Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

Conditions

• Unresectable or Metastatic Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — BIOLOGICAL
• Ipilimumab — BIOLOGICAL
• Placebo for Nivolumab — BIOLOGICAL
• Placebo for Ipilimumab — BIOLOGICAL

Study Details

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.

Key Dates

Start date

Jun 11, 2013

Status verified

May 2025

Primary completion

Aug 1, 2016

Completion

Apr 19, 2024

Study Design

Enrollment

945 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab
  Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Ipilimumab 0 mg/kg solution intravenously on weeks 1, 4 and Placebo matching with Nivolumab on weeks 4 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
• Experimental: Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab
  Nivolumab 1 mg/kg solution intravenously combined with Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Nivolumab on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
• Experimental: Arm C: Ipilimumab+Placebo for Nivolumab
  Ipilimumab 3 mg/kg solution intravenously every 3 weeks for a total of 4 doses plus Placebo matching with Nivolumab 0 mg/kg solution intravenously on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends (Placebo matching with Nivolumab is no longer required)

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months) ]

Locations (46)

Find similar trials in Gilbert, AZ