AzTrials
AzTrials

Colon AdenocarcinomaPhase 2/3NCT05710406

Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer

A Phase 2/3 study testing Encorafenib, Cetuximab and Biospecimen Collection in people with Colon Adenocarcinoma and Microsatellite Stable Colon Carcinoma, run by Alliance for Clinical Trials in Oncology at 202 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II/III trial compares the effect of the combination of 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Encorafenib, Cetuximab and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
202 sitesUnited States
Study dates
16 Aug 2023to 1 Jun 2034
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 38Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

202 sites in 1 country.

202 sites in 1 country

United States202 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Mission Cancer and Blood - Ankeny

    Ankeny, Iowa, 50023

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • ThedaCare Cancer Care - Berlin

    Berlin, Wisconsin, 54923

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Northwest Cancer Center - Main Campus

    Crown Point, Indiana, 46307

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Mission Cancer and Blood - Des Moines

    Des Moines, Iowa, 50309

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Memorial Sloan Kettering Westchester

    East White Plains, New York, 10604

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • CaroMont Regional Medical Center

    Gastonia, North Carolina, 28054

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Northwest Cancer Center - Hobart

    Hobart, Indiana, 46342

  • Saint Mary Medical Center

    Hobart, Indiana, 46342

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Saint Catherine Hospital

    Indianapolis, Indiana, 46312

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • Emory Johns Creek Hospital

    Johns Creek, Georgia, 30097

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Henry Ford Saint John Hospital - Macomb Medical

    Macomb, Michigan, 48044

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio, 44906

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Aspirus Medford Hospital

    Medford, Wisconsin, 54451

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Community Medical Center

    Missoula, Montana, 59804

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • The Community Hospital

    Munster, Indiana, 46321

  • Women's Diagnostic Center - Munster

    Munster, Indiana, 46321

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

  • ThedaCare Regional Medical Center - Neenah

    Neenah, Wisconsin, 54956

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

  • Upstate Cancer Center at Oswego

    Oswego, New York, 13126

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Aspirus Cancer Care - James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • Community Medical Center

    Scranton, Pennsylvania, 18510

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • ThedaCare Cancer Care - Shawano

    Shawano, Wisconsin, 54166

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, Wisconsin, 54481

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Cleveland Clinic Cancer Center Strongsville

    Strongsville, Ohio, 44136

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • SUNY Upstate Medical Center-Community Campus

    Syracuse, New York, 13215

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

  • MGC Hematology Oncology-Union

    Union, South Carolina, 29379

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Northwest Cancer Center - Valparaiso

    Valparaiso, Indiana, 46383

  • Upstate Cancer Center at Verona

    Verona, New York, 13478

  • South Pointe Hospital

    Warrensville Heights, Ohio, 44122

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

  • ThedaCare Cancer Care - Waupaca

    Waupaca, Wisconsin, 54981

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

  • Cleveland Clinic Wooster Family Health and Surgery Center

    Wooster, Ohio, 44691

  • Rush-Copley Healthcare Center

    Yorkville, Illinois, 60560

  • Huron Gastroenterology PC

    Ypsilanti, Michigan, 48106

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

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

This phase II/III trial compares the effect of the combination of 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 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 tumor cells. This may help keep tumor cells from growing. Giving encorafenib and cetuximab combination after standard surgery and chemotherapy may be more effective at reducing the chance of cancer recurrence compared to the usual patient observation.

Read the detailed description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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) once a day on days 1-28 and cetuximab intravenously (IV) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for a total of 6 cycles in the absence of disease recurrence or unacceptable toxicity. 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.

After completion of study treatment, patients are followed every 6 months for up to 6 years from the date of randomization or until death, whichever occurs first.

