eligibility_summary
Eligible: ≥18 with HER2+ (IHC 1–3+ by 4B5) metastatic/advanced endometrial cancer, evaluable disease, after ≥1 prior line, ECOG ≤2, tissue/biopsy, adequate organs, controlled HBV/HCV, treated brain mets OK. Exclude: ICIs ≤6 mo or ≥G3 irAEs, prior lenvatinib, recent surgery/VTE/stroke, cardiac disease, QTc≥480, EF<50, anticoagulation, bleeding/fistula/vessel invasion, malabsorption, immunodeficiency/autoimmune on immunosuppression, transplant, HIV+, pregnancy, uncontrolled illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06253494 tests a multi-immunotherapy strategy in HER2-positive advanced/metastatic endometrial cancer. Interventions: 1) AdHER2DC vaccine—autologous dendritic-cell cancer vaccine transduced with an adenoviral vector encoding HER2 ECD/TMD to present HER2 and prime HER2-specific T cells/antibodies. 2) Pembrolizumab—anti-PD-1 monoclonal antibody checkpoint inhibitor restoring exhausted T-cell function. 3) Lenvatinib—oral multikinase TKI (VEGFR1–3, FGFR1–4, PDGFRα, RET, KIT) that is anti-angiogenic and modulates the immunosuppressive tumor microenvironment. 4) N-803 (Arm 2)—IL-15 superagonist cytokine complex that expands/activates NK cells and CD8+ T cells. Targets/pathways: HER2 antigen on tumor cells, PD-1/PD-L1 axis, IL-15 signaling driving NK/CD8 cytotoxicity, VEGF/FGF/PDGF angiogenic pathways and TME immunosuppression.