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

John Kirkwood

Status: Enrolling

Conditions: Locally Advanced Melanoma

Treatments: Drug: Relatlimab + Nivolumab; Drug: Fianlimab + Cemiplimab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07223411

HCC 25-009

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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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Trial design

20 participants in 2 patient groups

fianlimab + cemiplimab

Description:

Patients who received fianlimab + cemiplimab treatment under protocol NCT06246916.

Treatment:

Drug: Fianlimab + Cemiplimab

Opdualag (relatlimab + nivolumab)

Description:

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

Treatment:

Drug: Relatlimab + Nivolumab