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  • NCT02388906

Active, Not Recruiting

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma - CA209-238

Updated: 5 January, 2024   |   ClinicalTrials.gov

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Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 15+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Ipilimumab and Placebo matching Nivolumab
Drug: Ipilimumab Other: Placebo matching Nivolumab
Experimental: Nivolumab and Placebo matching Ipilimumab
Drug: Nivolumab Other: Placebo matching Ipilimumab

Key Eligibility Criteria

Inclusion Criteria: - At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is ≥ 18 years of age - Completely removed melanoma by surgery performed within 12 weeks of randomization - Stage IIIb/C or Stage IV before complete resection - No previous anti-cancer treatment Exclusion Criteria: - Ocular or uveal melanoma - History of carcinomatosis meningitis - History of auto-immune disease - Treatment directed against the resected melanoma that is administrated after the surgery Other protocol-defined inclusion/exclusion criteria apply

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