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Neoadjuvant Immunoradiotherapy for Head and Neck Cancer
Phase 2
Recruiting
Led By R. Bryan Bell, MD, DDS, FACS
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of stage III-IVA HPV-negative HNSCC planned for surgical resection and able to safely undergo neoadjuvant anti-PD-1 and radiation
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 year
Awards & highlights
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.
Who is the study for?
Adults with stage III-IVA HPV-negative head and neck squamous cell carcinoma (HNSCC) who are candidates for surgery. They must have proper organ function, not be pregnant or breastfeeding, agree to use contraception, and have an ECOG performance status of 0 to 1. Excluded are those with prior head & neck radiotherapy, recent live vaccines, active autoimmune diseases requiring treatment in the past 2 years, active infections needing systemic therapy, certain psychiatric/substance abuse disorders.Check my eligibility
What is being tested?
The trial is testing neoadjuvant immunoradiotherapy (NIRT) using Pembrolizumab combined with Stereotactic Body Radiation Therapy over five days before surgical resection in patients with HNSCC. The goal is to assess how effective this pre-surgery treatment is at treating cancer.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions; infusion-related reactions; fatigue; hormonal gland issues like thyroid dysfunction; and can increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is stage III-IVA, HPV-negative, and I'm set for surgery with pre-surgery anti-PD-1 and radiation.
Select...
I am fully active or can carry out light work.
Select...
I am 18 years or older and have given my consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the pathologic response rate (MPR + pCR) at time of surgery
Secondary outcome measures
Adverse events
Clinical swallowing evaluation assessed by VFSS
Overall Response Rate
+7 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + SBRT + SurgeryExperimental Treatment3 Interventions
Pembrolizumab administration (3 dose) every 3 weeks and 1 dose before radiation (5 days) therapy followed by an additional administration of Pembrolizumab (2 doses) prior to restaging and surgical resection followed by risk-adapted adjuvant therapy, per standard of care. Patient will then be treated with adjuvant pembrolizumab every 3 weeks for 14 additional doses (17 doses total)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Surgical Resection
2018
Completed Phase 2
~420
Find a Location
Who is running the clinical trial?
Providence Cancer Center, Earle A. Chiles Research InstituteOTHER
18 Previous Clinical Trials
450 Total Patients Enrolled
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,507 Total Patients Enrolled
R. Bryan Bell, MD, DDS, FACSPrincipal InvestigatorProvidence Health & Services
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + SBRT + Surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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