EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
NCT ID: NCT06556563
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
741 participants
INTERVENTIONAL
2025-02-03
2029-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Treatment Group - Optune concomitant with maintenance TMZ and pembrolizumab.
Control Group - Optune concomitant with maintenance TMZ and placebo.
TREATMENT
QUADRUPLE
Study Groups
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Treatment Group
Optune® device
Optune® device delivering TTFields therapy at 200 kHz.
Temozolomide
Temozolomide per approved labeling.
Pembrolizumab
Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Control Group
Optune® device
Optune® device delivering TTFields therapy at 200 kHz.
Temozolomide
Temozolomide per approved labeling.
Placebo
Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Interventions
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Optune® device
Optune® device delivering TTFields therapy at 200 kHz.
Temozolomide
Temozolomide per approved labeling.
Pembrolizumab
Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Placebo
Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
NovoCure GmbH
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Hospital
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
UF Health Neuromedicine
Gainesville, Florida, United States
Mayo Clinic - Florida
Jacksonville, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
John Theurer Cancer Center/ Hackensack Meridian Health
Hackensack, New Jersey, United States
Northwell Health
Lake Success, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Montefiore Medical Center- Montefiore Medical Park
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
The University of Texas
Houston, Texas, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Nemocnice Na Homolce
Prague, , Czechia
Centre Hospitalier Universitaire de Lyon
Bron, , France
Hopital de la Timone
Marseille, , France
Hopital Saint-Louis
Paris, , France
Groupe Hospitalier Pitie - Salpetriere
Paris, , France
Institut Claudius Regaud
Toulouse, , France
Charité Campus Virchow-Klinikum
Berlin, , Germany
Universitätsklinikum Essen
Essen, , Germany
University Hospital Frankfurt
Frankfurt, , Germany
Rambam Medical Center
Haifa, , Israel
Rabin Medical Center- Beilinson Hospital
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Ospedale Bellaria
Bologna, , Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
Ospedale del Mare
Napoli, , Italy
UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCS
Padua, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano, , Italy
Kyushu University Hospital
Fukuoka, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Kanazawa University Hospital
Ishikawa, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
Kyorin University Hospital
Mitaka, , Japan
Nagoya University Hospital
Nagoya, , Japan
Saitama Medical University International Medical Center
Saitama, , Japan
Tohoku University Hospital
Sendai, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Centrum Onkologii
Bydgoszcz, , Poland
Narodowy Instytut Onkologii
Gliwice, , Poland
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet)
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitari i Politécnic La Fe
Valencia, , Spain
University Hospital Basel Medical Oncology
Basel, , Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Queen Elizabeth
Birmingham, , United Kingdom
Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)
Cambridge, , United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
The Christie Hospital
Manchester, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Royal Marsden
Sutton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Simon Khagi
Role: primary
Role: backup
Other Identifiers
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EF-41
Identifier Type: -
Identifier Source: org_study_id
2024-513550-30-00
Identifier Type: CTIS
Identifier Source: secondary_id
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