A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called "BRAF"; and * has not received prior treatment. Participants in this study will receive one of the following study treatments: * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone. The study team will monitor how each participant responds to the study treatment for up to about 3 years.
Study identification
- NCT ID
- NCT04607421
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 841 participants
Conditions and interventions
Conditions
Interventions
- Encorafenib Drug
- Cetuximab Drug
- Oxaliplatin Drug
- Irinotecan Drug
- Leucovorin Drug
- 5-FU Drug
- Capecitabine Drug
- Bevacizumab 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 21, 2020 (Actual)
- Primary completion
- Mar 1, 2025 (Actual)
- Completion
- Dec 28, 2027 (Estimated)
- Last update posted
- Jun 11, 2026
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 | — |
| The Ohio State University Wexner Medical Center Investigational Drug Services | Columbus | Ohio | 43210 | — |
| Stefanie Spielman Comprehensive Breast Cancer | Columbus | Ohio | 43212 | — |
| Martha Morehouse Medical Plaza | 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 Clinic | 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 210 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 Jun 11, 2026 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04607421 live on ClinicalTrials.gov.