Recruiting
Phase 2

Immunotherapy & Irreversible Electroporation

Sponsor:

University of Louisville

Code:

NCT03080974

Conditions

Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nivolumab

Irreversible Electroporation

Study Details

Brief summary:

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

Conditions

Pancreatic Adenocarcinoma

Study ID

NCT03080974

Start date

Aug 14, 2017

Status verified date

Oct, 2025

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥ 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Arm

All patients undergoing irreversible electroporation will be treated with nivolumab

Interventions

Nivolumab

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

Irreversible Electroporation

Non-thermal ablation of tumor

Primary outcome measure

  • Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment [ Time Frame: Baseline thru 100 days after receiving last dose ]

Central Contacts and Locations

Central contacts

Robert Martin, MD, PhD

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

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

More Information

Sponsor

University of Louisville

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • irreversible electroporation
  • Nivolumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2025-10-29.