In general, mild and moderate mucosal bleedings resolve without discontinuation of treatment. These events may include, but are not limited to the following: oEpistaxis oHemoptysis oGingival bleeding oHematuria Non-tumor Bleeding Grading Management Grade 2 If resolves to Grade ≤ 1 by the day before the next infusion, study intervention may be continued If not resolved to Grade ≤ 1 by the day before the next infusion, but is manageable and /or not clinically relevant, assessment if clinically reasonable to administer the following infusion will be per PI discretion. Grade 3 Permanently discontinue treatment unless an alternative explanation can be identified (such as concomitant use of antithrombotic agents, traumatic events, etc.) In case of alternative explanations, hold study treatment until the event recovers to Grade ≤ 1 Grade 4 Treatment must be permanently discontinued if no alternative explanation is identified. Tumor Bleeding Grade ≥ 2 Study treatment must be held till the event recovers to Grade ≤ 1 38 Abbreviated Title: Combo Immunotx in HPV OPSCC Version Date: 04.25.2023 Permanently discontinue treatment if the Investigator considers the participant to be at risk for additional severe bleeding. Table 7 Impaired Wound Healing Impaired wound healing is considered important potential risk for M7824 Elective surgery on study will be allowed per PI discretion It is recommended to hold study intervention for approximately 4 weeks post major surgery for observation. Post-operative wound healing should be closely monitored 39 Abbreviated Title: Combo Immunotx in HPV OPSCC Version Date: 04.25.2023 3.4 STUDY CALENDAR 3.4.1 Study Calendar for Phase I Procedure Screening1Baseline / Day 12Odd numbered Weeks (W1, W3, W5, W7 onwards)3EOT4Safety follow up5Long Term follow up6 Treatment3 X X NIH Advance Directives Form 7X Medical History 17X Height X Physical exam, weight, vital signs, ECOG 16 X X X X X Skin assessment 18X X X X HIV, HCV, HepB X EKG X X X CBC with differential X X X X X Biochemical profile 8X X X X X Tumor Markers 9X X X CD4 10X TSH with reflex Free T3 and T4, lipase, amylase, CRPX X11 Urinalysis X Urine or serum pregnancy testing in women of childbearing potential X X X PT, INR, PTT X Tumor evaluation (CT Scan / MRI) X X X12X Brain CT/MRI 13X Concomitant Medications X X X X Adverse events X X X X Biopsy for immune analysis 14X X Research Blood 15X X X Telephone Follow Up X X 40 Abbreviated Title: Combo Immunotx in HPV OPSCC Version Date: 04.25.2023 1. Screening evaluations performed within 28 days prior to the first drug administration, unless specified in Section 2.2.