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Alkylating agents
HPV Vaccine + Pembrolizumab + Cisplatin for Head and Neck Cancer
Phase 2
Recruiting
Led By Robert L Ferris, MD, PhD
Research Sponsored by Dan Zandberg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
N2c/N3 disease irrespective of tobacco exposure
T4 or N2c/N3 disease irrespective of tobacco exposure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial will test a new combination of drugs and radiation therapy for patients with a certain type of head and neck cancer.
Who is the study for?
This trial is for adults with newly diagnosed, intermediate risk HPV-16-associated head and neck squamous cell carcinoma without distant metastasis. Eligible patients must have a specific type of tumor in the oropharynx or unknown primary site, meet certain disease stage criteria, not have had prior treatments for head and neck cancer, be free from other cancers for at least 2 years (with some exceptions), and show adequate organ function.Check my eligibility
What is being tested?
The study tests a new treatment combo: pembrolizumab (an immune therapy), ISA101b (HPV-16 vaccine), cisplatin (chemotherapy), and IMRT (targeted radiotherapy). It's designed to see if this mix can better treat local-regionally advanced head and neck cancer linked to HPV-16 compared to current standards.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, infusion-related reactions from pembrolizumab or ISA101b, chemotherapy-induced nausea/vomiting from cisplatin, skin irritation from IMRT, fatigue, blood disorders that may increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to lymph nodes, regardless of my smoking history.
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My cancer is advanced, regardless of my smoking history.
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My cancer is p16 positive and HPV positive but its primary location is unknown.
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My cancer is at a stage where surgery cannot cure it.
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I had a second head/neck cancer more than 2 years after the first, treated with surgery only, and it hasn't come back.
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I have not had radiation therapy above my collarbone.
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I have a history of significant smoking and advanced lymph node involvement.
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I am fully active or can carry out light work.
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I haven't had chemotherapy, targeted therapy, or radiation for head and neck cancer.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS) at 2 years
Secondary outcome measures
Adverse Events Related to Study Treatment
Overall Survival (OS)
Progression-free Survival (PFS)
Side 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: IMRT + Pembrolizumab + Cisplatin + ISA101bExperimental Treatment4 Interventions
IMRT (Intensity Modulated Radiotherapy) of 70 Gy in 35 fractions over 7 weeks (5 fractions per week).
Pembrolizumab will be administered at 200 mg (fixed dose) IV every 3 weeks (+/- 3 days), beginning beginning one week (week -1) prior to concurrent cisplatin-IMRT.
Cisplatin will be administered at 100 mg/m2 IV on days 1(Week 0) and 22 (Week 3).
ISA101b will be administered as three rounds of vaccination 3-4 weeks apart via two SC injections per vaccination round at 100ug/peptide, before pembrolizumab treatment. Vaccination #1 will be administered 1 week before pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Dan ZandbergLead Sponsor
5 Previous Clinical Trials
238 Total Patients Enrolled
Robert FerrisLead Sponsor
6 Previous Clinical Trials
225 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,891 Previous Clinical Trials
5,060,371 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I haven't had monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.I have been treated with specific immune system targeting drugs before.I have moderate to severe numbness, tingling, or pain in my hands or feet.My condition is considered to be at an intermediate risk level.My throat cancer is HPV positive and I have a history of significant tobacco use.I have serious lung conditions, including high blood pressure in my lungs or lung inflammation that needed steroids.I agree to have a required biopsy before treatment starts and may agree to two more during treatment.My cancer has spread to lymph nodes, regardless of my smoking history.My cancer is advanced, regardless of my smoking history.My cancer is p16 positive and HPV positive but its primary location is unknown.My cancer is at a stage where surgery cannot cure it.I haven't taken antibiotics or antifungals for an infection in the last 7 days.I had a second head/neck cancer more than 2 years after the first, treated with surgery only, and it hasn't come back.I have not had radiation therapy above my collarbone.My electrolyte levels are stable or have been corrected.I have an autoimmune disease that needed treatment in the last 3 months.I have been cancer-free for at least 2 years, except for any completely removed and cured cancers.I have not had major surgery in the last 6 weeks or have fully recovered if I did.I haven't had any cancer except for certain skin, breast, cervix, bladder, or prostate cancers in the last 2 years.I do not have multiple primary cancers, except for certain HPV+ throat cancers or small, non-spreading thyroid cancer.I have a serious heart condition.I have a history of significant smoking and advanced lymph node involvement.My cancer originates in the mouth, voice box, lower throat, or upper throat.My cancer is a type of throat cancer that hasn't spread far and started in the oropharynx.I am fully active or can carry out light work.I haven't had chemotherapy, targeted therapy, or radiation for head and neck cancer.I had chemotherapy or radiation for another cancer type, but it was over 2 years ago.I have AIDS.I have been treated with anti-HPV drugs, not including vaccines.I am 18 years old or older.My cancer has not spread to distant parts of my body, including the brain.I have no severe allergies to medications or their ingredients.I've had a tonsillectomy but still have measurable nodal disease.I have not had any major blood clots in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: IMRT + Pembrolizumab + Cisplatin + ISA101b
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.
Has Pembrolizumab been studied in any additional clinical trials?
"Currently, 1555 clinical trials are utilizing Pembrolizumab to explore its efficacy and safety. 355 of those studies are in the advanced Phase 3 stage while 704 sites across the globe have enrolled patients into these studies."
Answered by AI
What is the cap for participants in this investigation?
"Affirmative. Clinicaltrials.gov lists this trial as actively recruiting, starting from July 6th 2020 and most recently updated on the 13th of July 2022. Fifty patients are needed to be enrolled across one medical site."
Answered by AI
Has Pembrolizumab obtained regulatory clearance from the U.S. Food and Drug Administration?
"Our experts at Power rated Pembrolizumab's safety a 2 on account of the fact that this is merely Phase 2, meaning there is some evidence for its security but none to suggest effectiveness."
Answered by AI
Are new participants currently being accepted for this scientific experiment?
"According to the data accessible on clinicaltrials.gov, this study has been ongoing since July 6th 2020 and was recently amended on July 13th 2022; thus implying that it is still in need of participants."
Answered by AI
What medical purpose does Pembrolizumab serve?
"Pembrolizumab is a favored therapy for malignant neoplasms, though it has also been used to treat unresectable melanoma, high microsatellite instability and cases of elevated recurrence risk."
Answered by AI
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