drugset
drugset / Trial / NCT05625399

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

NCT05625399 ↗

Phase 3 Active not recruiting 579 enrolled Bristol-Myers Squibb Halozyme Therapeutics · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-03-06
Primary completion
2025-08-04
Completion
2027-11-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody — Subcutaneous
Subject Relatlimab Monoclonal antibody — Subcutaneous
Background rHuPH20 Protein / enzyme biologic — —

Indications

melanoma