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Trial ID CA209-76K  |   NCT04099251

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 12+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.

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Key Eligibility Criteria

Inclusion Criteria: - Had a negative sentinel lymph node biopsy - Participant has not been previously treated for melanoma - ECOG 0 or 1 - Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma Exclusion Criteria: - History of ocular or mucosal melanoma. - Pregnant or nursing women - Participants with active known or suspected autoimmune disease - Known history of allergy or hypersensitivity to study drug components - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways Other protocol defined inclusion/exclusion criteria apply.

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Placebo Comparator: Placebo

ASSIGNED INTERVENTION
  • Other: Placebo

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