Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases
Trial Parameters
Brief Summary
This phase II trial studies the effects of binimetinib and encorafenib in treating patients with melanoma that has spread to the central nervous system (metastases). Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may help control melanoma that has spread to the brain.
Eligibility Criteria
Inclusion Criteria: * Able to provide written informed consent. * Age \>= 18 years at the time of informed consent * Histologically confirmed diagnosis of melanoma * Presence of BRAFV600 mutation in tumor tissue previously determined by a local assay (including immunohistochemistry \[IHC\]) at any time prior to Screening or during Screening * Cohort A: BRAF V600 mutant melanoma patients with progressive central nervous system (CNS) metastases. This includes patients with parenchymal brain metastases and/or LMD * Cohort A: Prior therapy with Food and Drug Administration (FDA)-approved BRAF inhibitors (+/- MEK inhibitors) is required * No washout period is required * Cohort A: Prior therapy with immunotherapy or other investigational agents is allowed * Washout period of 14 days since last dose * Cohort B: BRAF V600 mutant melanoma patients who are treatment naive to BRAF/MEK inhibitors with CNS metastases, including LMD. Prior treatment with immunotherapy is permitted * For patients wit