Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM

Completed · Not applicable

Conditions studied: Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT04471844

Run by

NovoCure Ltd.

People needed

981

Starts

2020-12-08

Expected to finish

2026-02-19

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of GBM according to WHO 2016 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 randomization
• Is able to have MRI with contrast of the brain

You may not qualify if…

• 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.
• Additional malignancies that are progressing or required active treatment in the last two years.
• 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 put the participant at risk according to the investigator.
• Standard TTFields exclusion criteria include
• Active implanted medical devices
• Bullet fragments
• Skull defects

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Mayo Clinic- Arizona — Phoenix, Arizona, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Providence St. Joseph Medical Center and The Roy and Patricia Disney Family Cancer Center — Burbank, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• TRIO - St. Jude Heritage Healthcare/St. Jude Medical Center — Fullerton, California, United States
• University of California at San Diego - Moores Cancer Center — La Jolla, California, United States
• Norris Comprehensive Cancer Center at USC — Los Angeles, California, United States
• Cedars - Sinai Medical Center — Los Angeles, California, United States
• Hoag Memorial Hospital - Hoag Cancer Center — Newport Beach, California, United States
• St. Joseph Hospital of Orange — Orange, California, United States
• University of California - Irvine/UCI Medical Center — Orange, California, United States
• Stanford University Cancer Institute — Palo Alto, California, United States
• Sharp Memorial Hospital - X-Ray Medical Group Radiation Oncology — San Diego, California, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• John Wayne Cancer Institute at St. John's Health Center — Santa Monica, California, United States
• University of Colorado Cancer Center Anschutz — Aurora, Colorado, United States
• HCA Research Institute - Blue Sky Neurology - Denver — Englewood, Colorado, United States
• Hartford Healthcare Medical Group - Hartford Hospital The Gray Cancer Center — Hartford, Connecticut, United States
• Lynn Cancer Institute, Marcus Neuroscience Institute — Boca Raton, Florida, United States
• Baptist Health - Jacksonville — Jacksonville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• AdventHealth — Orlando, Florida, United States
• Grandview Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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