Head and Neck Cancers Clinical Trial
Official title:
Phase I Trial Evaluating the Safety of Durvalumab in Combination With Docetaxel, Cisplatin and 5-FU in Induction for Locally Advanced Head and Neck Squamous Cell Carcinoma
The prognosis of patients with locally advanced SCCHN is poor. Results of recent randomized
trials evaluating induction chemotherapy by docetaxel, cisplatin, 5 fluorouracil are
conflicting, and benefit on overall survival is uncertain. Improve efficacy of induction
chemotherapy is important without increase toxicities. Durvalumab is a promising agent in
SSCHN. The safety of combination of docetaxel, cisplatin, 5 fluorouracil with durvalumab is
unknown.
The aim of the study is to evaluate the feasibility and the safety of the association of DCF
(standard regimen for induction in SSCCHN) and durvalumab. The safety profile of DCF and
durvalumab are different, so the expected toxicities should not be additive. The addition of
durvalumab to DCF could improve the efficacy of induction chemotherapy and the prognostic of
patients with SSCCHN.
Concerning the translational research, the aim will be to explore the relationships between
immune capacity, specificity, activation state and clinical outcome to help elucidate the
determinants of response to immunotherapy.
n/a
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