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Spots Global Cancer Trial Database for Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558

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Trial Identification

Brief Title: Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558

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

Study ID: NCT01176461

Conditions

Melanoma (Skin)

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Contact Details

Name: Nikhil I. Khushalani, M.D.

Affiliation: H. Lee Moffitt Cancer Center and Research Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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