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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
John Kirkwood
Study ID
NCT07223411
Status
Recruiting

Conditions

  • Locally Advanced Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fianlimab + Cemiplimab — DRUG
    Patients treated with Fianlimab 1600 mg + Cemiplimab 350 mg under protocol NCT06246916
  • Relatlimab + Nivolumab — DRUG
    Patients treated with Relatlimab 160 mg + Nivolumab 480 mg under protocol NCT06246916

Study Details

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.

Key Dates

Start date
Nov 19, 2025
Status verified
Nov 2025
Primary completion
Nov 1, 2028
Completion
Nov 1, 2031

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: fianlimab + cemiplimab
    Patients who received fianlimab + cemiplimab treatment under protocol NCT06246916.
  • Arm: Opdualag (relatlimab + nivolumab)
    Patients who received Opdualag (relatlimab + nivolumab) under protocol NCT06246916.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Danielle L Bednarz, RN
4126231191
Amy Rose, RN
4126478587
John M Kirkwood, MD (PRINCIPAL_INVESTIGATOR)

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