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NCT Number: NCT03080974

Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

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

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Key information

Conditions

Pancreatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

Location status: Recruiting

About this study

Immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma. This is a Phase II study in which all patients undergoing irreversible electroporation of locally advanced pancreatic adenocarcinoma will be treated with nivolumab post-operatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

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

irreversible electroporation

Procedure

Non-thermal ablation of tumor

Primary outcomes

  1. Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment

    Time frame: Baseline thru 100 days after receiving last dose

    Adverse events and Serious adverse events will be collected

Secondary outcomes

  1. Progression Free Survival

    Time frame: Every three months for 4 years.

    CT scans will be reviewed

  2. Overall Survival

    Time frame: Every three months for 4 years.

    CT scans will be reviewed

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Martin, MD, PhD

CONTACT

[email protected]

502-629-3355

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Important dates

Study start
2017
Primary completion
2028
Study completion
2029
First posted
Mar 15, 2017
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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