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

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 - PANFIRE III

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55025

Enrollment

Registered

2020-06-02

Start date

2020-12-05

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver metastases Pancreatic cancer

Interventions

Arm A (control arm): 3x i.v. infusion of 240 mg Nivolumab every 2 weeks, starting at T=0 , followed by 480 mg Nivolumab every 4 weeks Arm B: Percutaneous computed tomography (CT)-guided IRE of the pr

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Brain metastasis - Active epilepsy (last convulsion 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%

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is safety/toxicity of the combination of Nivolumab with either IRE alone, or with IRE + CpG, in terms of (serious) adverse events.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)