NCT05232851View on ClinicalTrials.gov

A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 16, 2022

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2026

Conditions
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Human Papillomavirus-Related CarcinomaLocally Advanced Oropharyngeal CarcinomaStage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
BIOLOGICAL

Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101

Given SC

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Computed Tomography

Undergo CT, FDG-PET/CT

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG-PET/CT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Biopsy

Undergo biopsy

Trial Locations (1)

55905

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

Mayo Clinic
All Listed Sponsors
lead

Mayo Clinic

OTHER

NCT05232851 - A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer | Biotech Hunter | Biotech Hunter