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DNA Vaccine
Vaccines + Pembrolizumab for Oropharyngeal Cancer
Phase 2
Recruiting
Led By Michael Gibson, MD, PhD
Research Sponsored by Michael K. Gibson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year
Awards & highlights
Study Summary
This trial tests a combination of vaccines and pembrolizumab to treat head and neck cancer caused by HPV. Vaccines may help the body's immune system attack the cancer and pembrolizumab may weaken tumors.
Who is the study for?
Adults (18+) with recurrent or metastatic PD-L1 CPS≥1, hrHPV+ oropharyngeal cancer who haven't been treated for this advanced stage. They must have a good performance status, adequate organ function, and not be pregnant or breastfeeding. Participants should agree to use contraception and not donate blood/sperm during the trial.Check my eligibility
What is being tested?
The trial is testing pBI-11 & TA-HPV vaccines combined with pembrolizumab against HPV-positive oropharyngeal cancer. It aims to see if these treatments together boost the immune system more effectively than pembrolizumab alone in fighting cancer.See study design
What are the potential side effects?
Potential side effects include typical reactions from immunotherapy like fatigue, flu-like symptoms, allergic reactions, and possibly autoimmune responses where the body's immune system may attack normal cells along with the cancer cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate (DCR)
Objective response rate (ORR)
Overall survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pBI-11, TA-HPV, pembrolizumab)Experimental Treatment7 Interventions
Patients receive pBI-11 vaccine IM, TA-HPV vaccine IM, and pembrolizumab IV on study. Patients undergo CT or MRI and blood sample collection during screening and on study. Patients may undergo tumor biopsy during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging (MRI)
2015
Completed Phase 4
~1800
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
DNA Vaccine
2013
Completed Phase 2
~210
Pembrolizumab
2017
Completed Phase 2
~2010
Computed Tomography (CT)
2012
N/A
~100
Biopsy
2014
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
Michael K. GibsonLead Sponsor
1 Previous Clinical Trials
Michael Gibson, MD, PhDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition can be treated with the goal of curing it.My side effects from previous treatments are not severe.I have more than one primary tumor in my throat.I have received treatment for recurrent or metastatic disease.My cancer has spread to my brain or its coverings.My tumor is positive for hrHPV and shows PD-L1 expression.I have not received a live vaccine in the last 30 days.I am fully active or can carry out light work.My primary cancer did not originate in the oropharynx.I have had another type of cancer in the last 3 years.I do not have an active or chronic infection with HIV, HCV, or HBV.I have received an HPV vaccine other than the L1 type.I have a history of heart inflammation or significant heart disease.I have an active autoimmune disease that affects my immune system.I have severe irregular heartbeats.I am 18 years old or older.I will not donate blood or sperm during the study and for 4 months after.I have or had lung inflammation treated with steroids.I have been diagnosed with an immune system disorder.I have recurrent/metastatic p16+ throat cancer with a PD-L1 score >= 1 and have not been treated for it yet.I do not have any uncontrolled illnesses.I have not taken immunosuppressive drugs in the last 60 days.I have open wounds or severe skin peeling.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pBI-11, TA-HPV, pembrolizumab)
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 the FDA recognized the efficacy of utilizing pBI-11, TA-HPV and pembrolizumab for medical treatment?
"Treatment (pBI-11, TA-HPV, pembrolizumab) safety is rated a 2 due to Phase 2 status. This implies that while there are some studies validating its security profile, none have been conducted testing efficacy."
Answered by AI
Is enrollment open for this experiment at present?
"According to the details on clinicaltrials.gov, this research initiative is no longer actively recruiting participants. The study was originally posted April 15th 2023 and most recently updated March 22nd 2023. On the bright side, there are still 2,533 other medical studies presently seeking patients for their experiments."
Answered by AI
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