Being tested
Encorafenib, Cetuximab, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EncorafenibDrug

    Also called Braftovi, LGX-818

    Given PO

  • CetuximabBiological

    Also called Cetuximab Biosimilar CDP-1, Cetuximab Biosimilar KL 140, Chimeric Monoclonal Antibody C225, Erbitux

    Given IV

  • Biospecimen CollectionProcedure or surgery

    Undergo collection of blood samples

  • Computed TomographyProcedure or surgery

    Also called CAT Scan, CT Scan

    Undergo CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called MRI

    Undergo MRI

  • Patient ObservationOther

    Also called Watchful Waiting

    Undergo observation per usual care

Study groups in NCT05710406
Study groupRoleWhat they receive
Arm I (encorafenib, cetuximab)ExperimentalPatients receive encorafenib PO QD on days 1-28 and cetuximab IV on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for a total of 6 cycles in the absence of disease recurrence or unacceptable toxicity. Patients also undergo collection of blood samples throughout the study and CT or MRI during screening and follow-up.
Receives: Drug: Encorafenib; Biological: Cetuximab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging
Arm II (patient observation)Active comparatorPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Patient Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Circulating tumor deoxyribonucleic acid (ctDNA) clearance rate (Phase II; ctDNA positive cohort)

    defined as the proportion of patients with undetectable ctDNA status at 6 months after randomization among patients with detectable ctDNA status at randomization. The ctDNA clearance rate at 6 months after randomization in experimental arm will be compared to control arm by Chi-squared test. The one-sided p-value will be reported. Due to small sample size, Cochran and Mantel-Haenszel test, stratified by stratification factors will be performed as sensitivity analysis.

    Measured: At 6 months after randomization

  2. tDNA recurrence-free survival rate (ctDNA-RFS) (Phase II; ctDNA negative cohort)

    Defined as the proportion of patients who remained undetectable ctDNA status, recurrence-free, and alive at 6 months after randomization among patients with undetectable ctDNA status at randomization. The ctDNA-RFS in experimental arm will be compared to control arm by Cochran and Mantel-Haenszel test, stratified by stratification factors. The one-sided p-value will be reported.

    Measured: at 6 months after randomization

  3. Disease free survival (DFS) (Phase III)

    Defined as the time from the date of randomization to the date of first documented recurrence or death due to all cause, whichever occurs first. Patients without events observed at the end of the study will be censored at the date of last disease evaluation which shows no evidence of disease. At each analysis (Interim #1, Interim #2, and Final), stratified Cox model will be conducted to compare DFS in the experimental arm to DFS in the control arm with stratification factors as stratum, based on all data collected at the analysis time point.

    Measured: Assessed up to 6 years after randomization

Secondary outcomes (3)

  1. Overall Survival

    Defined as the time from the date of randomization to death due to all causes. The distributions of time-to-event endpoints will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.

    Measured: Assessed up to 6 years

  2. Incidence of adverse events after randomization

    The maximum grade for each type of adverse events that are possibly, probably, or definitely related to study treatments will be summarized for each patient. The frequency tables will be reviewed to determine the patterns. The overall adverse event rates for grade 4 or higher adverse events will be compared between two treatment groups using Chi-square test (or Fisher's exact test if the data in the contingency table is sparse).

    Measured: up to 6 years

  3. Alternative disease free survival

    Defined as the time from the date of primary tumor resection to the date of first documented recurrence or death due to all cause, whichever occurs first. The distributions of time-to-event endpoints will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.

    Measured: assessed up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2023
  2. Study start16 Aug 2023
  3. Primary completion1 Jun 2034 (estimated)
  4. Study completion1 Jun 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05710406
Sponsor's protocol ID
A022004
Other IDs
NCI-2022-09129
Status last verified
Jun 2026
First submitted
24 Jan 2023
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Encorafenib, Cetuximab and Biospecimen Collection in people with Colon Adenocarcinoma and Microsatellite Stable Colon Carcinoma, run by Alliance for Clinical Trials in Oncology at 202 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 202 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circulating tumor deoxyribonucleic acid (ctDNA) clearance rate (Phase II; ctDNA positive cohort) (time frame: At 6 months after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05710406.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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