ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

ClinicalTrials.gov ID: NCT04607421

Public ClinicalTrials.gov record NCT04607421. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 27, 2026, 7:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST-LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E-MUTANT COLORECTAL CANCER

Study identification

NCT ID
NCT04607421
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pfizer
Industry
Enrollment
831 participants

Conditions and interventions

Conditions

Interventions

  • 5-FU Drug
  • Bevacizumab Drug
  • Capecitabine Drug
  • Cetuximab Drug
  • Encorafenib Drug
  • Irinotecan Drug
  • Leucovorin Drug
  • Oxaliplatin Drug

Drug

Eligibility (public fields only)

Age range
16 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 20, 2020
Primary completion
Dec 7, 2025
Completion
Dec 27, 2027
Last update posted
Aug 13, 2025

2020 – 2027

United States locations

U.S. sites
62
U.S. states
19
U.S. cities
41
Facility City State ZIP Site status
Mayo Clinic Hospital Phoenix Arizona 85054
Mayo Clinic in Arizona - Scottsdale Scottsdale Arizona 85259
Keck Hospital of USC Los Angeles California 90033
LAC & USC Medical Center Los Angeles California 90033
USC / Norris Comprehensive Cancer Center Los Angeles California 90033
USC/Norris Comprehensive Cancer Center/Investigational Drug Services Los Angeles California 90033
USC/Norris Comprehensive Cancer Center Los Angeles California 90033
Keck Hospital of USC Pasadena Pasadena California 91105
Mount Sinai Comprehensive Cancer Center, Aventura Aventura Florida 33180
Mount Sinai Comprehensive Cancer Center Miami Beach Florida 33140
Mount Sinai Medical Center Miami Beach Florida 33140
BRCR Global Plantation Florida 33322
BRCR Medical Center Inc. Plantation Florida 33322
UChicago Medicine - River East Chicago Illinois 60611
University of Chicago Medical Center Chicago Illinois 60637
UChicago Medicine at Ingalls - Flossmoor Flossmoor Illinois 60422
UChicago Medicine Ingalls Memorial Harvey Illinois 60426
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital New Lenox Illinois 60451
The University of Chicago Medicine Center for Advanced Care Orland Park Orland Park Illinois 60462
UChicago Medicine at Ingalls - Tinley Park Tinley Park Illinois 60477
Ochsner Clinic Foundation New Orleans Louisiana 70121
Mayo Clinic Rochester Rochester Minnesota 55905
Siteman Cancer Center - St Peters City of Saint Peters Missouri 63376
Siteman Cancer Center - West County Creve Coeur Missouri 63141
Siteman Cancer Center - North County Florissant Missouri 63031
Barnes- Jewish Hospital St Louis Missouri 63110
Washington University School of Medicine St Louis Missouri 63110
Siteman Cancer Center - South County St Louis Missouri 63129
Oncology Hematology West PC dba Nebraska Cancer Specialists Omaha Nebraska 68114
Oncology Hematology West PC dba Nebraska Cancer Specialists Omaha Nebraska 68124
Oncology Hematology West PC dba Nebraska Cancer Specialists Omaha Nebraska 68130
Oncology Hematology West PC dba Nebraska Cancer Specialists Papillion Nebraska 68046
Memorial Sloan Kettering Cancer Center - Basking Ridge Basking Ridge New Jersey 07920
Summit Medical Group Berkeley Heights New Jersey 07922
Summit Medical Group Florham Park New Jersey 07932
Memorial Sloan Kettering Cancer Center- Monmouth Middletown New Jersey 07748
Memorial Sloan Kettering Cancer Center- Bergen Montvale New Jersey 07645
Memorial Sloan Kettering Cancer Center Commack Commack New York 11725
Memorial Sloan Kettering Cancer Center - Westchester Harrison New York 10604
Memorial Sloan Kettering Cancer Center New York New York 10022
Memorial Sloan Kettering Cancer Center - Main Campus New York New York 10065
Memorial Sloan Kettering Cancer Center- Nassau Uniondale New York 11553
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy Cleveland Ohio 44195
Cleveland Clinic Cleveland Ohio 44195
The Ohio State University James Cancer Hospital and Solove Research Institute Columbus Ohio 43210
Stefanie Spielman Comprehensive Breast Cancer Columbus Ohio 43212
Martha Morehouse Medical Plaza Columbus Ohio 43221
The James Outpatient Care West Campus Columbus Ohio 43221
University of Oklahoma Health Sciences Center, OU Health Stephenson Cancer Center Oklahoma City Oklahoma 73104
Providence Cancer Institute Franz Clinic Portland Oregon 97213
Providence Portland Medical Center Portland Oregon 97213
Providence Onc and Heme Care Clinic - Westside Portland Oregon 97225
Providence St Vincent Medical Center Portland Oregon 97225
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232
The West Clinic. PLLC. dba West Cancer Center Germantown Tennessee 38138
Henry-Joyce Cancer Center Nashville Tennessee 37232
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232
The University of Texas MD Anderson Cancer Center Houston Texas 77030
Virginia Commonwealth University Richmond Virginia 23219
Seattle Cancer Care Alliance Seattle Washington 98109
University of Washington Medical Center Seattle Washington 98195
University of Wisconsin Clinical Science Center Madison Wisconsin 53792

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 206 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04607421, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 13, 2025 · Synced Apr 27, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04607421 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →