Pembrolizumab 200 mg for Head and Neck Cancers
This trial is testing whether adding pembrolizumab to radiotherapy (with or without cisplatin) before and after surgery improves outcomes in people with newly diagnosed, resectable head and neck squamous cell carcinoma.
- Head and Neck Cancers
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2023 Phase 3 trial • 616 Patients • NCT02578680
Awards & Highlights
Find a site
Who is running the clinical trial?
Frequently Asked Questions
What is the history of Pembrolizumab 200 mg in medical research?
"The first study involving pembrolizumab 200 mg was conducted at City of Hope Comprehensive Cancer Center in 1997. As of now, there have been 1158 completed studies and 1619 ongoing trials. A large number these clinical trials are based in Pittsburgh, Pennsylvania."
The FDA has greenlit Pembrolizumab 200 mg, correct?
"Pembrolizumab 200 mg is considered safe because it has passed Phase 3 clinical trials. This means that not only does the medication show some efficacy, but also that there are multiple rounds of data supporting its safety."
In how many distinct locations is this clinical trial running?
"Presently, 44 medical facilities are recruiting patients for this study with locations such as Pittsburgh, Sioux Falls and Bethlehem. It would be advantageous to choose the clinical trial site nearest you to limit travel time if enrolled."
Are patients still being recruited for this research project?
"Yes, this information can be found on the website clinicaltrials.gov. The trial was created on December 17th, 2018 and has been updated as recently as November 7th, 2020."
How many test subjects are participating in this experiment?
"Yes, this is an ongoing study that is recruiting patients from 44 different sites. According to the listing on clinicaltrials.gov, 704 people are needed for the trial. The dates you provided are accurate - it was posted on 12/17/2018 and last updated on 11/7/2022."
What goals does this research hope to achieve?
"According to the sponsor of this clinical trial, Merck Sharp & Dohme Corp., the primary outcome being measured over a period of up to 5 years is Major Pathological Response (mPR). In addition to measuring the primary outcome, this trial will also be measuring secondary outcomes including Percentage of Participants Experiencing An Adverse Event (AEs), which is defined as the percentage of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy. Anothersecondary outcome being measured is Pathological Complete Response (pCR), which is defined"
What are the standard conditions that Pembrolizumab 200 mg is used to address?
"Pembrolizumab 200 mg is the standard care medication for treating malignant neoplasms. However, this immunotherapy can also be useful in other cases such as unresectable melanoma, microsatellite instability high, and instances where there is a high risk of recurrence."