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

Running, not enrolling · Phase 3

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT04607421

Run by

Pfizer

People needed

841

Starts

2020-12-21

Expected to finish

2027-12-28

Last updated by the study team

2026-06-11

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Safety Lead-In = Male/female ≥ 18 years old
• Phase 3 and Cohort 3: Male/female ≥ 16 years old (where permitted locally)
• Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation
• Prior systemic treatment in metastatic setting: 0-1 regimens for Safety Lead In; none for Phase 3 and Cohort 3. (Note: Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis < 6 month from end of adj/neoadjuvant treatment )
• Measurable disease (Phase 3 and Cohort 3)/ Measurable or evaluable disease (Safety Lead-in)
• ECOG PS 0-1
• Adequate organ function

You may not qualify if…

• Tumors that are locally confirmed or unknown MSI-H or dMMR unless participant is ineligible to receive immune checkpoint inhibitors due to a pre-existing medical condition
• Active bacterial or viral infections in 2 weeks prior to starting dosing
• Symptomatic brain metastases

Where it is running

• Mayo Clinic in Arizona - Scottsdale — Scottsdale, Arizona, United States
• Keck Hospital of USC — Los Angeles, California, United States
• LAC & USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center/Investigational Drug Services — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Keck Hospital of USC Pasadena — Pasadena, California, United States
• Mount Sinai Comprehensive Cancer Center, Aventura — Aventura, Florida, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• BRCR Global — Plantation, Florida, United States
• BRCR Medical Center Inc. — Plantation, Florida, United States
• UChicago Medicine - River East — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• UChicago Medicine at Ingalls - Flossmoor — Flossmoor, Illinois, United States
• UChicago Medicine Ingalls Memorial — Harvey, Illinois, United States
• University of Chicago Comprehensive Cancer Center at Silver Cross Hospital — New Lenox, Illinois, United States
• The University of Chicago Medicine Center for Advanced Care Orland Park — Orland Park, Illinois, United States
• UChicago Medicine at Ingalls - Tinley Park — Tinley Park, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Siteman Cancer Center - St Peters — City of Saint Peters, Missouri, United States
• Siteman Cancer Center - West County — Creve Coeur, Missouri, United States
• Siteman Cancer Center - North County — Florissant, Missouri, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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