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Clinical Trial 19601

Cancer Type:
Interventions:BMS-936558 (Nivolumab); BMS-986213; Nivolumab; Not Applicable

Study Type: Treatment
Phase of Study: Phase II/III
Investigators:

  • Zeynep Eroglu

Overview

Study 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

Summary

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

Objective

The Phase 3 primary objective is to compare PFS of BMS-986213 to nivolumab monotherapy in participants with previously untreated, unresectable, or metastatic melanoma.

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 ocular melanoma
  • Participants must not have an active, known, or suspected autoimmune disease
  • Other protocol defined inclusion/exclusion criteria could apply