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Bevacizumab and NaviFUS System in Recurrent Glioblastoma Multiforme
NCT06329570Phase 2
Key facts
- Status
- Suspended
- Start
- Oct 2024
- Primary completion
- Dec 2027
- Countries
- 1
- Sponsor
- NaviFUS
- Modality
- Monoclonal Antibodies
- Conditions
- glioblastoma multiforme (GBM)
01
Overview
Phase 2, open-label, single-arm trial of bevacizumab and sulfur hexafluoride in glioblastoma multiforme (GBM), sponsored by NaviFUS. Primary endpoint: Adverse Events at 52 weeks. Started Oct 2024; status: suspended.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
FUS-MB+BEV
FUS treatment administered after BEV infusion to facilitate BBB opening.
03
Who it enrols
Adult patients with recurrent glioblastoma multiforme following prior radiotherapy and temozolomide, with adequate organ function and KPS >= 70, excluding those with prior anti-angiogenic therapy or significant cardiovascular/electronic device implants.
04
Endpoints
Primary
Adverse Events
Secondary
6-month Progression-Free Survival
Progression-Free Survival
One-year Survival Rate
Overall Survival
Objective Response Rate
Clinical Benefit Rate
Local Disease Control on the MRI Images
Corticosteroid Consumption
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