Durvalumab With or Without Tremelimumab in Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity

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