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Trial record 7 of 3256 for:    Louisville

Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03080974
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):

February 14, 2017
March 15, 2017
October 23, 2017
August 14, 2017
June 1, 2021   (Final data collection date for primary outcome measure)
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
Overall Survival [ Time Frame: Every three month for 4 years. ]
Complete list of historical versions of study NCT03080974 on ClinicalTrials.gov Archive Site
  • Progression Free Survival [ Time Frame: Every three months for 4 years. ]
    CT scans will be reviewed
  • Overall Survival [ Time Frame: Every three months for 4 years. ]
    CT scans will be reviewed
Progression Free Survival [ Time Frame: Every three months for 4 years. ]
Not Provided
Not Provided
 
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.
Immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma. This is a II study in which all patients undergoing irreversible electroporation of locally advanced pancreatic adenocarcinoma will be treated with nivolumab post-operatively.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Intervention Model Description:
All patients will undergo irreversible electroporation and treatment with Nivolumab
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Adenocarcinoma
  • 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
Experimental: Single Arm
All patients undergoing irreversible electroporation will be treated with nivolumab
Interventions:
  • Drug: Nivolumab
  • Procedure: Irreversible Electroporation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
April 1, 2022
June 1, 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Marilyn Donaldson, RN 502-629-3323 marilyn.donaldson@louisville.edu
United States
 
 
NCT03080974
CA209-99G
Yes
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
Not Provided
Robert C. Martin, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Robert Martin, MD, PhD University of Louisville
University of Louisville
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP