New drug cocktail aims to stop BRAF colon cancer in its tracks

NCT ID NCT05710406

Disease control Sponsor: Alliance for Clinical Trials in Oncology Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether adding two targeted drugs (encorafenib and cetuximab) after standard surgery and chemotherapy can lower the chance of cancer coming back in people with a specific genetic type of stage II/III colon cancer (BRAF V600E). Participants either receive the drug combo or are observed as usual. The trial tracks cancer recurrence and side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

1 person

The number who actually took part.

Started

Aug 2023

Expected to finish

Jun 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * PRE-REGISTRATION (STEP 0) ELIGIBILITY CRITERIA: * Pre-registration for central tumor testing will occur after colon resection. Pre-registration can occur at any time after surgery through a twelve week period after completion of standard adjuvant therapy * BRAF V600 mutational status may be determined either locally or by central testing. This testing is mandatory prior to registration to determine eligibility. Tissue submission should be initiated as soon after surgery as possible. For tumors evaluated at local laboratories, formalin-fixed paraffin-embedded (FFPE) tumor tissue must still be submitted for central confirmation of BRAF status * REGISTRATION (STEP 1) ELIGIBILITY CRITERIA: * Histologically-proven stage III (any T \[Tx, T1, T2, T3, or T4\], N1-2M0; includes N1C) or high-risk (pT4) stage II colon adenocarcinoma. Tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve) and must have been completely resected * BRAF V600E mutation * MMR proficient (pMMR) or microsatellite stable (MSS) tumor * Histologic documentation: adenocarcinoma * Stage: III (any T \[Tx, T1, T2, T3, or T4\], N1-2M0; includes N1C) or high-risk II (pT4) * Tumor site: colon * Patients must have received at least 3 months of adjuvant chemotherapy with either leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) (minimum of 5 cycles) or capecitabine and oxaliplatin (CAPOX) (minimum of 3 cycles) * Adjuvant therapy must be completed at most 8 weeks prior to registration * No other prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy) or radiation therapy for the current colon cancer is permitted * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 * Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L * Platelet count \>= 75 x 10\^9/L * Hemoglobin \> 9.0 g/dL * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3.0 x ULN * Corrected QT (QTc) Interval =\< 480 msec * Creatinine = calculated (calc.) creatinine clearance \>= 40 mL/min * No evidence of active and uncontrolled bacterial or viral infection (including active hepatitis B or hepatitis C infection) within 2 weeks prior to start of study intervention; exceptions include: * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial \* Participants who are hepatitis B surface antigen (HBsAg) negative (-), hepatitis B core antibody (HBcAb) positive (+) are eligible and should be monitored/treated as per local standard of care * No medical condition such as uncontrolled infection, uncontrolled diabetes mellitus, or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient * Patients with known history or current symptoms of cardiac disease or history of treatment with cardiotoxic agents in the last 12 months, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * No uncontrolled or poorly-controlled hypertension (\> 180 mmHg systolic or \> 130 mmHg diastolic) * No history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab * No "currently active" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for \>= 3 years * Patients are not considered to have a "currently active" malignancy if they had a gastric or bowel carcinoid \< 1 cm, ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS) of the breast without invasive cancer, or endometrial dysplasia/carcinoma in situ * Patients are not considered to have a "currently active" malignancy if they had a sebaceous neoplasm (sebaceous adenoma, sebaceous epithelioma, sebaceous adenocarcinoma, keratoacanthoma, and squamous cell carcinoma) that was noninvasive * No known medical condition causing an inability to swallow oral formulations of agents * No residual Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 grade \>= 2 toxicity from prior chemotherapy, with the exception of grade 2 alopecia or neuropathy * Drugs that prolong the QTc interval should be avoided if possible, as encorafenib can prolong the QTc interval. Drugs that are generally accepted to have a risk of causing Torsades de Pointes should be discontinued or replaced with drugs that do not carry this risk if at all possible. Patients who receive potential QTc-prolonging medications should be monitored closely * Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed during treatment on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed during treatment on this study. Patients must discontinue the drug 14 days prior to registration on the study Exclusion Criteria: N/A

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Conditions

The condition(s) this trial relates to.

colon adenocarcinoma colon carcinoma colonic neoplasm malignant colon neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colon adenocarcinoma Microsatellite stable colon carcinoma Stage IIB colon cancer ajcc V8 Stage IIC colon cancer ajcc V8 Stage III colon cancer ajcc V8

Contacts and locations

Locations

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States
Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501, United States
Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481, United States
Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States
Aspirus Medford Hospital

Medford, Wisconsin, 54451, United States
Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States
Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States
Aultman Health Foundation

Canton, Ohio, 44710, United States
Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States
Beebe South Coastal Health Campus

Millville, Delaware, 19967, United States
Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States
Billings Clinic Cancer Center

Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States
Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States
Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States
Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017, United States
Cancer Hematology Centers - Flint

Flint, Michigan, 48503, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States
Carle at The Riverfront

