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Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03080974
Recruitment Status : Active, not recruiting
First Posted : March 15, 2017
Last Update Posted : October 8, 2021
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville

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

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Drug: Nivolumab Procedure: Irreversible Electroporation Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients will undergo irreversible electroporation and treatment with Nivolumab
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : April 1, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Single Arm
All patients undergoing irreversible electroporation will be treated with nivolumab
Drug: Nivolumab
Given post-operatively every two weeks for a total of 4 doses. Dose based on weight.

Procedure: Irreversible Electroporation
Non-thermal ablation of tumor

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03080974

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United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
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Principal Investigator: Robert Martin, MD, PhD University of Louisville
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Responsible Party: Robert C. Martin, Principal Investigator, University of Louisville Identifier: NCT03080974    
Other Study ID Numbers: 16.1190
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Robert C. Martin, University of Louisville:
irreversible electroporation
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action