eligibility_summary
Eligible: adults with newly diagnosed stage I (T1–2 N1), II or III p16+ oropharyngeal SCC planned for definitive therapy, measurable disease (RECIST 1.1), ECOG ≤2, adequate labs, HIV/HBV/HCV allowed if undetectable (HIV CD4 ≥200, on ART), WOCBP contraception, agree to 2 biopsies. Exclude: recent (<4 wks) investigational/live vaccine/chemo/immuno/RT, major surgery <28 d, pregnancy, significant autoimmune/immunosuppression, interfering cancer, allogeneic transplant, SpO2 <92%, uncontrolled illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm neoadjuvant study in newly diagnosed p16+ HPV-associated oropharyngeal cancer. Interventions: PRGN-2009, a therapeutic cancer vaccine using a recombinant gorilla adenoviral vector encoding HPV16/18 E6/E7 antigens (SC x2), plus pembrolizumab, an anti-PD-1 IgG4 monoclonal antibody checkpoint inhibitor (200 mg IV once with first vaccine). Mechanisms: PRGN-2009 delivers E6/E7 to antigen-presenting cells to prime/expand HPV-specific CD8+ and CD4+ T cells, boosting tumor-infiltrating lymphocytes, pembrolizumab blocks PD-1 to reverse T-cell exhaustion and enhance effector function. Targets/pathways: HPV16/18 E6/E7–expressing tumor cells, dendritic cell antigen presentation (MHC I/II), PD-1/PD-L1 axis on T cells, with a primary goal of increasing CD3+ TILs pre- to post-treatment.