Irreversible Electroporation (IRE) Followed by Nivolumab in Patients With Metastatic Pancreatic Cancer.

Sponsor
University Hospital, Basel, Switzerland
Study ID
NCT04212026
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    The patients start treatment with nivolumab on day 1 after IRE and will be given nivolumab at a flat dose of 240 mg every 2 weeks (q2wk) for 5 cycles until Week 8.

Study Details

This proof of concept trial aims to assess whether the combination of IRE with Nivolumab is safe and effective to treat metastatic pancreatic cancer, based on the available preliminary evidence that IRE is able to cause a systemic anti-tumor immune response (i.e. abscopal effect), which may enhance the effect of subsequent Nivolumab treatment. In addition, the trial aims to clarify the systemic effects of IRE over time and thereby to provide more insight in the mechanism of work of the technique.

Key Dates

Start date
Jun 28, 2020
Status verified
Jul 2023
Primary completion
Jul 12, 2023
Completion
Jul 12, 2023

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Nivolumab treatment will be given every 2 weeks at a standard flat dose of 240 mg for a total of 5 doses, and the IRE procedure will be performed using the standard setting to ablate tumors at the level of the liver that is well tolerated by the patients. Two weeks after the last dose of nivolumab ("Week 8"), radiological restaging will be performed (="Week 10").

Primary Outcome Measure

The objective response rate (ORR) after the 5th dose of nivolumab of the reference liver metastasis that was not biopsied. [ Time Frame: At 2-4 weeks after the 5th dose of nivolumab ]

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