Maintenance Immune Check-point Inhibitor Following Post-operative Chemo-radiation in Subjects With HPV-negative HNSCC

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT03673735
Phase
PHASE3
Status
Withdrawn

Conditions

  • Squamous Cell Head and Neck Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab (one dose) before CRT and for 6 months Q4W after CRT
  • radiotherapy — RADIATION
    radiotherapy is administered in 33 fractions over 6.5 weeks fro a total of 66 Gy
  • Placebo — DRUG
    placebo (one dose) before CRT and for 6 months Q4W after CRT
  • Cisplatin — DRUG
    Cisplatin (100mg/m2) is administered at day 1, 22, 43 of radiotherapy

Study Details

This is a phase III randomized blind placebo-controlled study, designed to show the superiority of the experimental arm to the control arm. After surgery and checking eligibility criteria, patients will be randomized between the control and the experimental arms with a 1:1 ratio (randomization will take place at a maximum 4 weeks after surgery): * Experimental Arm: Durvalumab (one dose) before chemoradiotherapy (CRT) and for 6 months every 4 weeks (Q4W) after CRT * Control Arm: placebo (one dose) before CRT and for 6 months Q4W after CRT Radiotherapy planning will take place after randomization. The primary endpoint of this trial is disease free survival (DFS), measured from the date of randomization to the date of first occurrence of any loco-regional recurrence, metastatic progression, or death due to any cause.

Key Dates

Start date
Jun 30, 2021
Status verified
May 2021
Primary completion
Jul 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
    Patients will receive 1 infusion of 1500 mg Durvalumab within 1 week prior to concurrent chemoradiotherapy. Chemoradiation should start within 6 weeks after surgery and within 1 week maximum of the induction phase. Radiation will consist of 33 fractions over 6 weeks for a total of 66 Gy. Chemotherapy will consist of cisplatin 100 mg/m2 given on days 1, 22 and 43 of radiotherapy. Maintenance phase with Durvalumab will begin within 1 to 28 days maximum after the end of radiotherapy and will consist of 6 doses administered every 4 weeks.
  • Placebo Comparator: Control arm
    Patients will receive 1 infusion of placebo within 1 week prior to concurrent chemoradiotherapy. Chemoradiation should start within 6 weeks after surgery and within 1 week maximum of the induction phase. Radiation will consist of 33 fractions over 6 weeks for a total of 66 Gy. Chemotherapy will consist of cisplatin 100 mg/m2 given on days 1, 22 and 43 of radiotherapy. Maintenance phase with placebo will begin within 1 to 28 days maximum after the end of radiotherapy and will consist of 6 doses administered every 4 weeks.

Primary Outcome Measure

disease free survival [ Time Frame: 3 years and half after last pateint in ]

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