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

NCT03623646 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-08-08

No results posted yet for this study

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

DRUG

Chemoradiotherapy arm

Radiation Therapy in combination with Chemotherapy (Cisplatin)

DRUG

Immunotherapy + Radiotherapy arm

Radiation Therapy in combination with Immunotherapy drug (Durvalumab)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Institut Claudius Regaud

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2022-02-26
Completion
2023-02-14

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03623646 on ClinicalTrials.gov