Overview

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

Status:
Recruiting

Trial end date:
2027-08-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bristol-Myers Squibb

Treatments:

Nivolumab
Relatlimab

Criteria

Inclusion Criteria:

- Must have either metastatic melanoma and have not had previous treatment for their
cancer, or resected melanoma and have had the cancer removed fully with surgery no
later than 12 weeks before the start of treatment and confirmed free of disease

- Must have a low level of disability and cancer that is considered advanced for
metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for
resected melanoma

Exclusion Criteria:

- Must not have any brain cancer/disease treated with radiation, any cancer in the eyes
or mucous membranes (cells that cover inside surface of parts of the body and keep it
moist), any autoimmune disease, or any condition that is being treated with steroids
for inflammation (corticosteroids) or medication to decrease the body's immune system
response (immunosuppressive drugs)

Other protocol-defined inclusion/exclusion criteria apply.