NCT05799144

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

Recruiting now Phase 2 Last updated 22 October 2025

What this trial tests

Phase 2 trial testing DNA Vaccine in Metastatic Oropharyngeal Carcinoma in 54 participants. Currently enrolling.

Timeline

16 May 2023

Primary endpoint
30 September 2027

30 September 2028

Quick facts

Lead sponsor	Michael K. Gibson
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	16 May 2023
Primary completion	30 September 2027
Estimated completion	30 September 2028
Sites	2 locations across United States

Drugs / interventions tested

• DNA Vaccine — full drug profile →
• Human Papillomavirus Tumor Antigen Vaccine — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →
• Computed Tomography (CT)
• Magnetic Resonance Imaging (MRI)
• Magnetic Resonance Imaging
• Biopsy — full drug profile →

Conditions studied

• Metastatic Oropharyngeal Carcinoma — all drugs for Metastatic Oropharyngeal Carcinoma →
• Recurrent Oropharyngeal Carcinoma — all drugs for Recurrent Oropharyngeal Carcinoma →

Sponsor

Michael K. Gibson — full company profile →

Who can join

18 and older, any sex, with Metastatic Oropharyngeal Carcinoma or Recurrent Oropharyngeal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. DNA vaccines as promising immuno-therapeutics against cancer: a new insight.
   Shariati A, Khezrpour A, Shariati F, Afkhami H, et al · · 2024 · cited 13× · PMID 39872522 · DOI 10.3389/fimmu.2024.1498431
2. Recent Findings on Therapeutic Cancer Vaccines: An Updated Review.
   Sheikhlary S, Lopez DH, Moghimi S, Sun B. · · 2024 · cited 8× · PMID 38672519 · DOI 10.3390/biom14040503
3. Mini-review on the therapeutic vaccines targeting chronic infectious diseases: Evaluation system of therapeutic vaccines targeting HPV and EBV-related cancers.
   Woo S, Park PG, An T, Fatima M, et al · · 2025 · cited 5× · PMID 39957237 · DOI 10.1080/21645515.2025.2457187
4. Current development of therapeutic vaccines for the treatment of chronic infectious diseases.
   Park PG, Fatima M, An T, Moon YE, et al · · 2024 · cited 5× · PMID 38362373 · DOI 10.7774/cevr.2024.13.1.21
5. Immune responses, therapeutic anti-tumor effects, and tolerability upon therapeutic HPV16/18 E6/E7 DNA vaccination via needle-free biojector.
   Peng S, Tu H-F, Cheng M, Hu M-H, et al · · 2023 · cited 4× · PMID 37791765 · DOI 10.1128/mbio.02121-23
6. Improved efficacy of therapeutic HPV DNA vaccine using intramuscular injection with electroporation compared to conventional needle and needle-free jet injector methods.
   Peng S, Fan D, Tu HF, Cheng M, et al · · 2024 · cited 2× · PMID 39722048 · DOI 10.1186/s13578-024-01338-x
7. Clinical research progress and challenges of vaccine for human papillomavirus-associated cancers.
   Xue L, Li X, Guo X, Xing H, et al · · 2026 · PMID 42179134 · DOI 10.1080/21645515.2026.2676391
8. Therapeutic Vaccines for Head and Neck Squamous Cell Carcinoma and Nasopharyngeal Carcinoma.
   Baliton M, Alfatlawi D, Attarian S, Nabar R, et al · · 2026 · PMID 42042797 · DOI 10.3390/vaccines14040321