Phase II multicenter, single arm, open label study of nivolumab in combination with ipilimumab in untreated patients with metastatic uveal melanoma (GEM1402.NCT02626962)

Abstract

Background: Uveal melanoma (UM) accounts for 0.1% of cancer-related deaths. Liver disease is the most common finding. Life expectancy is reduced (<9 months) and chemotherapy seems not to improve overall survival (OS). Nivolumab plus ipilimumab (NIVO+IPI) has showed efficacy in metastatic skin melanoma, but to date no evidence on metastatic UM (MUM) is available.Methods: GEM1402 is a phase-II, single-arm trial, leaded by the Spanish Melanoma Group (GEM) on NIVO+IPI in 50 untreated pts with MUM and ECOG-PS 0/1, recruited in 10 Spanish Sites. NIVO (1mg/kg, q3wk) and IPI (3mg/kg q3wk) were administered during 4 inductions, followed by NIVO (3mg/kg q2wk) until progressive disease (PD), toxicity or withdrawal. OS, progression free survival (PFS), overall response rate (ORR) per RECIST 1.1 (q6wk), and safety were evaluated. Intention to treat analysis includes pts with PD at first radiological evaluation. All pts receiving at least one dose of study treatment were evaluable for safety. Final data is disclosed.