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Trial ID CA224-1044  |   NCT06101134

A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.

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Key Eligibility Criteria

Inclusion Criteria

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:
  • Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease
    1. Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma

      Exclusion Criteria

      Exclusion Criteria Icon
      :
      • Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs) Other protocol-defined inclusion/exclusion criteria apply.
        Additional Information *

        Treatment Options

        Study Arms

        ASSIGNED INTERVENTION

        Study Arms

        Experimental: Cohort 1: Metastatic Melanoma

        ASSIGNED INTERVENTION
        • Drug: relatlimab+nivolumab, relatlimab+nivolumab+rHuPH20

        Study Arms

        Experimental: Cohort 2: Resected Melanoma

        ASSIGNED INTERVENTION
        • Drug: nivolumab, nivolumab+rHuPH20

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