If hypersensitivity reaction occurs, the subject should be treated according to the best available medical practice. 3.4.5 Guidelines for Management of Immune- Mediated Adverse Reactions (In addition to the below guidelines, investigators may also use NCCN, ASCO, SITC or FDA guidelines for Immune Related Adverse Events) 43 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 Gastrointestinal irAEs Severity of Diarrhea/Colitis (NCI -CTCAE v 5) Initial Management Follow -up Management Grade 1 Diarrhea: < 4 stools/day over Baseline Colitis: asymptomatic Consider continuing M7824 Symptomatic treatment (e.g. loperamide) Consider close monitoring for worsening symptoms Consider educating subject to report worsening immediately If worsens: Treat as Grade 2, 3 or 4. Grade 2 Diarrhea: 4 to 6 stools per day over Baseline; IV fluids indicated < 24 hours; not interfering with ADL Colitis: abdominal pain; blood in stool Consider withholding M7824 Symptomatic treatment If improves to Grade ≤ 1: Consider resuming therapy If persists > 7 days or recurs: Consider treating as Grade 3 or 4. Grade 3 to 4 Diarrhea (Grade 3): ≥ 7 stools per day over Baseline; incontinence; IV fluids ≥ 24 h; interfering with ADL Colitis (Grade 3): severe abdominal pain, medical intervention indicated, peritoneal signs Grade 4: life -threatening, perforation Consider withholding or permanently discontinuing M7824 for Grade 3 events based upon if the clinical condition can be safely managed. For grade 4 events permanently discontinue treatment. Consider 1.0 to 2.0 mg/kg/day prednisone IV or equivalent Consider adding prophylactic antibiotics for opportunistic infections Consider lower endoscopy If improves: Consider continuing steroids until Grade ≤ 1, then tapering over at least 1 month; consider resuming therapy following steroids taper (for initial Grade 3). If worsens, persists > 7 days, or recurs after improvement: Consider adding infliximab 5mg/kg (if no contraindication). Note: infliximab should not be used in cases of perforation or sepsis. 44 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 Dermatological irAEs Grade of Rash (NCI -CTCAE v5) Initial Management Follow -up Management Grade 1 to 2 Covering ≤ 30% body surface area Consider continuing M7824 Consider symptomatic therapy (for example, antihistamines, topical steroids) If persists > 1 to 2 weeks or recurs: Consider withholding M7824 therapy Consider skin biopsy Consider 0.5- 1.0 mg/kg/day prednisone or equivalent. Once improving, consider tapering steroids over at least 1 month, consider prophylactic antibiotics for opportunistic infections, and consider resuming M7824 therapy following steroids taper. If worsens: Consider treating as Grade 3 to 4. Grade 3 to 4 Grade 3: Covering > 30% body surface area; Grade 4: Life threatening consequences Consider withholding or permanently discontinuing M7824 for Grade 3 events based upon if the clinical condition can be safely managed. For grade 4 events permanently discontinue treatment. Consider skin biopsy Consider dermatology consult Consider 1.0 to 2.0 mg/kg/day prednisone or equivalent Consider adding prophylactic antibiotics for opportunistic infections If improves to Grade ≤ 1: Consider tapering steroids over at least 1 month; consider resuming therapy following steroids taper (for initial Grade 3). Pulmonary irAEs Grade of Pneumonitis (NCI -CTCAE v5) Initial Management Follow -up Management Grade 1 Radiographic changes only Consider withholding M7824 Consider Pulmonary and Infectious Disease consults Consider re -assessing at least every 3 weeks If worsens: Consider treating as Grade 2 or Grade 3 to 4. Grade 2 Mild to moderate new symptoms Consider withholding M7824 If improves: 45 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 Consider pulmonary and Infectious Disease consults Consider monitoring symptoms daily; consider hospitalization Consider 1.0 to 2.0 mg/kg/day prednisone or equivalent Consider adding prophylactic antibiotics for opportunistic infections Consider bronchoscopy, lung biopsy When symptoms return to Grade ≤ 1, consider tapering steroids over at least 1 month, and then consider resuming therapy following steroids taper If not improving after 2 weeks or worsening: Consider treating as Grade 3 to 4. Grade 3 to 4 Grade 3: Severe new symptoms; New/worsening hypoxia; Grade 4: Life -threatening Consider withholding or permanently discontinuing M7824 for Grade 3 events based upon if the clinical condition can be safely managed. For grade 4 events permanently discontinue treatment.