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

NCT04099251

Description:

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.

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
  • Official Title: A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma

Clinical Trial IDs

  • ORG STUDY ID: CA209-76K
  • SECONDARY ID: 2019-001230-34
  • NCT ID: NCT04099251

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
NivolumabOpdivoNivolumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
NivolumabExperimentalspecified dose on specified days
  • Nivolumab
PlaceboPlacebo Comparatorplacebo equivalent specified dose on specified days

    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
    
              -  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
    
            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.
    
            Other protocol defined inclusion/exclusion criteria could apply.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:12 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Recurrence-Free Survival (RFS)
    Time Frame:approxiatemately 51 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Overall survival (OS)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Number of Participants with Serious Adverse Events (SAEs)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Number of Participants with Adverse Events (AEs)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Distant Metastases-Free Survival (DMFS)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Objective Response Rates (ORR)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Outcomes on Next-Line therapies (Objective response rate [if applicable], Duration of treatment on next-line therapies, Progression-Free Survival 2)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Incidence of change in Vital Signs
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Incidence of change in Electrocardiograms (ECGs)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Incidence of change in biomarkers
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Incidence of change in clinical laboratory values
    Time Frame:Up to 5 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Bristol-Myers Squibb

    Last Updated