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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
Must not have
Have non-removable implants with metal parts within 1 cm of the target lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline thru 100 days after receiving last dose
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have metal implants near my cancer that cannot be removed.

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

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Irreversible Electroporation
2017
Completed Phase 2
~50
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
348 Previous Clinical Trials
77,368 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
~1 spots leftby Jun 2025
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