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

PHASE3RecruitingINTERVENTIONAL
Enrollment

741

Participants

Timeline

Start Date

February 3, 2025

Primary Completion Date

April 30, 2029

Study Completion Date

April 30, 2029

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.

Trial Locations (64)

4031

RECRUITING

University Hospital Basel Medical Oncology, Basel

8091

RECRUITING

University Hospital Zurich, Zurich

10032

RECRUITING

Columbia University Irving Medical Center, New York

10461

RECRUITING

Montefiore Medical Center- Montefiore Medical Park, The Bronx

11042

RECRUITING

Northwell Health, Lake Success

13385

RECRUITING

Hopital de la Timone, Marseille

15232

RECRUITING

UPMC Hillman Cancer Center, Pittsburgh

18014

RECRUITING

Hospital Universitario Virgen de las Nieves, Granada

19107

RECRUITING

Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization, Philadelphia

21201

RECRUITING

University of Maryland, Baltimore

22031

RECRUITING

Inova Schar Cancer Institute, Fairfax

27710

RECRUITING

Duke University Medical Center, Durham

28034

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

31059

RECRUITING

Institut Claudius Regaud, Toulouse

32224

RECRUITING

Mayo Clinic - Florida, Jacksonville

32608

RECRUITING

UF Health Neuromedicine, Gainesville

33176

RECRUITING

Miami Cancer Institute, Miami

33612

RECRUITING

Moffitt Cancer Center, Tampa

40536

RECRUITING

University of Kentucky Medical Center, Lexington

41013

RECRUITING

Hospital Universitario Virgen del Rocio, Seville

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

44195

RECRUITING

The Cleveland Clinic, Cleveland

45147

RECRUITING

Universitätsklinikum Essen, Essen

46026

RECRUITING

Hospital Universitari i Politécnic La Fe, Valencia

55455

RECRUITING

Masonic Cancer Center, University of Minnesota, Minneapolis

55905

RECRUITING

Mayo Clinic - Rochester, Rochester

63110

RECRUITING

Washington University, St Louis

64239

RECRUITING

Tel-Aviv Sourasky Medical Center, Tel Aviv

69500

RECRUITING

Centre Hospitalier Universitaire de Lyon, Bron

75010

RECRUITING

Hopital Saint-Louis, Paris

75013

RECRUITING

Groupe Hospitalier Pitie - Salpetriere, Paris

77030

RECRUITING

The University of Texas, Houston

RECRUITING

University of Texas, MD Anderson Cancer Center, Houston

84112

RECRUITING

Huntsman Cancer Institute, University of Utah, Salt Lake City

85054

RECRUITING

Mayo Clinic Hospital, Phoenix

90033

RECRUITING

University of Southern California, Los Angeles

92663

RECRUITING

Hoag Memorial Hospital Presbyterian, Newport Beach

94305

RECRUITING

Stanford Cancer Institute, Palo Alto

98122

RECRUITING

Swedish Medical Center, Seattle

4941492

RECRUITING

Rabin Medical Center- Beilinson Hospital, Petah Tikva

5265601

RECRUITING

Chaim Sheba Medical Center, Ramat Gan

02111

RECRUITING

Tufts Medical Center, Boston

07601

RECRUITING

John Theurer Cancer Center/ Hackensack Meridian Health, Hackensack

02903

RECRUITING

Rhode Island Hospital, Providence

150 30

RECRUITING

Nemocnice Na Homolce, Prague

812-8582

RECRUITING

Kyushu University Hospital, Fukuoka

060-8648

RECRUITING

Hokkaido University Hospital, Hokkaido

920-8641

RECRUITING

Kanazawa University Hospital, Ishikawa

860-8556

RECRUITING

Kumamoto University Hospital, Kumamoto

606-8507

RECRUITING

Kyoto University Hospital, Kyoto

181-8611

RECRUITING

Kyorin University Hospital, Mitaka

466-8560

RECRUITING

Nagoya University Hospital, Nagoya

350-1298

RECRUITING

Saitama Medical University International Medical Center, Saitama

980-8574

RECRUITING

Tohoku University Hospital, Sendai

104-0045

RECRUITING

National Cancer Center Hospital, Tokyo

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

08908

RECRUITING

Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet), Barcelona

CB2 0QQ

RECRUITING

Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust), Cambridge

EH4 2XU

RECRUITING

Western General Hospital, Edinburgh

M20 4BX

RECRUITING

The Christie Hospital, Manchester

S10 2SJ

RECRUITING

Weston Park Hospital, Sheffield

SO16 6YD

RECRUITING

Southampton General Hospital, Southampton

SM2 5PT

RECRUITING

Royal Marsden, Sutton

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

NovoCure GmbH

INDUSTRY