Back to resultsImmunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Primary Purpose
Pancreatic Adenocarcinoma
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nivolumab
Irreversible Electroporation
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring irreversible electroporation, Nivolumab
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
Sites / Locations
- University of Louisville
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
All patients undergoing irreversible electroporation will be treated with nivolumab
Outcomes
Primary Outcome Measures
Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment
Adverse events and Serious adverse events will be collected
Secondary Outcome Measures
Progression Free Survival
CT scans will be reviewed
Overall Survival
CT scans will be reviewed
Full Information
NCT ID
NCT03080974
First Posted
February 14, 2017
Last Updated
October 24, 2022
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT03080974
Brief Title
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Official Title
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
Keywords
irreversible electroporation, Nivolumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
All patients will undergo irreversible electroporation and treatment with Nivolumab
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
All patients undergoing irreversible electroporation will be treated with nivolumab
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Given post-operatively every two weeks for a total of 4 doses. Dose based on weight.
Intervention Type
Procedure
Intervention Name(s)
Irreversible Electroporation
Intervention Description
Non-thermal ablation of tumor
Primary Outcome Measure Information:
Title
Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment
Description
Adverse events and Serious adverse events will be collected
Time Frame
Baseline thru 100 days after receiving last dose
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
CT scans will be reviewed
Time Frame
Every three months for 4 years.
Title
Overall Survival
Description
CT scans will be reviewed
Time Frame
Every three months for 4 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Martin, MD, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
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