NCT05435053

Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer

Irreversible Electroporation in Combination With Immune Checkpoint Inhibition, in Patients With Metastatic Pancreatic Cancer - A Prospective, Phase 2 Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Ismail Gögenur · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The trial investigates the safety and efficacy of irreversible electroporation in combination with checkpoint inhibition in patients with metastatic pancreatic cancer.

Detailed description

The trial is designed as an investigator initiated prospective phase 2 study in patients with metastatic pancreatic cancer (PC) to determine the efficacy and safety of checkpoint inhibition administered concurrently with irreversible electroporation. A recently published preclinical study by Zhao et al. (2019) showed that the combination of IRE and PD-1-inhibitor suppressed the tumour growth and increased the survival of mice bearing pancreatic cancer. The aim of the trial is to initiate an abscopal response, leveraging the patient's immune system in eliciting a sufficient immune response.

Conditions

• Pancreas Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Every 2 weeks (3 mg/kg, maximum of 240 mg) for up to 24 weeks Nivolumab is an immune checkpoint inhibitor (PD-1-inhibitor).
DEVICE	Irreversible electroporation (IRE)	Percutaneous ablation of a primary in-situ (or locally-recurrent) or metastatic lesion. Irreversible electroporation is delivered through the NanoKnife system (AngioDynamics, New York, USA). The system is FDA-approved for medical use.

Timeline

• Start date: 2022-09-08
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2022-06-28
• Last updated: 2023-09-15

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated drug study
• FDA-regulated device study