Abstract
9021 Background: Ipilimumab (ipi) is a monoclonal antibody directed against cytotoxic T-lymphocyte antigen-4. The current study was designed to determine the efficacy and safety of ipi in patients (pts) with advanced melanoma who developed progressive disease (PD) on prior therapies. Methods: Advanced melanoma pts with PD during or after >1 prior therapeutic regimen were eligible for enrollment into this single-arm, multicenter, phase II study. Ipi induction was given at 10 mg/kg every 3 weeks (Q3W)×4; eligible pts received maintenance Q12W starting at Week (Wk) 24. The primary objective was to evaluate the best overall response rate (BORR, complete + partial response [CR+PR]). Efficacy endpoints were assessed with modified World Health Organization (mWHO) criteria; the first assessment was at Wk 12. Follow-up tumor evaluation beyond PD (defined by an overall tumor burden increase of >25%) by mWHO and before the administration of non-ipi anticancer therapy was permitted as per protocol. Results: The study...
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