drugset / Trial / NCT06101134

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

NCT06101134

Phase 2 Active not recruiting 100 enrolled Bristol-Myers Squibb
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-11-06
Primary completion
2025-04-10
Completion
2027-08-31

Drugs

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

Indications