Conditions: Advanced Melanoma
Keywords: Untreated Advanced Melanoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 72
Healthy volunteers: no

Brief summary:
The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Ipilimumab intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Dacarbazine
Intervention descriptions: intervention 1: Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks intervention 2: Solution, intravenous, Area Under the Concentration Time Curve=6, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks intervention 3: Solution, intravenous, 175 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks intervention 4: Solution, intravenous, 850 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks

Protocol document: