A Phase 3 clinical trial investigating a subcutaneous fixed-dose combination of nivolumab and relatlimab for participants with previously untreated metastatic or unresectable melanoma reached its primary completion on 2025-08-04. The study, identified as NCT05625399, aims to demonstrate that the subcutaneous formulation's drug exposure is not worse than the intravenous administration.
Background
The trial investigates a fixed-dose combination of nivolumab and relatlimab. This combination is being studied for the treatment of melanoma, a serious form of skin cancer.
Trial design
The study, identified as NCT05625399, is a Phase 3 trial with an enrollment of 579 participants. It is designed to evaluate the subcutaneous fixed-dose combination of nivolumab and relatlimab in participants with previously untreated metastatic or unresectable melanoma. The primary objective of the study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than the nivolumab + relatlimab FDC intravenous (IV) administration.
What this means
The primary completion of this Phase 3 trial signifies a key milestone in the development of the subcutaneous nivolumab + relatlimab fixed-dose combination. This event indicates that data collection for the primary endpoint has concluded, and analysis of the comparative drug exposure levels between the subcutaneous and intravenous formulations can now proceed. The findings from this study will be crucial for understanding the potential of a subcutaneous administration option for patients with melanoma.
Source
The information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT05625399, titled "A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma," was recorded with an event date of 2025-08-04 on clinicaltrials.gov.