Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma

Conditions

• Metastatic Melanoma
• Unresectable Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG
• Ipilimumab — DRUG
• Placebo — DRUG
  Matching nivolumab

Study Details

The primary purpose of this study is to compare the objective response rate, as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in patients with untreated, unresectable, or metastatic melanoma

Key Dates

Start date

Aug 23, 2013

Status verified

Feb 2022

Primary completion

Jul 24, 2014

Completion

Feb 26, 2021

Study Design

Enrollment

142 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nivolumab + Ipilimumab
  Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
• Experimental: Placebo + Ipilimumab
  Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.

Primary Outcome Measure

Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants [ Time Frame: From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months) ]

Locations (19)

Find similar trials in San Francisco, CA

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