NCT04607421

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 831 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The purpose of the study is to evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of-care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC. Since encorafenib has not previously been combined with chemotherapy, the tolerability and PK of EC in combination with mFOLFOX6 and in combination with FOLFIRI will be evaluated in separate cohorts in the safety lead-in portion of the trial in order to identify which chemotherapy combination is to be used in the Phase 3 portion of the study.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	Encorafenib	75 mg capsules
DRUG	Cetuximab	Injection for intravenous use 100 mg/vial, 200 mg/vial, or 500 mg/vial
DRUG	Oxaliplatin	Powder for solution for intravenous use 50 mg/vial, 100 mg/vial, or 200 mg/vial
DRUG	Irinotecan	Solution for intravenous infusion 40 mg/vial, 100 mg/vial, or 300 mg/vial
DRUG	Leucovorin	Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial
DRUG	5-FU	Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial
DRUG	Capecitabine	150 mg or 500 mg Tablet
DRUG	Bevacizumab	Optional Injection for intravenous use 100 mg/vial or 400 mg/vial

Timeline

• Start date: 2020-12-21
• Primary completion: 2025-12-08
• Completion: 2027-12-28
• First posted: 2020-10-29
• Last updated: 2025-08-14

Locations

268 sites across 29 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Finland, Germany, India, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study