Phase 3 Study of Optune, Temozolomide, and Pembrolizumab for Newly Diagnosed Glioblastoma

This study is testing a new treatment combination for people recently diagnosed with glioblastoma (a type of brain cancer). It combines the Optune® device (which uses electric fields to fight cancer) with two medications: temozolomide (a chemotherapy drug) and pembrolizumab (an immunotherapy drug). Some participants will receive Optune®, temozolomide, and pembrolizumab, while others will receive Optune®, temozolomide, and a placebo (an inactive substance). The main goal is to see if this combination improves overall survival (how long people live). You may be able to join if you are 18 or older and have a new diagnosis of glioblastoma. The study plans to enroll 741 participants, but its current status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study with two groups, planning to enroll 741 participants. This means you would be randomly assigned to one of two treatment groups, and neither you nor your doctors would know which group you are in.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure overall survival at 24 months, indicating a follow-up period of at least two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06556563

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
NovoCure GmbH
~741 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Optune® deviceTemozolomidePembrolizumabPlacebo

At a glance

Recruiting sites
19 of 102 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival
Measured over 24 months
Glioblastoma
102 sites across 40 states
Japan10
Spain9
United Kingdom9
Italy6
France5
California4
Florida4
Israel4

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  • Overall survival24 months

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