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.
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
Evidence of active infection =< 7 days prior to initiation of study drug therapy (does not apply to viral infections that are presumed to be associated with the underlying tumor type required for study entry)
Use of non-oncology vaccines containing live virus for prevention of infectious diseases within 30 days of prior to study drug. Dead virus vaccines (e.g Flu) are allowed, even during treatment with study drug
Inability to swallow and retain study treatment
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) even if fully immunocompetent on antiretroviral therapy (ART)
Single group
Binimetinib
DrugGiven PO
Encorafenib
DrugGiven PO
Questionnaire Administration
Other interventionAncillary studies
Progression free survival (PFS) (Cohort A)
Incidence of dose-limiting toxicities (DLTs)
Incidence of adverse events (AEs)
Graded according to the NCI CTCAE version 4.03 and changes in clinical laboratory parameters, vital signs, ECGs, ECHO/MUGA scans and ophthalmic examinations.
Incidence of dose interruptions, dose modifications and discontinuations due to AEs
Progression free survival
Extracranial response rate
Extracranial response rate is defined as the proportion of patients with a best overall extracranial response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 per investigator assessment.
Intracranial response rate
Intracranial response rate is defined as the proportion of patients with a best overall Intracranial response of CR or PR according to modified (m)RECIST v1.1 per Investigator assessment. In addition, as part of our secondary endpoint, we will use Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria for response assessment.
Disease control rate
Defined as the proportion of patients with a best overall response of CR, PR or stable disease (SD) per Investigator assessment.
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