EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant With Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant With Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58).
NovoCure GmbH
741 participants
Feb 3, 2025
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Plain Language Summary
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Interventions
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.
Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Locations(93)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06556563