Newly Diagnosed Glioblastoma
Conditions
Interventions
Study intervention(s) will be administered by the investigator and/or study staff according to the specifications within the Pharmacy Manual.
The treatment(s) to be used in this study are outlined bel
Sponsors
Azuma Hisaya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The participant (or legally acceptable representative) has provided documented informed consent for the study. 2. Be > 18 years of age on day of providing informed consent. 3. Participant with new diagnosis of GBM according to WHO 2021 Classification. 4. Recovered from maximal debulking surgery (gross total resection, partial resection and biopsy-only patients are all acceptable), Gliadel wafers placement at the time of surgical resection is allowed. 5. Have completed standard adjuvant chemoradiotherapy of RT according to local practice (56-64 Gy), and concomitant TMZ chemotherapy. 6. Able to start treatment at least 4 weeks from the later of last dose of concomitant temozolomide or radiotherapy. 7. Amenable to treatment with NovoTTF-100A System concomitant with maintenance temozolomide (150-200 mg/m2 daily x 5, Q28 days). 8. All patients must have had tissue submitted for MGMT Promoter Methylation determination prior to randomization. 9. Have an ECOG Performance Status of 0 to 1 assessed within 7 days before randomization. 10. Life expectancy > 3 months. 11. Stable or decreasing dose of corticosteroids (dexamethasone < 2mg or equivalent) for the last 7 days prior to randomization, if applicable. 12. Have adequate organ function as defined in the following table. Specimens must be collected within 10 days prior to randomization. 13. A male participant is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: 14. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) b. Is a WOCBP and protocal. 15. Able to have MRI with contrast of the brain.
Exclusion criteria
Exclusion criteria: 1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137). 2. Ongoing requirement for >2 mg dexamethasone (or equivalent), due to intracranial mass effect. 3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization. Note: Participants must have recovered from all AEs due to previous therapies to Grade 3) to the experimental drug and/or any of its excipients. 9. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. 10. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 11. Has an active infection requiring systemic therapy. 12. Has a known history of human immunodeficiency virus (HIV), Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA (qualitative) is detected) infection Note: Hepatitis B and C screening tests are not required unless: Known history of HBV and HCV infection As mandated by local health authority 13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. 14. Has a known psychiatric or substance abuse disorder that would interfere with the part
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS will serve as primary efficacy endpoint in this study. OS is defined as the time from randomization to death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival per mRANO assessed by investigator Progression-Free Survival per RANO assessed by investigator Progression-Free Survival at 6 and 12 Months Next Progression-free survival (PFS2) 1- and 2-Year Survival Rates | — |
Countries
America, Canada, Czech, France, Germany, Israel, Italy, Japan, Poland, Spain, Switzerland, United Kingdom
Contacts
Public ContactHisaya Azuma
Novocure K.K.
Outcome results
None listed