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RECRUITING Phase 3 ClinicalTrials.gov

EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Sponsor: NovoCure GmbH • ClinicalTrials.gov ID: NCT06556563

Registry updated: 2026-08-19
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Description

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).

Interventions

  • Optune® device (Device)
    Optune® device delivering TTFields therapy at 200 kHz.
  • Temozolomide (Drug)
    Temozolomide per approved labeling.
  • Pembrolizumab (Drug)
    Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
  • Placebo (Drug)
    Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

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.

Conditions

Glioblastoma

Locations

  • 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
  • University of California — San Francisco, California, United States
  • MedStar Georgetown University Hospital — Washington D.C., District of Columbia, 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
  • Norton Cancer Institute — Louisville, 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
  • Renown Regional Medical Center — Reno, Nevada, United States
  • John Theurer Cancer Center/ Hackensack Meridian Health — Hackensack, New Jersey, United States
  • Rutgers Cancer Institute of New Jersey University Hospital — New Brunswick, 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 of Cincinnati Cancer Institute — Cincinnati, Ohio, 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
  • Cross Cancer Institute — Edmonton, Alberta, Canada
  • Hamilton Health Sciences-Juravinski Cancer Centre — Hamilton, Ontario, Canada
  • The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada
  • University Health Network - Princess Margaret Cancer Centre — Toronto, Ontario, Canada
  • CHUM — Montreal, Quebec, Canada
  • Montreal Neurological Institute-Hospital, Clinical Research Unit — 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) — Sherbrooke, Quebec, Canada
  • 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
  • Neuro-Oncologia Clinica Ospedale Molinette - AOU Città della Salute e della Scienza di Torino — Torino, Torino, Italy
  • Ospedale Bellaria — Bologna, Italy
  • Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy
  • Ospedale del Mare — Naples, Italy
  • UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCS — Padova, Italy
  • IRCCS Istituto Clinico Humanitas — Rozzano, Italy
  • U.O.C. Immunoterapia Oncologica A.O.U. Senese, Policlinico Santa Maria alle Scotte — Siena, Italy
  • Fujita Health University Hospital — Toyoake-shi, Aichi-ken, Japan
  • Tokai University Hospital — Isehara, Kanagawa, Japan
  • 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
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika-Zakład Teleradioterapii — Lodz, Poland
  • Hospital Universitario Clínico San Carlos — Madrid, Madrid, Spain
  • 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
  • Charing Cross Hospital — London, Greater London, United Kingdom
  • Mount Vernon Cancer Centre — Northwood, Middlesex, United Kingdom
  • 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 Clatterbridge Cancer Centre (Clatterbridge Cancer Centre NHS Foundation Trust) — Liverpool, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record