Phase II Study of Binimetinib With Encorafenib in Patients With Metastatic Melanoma and CNS Metastases
M.D. Anderson Cancer Center
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.
Description
PRIMARY OBJECTIVES: I. To evaluate antitumor activity of high dosing regimen of encorafenib + binimetinib combination therapy for patients with BRAFV600-mutant melanoma brain metastases and/or leptomeningeal disease (LMD) as measured by progression free survival (PFS). II. To evaluate the safety/tolerability of high dosing regimen of encorafenib + binimetinib combination therapy for patients with BRAFV600-mutant melanoma brain metastases and/or LMD. SECONDARY OBJECTIVE: I. To further evaluate antitumor activity of high dosing regimen of encorafenib + binimetinib combination therapy for pat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 inh…
Interventions
- DrugBinimetinib
Given PO
- DrugEncorafenib
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Location
- M D Anderson Cancer CenterHouston, Texas