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

a study on Skin Cancer/Melanoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Melanoma, Patient preference, Nivolumab Relatlimab IV, Nivolumab Relatimab SC, rHuPH20, FDC IV, FDC SC, Adjuvant, Metastatic, Switch, Nivolumab, Relatlimab, relatlimab+nivolumab, relatlimab+nivolumab+rHuPH20, nivolumab+rHuPH20, Metastatic Melanoma, Resected Melanoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • UCSF, Medical Center at Mount Zion accepting new patients
    San Francisco California 94115-3010 United States
  • Mayo Clinic Hospital - Phoenix not yet accepting patients
    Phoenix Arizona 85054-4502 United States
  • University of New Mexico Cancer Center accepting new patients
    Albuquerque New Mexico 87106 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT06101134
Phase
Phase 2 Skin Cancer/Melanoma Research Study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated
Contact us about this trial