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A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
Recruiting
I'm InterestedTrial 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
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
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Phuong Q Pham
650-725-9810