Real-Time MRI Stereotaxis Aided Smartflow Convection Delivery of DNX-2401

INTRODUCTION: The Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects (CAPTIVE) study is a phase II clinical trial testing the efficacy of a recombinant adenovirus DNX-2401 combined with the immune checkpoint inhibitor pembrolizumab. METHODS: Prospective case series. RESULTS: Precise catheter placement was achieved in all patients treated, and no adverse events were noted. Average radial error from target was 0.9 mm. The average procedural time was 3 hours and 16 minutes, and comparable to other CED techniques. In two patients, delivery of DNX-2401 was visualized as T1-hypointensity using an MRI taken within 30 minutes of procedure completion. These patients exhibited partial response based on RANO assessment. Infusion associated T1-hypointensity in tumor core was not seen in the other patients, who showed no evidence of therapeutic response. CONCLUSIONS: Our pilot study supports the safety of MRI guided SmartFlow convection delivery of the DNX-2401 adenovirus in recurrent glioblastoma patients. Visualization of drug delivery may serve as an imaging biomarker for therapeutic response.