Study design and treatment
Toxicities, DLTs, fatigue, toxicity, infection
INFECTION, THROMBOCYTOPENIA, FEBRILE NEUTROPENIA
Patients received up to 8 cycles of intravenous V937 at 1 × 10Study schema and endpoints. The study was planned to enroll 6 patients for a 6-week dose-limiting toxicity (DLT) observation period that began with the commencement of ipilimumab therapy on day 8 and ended on day 50. Patients enrolled in the DLT observation period received study treatment per the protocol schedule. DLTs included any of the following considered related to V937 or ipilimumab: grade ≥ 4 hematologic toxicity lasting ≥ 7 days and/or complicated by infection; grade ≥ 4 thrombocytopenia; grade ≥ 3 febrile neutropenia; and any grade ≥ 3 nonhematologic toxicity (with the exception of grade 3 fatigue lasting < 7 days) that was considered a DLT and not a standard ipilimumab toxicity. If at least 2 patients experienced a DLT during the observation period, then V937 dosing would be stopped and the sponsor and investigator would determine whether to continue at a lower V937 dose. If no more than 1 patient experienced a DLT during the observation period, up to 4 additional patients were enrolled (ie, 10 total patients). If V937 treatment was discontinued due to toxicity, ipilimumab treatment could continue. Toxicities related to ipilimumab were managed according to the ipilimumab prescribing information (Yervoy® 