Immunotherapy And Irreversible Electroporation In The Treatment Of Advanced Pancreatic Adenocarcinoma

Study Overview

Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

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

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.

Pancreatic Adenocarcinoma

DRUG: Nivolumab
PROCEDURE: Irreversible Electroporation

16.1190

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-02-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-23
First Submitted that Met QC Criteria 2017-03-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-25
First Posted (ACTUAL) 2017-03-15	Results First Posted N/A	Last Verified 2025-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Single Arm All patients undergoing irreversible electroporation will be treated with nivolumab	DRUG: Nivolumab Given post-operatively every two weeks for a total of 4 doses. Dose based on weight. PROCEDURE: Irreversible Electroporation Non-thermal ablation of tumor

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Single Arm

All patients undergoing irreversible electroporation will be treated with nivolumab

DRUG: Nivolumab

Given post-operatively every two weeks for a total of 4 doses. Dose based on weight.

PROCEDURE: Irreversible Electroporation

Non-thermal ablation of tumor

Primary Outcome Measures	Measure Description	Time Frame
Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment	Adverse events and Serious adverse events will be collected	Baseline thru 100 days after receiving last dose

Secondary Outcome Measures	Measure Description	Time Frame
Progression Free Survival	CT scans will be reviewed	Every three months for 4 years.
Overall Survival	CT scans will be reviewed	Every three months for 4 years.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Marilyn Donaldson, RN

Phone Number: 502-629-3323

Email: marilyn.donaldson@louisville.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

≥ 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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Robert Martin, MD, PhD, University of Louisville

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record