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

Conditions

• Metastatic Oropharyngeal Carcinoma
• Recurrent Oropharyngeal Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• DNA Vaccine — BIOLOGICAL
  Given pBI-11 IM
• Human Papillomavirus Tumor Antigen Vaccine — BIOLOGICAL
  Given into a muscle
• Pembrolizumab — BIOLOGICAL
  Given into vein
• Computed Tomography (CT) — PROCEDURE
  Undergo a CT
• Magnetic Resonance Imaging (MRI) — PROCEDURE
  Undergo an MRI
• Magnetic Resonance Imaging — PROCEDURE
  Undergo blood sample collection
• Biopsy — PROCEDURE
  Undergo tumor biopsy

Study Details

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.

Key Dates

Start date

May 16, 2023

Status verified

Oct 2025

Primary completion

Sep 30, 2027

Completion

Sep 30, 2028

Study Design

Enrollment

54 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (pBI-11, TA-HPV, pembrolizumab)
  Patients 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.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to approximately 1 year ]

Central Contacts

• Vanderbilt-Ingram Services for Timely Access
  800-811-8480
  [email protected]

Locations (2)

Find similar trials in Birmingham, AL

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