pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS≥1, hrHPV+ Oropharyngeal Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This phase II trial tests how well pB1-11 and human papillomavirus tumor antigen (TA-HPV) vaccines in combination with pembrolizumab work in treating patients with oropharyngeal cancer that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) and that is PD-L1 and human papillomavirus (HPV) positive. Oropharyngeal cancer is a type of head and neck cancer involving structures in the back of the throat (the oropharynx), such as the non-bony back roof of the mouth (soft palate), sides and back wall of the throat, tonsils, and back third of the tongue. Scientists have found that some strains or types of a virus called HPV can cause oropharyngeal cancer. pBI-11 is a circular deoxyribonucleic acid (DNA) (plasmid) vaccine that promotes antibody, cytotoxic T cell, and protective immune responses. TA-HPV is an investigational recombinant vaccina virus derived from a strain of the vaccina virus which was widely used for smallpox vaccination. Vaccination with this TA-HPV vaccine may stimulate the immune system to mount a cytotoxic T cell response against tumor cells positive for HPV, resulting in decreased tumor growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread by inhibiting the PD-1 receptor. These investigational vaccines could cause or enhance an immune response in the body against HPV, during which time the activity of pembrolizumab against oropharyngeal cancer associated with HPV may be strengthened. These drugs in combination may be more effective in increasing the ability of the immune system to fight oropharyngeal cancer than pembrolizumab alone.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Diagnoza: rak gardła związany z HPV, który powrócił lub rozprzestrzenił się, nie leczony wcześniej w tej formie
- •Potwierdzenie HPV i cechy PD-L1 w badaniu tkanki guza
- •Vidoczne zmiany nowotworowe widoczne w tomografii lub rezonansie magnetycznym
- •Liczba neutrofili we krwi co najmniej 1000/µL
- •Liczba limfocytów CD4 powyżej 200/µL
- •Liczba płytek krwi co najmniej 75 000/µL
- •Ogólny stan zdrowia pozwalający na podjęcie leczenia
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
University of Alabama Birmingham
Birmingham, United States
Vanderbilt University/Ingram Cancer Center
Nashville, United States
Trial contact
Vanderbilt-Ingram Services for Timely Access
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/16/2026.
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