RecruitingRecruiting
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
NCT06556563 · NovoCure Ltd.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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).
About this study
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).
Eligibility 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.
Study design
Enrollment target: 741 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-02-03
Estimated completion: 2029-04
Last updated: 2026-08-19
Interventions
Device: Optune® deviceDrug: TemozolomideDrug: PembrolizumabDrug: Placebo
Primary outcomes
- • Overall survival (24 months)
Sponsor
NovoCure GmbH · industry
With: Merck Sharp & Dohme LLC
Contacts & investigators
ContactUz Stammberger · contact · clinicaltrials@novocure.com · 1-877-678-8611
All locations (102)
Mayo Clinic HospitalActive Not Recruiting
Phoenix, Arizona, United States
University of Southern CaliforniaActive Not Recruiting
Los Angeles, California, United States
Hoag Memorial Hospital PresbyterianActive Not Recruiting
Newport Beach, California, United States
Stanford Cancer InstituteActive Not Recruiting
Palo Alto, California, United States
University of CaliforniaActive Not Recruiting
San Francisco, California, United States
MedStar Georgetown University HospitalActive Not Recruiting
Washington D.C., District of Columbia, United States
UF Health NeuromedicineActive Not Recruiting
Gainesville, Florida, United States
Mayo Clinic - FloridaActive Not Recruiting
Jacksonville, Florida, United States
Miami Cancer InstituteActive Not Recruiting
Miami, Florida, United States
Moffitt Cancer CenterActive Not Recruiting
Tampa, Florida, United States
Northwestern Memorial HospitalActive Not Recruiting
Chicago, Illinois, United States
University of Kentucky Medical CenterActive Not Recruiting
Lexington, Kentucky, United States
Norton Cancer InstituteActive Not Recruiting
Louisville, Kentucky, United States
University of MarylandActive Not Recruiting
Baltimore, Maryland, United States
Tufts Medical CenterActive Not Recruiting
Boston, Massachusetts, United States
Masonic Cancer Center, University of MinnesotaActive Not Recruiting
Minneapolis, Minnesota, United States
Mayo Clinic - RochesterActive Not Recruiting
Rochester, Minnesota, United States
Washington UniversityActive Not Recruiting
St Louis, Missouri, United States
Renown Regional Medical CenterActive Not Recruiting
Reno, Nevada, United States
John Theurer Cancer Center/ Hackensack Meridian HealthActive Not Recruiting
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey University HospitalActive Not Recruiting
New Brunswick, New Jersey, United States
Northwell HealthActive Not Recruiting
Lake Success, New York, United States
Columbia University Irving Medical CenterActive Not Recruiting
New York, New York, United States
Montefiore Medical Center- Montefiore Medical ParkActive Not Recruiting
The Bronx, New York, United States
Duke University Medical CenterActive Not Recruiting
Durham, North Carolina, United States
University of Cincinnati Cancer InstituteActive Not Recruiting
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical CenterActive Not Recruiting
Cleveland, Ohio, United States
The Cleveland ClinicActive Not Recruiting
Cleveland, Ohio, United States
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials OrganizationActive Not Recruiting
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer CenterActive Not Recruiting
Pittsburgh, Pennsylvania, United States
Rhode Island HospitalActive Not Recruiting
Providence, Rhode Island, United States
The University of TexasActive Not Recruiting
Houston, Texas, United States
University of Texas, MD Anderson Cancer CenterActive Not Recruiting
Houston, Texas, United States
Huntsman Cancer Institute, University of UtahActive Not Recruiting
Salt Lake City, Utah, United States
Inova Schar Cancer InstituteActive Not Recruiting
Fairfax, Virginia, United States
Swedish Medical CenterActive Not Recruiting
Seattle, Washington, United States
Cross Cancer InstituteRecruiting
Edmonton, Alberta, Canada
Hamilton Health Sciences-Juravinski Cancer CentreRecruiting
Hamilton, Ontario, Canada
The Ottawa Hospital Cancer CentreRecruiting
Ottawa, Ontario, Canada
University Health Network - Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
CHUMRecruiting
Montreal, Quebec, Canada
Montreal Neurological Institute-Hospital, Clinical Research UnitRecruiting