Danville, Illinois, 61832, United States
CaroMont Regional Medical Center

Gastonia, North Carolina, 28054, United States
Chelsea Hospital

Chelsea, Michigan, 48118, United States
Cleveland Clinic Cancer Center Independence

Independence, Ohio, 44131, United States
Cleveland Clinic Cancer Center Mansfield

Mansfield, Ohio, 44906, United States
Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, 44136, United States
Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, 44691, United States
Community Hospital of Anaconda

Anaconda, Montana, 59711, United States
Community Medical Center

Missoula, Montana, 59804, United States
Community Medical Center

Scranton, Pennsylvania, 18510, United States
Crossroads Cancer Center

Effingham, Illinois, 62401, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States
Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States
Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Fairview Southdale Hospital

Edina, Minnesota, 55435, United States
Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, 17901, United States
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, 18201, United States
Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States
Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States
Genesee Hematology Oncology PC

Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States
Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, 29341, United States
Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States
Glens Falls Hospital

Glens Falls, New York, 12801, United States
Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, 96701, United States
Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States
Helen F Graham Cancer Center

Newark, Delaware, 19713, United States
Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044, United States
Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States
Hurley Medical Center

Flint, Michigan, 48503, United States
Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States
Illinois CancerCare - Washington

Washington, Illinois, 61571, United States
Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton

Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States
Illinois CancerCare-Dixon

Dixon, Illinois, 61021, United States
Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States
Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru

Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States
Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864, United States
Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States
Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409, United States
Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States
Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States
Logan Health Medical Center

Kalispell, Montana, 59901, United States
MGC Hematology Oncology-Union

Union, South Carolina, 29379, United States
Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States
Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States
Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States
Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Memorial Sloan Kettering Commack

Commack, New York, 11725, United States
Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States
Memorial Sloan Kettering Westchester

East White Plains, New York, 10604, United States
Mercy Hospital

Cedar Rapids, Iowa, 52403, United States
Mercy Hospital

Coon Rapids, Minnesota, 55433, United States
Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331, United States
Miami Valley Hospital

Dayton, Ohio, 45409, United States
Miami Valley Hospital North

Dayton, Ohio, 45415, United States
Miami Valley Hospital South

Centerville, Ohio, 45459, United States
Mission Cancer and Blood - Ankeny

Ankeny, Iowa, 50023, United States
Mission Cancer and Blood - Des Moines

Des Moines, Iowa, 50309, United States
MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States
North Coast Cancer Care

Sandusky, Ohio, 44870, United States
Northwest Cancer Center - Hobart

Hobart, Indiana, 46342, United States
Northwest Cancer Center - Main Campus

Crown Point, Indiana, 46307, United States
Northwest Cancer Center - Valparaiso

Valparaiso, Indiana, 46383, United States
Northwest Oncology LLC

Dyer, Indiana, 46311, United States
Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States
Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States
Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026, United States
Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030, United States
Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States
Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States
Northwestern University

Chicago, Illinois, 60611, United States
Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States
Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States
Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States
Parkland Memorial Hospital

Dallas, Texas, 75235, United States
Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States
Premier Blood and Cancer Center

Dayton, Ohio, 45409, United States
Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States
Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States
Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States
ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149, United States
ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States
Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813, United States
Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817, United States
Queen's Medical Center

Honolulu, Hawaii, 96813, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Rush - Copley Medical Center

Aurora, Illinois, 60504, United States
Rush-Copley Healthcare Center

Yorkville, Illinois, 60560, United States
SUNY Upstate Medical Center-Community Campus

Syracuse, New York, 13215, United States
Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States
Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States
Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914, United States
Saint Catherine Hospital

Indianapolis, Indiana, 46312, United States
Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States
Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States
Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States
Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301, United States
Saint Mary Medical Center

Hobart, Indiana, 46342, United States
Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States
Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States
Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States
Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States
Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States
South Pointe Hospital

Warrensville Heights, Ohio, 44122, United States
Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, 28328, United States
Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534, United States
Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, 28546, United States
Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States
Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States
Springfield Clinic

Springfield, Illinois, 62702, United States
Springfield Memorial Hospital

Springfield, Illinois, 62781, United States
State University of New York Upstate Medical University

Syracuse, New York, 13210, United States
Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States
Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026, United States
Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States
Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States
The Community Hospital

Munster, Indiana, 46321, United States
The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, 96706, United States
ThedaCare Cancer Care - Berlin

Berlin, Wisconsin, 54923, United States
ThedaCare Cancer Care - Shawano

Shawano, Wisconsin, 54166, United States
ThedaCare Cancer Care - Waupaca

Waupaca, Wisconsin, 54981, United States
ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States
ThedaCare Regional Medical Center - Neenah

Neenah, Wisconsin, 54956, United States
Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, 43623, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States
Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States
UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451, United States
UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080, United States
UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, 75237, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104, United States
UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States
United Hospital

Saint Paul, Minnesota, 55102, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States
Upper Valley Medical Center

Troy, Ohio, 45373, United States
Upstate Cancer Center at Oswego

Oswego, New York, 13126, United States
Upstate Cancer Center at Verona

Verona, New York, 13478, United States
West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States
Women's Diagnostic Center - Munster

Munster, Indiana, 46321, United States

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