NCT05625399

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 579 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab + Relatlimab	Specified dose on specified days
DRUG	rHuPH20	Specified dose on specified days

Timeline

• Start date: 2023-03-06
• Primary completion: 2025-08-04
• Completion: 2027-11-18
• First posted: 2022-11-22
• Last updated: 2025-08-24

Locations

149 sites across 19 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Finland, France, Germany, Israel, Italy, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study