Consenting investigators (and participant/consent designee, when in person) will be located in a private area (e.g., clinic consult room). When consent is conducted remotely, the participant/consent designee will be informed of the private nature of the discussion and will be encouraged to relocate to a more private setting if needed. Consent will be documented with required signatures on the physical document (which includes the printout of an electronic document sent to participant) or as described below, with a manual (non- electronic) signature on the electronic document. When required, witness signature will be obtained similarly as described for the investigator and participant. Manual (n on-electro nic) signature on electronic document: When a manual signature on an electronic document is used for the documentation of consent at the NIH Clinical Center, this study will use the following to obtain the required signatures : • Adobe platform (which is not 21 CFR Part 11 compliant); or, • iMedConsent platform (which is 21 CFR Part 11 compliant) During the consent process, participants and investigators will view individual copies of the approved consent document on screens at their respective locations (if remote consent); the same screen may be used when at the same location, but is not required . Both the investigator and the subject will sign the document using a finger, stylus or mouse. Note: Refer to the CCR SOP PM -2, Obtaining and Documenting the Informed Consent Process for additional information (e.g., verification of participant identity when obtaining consent remotely) found at https://ccrod.cancer.gov/confluence/pages/viewpage.action?pageId=73203825. As there is an optional biopsy for research in this protocol, the participant will be asked to sign a separate consent at the time of the procedure. If the participant refuses the optional biopsy at that time, the refusal will be documented in the medical record and in the research record. 12.5.1 Consent Process for Participants Who Decline Other Treatment Options Participants who are eligible because they decline the treatment options described in the eligibility criteria (see Section 2.1) will have consent obtained in the presence of an independent consent monitor from the Bioethics department or Human Subjects Protection Unit (HSPU). 12.5.2 Consent Process for Adults Who Lack Capacity to Consent to Research Participation For participants addressed in Section 12.3, a n LAR will be identified consistent with Policy 403 and informed consent obtained from the LAR, as described in Section 12.5. 82 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 13 REGULATORY AND OPERATIONAL CONSIDERATIONS 13.1 STUDY DISCONTINUATION AND CLOSURE This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. Written notification, documenting the reason for study suspension or termination, will be provided by the suspending or terminating party to study participants, investigator, the Investigational New Drug (IND) and regulatory authorities.