RecruitingPhase 3NCT04747054

Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers

Randomized Trial of Loco-regional Radiotherapy Added to Pembrolizumab Alone or With Chemotherapy Versus Systemic Treatment Alone for Patients With Newly Diagnosed Head and Neck Squamous Cell Carcinoma With Synchronous Metastases


Sponsor

UNICANCER

Enrollment

102 participants

Start Date

Dec 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head \& neck cancers


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining radiation therapy with pembrolizumab (an immunotherapy drug) as a first-line treatment improves outcomes for people newly diagnosed with metastatic head and neck cancer — cancer that has already spread at the time of diagnosis. **You may be eligible if...** - You have a new diagnosis of squamous cell carcinoma of the head and neck (mouth, throat, voice box, or unknown primary) with distant metastases - Your cancer has been confirmed by tissue biopsy - You have not yet received treatment for your metastatic disease - You have a good performance status and adequate organ function - You are 18 or older and able to give informed consent **You may NOT be eligible if...** - You have already been treated with chemotherapy or immunotherapy for this metastatic disease - You have an autoimmune condition that could be worsened by immunotherapy - You have brain metastases that are not stable - You have serious cardiac, pulmonary, or liver conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab 200 mg every 3 weeks until disease progression (as confirmed according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)) or unacceptable toxicity. The treatment of pembrolizumab should not be delayed because of radiotherapy planning.

RADIATIONLoco-regional radiotherapy

Depending on the choice of radiotherapy timing: * Before 3 cycles of pembrolizumab with or without chemotherapy : radiotherapy could start at any time between one week after the first administration of pembrolizumab and the first day of the 3rd cycle. * After 3 cycles of pembrolizumab with or without chemotherapy : radiotherapy could start at any time after 3rd cycle (C3D1) and up to a maximum of 4 weeks after the 6th cycle of pembrolizumab. Dose/fraction of radiotherapy: 54 Gy/18 fractions (recommended schedule) or 70Gy/33-35 fractions or other curative dose/fraction schedules with shorter duration and biologically equivalent dose of at least 60Gy at the discretion of local investigators, in the head and neck region. The volume of RT will include only involved loco-regional tumor region and no prophylactic neck volume will be necessary. Other cycles of pembrolizumab will be administered during and after radiotherapy.

DRUGChemotherapy

If the investigator decide to add chemotherapy with pembrolizumab, and depending on the radiotherapy timing: * Start of radiotherapy planned before 3rd cycle: Chemotherapy could be delayed after the end of radiotherapy and start from cycle 3 or 4 of pembrolizumab. Administration of chemotherapy can be delayed in case of non resolved grade 3 or higher toxicity from radiotherapy. * Radiotherapy planned after 3rd cycle: Chemotherapy should start at the same time of pembrolizumab. Chemotherapy will combine carboplatin AUC 5mg/mL/min or cisplatin 100mg/m² every 3 weeks with 5-FU 1000mg/m²/j during 4 days every 3 weeks for a maximum of 6 cycles


Locations(26)

Institut Sainte Catherine

Avignon, France

CHU Jean Minjoz

Besançon, France

CHU Bordeaux

Bordeaux, France

Institut Bergonié

Bordeaux, France

Centre François Baclesse

Caen, France

CH Carcassonne

Carcassonne, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Georges François Leclerc

Dijon, France

Centre Guillaume le Conquérant

Le Havre, France

Centre Jean Bernard - Clinique Victor Hugo

Le Mans, France

Centre Oscar Lambret

Lille, France

Groupe Hospitalier Bretagne Sud

Lorient, France

Centre Léon Bérard

Lyon, France

Hopital de la Timone

Marseille, France

Hopital Nord Franche Comté - Site de Mittan

Montbéliard, France

Centre Antoine Lacassagne

Nice, France

Institut Jean Godinot

Reims, France

Centre Henri Becquerel

Rouen, France

CHU de Saint Etienne

Saint-Priest-en-Jarez, France

Institut de Cancérologie Strasbourg-Europe

Strasbourg, France

Polyclinique de l'Ormeau

Tarbes, France

Institut Claudius Regaud

Toulouse, France

Hopital Privé Drome Ardeche

Valence, France

CH Valence

Valence, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Gustave Roussy

Villejuif, France

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NCT04747054


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