Trial Purpose

This is a randomised, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery, in combination with radiotherapy (with or without cisplatin), improves major pathological response and event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

Learn More on ClinicalTrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT03765918

When speaking to your doctor, please have the trial identifier number available.

About The Study

All patients who enrol in the trial will receive medication while on the study.

50% will receive pembrolizumab before surgery and pembrolizumab plus radiation therapy with or without cisplatin after surgery.

50% will receive radiation therapy with or without cisplatin after surgery.

*You will be assigned by chance (a process called randomisation) to receive one of the above treatments.

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Phase 3

Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics, or physician offices.

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Dates

  • Actual study start date 17 December 2018
  • Estimated primary completion date 30 July 2025
  • Estimated study completion date 30 July 2026

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

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Conditions

Head and Neck Neoplasms

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Age Range

18 - No Age Maximum

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Sex

All

Trial locations

Locations provided may not reflect the most current site information. Please call the number provided in the location results to confirm.