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Checkpoint Inhibitor

HPV Vaccine + Pembrolizumab for Oropharyngeal Cancer

Phase 2
Recruiting
Led By Charalampos Floudas, M.D.
Research Sponsored by National Cancer Institute (NCI)
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 5 years
Awards & highlights

Study Summary

This trial is to study a vaccine and drug combo to treat HPV-associated oropharyngeal cancer before definitive therapy. Participants will receive two doses of vaccine and one dose of drug. Up to 20 people are enrolling.

Who is the study for?
Adults over 18 with newly diagnosed HPV-positive oropharyngeal cancer, who are planning standard treatment and can sign consent. They must be willing to undergo biopsies, have measurable disease, and meet certain health criteria including HIV, Hepatitis B/C status. Women must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the combination of an immunotherapeutic HPV vaccine (PRGN-2009) with Pembrolizumab before standard cancer treatments in patients with HPV-associated mouth cancers. It involves injections and infusions followed by multiple clinic visits for monitoring.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, immune-related adverse effects due to pembrolizumab such as fatigue, skin issues or inflammation in organs; flu-like symptoms from the vaccine; plus risks associated with blood draws and biopsies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine if there is an increase in CD3+ tumor infiltrating T cells post treatment compared with pre-treatment
Secondary outcome measures
Determine the rate of increase in TILs by immunohistologyCHANGE TO: Determine the rate of increase in tumor infiltrating lymphocytes (TILs) by immunohistology
Overall Survival
Prolonged Survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment2 Interventions
PRGN 5x10^11 Viral Particles (VP) SC plus pembrolizumab 200mg IV as induction/ neoadjuvant therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,412 Total Patients Enrolled
Charalampos Floudas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
652 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05996523 — Phase 2
Oral Squamous Cell Carcinoma Research Study Groups: Arm 1
Oral Squamous Cell Carcinoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05996523 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05996523 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept participants over two decades of age?

"According to the requirements of this medical trial, any potential participant must be aged 18 years or older and not exceed 120."

Answered by AI

Has Arm 1 secured FDA approval?

"Because the trial is in Phase 2, with safety data existing but no efficacy evidence, Arm 1's safety was rated on a scale of 1 to 3 as a score of 2."

Answered by AI

What characteristics are necessary for an individual to qualify as a participant in this experiment?

"To qualify for this trial, patients should have been diagnosed with oral squamous cell carcinoma and be within the age brackets of 18 to 120. We plan on enrolling a total of 29 individuals in this protocol."

Answered by AI

Are any new participants being sought for this research endeavor?

"According to clinicaltrials.gov, this trial is not taking on any more individuals at the present moment; however, it was initially posted in August of 2023 and last updated that same month. Although recruitment for this specific study has closed, there are 562 other studies currently recruiting patients."

Answered by AI

Who else is applying?

What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria

What questions have other patients asked about this trial?

Does NIH provide lodging for these studies?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer
2023. "Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05996523.
~16 spots leftby Nov 2024
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