RecruitingNCT07223411

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)


Sponsor

John Kirkwood

Enrollment

20 participants

Start Date

Nov 19, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a companion research project attached to a larger clinical trial (HCC 24-056) for people with advanced or inoperable melanoma (skin cancer). Its goal is to collect extra tumor biopsies and blood samples to understand how two different immunotherapy drug combinations change the immune environment inside tumors over time. **You may be eligible if...** - You already qualify to enroll in the linked parent study (HCC 24-056) for unresectable or metastatic melanoma - You are willing to provide 3 additional tumor biopsies and 3 additional blood draws beyond what the main study requires - You have tumor lesions that can be safely biopsied at least 3 times - You are able to understand and sign the consent form **You may NOT be eligible if...** - You do not qualify for the parent study (HCC 24-056) - Your tumors are not safely accessible for repeated biopsy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFianlimab + Cemiplimab

Patients treated with Fianlimab 1600 mg + Cemiplimab 350 mg under protocol NCT06246916

DRUGRelatlimab + Nivolumab

Patients treated with Relatlimab 160 mg + Nivolumab 480 mg under protocol NCT06246916


Locations(1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

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NCT07223411


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