The use of any stored specimens for research purposes is only allowed when the appropriate IRB approval has been obtained. In some cases, this approval has been obtained via the original protocol on which the participant was enrolled. 5.3.3 Protocol Completion/Sample Destruction All specimens obtained in the protocol are used as defined in the protocol. Any specimens that are remaining at the completion of the protocol will be stored in the conditions described above. The study will remain open so long as sample or data analysis continues. Samples from consenting subjects will be stored until they are no longer of scientific value or if a subject withdraws consent for their continued use, at which time they will be destroyed. The PI will report any loss or unanticipated destruction of samples per Section 7.2.1. If the patient withdraws consent the participant’s data will be excluded from future distributions, but data that have already been distributed for approved research use will not be able to be retrieved. Samples will also be reported as lost if they are lost in transit between facilities or misplaced by a researcher. Freezer problems, lost samples , or other problems associated with samples that meet expedited reporting requirements (see Section 7.2.1 ) will also be reported. 6 DATA COLLECTION AND EVALUATION 6.1 D ATA COLLECTION The PI will be responsible for overseeing entry of data into a 21 CFR Part 11- compliant data capture system provided by the NCI CCR and ensuring data accuracy, consistency and timeliness. The principal investigator, associate investigators/research nurses and/or a contracted data manager will assist with the data management efforts. Primary and final analyzed data will have identifiers so that research data can be attributed to an individual human subject participant. All adverse events , including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. Document AEs from the first study drug administration, Study Day 1 through 28 days a fter removal from study treatment or until off -study, whichever comes first . Adverse events that are serious need to be recorded through 28 days after the last intervention. Beyond 28 days after the last intervention and through long term follow up (survival of subject), only adverse events which are serious and related to the study intervention need to be recorded. An abnormal laboratory value will be recorded in the database as an AE only if the laboratory abnormality is characterized by any of the following: • Results in discontinuation from the study • Is associated with clinical signs or symptoms • Requires treatment or any other therapeutic intervention • Is associated with death or another serious adverse event, including hospitalization. • Is judged by the Investigator to be of significant clinical impact 61 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 • If any abnormal laboratory result is considered clinically significant, the investigator will provide details about the action taken with respect to the test drug and about the participant ’s outcome. End of study procedures: Data will be stored according to HHS , FDA regulations, and NIH Intramural Records Retention Schedule as applicable.