An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis
This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and
pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in
patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will
be enrolled, including 9 patients in a Safety Lead-in of the high-dose treatment arm. After a
Screening Period, treatment will be administered in 28-day cycles and will continue until
disease progression, unacceptable toxicity, withdrawal of consent, start of subsequent
anticancer therapy, death.