• Systemic anticancer treatment. 55 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 5 CORRELATIVE STUDIES FOR RESEARCH/PHARMACOKINETIC STUDIES 5.1 BIOSPECIMEN COLLECTION Test/assay Volume (approx.) per Timepoint Type of tubea Collection point Location of specimen analysis* Standard and 123 immune cell subsets by FACS 60-80 mL blood for PBMCs Sodium heparin (green top) tubes See study calendar 3.5 LTIB Functional Analysis of immune cell subsets by FACS LTIB Antigen Specific Immune Response by cytokine staining assay LTIB T cell clonality by immunseq platform LTIB and NCI Frederick Genomic Core Facility RNA expression level of 770 genes LTIB and NCI Frederick Genomic Core Facility Soluble Factors (to include sCD27 and sCD40 ligand) by ELISA 16 mL blood for serum SST LTIB Immune Markers by IHC Tumor samples N/A GMB TIME Lab RNA expression level of 770 genes Tumor samples N/A LTIB and NCI Frederick Genomic Core Facility 56 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 Test/assay Volume (approx.) per Timepoint Type of tubea Collection point Location of specimen analysis* HPV status by PCR of DNA Tumor samples N/A Dr. Hinrich’s Lab Circulating tumor DNA (ctDNA) by PCR system Plasma EDTA (lavender top) LTIB and NIH Core Facility T cell clonality by immun oseq platform Tumor samples N/A LTIB and NCI Frederick Genomic Core Facility a Please note that tubes and media may be substituted based on availability with the permission of the PI or laboratory investigator.