Vaccine Combining Multiple Class I Peptides and Montanide ISA 51VG With Escalating Doses of Anti-PD-1 Antibody Nivolumab or Ipilimumab With Nivolumab For Patients With Resected Stages IIIC/ IV Melanoma

PHASE1CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

August 13, 2010

Primary Completion Date

August 31, 2020

Study Completion Date

January 6, 2023

Conditions
Melanoma (Skin)
Interventions
BIOLOGICAL

NY-ESO-1 157-165 (165V)

"The vaccine contains two peptides from two different proteins (peptides are pieces that make up proteins) called gpl00 and NY-ES0-1.~Route of Administration: When prepared as a vaccine emulsion with Montanide ISA 51 VG, the vaccine is given by deep subcutaneous injection.~Method of Administration: The 0.5 mg vaccine emulsion dose is administered as a 1 mL injection (0.5 mg/1 mL) as a deep subcutaneous injection in the anterior thigh of the same extremity. Injections should be separated by at least 3 cm to avoid the formation of coalescent granulomas. All 4 peptides (total of 6 injections) will be administered in the same thigh and alternating thighs will be used for each subsequent treatment."

DRUG

Nivolumab

"Nivolumab (BMS-936558) is a fully human monoclonal antibody (HuMAb) against programmed death-1 (PD-1).~Nivolumab will be given at the following dosages: 1, 3, or 10 mg/kg.~Nivolumab 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."

BIOLOGICAL

gp100:280-288 (288V)

"The vaccine contains two peptides from two different proteins (peptides are pieces that make up proteins) called gpl00 and NY-ES0-1.~Route of Administration: When prepared as a vaccine emulsion with Montanide ISA 51 VG, the vaccine is given by deep subcutaneous injection.~Method of Administration: The 0.5 mg vaccine emulsion dose is administered as a 1 mL injection (0.5 mg/1 mL) as a deep subcutaneous injection in the anterior thigh of the same extremity."

DRUG

Montanide ISA 51 vegetable grade (VG)

"Route of Administration: Administer peptide vaccine emulsions prepared with Montanide® ISA 51 VG by deep subcutaneous injection.~Method of Administration: Divide peptide vaccine emulsion dose volumes of greater than 1.5 mL into 2 or more injections. Administer injections typically into the anterior thigh deep subcutaneous tissue. Perform subsequent injections in rotating sites. Use a 20 or 21 gauge needle for deep subcutaneous injection of the peptide vaccine emulsion."

DRUG

Ipilimumab

"Ipilimumab will be given at the following dosage: 3 mg/kg.~Ipilimumab 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."

PROCEDURE

Apheresis Procedure

"Some blood will be removed from the participant's veins and processed by a machine to remove a small portion of the white cells. The rest of the blood will be returned into their veins. This procedure is called apheresis. Apheresis is done to collect cells to allow the investigators to understand how their immune system is functioning before and after receiving nivolumab and vaccine. This will be done for research purposes only. The red cells and blood clotting cells will not be permanently removed during this procedure. White blood cells will need to be removed by apheresis before participants receive the study drug."

Trial Locations (1)

33612-9497

H. Lee Moffitt Cancer Center and Research Institute, Tampa

Sponsors
All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Medarex

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER