Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Pancreatic Adenocarcinoma Clinical Trial

Official title:

Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03080974
• Other study ID #: 16.1190
• Status: Recruiting
• Phase: Phase 2
• Start date: August 14, 2017
• Est. completion date: April 1, 2026

Study information

• Verified date: November 2023
• Source: University of Louisville
• Contact: Marilyn Donaldson, RN
• Phone: 502-629-3323
• Email: marilyn.donaldson[@]louisville.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

Drug:
• Nivolumab
Given post-operatively every two weeks for a total of 4 doses. Dose based on weight.

Procedure:
• Irreversible Electroporation
Non-thermal ablation of tumor

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression Free Survival	CT scans will be reviewed	Every three months for 4 years.
Secondary	Overall Survival	CT scans will be reviewed	Every three months for 4 years.