Status:
RECRUITING
Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma
Lead Sponsor:
John Kirkwood
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Locally Advanced Melanoma
Eligibility:
All Genders
18+ years
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 ...
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 t...
Eligibility Criteria
Inclusion
- Study participants who meet inclusion criteria for the HCC 24-056 study will be eligible for this study.
- Participants must be willing to provide additional samples beyond what is required of them in HCC 24-056. These include:
- 3 additional tumor biopsies
- 3 additional blood draws
- Participants must have biopsiable non-target disease amenable to at least 3 biopsies.
- Must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion
- 1\. Study participants who do not qualify to enroll in the HCC 24-056 study will not be eligible for this study.
- \-
Key Trial Info
Start Date :
November 19 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2031
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07223411
Start Date
November 19 2025
End Date
November 1 2031
Last Update
November 26 2025
Active Locations (1)
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1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232