Conditions: Melanoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 418
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma

Detailed description:

Arms:
arm 1: Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may switch to nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends. arm 2: Participants received dacarbazine, 1000 mg/m\^2, solution administered IV every 3 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may cross-over to nivolumab open label treatment, either 3 mg/kg every 2 weeks or 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

Interventions: intervention 1: BMS-936558 (Nivolumab) intervention 2: Placebo matching BMS-936558 (Nivolumab) intervention 3: Dacarbazine intervention 4: Placebo matching Dacarbazine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: