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UNKNOWNPHASE1

Durvalumab in Combination With Docetaxel, Cisplatin and 5-FU for Locally Advanced Head and Neck Squamous Cell Carcinoma

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

NCT02997332•Gustave Roussy, Cancer Campus, Grand Paris

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years and \< 75 years
•2. 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.
•3. Absence of metastases determined by CT scan or PET scan
•4. ECOG performance status \< 1
•5. Subjects must have at least 1 measurable lesion per RECIST v1.1 guidelines
•6. Adequate organ and marrow function as defined below:
•* Hemoglobin ≥ 9,0 g/dL
•* Absolute neutrophil count (ANC) ≥ 1,500/mm3
•* Platelet count ≥ 100,000/mm3
•* AST and ALT ≤ 2.5 × institutional upper limit of normal (ULN);
+9 more criteria

Exclusion Criteria

•1. Primary site of head and neck carcinoma in nasopharynx, or skin
•2. 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.
•3. 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.
•4. No relevant toxicities (\>grade 1 CTCAE) due to prior medical treatment at time of study entry
•5. Participation in another clinical study with an investigational product during the last 30 days
•6. Patient with dihydropyrimidine dehydrogenase (DPD) deficiency
•7. 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
•8. Patient with active cardiac disease or with a history of cardiac dysfunction any of the following:
•* Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO),
•* Mean QT interval corrected for heart rate (QTc) ≥ 470 msec calculated from 3 electrocardiograms (ECGs) performed at screening, using Fredericia's correction (QTcF),
+20 more criteria

Locations (1)

Gustave Roussy

Villejuif, Val De Marne, France

Key Dates

Start Date

March 30, 2017

Primary Completion Date

December 1, 2019

Completion Date

December 1, 2019

Last Updated

January 3, 2019

Enrollment

ESTIMATED participants

Conditions

Head and Neck Cancers

Interventions

Durvalumab

DRUG

Docetaxel

DRUG

Cisplatin

DRUG

5 Fluorouracil

DRUG

Contacts

Caroline EVEN, MD

CONTACT

0142116537 caroline.even@gustaveroussy.fr

Matthieu TEXIER

CONTACT

0142116309 matthieu.texier@gustaveroussy.fr

Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer

NCT05526924

Head and Neck CancerHead and Neck Squamous Cell Carcinoma+3 more

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RECRUITINGPHASE1

Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer

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Head and Neck Cancers- Squamous CellHead and Neck Cancer+11 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Durvalumab in Combination With Docetaxel, Cisplatin and 5-FU for Locally Advanced Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer

Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer

StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients

Prospective Evaluation of Frailty in Patients With Head and Neck Tumors Before Curative Intended Therapy

Collection Of Tissue, Blood, and Other Specimens From Patients With Head and Neck Tumors To Study the Causes, Diagnosis, Prevention and Treatment of Cancers

Relaxation Therapy for Pain, Fatigue and Vital Signs in Post-operation With Head and Neck Cancer