EF-41 / KEYNOTE D58 - En randomiseret, dobbeltblind, placebo-kontrolleret undersøgelse af Optune® (TTFields, 200 kHz) samtidig med vedligeholdelse TMZ og Pembrolizumab versus Optune® samtidig med vedligeholdelse TMZ og placebolastom til behandling af nydiagnosticeret Gli. (EF-41)
4. november 2026 opdateret af: NovoCure GmbH
En randomiseret, dobbeltblind, placebo-kontrolleret undersøgelse af Optune® (TTFields, 200 kHz) samtidig med vedligeholdelse TMZ og Pembrolizumab versus Optune® samtidig med vedligeholdelse TMZ og placebo til behandling af nydiagnosticeret glioblastom (EF-41/KEYNOTE D58KEYNOTE
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).
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
741
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 5C2
- Hamilton Health Sciences-Juravinski Cancer Centre
-
Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital Cancer Centre
-
Toronto, Ontario, Canada, M5G 2C1
- University Health Network - Princess Margaret Cancer Centre
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 3E4
- CHUM
-
Montreal, Quebec, Canada, H3A 2B4
- Montreal Neurological Institute-Hospital, Clinical Research Unit
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie-CHUS)
-
-
-
-
-
Birmingham, Det Forenede Kongerige, B15 2TH
- Queen Elizabeth
-
Cambridge, Det Forenede Kongerige, CB2 0QQ
- Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)
-
Cardiff, Det Forenede Kongerige, CF14 2TL
- Velindre Cancer Centre
-
Edinburgh, Det Forenede Kongerige, EH4 2XU
- Western General Hospital
-
Liverpool, Det Forenede Kongerige, L7 8YA
- The Clatterbridge Cancer Centre (Clatterbridge Cancer Centre NHS Foundation Trust)
-
Manchester, Det Forenede Kongerige, M20 4BX
- The Christie Hospital
-
Sheffield, Det Forenede Kongerige, S10 2SJ
- Weston Park Hospital
-
Southampton, Det Forenede Kongerige, SO16 6YD
- Southampton General Hospital
-
Sutton, Det Forenede Kongerige, SM2 5PT
- Royal Marsden
-
-
Greater London
-
London, Greater London, Det Forenede Kongerige, W6 8RF
- Charing Cross Hospital
-
-
Middlesex
-
Northwood, Middlesex, Det Forenede Kongerige, HA6 2RN
- Mount Vernon Cancer Centre
-
-
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic Hospital
-
-
California
-
Los Angeles, California, Forenede Stater, 90033
- University of Southern California
-
Newport Beach, California, Forenede Stater, 92663
- Hoag Memorial Hospital Presbyterian
-
Palo Alto, California, Forenede Stater, 94305
- Stanford Cancer Institute
-
San Francisco, California, Forenede Stater, 94143
- University of California
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forenede Stater, 20007
- MedStar Georgetown University Hospital
-
-
Florida
-
Gainesville, Florida, Forenede Stater, 32608
- UF Health Neuromedicine
-
Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic - Florida
-
Miami, Florida, Forenede Stater, 33176
- Miami Cancer Institute
-
Tampa, Florida, Forenede Stater, 33612
- Moffitt Cancer Center
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60611
- Northwestern Memorial Hospital
-
-
Kentucky
-
Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky Medical Center
-
Louisville, Kentucky, Forenede Stater, 40241
- Norton Cancer Institute
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02111
- Tufts Medical Center
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55455
- Masonic Cancer Center, University of Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic - Rochester
-
-
Missouri
-
St Louis, Missouri, Forenede Stater, 63110
- Washington University
-
-
Nevada
-
Reno, Nevada, Forenede Stater, 89502
- Renown Regional Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, Forenede Stater, 07601
- John Theurer Cancer Center/ Hackensack Meridian Health
-
New Brunswick, New Jersey, Forenede Stater, 08901
- Rutgers Cancer Institute of New Jersey University Hospital
-
-
New York
-
