A Phase II Study of Encorafenib, Binimetinib, and Cetuximab Given Together in Patients with Untreated Metastatic Colorectal Cancer Containing the BRAF V600E Mutation

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Full Title

Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib plus Cetuximab in Subjects with Previously Untreated BRAF V600E-mutant Metastatic Colorectal Cancer

Purpose

The purpose of this study is to evaluate the safety and effectiveness of treatment combining encorafenib, binimetinib, and cetuximab in patients with untreated metastatic colorectal cancer that contains a BRAF gene mutation called V600E. Encorafenib and binimetinib are used to treat melanoma. Cetuximab is used to treat colorectal cancer. The combined use of cetuximab with encorafenib and binimetinib is considered investigational. This triplet regimen has received FDA breakthrough therapy designation for the treatment of patients with BRAF V600E-mutant metastatic colorectal cancer who have already received standard chemotherapy for metastatic disease.

BRAF sends signals inside cells that direct cells to grow, but the BRAF mutation can trigger abnormal, uncontrolled tumor growth. Each of the study drugs blocks different proteins involved in tumor growth: encorafenib particularly blocks mutated BRAF, binimetinib targets a protein called MEK, and cetuximab targets the epidermal growth factor receptor (EGFR). Combining these drugs could slow or stop the growth of tumors with mutated BRAF.

Encorafenib and binimetinib are taken orally (by mouth) and cetuximab is 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 and may not have previously received treatment for metastatic disease.
  • Patients’ tumors must contain the V600E BRAF mutation.
  • Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab, or other anti-EGFR treatment is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • 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

18-535

Phase

II

Investigator

Co-Investigators