Montreal, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie-CHUS)Recruiting
Sherbrooke, Quebec, Canada
Nemocnice Na HomolceActive Not Recruiting
Prague, Czechia
Centre Hospitalier Universitaire de LyonActive Not Recruiting
Bron, France
Hopital de la TimoneActive Not Recruiting
Marseille, France
Hopital Saint-LouisActive Not Recruiting
Paris, France
Groupe Hospitalier Pitie - SalpetriereActive Not Recruiting
Paris, France
Institut Claudius RegaudActive Not Recruiting
Toulouse, France
Charité Campus Virchow-KlinikumActive Not Recruiting
Berlin, Germany
Universitätsklinikum EssenActive Not Recruiting
Essen, Germany
University Hospital FrankfurtActive Not Recruiting
Frankfurt, Germany
Rambam Medical CenterActive Not Recruiting
Haifa, Israel
Rabin Medical Center- Beilinson HospitalActive Not Recruiting
Petah Tikva, Israel
Chaim Sheba Medical CenterActive Not Recruiting
Ramat Gan, Israel
Tel-Aviv Sourasky Medical CenterActive Not Recruiting
Tel Aviv, Israel
Neuro-Oncologia Clinica Ospedale Molinette - AOU Città della Salute e della Scienza di TorinoActive Not Recruiting
Torino, Torino, Italy
Ospedale BellariaActive Not Recruiting
Bologna, Italy
Fondazione IRCCS Istituto Neurologico Carlo BestaActive Not Recruiting
Milan, Italy
Ospedale del MareActive Not Recruiting
Naples, Italy
UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCSActive Not Recruiting
Padova, Italy
IRCCS Istituto Clinico HumanitasActive Not Recruiting
Rozzano, Italy
U.O.C. Immunoterapia Oncologica A.O.U. Senese, Policlinico Santa Maria alle ScotteActive Not Recruiting
Siena, Italy
Fujita Health University HospitalRecruiting
Toyoake-shi, Aichi-ken, Japan
Tokai University HospitalRecruiting
Isehara, Kanagawa, Japan
Kyushu University HospitalRecruiting
Fukuoka, Japan
Hokkaido University HospitalRecruiting
Hokkaido, Japan
Kanazawa University HospitalRecruiting
Ishikawa, Japan
Kumamoto University HospitalRecruiting
Kumamoto, Japan
Kyoto University HospitalRecruiting
Kyoto, Japan
Kyorin University HospitalRecruiting
Mitaka, Japan
Nagoya University HospitalRecruiting
Nagoya, Japan
Saitama Medical University International Medical CenterRecruiting
Saitama, Japan
Tohoku University HospitalRecruiting
Sendai, Japan
National Cancer Center HospitalRecruiting
Tokyo, Japan
Centrum OnkologiiActive Not Recruiting
Bydgoszcz, Poland
Narodowy Instytut OnkologiiActive Not Recruiting
Gliwice, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika-Zakład TeleradioterapiiActive Not Recruiting
Lodz, Poland
Hospital Universitario Clínico San CarlosActive Not Recruiting
Madrid, Madrid, Spain
Hospital Universitari Vall d'HebronActive Not Recruiting
Barcelona, Spain
Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet)Active Not Recruiting
Barcelona, Spain
Hospital Universitario Reina SofiaActive Not Recruiting
Córdoba, Spain
Hospital Universitario Virgen de las NievesActive Not Recruiting
Granada, Spain
Hospital Universitario Ramón y CajalActive Not Recruiting
Madrid, Spain
Hospital Universitario 12 de OctubreActive Not Recruiting
Madrid, Spain
Hospital Universitario La PazActive Not Recruiting
Madrid, Spain
Hospital Universitario Virgen del RocioActive Not Recruiting
Seville, Spain
Hospital Universitari i Politécnic La FeActive Not Recruiting
Valencia, Spain
University Hospital Basel Medical OncologyActive Not Recruiting
Basel, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)Active Not Recruiting
Lausanne, Switzerland
University Hospital ZurichActive Not Recruiting
Zurich, Switzerland
Charing Cross HospitalActive Not Recruiting
London, Greater London, United Kingdom
Mount Vernon Cancer CentreActive Not Recruiting
Northwood, Middlesex, United Kingdom
Queen ElizabethActive Not Recruiting
Birmingham, United Kingdom
Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)Active Not Recruiting
Cambridge, United Kingdom
Velindre Cancer CentreActive Not Recruiting
Cardiff, United Kingdom
Western General HospitalActive Not Recruiting
Edinburgh, United Kingdom
The Clatterbridge Cancer Centre (Clatterbridge Cancer Centre NHS Foundation Trust)Active Not Recruiting
Liverpool, United Kingdom
The Christie HospitalActive Not Recruiting
Manchester, United Kingdom
Weston Park HospitalActive Not Recruiting
Sheffield, United Kingdom
Southampton General HospitalActive Not Recruiting
Southampton, United Kingdom
Royal MarsdenActive Not Recruiting
Sutton, United Kingdom