A Single-Arm, Open-Label, Phase Ii Study To Evaluate The Safety Of Vemurafenib (Vem) Followed By Ipilimumab (Ipi) In Braf V600-Mutated Metastatic Melanoma (Mm).

9032 Background: There is much interest in determining how to incorporate BRAF inhibitors with immune checkpoint inhibitors in the treatment of patients (pts) with BRAF-mutant MM. A phase I study showed that concurrent administration of IPI, an antibody that blocks cytotoxic T-lymphocyte antigen-4, and VEM, an inhibitor of BRAF V600-mutated kinase, caused significant dose-limiting hepatotoxicity in BRAF-mutant MM pts. An alternate strategy is to use these agents sequentially in order to minimize toxicities observed with concurrent administration and to improve efficacy over either agent alone. Methods: This single-arm, open-label, phase II study evaluated the safety of VEM followed by IPI in treatment-naive MM pts harboring a BRAF V600 mutation. Pts initially received VEM for 6 weeks (960 mg twice daily) followed by IPI at 10 mg/kg (Q3W x 4 doses, then Q12W beginning at week 24 until disease progression or unacceptable toxicity) [VEM1-IPI phase]; VEM was then restarted. The primary objective was to estima...