NCT05902169

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM

A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial of SonoCloud-9 Combined With Carboplatin (CBDCA) vs Standard of Care Lomustine (CCNU) or Temozolomide (TMZ) in Patients Undergoing Planned Resection for First Recurrence Glioblastoma.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: CarThera · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.

Conditions

• Glioblastoma
• Recurrent Glioblastoma
• GBM

Interventions

Type	Name	Description
DEVICE	SonoCloud-9 (SC9)	Implantation of SC9 device and repeat activation at constant acoustic pressure
DRUG	Carboplatin	Dose of carboplatin AUC 5 mg/ml.min-1 calculated using Calvert's formula: Dose (mg) = target AUC (mg/mL x minute) x \[glomerular filtration rate (GFR) mL/minute + 25\].
DRUG	Lomustine	Dosed and administered per labelling.
DRUG	Temozolomide	Dosed and administered per labelling.

Timeline

• Start date: 2024-01-29
• Primary completion: 2028-01-28
• Completion: 2028-06-30
• First posted: 2023-06-13
• Last updated: 2025-11-10

Locations

48 sites across 10 countries: United States, Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Spain, Switzerland

Regulatory

• FDA-regulated drug study