Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

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

Detailed Description
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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.

Official Title
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Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Conditions
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Pancreatic Adenocarcinoma

Intervention / Treatment
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* Drug: Nivolumab
* Procedure: Irreversible Electroporation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All patients will undergo irreversible electroporation and treatment with Nivolumab
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>All patients undergoing irreversible electroporation will be treated with nivolumab | Drug: Nivolumab<br>* Given post-operatively every two weeks for a total of 4 doses. Dose based on weight.<br>Procedure: Irreversible Electroporation<br>* Non-thermal ablation of tumor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment | Adverse events and Serious adverse events will be collected | Baseline thru 100 days after receiving last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | CT scans will be reviewed | Every three months for 4 years. | 
| Overall Survival | CT scans will be reviewed | Every three months for 4 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irreversible electroporation, Nivolumab