NCT03623646

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Chemoradiotherapy arm	Radiation Therapy in combination with Chemotherapy (Cisplatin)
DRUG	Immunotherapy + Radiotherapy arm	Radiation Therapy in combination with Immunotherapy drug (Durvalumab)

Timeline

• Start date: 2019-03-15
• Primary completion: 2022-02-26
• Completion: 2023-02-14
• First posted: 2018-08-09
• Last updated: 2025-08-08

Locations

2 sites across 1 country: France