Conditions
Head And Neck Neoplasms
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.
NATIONAL TRIAL REFERENCE NUMBER
NCT03765918
When you talk with your doctor or clinical trial team member, please have the trial identifier number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
18+
Sex
All
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.
Current trial phase
Trial Phase 3
In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participants who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial start and end dates
- Trial start date December 17, 2018
- Estimated primary completion date July 30, 2025
- Estimated trial completion date July 30, 2026
Trial locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about