pharmacist) will maintain an ongoing inventory of the investigational product supply according to standard site procedures. The investigational product will be dispensed at the direction of an investigator for administration to a study participant enrolled on the clinical trial. Disposal of expired or unused product will be returned to the manufacturer or disposed of according to standard site procedures based on agreement between the manufacturer and the site. 14.2.2 Toxicity In a phase 1, open-label 3+3 dose-escalation study of M7824 in 16 patients, 3 patients experienced grade 3 drug-related adverse events including skin infection secondary to grade 2 bullous pemphigoid, lipase increased, and colitis with associated anemia. There was no grade 4 – 5 treatment related adverse events. Please see table below for details: Treatment-related TEAE Leading to Permanent Treatment Discontinuation by System Organ Class and Preferred Term in ≥ 2 participants in the Pooled Analysis of Dose Expansion Cohorts (Source: Investigator Brochure v6) 78 Abbreviated Title: Neoadjuvant IO for HNSCC Version Date: August 31, 2022 As of the data cutoff of 24 August 2018, 7 deaths (1.1%) were reported as due to treatment- related TEAE, however an additional death (primary cause of intra-abdominal hemorrhage, assessed as treatment-related) started more than 30 days after the end of treatment and is therefore is not included in above count of treatment-related death. In Study EMR200647-001, 3 participants had a treatment-related death: 1 participant had dyspnea, hemolysis and thrombocytopenia, 1 participant had an intracranial tumor hemorrhage and 1 participant had pneumonia. In Study MS200647-0008, 4 participants had a treatment-related death: 2 participants died due to ILD, 1 participant due to sudden death and 1 participant due to septic shock.