John Kirkwood
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.
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 + niv…
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-…
Patients treated with Fianlimab 1600 mg + Cemiplimab 350 mg under protocol NCT06246916
Patients treated with Relatlimab 160 mg + Nivolumab 480 mg under protocol NCT06246916
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