Description:
Compare the efficacy and tolerability of irreversible electroporation in combination with
Nivolumab in patients with locally advanced pancreatic cancer.
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
Drug | Synonyms | Arms |
---|
Nivolumab | | Single 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
Name | Type | Description | Interventions |
---|
Single Arm | Experimental | All patients undergoing irreversible electroporation will be treated with 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: | Active, not recruiting |
Lead Sponsor: | University of Louisville |
Trial Keywords
- irreversible electroporation
- Nivolumab
Last Updated
August 2, 2021