NCT03673735

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

A Randomized Phase III Study on Maintenance Durvalumab vs Placebo Following Post-operative Concomitant Chemoradiation in Subjects With HPV-negative Squamous Cell Head and Neck Carcinoma (HNSCC) With High Risk of Recurrence

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Squamous Cell Head and Neck Carcinoma

Interventions

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

Timeline

• Start date: 2021-06-01
• Primary completion: 2026-07-01
• Completion: 2027-12-01
• First posted: 2018-09-17
• Last updated: 2021-05-10