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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT02997332
Phase
PHASE1
Status
Terminated

Conditions

  • Head and Neck Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab will be administered every 3 weeks for 3 injections at week 1, 4, 7. Dose levels: the durvalumab first dose level is 1120 mg Q3W, and the dose level -1 is 750 mg Q3W.
  • Docetaxel — DRUG
    Docetaxel 75mg/m² on D2, IV in 1 hour
  • Cisplatin — DRUG
    Cisplatin 75mg/m² on D2, IV in 3 hours
  • 5 Fluorouracil — DRUG
    5 Fluorouracil 750mg/m²/day on D2, D3, D4, D5, D6 IV in 24 hours

Study Details

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.

Key Dates

Start date
Mar 30, 2017
Status verified
Mar 2026
Primary completion
Mar 17, 2020
Completion
Dec 1, 2022

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with squamous cell carcinoma of the oral cavity,
    The aim is to evaluate safety, PK and pharmacodynamics of durvalumab in adult patients with squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx previously untreated, with indication of induction chemotherapy.

Primary Outcome Measure

Recommended Phase 2 dose (RP2D) [ Time Frame: Up to 10 weeks ]

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