At a glance
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Stimulating Immune Response With Neoadjuvant Human Papilloma Virus (HPV)-16 Specific Vaccination in HPV-Oropharyngeal Squamous Cell Carcinoma (HPV-OPSCC)
In Brief
A Phase 2 clinical trial evaluating Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101, Pembrolizumab, and 4 other interventions for Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and 4 related conditions. Active but no longer recruiting, targeting 20 participants across 1 site.
Detailed Summary
This phase I/II trial studies how well PDS0101 alone or in combination with pembrolizumab works to shrink tumor in patients with human papillomavirus-associated oropharynx cancer that has spread to nearby tissue or lymph nodes (locally advanced). PDS0101 is a vaccine made from specific peptides that may help the body build an effective immune response to kill tumor cells. 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. Giving PDS0101 with or without pembrolizumab may kill more tumor cells in patients with locally advanced human papillomavirus-associated oropharynx cancer before surgery so that it may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.
Study Details
Timeline
Interventions
Given SC
Given IV
Undergo CT, FDG-PET/CT
Undergo FDG-PET/CT
Undergo blood sample collection
Undergo biopsy