Cancer Vaccine
Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 for Oropharyngeal Cancer
Mayo Clinic in Rochester, Rochester, MN
Targeting 6 different conditionsLiposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 +1 morePhase 1 & 2RecruitingLed by David M RoutmanResearch Sponsored by Mayo ClinicEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Candidate for surgical resection
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 2 years
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is studying PDS0101, a vaccine made from specific peptides, either alone or in combination with pembrolizumab, to see how well it works in treating patients with human papillomavirus-associated oropharynx cancer that has spread to nearby tissue or lymph nodes.
Eligible Conditions
- Oropharyngeal Cancer
- Oropharyngeal Carcinoma
- Carcinoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are a candidate for surgery to remove the affected area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of pathologic and human papillomavirus cell-free tumor deoxyribonucleic acid (ctHPVDNA) response
Secondary outcome measures
Incidence of adverse events (AEs)
Overall survival (OS)
Progression-free survival (PFS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (PDS0101, pembrolizumab)Experimental Treatment2 Interventions
Patients receive PDS0101 SC on day 1 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (PDS0101)Experimental Treatment1 Intervention
Patients receive PDS0101 SC on day 1. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2210
Find a site
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,048 Previous Clinical Trials
3,484,711 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,369 Previous Clinical Trials
41,215,241 Total Patients Enrolled
David M RoutmanPrincipal Investigator
Mayo Clinic in Rochester1 Previous Clinical Trials
320 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment capacity for this medical experiment?
"Affirmative. Clinicaltrials.gov's records show that the trial was first made public on March 7th 2022 and has been actively searching for participants since then; it is currently seeking 24 volunteers from 1 medical centre."
Answered by AI
Is enrollment still open for this research project?
"According to the information provided by clinicaltrials.gov, this medical trial is presently enrolling patients with its initial posting on March 7th 2022 and a recent update taking place on March 11th 2022."
Answered by AI