Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer
NCT05435053 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2023-09-15
Summary
The trial investigates the safety and efficacy of irreversible electroporation in combination with checkpoint inhibition in patients with metastatic pancreatic cancer.
Conditions
- Pancreas Cancer
Interventions
- DRUG
-
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.
Sponsors & Collaborators
-
Ismail Gögenur
lead OTHER
Principal Investigators
-
Ismail Gögenur, Professor · Zealand University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-08
- Primary Completion
- 2023-08-30
- Completion
- 2023-08-30
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- Denmark
Study Locations
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