Observational Study of Immunological Response in Melanoma

This study is looking at how your immune system responds to two different drug combinations for advanced melanoma: Fianlimab + Cemiplimab, or Relatlimab + Nivolumab (also known as Opdualag). Researchers will examine samples from your tumor and blood to understand the immune system's activity. This study is for adults aged 18 and older who are already participating in another clinical trial (HCC 24-056) for unresectable (cannot be removed by surgery) or metastatic (spread to other parts of the body) melanoma. The main goal is to analyze specific immune cells (CD4+ T cells) over a period of up to 39 months. The current status of this study is unclear, and it plans to enroll 20 participants.

Study design
This is an observational study, meaning researchers will be watching and collecting information from participants already receiving treatment in another trial. It is designed to enroll 20 participants.
What's involved
You would need to provide additional samples beyond what is required in the parent study, including 3 extra tumor biopsies and 3 extra blood draws.
Compensation
Not stated in the trial record.
Follow-up
Researchers will analyze immune cells for up to 39 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07223411

Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma

Recruiting
Not specifiedAges 18+Observational
John Kirkwood
~20 participants
Updated 2025-11-26 on ClinicalTrials.gov
What's tested:Fianlimab + CemiplimabRelatlimab + Nivolumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Single-cell analysis of CD4+ T cells
Measured over Up to 39 months
Locally Advanced Melanoma
1 sites across 1 states
Pennsylvania1
  • John M Kirkwood, MD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center

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  • Single-cell analysis of CD4+ T cellsUp to 39 months

    Single-cell RNAseq analysis of CD8+ T cells and other immune cells in blood and tumor biopsies.