Bleeding AEs. 8.2 ASSESSMENT OF S AFETY EVENTS AE information collected will include event description, date of onset, assessment of severity and relationship to study product and alternate etiology (if not related to study product), date of resolution of the event, seriousness and outcome. The assessment of severity and relationship to the study product will be done only by those with the training and authority to make a diagnosis and listed on the Form FDA 1572 as the site principal investigator or sub-investigator. AEs occurring during the collection and reporting period will be documented appropriately regardless of relationship. AEs will be followed through resolution. SAEs will be: Assessed for severity and relationship to study product and alternate etiology (if not related to study product) by a licensed study physician listed on the Form FDA 1572 as the site principal investigator or sub-investigator. Recorded on the appropriate SAE report form, the medical record and captured in the clinical database. 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 from the time of first investigational product administration must be reported to the sponsor with the exception of any listed in Section 8.4. 68 Abbreviated Title: Combo Immunotx in HPV OPSCC Version Date: 04.25.2023 8.3 REPORTING OF SERIOUS A DVERSE EVENTS Any AE that meets a protocol-defined serious criterion 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. Hospitalizations related to adverse events attributed to disease progression will not need to be reported expeditiously as these events will be captured as a separate study endpoint. All SAE reporting must include the elements described in Section 8.1.6. 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. In addition, the Sponsor is responsible for reporting adverse events to the FDA in compliance with 21 CFR 312.32. The Sponsor must report all serious, unexpected and related or possibly related adverse events within 15 calendar days after the study team receives knowledge of the event, and all life-threatening and/or fatal unexpected events related or possibly related to the use of the investigational agent within 7 calendar days after the study team receives knowledge of the event. 8.4 WAIVER OF EXPEDITED REPORTING TO CCR As death/hospitalization due to disease progression is/are part of the study objectives, and captured as an endpoint in this study, they will not be reported in expedited manner to the sponsor. However, if there is evidence suggesting a causal relationship between the study drug and the event, report the event in an expedited manner according to Section 8.3 As M7824 is known to result in immune related toxicities as well as an increased risk of mucosal bleeding as documented in the informed consent and protocol and shared with the FDA, only those SAEs that are unexpected will be reported to the Sponsor in an expedited manner. The PI will submit a summary table of all grade 3-5 events, whether or not considered related to the product, every 6 months. The report shall include the number of participants treated in the timeframe, the number of events per AE term per grade which occurred in the 6-month timeframe and in total since the start of the study, attribution, and type/category of serious. Reports will be submitted to the Center for Cancer Research (CCR) at OSROSafety@mail.nih.gov. The Sponsor might request case summaries for those events if, upon review, the Sponsor determines that an aggregate safety report is required (21CFR312.32(c)(1)(iv)). 8.5 SAFETY R EPORTING 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 69 Abbreviated Title: Combo Immunotx in HPV OPSCC Version Date: 04.25.2023 can be found here: https://ccrod.cancer.gov/confluence/display/CCRCRO/Forms+and+Instructions 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 no later than 24 hours of when the Investigator becomes aware of it. The Investigator should notify the Sponsor no later than 24 hours of when the outcome of the Pregnancy becomes known.