Consider initiating corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) followed by corticosteroids taper during at least 1 month. • Consider adding prophylactic antibiotics for opportunistic infections. Other irAEs (not described above) Grade of other irAEs (NCI -CTCAE v 5) Initial Management Follow -up Management Grade 2 or Grade 3 clinical signs or symptoms suggestive of a potential irAE Consider w ithholding M7824 pending clinical investigation If irAE is ruled out, consider managing as appropriate according to the diagnosis and consider re -starting therapy If irAE is confirmed, consider treating as Grade 2 or 3 irAE. Grade 2 irAE or first occurrence of Grade 3 irAE Consider w ithholding M7824 based upon if the clinical condition can be safely managed. Consider 1.0 to 2.0 mg/kg/day prednisone or equivalent Consider a dding prophylactic antibiotics for opportunistic infections Specialty consult as appropriate If improves to Grade ≤ 1: Consider t apering steroids over at least 1 month and resuming therapy following steroids taper. Recurrence of same Grade 3 irAEs Consider permanently discontinuing M7824 based upon if the clinical condition can be safely managed ; Consider 1.0 to 2.0 mg/kg/day prednisone or equivalent Consider adding prophylactic antibiotics for opportunistic infections Specialty consult as appropriate If improves to Grade ≤ 1: Consider t apering steroids over at least 1 month. 50 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 Grade 4 Permanently discontinue M7824 Consider to 2.0 mg/kg/day prednisone or equivalent and/or other immunosuppressant as needed Consider a dding prophylactic antibiotics for opportunistic infections Consider s pecialty consult as appropriate If improves to Grade ≤ 1: Consider t apering steroids over at least 1 month Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks for reasons other than hormonal replacement for adrenal insufficiency Persistent Grade 2 or 3 irAE lasting 12 weeks or longer Consider permanently discontinuing M7824 Consider s pecialty consult as appropriate Abbreviations: ACTH=adrenocorticotropic hormone; ADL=activities of daily living; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BNP=B -type natriuretic peptide; CK-MB=creatine kinase MB; CT= computed tomography; FSH=follicle- stimulating hormone; GH=growth hormone; IGF-1=insulin- like growth factor 1; irAE=immune related adverse event; IV=intravenous; LH=luteinizing hormone; MRI=magnetic resonance imaging; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; PRL=pr olactin;T4=thyroxine; TSH=thyroid stimulating hormone; ULN=upper limit of normal 51 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 3.5 STUDY CALENDAR Procedure Screening1 Baseline / Week 12 Week (2N+1)3 EOT4 Safety follow up5 Long Term follow up6 Treatment3 X X NIH Advance Directives Form7 X Medical History X Height X Physical exam, weight, vital signs, ECOG X X X X X HIV, HCV, HepB X EKG X X X CBC with differential X X X X X Biochemical profile8 X X X X X Tumor Markers9 X X X CD4 10 X HLA typing X ACTH, TSH, reflex Free T4, lipase, amylase, CRP X X11 Urinalysis X Urine or serum pregnancy testing in women of childbearing potential X X X PT, INR, aPTT X Tumor evaluation (CT Scan)12 X X X Brain CT 13 X Concomitant Medications X X X X Adverse events X X X X Optional biopsy for immune analysis 14 X X Research Blood 15 X X X Telephone Follow Up X X 52 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 1. Screening evaluations performed within 28 days prior to the first drug administration, unless specified in Section 2.2.