NCT05799144View on ClinicalTrials.gov

pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS≥1, hrHPV+ Oropharyngeal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

May 16, 2023

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2028

Conditions
Metastatic Oropharyngeal CarcinomaRecurrent Oropharyngeal Carcinoma
Interventions
BIOLOGICAL

DNA Vaccine

Given pBI-11 IM

BIOLOGICAL

Human Papillomavirus Tumor Antigen Vaccine

Given into a muscle

BIOLOGICAL

Pembrolizumab

Given into vein

PROCEDURE

Computed Tomography (CT)

Undergo a CT

PROCEDURE

Magnetic Resonance Imaging (MRI)

Undergo an MRI

PROCEDURE

Magnetic Resonance Imaging

Undergo blood sample collection

PROCEDURE

Biopsy

Undergo tumor biopsy

Trial Locations (2)

35249

RECRUITING

University of Alabama Birmingham, Birmingham

37232

RECRUITING

Vanderbilt University/Ingram Cancer Center, Nashville

All Listed Sponsors
lead

Michael K. Gibson

OTHER