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About
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.
Enrollment
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Inclusion criteria
Age ≥ 18 years and < 75 years
Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, amenable to induction chemotherapy according to the investigator. Patients with a diagnosis of SCCHN of occult primary could be enrolled.
Absence of metastases determined by CT scan or PET scan
ECOG performance status < 1
Subjects must have at least 1 measurable lesion per RECIST v1.1 guidelines
Adequate organ and marrow function as defined below:
Negative serology for hepatitis B and C
Availability of a recent formalin-fixed tumour tissue (< 3 months) to determine HPV status and for translational research (IHC)
a. All patients without available tumour tissue will undergo a panendoscopy with biopsies.
Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior to the administration of the first study treatment and/or urine pregnancy 48 hours prior to the administration of the first study treatment. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 6 months after last dose of study drugs.
Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Patients must be affiliated to a Social Security System or beneficiary of the same
Patient information and written informed consent form signed
Exclusion criteria
Primary site of head and neck carcinoma in nasopharynx, or skin
Patients receiving other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) or other investigational agent within 30 days prior to the first dose of study drug and while on study treatment.
Patients receiving other anti-cancer non-drug therapies: radiation, or tumor embolization within 30 days prior to the first dose of study drug and while on study treatment.
No relevant toxicities (>grade 1 CTCAE) due to prior medical treatment at time of study entry
Participation in another clinical study with an investigational product during the last 30 days
Patient with dihydropyrimidine dehydrogenase (DPD) deficiency
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, active bleeding diatheses. Or patient under guardianship or deprived of his liberty by a judicial or administrative decision or any condition (e.g psychiatric illness/social/familial/geographical condition) that would limit compliance with study requirement or compromise the ability of the subject to give written informed consent
Patient with active cardiac disease or with a history of cardiac dysfunction any of the following:
Other invasive malignancy within 5 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured
Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid
Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab
Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
Active or prior documented inflammatory bowel disease (eg, Crohn's disease,ulcerative colitis)
History of primary immunodeficiency
History of allogenic organ transplant that requires use of immunosuppressives
Known history of previous clinical diagnosis of tuberculosis
Patients with a known HIV status
Pregnant or breast-feeding women
Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
History of hypersensitivity to durvalumab or any excipients or to other humanized mAbs
Any contraindication to the use of cisplatin, docetaxel and 5FU and/or known history of hypersensitivity to any of those drugs
Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Primary purpose
Allocation
Interventional model
Masking
36 participants in 1 patient group
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Central trial contact
Matthieu TEXIER; Caroline EVEN, MD
Data sourced from clinicaltrials.gov
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