Safety and Efficacy of Sonocloud Device Combined With Nivolumab in Brain Metastases From Patients With Melanoma
Status:
Recruiting
Trial end date:
2023-07-05
Target enrollment:
Participant gender:
Summary
Anti PD-1 monoclonal antibodies (nivolumab and pembrolizumab) alone or in association with
antiCTLA4 (Ipilimumab) are established as indisputable treatment of metastatic melanoma, with
unprecedented overall survival, and are indicated for first-line treatment including patients
with BRAF mutation. Given their high molecular weight, their penetration in the brain
sanctuary is uncertain and relies on disruption of the Blood Brain Barrier (BBB) which occurs
occasionally.
SonoCloud® is an implantable device delivering low intensity pulsed UltraSound (US). Along
with systemic injection of an US resonator, SonoCloud® demonstrated safe and efficient at
repetitively opening the BBB. The investigators anticipate that BBB opening could help at
increasing brain penetration of monoclonal antibodies and potentially boosting immunity in
the brain. This could translate in controlling brain disease with the same magnitude as for
extra-cranial disease. This would also open avenues for optimizing the treatment of brain
metastases in combination with checkpoint inhibitors in many other cancers.