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

NCT07223411 | Recruiting DMC FDA Drug

• 1 other identifier: HCC 25-009
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Melanoma

Keywords

immune checkpoint inhibitor; immunological response

Outcome Measures

Primary Outcomes (1)

• Single-cell analysis of CD4+ T cells

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

  Up to 39 months

Secondary Outcomes (3)

• Immunological response of CD4+ T cells

  Up to 39 months

• Multiplexed immunofluorescence

  Up to 39 months

• Multiplexed immunofluorescence

  Up to 39 months

Study Arms (2)

fianlimab + cemiplimab

Patients who received fianlimab + cemiplimab treatment under protocol NCT06246916.

Drug: Fianlimab + Cemiplimab

Opdualag (relatlimab + nivolumab)

Patients who received Opdualag (relatlimab + nivolumab) under protocol NCT06246916.

Drug: Relatlimab + Nivolumab

Interventions

Fianlimab + Cemiplimab DRUG

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

fianlimab + cemiplimab

Relatlimab + Nivolumab DRUG

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

Also known as: Opdualag

Opdualag (relatlimab + nivolumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants who met inclusion criteria for clinical trial NCT06246916

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• John Kirkwood: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Interventions

cemiplimab; relatlimab; Nivolumab; Opdualag

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John M Kirkwood, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle L Bednarz, RN

CONTACT

4126231191; bednarzdl@upmc.edu

Amy Rose, RN

CONTACT

4126478587; kennaj@upmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 30, 2025
• First Posted: October 31, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2031
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)