapted for immunotherapy (irRC-PFS) in patients treated with nivolumab + encorafenib + cetuximab. BANKING OBJECTIVE: I. To bank tissue and blood specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive encorafenib orally (PO) once daily (QD) on days 1-28, cetuximab intravenously (IV) on days 1 and 15, and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive encorafenib PO QD on days 1-28 and cetuximab IV on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed until death or 3 years after registration, whichever occurs first.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

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 Luke's Cancer Institute - Nampa, Nampa, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa, Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States

Kootenai Cancer Clinic, 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

Memorial Medical Center, 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

Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, United States

Henry Ford Hospital, Detroit, Michigan, United States

Ascension Saint John Hospital, Detroit, Michigan, United States

Great Lakes Cancer Management Specialists-Doctors Park, East China Township, Michigan, United States

Genesee Cancer and Blood Disease Treatment Center, 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

Academic Hematology Oncology Specialists, Grosse Pointe Woods, Michigan, United States

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center, Grosse Pointe Woods, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Ascension Borgess 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

Great Lakes Cancer Management Specialists-Macomb Medical Campus, Macomb, Michigan, United States

Trinity Health Muskegon Hospital, Muskegon, Michigan, United States

Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores, Michigan, United States

Ascension Providence Hospitals - Novi, Novi, Michigan, United States

Corewell Health Reed City Hospital, Reed City, Michigan, United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph, Michigan, United States

Ascension Providence Hospitals - Southfield, Southfield, Michigan, United States

Bhadresh Nayak MD PC-Sterling Heights, Sterling Heights, Michigan, United States

Munson Medical Center, Traverse City, Michigan, United States

Great Lakes Cancer Management Specialists-Macomb Professional Building, Warren, Michigan, United States

Macomb Hematology Oncology PC, Warren, Michigan, United States

Saint John Macomb-Oakland Hospital, Warren, 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

Kalispell Regional 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 Medical 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-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 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

Marshfield Clinic-Minocqua Center, 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

Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers, Wisconsin, United States

UW Cancer Center at ProHealth Care, Waukesha, Wisconsin, United States

Marshfield Medical Center - Weston, Weston, Wisconsin, United States

Centro Comprensivo de Cancer de UPR, San Juan, , Puerto Rico

PROncology, San Juan, , Puerto Rico

San Juan City Hospital, San Juan, , Puerto Rico

Contact Details

Name: Van K Morris

Affiliation: SWOG Cancer Research Network

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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