Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiation Therapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

Official Title

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 (LA HNSCC)

Summary:

This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiation therapy (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 radiation therapy (with or without cisplatin) improves major pathological response and event-free survival compared to radiation therapy (with or without cisplatin) given after surgery alone.

Trial Description

Primary Outcome:

• Major Pathological Response (mPR)
• Event-free Survival (EFS)

• Overall Survival (OS)
• Pathological Complete Response (pCR)
• Change From Baseline in Global Health Status/Quality of Life Scale (GHS/QoL)
• Change From Baseline in Global Health Status/Physical Functioning Scales
• Change from Baseline in Swallowing, Speech, and Pain Symptoms
• Percentage of Participants Experiencing An Adverse Event (AEs)
• Percentage of Participants Discontinuing Study Drug Due to AEs

View this trial on ClinicalTrials.gov