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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (11 UK sites)
Charing Cross Hospital
London W6 8RF, United Kingdom
Mount Vernon Cancer Centre
Northwood HA6 2RN, United Kingdom
Queen Elizabeth
Birmingham B15 2TH, United Kingdom
Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)
Cambridge CB2 0QQ, United Kingdom
Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
The Clatterbridge Cancer Centre (Clatterbridge Cancer Centre NHS Foundation Trust)
Liverpool L7 8YA, United Kingdom
The Christie Hospital
Manchester M20 4BX, United Kingdom
Weston Park Hospital
Sheffield S10 2SJ, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
Royal Marsden
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Uz Stammberger
Sponsor contactCONTACT