Lake Success, New York, Forenede Stater, 11042
- Northwell Health
-
New York, New York, Forenede Stater, 10032
- Columbia University Irving Medical Center
-
The Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center- Montefiore Medical Park
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45219
- University of Cincinnati Cancer Institute
-
Cleveland, Ohio, Forenede Stater, 44195
- The Cleveland Clinic
-
Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals Cleveland Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232
- UPMC Hillman Cancer Center
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- The University of Texas
-
Houston, Texas, Forenede Stater, 77030
- University of Texas, MD Anderson Cancer Center
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute, University of Utah
-
-
Virginia
-
Fairfax, Virginia, Forenede Stater, 22031
- Inova Schar Cancer Institute
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98122
- Swedish Medical Center
-
-
-
-
-
Bron, Frankrig, 69500
- Centre Hospitalier Universitaire de Lyon
-
Marseille, Frankrig, 13385
- Hopital de la Timone
-
Paris, Frankrig, 75010
- Hopital Saint-Louis
-
Paris, Frankrig, 75013
- Groupe Hospitalier Pitie - Salpetriere
-
Toulouse, Frankrig, 31059
- Institut Claudius Regaud
-
-
-
-
-
Haifa, Israel, 3109601
- Rambam Medical Center
-
Petah Tikva, Israel, 4941492
- Rabin Medical Center- Beilinson Hospital
-
Ramat Gan, Israel, 5265601
- Chaim Sheba Medical Center
-
Tel Aviv, Israel, 64239
- Tel-Aviv Sourasky Medical Center
-
-
-
-
-
Bologna, Italien, 40139
- Ospedale Bellaria
-
Milan, Italien, 20133
- Fondazione IRCCS Istituto Neurologico Carlo Besta
-
Naples, Italien, 80147
- Ospedale del Mare
-
Padova, Italien, 35128
- UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCS
-
Rozzano, Italien, 20089
- IRCCS Istituto Clinico Humanitas
-
Siena, Italien, 53100
- U.O.C. Immunoterapia Oncologica A.O.U. Senese, Policlinico Santa Maria alle Scotte
-
-
Torino
-
Torino, Torino, Italien, 10126
- Neuro-Oncologia Clinica Ospedale Molinette - AOU Città della Salute e della Scienza di Torino
-
-
-
-
-
Fukuoka, Japan, 812-8582
- Kyushu University Hospital
-
Hokkaido, Japan, 060-8648
- Hokkaido University Hospital
-
Ishikawa, Japan, 920-8641
- Kanazawa University Hospital
-
Kumamoto, Japan, 860-8556
- Kumamoto University Hospital
-
Kyoto, Japan, 606-8507
- Kyoto University Hospital
-
Mitaka, Japan, 181-8611
- Kyorin University Hospital
-
Nagoya, Japan, 466-8560
- Nagoya University Hospital
-
Saitama, Japan, 350-1298
- Saitama Medical University International Medical Center
-
Sendai, Japan, 980-8574
- Tohoku University Hospital
-
Tokyo, Japan, 104-0045
- National Cancer Center Hospital
-
-
Aichi-ken
-
Toyoake-shi, Aichi-ken, Japan, 470-1192
- Fujita Health University Hospital
-
-
Kanagawa
-
Isehara, Kanagawa, Japan, 259-1193
- Tokai University Hospital
-
-
-
-
-
Bydgoszcz, Polen, 85-796
- Centrum Onkologii
-
Gliwice, Polen, 44-102
- Narodowy Instytut Onkologii
-
Lodz, Polen, 93-513
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika-Zakład Teleradioterapii
-
-
-
-
-
Basel, Schweiz, 4031
- University Hospital Basel Medical Oncology
-
Lausanne, Schweiz, 1005
- Centre Hospitalier Universitaire Vaudois (CHUV)
-
Zurich, Schweiz, 8091
- University Hospital Zurich
-
-
-
-
-
Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron
-
Barcelona, Spanien, 08908
- Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet)
-
Córdoba, Spanien, 14004
- Hospital Universitario Reina Sofia
-
Granada, Spanien, 18014
- Hospital Universitario Virgen de las Nieves
-
Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, Spanien, 28046
- Hospital Universitario La Paz
-
Madrid, Spanien, 28034
- Hospital Universitario Ramón y Cajal
-
Seville, Spanien, 41013
- Hospital Universitario Virgen del Rocio
-
Valencia, Spanien, 46026
- Hospital Universitari i Politécnic La Fe
