Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-sur… (NCT03765918) | Clinical Trial Compass
Active — Not RecruitingPhase 3
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)
United States, Argentina, Australia714 participantsStarted 2018-12-17
Plain-language summary
This is a randomized, active-controlled, open-label study of pembrolizumab 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 event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries.
* Is eligible for primary surgery based on investigator decision and per local practice
* Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy.
* Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy
* Female participant that is not pregnant or breastfeeding
* Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
* Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Has results from testing of HPV status for oropharyngeal cancer defined as p16
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization
Exclusion Criteria:
* Has Stage T4B and/or N3 locoregionally advanced head and neck squam…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 3 and is no longer enrolling — does that mean there's any way to access pembrolizumab through a compassionate use or expanded access program while the trial results are still being analyzed?
2This study gives pembrolizumab before surgery and then combines it with radiation after surgery — how does adding an immunotherapy drug to both stages of my treatment change the risks compared to just having surgery and radiation on their own?
3The trial measures outcomes specifically based on a PD-L1 score called CPS, with separate goals for scores of 1 or higher and 10 or higher — do you know what my PD-L1 CPS score is, and does it affect whether this kind of treatment approach might be relevant for me?
4Since this is a Phase 3 trial studying pembrolizumab for advanced head and neck squamous cell cancer, what does the current evidence suggest about event-free survival compared to the standard treatment path you would normally recommend for my situation?
5Given that this trial is active but not recruiting, are there similar trials or other immunotherapy combinations for advanced head and neck squamous cell carcinoma that I might currently be eligible to discuss as an option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Event-free Survival (EFS)
Timeframe: Up to ~66 months
2
EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10