MRI-aided SmartFlow convection delivery of DNX-2401: a pilot, prospective case series.

BACKGROUND: The Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects (CAPTIVE) study (NCT02798406) is a phase II clinical trial testing the efficacy of a recombinant adenovirus DNX-2401 combined with the immune checkpoint inhibitor pembrolizumab.

OBJECTIVE: Here we report the first patients in this study who underwent viral delivery through real-time MRI stereotaxis guided SmartFlow convection delivery of DNX-2401.

METHODS: The clinical course of the patients who underwent real-time MRI guided adenovirus (DNX-2401) delivery through the Clearpoint SmartFlow convection catheter were prospectively followed.

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 > 1 cm maximal diameter of T1-hypointensity infusate on an MRI taken immediately after completion of viral infusion. These patients exhibited partial response based on RANO assessment. The remaining patient showed < 1 cm maximal diameter of infusate on the immediate post-infusion MRI showed disease progression on the subsequent MRI.

CONCLUSION: Our pilot case series supports compatibility of the SmartFlow system with oncolytic adenovirus delivery and provides the basis for future validation studies.