Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma
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)
John Kirkwood
20 participants
Nov 19, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- Participants must be willing to provide additional samples beyond what is required of them in HCC 24-056. These include:
- additional tumor biopsies
- 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.
Exclusion Criteria2
- \. Study participants who do not qualify to enroll in the HCC 24-056 study will not be eligible for this study.
- \-
Interventions
Patients treated with Fianlimab 1600 mg + Cemiplimab 350 mg under protocol NCT06246916
Patients treated with Relatlimab 160 mg + Nivolumab 480 mg under protocol NCT06246916
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07223411