drugset / Trial / NCT04612530

PANFIRE-3 Trial: Assessing Safety and Efficacy of Irreversible Electroporation (IRE) + Nivolumab + CpG for Metastatic Pancreatic Cancer

NCT04612530 ↗

Phase 1 Unknown 18 enrolled Amsterdam UMC, location VUmc
RandomizedParallel-groupOpen-labelTreatment

Summary

Irreversible electroporation is a local ablative technique used in the treatment of pancreatic cancer. In addition to its cytoreductive ability, IRE also induces a systemic immune response. However, this immune response is not potent enough to establish durable regression of the tumor. The immune response can be leveraged by combining IRE with immunotherapy. The primary aim of this study is to determine the safety of IRE + Nivolumab (arm B) and IRE + Nivolumab + CpG (arm C). The secondary aim is to assess efficacy of the experimental arms (B, C) and control arm A (Nivolumab monotherapy), based on overall and progression-free survival as well as locoregional and systemic immune modulation.

Timeline

Start
2020-09-01
Primary completion
2023-04-01
Completion
2023-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject CpG Oligonucleotide (other) — —
Subject Nivolumab Monoclonal antibody 480 mg —