Clinical Research Directory

Inclusion Criteria: * Resectable locally advanced oral cavity SCC stage IV * Newly diagnosed disease * Age ≥18 years at the time of screening * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment * No active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix * No prior chemotherapy, radiotherapy or targeted therapy including PD-1, PD-L1 or CTLA-4 antibodies for SCCHN, including durvalumab or tremelimumab * Availability of blood samples for Translational research * Negative pregnancy test * Normal organ function * No participation in another interventional clinical trial in the preceding 30 days prior to randomization * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations * Body weight \> 30 kg Exclusion Criteria: * Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck * Receipt of other treatments for cancer within 30 days prior to first dose of study treatment * Previous radiotherapy in the head and neck region * Previous systemic therapy for SCCHN * Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned IP. * History of allogeneic organ transplantation * Active or prior documented autoimmune or inflammatory * Uncontrolled intercurrent illness * Active relevant second malignancy during the last five years * Mean QT interval corrected for heart rate ≥470 ms * History of active primary immunodeficiency * Active infection Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP. * Female patients of childbearing potential who are pregnant or breast- * Known allergy or hypersensitivity to IP or any IP excipient * Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of patient safety or study results * Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP * Metastatic disease