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 Clinic

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 below
Select...
You are a candidate for surgery to remove the affected area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
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 more

Awards & 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 Rochester
1 Previous Clinical Trials
320 Total Patients Enrolled

Media Library

Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05232851 — Phase 1 & 2
Oropharyngeal Cancer Research Study Groups: Arm B (PDS0101, pembrolizumab), Arm A (PDS0101)
Oropharyngeal Cancer Clinical Trial 2023: Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 Highlights & Side Effects. Trial Name: NCT05232851 — Phase 1 & 2
Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05232851 — Phase 1 & 2

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
~8 spots leftby Jul 2024