Clinical Trial

EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Study acronym: EF-41
Recruiting Phase 3
View on ClinicalTrials.gov →
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).
Protocol Amendment History 2 changes
notable Trial sites expanded: 93 -> 102 locations 2026-07-23
notable Trial sites expanded: 82 -> 93 locations 2026-05-02
Trial Details
NCT Number NCT06556563
Lead Sponsor NovoCure GmbH
Collaborators: Merck Sharp & Dohme LLC
Conditions Glioblastoma
Enrollment 741 participants
Start Date 2025-02-03
Primary Completion 2029-04 (estimated)
Study Completion 2029-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-22