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Clinical Trial 19601

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT03470922

Phase: Phase II/III
Prinicipal Investigator:

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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.

Treatments

Therapies

Medications

BMS-936558 (Nivolumab); BMS-986213 (); Nivolumab (); Not Applicable ()

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
  • Prior radiotherapy must have been completed at least 2 weeks prior to study treatment administration.

  • 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
  • Pregnant or breastfeeding women
  • Participants must not have an active, known or suspected autoimmune disease.
  • Participants must not have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment. Some exceptions apply.
  • Participants must not have a history of myocarditis.
  • Other protocol defined inclusion/exclusion criteria could apply

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