Phase II DeCOG-Study of Ipilimumab in Pretreated and Treatment-Naïve Patients with Metastatic Uveal Melanoma

摘要: Purpose Up to 50% of patients with uveal melanoma (UM) develop metastatic disease limited treatment options. The immunomodulating agent ipilimumab has shown an overall survival (OS) benefit in cutaneous two phase III trials. As UM were excluded these studies, the Dermatologic Cooperative Oncology Group (DeCOG) conducted a II assess efficacy and safety UM. Patients Methods We undertook multicenter study different subtypes melanoma. Here we present data on (pretreated treatment-naive) who received up four cycles administered at dose 3 mg/kg week intervals. Tumor assessments baseline, weeks 12, 24, 36 48 according RECIST 1.1 criteria. Adverse events (AEs), including immune-related AEs graded National Cancer Institute Common Toxicity Criteria (CTC) v.4.0. Primary endpoint was OS rate 12 months. Results Forty five pretreated (85%) eight treatment-naive (15%) least one ipilimumab. 1-year 2-year rates 22% 7%, respectively. Median 6.8 months (95% CI 3.7–8.1), median progression-free 2.8 2.5–2.9). control 24 47% 21%, Sixteen had stable (47%), none experienced partial or complete response. Treatment-related observed 35 (66%), 19 grade 3–4 (36%). One drug-related death due pancytopenia observed. Conclusions Ipilimumab very clinical activity UM. manageable when treated as per protocol-specific guidelines. Trial Registration ClinicalTrials.gov NCT01355120