EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
EF-41
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).
2 other identifiers
interventional
741
12 countries
102
Brief 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) patients. The primary objective of the study is to evaluate the Overall Survival (OS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2025
Typical duration for phase_3
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2024
CompletedFirst Posted
Study publicly available on registry
August 16, 2024
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
July 22, 2026
February 1, 2026
4.2 years
August 13, 2024
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Overall survival (OS) is defined as the time from randomization to death due to any cause
24 months
Secondary Outcomes (2)
Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator
24 months
Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator
24 months
Study Arms (2)
Treatment Group
EXPERIMENTALControl Group
PLACEBO COMPARATORInterventions
Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Optune® device delivering TTFields therapy at 200 kHz.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLCcollaborator
- NovoCure GmbHlead
Study Sites (102)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
University of Southern California
Los Angeles, California, 90033, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Stanford Cancer Institute
Palo Alto, California, 94305, United States
University of California
San Francisco, California, 94143, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
UF Health Neuromedicine
Gainesville, Florida, 32608, United States
Mayo Clinic - Florida
Jacksonville, Florida, 32224, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Norton Cancer Institute
Louisville, Kentucky, 40241, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
John Theurer Cancer Center/ Hackensack Meridian Health
Hackensack, New Jersey, 07601, United States
Rutgers Cancer Institute of New Jersey University Hospital
New Brunswick, New Jersey, 08901, United States
Northwell Health
Lake Success, New York, 11042, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Montefiore Medical Center- Montefiore Medical Park
The Bronx, New York, 10461, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization
Philadelphia, Pennsylvania, 19107, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The University of Texas
Houston, Texas, 77030, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1, Canada
CHUM
Montreal, Quebec, H2X 3E4, Canada
Montreal Neurological Institute-Hospital, Clinical Research Unit
Montreal, Quebec, H3A 2B4, Canada
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, Canada
Nemocnice Na Homolce
Prague, 150 30, Czechia
Centre Hospitalier Universitaire de Lyon
Bron, 69500, France
Hopital de la Timone
Marseille, 13385, France
Hopital Saint-Louis
Paris, 75010, France
Groupe Hospitalier Pitie - Salpetriere
Paris, 75013, France
Institut Claudius Regaud
Toulouse, 31059, France
Charité Campus Virchow-Klinikum
Berlin, 10117, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
University Hospital Frankfurt
Frankfurt, 60528, Germany
Rambam Medical Center
Haifa, 3109601, Israel
Rabin Medical Center- Beilinson Hospital
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Neuro-Oncologia Clinica Ospedale Molinette - AOU Città della Salute e della Scienza di Torino
Torino, Torino, 10126, Italy
Ospedale Bellaria
Bologna, 40139, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133, Italy
Ospedale del Mare
Naples, 80147, Italy
UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCS
Padova, 35128, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, 20089, Italy
U.O.C. Immunoterapia Oncologica A.O.U. Senese, Policlinico Santa Maria alle Scotte
Siena, 53100, Italy
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, 470-1192, Japan
Tokai University Hospital
Isehara, Kanagawa, 259-1193, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Hokkaido University Hospital
Hokkaido, 060-8648, Japan
Kanazawa University Hospital
Ishikawa, 920-8641, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Kyorin University Hospital
Mitaka, 181-8611, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
Saitama Medical University International Medical Center
Saitama, 350-1298, Japan
Tohoku University Hospital
Sendai, 980-8574, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
Centrum Onkologii
Bydgoszcz, 85-796, Poland
Narodowy Instytut Onkologii
Gliwice, 44-102, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika-Zakład Teleradioterapii
Lodz, 93-513, Poland
Hospital Universitario Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet)
Barcelona, 08908, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitari i Politécnic La Fe
Valencia, 46026, Spain
University Hospital Basel Medical Oncology
Basel, 4031, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1005, Switzerland
University Hospital Zurich
Zurich, 8091, Switzerland
Charing Cross Hospital
London, Greater London, W6 8RF, United Kingdom
Mount Vernon Cancer Centre
Northwood, Middlesex, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2024
First Posted
August 16, 2024
Study Start
February 3, 2025
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
July 22, 2026
Record last verified: 2026-02