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A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma

Purpose

This is a randomized, 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.

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) alone.

Gender

N/A

Monetary compensation

No

Can be done from home

No

Keywords

pembrolizumab, head and neck cancer, radiotherapy

Principal Investigator

Frederic J Kaye, M.D.

Sponsoring Group

Department of Medicine

Department

Department of Medicine

Contact Information

fkaye@ufl.edu

(352) 265-0725

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