Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Sponsor: University of Louisville

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03080974

This Phase II study evaluates the efficacy and tolerability of combining irreversible electroporation with Nivolumab in patients with stage III pancreatic cancer. Eligible participants are adults with measurable tumors and adequate renal function. Exclusions include recent myocardial infarction and certain implants. Nivolumab is administered post-operatively every two weeks for four doses.

Patient Parameters

Program Overview

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

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.

Eligibility Criteria

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

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