Immunotherapy and Irreversible Electroporation (IRE) in the Treatment of Locally Advanced Pancreatic Adenocarcinoma

November 5, 2026 updated by: Robert C. Martin

Immunotherapy and Irreversible Electroporation in the Treatment of Locally Advanced Pancreatic Adenocarcinoma

The purpose of this study is to test the safety, tolerability, and preliminary effectiveness of the study drug, IP-001, in patients with locally advanced pancreatic cancer that is treated with IRE.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 1b, single-arm trial designed to evaluate the safety and efficacy of administration of intratumoral IP-001 injection following IRE ablation in patients with Stage III, locally advanced pancreatic adenocarcinoma (LAPC).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years at time of signing Informed consent Form

  • Diagnosed with clinical stage III pancreatic cancer (per National Comprehensive Cancer Network [NCCN] guidelines)

  • Has undergone standard of care (per NCCN guidelines) neoadjuvant/induction base chemotherapy for at least 2 months in duration and demonstrated stable or responsive disease, and completed a wash-out period of at least 21 days prior to study treatment

  • Pancreatic tumor is measurable (bi-dimensional tumor measurements per 3-phase CT scan). If preoperative CT cannot provide 2-dimensional size criteria, then intra-operative ultrasound will be used for baseline size criteria

  • Is a candidate for irreversible electroporation

  • Able to tolerate surgery

  • Glomerular filtration rate > 30 mL/min/1.73 m2

  • Aspartate aminotransferase/Alanine aminotransferase < 3 times the upper limit of normal (ULN) and total bilirubin < 1.5 ULN

  • Absolute neutrophil count ≥1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, and hemoglobin ≥ 9 g/dL

  • Stable surgical post-operative course as defined by the operative surgeon (Eastern Cooperative Oncology Group [ECOG]) of 0 or 1

  • Women of childbearing potential

    1. Must have a negative serum human chorionic gonadotropin pregnancy test prior to irreversible electroporation
    2. Are using highly effective contraception, are not lactating, and agree not to become pregnant prior to and during the trial treatment period and for 187 days after treatment with the investigational drug

  • Men agree not to donate sperm or to father a child during the trial treatment period and for 97 days after treatment with the investigational drug

  • Participants on therapeutic anticoagulation are eligible if therapy can be safely held or bridged to achieve an INR < 1.5 per institutional guidelines

  • Adverse events from prior therapy must be resolved to Grade ≤ 1 severity.

  • Able to comprehend and have signed the Informed Consent Form to participate in the study

Exclusion Criteria:

  • Known allergic reaction to shellfish, crabs, crustaceans, or any trial components
  • Participating in another clinical trial for the treatment of pancreatic cancer at the time of screening
  • Are pregnant or currently breastfeeding
  • New York Heart Association Class III or IV heart disease
  • Inability to discontinue medications known to prolong the QT interval or induce Torsades de Pointes before study entry, with drug-specific discontinuation timing documented
  • Uncontrolled infection requiring antibiotic therapy
  • Contraindication to heparin
  • Major surgery within 14 days of enrollment
  • Prior high dose radiation therapy defined as total dose of > 5400 cGy
  • Have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE procedure
  • Clinically significant history of epilepsy or cardiac arrhythmia
  • Have nonremovable implants with metal parts within 1cm of the target lesion
  • Had a myocardial infarction within 3 months prior to enrollment (informed consent date)
  • Actively bleeding, anticoagulated, or have a known or suspected coagulopathy which has not been corrected
  • Autoimmune disease and/or medical condition requiring systemic treatment with corticosteroids that cannot be stopped during treatment

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1% IP-001 for injection following IRE

Participants will receive intratumoral injection of 1% IP-001 (diluted to 1 mg/mL, up to 12 mL total) into and around the treated tumor and ablated area immediately following IRE
Drug: 1.0% IP-001 for injection

Participants will receive intratumoral injection of 1% IP-001 (diluted to 1 mg/mL, up to 12 mL total) into and around the treated tumor and ablated area immediately following IRE

Procedure: Irreversible Electroporation

Participants will undergo IRE of the tumor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability of IP-001 administered intratumorally following IRE
Time Frame: Day 0 to 90 days after treatment or the start of subsequent anti-cancer therapy, whichever comes first

Incidence, severity, and outcomes of adverse events assessed by CTCAE v4.0, clinical assessments, and laboratory test abnormalities, as well as a return to baseline patient reported outcomes.
Day 0 to 90 days after treatment or the start of subsequent anti-cancer therapy, whichever comes first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Months 12 and 24

Assessed from Treatment Day 0 to the first documented occurrence of progression (local or distant) or death, whichever comes first. Progression will be determined by the investigator's radiological review per RECIST v1.1
Months 12 and 24

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Robert C. Martin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Martin, MD, PhD, University of Louisville

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 Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26.0674

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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