Phase II study evaluating ipilimumab as a single agent in the first-line treatment of adult patients (Pts) with metastatic uveal melanoma (MUM): The GEM-1 trial.

9033 Background: Uveal melanoma is the most common primary intraocular malignant tumor in adults. Overall survival (OS) at 5 years is 62% due to high incidence of liver metastasis that are fatal within 4 -9 months from diagnosis. No standard treatment exists for MUM. Ipilimumab has demonstrated to improve both overall and long-term survival in patients with advanced cutaneous melanoma (Hodi FS, et al., NEJM 2010; Robert C, et al., NEJM 2011). However, MUM patients were excluded in these trials. Methods: GEM-1 (EudraCT 2010-024415-14) is an open label, single arm phase 2 trial that evaluates first line ipilimumab in adult pts with MUM.The study was conducted in 5 centers in Spain, belonging to the Spanish Melanoma Group (GEM). Eligible pts had progressive metastatic disease, ECOG-PS 0 or 1, and no prior systemic treatment for MUM. Treatment consisted of ipilimumab 10 mg/kg iv q3 weeks (wk) for 4 doses (induction) followed by q12 wk (maintenance) until progression, intolerance or withdrawal. Primary end poi...