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Procedure

Immunotherapy + Electroporation for Pancreatic Cancer

Phase 2
Recruiting
Led By Robert Martin, MD, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years of age
Diagnosed with stage III pancreatic cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline thru 100 days after receiving last dose
Awards & highlights

Study Summary

This trial is testing a new treatment for pancreatic cancer that uses electric fields to kill cancer cells. The treatment is being given with nivolumab, which is a immunotherapy drug.

Who is the study for?
This trial is for adults over 18 with stage III pancreatic cancer who can follow the study plan and have signed consent. They must have a measurable tumor and good kidney function. It's not for those in other cancer trials, pregnant or breastfeeding individuals, people with certain heart devices or metal implants near the tumor, or recent heart attack survivors.Check my eligibility
What is being tested?
The study tests how well irreversible electroporation (a technique to destroy cancer cells using electricity) works alongside Nivolumab (an immunotherapy drug) in treating advanced pancreatic cancer. The goal is to see if this combination improves patient outcomes.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation of organs due to Nivolumab, as well as discomfort, bruising, and potential tissue damage from the electroporation procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My condition is stage III pancreatic cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline thru 100 days after receiving last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline thru 100 days after receiving last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment
Secondary outcome measures
Overall Survival
Progression Free Survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 Interventions
All patients undergoing irreversible electroporation will be treated with nivolumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Irreversible Electroporation
2017
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,974 Total Patients Enrolled
Robert Martin, MD, PhDPrincipal InvestigatorUniversity of Louisville
5 Previous Clinical Trials
18,068 Total Patients Enrolled

Media Library

Irreversible Electroporation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03080974 — Phase 2
Pancreatic Adenocarcinoma Research Study Groups: Single Arm
Pancreatic Adenocarcinoma Clinical Trial 2023: Irreversible Electroporation Highlights & Side Effects. Trial Name: NCT03080974 — Phase 2
Irreversible Electroporation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03080974 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any research endeavors that have focused on Nivolumab?

"Currently, 82 trials for Nivolumab are in the third phase of research and development, out of a total 718 active studies. Most trials for this drug take place in Basel, BE; however there are 40237 sites offering clinical testing worldwide."

Answered by AI

Has a comparable study of this type been conducted before?

"Presently, 718 active studies on Nivolumab have been organized in 2354 cities and 49 nations. This medication was first tested for efficacy back in 2012 by Ono Pharmaceutical Co. Ltd with a Phase 1 & 2 trial involving 659 patients. Since then, 255 additional trials have concluded."

Answered by AI

What is the upper limit of participants for this experiment?

"Unfortunately, no more patients are being sought for this trial. It was first introduced on the 14th of August 2017 and most recently updated on October 24th 2022. For those looking to join an ongoing study, 787 clinical trials with adenocarcinoma as a focus and 718 studies involving Nivolumab remain in search of participants."

Answered by AI

What has been the traditional application of Nivolumab?

"Nivolumab is suitable for the management of many malignant neoplasms, ranging from inoperable melanomas to metastatic esophageal adenocarcinoma and squamous cell carcinoma."

Answered by AI

What unfavorable effects has Nivolumab been associated with?

"Considering the phase of this trial, there is enough evidence to suggest Nivolumab's safety merits a score of 2. Unfortunately, no trials have been conducted to confirm its efficacy as yet."

Answered by AI

Are there still openings available for prospective subjects in this research endeavor?

"As per the information on clinicaltrials.gov, this study has finished recruiting participants. The trial was initially posted in August 2017 and last updated in October 2022. Nevertheless, at present there are 1,505 other medical studies actively seeking volunteers."

Answered by AI
~1 spots leftby Jun 2025