NCT01176461

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	MART-1	THIS PEPTIDE REMOVED FROM STUDY ON 1/1/2013. MART-1:26-35(27L) peptide vaccine
BIOLOGICAL	NY-ESO-1	NY-ESO-1 peptide vaccine
BIOLOGICAL	gp100:209-217(210M)	THIS PEPTIDE REMOVED FROM STUDY ON 1/1/2013. gp100:209-217(210M) peptide vaccine
BIOLOGICAL	gp100:280-288(288V)	gp100:280-288(288V) peptide vaccine
DRUG	Montanide ISA 51 VG	Administer peptide vaccine emulsions prepared with Montanide® ISA 51 VG by deep subcutaneous injection.
BIOLOGICAL	BMS-936558	BMS-936558 is a fully human monoclonal antibody (HuMAb) against programmed death-1 (PD-1). Level 1: 1 mg/kg cohort; Level 2: 3 mg/kg cohort; Level 3: 10 mg/kg cohort; Level 4: 3 mg/kg prior ipi gr 0/1/2 cohort; Level 5: 3 mg/kg prior ipi gr 3 cohort; Level 6: 3 mg/kg BMS-936558 (no peptide vaccine; human leukocyte antigen \[HLA\] unrestricted)

Timeline

• Start date: 2010-08-04
• Primary completion: 2016-12-12
• Completion: 2016-12-12
• First posted: 2010-08-06
• Last updated: 2023-01-18

Locations

1 site across 1 country: United States