Immunotherapy and Irreversible Electroporation in the Tre... | NCT03080974

Studies
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

NCT03080974

Sponsor

University of Louisville

Status

Recruiting

Last Update Posted

Oct 29, 2025Actual

Enrollment

10Estimated

Phase

Phase 2

Conditions

Pancreatic Adenocarcinoma

Interventions

Nivolumab
Irreversible Electroporation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 14, 2017Actual

Primary Completion Date

Jun 1, 2028Estimated

Completion Date

Apr 1, 2029Estimated

First Submitted Date

Feb 14, 2017

First Submission Date that Met QC Criteria

Mar 8, 2017

First Posted Date

Mar 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2025

Last Update Posted Date

Oct 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental	All patients undergoing irreversible electroporation will be treated with nivolumab	Drug: Nivolumab Procedure: Irreversible Electroporation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Drug	Given post-operatively every two weeks for a total of 4 doses. Dose based on weight.	Single Arm

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robert Martin, MD, PhD	Contact	502-629-3355		robert.martin@louisville.edu

Overall Officials

Name	Affiliation	Role
Robert Martin, MD, PhD	University of Louisville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Louisville	Recruiting	Louisville	Kentucky	40202	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000077594	Nivolumab
D018274	Electroporation

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided