Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way
to increase efficacy and give further insights in early immunological mechanisms.
In the first phase Ib part, 20 patients will be enrolled and followed for a minimum of 3
months. An independent data safety monitoring board (DSMB) will continuously review safety
and judge the seriousness of the events and also recommend the study to stop if necessary. If
the DSMB do not find safety issues, the trial will continue as a phase II trial.