NCT04835402

Electroporation Potentiated Immunotherapy in Cancer

A Phase II Study of Electroporation Potentiated Immunotherapy in Liver Metastatic

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is investigating the efficacy and safety of combined irreversible electroporation (IRE) and checkpoint inhibition in metastatic pancreatic cancer.

Detailed description

The aim of the study is to investigate whether checkpoint inhibition in conjunction with IRE of a single liver metastasis can elicit a systemic anticancer immune response in patients with pancreatic cancer. Adult patients, in WHO performance status 0-1, with liver metastatic pancreatic cancer, intolerant to or progressing on first or further lines of chemotherapy can enter the trial. Pembrolizumab infusion is given every six weeks for up to six months. IRE of a single liver metastasis is performed between the first and second pembrolizumab infusion. Response to the therapy is examined by CT (RECIST) on non-IRE-ablated lesions every 2 months. Assessments of changes in peripheral blood immune cell composition, tumor gene expression and tumor infiltrating lymphocytes is performed on serial biopsies and blood samples.

Conditions

• Pancreas Cancer, Metastatic

Interventions

Type	Name	Description
DRUG	Pembrolizumab	400mg every 6 weeks
DEVICE	Irreversible electroporation	Percutaneous ablation of one liver metastasis

Timeline

• Start date: 2021-05-26
• Primary completion: 2022-03-07
• Completion: 2025-12-01
• First posted: 2021-04-08
• Last updated: 2022-03-09

Locations

1 site across 1 country: Denmark

Regulatory

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