Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

NCT03080974 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 16.1190
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Adenocarcinoma

Keywords

irreversible electroporation; Nivolumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression Free Survival

  Every three months for 4 years.

• Overall Survival

  Every three months for 4 years.

Study Arms (1)

Single Arm

EXPERIMENTAL

All patients undergoing irreversible electroporation will be treated with nivolumab

Drug: Nivolumab; Procedure: Irreversible Electroporation

Interventions

Nivolumab DRUG

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

Single Arm

Irreversible Electroporation PROCEDURE

Non-thermal ablation of tumor

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Interventions

Nivolumab; Electroporation

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Robert Martin, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Martin, MD, PhD

CONTACT

502-629-3355; robert.martin@louisville.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients will undergo irreversible electroporation and treatment with Nivolumab

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: March 15, 2017
• Study Start: August 14, 2017
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (1)