OncoMatch/Clinical Trials/NCT05799144
pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS≥1, hrHPV+ Oropharyngeal Cancer
Is NCT05799144 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including DNA Vaccine and Human Papillomavirus Tumor Antigen Vaccine for metastatic oropharyngeal carcinoma.
Treatment: DNA Vaccine · Human Papillomavirus Tumor Antigen Vaccine · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A overexpression (p16+)
R/M p16+ PD-L1 CPS ≥ 1 OPC
Required: PD-L1 (CD274) overexpression (CPS ≥ 1)
PD-L1 CPS ≥ 1
Required: HPV high-risk HPV positive (positive)
hrHPV(+) status (staining with p16 is adequate)
Disease stage
Required: Stage IV
Excluded: Stage DISEASE THAT CAN BE TREATED WITH CURATIVE INTENT
Metastatic disease required
Having been diagnosed with R/M p16+ PD-L1 CPS ≥ 1 OPC not previously treated for R/M disease
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any therapy for recurrent/metastatic disease
Exception: Therapy in the setting of curative intent is allowed
Has received any therapy for R/M disease. Therapy in the setting of curative intent is allowed
Cannot have received: prophylactic or therapeutic vaccination with any human papillomavirus (HPV) antigen except L1
Exception: previous receipt of Gardasil or Cervarix does not exclude
Prior prophylactic or therapeutic vaccination with any human papillomavirus (HPV) antigen except L1
Lab requirements
Blood counts
ANC ≥ 1,000/uL; CD4 T cell count > 200/uL; Platelets ≥ 75,000/uL; Hemoglobin ≥ 7.0 g/dL
Kidney function
eGFR ≥ 45 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN, or direct bilirubin ≤ ULN for participants with total bilirubin > 1.5 x ULN; AST and ALT ≤ 2.5 x ULN
ANC ≥ 1,000/uL; CD4 T cell count > 200/uL; Platelets ≥ 75,000/uL; Hemoglobin ≥ 7.0 g/dL; eGFR ≥ 45 mL/min; Total bilirubin ≤ 1.5 x ULN, or direct bilirubin ≤ ULN for participants with total bilirubin > 1.5 x ULN; AST and ALT ≤ 2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama Birmingham · Birmingham, Alabama
- Vanderbilt University/Ingram Cancer Center · Nashville, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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