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

Durvalumab has shown activity in squamous cell carcinoma of the head and neck. Locallyadvanced resectable cancers of this type represent a challenge, as the majority of thesepatients still die from this disease in spite of surgery, radio‐ and chemotherapy.Checkpoint inhibitors have recently proven to prolong life in recurrent/metastatic SCCHN,and several new molecules are currently tested in clinical trials in this indication,including PD‐1, PD‐L1, and CTLA‐4 antibodies, either as single agent or in combination.These compounds might represent a valuable treatment for SCCHN patients in the adjuvantsetting, given the favorable toxicity profile. Combination of Durvalumab (PD‐L1inhibition) and Tremelimumab (CTLA‐4 inhibition) is currently tested inrecurrent/metastatic head and neck cancer, and compared to Durvalumab as single agent,and to standard of care chemotherapy.In this study both options, i.e. durvalumab as a single agent or Durvalumab incombination with Tremelimumab, will be tested in a randomized fashion. Randomizationwould be used to reduce selection bias, in a non‐comparative study. Newly diagnosedpatients with SCCHN of the oral cavity, will be treated with a single dose of Durvalumabwith or without Tremelimumab two weeks before scheduled surgery.When patients are first diagnosed with a resectable oral SCC, a biopsy is taken toconfirm the diagnosis, and surgery is planned. This standard practice thus involvessequential tissue harvesting, both at the time of biopsy as well as the final resectionspecimen, making it possible to observe hallmarks of immune response when patients aretreated once with Durvalumab with or without Tremelimumab after confirmation of thediagnosis on biopsy, but before surgery.