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.
Study participants who meet inclusion criteria for the HCC 24-056 study will be eligible for this study.
3 additional tumor biopsies
3 additional blood draws
Participants must have biopsiable non-target disease amenable to at least 3 biopsies.
None
Study participants who met inclusion criteria for clinical trial NCT06246916
Cohort
Prospective
Fianlimab + Cemiplimab
DrugPatients treated with Fianlimab 1600 mg + Cemiplimab 350 mg under protocol NCT06246916
Relatlimab + Nivolumab
DrugPatients treated with Relatlimab 160 mg + Nivolumab 480 mg under protocol NCT06246916
Single-cell analysis of CD4+ T cells
Single-cell RNAseq analysis of CD8+ T cells and other immune cells in blood and tumor biopsies.
Immunological response of CD4+ T cells
Single-cell analysis of CD4+ T cell (frequency) and other immune cells in blood and tumor biopsies. Analysis of single-cell RNA-seq data to obtain gene module scores for each CD4+ T cell or myeloid cell in whole blood and tumor biopsies will be classified as binary: 1 (co-expressing cytotoxic and exhaustion gene modules) or 0 (no co-expression).
Multiplexed immunofluorescence
Degree of immune infiltration major immune subsets in the tumor microenvironment. The density of immune cells relative to the total number of cells in the tumor tissue will be calculated for each patient.
Multiplexed immunofluorescence
Frequencies of major immune subsets in the tumor microenvironment. The density of immune cells relative to the total number of cells in the tumor tissue will be calculated for each patient.
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John Kirkwood
Lead sponsor
University of Pittsburgh
Sponsor institution
Regeneron Pharmaceuticals
Collaborator
