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

Squamous Cell Head and Neck Carcinoma Clinical Trial

Official title: 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Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Carcinoma
• Squamous Cell Head and Neck Carcinoma

• NCT number: NCT03673735
• Study type: Interventional
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 2021
• Completion date: December 2027