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

NCT ID: NCT07223411

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-01

Study Completion Date

2031-11-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Locally Advanced Melanoma

Keywords

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immune checkpoint inhibitor immunological response

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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fianlimab + cemiplimab

Patients who received fianlimab + cemiplimab treatment under protocol NCT06246916.

Fianlimab + Cemiplimab

Intervention Type DRUG

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

Opdualag (relatlimab + nivolumab)

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

Relatlimab + Nivolumab

Intervention Type DRUG

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

Interventions

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Fianlimab + Cemiplimab

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

Intervention Type DRUG

Relatlimab + Nivolumab

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

Intervention Type DRUG

Other Intervention Names

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Opdualag

Eligibility Criteria

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Inclusion Criteria

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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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

John Kirkwood

OTHER

Sponsor Role lead

Responsible Party

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John Kirkwood

Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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John M Kirkwood, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Hillman Cancer Center

Locations

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UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Danielle L Bednarz, RN

Role: CONTACT

Phone: 4126231191

Email: [email protected]

Amy Rose, RN

Role: CONTACT

Phone: 4126478587

Email: [email protected]

Facility Contacts

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Danielle L Bednarz, RN

Role: primary

Amy Rose, RN

Role: backup

Other Identifiers

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HCC 25-009

Identifier Type: -

Identifier Source: org_study_id