A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer (NCT04607421)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Hospital — Phoenix, Arizona
Age range: 16 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (272 Sites)
Showing the first 25 of 272 sites.
- Mayo Clinic Hospital — Phoenix, Arizona
- Mayo Clinic in Arizona - Scottsdale — Scottsdale, Arizona
- Keck Hospital of USC — Los Angeles, California
- LAC & USC Medical Center — Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- USC/Norris Comprehensive Cancer Center/Investigational Drug Services — Los Angeles, California
- USC/Norris Comprehensive Cancer Center — Los Angeles, California
- Keck Hospital of USC Pasadena — Pasadena, California
- Mount Sinai Comprehensive Cancer Center, Aventura — Aventura, Florida
- Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida
- Mount Sinai Medical Center — Miami Beach, Florida
- BRCR Global — Plantation, Florida
- BRCR Medical Center Inc. — Plantation, Florida
- UChicago Medicine - River East — Chicago, Illinois
- University of Chicago Medical Center — Chicago, Illinois
- UChicago Medicine at Ingalls - Flossmoor — Flossmoor, Illinois
- UChicago Medicine Ingalls Memorial — Harvey, Illinois
- University of Chicago Comprehensive Cancer Center at Silver Cross Hospital — New Lenox, Illinois
- The University of Chicago Medicine Center for Advanced Care Orland Park — Orland Park, Illinois
- UChicago Medicine at Ingalls - Tinley Park — Tinley Park, Illinois
- Ochsner Clinic Foundation — New Orleans, Louisiana
- Mayo Clinic Rochester — Rochester, Minnesota
- Siteman Cancer Center - St Peters — City of Saint Peters, Missouri
- Siteman Cancer Center - West County — Creve Coeur, Missouri
- Siteman Cancer Center - North County — Florissant, Missouri
📞 Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.