Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg in Subjects with Previously untreated, unresectable or Metastatic Melanoma
Investigational Product(s), Dose and Mode of Administration, Duration of Treatment with Investigational Product(s):
Arm A: nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg (N3I1) IV every 3 weeks for 4 doses then flat dose nivolumab 480 mg every 4 weeks. Arm B: nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg (N1I3) IV every 3 weeks for 4 doses then flat dose nivolumab 480 mg every 4 weeks. Study Phase: IIIb/IV Research Hypothesis: Treatment with N3I1 will show a reduced rate of drug-related Grade 3 - 5 adverse Events compared with N1I3 and have similar efficacy in patients with previously untreated, unresectable or metastatic melanoma.
