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

Trial Information
Eligibility
Locations

Trial 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 (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.

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT03765918

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

About The Trial

All patients who enroll 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 randomization) to receive one of the above treatments.

Phase 3

Tests the medicine or vaccine in approximately 1,000 to 5,000 volunteers. 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.

Dates

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

Eligibility

Conditions

Head and Neck Neoplasms

Age Range

18 - No Age Maximum

Sex

All

Trial locations

What Can You Do Next?

If you think this trial might be a fit and are interested in participating, take the next step to see if you are eligible.

Discuss With Your Doctor

Print this page or email it to your doctor to discuss at your next visit.

CLINICALTRIALS.GOV IDENTIFIER:

NCT03765918

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

Participating in a clinical trial is an important decision.

Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.