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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: 2026-03-13
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 (82)
Mayo Clinic HospitalRecruiting
Phoenix, Arizona, United States
University of Southern CaliforniaRecruiting
Los Angeles, California, United States
Hoag Memorial Hospital PresbyterianRecruiting
Newport Beach, California, United States
Stanford Cancer InstituteRecruiting
Palo Alto, California, United States
UF Health NeuromedicineRecruiting
Gainesville, Florida, United States
Mayo Clinic - FloridaRecruiting
Jacksonville, Florida, United States
Miami Cancer InstituteRecruiting
Miami, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Northwestern Memorial HospitalRecruiting
Chicago, Illinois, United States
University of Kentucky Medical CenterRecruiting
Lexington, Kentucky, United States
University of MarylandRecruiting
Baltimore, Maryland, United States
Tufts Medical CenterRecruiting
Boston, Massachusetts, United States
Masonic Cancer Center, University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Mayo Clinic - RochesterRecruiting
Rochester, Minnesota, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
John Theurer Cancer Center/ Hackensack Meridian HealthRecruiting
Hackensack, New Jersey, United States
Northwell HealthRecruiting
Lake Success, New York, United States
Columbia University Irving Medical CenterRecruiting
New York, New York, United States
Montefiore Medical Center- Montefiore Medical ParkRecruiting
The Bronx, New York, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
The Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials OrganizationRecruiting
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Rhode Island HospitalRecruiting
Providence, Rhode Island, United States
The University of TexasRecruiting
Houston, Texas, United States
University of Texas, MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Huntsman Cancer Institute, University of UtahRecruiting
Salt Lake City, Utah, United States
Inova Schar Cancer InstituteRecruiting
Fairfax, Virginia, United States
Swedish Medical CenterRecruiting
Seattle, Washington, United States
Nemocnice Na HomolceRecruiting
Prague, Czechia
Centre Hospitalier Universitaire de LyonRecruiting
Bron, France
Hopital de la TimoneRecruiting
Marseille, France
Hopital Saint-LouisRecruiting
Paris, France
Groupe Hospitalier Pitie - SalpetriereRecruiting
Paris, France
Institut Claudius RegaudRecruiting
Toulouse, France
Charité Campus Virchow-KlinikumRecruiting
Berlin, Germany
Universitätsklinikum EssenRecruiting
Essen, Germany
University Hospital FrankfurtRecruiting
Frankfurt, Germany
Rambam Medical CenterRecruiting
Haifa, Israel
Rabin Medical Center- Beilinson HospitalRecruiting
Petah Tikva, Israel
Chaim Sheba Medical CenterRecruiting
Ramat Gan, Israel
Tel-Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Ospedale BellariaRecruiting
Bologna, Italy
Fondazione IRCCS Istituto Neurologico Carlo BestaRecruiting
Milan, Italy
Ospedale del MareRecruiting
Naples, Italy
UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCSRecruiting
Padova, Italy
IRCCS Istituto Clinico HumanitasRecruiting
Rozzano, Italy
U.O.C. Immunoterapia Oncologica A.O.U. Senese, Policlinico Santa Maria alle ScotteRecruiting
Siena, Italy
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 OnkologiiRecruiting
Bydgoszcz, Poland
Narodowy Instytut OnkologiiRecruiting
Gliwice, Poland
Hospital Universitario Clínico San CarlosEnrolling By Invitation
Madrid, Madrid, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet)Recruiting
Barcelona, Spain
Hospital Universitario Reina SofiaRecruiting
Córdoba, Spain
Hospital Universitario Virgen de las NievesRecruiting
Granada, Spain
Hospital Universitario Ramón y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Universitario Virgen del RocioRecruiting
Seville, Spain
Hospital Universitari i Politécnic La FeRecruiting
Valencia, Spain
University Hospital Basel Medical OncologyRecruiting
Basel, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)Recruiting
Lausanne, Switzerland
University Hospital ZurichRecruiting
Zurich, Switzerland
Queen ElizabethRecruiting
Birmingham, United Kingdom
Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)Recruiting
Cambridge, United Kingdom
Velindre Cancer CentreRecruiting
Cardiff, United Kingdom
Western General HospitalRecruiting
Edinburgh, United Kingdom
The Christie HospitalRecruiting
Manchester, United Kingdom
Weston Park HospitalRecruiting
Sheffield, United Kingdom
Southampton General HospitalRecruiting
Southampton, United Kingdom
Royal MarsdenRecruiting
Sutton, United Kingdom