Actively Recruiting
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Led by NovoCure GmbH · Updated on 2026-05-01
741
Participants Needed
93
Research Sites
216 weeks
Total Duration
On this page
Sponsors
N
NovoCure GmbH
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent for the study.
- Age 18 years or older at consent.
- New diagnosis of Glioblastoma per WHO 2021 Classification.
- Recovered from maximal debulking surgery; Gliadel wafers placement not allowed.
- Completed standard chemoradiotherapy including radiotherapy (56-64 Gy) and concomitant Temozolomide.
- Eligible for treatment with Optune device together with maintenance Temozolomide (150-200 mg/m2 daily for 5 days every 28 days).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 within 7 days before randomization.
- Stable or decreasing corticosteroid dose (dexamethasone 2 mg or equivalent) for at least 7 days prior to randomization, if applicable.
You will not qualify if you...
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents or other T-cell receptor targeted agents (e.g., CTLA-4, OX 40, CD137).
- Ongoing need for more than 2 mg dexamethasone (or equivalent) due to intracranial mass effect.
- Prior systemic anti-cancer therapy including investigational agents within 4 weeks before randomization.
- Received live or live-attenuated vaccine within 30 days before first study dose; killed vaccines allowed.
- Participation in another investigational study or use of an investigational device within 4 weeks prior to first treatment.
- Diagnosis of immunodeficiency or use of chronic systemic steroids exceeding 10 mg prednisone equivalent daily or other immunosuppressive therapy within 7 days before first dose.
- Known additional progressing malignancy requiring active treatment within past 3 years.
- History of noninfectious pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease.
- Early progressive disease after chemoradiotherapy; if suspected pseudo progression, additional imaging needed.
- Presence of infratentorial or leptomeningeal disease.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 93 locations
1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
3
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
4
Stanford Cancer Institute
Palo Alto, California, United States, 94305
Actively Recruiting
5
University of California
San Francisco, California, United States, 94143
Actively Recruiting
6
UF Health Neuromedicine
Gainesville, Florida, United States, 32608
Actively Recruiting
7
Mayo Clinic - Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
8
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
9
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
10
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
11
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
12
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
13
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
14
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
15
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
16
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
17
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
18
John Theurer Cancer Center/ Hackensack Meridian Health
Hackensack, New Jersey, United States, 07601
Actively Recruiting
19
Northwell Health
Lake Success, New York, United States, 11042
Actively Recruiting
20
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
21
Montefiore Medical Center- Montefiore Medical Park
The Bronx, New York, United States, 10461
Actively Recruiting
22
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
23
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
24
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
25
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
26
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
27
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
28
The University of Texas
Houston, Texas, United States, 77030
Actively Recruiting
29
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
30
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
31
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
32
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
33
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
34
CHUM
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
35
Montreal Neurological Institute-Hospital, Clinical Research Unit
Montreal, Quebec, Canada, H3A 2B4
Actively Recruiting
36
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie-CHUS)
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
37
Nemocnice Na Homolce
Prague, Czechia, 150 30
Actively Recruiting
38
Centre Hospitalier Universitaire de Lyon
Bron, France, 69500
Actively Recruiting
39
Hopital de la Timone
Marseille, France, 13385
Actively Recruiting
40
Hopital Saint-Louis
Paris, France, 75010
Actively Recruiting
41
Groupe Hospitalier Pitie - Salpetriere
Paris, France, 75013
Actively Recruiting
42
Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
43
Charité Campus Virchow-Klinikum
Berlin, Germany, 10117
Actively Recruiting
44
Universitätsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
45
University Hospital Frankfurt
Frankfurt, Germany, 60528
Actively Recruiting
46
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
47
Rabin Medical Center- Beilinson Hospital
Petah Tikva, Israel, 4941492
Actively Recruiting
48
Chaim Sheba Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
49
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
50
Neuro-Oncologia Clinica Ospedale Molinette - AOU Città della Salute e della Scienza di Torino
Torino, Torino, Italy, 10126
Actively Recruiting
51
Ospedale Bellaria
Bologna, Italy, 40139
Actively Recruiting
52
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy, 20133
Actively Recruiting
53
Ospedale del Mare
Naples, Italy, 80147
Actively Recruiting
54
UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCS
Padova, Italy, 35128
Actively Recruiting
55
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
56
U.O.C. Immunoterapia Oncologica A.O.U. Senese, Policlinico Santa Maria alle Scotte
Siena, Italy, 53100
Actively Recruiting
57
Tokai University Hospital
Isehara, Kanagawa, Japan, 259-1193
Actively Recruiting
58
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Actively Recruiting
59
Hokkaido University Hospital
Hokkaido, Japan, 060-8648
Actively Recruiting
60
Kanazawa University Hospital
Ishikawa, Japan, 920-8641
Actively Recruiting
61
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Actively Recruiting
62
Kyoto University Hospital
Kyoto, Japan, 606-8507
Actively Recruiting
63
Kyorin University Hospital
Mitaka, Japan, 181-8611
Actively Recruiting
64
Nagoya University Hospital
Nagoya, Japan, 466-8560
Actively Recruiting
65
Saitama Medical University International Medical Center
Saitama, Japan, 350-1298
Actively Recruiting
66
Tohoku University Hospital
Sendai, Japan, 980-8574
Actively Recruiting
67
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Actively Recruiting
68
Centrum Onkologii
Bydgoszcz, Poland, 85-796
Actively Recruiting
69
Narodowy Instytut Onkologii
Gliwice, Poland, 44-102
Actively Recruiting
70
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika-Zakład Teleradioterapii
Lodz, Poland, 93-513
Actively Recruiting
71
Hospital Universitario Clínico San Carlos
Madrid, Madrid, Spain, 28040
Enrolling by Invitation
72
Hospital Universitario Clínico San Carlos
Madrid, Madrid, Spain, 28040
Actively Recruiting
73
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
74
Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet)
Barcelona, Spain, 08908
Actively Recruiting
75
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
76
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Actively Recruiting
77
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
78
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
79
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
80
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
81
Hospital Universitari i Politécnic La Fe
Valencia, Spain, 46026
Actively Recruiting
82
University Hospital Basel Medical Oncology
Basel, Switzerland, 4031
Actively Recruiting
83
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1005
Actively Recruiting
84
University Hospital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
85
Queen Elizabeth
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
86
Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
87
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
88
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
89
The Clatterbridge Cancer Centre (Clatterbridge Cancer Centre NHS Foundation Trust)
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
90
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
91
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Actively Recruiting
92
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
93
Royal Marsden
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
U
Uz Stammberger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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