There is no DNA seq uencing. 5.2 S AMPLES FOR GENETIC /GENOMIC ANALYSIS 5.2.1 Description of the scope of genetic/genomic analysis 5.2.1.1 RNA and T -cell Receptor Clonality Analysis of Blood and Tumor Tissue Where possible, RNA expression and T -cell receptor clonality analysis will be done on the peripheral blood as well as archived tumor tissue or optional biopsies to help further evaluate changes in immune response and RNA expression levels with treatment as well as to determine tumor and infiltrating lymphocyte characteristics which may be predictive of response to treatment. In addition, these analyses will also be used to gauge resistance mechanisms and additional targets for future therapy. C oded , linked samples may be analyzed for RNA expression levels using the Nanostring platform and T -cell receptor clonality using the ImmunoSeq platform (LTIB and NCI Frederick Genomic Core Facility). NCI Fredrick Genomic Core Facility: 58 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 Leidos Biomedical Research, Inc: Dr. Xiaolin Wu ATRF, Rm C3016 8560 Progress Drive Frederick, MD 21701 Ph. 301-846-7677 5.2.2 Description of how privacy and confidentiality of medical information/biological specimens will be maximized Confidentiality for genetic samples will be maintained as described (Section 5.3.1 and 5.3.2). 5.2.3 Management of Results Subjects will be contacted if a clinically actionable gene variant is discovered. Clinically actionable findings for the purpose of this study are defined as disorders appearing in the American College of Medical Genetics and Genomics recommendations for t he return of incidental findings that is current at the time of primary analysis. (A list of current guidelines is maintained on the CCR intranet: https://ccrod.cancer.gov/confluence/display/CCRCRO/Incidental+Findings+Lists ). Subjects will be contacted at this time with a request to provide a blood sample to be sent to a CLIA certified laboratory. If the research findings are verified in the CLIA certified lab, the subject will be offered the opportunity to come to NIH (at our expense) to have genetic education and counseling to explain this result. If the subject does not want to come to NIH, a referral to a local genetic healthcare provider will be provided (at their expense). This is the only time during the course of the study that incidental findings will be returned. No interr ogations regarding clinically actionable findings will be made after the primary analysis. 5.3 SAMPLE STORAGE , TRACKING AND DISPOSITION Samples will be ordered in CRIS and tracked through a Clinical Trial Data Management system. Should a CRIS screen not be available, the CRIS downtime procedures will be followed. Samples will not be sent outside the National Institutes for Health (NIH) appropriate approvals and/or agreements, if required . 5.3.1 Sample Management and Storage at Clinical Services Program – Leidos Biomedical Research, Inc. (CSP) Clinical Services Program - Leidos Biomedical Research , Inc. Attn: Theresa Burks 1050 Boyles Street Bldg. 496/Room 121 Frederick, MD 21702 On days samples are drawn, Jen Bangh at CSP (part of NCI Frederick Central Repositories) should be notified (phone: [301] 846- 5893; fax [301] 846-6222). She will arrange same- day courier delivery of the specimens.