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

NCT04747054 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-10-26

No results posted yet for this study

Summary

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

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

Pembrolizumab

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.

RADIATION

Loco-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.

DRUG

Chemotherapy

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

Sponsors & Collaborators

  • GORTEC

    collaborator OTHER

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • UNICANCER

    lead OTHER

Principal Investigators

  • Yungan TAO, Dr · Gustave Roussy, Cancer Campus, Grand Paris

  • Caroline EVEN, Dr · Gustace Roussy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2025-10-01
Completion
2029-10-01

Countries

  • France

Study Locations

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Entities

Drugs

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 NCT04747054 on ClinicalTrials.gov