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

Prior treatment

• Prior radiation treatment to the brain for the treatment of GBM

Other illness

• Progressive disease (per investigator's assessment)
• Infratentorial or leptomeningeal disease
• Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
• 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.
• Known allergies to medical adhesives or hydrogel
• Any serious surgical/post-operative condition that may put the participant at risk according to the investigator.

Lab values

• 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

Other

• Participation in another clinical treatment study during the pre-treatment and/or the treatment phase of the study
• Pregnancy or breast-feeding.
• Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
• Admitted to an institution by administrative or court order.
• A skull defect (such as, missing bone with no replacement)
• Standard TTFields exclusion criteria include
  • Active implanted medical devices
  • Bullet fragments
  • Skull defects

• 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

Criteria the registry did not label

• \*Age Limits - 18 years or older outside of the US, 22 years or older within the US.