Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer

Sponsor
Ismail Gögenur
Study ID
NCT05435053
Phase
PHASE2
Status
Terminated

Conditions

  • Pancreas Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Every 2 weeks (3 mg/kg, maximum of 240 mg) for up to 24 weeks Nivolumab is an immune checkpoint inhibitor (PD-1-inhibitor).
  • Irreversible electroporation (IRE) — DEVICE
    Percutaneous ablation of a primary in-situ (or locally-recurrent) or metastatic lesion. Irreversible electroporation is delivered through the NanoKnife system (AngioDynamics, New York, USA). The system is FDA-approved for medical use.

Study Details

The trial investigates the safety and efficacy of irreversible electroporation in combination with checkpoint inhibition in patients with metastatic pancreatic cancer.

Key Dates

Start date
Sep 8, 2022
Status verified
Sep 2023
Primary completion
Aug 30, 2023
Completion
Aug 30, 2023

Study Design

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

Arms

  • Experimental: IRE + Nivolumab
    IRE on Day 1, followed by Nivolumab on Day 2/3 and then every 2 weeks (q2w) for a maximum of 24 weeks.

Primary Outcome Measure

Incidence of treatment related adverse events [Safety and Tolerability] [ Time Frame: 6 months after start of treatment ]

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