Phase II Study of Oral Binimetinib and Encorafenib for Patients With Metastatic Melanoma That Has Spread to the Brain or Central Nervous System

What this Trial Is About

Researchers are evaluating the effects of binimetinib and encorafenib in patients with melanoma that has spread to the central nervous system, including brain metastases and leptomeningeal disease. This phase II study focuses on patients with BRAF V600 mutation-positive melanoma to assess how this combination therapy may control tumor growth and improve outcomes such as progression-free survival and overall survival. The study also aims to understand the safety and immune effects of these drugs in the brain and blood. Participants receive oral encorafenib once daily and binimetinib twice daily in 28-day treatment cycles. These cycles continue as long as the disease does not progress and side effects remain manageable. After finishing treatment, patients have follow-up visits starting 30 days later and then every 12 weeks to monitor their health and disease status. The study evaluates responses in brain metastases, extracranial sites, and overall tumor control. During the trial, patients undergo regular assessments to track tumor progression and side effects, including imaging scans and questionnaires measuring cognitive function and symptoms related to brain tumors. Researchers also collect samples to study drug levels and immune responses in the cerebrospinal fluid and blood. Safety is closely monitored during treatment and for up to three years to observe any dose-limiting toxicities or adverse events. This comprehensive monitoring helps understand the impact of the therapy on disease and patient well-being.

Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases