Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Phase 2

Recruiting

• Conditions: Pancreatic Adenocarcinoma
• Interventions: Drug: Nivolumab; Procedure: Irreversible Electroporation

• Registration Number: NCT03080974
• Lead Sponsor: University of Louisville

Brief Summary

Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.

Detailed Description

Immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma. This is a Phase II study in which all patients undergoing irreversible electroporation of locally advanced pancreatic adenocarcinoma will be treated with nivolumab post-operatively.

Study Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-15
• Study Start: 2017-08-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-06-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• ≥ 18 years if age
• Diagnosed with stage III pancreatic cancer
• Tumor is measurable
• Glomerular Filtration Rate > 60 m/L/min/1.73 m(2)
• Willing and able to comply with the protocol requirements
• Able to comprehend and have signed the informed consent to participate

Exclusion Criteria

• Participating in another clinical trial for the treatment of cancer at time of screening
• Are pregnant or currently breast feeding
• Have a cardiac pacemaker or Implantable Cardioverter Defibrillator implanted that cannot be deactivated during the procedure
• Have non-removable implants with metal parts within 1 cm of the target lesion
• Had a myocardial infarction within 3 months prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Nivolumab	All patients undergoing irreversible electroporation will be treated with nivolumab
Single Arm	Irreversible Electroporation	All patients undergoing irreversible electroporation will be treated with nivolumab

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment	Baseline thru 100 days after receiving last dose	Adverse events and Serious adverse events will be collected

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	Every three months for 4 years.	CT scans will be reviewed
Overall Survival	Every three months for 4 years.	CT scans will be reviewed

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States