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Brief Title: Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer
Official Title: Randomized Trial of Consolidation Targeted Adjuvant Therapy With Encorafenib and Cetuximab Versus Usual Care for Patients With Stage II/III BRAF V600E Colon Cancer
Study ID: NCT05710406
Brief Summary: This phase II/III trial compares treatment with encorafenib and cetuximab to usual care (patient observation) for reducing the chance of cancer recurrence after standard surgery and chemotherapy in patients with BRAF-mutated stage IIB-III colon cancer. Encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Giving encorafenib and cetuximab after standard surgery and chemotherapy may be more effective at reducing the chance of cancer recurrence compared to the usual patient observation.
Detailed Description: The primary and secondary objectives of the study: PRIMARY OBJECTIVES: I. To evaluate and compare 6 month circulating tumor deoxyribonucleic acid (ctDNA) clearance rate in study patients with detectable ctDNA prior to randomization to targeted BRAF therapy versus usual care after standard adjuvant chemotherapy. (Phase II) II. To evaluate and compare 6 month ctDNA recurrence-free survival (ctDNA-RFS) rate in study patients with undetectable ctDNA prior to randomization to targeted BRAF therapy versus usual care after standard adjuvant chemotherapy. (Phase II) III. To evaluate and compare disease-free survival (DFS) (measured from randomization) in patients with resected stage III or high-risk (pT4) stage II mismatch repair protein (MMR) proficient BRAF V600E colon cancer treated with targeted BRAF therapy versus usual care after standard adjuvant chemotherapy. (Phase III) SECONDARY OBJECTIVES: I. To evaluate and compare overall survival (OS) between the two treatment arms. II. To evaluate and compare the toxicity profile between the two treatment arms. III. To evaluate and compare the alternative DFS endpoint (measured from date of primary tumor resection) between the two treatment arms. IV. To evaluate and compare DFS in the subset of patients with detectable ctDNA prior to randomization between the two treatment arms. EXPLORATORY OBJECTIVE: I. To evaluate and compare patient-reported outcomes for symptoms of rash, diarrhea, and fatigue according to Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) between the two treatment arms. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive encorafenib orally (PO) and cetuximab intravenously (IV) on study. Patients also undergo collection of blood samples throughout the study and computed tomography (CT) or magnetic resonance imaging (MRI) during screening and follow-up. ARM II: Patients undergo observation per usual care on study. Patients also undergo collection of blood samples throughout the study and CT or MRI during screening and follow-up.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beebe South Coastal Health Campus, Frankford, Delaware, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Medical Oncology Hematology Consultants PA, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
Hawaii Cancer Care - Westridge, 'Aiea, Hawaii, United States
Pali Momi Medical Center, 'Aiea, Hawaii, United States
Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I, Honolulu, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini, 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
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, 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
Northwestern Medicine Cancer Center Kishwaukee, DeKalb, Illinois, United States
Illinois CancerCare-Dixon, Dixon, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States
Northwestern Medicine Glenview Outpatient Center, Glenview, Illinois, United States
Northwestern Medicine Grayslake Outpatient Center, Grayslake, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
Northwestern Medicine Lake Forest Hospital, Lake Forest, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States
Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States
Northwestern Medicine Orland Park, Orland Park, Illinois, United States
University of Chicago Medicine-Orland Park, Orland Park, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, 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
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Illinois CancerCare - Washington, Washington, 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
Saint Catherine Hospital, Indianapolis, 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
Mission Cancer and Blood - Ankeny, Ankeny, Iowa, United States
Mercy Hospital, Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, United States
Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor, 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
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
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus, Macomb, Michigan, United States
Huron Gastroenterology PC, Ypsilanti, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti, Michigan, United States
Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
United Hospital, Saint Paul, 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
Community Medical Center, Missoula, Montana, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Glens Falls Hospital, Glens Falls, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Upstate Cancer Center at Oswego, Oswego, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
SUNY Upstate Medical Center-Community Campus, Syracuse, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
Upstate Cancer Center at Verona, Verona, 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
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
Aultman Health Foundation, Canton, Ohio, United States
Miami Valley Hospital South, Centerville, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Premier Blood and Cancer Center, Dayton, Ohio, United States
Miami Valley Hospital North, Dayton, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States
Miami Valley Cancer Care and Infusion, Greenville, Ohio, United States
Cleveland Clinic Cancer Center Independence, Independence, Ohio, United States
Cleveland Clinic Cancer Center Mansfield, Mansfield, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
North Coast Cancer Care, Sandusky, Ohio, United States
Cleveland Clinic Cancer Center Strongsville, Strongsville, Ohio, United States
Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States
Upper Valley Medical Center, Troy, Ohio, United States
South Pointe Hospital, Warrensville Heights, Ohio, United States
Cleveland Clinic Wooster Family Health and Surgery Center, Wooster, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Saint Alphonsus Medical Center-Ontario, Ontario, 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
Geisinger Medical Center, Danville, Pennsylvania, United States
Pocono Medical Center, East Stroudsburg, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States
Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, United States
Community Medical Center, Scranton, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States
Gibbs Cancer Center-Gaffney, Gaffney, 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 Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Gibbs Cancer Center-Pelham, Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
MGC Hematology Oncology-Union, Union, South Carolina, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Parkland Memorial Hospital, Dallas, 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
UT Southwestern Clinical Center at Richardson/Plano, Richardson, Texas, United States
University of Virginia Cancer Center, Charlottesville, Virginia, 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
West Virginia University Charleston Division, Charleston, West Virginia, United States
Langlade Hospital and Cancer Center, Antigo, Wisconsin, United States
ThedaCare Regional Cancer Center, Appleton, Wisconsin, United States
ThedaCare Cancer Care - Berlin, Berlin, Wisconsin, United States
Aspirus Medford Hospital, Medford, Wisconsin, United States
ProHealth D N Greenwald Center, Mukwonago, Wisconsin, United States
ThedaCare Regional Medical Center - Neenah, Neenah, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States
Ascension Saint Mary's Hospital, Rhinelander, Wisconsin, United States
ThedaCare Cancer Care - Shawano, Shawano, Wisconsin, United States
Ascension Saint Michael's Hospital, Stevens Point, Wisconsin, United States
UW Cancer Center at ProHealth Care, Waukesha, Wisconsin, United States
ThedaCare Cancer Care - Waupaca, Waupaca, Wisconsin, United States
Aspirus Regional Cancer Center, Wausau, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids, Wisconsin, United States