GlioblastomaPhase 3EF-41NCT06556563
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
A Phase 3 study testing Optune® device, Temozolomide and Pembrolizumab in people with Glioblastoma, run by NovoCure GmbH at 102 sites in 12 countries.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Optune® device, Temozolomide and Pembrolizumab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 741 participants
- Where
- 102 sitesin 12 countries
- Study dates
- 3 Feb 2025to Apr 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant (or legally acceptable representative) has provided documented informed consent for the study.
- Be ≥ 18 years of age on day of providing informed consent.
- Participant with new diagnosis of GBM according to World Health Organization (WHO) 2021 Classification.
- 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.
- Have completed standard adjuvant chemoradiotherapy of radiotherapy (RT) according to local practice (56-64 Gy), and concomitant TMZ chemotherapy.
- Amenable to treatment with Optune concomitant with maintenance TMZ (150-200 mg/m^2 daily x 5, Q28 days).
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before randomization.
- Stable or decreasing dose of corticosteroids (dexamethasone ≤ 2mg or equivalent) for the last 7 days prior to randomization, if applicable.
Who cannot join
- 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).
- 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. Administration of killed vaccines are allowed.
- 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.
- 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.
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- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- 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.
- Infratentorial or leptomeningeal disease.
Trial locations and contacts
102 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
102 sites in 12 countries
United States36 sites
- Active, not recruiting
University of Maryland
Baltimore, Maryland, 21201
- Active, not recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
- Active, not recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
- Active, not recruiting
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45219
- Active, not recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Active, not recruiting
The Cleveland Clinic
Cleveland, Ohio, 44195
- Active, not recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Active, not recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
- Active, not recruiting
UF Health Neuromedicine
Gainesville, Florida, 32608
- Active, not recruiting
John Theurer Cancer Center/ Hackensack Meridian Health
Hackensack, New Jersey, 07601
- Active, not recruiting
The University of Texas
Houston, Texas, 77030
- Active, not recruiting
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
- Active, not recruiting
Mayo Clinic - Florida
Jacksonville, Florida, 32224
- Active, not recruiting
Northwell Health
Lake Success, New York, 11042
- Active, not recruiting
University of Kentucky Medical Center
Lexington, Kentucky, 40536
- Active, not recruiting
University of Southern California
Los Angeles, California, 90033
- Active, not recruiting
Norton Cancer Institute
Louisville, Kentucky, 40241
- Active, not recruiting
Miami Cancer Institute
Miami, Florida, 33176
- Active, not recruiting
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
- Active, not recruiting
Rutgers Cancer Institute of New Jersey University Hospital
New Brunswick, New Jersey, 08901
- Active, not recruiting
Columbia University Irving Medical Center
New York, New York, 10032
- Active, not recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
- Active, not recruiting
Stanford Cancer Institute
Palo Alto, California, 94305
- Active, not recruiting
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization
Philadelphia, Pennsylvania, 19107
- Active, not recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
- Active, not recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Active, not recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
- Active, not recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
- Active, not recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
- Active, not recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
- Active, not recruiting
University of California
San Francisco, California, 94143
- Active, not recruiting
Swedish Medical Center
Seattle, Washington, 98122
- Active, not recruiting
Washington University
St Louis, Missouri, 63110
- Active, not recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
- Active, not recruiting
Montefiore Medical Center- Montefiore Medical Park
The Bronx, New York, 10461
- Active, not recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Japan12 sites, 12 recruiting
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
Uz Stammberger, 1-877-678-8611, clinicaltrials@novocure.com
- Recruiting
Hokkaido University Hospital
Hokkaido, 060-8648
Uz Stammberger, 1-877-678-8611, clinicaltrials@novocure.com
- Recruiting
Tokai University Hospital
Isehara, Kanagawa, 259-1193
Masamichi Takahashi, +81-463-93-1121, masataka@tokai.ac.jp
- Recruiting
Kanazawa University Hospital
Ishikawa, 920-8641
Uz Stammberger, 1-877-678-8611, clinicaltrials@novocure.com
- Recruiting
Kumamoto University Hospital
Kumamoto, 860-8556
Uz Stammberger, 1-877-678-8611, clinicaltrials@novocure.com
- Recruiting
Kyoto University Hospital
Kyoto, 606-8507
Uz Stammberger, 1-877-678-8611, clinicaltrials@novocure.com
