eligibility_summary
Eligible: ≥18 with resectable HPV+ oropharyngeal SCC stage I–II (M0), ECOG 0–2, limited smoking (current <10 pack‑yrs, former quit >10y or <10 pack‑yrs), surgery planned, adequate organ function, controlled HIV (ART, CD4≥200), undetectable HBV/HCV, contraception, halt breastfeeding, biopsy‑amenable tumor, PET/CT, consent. Exclude: neuropathy >G2, recent anticancer/investigational therapy, CYP3A modulators, allergy, recent steroids/immunosuppression, active malignancy, prior allogeneic transplant, heart failure, pregnancy, uncontrolled illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II randomized neoadjuvant trial in HPV+ oropharyngeal cancer comparing: (1) Docetaxel + cisplatin vs (2) Docetaxel + cisplatin + PRGN-2009. Drugs/mechanisms: Docetaxel (taxane chemotherapeutic) stabilizes microtubules, causing mitotic arrest, Cisplatin (platinum chemotherapeutic) creates DNA crosslinks, triggering DNA damage–mediated apoptosis, PRGN-2009 (gorilla adenoviral therapeutic cancer vaccine) induces HPV16/18-specific T-cell responses. Targets: dividing tumor cells via microtubule dynamics and DNA damage pathways, activation of CD8+/CD4+ T cells against HPV-expressing tumor cells (notably E6/E7 antigens), with potential tumor microenvironment remodeling.