NCT07223411

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

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: John Kirkwood · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Locally Advanced Melanoma

Interventions

Type	Name	Description
DRUG	Fianlimab + Cemiplimab	Patients treated with Fianlimab 1600 mg + Cemiplimab 350 mg under protocol NCT06246916
DRUG	Relatlimab + Nivolumab	Patients treated with Relatlimab 160 mg + Nivolumab 480 mg under protocol NCT06246916

Timeline

• Start date: 2025-11-19
• Primary completion: 2028-11-01
• Completion: 2031-11-01
• First posted: 2025-10-31
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study