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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
741
Optune® device delivering TTFields therapy at 200 kHz.
Temozolomide per approved labeling.
Pembrolizumab 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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Mayo Clinic Hospital
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITINGUniversity of Southern California
Los Angeles, California, United States
ACTIVE_NOT_RECRUITINGHoag Memorial Hospital Presbyterian
Newport Beach, California, United States
ACTIVE_NOT_RECRUITINGStanford Cancer Institute
Palo Alto, California, United States
ACTIVE_NOT_RECRUITINGUniversity of California
San Francisco, California, United States
ACTIVE_NOT_RECRUITINGMedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
ACTIVE_NOT_RECRUITINGUF Health Neuromedicine
Gainesville, Florida, United States
ACTIVE_NOT_RECRUITINGMayo Clinic - Florida
Jacksonville, Florida, United States
ACTIVE_NOT_RECRUITINGMiami Cancer Institute
Miami, Florida, United States
ACTIVE_NOT_RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
ACTIVE_NOT_RECRUITING...and 92 more locations