Clinical Trial

Advanced Head and Neck Squamous Cell Carcinoma

Study Description

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

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 naA?ve 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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Biological - Pembrolizumab 200 mg

200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Radiation - Radiotherapy 60 Gray/day

Low risk participants administered 2 Gray/day in 30 fractions. Administered using intensity modulated radiation therapy.

Radiation - Radiotherapy 66 Gray/day

High risk participants administered 2 Gray/day in 33 fractions. Administered using intensity modulated radiation therapy.

Radiation - Radiotherapy 70 Gray/day

Participants with gross residual disease administered 2 Gray/day in 35 fractions. Administered using intensity modulated radiation therapy.

Drug - Cisplatin 100 mg/m^2

100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle

Additional Information

Official Study 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)

Clinical Trial ID

NCT03765918

ParticipAid ID

dPN5za