EF-41 / 主题演讲 D58 - Optune®（TTFields，200 kHz）联合维持 TMZ 和 Pembrolizumab 与 Optune® 联合维持 TMZ 和安慰剂治疗新诊断胶质母细胞瘤的随机、双盲、安慰剂对照研究 (EF-41)
2026年11月4日 更新者：NovoCure GmbH
Optune®（TTFields，200 kHz）联合维持 TMZ 和 Pembrolizumab 与 Optune® 联合维持 TMZ 和安慰剂治疗新诊断胶质母细胞瘤的随机、双盲、安慰剂对照研究 (EF-41/KEYNOTE D58)
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).
研究概览
研究类型
介入性
注册 (估计的)
741
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Haifa、以色列、3109601
- Rambam Medical Center
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Petah Tikva、以色列、4941492
- Rabin Medical Center- Beilinson Hospital
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Ramat Gan、以色列、5265601
- Chaim Sheba Medical Center
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Tel Aviv、以色列、64239
- Tel-Aviv Sourasky Medical Center
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Alberta
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Edmonton、Alberta、加拿大、T6G 1Z2
- Cross Cancer Institute
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Ontario
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Hamilton、Ontario、加拿大、L8V 5C2
- Hamilton Health Sciences-Juravinski Cancer Centre
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Ottawa、Ontario、加拿大、K1H 8L6
- The Ottawa Hospital Cancer Centre
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Toronto、Ontario、加拿大、M5G 2C1
- University Health Network - Princess Margaret Cancer Centre
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Quebec
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Montreal、Quebec、加拿大、H2X 3E4
- CHUM
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Montreal、Quebec、加拿大、H3A 2B4
- Montreal Neurological Institute-Hospital, Clinical Research Unit
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Sherbrooke、Quebec、加拿大、J1H 5N4
- Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie-CHUS)
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Berlin、德国、10117
- Charité Campus Virchow-Klinikum
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Essen、德国、45147
- Universitätsklinikum Essen
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Frankfurt、德国、60528
- University Hospital Frankfurt
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Bologna、意大利、40139
- Ospedale Bellaria
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Milan、意大利、20133
- Fondazione IRCCS Istituto Neurologico Carlo Besta
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Naples、意大利、80147
- Ospedale del Mare
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Padova、意大利、35128
- UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCS
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Rozzano、意大利、20089
- IRCCS Istituto Clinico Humanitas
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Siena、意大利、53100
- U.O.C. Immunoterapia Oncologica A.O.U. Senese, Policlinico Santa Maria alle Scotte
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Torino
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Torino、Torino、意大利、10126
- Neuro-Oncologia Clinica Ospedale Molinette - AOU Città della Salute e della Scienza di Torino
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Prague、捷克语、150 30
- Nemocnice Na Homolce
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Fukuoka、日本、812-8582
- Kyushu University Hospital
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Hokkaido、日本、060-8648
- Hokkaido University Hospital
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Ishikawa、日本、920-8641
- Kanazawa University Hospital
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Kumamoto、日本、860-8556
- Kumamoto University Hospital
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Kyoto、日本、606-8507
- Kyoto University Hospital
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Mitaka、日本、181-8611
- Kyorin University Hospital
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Nagoya、日本、466-8560
- Nagoya University Hospital
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Saitama、日本、350-1298
- Saitama Medical University International Medical Center
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Sendai、日本、980-8574
- Tohoku University Hospital
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Tokyo、日本、104-0045
- National Cancer Center Hospital
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Aichi-ken
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Toyoake-shi、Aichi-ken、日本、470-1192
- Fujita Health University Hospital
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Kanagawa
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Isehara、Kanagawa、日本、259-1193
- Tokai University Hospital
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Bron、法国、69500
- Centre Hospitalier Universitaire de Lyon
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Marseille、法国、13385
- Hopital de la Timone
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Paris、法国、75010
- Hopital Saint-Louis
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Paris、法国、75013
- Groupe Hospitalier Pitie - Salpetriere
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Toulouse、法国、31059
- Institut Claudius Regaud
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Bydgoszcz、波兰、85-796
- Centrum Onkologii
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Gliwice、波兰、44-102
- Narodowy Instytut Onkologii
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Lodz、波兰、93-513
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika-Zakład Teleradioterapii
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Basel、瑞士、4031
- University Hospital Basel Medical Oncology
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Lausanne、瑞士、1005
- Centre Hospitalier Universitaire Vaudois (CHUV)
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Zurich、瑞士、8091
- University Hospital Zurich
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Arizona
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Phoenix、Arizona、美国、85054
- Mayo Clinic Hospital
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California
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Los Angeles、California、美国、90033
- University of Southern California
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Newport Beach、California、美国、92663
- Hoag Memorial Hospital Presbyterian
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Palo Alto、California、美国、94305
- Stanford Cancer Institute
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San Francisco、California、美国、94143
- University of California
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District of Columbia
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Washington D.C.、District of Columbia、美国、20007
- MedStar Georgetown University Hospital
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Florida
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Gainesville、Florida、美国、32608
- UF Health Neuromedicine
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Jacksonville、Florida、美国、32224
- Mayo Clinic - Florida
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Miami、Florida、美国、33176
- Miami Cancer Institute
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Tampa、Florida、美国、33612
- Moffitt Cancer Center
