pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS≥1, hrHPV+ Oropharyngeal Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Michael K. Gibson
You may qualify if…
- ✓ Signed and dated written informed consent
- ✓ Male or female \>= 18 years of age on the day of signing informed consent
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- ✓ Having been diagnosed with R/M p16+ PD-L1 CPS \>= 1 OPC not previously treated for R/M disease. They must be eligible for, and planning to start therapy with pembrolizumab, according to standard of care
- ✓ hrHPV(+) status (staining with p16 is adequate) and PD-L1 expression (CPS≥1) in tumor based on validated testing methods performed on FFPE tumor tissue (needle core biopsy or resection; fine needle aspiration/biopsy \[FNA\] cell blocks acceptable if with adequate tissue) at local labs or VUMC labs. \[This biopsy tissue will also be used for the pre-treatment tissue research correlate studies.\] For patients with neither existing tumor hrHPV and PD-L1 CPS test results nor adequate archived tissue available for PD-L1 and hrHPV testing, a biopsy performed during screening is necessary to obtain diagnostic tissue. If no tissue is available for PD-L1 and hrHPV testing on either archived or newly obtained tissue, the patient cannot be enrolled.
- ✓ Evaluable tumor burden (measurable and/or non-measurable tumor lesion\[s\]) which can be followed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by the local site investigator/radiology. Tumors that are biopsied (for diagnosis and research use) will not be considered in the iRECIST version (v)1.1 assessment. However, if patient has only one evaluable tumor, patient may still be eligible for participation
- ✓ Absolute neutrophil count (ANC) \>= 1,000/uL (resulted =\< 28 days prior to first dose of protocol-indicated treatment)
- ✓ CD4 T cell count \> 200/uL (resulted =\< 28 days prior to first dose of protocol-indicated treatment)
You may not qualify if…
- ✕ Disease that can be treated with curative intent as assessed by patient's study physician. If patient in this situation wishes for treatment with palliative intent then they may enroll
- ✕ Multiple primary oropharyngeal (OP) tumors
- ✕ Primary cancer not originated from the oropharynx
- ✕ Has received any therapy for R/M disease. Therapy in the setting of curative intent is allowed
- ✕ Patient is pregnant or breastfeeding
- ✕ Prior prophylactic or therapeutic vaccination with any human papillomavirus (HPV) antigen except L1
- ✕ \* Note: previous receipt of the Gardasil (registered trademark) vaccine (including Gardasil 9 \[registered trademark\]) or the Cervarix (registered trademark) vaccine does not exclude
- ✕ Has received a live vaccine within 30 days prior to first dose of study treatment
Where it's recruiting
Source: ClinicalTrials.gov · NCT05799144 · last updated 2026-07-15