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Trial ID CA224-098  |   NCT05002569

A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

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Summary

  • 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 assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
    1. Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and < 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%
      1. Complete resection must be performed within 90 days prior to randomization
        1. All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
          1. Tumor tissue must be provided for biomarker analyses

            Exclusion Criteria

            Exclusion Criteria Icon
            :
            • History of ocular melanoma
              1. Untreated/unresected CNS metastases or leptomeningeal metastases
                1. Active, known, or suspected autoimmune disease
                  1. Participants with serious or uncontrolled medical disorder
                    1. Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
                      1. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
                        1. History of myocarditis, regardless of etiology. Other protocol-defined inclusion/exclusion criteria apply
                          Additional Information *

                          Treatment Options

                          Study Arms

                          ASSIGNED INTERVENTION

                          Study Arms

                          Experimental: Arm A: Nivolumab Plus Relatlimab

                          ASSIGNED INTERVENTION
                          • Biological: Nivolumab + Relatlimab Fixed Dose Combination

                          Study Arms

                          Experimental: Arm B: Nivolumab

                          ASSIGNED INTERVENTION
                          • Biological: Nivolumab

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