Study on Subcutaneous Nivolumab and Relatlimab Combination for Untreated Advanced Melanoma

Sponsor: Bristol-Myers Squibb

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05625399

Provider View

This clinical trial is testing a new way to give a combination of two drugs, nivolumab and relatlimab, to patients with advanced melanoma that cannot be removed by surgery or has spread to other parts of the body. The study aims to see if giving the drugs as a shot under the skin is as effective as giving them through an IV.

Patient Parameters

Program Overview

The goal of this study is to find out if a new method of administering a combination of two drugs, nivolumab and relatlimab, as a subcutaneous injection (a shot under the skin) is as effective as the traditional intravenous (IV) method (given through a vein) in patients who have not yet received treatment for advanced melanoma that cannot be surgically removed or has spread.

Eligibility Criteria

Inclusion Criteria

  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
  • Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
  • Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
  • Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
  • Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).

Exclusion Criteria

  • Participants must not have ocular melanoma.
  • Participants must not have a history of myocarditis, regardless of etiology.
  • Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

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