clinical trial · NCT06556563
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
NovoCure GmbH·phase3·recruiting·n = 741
GlioblastomaOptune® deviceTemozolomidePembrolizumabPlacebo
brief 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).
started
Feb 3, 2025
primary completion
Apr 1, 2029
completion
Apr 1, 2029
last updated
Mar 13, 2026
official title
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).
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol