This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).
The participant (or legally acceptable representative) has provided documented informed consent for the study.
Be ≥ 18 years of age on day of providing informed consent.
Participant with new diagnosis of GBM according to World Health Organization (WHO) 2021 Classification.
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 not allowed.
Has received prior therapy with an anti-Programmed Cell Death 1 (PD-1), anti- Programmed Cell Death-Ligand 1(PD-L1), or anti Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.Cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4), OX 40, CD137).
Ongoing requirement for >2 mg dexamethasone (or equivalent), due to intracranial mass effect.
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Parallel
Optune® device
DeviceOptune® device delivering TTFields therapy at 200 kHz.
Temozolomide
DrugTemozolomide per approved labeling.
Pembrolizumab
DrugPembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Placebo
DrugPlacebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Overall survival
Overall survival (OS) is defined as the time from randomization to death due to any cause
Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator
PFS is defined as the time interval, in months, between randomization and the first documented disease progression per RANO 2.0 assessed by investigator or death due to any cause, whichever occurs first. Note: RANO 2.0 = Modified Radiographic Response Assessment in Neuro-Oncology
Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator
PFS is defined as the time interval, in months, between randomization and the first documented disease progression per RANO 2.0 assessed by investigator or death due to any cause, whichever occurs first. Note: RANO 2.0 = Response Assessment in Neuro-Oncology
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NovoCure GmbH
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
