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NCT05799144 · ClinicalTrials.gov registry record · Phase 2
pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS≥1, hrHPV+ Oropharyngeal Cancer
A Phase 2 study of Metastatic Oropharyngeal Carcinoma and Recurrent Oropharyngeal Carcinoma, sponsored by Michael K. Gibson.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 2
- Study locations
NCT05799144 is a Phase 2 study of Metastatic Oropharyngeal Carcinoma and Recurrent Oropharyngeal Carcinoma that is actively recruiting participants, run by Michael K. Gibson. The registered enrollment target is 54 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT05799144, a Phase 2 study of Metastatic Oropharyngeal Carcinoma and Recurrent Oropharyngeal Carcinoma, is actively recruiting participants, sponsored by Michael K. Gibson.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 2
- Study locations
Study 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) 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 Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Computed Tomography (CT)
- PROCEDURE Magnetic Resonance Imaging (MRI)
- BIOLOGICAL DNA Vaccine
- BIOLOGICAL Human Papillomavirus Tumor Antigen Vaccine
Study Locations (2)
Alabama
- University of Alabama Birmingham - Birmingham
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2023-05-16 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05799144
The ClinicalTrials.gov registry entry for NCT05799144 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michael K. Gibson, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Metastatic Oropharyngeal Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05799144 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Alabama, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05799144 about?
NCT05799144 is a clinical study titled "pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/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...
What is the current status of trial NCT05799144?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2023-05-16. Estimated completion is 2028-09-30.
What conditions does trial NCT05799144 study?
This clinical trial studies the following conditions: Metastatic Oropharyngeal Carcinoma, Recurrent Oropharyngeal Carcinoma.
What interventions are being tested in trial NCT05799144?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Computed Tomography (CT) (PROCEDURE), Magnetic Resonance Imaging (MRI) (PROCEDURE), DNA Vaccine (BIOLOGICAL), Human Papillomavirus Tumor Antigen Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05799144?
This trial is sponsored by Michael K. Gibson, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05799144 being conducted?
This trial has 2 study locations across Alabama, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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