- Recruiting
Kyorin University Hospital
Mitaka, 181-8611
Uz Stammberger, 1-877-678-8611, clinicaltrials@novocure.com
- Recruiting
Nagoya University Hospital
Nagoya, 466-8560
Uz Stammberger, 1-877-678-8611, clinicaltrials@novocure.com
- Recruiting
Saitama Medical University International Medical Center
Saitama, 350-1298
Uz Stammberger, 1-877-678-8611, clinicaltrials@novocure.com
- Recruiting
Tohoku University Hospital
Sendai, 980-8574
Uz Stammberger, 1-877-678-8611, clinicaltrials@novocure.com
- Recruiting
National Cancer Center Hospital
Tokyo, 104-0045
Uz Stammberger, 1-877-678-8611, clinicaltrials@novocure.com
- Recruiting
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, 470-1192
Yuichi Hirose, 81562932111, yhirose@fujita-hu.ac.jp
United Kingdom11 sites
- Active, not recruiting
Queen Elizabeth
Birmingham, B15 2TH
- Active, not recruiting
Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)
Cambridge, CB2 0QQ
- Active, not recruiting
Velindre Cancer Centre
Cardiff, CF14 2TL
- Active, not recruiting
Western General Hospital
Edinburgh, EH4 2XU
- Active, not recruiting
The Clatterbridge Cancer Centre (Clatterbridge Cancer Centre NHS Foundation Trust)
Liverpool, L7 8YA
- Active, not recruiting
Charing Cross Hospital
London, Greater London, W6 8RF
- Active, not recruiting
The Christie Hospital
Manchester, M20 4BX
- Active, not recruiting
Mount Vernon Cancer Centre
Northwood, Middlesex, HA6 2RN
- Active, not recruiting
Weston Park Hospital
Sheffield, S10 2SJ
- Active, not recruiting
Southampton General Hospital
Southampton, SO16 6YD
- Active, not recruiting
Royal Marsden
Sutton, SM2 5PT
Spain10 sites
- Active, not recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Active, not recruiting
Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet)
Barcelona, 08908
- Active, not recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
- Active, not recruiting
Hospital Universitario Virgen de las Nieves
Granada, 18014
- Active, not recruiting
Hospital Universitario Clínico San Carlos
Madrid, Madrid, 28040
- Active, not recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
- Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Active, not recruiting
Hospital Universitario La Paz
Madrid, 28046
- Active, not recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
- Active, not recruiting
Hospital Universitari i Politécnic La Fe
Valencia, 46026
Canada7 sites, 7 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Jay Easaw, (403) 521-3031, jay.easaw@albertahealthservices.ca
- Recruiting
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Ronald Ramos, (905) 521-2100 ext. 44657, ramosr@hhsc.ca
- Recruiting
CHUM
Montreal, Quebec, H2X 3E4
Sarah Lapointe, 514-890-8000 ext. 26531, sarah.lapointe.chum@ssss.gouv.qc.ca
- Recruiting
Montreal Neurological Institute-Hospital, Clinical Research Unit
Montreal, Quebec, H3A 2B4
Bassam Abdulkarim, 514-934 1934 ext. 45461, bassam.abdulkarim@mcgill.ca
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Nicholas Garth, (613) 737-7700, gnicholas@toh.ca
- Recruiting
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie-CHUS)
Sherbrooke, Quebec, J1H 5N4
David Mathieu, (819) 346-1110 ext. 71113, david.mathieu@usherbrooke.ca
- Recruiting
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1
Warren Mason, (416) 946-2249, warren.mason@uhn.on.ca
Italy7 sites
- Active, not recruiting
Ospedale Bellaria
Bologna, 40139
- Active, not recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133
- Active, not recruiting
Ospedale del Mare
Naples, 80147
- Active, not recruiting
UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCS
Padova, 35128
- Active, not recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
- Active, not recruiting
U.O.C. Immunoterapia Oncologica A.O.U. Senese, Policlinico Santa Maria alle Scotte
Siena, 53100
- Active, not recruiting
Neuro-Oncologia Clinica Ospedale Molinette - AOU Città della Salute e della Scienza di Torino
Torino, Torino, 10126
France5 sites
- Active, not recruiting
Centre Hospitalier Universitaire de Lyon
Bron, 69500
- Active, not recruiting
Hopital de la Timone
Marseille, 13385
- Active, not recruiting
Hopital Saint-Louis
Paris, 75010
- Active, not recruiting
Groupe Hospitalier Pitie - Salpetriere
Paris, 75013
- Active, not recruiting
Institut Claudius Regaud
Toulouse, 31059
Israel4 sites
- Active, not recruiting
Rambam Medical Center
Haifa, 3109601
- Active, not recruiting
Rabin Medical Center- Beilinson Hospital
Petah Tikva, 4941492
- Active, not recruiting
Chaim Sheba Medical Center
Ramat Gan, 5265601
- Active, not recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Germany3 sites
- Active, not recruiting
Charité Campus Virchow-Klinikum
Berlin, 10117
- Active, not recruiting
Universitätsklinikum Essen
Essen, 45147
- Active, not recruiting
University Hospital Frankfurt
Frankfurt, 60528
Poland3 sites
- Active, not recruiting
Centrum Onkologii
Bydgoszcz, 85-796
- Active, not recruiting
Narodowy Instytut Onkologii
Gliwice, 44-102
- Active, not recruiting
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika-Zakład Teleradioterapii
Lodz, 93-513
Switzerland3 sites
- Active, not recruiting
University Hospital Basel Medical Oncology
Basel, 4031
- Active, not recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1005
- Active, not recruiting
University Hospital Zurich
Zurich, 8091
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant With Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant With Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58).
