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Looking for participantsPhase3

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

Sponsor: NovoCure GmbH

NCT ID: NCT06556563

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Optune® device (device), Temozolomide (drug), Pembrolizumab (drug), Placebo (drug)
How long the study runs
Study runs about 50 months (dates as stated)
About the drug or intervention
Optune® device — device: Optune® device delivering TTFields therapy at 200 kHz. · Temozolomide — drug: Temozolomide per approved labeling. · Pembrolizumab — drug: Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles. · Placebo — drug: Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Patient visit burden
Not specified by the sponsor

In plain English

This phase 3 study looks at whether Optune, a device-based treatment, can help adults newly diagnosed with glioblastoma (a type of brain tumour) when used together with two medicines: temozolomide and pembrolizumab. Glioblastoma is a fast-growing brain cancer. The study is run by NovoCure GmbH.

Who can take part

  • Adults aged 18 or over who have given informed consent (personally or through a legal representative)
  • Newly diagnosed glioblastoma, confirmed using the World Health Organization 2021 classification
  • Recovered from surgery to remove as much of the tumour as possible (full removal, partial removal, or biopsy only are all acceptable, but Gliadel wafers are not allowed)
  • Completed standard radiotherapy (56-64 Gy) together with temozolomide chemotherapy
  • Able to have Optune treatment alongside maintenance temozolomide (150-200 mg/m² daily for 5 days, every 28 days)
  • Good day-to-day functioning (Eastern Cooperative Oncology Group performance status of 0 to 1) checked within 7 days before joining
  • On a stable or reducing dose of steroid tablets (2 mg dexamethasone or less, or equivalent) for the last 7 days before joining, if applicable

Who may not be able to

  • Previous treatment with certain immunotherapy drugs (anti-PD-1, anti-PD-L1, anti-PD-L2) or drugs targeting other immune system switches (such as CTLA-4, OX 40, CD137)
  • Needing more than 2 mg dexamethasone (or equivalent) because of pressure from the tumour in the brain
  • Having had other anti-cancer treatment, including experimental drugs, within 4 weeks before joining
  • Having had a live or live-weakened vaccine within 30 days before the first study treatment (killed vaccines are allowed)
  • Taking part in another study of an experimental drug or device within 4 weeks before the first study treatment
  • Having a diagnosed immune deficiency, taking long-term high-dose steroids (more than 10 mg prednisone equivalent daily) or other immune-suppressing treatment within 7 days of the first dose
  • Having another cancer that is growing or needed treatment in the past 3 years
  • Past or current inflammation of the lungs (pneumonitis or interstitial lung disease) that needed steroids
  • Early worsening of the disease after finishing radiotherapy and temozolomide (extra scans may be done to check)
  • Tumour in the lower back part of the brain or spread to the linings of the brain and spinal cord

What taking part involves

  • • Optune, a wearable treatment device, used at the same time as temozolomide chemotherapy
  • • Maintenance temozolomide tablets (150-200 mg/m² daily for 5 days, repeated every 28 days)
  • • Pembrolizumab, an immunotherapy medicine given as part of the study

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
741
Started
2025-02-03
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for glioblastoma
  • • Phase3 - 741 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with glioblastoma

Where?

  • • London - Charing Cross Hospital
  • • Northwood - Mount Vernon Cancer Centre
  • • Birmingham - Queen Elizabeth
  • • Cambridge - Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)
  • • +7 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Glioblastoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PD-L1CD137

What the study is looking for

  • ✓The participant (or legally acceptable representative) has provided documented agreement to take part for the study.
  • ✓Be ≥ 18 years of age on day of providing agreement to take part.
  • ✓Participant with new diagnosis of GBM according to World Health Organization (WHO) 2021 Classification.
  • ✓Have completed standard after surgery chemoradiotherapy of radiotherapy (RT) according to local practice (56-64 Gy), and...
  • ✓Amenable to treatment with Optune concomitant with maintenance TMZ (150-200 mg/m\^2 daily x 5, Q28 days).

Who cannot take part

  • ✗Ongoing requirement for \>2 mg dexamethasone (or equivalent), due to intracranial mass effect.
  • ✗Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.
  • ✗Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention....
  • ✗Is currently participating in or has participated in a study of an investigational agent or has used an...
  • ✗Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current...
See the full criteria
Inclusion Criteria: 1. The participant (or legally acceptable representative) has provided documented informed consent for the study. 2. Be ≥ 18 years of age on day of providing informed consent. 3. Participant with new diagnosis of GBM according to World Health Organization (WHO) 2021 Classification. 4. Recovered from maximal debulking surgery (gross total resection, partial resection and biopsy-only patients are all acceptable), Gliadel wafers placement at the time of surgical resection is not allowed. 5. Have completed standard adjuvant chemoradiotherapy of radiotherapy (RT) according to local practice (56-64 Gy), and concomitant TMZ chemotherapy. 6. Amenable to treatment with Optune concomitant with maintenance TMZ (150-200 mg/m\^2 daily x 5, Q28 days). 7. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before randomization. 8. Stable or decreasing dose of corticosteroids (dexamethasone ≤ 2mg or equivalent) for the last 7 days prior to randomization, if applicable. Exclusion Criteria: 1. Has received prior therapy with an anti-Programmed Cell Death 1 (PD-1), anti- Programmed Cell Death-Ligand 1(PD-L1), or anti Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.Cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4), OX 40, CD137). 2. Ongoing requirement for \>2 mg dexamethasone (or equivalent), due to intracranial mass effect. 3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization. 4. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. 5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first study treatment. 6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. 7. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 8. Early progressive disease after the end of TMZ/RT. If pseudo progression is suspected, additional imaging studies should be performed to rule out true progression. 9. Infratentorial or leptomeningeal disease.

Where Is This Study? (11 UK sites)

Charing Cross Hospital

London W6 8RF, United Kingdom

ACTIVE_NOT_RECRUITING

Mount Vernon Cancer Centre

Northwood HA6 2RN, United Kingdom

ACTIVE_NOT_RECRUITING

Queen Elizabeth

Birmingham B15 2TH, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Tom Dymond

research&development@qehkl.nhs.uk01553 613532

Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)

Cambridge CB2 0QQ, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

The Clatterbridge Cancer Centre (Clatterbridge Cancer Centre NHS Foundation Trust)

Liverpool L7 8YA, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

The Christie Hospital

Manchester M20 4BX, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Weston Park Hospital

Sheffield S10 2SJ, United Kingdom

ACTIVE_NOT_RECRUITING

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Royal Marsden

Sutton SM2 5PT, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Uz Stammberger

Sponsor contact

CONTACT

1-877-678-8611 clinicaltrials@novocure.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-02