CLINICAL RESPONSE, PROGRESSION-FREE SURVIVAL (PFS) AND SAFETY IN PATIENTS (PTS) WITH ADVANCED MELANOMA (MEL) RECEIVING NIVOLUMAB (NIVO) COMBINED WITH IPILIMUMAB (IPI) VERSUS IPI MONOTHERAPY IN CHECKMATE 069 STUDY

9004 Background: Combined blockade of T-cell checkpoints by NIVO and IPI demonstrated a high objective response rate (ORR), promising overall survival (OS), and a manageable safety profile in pts with advanced MEL in a phase I study, based on which an appropriate dose was selected for registrational trials. We report efficacy and safety of the NIVO + IPI combination vs IPI alone in treatment-naive pts with advanced MEL, including pts with poor prognostic factors, in a phase II study. Methods: Pts (N = 142) with metastatic or unresectable MEL were randomized 2:1 to receive IPI 3 mg/kg combined with either NIVO 1 mg/kg or placebo Q3W × 4, followed by NIVO 3 mg/kg or placebo Q2W until disease progression or unacceptable toxicity. The primary endpoint was ORR in BRAF wild-type (WT) pts. Secondary and exploratory objectives included PFS in BRAF WT pts, ORR and PFS in BRAF V600 mutation-positive (MT) pts, and safety. Results: In BRAF WT pts (n = 109), ORR was 60% (43/72) for NIVO + IPI; 11% (4/37) for IPI alone...