Design
tumor, tumors, DNX-2401
DISEASE PROGRESSION, TUMOR, TUMORS
To evaluate the safety of combining DNX-2401 with pembrolizumab, we conducted an initial dose-escalation phase to determine a safe dose of DNX-2401 in combination with pembrolizumab and followed by a dose-expansion phase. All patients received a single dose of DNX-2401 by stereotactic injection at the time of standard tumor biopsy followed by 200 mg pembrolizumab infused intravenously at a dose of 200 mg over 30 min every 3 weeks starting 7 days after DNX-2401. Resection of tumors was not permitted. Treatment with pembrolizumab continued for up to 2 years, or until one of the following occurred: disease progression, unacceptable toxic effects or withdrawal of consent. Dose escalation evaluated 5 × 10All patients underwent a stereotactic biopsy to document the presence of tumor tissue before delivery of DNX-2401. Immediately after biopsy, a stereotactic-compatible neuro-ventricular cannula (Alcyone MEMS; ClearPoint SmartFlow) was inserted into the tumor to deliver the precise targeted dose of DNX-2401 via a single micro-tip at a rate of 0.9 ml h