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NCT Number: NCT07223411

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

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.

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Key information

Conditions

Locally Advanced Melanoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Cutaneous melanoma is an aggressive skin cancer which, in the metastatic setting, has a historic 5-year survival rate of <30%. In 2023, about 97,610 new cases of melanoma were estimated to occur in the US, with about 7,990 deaths. GLOBACON reported 324,635 cases of melanoma globally in 2020, which constituted about 1.7% of all cancers and 57,043 melanoma-associated deaths.

The parent trial of this corollary study is a randomized, open-label, multicenter phase 3 study comparing the anti-tumor activity of fixed-dose combination (FDC) of fianlimab + cemiplimab versus the FDC of relatlimab + nivolumab (referred to as Opdualag™) in participants with unresectable or metastatic melanoma (stage III-IV). This corollary study will explore the immunological response of CD8, CD4, and other immune cells in the blood and tumor microenvironment of patients in response to the provided treatments.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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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Treatment and study plan

Fianlimab + Cemiplimab

Drug

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

Relatlimab + Nivolumab

Drug

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

Other names: Opdualag

Primary outcomes

  1. Single-cell analysis of CD4+ T cells

    Time frame: Up to 39 months

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

Secondary outcomes

  1. Immunological response of CD4+ T cells

    Time frame: Up to 39 months

    Single-cell analysis of CD4+ T cell (frequency) and other immune cells in blood and tumor biopsies. Analysis of single-cell RNA-seq data to obtain gene module scores for each CD4+ T cell or myeloid cell in whole blood and tumor biopsies will be classified as binary: 1 (co-expressing cytotoxic and exhaustion gene modules) or 0 (no co-expression).

  2. Multiplexed immunofluorescence

    Time frame: Up to 39 months

    Degree of immune infiltration major immune subsets in the tumor microenvironment. The density of immune cells relative to the total number of cells in the tumor tissue will be calculated for each patient.

  3. Multiplexed immunofluorescence

    Time frame: Up to 39 months

    Frequencies of major immune subsets in the tumor microenvironment. The density of immune cells relative to the total number of cells in the tumor tissue will be calculated for each patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Rose, RN

CONTACT

[email protected]

4126478587

Danielle L Bednarz, RN

CONTACT

[email protected]

4126231191

Sponsors and collaborators

Lead sponsor

John Kirkwood

Other

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Oct 31, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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