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

Enrollment

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