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Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03080974
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : February 15, 2018
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab
U.S. FDA Resources

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 ClinicalTrials.gov identifier (NCT number): NCT03080974

Contact: Marilyn Donaldson, RN 502-629-3323 marilyn.donaldson@louisville.edu

United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Principal Investigator: Robert Martin, MD, PhD University of Louisville

Responsible Party: Robert C. Martin, Principal Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT03080974     History of Changes
Other Study ID Numbers: CA209-99G
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: September 2017

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:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents