Ipilimumab for stage unresectable III/IV melanoma: Brazilian experience in an expanded access program.

e20045 Background: Expanded Access Programs (EAP) for ipilimumab (IPI) were established around the world in order to provide appropriate drug access. This abstract reports the experience with IPI in major melanoma treatment centers in Brazil. Methods: Patients (pts) with unresectable stage III/IV melanoma who had either failed or were intolerant to previous therapy were eligible to receive intravenous IPI therapy (3mg/kg every 3 weeks for 4 cycles), in an open-label, multicenter prospective program. Re-induction was allowed. Data on demographics, survival, and safety were collected. Results: From March 2011 to November 2012, 450 pts across 11 centers were included and treated with at least 1 IPI dose in Brazilian EAP. This analysis includes data until database lock in October 2013 (maximum follow up: 30 months). Median age was 56 years (min-max: 18-88), 59.1% were males, 19.3% had brain metastases, 8.4% ocular melanoma and 8.0% mucosal melanoma. In total, 58.0% presented drug-related adverse event (AE) of...