Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2021

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Single Arm
    • All patients undergoing irreversible electroporation will be treated with nivolumab

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Progression Free Survival
    • Time Frame: Every three months for 4 years.
    • CT scans will be reviewed
  • Overall Survival
    • Time Frame: Every three months for 4 years.
    • CT scans will be reviewed

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Louisville
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robert C. Martin, Principal Investigator – University of Louisville
  • Overall Official(s)
    • Robert Martin, MD, PhD, Principal Investigator, University of Louisville
  • Overall Contact(s)
    • Marilyn Donaldson, RN, 502-629-3323, marilyn.donaldson@louisville.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.