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.
NovoCure GmbH
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator