A phase II, open-label, randomized, multicenter trial of encorafenib plus binimetinib evaluating a standard-dose and a high-dose regimen in patients with BRAFV600-mutant melanoma brain metastasis (MBM) (POLARIS)

Abstract

Background Melanoma that metastasizes to the brain has a poor prognosis, and accounts for up to 54% of melanoma deaths. Clinical data show that treatment with BRAF-targeted agents induces responses in RAFV600-mutant MBM. Duration of response in the brain is shorter than that observed with extracranial disease. The BRAF/MEK-targeted combination encorafenib + binimetinib demonstrated favorable efficacy and safety for patients with BRAFV600-mutant melanoma in the COLUMBUS study, but excluded patients with active MBM. The aim of this study is to evaluate encorafenib + binimetinib in a population of patients with BRAFV600-mutated active MBM. A higher dose of combination therapy will be studied ve..