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 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,

Trial Details

NCT ID
NCT05799144
Phase
PHASE2
Sponsor
Michael K. Gibson
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • DNA Vaccine
  • Human Papillomavirus Tumor Antigen Vaccine
  • Pembrolizumab
  • Computed Tomography (CT)
  • Magnetic Resonance Imaging (MRI)
  • Magnetic Resonance Imaging
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Nashville, Tennessee, United States|36.16589,-86.78444

Key Eligibility Criteria

  • 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 th…

For full eligibility, visit ClinicalTrials.gov.

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