- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03080974
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
November 16, 2023 updated by: Robert C. Martin, University of Louisville
Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marilyn Donaldson, RN
- Phone Number: 502-629-3323
- Email: marilyn.donaldson@louisville.edu
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Recruiting
- University of Louisville
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
All patients undergoing irreversible electroporation will be treated with nivolumab
|
Given post-operatively every two weeks for a total of 4 doses.
Dose based on weight.
Non-thermal ablation of tumor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline thru 100 days after receiving last dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: Every three months for 4 years.
|
CT scans will be reviewed
|
Every three months for 4 years.
|
Overall Survival
Time Frame: Every three months for 4 years.
|
CT scans will be reviewed
|
Every three months for 4 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Martin, MD, PhD, University of Louisville
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2017
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
February 14, 2017
First Submitted That Met QC Criteria
March 8, 2017
First Posted (Actual)
March 15, 2017
Study Record Updates
Last Update Posted (Actual)
November 18, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16.1190
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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