Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: A Phase I Trial of a 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

Study ID: NCT01176474

Conditions

Melanoma (Skin)

Interventions

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

Nivolumab

gp100:280-288 (288V)

Montanide ISA 51 vegetable grade (VG)

Ipilimumab

Apheresis Procedure

Study Description

Brief Summary: The purpose of this study is to test the side effects of an investigational vaccine with an immune booster, or 2 different boosters together. Investigators also want to find out its effects on the immune system and whether it will decrease the chance that melanoma will return.

Detailed Description: Up to 5 dose cohorts will be studied. Participants will be assigned to a dose cohort in the order they enter the study. * 1 mg/kg of NIVOLUMAB + peptide vaccine (1 mg/kg cohort), then * 3 mg/kg of NIVOLUMAB + peptide vaccine (3 mg/kg cohort), then * 10 mg/kg of NIVOLUMAB + peptide vaccine (10 mg/kg cohort), then * 1 mg/kg NIVOLUMAB + ipilimumab 3 mg/kg combination cohort * 3 mg/kg NIVOLUMAB + ipilimumab 1 mg/kg combination cohort