-
-
Madrid
-
Madrid, Madrid, Spanien, 28040
- Hospital Universitario Clínico San Carlos
-
-
-
-
-
Prague, Tjekkiet, 150 30
- Nemocnice Na Homolce
-
-
-
-
-
Berlin, Tyskland, 10117
- Charité Campus Virchow-Klinikum
-
Essen, Tyskland, 45147
- Universitätsklinikum Essen
-
Frankfurt, Tyskland, 60528
- University Hospital Frankfurt
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- The participant (or legally acceptable representative) has provided documented informed consent for the study.
- Be ≥ 18 years of age on day of providing informed consent.
- Participant with new diagnosis of GBM according to World Health Organization (WHO) 2021 Classification.
- 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.
- Have completed standard adjuvant chemoradiotherapy of radiotherapy (RT) according to local practice (56-64 Gy), and concomitant TMZ chemotherapy.
- Amenable to treatment with Optune concomitant with maintenance TMZ (150-200 mg/m^2 daily x 5, Q28 days).
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before randomization.
- Stable or decreasing dose of corticosteroids (dexamethasone ≤ 2mg or equivalent) for the last 7 days prior to randomization, if applicable.
Exclusion Criteria:
- 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).
- Ongoing requirement for >2 mg dexamethasone (or equivalent), due to intracranial mass effect.
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- 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.
- 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.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- 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.
- Infratentorial or leptomeningeal disease.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Kontrolgruppe
|
Optune® device delivering TTFields therapy at 200 kHz.
Andre navne:
Temozolomide per approved labeling. Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles. |
|
Eksperimentel: Behandlingsgruppe
|
Optune® device delivering TTFields therapy at 200 kHz.
Andre navne:
Temozolomide per approved labeling. Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival
Tidsramme: 24 months
|
Overall survival (OS) is defined as the time from randomization to death due to any cause |
24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator
Tidsramme: 24 months
|
PFS is defined as the time interval, in months, between randomization and the first documented disease progression per RANO 2.0 assessed by investigator or death due to any cause, whichever occurs first. Note: RANO 2.0 = Modified Radiographic Response Assessment in Neuro-Oncology |
24 months
|
|
Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator
Tidsramme: 24 months
|
PFS is defined as the time interval, in months, between randomization and the first documented disease progression per RANO 2.0 assessed by investigator or death due to any cause, whichever occurs first. Note: RANO 2.0 = Response Assessment in Neuro-Oncology |
24 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. februar 2025
Primær færdiggørelse (Anslået)
1. april 2029
Studieafslutning (Anslået)
1. april 2029
Datoer for studieregistrering
Først indsendt
13. august 2024
Først indsendt, der opfyldte QC-kriterier
13. august 2024
Først opslået (Faktiske)
16. august 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. november 2026
Sidst verificeret
1. februar 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Astrocytom
- Gliom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Glioblastom
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Azoler
- Dacarbazine
- Triazener
- Imidazoler
- Temozolomid
- pembrolizumab
Andre undersøgelses-id-numre
- EF-41
- 2024-513550-30-00 (Ctis)
- MK3475-D58 (Anden identifikator: Merck Sharp & Dohme LLC)
- KEYNOTE D58 (Anden identifikator: Merck Sharp & Dohme LLC)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .