MedTrace Logo

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

NCT06556563 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 741

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2029-04-30
Completion
2029-04-30
FDA Drug
Yes
FDA Device
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06556563 on ClinicalTrials.gov