Evaluation of the Efficacy and Safety of Nivolumab Neoadjuvant Treatment of Patients With Locally Advanced Oral Squamous Cell Carcinoma

Inclusion Criteria: * The subject is willing to participate and has given their written and dated consent to participate in the trial. * Naïve to immunotherapy. ≥ 18 years of age at the time of signing the informed consent. * Primary histologically or cytologically confirmed Oral Squamous Cell Carcinoma classified according to the ICD-10 classification. * Stage T2-4 N0-3 M0. * The subject is planned for curative surgery as the primary treatment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Distant metastases (pathologically proven, radiologic or clinical evidence of distant metastatic disease). This includes all diseases below the clavicles, as well as disease metastatic to the bone, brain, or in the spinal canal. * Active malignancy requiring concurrent treatment or history of another primary malignancy. * History of radio- and/or chemotherapy. * Pregnant, breastfeeding, planning pregnancy or refusal to use highly effective contraception method during the treatment period and for at least 5 months after the last dose. * History of systemic treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. * Prior organ transplantation. * Treatment with a live (attenuated) vaccine within 4 weeks before Screening visit. * Initiation of allergen immunotherapy within 3 months prior Screening visit or a plan to begin therapy …