A Study of Encorafenib plus Cetuximab Alone and with Chemotherapy in Patients with Metastatic BRAF-Mutant Colorectal Cancer

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Full 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 (WIRB)

Purpose

The purpose of the study is to evaluate whether encorafenib plus cetuximab, alone or in combination with chemotherapy, is more effective than standard chemotherapy in patients with previously untreated metastatic colorectal cancer that contains a mutation called BRAF V600E. Encorafenib and cetuximab are used together to treat patients with BRAF-mutant metastatic colorectal cancer after prior treatments, but their use before other treatments is considered investigational.

Patients in the first part of this study will be randomly assigned to receive encorafenib and cetuximab with either mFOLFOX6 chemotherapy or FOLFIRI chemotherapy to assess the treatment’s safety. In the second part of the study, patients will be randomly assigned to receive either encorafenib and cetuximab alone, standard chemotherapy, or encorafenib and cetuximab with either mFOLFOX6 or FOLFIRI (with the combination selected based on data from the first part of the study). Encorafenib is taken orally (by mouth) and the other medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic colorectal cancer that contains a mutation called BRAF V600E.
  • Patients in the first (safety) part of the study may have received up to one prior regimen of therapy. Patients being treated in the second part of the study may not have received treatment for metastatic disease.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Rona Yaeger at 646-888-5109.

Protocol

21-134

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators