Pancreatic Adenocarcinoma
Conditions
Keywords
irreversible electroporation, Nivolumab
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.
Interventions
DRUGNivolumab
Given post-operatively every two weeks for a total of 4 doses. Dose based on weight.
PROCEDUREIrreversible Electroporation
Non-thermal ablation of tumor
Sponsors
University of Louisville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All patients will undergo irreversible electroporation and treatment with Nivolumab
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment | Baseline thru 100 days after receiving last dose | Adverse events and Serious adverse events will be collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | Every three months for 4 years. | CT scans will be reviewed |
| Overall Survival | Every three months for 4 years. | CT scans will be reviewed |
Countries
United States
Contacts
Primary ContactRobert Martin, MD, PhD
Outcome results
None listed