Adding pembrolizumab to Optune and temozolomide for newly diagnosed glioblastoma
Official title: EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This study is testing whether adding a drug called pembrolizumab to standard Optune and chemotherapy helps people with a new glioblastoma: The fastest-growing type of glioma (grade 4). Treatment usually starts soon after diagnosis: surgery first, then radiation and chemotherapy. See the glossary diagnosis.
Read our full plain-language summary
What the trial team says
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).
Key facts
- Registry number
- NCT06556563
- Stage of testing
- Phase 3
- Conditions studied
- Glioblastoma
Where it is running
This trial lists 102 sites.
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Aichi-ken
- Fujita Health University Hospital (Toyoake-shi)
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Alberta
- Cross Cancer Institute (Edmonton)
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Arizona
- Mayo Clinic Hospital (Phoenix)
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California
- University of Southern California (Los Angeles)
- Hoag Memorial Hospital Presbyterian (Newport Beach)
- Stanford Cancer Institute (Palo Alto)
- University of California (San Francisco)
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Czechia
- Nemocnice Na Homolce (Prague)
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District of Columbia
- MedStar Georgetown University Hospital (Washington D.C.)
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Florida
- UF Health Neuromedicine (Gainesville)
- Mayo Clinic - Florida (Jacksonville)
- Miami Cancer Institute (Miami)
- Moffitt Cancer Center (Tampa)
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France
- Centre Hospitalier Universitaire de Lyon (Bron)
- Hopital de la Timone (Marseille)
- Hopital Saint-Louis (Paris)
- Groupe Hospitalier Pitie - Salpetriere (Paris)
- Institut Claudius Regaud (Toulouse)
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Germany
- Charité Campus Virchow-Klinikum (Berlin)
- Universitätsklinikum Essen (Essen)
- University Hospital Frankfurt (Frankfurt)
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Greater London
- Charing Cross Hospital (London)
-
Illinois
- Northwestern Memorial Hospital (Chicago)
-
Israel
- Rambam Medical Center (Haifa)
- Rabin Medical Center- Beilinson Hospital (Petah Tikva)
- Chaim Sheba Medical Center (Ramat Gan)
- Tel-Aviv Sourasky Medical Center (Tel Aviv)
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Italy
- Ospedale Bellaria (Bologna)
- Fondazione IRCCS Istituto Neurologico Carlo Besta (Milan)
- Ospedale del Mare (Naples)
- UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCS (Padova)
- IRCCS Istituto Clinico Humanitas (Rozzano)
- U.O.C. Immunoterapia Oncologica A.O.U. Senese, Policlinico Santa Maria alle Scotte (Siena)
-
Japan
- Kyushu University Hospital (Fukuoka)
- Hokkaido University Hospital (Hokkaido)
- Kanazawa University Hospital (Ishikawa)
- Kumamoto University Hospital (Kumamoto)
- Kyoto University Hospital (Kyoto)
- Kyorin University Hospital (Mitaka)
- Nagoya University Hospital (Nagoya)
- Saitama Medical University International Medical Center (Saitama)
- Tohoku University Hospital (Sendai)
- National Cancer Center Hospital (Tokyo)
-
Kanagawa
- Tokai University Hospital (Isehara)
-
Kentucky
- University of Kentucky Medical Center (Lexington)
- Norton Cancer Institute (Louisville)
-
Madrid
- Hospital Universitario Clínico San Carlos (Madrid)
-
Maryland
- University of Maryland (Baltimore)
-
Massachusetts
- Tufts Medical Center (Boston)
-
Middlesex
- Mount Vernon Cancer Centre (Northwood)
-
Minnesota
- Masonic Cancer Center, University of Minnesota (Minneapolis)
- Mayo Clinic - Rochester (Rochester)
-
Missouri
- Washington University (St Louis)
-
Nevada
- Renown Regional Medical Center (Reno)
-
New Jersey
- John Theurer Cancer Center/ Hackensack Meridian Health (Hackensack)
- Rutgers Cancer Institute of New Jersey University Hospital (New Brunswick)
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New York
- Northwell Health (Lake Success)
- Columbia University Irving Medical Center (New York)
- Montefiore Medical Center- Montefiore Medical Park (The Bronx)
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North Carolina
- Duke University Medical Center (Durham)
-
Ohio
- University of Cincinnati Cancer Institute (Cincinnati)
- University Hospitals Cleveland Medical Center (Cleveland)
- The Cleveland Clinic (Cleveland)
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Ontario
- Hamilton Health Sciences-Juravinski Cancer Centre (Hamilton)
- The Ottawa Hospital Cancer Centre (Ottawa)
- University Health Network - Princess Margaret Cancer Centre (Toronto)
-
Pennsylvania
- Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization (Philadelphia)
- UPMC Hillman Cancer Center (Pittsburgh)
-
Poland
- Centrum Onkologii (Bydgoszcz)
- Narodowy Instytut Onkologii (Gliwice)
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika-Zakład Teleradioterapii (Lodz)
-
Quebec
- CHUM (Montreal)
- Montreal Neurological Institute-Hospital, Clinical Research Unit (Montreal)
- Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie-CHUS) (Sherbrooke)
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Rhode Island
- Rhode Island Hospital (Providence)
-
Spain
- Hospital Universitari Vall d'Hebron (Barcelona)
- Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet) (Barcelona)
- Hospital Universitario Reina Sofia (Córdoba)
- Hospital Universitario Virgen de las Nieves (Granada)
- Hospital Universitario Ramón y Cajal (Madrid)
- Hospital Universitario 12 de Octubre (Madrid)
- Hospital Universitario La Paz (Madrid)
- Hospital Universitario Virgen del Rocio (Seville)
- Hospital Universitari i Politécnic La Fe (Valencia)
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Switzerland
- University Hospital Basel Medical Oncology (Basel)
- Centre Hospitalier Universitaire Vaudois (CHUV) (Lausanne)
- University Hospital Zurich (Zurich)
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Texas
- The University of Texas (Houston)
- University of Texas, MD Anderson Cancer Center (Houston)
-
Torino
- Neuro-Oncologia Clinica Ospedale Molinette - AOU Città della Salute e della Scienza di Torino (Torino)
-
United Kingdom
- Queen Elizabeth (Birmingham)
- Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust) (Cambridge)
- Velindre Cancer Centre (Cardiff)
- Western General Hospital (Edinburgh)
- The Clatterbridge Cancer Centre (Clatterbridge Cancer Centre NHS Foundation Trust) (Liverpool)
- The Christie Hospital (Manchester)
- Weston Park Hospital (Sheffield)
- Southampton General Hospital (Southampton)
- Royal Marsden (Sutton)
-
Utah
- Huntsman Cancer Institute, University of Utah (Salt Lake City)
-
Virginia
- Inova Schar Cancer Institute (Fairfax)
-
Washington
- Swedish Medical Center (Seattle)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.