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NCT05625399 · ClinicalTrials.gov record · last posted 2026-08-26

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

Study acronym: RELATIVITY-127
StatusActive, Not Recruiting
PhasePhase 3
Started2023-03-06
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from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-08-27
Primary endpoint(s) modified
WasCavgd28 of Relatlimab, Cminss of Relatlimab, Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab, Trough serum concentration at steady state (Cminss) of Nivolumab
NowAdjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale, Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale, Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale, Adjusted Trough Relatlimab Serum Concentration at Steady-State (Cminss-Rela) on Natural Logarithmic Scale
Trial Details
NCT Number NCT05625399
Lead Sponsor Bristol-Myers Squibb
Collaborators: Halozyme Therapeutics
Conditions Melanoma
Enrollment 579 participants
Start Date 2023-03-06
Primary Completion 2025-08-04 (estimated)
Study Completion 2027-11-18 (estimated)
Updated on ClinicalTrials.gov 2026-08-26