Overview

Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.

Status:
Active, not recruiting

Trial end date:
2022-03-01

Target enrollment:

Participant gender:

Summary

This study is a phase II, multicenter, open-label study that has been designed to evaluate the efficacy and the safety of definitive Radiotherapy (RT) (70 Gy) delivered in combination with the anti-PD-L1 Durvalumab immunotherapy in patients with Human Papilloma Virus (HPV)-related oropharyngeal squamous cell carcinoma. In this phase II trial, patients will be assigned in one of the two treatment arms: - Arm A (standard arm): Chemoradiotherapy arm - Arm B (Experimental arm): Immunotherapy + Radiotherapy arm Total duration of treatment will be 6 months (at maximum in the experimental arm). Patients will be followed for a maximum of 2 years following the date of randomization.

Phase:

Phase 2

Details

Lead Sponsor:

Institut Claudius Regaud

Collaborator:

AstraZeneca

Treatments:

Cisplatin