NCT06556563

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).

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 741 (estimated)
• Sponsor: NovoCure GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DEVICE	Optune® device	Optune® device delivering TTFields therapy at 200 kHz.
DRUG	Temozolomide	Temozolomide per approved labeling.
DRUG	Pembrolizumab	Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
DRUG	Placebo	Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

Timeline

• Start date: 2025-02-03
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2024-08-16
• Last updated: 2026-03-13

Locations

82 sites across 11 countries: United States, Czechia, France, Germany, Israel, Italy, Japan, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study