eligibility_summary
Eligible: Confirmed PDAC, ECOG 0-1, adv/met with >=16 wks SOC chemo/chemoradiotherapy and PR/SD, or resected R0/R1 with >=3 mo peri-adjuvant multiagent chemo, no progression, start <=12 wks post-curative (resected), life expectancy >=12 mo (resected) or >=6 mo (adv/met), archival tumor for KRAS, FOLFIRINOX 8-12 cycles if Part C. Exclude: not recovered, GI obstruction, other cancer <3 yrs, chemo <=14/28 d, RT <=14 d (adv/met) or none (resected), prior immunotherapy, immunodeficiency/transplant, systemic steroids/immunosuppression, autoimmune tx <=2 yrs, active infections, major surgery <=12 wks, tamoxifen <=1 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05846516 tests KISIMA-02, a heterologous prime–boost cancer vaccine, alone or with ezabenlimab in PDAC. Interventions: ATP150/ATP152 (protein subunit therapeutic vaccines) with VSV-GP154 (VSV-based viral vector vaccine) in Parts A/B, ATP162 with VSV-GP154 plus ezabenlimab in Part C. Ezabenlimab (BI 754091) is an anti–PD-1 monoclonal antibody checkpoint inhibitor. Mechanisms: Protein vaccines deliver tumor antigens to antigen-presenting cells to prime adaptive immunity, VSV-GP154 boosts via in vivo antigen delivery and innate stimulation, expanding cytotoxic CD8+ and helper CD4+ T cells. Ezabenlimab blocks the PD‑1 pathway to reverse T-cell exhaustion and enhance effector function. Targets: dendritic cells/APCs, tumor-specific T cells, innate sensing/IFN pathways activated by the viral vector, and the PD‑1/PD‑L1 checkpoint in the tumor microenvironment.