EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Nowo zdiagnozowany glejak mózgu (według klasyfikacji WHO 2021)
- •Wyleczony po operacji mózgu (niezależnie od zakresu usunięcia guza)
- •Ukończona standardowa radioterapia i chemioterapia
- •Możliwość leczenia Optune z chemioterapią
- •Dobra ogólna kondycja pacjenta (ocena ECOG 0-1)
- •Stabilna lub zmniejszająca się dawka leków sterydowych przez ostatnie 7 dni
✗ Disqualifies
- •Poprzednie leczenie immunoterapią (przeciw PD-1, PD-L1, PD-L2 lub CTLA-4)
- •Potrzeba wysokich dawek sterydów (powyżej 2 mg deksametazonu) z powodu obrzęku mózgu
- •Poprzednia chemioterapia lub testy nowych leków w ciągu 4 tygodni
- •Szczepienie na żywe patogeny w ciągu ostatnich 30 dni
- •Udział w innym badaniu klinicznym w ciągu 4 tygodni
- •Niedobór odporności lub immunosupresja
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 22, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (102)
Mayo Clinic Hospital
Phoenix, United States
University of Southern California
Los Angeles, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, United States
Stanford Cancer Institute
Palo Alto, United States
University of California
San Francisco, United States
MedStar Georgetown University Hospital
Washington D.C., United States
UF Health Neuromedicine
Gainesville, United States
Mayo Clinic - Florida
Jacksonville, United States
Miami Cancer Institute
Miami, United States
Moffitt Cancer Center
Tampa, United States
Northwestern Memorial Hospital
Chicago, United States
University of Kentucky Medical Center
Lexington, United States
Norton Cancer Institute
Louisville, United States
University of Maryland
Baltimore, United States
Tufts Medical Center
Boston, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, United States
Mayo Clinic - Rochester
Rochester, United States
Washington University
St Louis, United States
Renown Regional Medical Center
Reno, United States
John Theurer Cancer Center/ Hackensack Meridian Health
Hackensack, United States
Rutgers Cancer Institute of New Jersey University Hospital
New Brunswick, United States
Northwell Health
Lake Success, United States
Columbia University Irving Medical Center
New York, United States
Montefiore Medical Center- Montefiore Medical Park
The Bronx, United States
Duke University Medical Center
Durham, United States
University of Cincinnati Cancer Institute
Cincinnati, United States
University Hospitals Cleveland Medical Center
Cleveland, United States
The Cleveland Clinic
Cleveland, United States
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization
Philadelphia, United States
UPMC Hillman Cancer Center
Pittsburgh, United States
Rhode Island Hospital
Providence, United States
The University of Texas
Houston, United States
University of Texas, MD Anderson Cancer Center
Houston, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, United States
Inova Schar Cancer Institute
Fairfax, United States
Swedish Medical Center
Seattle, United States
Cross Cancer Institute
Edmonton, Canada
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Canada
CHUM
Montreal, Canada
Montreal Neurological Institute-Hospital, Clinical Research Unit
Montreal, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie-CHUS)
Sherbrooke, 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, 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, Japan
Tokai University Hospital
Isehara, 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, 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, United Kingdom
Mount Vernon Cancer Centre
Northwood, 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
Trial contact
Uz Stammberger
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/23/2026.
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