A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

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Trial ID: NCT05625399

Purpose

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

Official Title

A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma

Stanford Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology

Eligibility


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.

Intervention(s):

drug: Nivolumab + Relatlimab

drug: rHuPH20

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Q Pham
650-725-9810

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