Actively Recruiting
pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS≥1, hrHPV+ Oropharyngeal Cancer
Led by Michael K. Gibson · Updated on 2025-10-22
54
Participants Needed
2
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS≥1, hrHPV+ Oropharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated written informed consent
- Male or female aged 18 years or older on the day of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Diagnosed with recurrent/metastatic p16+ PD-L1 CPS �31 oropharyngeal carcinoma not previously treated for recurrent/metastatic disease
- Eligible for and planning to start pembrolizumab therapy as standard of care
- High-risk HPV positive status (p16 staining acceptable) and PD-L1 expression (CPS �31) confirmed on tumor tissue by validated testing
- Evaluable tumor burden measurable by CT or MRI according to iRECIST criteria
- Absolute neutrophil count �31,000/uL within 28 days prior to first treatment dose
- CD4 T cell count greater than 200/uL within 28 days prior to first treatment dose
- Platelets �375,000/uL within 28 days prior to first treatment dose
- Hemoglobin �7.0 g/dL within 28 days prior to first treatment dose
- Estimated glomerular filtration rate (eGFR) �345 mL/min within 28 days prior to first treatment dose
- Total bilirubin �31.5 times upper limit of normal or direct bilirubin �31 times upper limit of normal if total bilirubin is elevated within 28 days prior to first treatment dose
- AST and ALT �32.5 times upper limit of normal within 28 days prior to first treatment dose
- Calcium �311.5 mg/dL or 2.9 mmol/L, corrected for albumin if needed, within 28 days prior to first treatment dose
- INR or prothrombin time �31.5 times upper limit of normal unless on anticoagulants with therapeutic range within 28 days prior to first treatment dose
- aPTT or PTT �31.5 times upper limit of normal unless on anticoagulants with therapeutic range within 28 days prior to first treatment dose
- Not breastfeeding and agree not to breastfeed during study treatment and for at least 120 days after final dose
- Women of childbearing potential must have negative pregnancy test within 28 days prior to treatment and agree to use contraception until at least 180 days after final dose
- Men able to father children must agree to use contraception until at least 120 days after final dose
- Agree to refrain from blood or sperm donation during treatment and for at least 120 days after final dose
You will not qualify if you...
- Disease treatable with curative intent unless patient opts for palliative treatment
- Multiple primary oropharyngeal tumors
- Primary cancer originating outside the oropharynx
- Prior therapy for recurrent or metastatic disease (curative intent therapy allowed)
- Current pregnancy or breastfeeding
- Prior HPV vaccination except for L1 antigen (Gardasil or Cervarix vaccines allowed)
- Live vaccine within 30 days prior to first treatment dose
- Participation in investigational study or use of investigational device within 4 weeks prior to treatment
- Diagnosis of immunodeficiency
- Non-localized or progressing additional malignancy requiring active treatment within past 3 years
- Central nervous system metastases or carcinomatous meningitis
- Previous allogeneic tissue or solid organ transplant
- Severe hypersensitivity to pembrolizumab or its components
- History of significant heart disease including myocarditis or pericarditis
- Uncontrolled illness including active infection or psychiatric/social issues limiting compliance
- Active infection with HIV, hepatitis B or C
- Active autoimmune disease involving immunodeficiency
- Immunosuppressive therapy within 60 days prior to treatment
- Recognized immunodeficiency disorders
- Non-healed wounds or active exfoliative skin conditions in patient or close contacts
- History or presence of atopic dermatitis
- Conditions causing immunosuppression in patient or close contacts
- Severe cardiac arrhythmias or uncontrolled heart rhythm issues
- Active or history of interstitial lung disease or pneumonitis requiring steroid treatment
- Low oxygen saturation below 92% without oxygen supplementation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35249
Actively Recruiting
2
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
V
Vanderbilt-Ingram Services for Timely Access
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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