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Monoclonal Antibodies
Immunotherapy + Radiation + Surgery for Head and Neck Cancer
Phase 1
Recruiting
Led By Dukagjin M Blakaj, MD, PhD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed either persistent and/ or locoregionally recurrent HNSCC of oral cavity, pharynx, larynx, unknown primary head and neck (H&N) squamous cell carcinoma
Patients who plan to or have undergone therapy for their cancer, such as surgery and/or chemotherapy and/or radiotherapy and recurred
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer.
Who is the study for?
This trial is for adults with certain types of head and neck cancers that are treatable by surgery but have persisted or returned after treatment. Participants must be in good health with proper organ function, not pregnant, and willing to use contraception. They should not have other recent cancers, HIV, hepatitis B or C, severe autoimmune diseases, untreated brain metastases, a history of severe immunotherapy side effects, or be on current immunosuppressive drugs.Check my eligibility
What is being tested?
The study tests the effectiveness of pembrolizumab (an immune system-boosting drug) combined with radiation therapy before and during cancer surgery. The goal is to see if this combination helps reduce tumor size more effectively than previous treatments for persistent or recurrent head and neck squamous cell carcinoma.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs; fatigue; skin reactions; potential complications from radiation like skin burns; surgical risks like infection; plus any typical side effects from pembrolizumab including fever and chills.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a confirmed case of head and neck squamous cell carcinoma.
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My cancer came back after treatment like surgery, chemo, or radiation.
Select...
I am 18 years old or older.
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I can do most activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Health related quality of life
Incidence of adverse events
Secondary outcome measures
Local control rate
Objective-response rate (ORR)
Overall survival
+2 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
3Treatment groups
Experimental Treatment
Group I: Arm C (pembrolizumab, EBRT, salvage surgery, IORT)Experimental Treatment5 Interventions
Patients receive pembrolizumab IV on day 1 of week 1, and undergo high dose EBRT for 2 fractions on 2 consecutive days during week 4. Patients also undergo salvage surgery during week 8. Beginning week 11, patients receive pembrolizumab IV every 3 weeks for up to 18 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo IORT for 1 fraction during week 11. Treatment with pembrolizumab may continue beyond initial progression per investigator-assessed clinical benefit and if the patient is tolerating pembrolizumab.
Group II: Arm B (pembrolizumab, EBRT, salvage surgery, IORT)Experimental Treatment5 Interventions
Patients receive pembrolizumab IV on day 1 of week 1, and undergo low dose EBRT for 2 fractions on 2 consecutive days during week 4. Patients also undergo salvage surgery during week 8. Beginning week 11, patients receive pembrolizumab IV every 3 weeks for up to 18 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo IORT for 1 fraction during week 11. Treatment with pembrolizumab may continue beyond initial progression per investigator-assessed clinical benefit and if the patient is tolerating pembrolizumab.
Group III: Arm A (pembrolizumab, salvage surgery, IORT)Experimental Treatment4 Interventions
Patients receive pembrolizumab IV on day 1 of week 1, and undergo salvage surgery during week 4. Beginning week 8, patients receive pembrolizumab IV every 3 weeks for up to 18 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo IORT for 1 fraction during week 9. Treatment with pembrolizumab may continue beyond initial progression per investigator-assessed clinical benefit and if the patient is tolerating pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Intraoperative Radiation Therapy
2012
N/A
~500
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,122 Total Patients Enrolled
Dukagjin M Blakaj, MD, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken immunosuppressive drugs in the last 14 days.I had a severe reaction to previous immunotherapy.My kidney function, measured by creatinine levels or clearance, is within the required range.My cancer is in the salivary glands, lips, or skin.I have an autoimmune disease, but it's not severe and doesn't need systemic treatment.You have had a bad allergic reaction to any of the trial medications or the solutions they are mixed into.I have had chemotherapy before.I have previously used immune checkpoint inhibitors.I can provide samples from my tumor, blood, and urine for testing.I have tested positive for HIV, hepatitis B, or hepatitis C.My cancer is a confirmed case of head and neck squamous cell carcinoma.I am a man who will use highly effective birth control for 31 weeks after my last treatment dose.My cancer came back after treatment like surgery, chemo, or radiation.I have had radiation therapy before.I am using birth control to prevent pregnancy during and after my treatment.I have not had palliative radiotherapy in the last 14 days.I have brain metastases that have not been treated.I am 18 years old or older.I am willing and able to give my consent to participate.I have not had any cancer treatments in the last 2 weeks.I can do most activities without help.I have not had any cancer other than skin cancer or cervical carcinoma in situ in the past 3 years.My condition cannot be treated with surgery, as decided by my medical team.My surgeon says my cancer can be removed with surgery.My blood, kidney, and liver functions are all within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (pembrolizumab, salvage surgery, IORT)
- Group 2: Arm C (pembrolizumab, EBRT, salvage surgery, IORT)
- Group 3: Arm B (pembrolizumab, EBRT, salvage surgery, IORT)
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 medical purposes is Pembrolizumab typically prescribed for?
"Pembrolizumab can be used to treat a variety of malignant neoplasms, particularly those with unresectable melanoma and microsatellite instability high. Additionally, it has been found effective in treating some conditions post-chemotherapy."
Answered by AI
Has Pembrolizumab been certified by the FDA?
"The safety of Pembrolizumab has been assessed at 1 on the scale due to it being a Phase 1 trial, thus implying that there is limited evidence supporting its therapeutic efficacy and protective effects."
Answered by AI
What primary purpose is this medical trial attempting to achieve?
"The primary outcome evaluated in this clinical trial up to 100 days after the final dose of medication is related to health-related quality of life. Secondary endpoints being assessed include overall survival, progression-free survival (PFS), and PD-L1 expression. Analyses for these metrics will use a combination of Kaplan Meier methods, two sided log rank tests and Cox proportional hazards models stratified by other factors."
Answered by AI
What is the current participant count of this research experiment?
"Indeed, clinicaltrials.gov states that this trial is currently in search of candidates. It was initially published on May 1st 2022 and underwent its most recent update a few months later, on March 1st 2022. The study needs to enlist 45 individuals from just one medical centre."
Answered by AI
What additional research has been undertaken to explore the potential of Pembrolizumab?
"Pembrolizumab is currently in the spotlight of 961 ongoing trials, with 122 being at Phase 3. Houston, Texas has a significant number of these studies; however, there are 35731 other sites around the world participating as well."
Answered by AI
Is there capacity to enrol new participants in this experiment?
"Clinicaltrials.gov displays that this clinical investigation is still recruiting candidates. The trial was posted on the first of May in 2022, and underwent its most recent update on March 1st of the same year."
Answered by AI
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