Recruiting

Two-Drug Combination

Sponsor:

John Kirkwood

Code:

NCT07223411

Conditions

Locally Advanced Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fianlimab + Cemiplimab

Relatlimab + Nivolumab

Study Details

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

Study ID

NCT07223411

Start date

Nov 19, 2025

Status verified date

Nov, 2025

Completion date

Nov 1, 2031

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

fianlimab + cemiplimab

Patients who received fianlimab + cemiplimab treatment under protocol NCT06246916.

Opdualag (relatlimab + nivolumab)

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

Interventions

Fianlimab + Cemiplimab

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

Relatlimab + Nivolumab

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

Primary outcome measure

  • Single-cell analysis of CD4+ T cells [ Time Frame: Up to 39 months ]

Central Contacts and Locations

Central contacts

Danielle L Bednarz, RN

4126231191bednarzdl@upmc.edu

Amy Rose, RN

4126478587kennaj@upmc.edu

Locations

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Danielle L Bednarz, RN

4126231191bednarzdl@upmc.edu

Amy Rose, RN

4126478587kennaj@upmc.edu

Principal Investigator:

John M Kirkwood, MD

More Information

Sponsor

John Kirkwood

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

  • immune checkpoint inhibitor
  • immunological response

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by John Kirkwood on 2025-11-26.