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Neoadjuvant Immunoradiotherapy for Head and Neck Cancer
Study Summary
This trial is testing a new cancer treatment that combines immunotherapy and radiotherapy given before surgery for people with stage III or IVA HPV-associated 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 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
Media Library
- I have active brain metastases or carcinomatous meningitis.I have an immune system disorder or I'm on long-term steroids.My cancer is stage III-IVA, HPV-negative, and I'm set for surgery with pre-surgery anti-PD-1 and radiation.I am fully active or can carry out light work.I have moderate to severe nerve damage in my hands or feet.I have not received a live vaccine in the last 30 days.My larynx cancer is classified as T1, T2, or T3.I haven't had cancer treatment in the last 4 weeks.I have previously been treated with drugs targeting the immune system.I agree to use birth control during and for 75 days after my treatment.I have or had lung inflammation that needed steroids.I have an active tuberculosis infection.I have had radiation therapy to my head or neck.I have another cancer that is getting worse or was treated in the last 2 years.My organs are functioning well enough for the study.I do not have any health issues that could affect the study's results.I have not needed treatment for an autoimmune disease in the last 2 years.I have provided a recent tumor tissue sample.I am 18 years or older and have given my consent.I am currently on medication for an infection.I am a woman of childbearing potential and not pregnant.I have a history of HIV, Hepatitis B, or active Hepatitis C.I am not pregnant or breastfeeding and will follow birth control advice during and for 75 days after treatment.
- Group 1: Pembrolizumab + SBRT + Surgery
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 maladies has Pembrolizumab been found to combat?
"Pembrolizumab is the primary drug used to treat malignant neoplasms, and it can also be prescribed for conditions such as unresectable melanoma, microsatellite instability high or when chemotherapy ceases to have a positive effect."
Could you elucidate the other experiments done utilizing Pembrolizumab?
"Currently, 961 clinical trials are investigating Pembrolizumab. Of those studies, 122 have advanced to Phase 3 testing. Houston is the hub for these experiments; however, there are an additional 35 731 sites studying this treatment across the globe."
How many individuals are enrolled in this trial at the maximum capacity?
"Affirmative. The clinical trial registry reveals that this research is currently recruiting as of January 11th 2022, when the study was first posted and last updated. 28 enrollees are required from 2 different locations."
Is this experiment actively seeking participants?
"At present, the trial is recruiting participants. According to clinicaltrials.gov, this study was first published on November 1st 2022 and has been recently updated as of that same date."
Can Pembrolizumab be administered without significant risks to patients?
"Evaluation of the safety profile of pembrolizumab was scored a 2 since it's currently in Phase 2 trials, pointing to some evidence backing its security but no data that verifies its efficacy."
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