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Trial ID CA224-047  |   NCT03470922

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

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Summary

  • Phase 2/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 whether relatlimab in combination with nivolumab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread.

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Key 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm A: Relatlimab + Nivolumab

ASSIGNED INTERVENTION
  • Biological: Relatlimab, Nivolumab

Study Arms

Experimental: Arm B: Nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab