Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM
About the study
To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Histologically confirmed diagnosis of GBM according to WHO classification criteria.
- Age ≥ 22 years in US and Age ≥ 18 years in Ex-US
- Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection, and biopsy-only patients are all acceptable)
- Planned treatment with RT/TMZ followed by TTFields and maintenance TMZ (150-200 mg/m2 daily x 5 d, q28 days)
- Karnofsky performance status ≥ 70
- Life expectancy ≥ least 3 months
- Participants of childbearing age must use highly effective contraception. An effective method of birth control is defined as one that results in a failure rate of less than 1% per year when used consistently and correctly. The Investigator must approve the selected method, and may consult with a gynecologist as needed.
- All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
- Stable or decreasing dose of corticosteroids for the last 7 days prior to randomization, if applicable.
- Concomitant RT with TMZ treatment planned to start no later than 8 weeks from surgery
- Women of childbearing potential must have a negative β-HCG pregnancy test documented within 14 days prior to registration
- Is able to have MRI with contrast of the brain
EXCLUSION CRITERIA
Exclusion Criteria:
- Progressive disease (per investigator's assessment)
- Infratentorial or leptomeningeal disease
- Participation in another clinical treatment study during the pre-treatment and/or the treatment phase of the study
- Pregnancy or breast-feeding.
Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment, as determined by the investigator:
- Thrombocytopenia (platelet count < 100 x 103/μL)
- Neutropenia (absolute neutrophil count < 1.5 x 103/μL)
- CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
- Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
- Total bilirubin > 1.5 x upper limit of normal
- Significant renal impairment (serum creatinine > 1.7 mg/dL, or > 150 µmol/l)
- History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
- Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
- Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.
- Any other cytotoxic or biologic anti-tumor therapy received prior to enrollment will be considered exclusion.
- Admitted to an institution by administrative or court order.
- Known allergies to medical adhesives or hydrogel
- A skull defect (such as, missing bone with no replacement)
- Prior radiation treatment to the brain for the treatment of GBM
- Any serious surgical/post-operative condition that may risk the patient according to the investigator
Standard TTFields exclusion criteria include
- Active implanted medical devices
- Bullet fragments
- Skull defects
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Glioblastoma Multiforme
Age (in years)
18+
Phase
Not Applicable
Participants Needed
950
Est. Completion Date
Aug 31, 2026
Treatment Type
Interventional
Sponsor
NovoCure Ltd.
ClinicalTrials.gov NCT Identifier
NCT04471844
Study Number
TRIDENT EF-32
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