A Phase I/II Study of Binimetinib and Encorafenib in Advanced BRAF-Mutant Cancers

Full Title

A Phase I/II Study of Binimetinib with Encorafenib in Patients with non-V600 Activating BRAF Mutant Advanced Malignancies

Purpose

The purpose of this study is to evaluate the safety and effectiveness of treatment combining binimetinib and encorafenib in patients with advanced cancers that contain a BRAF gene mutation other than at the V600 site. Encorafenib and binimetinib are already used to treat melanoma with BRAF V600E mutations.

BRAF sends signals inside cells that direct cells to grow, and mutations in BRAF can trigger abnormal, uncontrolled tumor growth. Each of the study drugs blocks different proteins involved in tumor growth: encorafenib blocks mutated BRAF, while binimetinib targets a protein called MEK that is activated by BRAF. In this study, researchers are assessing higher doses of binimetinib than are currently used in combination with encorafenib against melanoma.

Encorafenib and binimetinib are taken orally (by mouth).

Eligibility

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

  • Patients must have a BRAF-mutant advanced or metastatic cancer that cannot be successfully treated with standard therapy.
  • Patients with V600 BRAF mutations may not participate.
  • Patients must recover from the serious side effects of previous treatments before entering the study.
  • 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

18-547

Phase

I/II

Investigator

Co-Investigators