Maintenance Immune Check-point Inhibitor Following Post-operative Chemo-radiation in Subjects With HPV-negative HNSCC
Status:
Withdrawn
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC