eligibility_summary
Eligibility: Adults ≥18 with PD-L1+ (SP263 ≥5%) and HPV16+ R/M (IVB) cervical SCC/adenoca/adenosquamous cancer, progressed after 1L pembrolizumab + platinum ± bevacizumab (≥4 cycles), ≤1 prior R/M regimen, start ≤12 weeks post progression, measurable disease, ECOG 0–1, GRIm ≤1. Exclude: curative local options, rapid progression, neuroendocrine, recent RT/surgery/systemic Tx/vaccines, prior transplant/CAR-T/T-cell–targeted IO (except pembro in R/M), tisotumab vedotin/HPV16 vaccine, severe pembro/atezo AEs, immunosuppression/steroids, planned major surgery, other active cancers (except noninvasive skin, superficial bladder, DCIS, or cured >2y).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06099418 (withdrawn) tested VB10.16 alone vs with atezolizumab in HPV16+, PD‑L1+ recurrent/metastatic cervical cancer refractory to pembrolizumab. Interventions: VB10.16—therapeutic DNA vaccine (biologic) encoding HPV16 E6/E7 antigens, designed to target antigen‑presenting cells, enhance cross‑presentation, and prime robust HPV16‑specific CD8+ cytotoxic and CD4+ helper T‑cell responses, Atezolizumab (Tecentriq)—anti‑PD‑L1 IgG1 monoclonal antibody checkpoint inhibitor that blocks PD‑L1 interaction with PD‑1/B7.1 to restore T‑cell activity. Cells/pathways targeted: HPV16 E6/E7‑expressing tumor cells, dendritic cell antigen presentation, effector T‑cell activation, PD‑1/PD‑L1 immune checkpoint on tumor and immune cells.