Clinical Trials /

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

URL:

https://clinicaltrials.gov/show/NCT04099251

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
  • SECONDARY ID: U1111-1229-8927
  • 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
NivolumabExperimental
  • Nivolumab
PlaceboPlacebo Comparator

    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 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:Approximately 68 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Overall survival (OS)
    Time Frame:Up to 7 years
    Safety Issue:
    Description:
    Measure:Occurrence of Adverse Events (AEs) as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Severity of AEs as defined by NCI CTCAE v5
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Distant Metastases-Free Survival (DMFS)
    Time Frame:Up to 7 years
    Safety Issue:
    Description:
    Measure:Investigator-assessed outcomes on next-line therapies [Objective response rates (if applicable), Duration of treatment on next-line therapies, Progression-Free Survival 2, End-of-next-line-treatment]
    Time Frame:Up to 7 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Bristol-Myers Squibb

    Last Updated

    July 26, 2021