NCT03080974PHASE2Recruiting
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
University of Louisville
Start Date
8/14/2017
Completion Date
4/1/2029
Summary
Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DRUG
Nivolumab
PROCEDURE
Irreversible Electroporation
Conditions
Pancreatic Adenocarcinoma
Locations
University of Louisville
Louisville, Kentucky 40202
United States