Combining immunotherapy with irreversible electroporation for advanced pancreatic cancer
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
This study is testing if combining a special cancer treatment called irreversible electroporation with the immunotherapy drug Nivolumab can help people with advanced pancreatic cancer do better than with standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Drugs / interventions | Nivolumab, Immunotherapy |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT03080974 on ClinicalTrials.gov |
What this trial studies
This Phase II study evaluates the effectiveness and safety of using irreversible electroporation in conjunction with the immunotherapy drug Nivolumab for patients with locally advanced pancreatic adenocarcinoma. Patients will undergo irreversible electroporation followed by treatment with Nivolumab to assess the combined impact on tumor response. The study aims to determine if this combination can improve outcomes compared to standard treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with stage III pancreatic cancer who have measurable tumors.
Not a fit: Patients who are pregnant, breastfeeding, or have certain medical devices or recent cardiac events may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option that enhances the effectiveness of therapy for patients with advanced pancreatic cancer.
How similar studies have performed: While the combination of immunotherapy and irreversible electroporation is a novel approach, similar studies have shown promise in enhancing treatment efficacy for other cancers.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Louisville, Kentucky
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Robert Martin, MD, PhD — University of Louisville
- Study coordinator: Robert Martin, MD, PhD
- Email: robert.martin@louisville.edu
- Phone: 502-629-3355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.