Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Giovanni Tommaselli 1-877-678-8611
clinicaltrials@novocure.com


Study Location:

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

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

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Glioblastoma


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2025 Apr 2029

INTERVENTIONAL

Intervention Type : DEVICE
Intervention Description : Optune® device delivering TTFields therapy at 200 kHz.

Intervention Arm Group : Control Group;Treatment Group;

Intervention Type : DRUG
Intervention Description : Temozolomide per approved labeling.

Intervention Arm Group : Control Group;Treatment Group;

Intervention Type : DRUG
Intervention Description : Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

Intervention Arm Group : Treatment Group;

Intervention Type : DRUG
Intervention Description : Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

Intervention Arm Group : Control Group;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Queen Elizabeth Hospital
    Birmingham
    B15 2TH
  • The Christie Hospital
    Manchester
    M20 4BX
  • Royal Marsden
    Sutton
    SM2 5PT
  • Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)
    Cambridge
    CB2 0QQ


The study is sponsored by NovoCure GmbH and is in collaboration with Merck Sharp & Dohme LLC.




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Read full details for Trial ID: NCT06556563
Last updated 22 July 2025

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