• Followed through resolution by a licensed study physician listed on the Form FDA 1572 as the site principal investigator or sub-investigator. For timeframe of recording adverse events, please refer to Section 6.1. All serious adverse events recorded must be reported to the sponsor. All serious adverse events recorded from the time of first investigational product administration must be reported to the sponsor with the exception of any listed in section 8.4. 8.3 R EPORTING OF SERIOUS ADVERSE EVENTS Any AE that meets protocol -defined serious criteria or meets the definition of Adverse Event of Special Interest that require expedited reporting must be submitted immediately (within 24 hours of awareness) to OSRO Safety using the CCR SAE report form. Any exceptions to the expedited reporting requirements are found in section 8.4. All SAE reporting must include the elements described in Section 8.2. SAE reports will be submitted to the Center for Cancer Research (CCR) at: OSROSafety@mail.nih.gov and to the CCR PI and study coordinator. CCR SAE report form and instructions can be found at: https://ccrod.cancer.gov/confluence/display/CCRCRO/Forms+and+Instructions Following the assessment of the SAE by OSRO, other supporting documentation of the event may be requested by the OSRO Safety and should be provided as soon as possible. 8.4 WAIVER OF EXPEDITED REPORTING TO CCR As overall survival, which includes death due to disease progression and hospitalization due to disease progression are part of the study objectives, and captured as an endpoint in this study, death/hospitalization due to disease progression will not be reported in expedited manner to the sponsor. However, if there is evidence suggesting a c ausal relationship between the study drug and the event, report the event in an expedited manner according to S ection 8.3. 8.5 SAFETY REPORTING CRITERIA TO THE PHARMACEUTICAL COLLABORATORS Reporting will be per the collaborative agreement. 8.6 REPORTING PREGNANCY All required pregnancy reports/follow -up to OSRO will be submitted to : OSROSafety@mail.nih.gov and to the CCR PI and study coordinator. Forms and instructions can be found here: https://ccrod.cancer.gov/confluence/display/CCRCRO/Forms+and+Instructions 73 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 8.6.1 Maternal exposure If a participant becomes pregnant during the course of the study, the study treatment should be discontinued immediately , and the pregnancy reported to the Sponsor. The potential risk of exposure of the fetus to the investigational agent(s) or chemotherapy agents (s) should be documented in box B5 of the M edWatch form “Describe Event or Problem”.