Back to Trials
NCT06556563PHASE3Recruiting

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

NovoCure GmbH

Start Date

2/3/2025

Completion Date

4/1/2029

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Optune® device

DRUG

Temozolomide

DRUG

Pembrolizumab

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Glioblastoma

Locations

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