A Multi-Center Phase Ii Open-Label Study (Checkmate 204) To Evaluate Safety And Efficacy Of Nivolumab (Nivo) In Combination With Ipilimumab (Ipi) Followed By Nivo Monotherapy In Patients (Pts) With Melanoma (Mel) Metastatic To The Brain.

TPS9080 Background: Brain metastasis develops in approximately 50% of pts with metastatic MEL. In these pts, progressive brain disease is the major cause of tumor-related death (median overall survival [OS] after diagnosis, 4 months). NIVO (a fully human IgG4 PD-1 immune checkpoint inhibitor antibody) and IPI (a fully human IgG1 CTLA-4 immune checkpoint inhibitor antibody) are each approved as monotherapy for advanced MEL. In a phase II study, IPI showed activity in some pts with advanced MEL and brain metastases. Building upon the success of that study, this open-label, multi-site, US, phase II study is the first to evaluate NIVO combined with IPI followed by NIVO monotherapy for pts with MEL metastatic to the brain. It is anticipated that approximately 50% of enrolled pts will have had prior stereotactic radiotherapy (SRT). Methods: Pts ≥ 18 years of age with MEL measurable in extracranial sites and with asymptomatic brain metastases are eligible. Pts with a history of leptomeningeal involvement, a hist...