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Study details
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EF-41/KEYNOTE D58: Phase 3 Trial of Optune With Temozolomide and Pembrolizumab

NovoCure GmbH
NCT IDNCT06556563ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

741

Study length

about 4.2 years

Ages

18+

Locations

30 sites in AZ, CA, FL +16

What this study is about

This trial is testing whether using the Optune device with maintenance Temozolomide chemotherapy agent and pembrolizumab improves survival compared to using the Optune device with maintenance Temozolomide chemotherapy agent and placebo in people who have newly diagnosed Glioblastoma. The primary goal of it is to see if it increases overall survival.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Pembrolizumab
  • 2.Take Placebo
  • 3.Take Temozolomide
  • +1 more

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IVInjection / IV

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer), temozolomide

Drug routes

infusion, injection, intravenous

Endpoints

Primary: Overall survival

Secondary: Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator

Body systems

Oncology