Melanoma (Skin) Clinical Trial
Official title:
A Pilot Trial of a Vaccine Combining Multiple Class I Peptides and Montanide ISA 51 VG With Escalating Doses of Anti-PD-1 Antibody BMS-936558 for Patients With Unresectable Stages III/IV Melanoma
This is a pilot phase 1, open-label, single center, multi-dose, dose-escalation study of BMS-936558 in combination with or without a peptide vaccine. The purpose of this study is to test the side effects of an investigational vaccine with an immune booster. Investigators also wish to find out its effects on the patient's immune system and whether it will shrink their melanoma.
BMS-936558 will be administered as an i.v. infusion, using a volumetric pump with a 0.2 micron in-line filter at the protocol-specified dose(s) and rate. The vaccine consists of the following peptides: gp100280-288 (288V), and NY-ESO-1157-165 (165V). NOTE: *Patients in cohorts 1-5 will receive the peptide vaccine, but not those in cohort 6. Blood samples are collected for pharmacokinetic and immunologic analysis. After completion of study therapy, patients are followed up periodically for 2 years. ;
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