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Pembrolizumab + Radiotherapy for Head and Neck Cancer
Study Summary
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 616 Patients • NCT02578680Trial Design
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Who is running the clinical trial?
Media Library
- I have been treated for an autoimmune disease in the last 2 years.My oropharyngeal cancer has been tested for HPV status.I am highly allergic to pembrolizumab, radiotherapy, cisplatin, or similar treatments.I have severe bleeding caused by my cancer.I agree to use birth control during and up to 6 months after the study.I have not received a live vaccine in the last 30 days.My doctor agrees I can have the main surgery for my condition.I have or am currently positive for Hepatitis B or C.I agree not to donate sperm during and up to 6 months after the study.My cancer is a specific type of throat or mouth cancer that can be surgically removed and has not spread to distant parts of my body.I have had previous cancer treatments, including radiotherapy or drugs, for my head and neck cancer.I have had a transplant from another person.My head or neck cancer is at an advanced stage with significant spread.I have been treated with drugs targeting immune checkpoints.My cancer can be measured by scans.I am not pregnant or breastfeeding.I have not fully recovered from major surgery or its complications.I have or had lung inflammation treated with steroids.I am not pregnant, as confirmed by a recent test.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.You have recently taken part in a study testing a new drug or device within the past month.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is not in my mouth or throat but in areas like my nose or sinuses.I have detectable brain or spinal cord cancer spread, treated or not.I have moderate to severe hearing loss.I have not had active treatment for another cancer, except for certain skin cancers or in situ cancers, in the last 3 years.I am currently being treated for an infection.I have been diagnosed with HIV.I experience significant numbness or pain in my hands or feet.I have provided a recent biopsy of a tumor that has not been treated with radiation.
- Group 1: Pembro Neoadjuvant+Pembro SOC Adjuvant
- Group 2: No Neoadjuvant+SOC Adjuvant
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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