Irreversible electroporation and Nivolumab combined with intratumoral administration of a toll like receptor ligand as a means of in vivo vaccination for metastatic pancreatic cancer

Recruiting

Conditions: Liver metastases
Pancreatic cancer
10017990
10017991

Registration Number: NL-OMON55025

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

- Radiological and histopathologically proven stage IV pancreatic cancer
(according to the AJCC staging system for pancreatic cancer)
- Primary metastatic disease, defined as at least 1 bioptable metastasis.
- Maximum of 5 unequivocal metasases of 1cm or larger may be present at the
time of inclusion (i.e., after chemotherapy).
- Primary tumor is in situ.
- A minimum of 4 cycles of FOLFIRINOX chemotherapy is required but with the
explicit aim to strive for completion of 8 cycles of FOLFIRINOX before study
inclusion, with at least stable disease on CTscan.
- A recovery periodof 4-6 weeks after final administration of FOLIRINOX is
mandatory
- Age >= 18 years.
- World Health Organisation scale (WHO) performance status 0 - 2;
- Adequate bile drainage in case of biliary obstruction.

Exclusion Criteria

- Brain metastasis
- Active epilepsy (last convulsion < 5 years);
- History of cardiac disease:Congestive heart failure > NYHA Class 2
- Active autoimmune disease requiring disease-modifying therapy at the time of
screening: i.e. > 10 mg prednisolone per day or equivalent to this regimen.
- Previous surgical therapy for pancreatic cancer
- Any implanted stimulation device
- Portal vein or VMS stenosis > 70%, or any arterial stenosis (AMS, celiac
artery, common hepatic artery) > 70%

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of the study is safety/toxicity of the combination of<br /><br>Nivolumab with either IRE alone, or with IRE + CpG, in terms of (serious)<br /><br>adverse events. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are efficacy of Nivolumab combined with either IRE alone, or<br /><br>with IRE + CpG compared to Nivolumab monotherapy (control arm) in terms of<br /><br>overall survival, progression free survival, observable response based on<br /><br>imaging: decrease of tumor diameter and/or decrease in tracer uptake in primary<br /><br>and distant (metastatic) lesions, biological response based on histopathology<br /><br>and immunohistochemistry from tissue samples and tumor markers, and<br /><br>immunomodulation based on immune monitoring of blood samples, quality of life<br /><br>and pain scores.</p><br>