Double-blind study of Nivolumab versus Ipilimumab in previously untreated unresectable or metastatic melanoma

This is a double-blind study, which means that neither you nor the study doctor will know to which group you have been assigned. Participants will be assigned to receive nivolumab plus placebo (inactive drug), nivolumab plus ipilimumab, or ipilimumab plus placebo. For this study, the nivolumab placebo will be 0.9% Sodium Chloride injection and the ipilimumab placebo will be either 0.9% Sodium Chloride Injection or 5% Dextrose Injection. Participants will be randomly assigned to one of 3 groups. One group will receive 3 mg/kg of nivolumab plus placebo for the first 12 weeks followed by 3 mg/kg nivolumab. Another group will receive 1 mg/kg nivolumab plus 3 mg/kg ipilimumab plus placebo for the first 12 weeks followed by 3 mg/kg nivolumab. Another group will receive 3 mg/kg ipilimumab plus placebo for the first 12 weeks followed by placebo. There is a one out of three chance that participants will be assigned to receive nivolumab plus placebo, a one out of three chance that they will be assigned to receive nivolumab plus ipilimumab plus placebo, and a one out of three chance that they will receive ipilimumab plus placebo. Nivolumab and ipilimumab and their respective placebos are solutions that are administered by intravenous (IV) infusion (through a needle inserted into a vein in your arm).