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).
- Conditions
- Glioblastoma
- Being tested
- Optune® device, Temozolomide, Pembrolizumab, Placebo
- Keywords
- TTFields, Pembrolizumab, Glioblastoma, Tumor Treating Fields, Immunotherapy, Merck Sharp & Dohme LLC, GBM, KEYNOTE D58, MK3475-D58
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optune® deviceDevice
Also called TTFields
Optune® device delivering TTFields therapy at 200 kHz.
TemozolomideDrug
Temozolomide per approved labeling.
PembrolizumabDrug
Also called KEYTRUDA®
Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
PlaceboDrug
Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Device: Optune® device; Drug: Temozolomide; Drug: Pembrolizumab |
| Control Group | Placebo comparator | Not described Receives: Device: Optune® device; Drug: Temozolomide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival (OS) is defined as the time from randomization to death due to any cause
Measured: 24 months
Secondary outcomes (2)
Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator
PFS is defined as the time interval, in months, between randomization and the first documented disease progression per RANO 2.0 assessed by investigator or death due to any cause, whichever occurs first.
Note: RANO 2.0 = Modified Radiographic Response Assessment in Neuro-Oncology
Measured: 24 months
Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator
PFS is defined as the time interval, in months, between randomization and the first documented disease progression per RANO 2.0 assessed by investigator or death due to any cause, whichever occurs first.
Note: RANO 2.0 = Response Assessment in Neuro-Oncology
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start3 Feb 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants in the study will be randomized in a ratio of 2:1 in favor of the treatment group to one of the following groups: Treatment Group - Optune concomitant with maintenance TMZ and pembrolizumab (KEYTRUDA®). Control Group - Optune concomitant with maintenance TMZ and placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 741 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovoCure GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556563
- Sponsor's protocol ID
- EF-41
- Other IDs
- 2024-513550-30-00, MK3475-D58, KEYNOTE D58
- Acronym
- EF-41
- Status last verified
- Feb 2026
- First submitted
- 13 Aug 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant With Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant With Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58).
- ClinicalTrials.gov ID
- NCT06556563
- Acronym / sponsor ID
- EF-41 / EF-41
- Conditions
- Glioblastoma
- Keywords
- TTFields, Pembrolizumab, Glioblastoma, Tumor Treating Fields, Immunotherapy, Merck Sharp & Dohme LLC, GBM, KEYNOTE D58
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 741 participants (estimated)
- Lead sponsor
- NovoCure GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants in the study will be randomized in a ratio of 2:1 in favor of the treatment group to one of the following groups: Treatment Group - Optune concomitant with maintenance TMZ and pembrolizumab (KEYTRUDA®). Control Group - Optune concomitant with maintenance TMZ and placebo.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Optune® device, Drug: Temozolomide, Drug: Pembrolizumab |
| Control Group | Placebo comparator | Device: Optune® device, Drug: Temozolomide, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The participant (or legally acceptable representative) has provided documented informed consent for the study.
- Be ≥ 18 years of age on day of providing informed consent.
- Participant with new diagnosis of GBM according to World Health Organization (WHO) 2021 Classification.
- 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.
- Have completed standard adjuvant chemoradiotherapy of radiotherapy (RT) according to local practice (56-64 Gy), and concomitant TMZ chemotherapy.
Key exclusion criteria (9 listed)
- 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).
- 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. Administration of killed vaccines are allowed.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optune® deviceAlso: TTFieldsOptune® device delivering TTFields therapy at 200 kHz. | Device | Control Group, Treatment Group |
| TemozolomideTemozolomide per approved labeling. | Drug | Control Group, Treatment Group |
| PembrolizumabAlso: KEYTRUDA®Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles. | Drug | Treatment Group |
| PlaceboPlacebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles. | Drug | Control Group |
Primary outcome
Overall survival
Time frame: 24 months
Overall survival (OS) is defined as the time from randomization to death due to any cause
2 secondary outcomes
Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator
Time frame: 24 months
Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
102 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Optune® device, Temozolomide and Pembrolizumab in people with Glioblastoma, run by NovoCure GmbH at 102 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites in United States, Japan, United Kingdom, Spain, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uz Stammberger (1-877-678-8611, clinicaltrials@novocure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.