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Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

University of Louisville (UOFL) logo

University of Louisville (UOFL)

Status and phase

Enrolling
Phase 2

Conditions

Pancreatic Adenocarcinoma

Treatments

Drug: Nivolumab
Procedure: Irreversible Electroporation

Study type

Interventional

Funder types

Other

Identifiers

NCT03080974
16.1190

Details and patient eligibility

About

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

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Single Arm
Experimental group
Description:
All patients undergoing irreversible electroporation will be treated with nivolumab
Treatment:
Procedure: Irreversible Electroporation
Drug: Nivolumab

Trial contacts and locations

1

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Central trial contact

Robert Martin, MD, PhD

Data sourced from clinicaltrials.gov

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