eligibility_summary
Adults ≥18 with incurable recurrent/metastatic OPSCC, no prior systemic therapy in this setting, HPV16+ & PD‑L1 CPS≥20, measurable disease, ECOG 0–1, adequate organ function. Exclude: PD ≤6 mo post-curative therapy, short life expectancy/high-risk, pregnant/breastfeeding, prior severe CPI irAE, recent steroids/live vaccine/trial, transplant, immunodeficiency/immunosuppression, other recent cancer, CNS mets, pembro hypersensitivity, autoimmune disease, pneumonitis/infection, AIDS, HBV, HCV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: HB-202/HB-201 alternating 2-vector therapy (replicating arenavirus-based genetic vectors: Pichinde virus and lymphocytic choriomeningitis virus) plus pembrolizumab vs pembrolizumab + placebo in first-line HPV16+ recurrent/metastatic OPSCC with PD-L1 CPS≥20. Mechanisms: HB-202/HB-201 deliver non-oncogenic HPV16 antigens to elicit strong, tumor-specific immune responses, pembrolizumab is an anti–PD-1 monoclonal antibody checkpoint inhibitor that blocks PD-1 to restore T-cell activity. Targets: HPV16-positive tumor cells via antigen-specific cytotoxic T cells, PD-1/PD-L1 immune checkpoint pathway on T cells. Status: Withdrawn (company decision to stop HB-202/HB-201 development in this indication).