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