A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubble-mediated Focused Ultrasound (FUS-MB) Using NaviFUS System in Recurrent Glioblastoma Multiforme Patients

Recruiting now · Phase 3

Conditions studied: Glioblastoma Multiforme, Glioblastoma, Glioblastoma Multiforme, Adult, Glioma, Brain Tumor, Brain Tumor, Recurrent, Neoplasms, Neoplasms, Nerve Tissue

In brief

This will be a prospective, randomized, standard of care (SoC) controlled, parallel, open-label, multicenter pivotal study to investigate the efficacy and safety of Bevacizumab (BEV) in combination with or without microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.

Key facts

Study ID

NCT06496971

Run by

NaviFUS Corporation

People needed

32

Starts

2024-11-08

Expected to finish

2027-03-31

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients ≥ 18 years of age at the time of study enrollment.
• Body mass index (BMI) ≥ 17 kg/m2.
• Patients diagnosed with glioblastoma must have unequivocal evidence of recurrence, as determined by contrast-enhanced magnetic resonance imaging (CE-MRI), following prior radiotherapy and temozolomide chemotherapy.
• Patients may have undergone surgery for recurrence. The patients should have completed surgery and adequately recovered prior to the time of study enrollment.
• Patients must have radiographic evidence of either at least an 80% resection of enhancing tumor following recurrence or a maximal measurable residual tumor ≤ 20 cm3.
• If patients are receiving corticosteroids, they must have been on a stable or decreasing dose of corticosteroids for at least 1 week prior to the planned first treatment.
• At the time of study enrollment, the minimum interval since the last event:
• 4 weeks out from invasive procedures (e.g., open biopsy, surgical resection, significant traumatic injury, or any other major surgery involving entry into a body cavity) and the patient must have recovered from the effects of surgery
• 1 week out from minor surgical procedures or core biopsies
• Patients must have recovered from the toxic effects of prior therapy at the time of study enrollment as follows:
• 4 weeks out from any investigational drug or device
• 4 weeks out from chemotherapy
• 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., Carmustine (BCNU))
• 12 weeks out from completion of radiotherapy
• Patients should have a life expectancy ≥ 12 weeks.
• Patients must have Karnofsky Performance Status (KPS) ≥ 70.
• Adequate hematopoietic, renal, hepatic, and coagulation function, defined as:
• Hemoglobin ≥ 10 g/dL
• Platelets ≥ 100,000/mm3
• Neutrophils ≥ 1,500/mm3
• Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
• Urine protein creatinine ratio (UPCR) < 1 or urine dipstick for proteinuria ≤ 2+
• Alanine aminotransferase (ALT) < 3 × ULN
• Aspartate aminotransferase (AST) < 3 × ULN
• Total bilirubin (TBL) < 2 × ULN

You may not qualify if…

• Patients who have radiographic evidence of multifocal enhancing tumors.
• Patients who have undergone previous treatment with anti-angiogenic therapy, including Bevacizumab, or other VEGF inhibitors or VEGF-receptor signaling inhibitors.
• Patients who have previously received Carmustine wafers implantation during re-operation.
• Patients who have previously received or are currently undergoing tumor treating fields (TTF) treatment.
• Uncontrolled or significant cardiovascular disease, including any of the following:
• New York Heart Association (NYHA) Grade II or above congestive heart failure (CHF) within 12 months prior to study enrollment
• Unstable angina pectoris
• Medical history of myocardial infarction within 6 months prior to study enrollment
• Cardiac shunt
• Stroke (except for transient ischemic attack; TIA) within 6 months prior to study enrollment.
• Patients with implanted electronic device, for example, implanted cardioverter-defibrillator (ICD), cardiac pacemaker, permanent medication pumps, cochlear implants, responsive neurostimulator (RNS), deep brain stimulation (DBS), or other electronic devices implanted in the brain. Patients with contraindications for MRI as judged by Investigator, including non-MRI compatible metallic implant(s).
• Patients with inadequately controlled hypertension, defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg while on medication, within 2 weeks prior to first treatment.
• Patients with evidence of any thrombotic or hemorrhagic events, including but not limited to:
• Inherited bleeding diathesis or significant coagulopathy with the risk of bleeding (i.e., in the absence of therapeutic anticoagulation).
• History of pulmonary haemorrhage/haemoptysis ≥ grade 2 according to the CTCAE version 5.0 criteria within 1 month prior to study enrollment
• Arterial or venous thrombosis (e.g., pulmonary embolism) within 3 months prior to study enrollment
• Patients with unstable pulmonary disease or chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study enrollment.
• Patients who have psychiatric illness/social situations that would limit compliance with study requirements.
• Known HIV-positive patient, however, that HIV testing is not required for entry into this study.
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study enrollment.
• History or evidence of active gastroduodenal ulcer, gastrointestinal perforations/fistula, or intra-abdominal abscess within 6 months prior to study enrollment.
• Receiving anticoagulant (e.g., warfarin or LMW heparin) or antiplatelet (e.g., aspirin) therapy within 1 week prior to beginning treatment.
• Known sensitivity/allergy to Magnetic Resonance Imaging (MRI) contrast agents, Computer Tomography (CT) contrast agents, SonoVue®, Bevacizumab, or any of their components.
• Pregnant (positive pregnancy test) or breast-feeding women.
• Use of any recreational drugs or history of drug addiction.

Where it is running

• National Taiwan University Hospital — Taipei, Taiwan (enrolling)
• Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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