Clinical Trials /

Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

NCT03080974

Description:

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

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-99G
  • NCT ID: NCT03080974

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DrugSynonymsArms
NivolumabSingle Arm

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Single ArmExperimentalAll patients undergoing irreversible electroporation will be treated with nivolumab
  • 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment
Time Frame:Baseline thru 100 days after receiving last dose
Safety Issue:
Description:Adverse events and Serious adverse events will be collected

Secondary Outcome Measures

Measure:Progression Free Survival
Time Frame:Every three months for 4 years.
Safety Issue:
Description:CT scans will be reviewed
Measure:Overall Survival
Time Frame:Every three months for 4 years.
Safety Issue:
Description:CT scans will be reviewed

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Louisville

Trial Keywords

  • irreversible electroporation
  • Nivolumab

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