Clinical Trials /

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

NCT03470922

Description:

The purpose of this study is to determine whether nivolumab in combination with relatlimab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
  • Official Title: A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

Clinical Trial IDs

  • ORG STUDY ID: CA224-047
  • SECONDARY ID: 2017-003583-12
  • NCT ID: NCT03470922

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
RelatlimabArm A: Relatlimab + Nivolumab
NivolumabArm A: Relatlimab + Nivolumab

Purpose

The purpose of this study is to determine whether nivolumab in combination with relatlimab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread

Trial Arms

NameTypeDescriptionInterventions
Arm A: Relatlimab + NivolumabExperimentalCombination
  • Relatlimab
  • Nivolumab
Arm B: NivolumabExperimentalMonotherapy
  • Nivolumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Participants must have histologically confirmed Stage III (unresectable) or Stage IV
             melanoma, per the AJCC staging system

          -  Participants must not have had prior systemic anticancer therapy for unresectable or
             metastatic melanoma

          -  Tumor tissue from an unresectable or metastatic site of disease must be provided for
             biomarker analyses

        Exclusion Criteria:

          -  Participants must not have active brain metastases or leptomeningeal metastases

          -  Participants must not have uveal melanoma

          -  Participants must not have an active, known, or suspected autoimmune disease

        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:Progression Free Survival (PFS)
Time Frame:Up to 5 years
Safety Issue:
Description:Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR)

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Up to 5 years
Safety Issue:
Description:Phase 3 portion of trial
Measure:ORR
Time Frame:Up to 5 years
Safety Issue:
Description:Phase 3 portion of trial, assessed by a BICR
Measure:ORR
Time Frame:Up to 5 years
Safety Issue:
Description:Phase 2 portion of trial, assessed by a BICR. In the randomized population and in subgroups
Measure:Duration of Response (DOR)
Time Frame:Up to 5 years
Safety Issue:
Description:Phase 2 portion of trial. In the randomized population and in subgroups
Measure:PFS
Time Frame:Up to 5 years
Safety Issue:
Description:Phase 2 portion of trial. In subgroups.
Measure:OS
Time Frame:Up to 5 years
Safety Issue:
Description:Phase 2 portion of trial. In the randomized population and in subgroups
Measure:Number of Adverse Events (AEs)
Time Frame:Up to 5 years
Safety Issue:
Description:Phase 2 portion of the trial
Measure:Number of Serious Adverse Events (SAEs)
Time Frame:Up to 5 years
Safety Issue:
Description:Phase 2 portion of the trial
Measure:Number of AEs Leading to Discontinuation
Time Frame:Up to 5 years
Safety Issue:
Description:Phase 2 portion of the trial
Measure:Number of Deaths
Time Frame:Up to 5 years
Safety Issue:
Description:Phase 2 portion of the trial
Measure:Number of Laboratory Abnormalities
Time Frame:Up to 5 years
Safety Issue:
Description:Phase 2 portion of the trial

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Trial Keywords

  • Cancer
  • Advanced Cancer

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