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

Protocol No
Principal Investigator
Ben George
The purpose of this study is to learn about the effects of the study medications Encorafenib and Cetuximab for the treatment of BRAF V600E-mutant metastatic colorectal cancer. These study medications are investigational medications because they are not approved in combination for use in this country as the first treatment for BRAF V600E-mutant metastatic colorectal cancer. Encorafenib and Cetuximab in combination have been approved by the US FDA for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation after prior treatments, but they have not been approved for patients who have received no prior treatments. In this study, Encorafenib and Cetuximab will be administered alone, in combination with, or in comparison to standard treatments of metastatic colorectal cancer: mFOLFOX6 FOLFOXIRI, CAPOX, and Bevacizumab regimens. Results of prescreening testing show that your tumor has the specific V600E mutations in the BRAF gene which is needed to be eligible for this study. This consent form will explain to you the procedures and risks of participating in the main study. We don’t know if this study will help you. Your condition may get better, but it could stay the same or even get worse. We hope the information from this study will help us develop a better treatment for colorectal cancer in the future.
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Participating Institutions
Froedtert Hospital