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).

NCT06556563 Phase 3 RECRUITING

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).

Details

Lead sponsor	NovoCure GmbH
Phase	Phase 3
Status	RECRUITING
Enrolment	741
Start date	2025-02-03
Completion	2029-04

Conditions

• Glioblastoma

Interventions

• Optune® device
• Temozolomide
• Pembrolizumab
• Placebo

Primary outcomes

• Overall survival — 24 months
  Overall survival (OS) is defined as the time from randomization to death due to any cause

Countries

United States, Canada, Czechia, France, Germany, Israel, Italy, Japan, Poland, Spain, Switzerland, United Kingdom