Dose-response Analysis of Nivolumab/Relatlimab in the Fixed-dosed Combination 'Opdualag' vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood for Participants With Unresectable or Metastatic Melanoma: A Corollary Study of HCC 24-056 (NCT06246916)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY
This translational study will examine the immune effector responses of patients who received a two-drug combination for first line therapy by examining tumor and peripheral blood of participants with unresectable locally advanced or metastatic melanoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:
• Study participants who meet inclusion criteria for the HCC 24-056 study will be eligible for this study.
• Participants must be willing to provide additional samples beyond what is required of them in HCC 24-056. These include:
‣ 3 additional tumor biopsies
⁃ 3 additional blood draws
• Participants must have biopsiable non-target disease amenable to at least 3 biopsies.
• Must have the ability to understand and the willingness to sign a written informed consent document.
Locations
United States
Pennsylvania
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Contact Information
Primary
Danielle L Bednarz, RN
bednarzdl@upmc.edu
4126231191
Backup
Amy Rose, RN
kennaj@upmc.edu
4126478587
Time Frame
Start Date: 2025-11-19
Estimated Completion Date: 2031-11-01
Participants
Target number of participants: 20
Treatments
fianlimab + cemiplimab
Patients who received fianlimab + cemiplimab treatment under protocol NCT06246916.
Opdualag (relatlimab + nivolumab)
Patients who received Opdualag (relatlimab + nivolumab) under protocol NCT06246916.
Related Therapeutic Areas
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: John Kirkwood