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RECRUITING

NCT06556563

PHASE3

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

Sponsor: NovoCure GmbH

View on ClinicalTrials.gov

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).

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

741

Start Date

2025-02-03

Completion Date

2029-04

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Glioblastoma

Interventions

DEVICE

Optune® device

Optune® device delivering TTFields therapy at 200 kHz.

DRUG

Temozolomide

Temozolomide per approved labeling.

DRUG

Pembrolizumab

Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

DRUG

Placebo

Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.

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.

Locations (82)

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

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

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 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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (82)