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Metastatic Oropharyngeal CarcinomaPhase 2NCT05799144

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

A Phase 2 study testing DNA Vaccine, Human Papillomavirus Tumor Antigen Vaccine and Pembrolizumab in people with Metastatic Oropharyngeal Carcinoma and Recurrent Oropharyngeal Carcinoma, run by Michael K. Gibson at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DNA Vaccine, Human Papillomavirus Tumor Antigen Vaccine and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesUnited States
Study dates
26 Jul 2023to 30 Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • 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
  • Note: Participants with usual basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (for example, in situ cervical cancer or breast carcinoma, superficial bladder cancer, or non-invasive intraductal carcinoma of the prostate) that have undergone potentially curative therapy are not excluded
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vanderbilt-Ingram Services for Timely Access contact

800-811-8480

cip@vumc.org

United States2 sites, 2 recruiting

  • University of Alabama Birmingham

    Birmingham, Alabama, 35249

    Lisle Nabell

    Lisle Nabell

    Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

    Vanderbilt-Ingram Service for Timely Access, 800-811-8480, cip@vumc.org

    Michael Gibson, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: An Open-Label Phase II Clinical Trial Assessing the Safety, Feasibility, Efficacy and Immunological Correlates of Heterologous Prime-Boost With pBI-11 (IM) and TA-HPV (IM) Combined With Pembrolizumab as Treatment for Patients With Advanced, PD-L1 CPS≥1, hrHPV+ Oropharyngeal Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the safety and feasibility of intramuscular PVX7 (pBI-11/pBI-11/human papillomavirus tumor antigen vaccine [TA-HPV]) immunization in patients with HPV+ recurrent/metastatic (R/M) oropharyngeal carcinoma (OPC) undergoing treatment with pembrolizumab.

SECONDARY OBJECTIVE:

  1. To assess the response rate (RR) of the addition of pBI-11 and TA-HPV to pembrolizumab (P) as first line therapy for patients with PD-L1+ (combined positive score [CPS] >= 1), HPV+, R/M OPC.

EXPLORATORY OBJECTIVES:

  1. To evaluate the overall survival (OS), progression free survival (PFS) and safety of the combination of PVX7 and pembrolizumab in this population.

II. To evaluate correlates of clinical activity by: (1) comparing HPV16/18 E6/E7-specific cellular and humoral immunity in pre- versus (vs.) post-pBI-11 and TA HPV-treated OPC patients that are pembrolizumab responders (R) and/or non-responders (NR).

OUTLINE:

Patients receive pBI-11 vaccine intramuscularly (IM), TA-HPV vaccine IM, and pembrolizumab intravenously (IV) on study. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood sample collection during screening and on study. Patients may undergo tumor biopsy during screening and on study.

Being tested
DNA Vaccine, Human Papillomavirus Tumor Antigen Vaccine, Pembrolizumab, Computed Tomography (CT), Magnetic Resonance Imaging (MRI)
Medical subject headings
Oropharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DNA VaccineBiological

    Given pBI-11 IM

  • Human Papillomavirus Tumor Antigen VaccineBiological

    Given into a muscle

  • PembrolizumabBiological

    Given into vein

  • Computed Tomography (CT)Procedure or surgery

    Undergo a CT

  • Magnetic Resonance Imaging (MRI)Procedure or surgery

    Undergo an MRI

  • Magnetic Resonance ImagingProcedure or surgery

    Undergo blood sample collection

  • BiopsyProcedure or surgery

    Undergo tumor biopsy

Study groups in NCT05799144
Study groupRoleWhat they receive
Treatment (pBI-11, TA-HPV, pembrolizumab)ExperimentalPatients receive pBI-11 vaccine IM, TA-HPV vaccine IM, and pembrolizumab IV on study. Patients undergo CT or MRI and blood sample collection during screening and on study. Patients may undergo tumor biopsy during screening and on study.
Receives: Biological: DNA Vaccine; Biological: Human Papillomavirus Tumor Antigen Vaccine; Biological: Pembrolizumab; Procedure: Computed Tomography (CT); Procedure: Magnetic Resonance Imaging (MRI); Procedure: Magnetic Resonance Imaging; Procedure: Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    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.

    Measured: Up to approximately 1 year

  2. Disease control rate (DCR)

    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.

    Measured: Up to approximately 1 year

  3. Progression-free survival (PFS)

    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.

    Measured: Up to approximately 1 year

  4. Overall survival (OS)

    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.

    Measured: Up to approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2023
  2. Study start26 Jul 2023
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05799144
Sponsor's protocol ID
VICCHN2208
Other IDs
NCI-2023-02083
Status last verified
Oct 2025
First submitted
22 Mar 2023
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DNA Vaccine, Human Papillomavirus Tumor Antigen Vaccine and Pembrolizumab in people with Metastatic Oropharyngeal Carcinoma and Recurrent Oropharyngeal Carcinoma, run by Michael K. Gibson at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vanderbilt-Ingram Services for Timely Access (800-811-8480, cip@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to approximately 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05799144.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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