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern Memorial Hospital
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Kentucky
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Lexington、Kentucky、美国、40536
- University of Kentucky Medical Center
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Louisville、Kentucky、美国、40241
- Norton Cancer Institute
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland
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Massachusetts
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Boston、Massachusetts、美国、02111
- Tufts Medical Center
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Minnesota
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Minneapolis、Minnesota、美国、55455
- Masonic Cancer Center, University of Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic - Rochester
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Missouri
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St Louis、Missouri、美国、63110
- Washington University
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Nevada
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Reno、Nevada、美国、89502
- Renown Regional Medical Center
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New Jersey
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Hackensack、New Jersey、美国、07601
- John Theurer Cancer Center/ Hackensack Meridian Health
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New Brunswick、New Jersey、美国、08901
- Rutgers Cancer Institute of New Jersey University Hospital
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New York
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Lake Success、New York、美国、11042
- Northwell Health
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New York、New York、美国、10032
- Columbia University Irving Medical Center
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The Bronx、New York、美国、10461
- Montefiore Medical Center- Montefiore Medical Park
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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Ohio
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Cincinnati、Ohio、美国、45219
- University of Cincinnati Cancer Institute
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Cleveland、Ohio、美国、44195
- The Cleveland Clinic
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Cleveland、Ohio、美国、44106
- University Hospitals Cleveland Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization
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Pittsburgh、Pennsylvania、美国、15232
- UPMC Hillman Cancer Center
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Rhode Island
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Providence、Rhode Island、美国、02903
- Rhode Island Hospital
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Texas
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Houston、Texas、美国、77030
- The University of Texas
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Houston、Texas、美国、77030
- University of Texas, MD Anderson Cancer Center
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Utah
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Salt Lake City、Utah、美国、84112
- Huntsman Cancer Institute, University of Utah
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Virginia
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Fairfax、Virginia、美国、22031
- Inova Schar Cancer Institute
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Washington
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Seattle、Washington、美国、98122
- Swedish Medical Center
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Birmingham、英国、B15 2TH
- Queen Elizabeth
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Cambridge、英国、CB2 0QQ
- Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust)
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Cardiff、英国、CF14 2TL
- Velindre Cancer Centre
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Edinburgh、英国、EH4 2XU
- Western General Hospital
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Liverpool、英国、L7 8YA
- The Clatterbridge Cancer Centre (Clatterbridge Cancer Centre NHS Foundation Trust)
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Manchester、英国、M20 4BX
- The Christie Hospital
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Sheffield、英国、S10 2SJ
- Weston Park Hospital
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Southampton、英国、SO16 6YD
- Southampton General Hospital
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Sutton、英国、SM2 5PT
- Royal Marsden
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Greater London
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London、Greater London、英国、W6 8RF
- Charing Cross Hospital
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Middlesex
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Northwood、Middlesex、英国、HA6 2RN
- Mount Vernon Cancer Centre
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Barcelona、西班牙、08035
- Hospital Universitari Vall d'Hebron
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Barcelona、西班牙、08908
- Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet)
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Córdoba、西班牙、14004
- Hospital Universitario Reina Sofia
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Granada、西班牙、18014
- Hospital Universitario Virgen de las Nieves
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Madrid、西班牙、28041
- Hospital Universitario 12 de Octubre
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Madrid、西班牙、28046
- Hospital Universitario La Paz
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Madrid、西班牙、28034
- Hospital Universitario Ramón y Cajal
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Seville、西班牙、41013
- Hospital Universitario Virgen del Rocio
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Valencia、西班牙、46026
- Hospital Universitari i Politécnic La Fe
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Madrid
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Madrid、Madrid、西班牙、28040
- Hospital Universitario Clínico San Carlos
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：控制组
|
Optune® device delivering TTFields therapy at 200 kHz.
其他名称：
Temozolomide per approved labeling. Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles. |
|
实验性的：治疗组
|
Optune® device delivering TTFields therapy at 200 kHz.
其他名称：
Temozolomide per approved labeling. Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall survival
大体时间：24 months
|
Overall survival (OS) is defined as the time from randomization to death due to any cause |
24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年2月3日
初级完成 (估计的)
2029年4月1日
研究完成 (估计的)
2029年4月1日
研究注册日期
首次提交
2024年8月13日
首先提交符合 QC 标准的
2024年8月13日
首次发布 (实际的)
2024年8月16日
研究记录更新
最后更新发布 (实际的)
2026年11月6日
上次提交的符合 QC 标准的更新
2026年11月4日
最后验证
2026年2月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- EF-41
- 2024-513550-30-00 (克蒂斯)
- MK3475-D58 (其他标识符：Merck Sharp & Dohme LLC)
- KEYNOTE D58 (其他标识符：Merck Sharp & Dohme LLC)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
是的
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.