Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 Antibody BMS936558
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 immune system and whether it will decrease the chance that melanoma will return.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I 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 Resected Stage IIIC/IV Melanoma|
- Time to Relapse [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]The primary efficacy analysis is time to relapse, to determine relapse at the end of each cycle (Weeks 12 and 24). Time to relapse will be summarized using descriptive statistics.
- Overall Survival (OS) [ Time Frame: 2 years, 6 months ] [ Designated as safety issue: No ]Overall survival will be the secondary efficacy endpoint.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Phase I Dose Escalation
Vaccine Combining Multiple Class I Peptides and Montanide ISA 51 VG with Escalating Doses of Anti-PD-1 Antibody BMS-936558. Level 1: 1 mg/kg BMS-936558 + peptide vaccine. Level 2: 3 mg/kg BMS-936558 + peptide vaccine. Level 3: 10 mg/kg BMS-936558 + peptide vaccine.
NY-ESO-1 peptide vaccine
Other Names:Biological: BMS-936558
BMS-936558 is a fully human monoclonal antibody (HuMAb) against programmed death-1 (PD-1).
Other Names:Biological: gp100:280-288(288V)
gp100:280-288(288V) peptide vaccine
Other Names:Drug: Montanide
Montanide ISA 51 VG
Other Name: NSC 737063
This phase I trial is studying the side effects and best dose of anti-PD-1 human monoclonal antibody MDX-1106 when given together with and vaccine therapy in treating patients with stage IIIC or stage IV melanoma that has been removed by surgery.
Blood and serum samples are collected periodically for immunology and pharmacokinetic studies.
After completion of study treatment, patients are followed up for up to 2 years.
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Principal Investigator:||Jeffrey S. Weber, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|