Patients will be initially enrolled to the approved dose of encorafenib 450 mg oral QD and binimetinib 45 mg PO BID, dose level 1. If confirmed this dose level is safely tolerated in the study population, we will then escalate treatment to dose level 2 with the novel dosing regimen of encorafenib 450 mg oral QD continuous and binimetinib 60 mg oral BID 21 days on/7 days off.

Dose level 1 binimetinib 45 mg PO BID. Dose level 2 binimetinib 60 mg oral BID

Binimetinib

Encorafenib

Rona Yaegar, MD

The goal of this trial is to test the safety and efficacy of an innovative combination aimed to more profoundly inhibit ERK signaling in tumors.

This phase I/II study consists of a Phase I part followed by an efficacy analysis (Phase II) of the dosing schedule deemed safe in patients with advanced cancer with activating non-V600 BRAF mutant tumors. As patients in the phase I part of the start will start at the lower dose level 1, they will not be included in the stage one efficacy cohort.

A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers

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

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5,

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers	NCT03843775	Advanced BRAF M...	Binimetinib Encorafenib	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers	NCT03843775	Advanced BRAF M...	Binimetinib Encorafenib	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for advanced braf mutant cancers