Neoadjuvant Sintilimab Combined With Reduction of Cycles of Chemotherapy in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma (OOC-002)

Cannot have received: immune-mediated therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2)

Exception: excluding therapeutic anticancer vaccines

no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein 4 (CTLA-4), anti-programmed cell death 1, anti-programmed cell death 1 ligand 1 (PD-L1), or anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines

Cannot have received: investigational agent

currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment

Cannot have received: systemic corticosteroids or other immunosuppressive medications

Exception: inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease

condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day -5

Cannot have received: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways

received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways