NCT06101134

A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for Nivolumab + Relatlimab Fixed-dose Combination Subcutaneous Versus Nivolumab + Relatlimab Fixed-dose Combination Intravenous and Nivolumab Subcutaneous Versus Nivolumab Intravenous in Participants With Melanoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	relatlimab+nivolumab	Specified dose on specified days
DRUG	relatlimab+nivolumab+rHuPH20	Specified dose on specified days
DRUG	nivolumab	Specified dose on specified days
DRUG	nivolumab+rHuPH20	Specified dose on specified days

Timeline

• Start date: 2023-11-06
• Primary completion: 2025-04-10
• Completion: 2027-08-31
• First posted: 2023-10-26
• Last updated: 2026-04-09
• Results posted: 2026-04-09

Locations

31 sites across 5 countries: United States, Chile, Greece, Italy, Spain

Regulatory

• FDA-regulated drug study