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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)

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

1. Study participants who meet inclusion criteria for the HCC 24-056 study will be eligible for this study.
2. Participants must be willing to provide additional samples beyond what is required of them in HCC 24-056. These include:

   1. 3 additional tumor biopsies
   2. 3 additional blood draws
3. Participants must have biopsiable non-target disease amenable to at least 3 biopsies.
4. Must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1\. Study participants who do not qualify to enroll in the HCC 24-056 study will not be eligible for this study.

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About the study

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.

What is being tested

• Fianlimab + Cemiplimab (drug)
• Relatlimab + Nivolumab (drug)

Sponsor: John Kirkwood · Participants: 20 · Started: Nov 19, 2025

Contact the study team

• Danielle L Bednarz, RN · Phone: 4126231191
• Amy Rose, RN · Phone: 4126478587

Official record on ClinicalTrials.gov — NCT07223411

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.