Study of pBI-11 & TA-HPV with Pembrolizumab for Advanced Oropharyngeal Cancer
This study is testing a combination of treatments for advanced oropharyngeal cancer that has returned (recurrent) or spread (metastatic), and is positive for HPV and PD-L1. The treatments are two vaccines, pBI-11 and TA-HPV, given into a muscle, along with pembrolizumab, given into a vein. Oropharyngeal cancer affects the back of the throat, and some types are caused by HPV. Researchers want to see how safe and effective this combination is, specifically looking at how many patients respond to the treatment and how long they live without the cancer getting worse. To join, you must be at least 18 years old, have recurrent or metastatic oropharyngeal cancer that is HPV and PD-L1 positive, and not have been treated for this advanced stage before. The study plans to enroll 54 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 54 participants.
- What's involved
- You would receive pBI-11 and TA-HPV vaccines into a muscle, and pembrolizumab into a vein. You would also undergo CT or MRI scans and blood tests during screening and throughout the study. A tumor biopsy may also be done.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be measured for up to approximately 1 year.
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NCT05799144
pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS≥1, hrHPV+ Oropharyngeal Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentMichael K. GibsonInvestigator-initiated
~54 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:DNA VaccineHuman Papillomavirus Tumor Antigen VaccinePembrolizumabComputed Tomography (CT)Magnetic Resonance Imaging (MRI)Magnetic Resonance Imaging
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over Up to approximately 1 year
+3 more outcomes measured
Conditions
Where it's being run
2 sites across 2 statesAlabama1
Tennessee1
Study leadership
- Michael Gibson, MD, PhD · PRINCIPAL_INVESTIGATOR · Vanderbilt University/Ingram Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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)
Platelets \>= 75,000/uL (resulted =\< 28 days prior to first dose of protocol-indicated treatment)
Hemoglobin \>= 7.0 g/dL (resulted =\< 28 days prior to first dose of protocol-indicated treatment)
Estimated glomerular filtration rate (eGFR) \>= 45 mL/min (as calculated by the Cockcroft-Gault Formula or calculated/measured by an alternative established institutional standard consistently applied across participants at the site) (resulted =\< 28 days prior to first dose of protocol-indicated treatment)
Total bilirubin =\< 1.5 times institutional upper limit of normal (ULN), or direct bilirubin =\< ULN for participants with total bilirubin \> 1.5 x ULN (resulted =\< 28 days prior to first dose of protocol-indicated treatment)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 times institutional ULN (resulted =\< 28 days prior to first dose of protocol-indicated treatment)
Calcium =\< 11.5 mg/dL or =\< 2.9 mmol/L; in patients with albumin outside the normal range, calcium (corrected for albumin) must be =\< 11.5 mg/dL or =\< 2.9 mmol/L (resulted =\< 28 days prior to first dose of protocol-indicated treatment)
International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 times institutional ULN; except for patients receiving anticoagulant therapy as long as PT in such patients per investigator judgment is within therapeutic range of intended use of anticoagulants (resulted =\< 28 days prior to first dose of protocol-indicated treatment)
Activated partial thromboplastin time (aPTT) preferred or partial thromboplastin time (PTT) =\< 1.5 times institutional ULN; except for patients receiving anticoagulant therapy as long as PTT in such patients per investigator judgment is within therapeutic range of intended use of anticoagulants (resulted =\< 28 days prior to first dose of protocol-indicated treatment)
Patients must not be breastfeeding and further agree to not breastfeed during study treatment; and for at least 120 days after patient's final dose of heterologous vaccination and pembrolizumab
A woman of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test during screening within 28 days prior to receiving first dose of protocol-indicated treatment, and must agree to follow instructions for using acceptable contraception from the time of signing consent, and until at least 180 days after her final dose of heterologous vaccination and pembrolizumab. In order to be considered not of childbearing potential, women under the age of 62 must have a documented serum follicle stimulating hormone (FSH) level more than 40 mIU/mL (or within local laboratory reference range for postmenopausal women
Patients must refrain from donating blood or sperm throughout the duration of study treatment followed by at least 120 days after patients' final dose of heterologous vaccination or pembrolizumab
A patient able to father children who is sexually active with a WOCBP must agree to follow instructions for using acceptable contraception, from the time of signing consent, and until at least 120 days after his final dose of heterologous vaccination and pembrolizumab
Exclusion
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
Has received a live vaccine within 30 days prior to first dose of study treatment
Examples of prohibited live vaccines include, but are not limited to measles, mumps, rubella, varicella (chickenpox), zoster (shingles; Zostavax \[registered trademark\] \[not including Shingrix (registered trademark)\]), yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine
Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\] Quadrivalent) are live attenuated vaccines and are not allowed. The three United States (US) FDA-approved coronavirus disease 2019 (COVID-19) vaccines (by Pfizer BioNTech, Moderna, and Janssen) and AstraZeneca COVID-19 vaccine are based on messenger (m)RNA or replication-deficient adenoviral vectors and are allowed
Is currently participating in or, within 4 weeks prior to first dose of study treatment, has participated in a study of an investigational agent or has used an investigational device
Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent
Patients with persistent toxicities of =\< grade 3 (National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) will be excluded
Diagnosis of immunodeficiency
Known additional malignancy that is non-localized or progressing or has required active treatment within the past 3 years prior to first dose of study treatment
Radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator and radiology review
Recipient of previous allogeneic tissue/solid organ transplant
Known severe hypersensitivity (\>= grade 3) to pembrolizumab and/or any of its excipients
History of myocarditis or pericarditis or other known clinically significant underlying heart disease (e.g., cardiomyopathy, congestive heart failure, symptomatic arrhythmia not controlled by medication, unstable angina, history of acute myocardial infarction)
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, sepsis, or psychiatric illness/social situations that would limit compliance with study requirements
Active or chronic infection with any of the following (with testing for all three conditions required during screening for this study):
Human immunodeficiency virus (HIV)
Hepatitis C virus (HCV)
Hepatitis B virus (HBV)
Active autoimmune disease with immunodeficiency as a clinical component (e.g., rheumatoid arthritis, systemic lupus erythematosus \[SLE\], ulcerative colitis, Crohn's disease, multiple sclerosis \[MS\], ankylosing spondylitis)
Within 60 days prior to initiating first dose of protocol-indicated treatment, patient has received therapy with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), alkylating agents, antimetabolites, radiation, tumor necrosis factor (TNF) inhibitors, or systemic corticosteroids
Recognized immunodeficiency diseases including cellular immunodeficiencies; hypo-gammaglobulinemia or dys-gammaglobulinemia; or acquired, hereditary, or congenital immunodeficiencies
Patients and their close social, sexual, or domestic contacts may not have non-healed wounds or active exfoliative skin conditions, such as eczema, burns, impetigo, varicella-zoster virus infection, herpes simplex virus infection, severe acne, severe diaper dermatitis with extensive areas of denuded skin, psoriasis, lichen planus, or Darier disease (keratosis follicularis)
History and presence of atopic dermatitis
Patients and their close social, sexual, or domestic contacts may not have known conditions associated with immunosuppression, such as HIV/acquired immunodeficiency syndrome (AIDS), leukemia, lymphoma, generalized malignancy, solid organ transplant recipient, or hematopoietic stem cell transplant recipient \< 24 months post-transplant OR \>= 24 months, but who have graft-versus-host disease or disease relapse, or be of less than 1 year of age
Found at screening visit to have severe arrhythmias (e.g., atrial fibrillations), sinus bradycardia (\< 50 beats per minute \[BPM\]), sinus tachycardia (\> 100 BPM) via resting electrocardiography (EKG). Patients with controlled arrhythmias followed by a cardiologist are eligible
Patients with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids. Hypoxemia (oxygen saturation \[SpO2\] \< 92% for 5 min or longer) by finger pulse oximetry corrected by oxygen supplementation is allowed
What this trial measures
- Objective response rate (ORR)Up to approximately 1 year
The proportion of eligible, response evaluable patients with a best overall response (BOR). Objective response rate will be summarized as proportions of the total number of eligible, response evaluable patients with 95% confidence intervals. Logistic and Cox (proportional hazards) regression will be used to assess the association between important prognostic variables (e.g, gender, age) with objective response rate. Objective response rate will be monitored using Simon's minimax design.
- Disease control rate (DCR)Up to approximately 1 year
The proportion of eligible, response evaluable patients with a best overall response of complete response, partial response or stable disease. Disease control rate will be summarized as proportions of the total number of eligible, response evaluable patients with 95% confidence intervals.
- Progression-free survival (PFS)Up to approximately 1 year
Estimated using the method of Kaplan and Meier (product limit estimator). Logistic and Cox (proportional hazards) regression will be used to assess the association between important prognostic variables (e.g, gender, age) with progression-free survival. The odds ratio (OR) for response and hazard ratio (HR) for progression-free survival will be presented with 95% confidence intervals as measure of effect size.
- Overall survival (OS)Up to approximately 1 year
Estimated using the method of Kaplan and Meier (product limit estimator). Logistic and Cox (proportional hazards) regression will be used to assess the association between important prognostic variables (e.g, gender, age) with overall survival. The odds ratio for response and hazard ratio for overall survival will be presented with 95% confidence intervals as measure of effect size.