Study: NCT01176474

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: NY-ESO-1 157-165 (165V)
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: gp100:280-288 (288V)
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Montanide ISA 51 vegetable grade (VG)
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ipilimumab
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Apheresis Procedure
Description: 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.