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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513550-30-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental |
| |
| Control Group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optune® device | Device | Optune® device delivering TTFields therapy at 200 kHz. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival (OS) is defined as the time from randomization to death due to any cause | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uz Stammberger | Contact | 1-877-678-8611 | clinicaltrials@novocure.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Recruiting | Phoenix | Arizona | 85054 | United States |
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The participants in the study will be randomized in a ratio of 2:1 in favor of the treatment group to one of the following groups:
Treatment Group - Optune concomitant with maintenance TMZ and pembrolizumab.
Control Group - Optune concomitant with maintenance TMZ and placebo.
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| Temozolomide | Drug | Temozolomide per approved labeling. |
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| Pembrolizumab | Drug | Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles. |
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| Placebo | Drug | Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles. |
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| Progression-Free Survival (PFS) per RANO 2.0 assessed by investigator | 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 |
| University of Southern California | Recruiting | Los Angeles | California | 90033 | United States |
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| Hoag Memorial Hospital Presbyterian | Recruiting | Newport Beach | California | 92663 | United States |
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| Stanford Cancer Institute | Recruiting | Palo Alto | California | 94305 | United States |
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| University of California | Recruiting | San Francisco | California | 94143 | United States |
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| UF Health Neuromedicine | Recruiting | Gainesville | Florida | 32608 | United States |
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| Mayo Clinic - Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Miami Cancer Institute | Recruiting | Miami | Florida | 33176 | United States |
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| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
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| University of Kentucky Medical Center | Recruiting | Lexington | Kentucky | 40536 | United States |
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| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
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| Masonic Cancer Center, University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Mayo Clinic - Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
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| Renown Regional Medical Center | Recruiting | Reno | Nevada | 89502 | United States |
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| John Theurer Cancer Center/ Hackensack Meridian Health | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Northwell Health | Recruiting | Lake Success | New York | 11042 | United States |
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| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
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| Montefiore Medical Center- Montefiore Medical Park | Recruiting | The Bronx | New York | 10461 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| The Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center, Clinical Trials Organization | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
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| The University of Texas | Recruiting | Houston | Texas | 77030 | United States |
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| University of Texas, MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Huntsman Cancer Institute, University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| Inova Schar Cancer Institute | Recruiting | Fairfax | Virginia | 22031 | United States |
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| Swedish Medical Center | Recruiting | Seattle | Washington | 98122 | United States |
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| The Ottawa Hospital Cancer Centre | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| CHUM | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
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| Montreal Neurological Institute-Hospital, Clinical Research Unit | Recruiting | Montreal | Quebec | H3A 2B4 | Canada |
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| Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie-CHUS) | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| Nemocnice Na Homolce | Recruiting | Prague | 150 30 | Czechia |
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| Centre Hospitalier Universitaire de Lyon | Recruiting | Bron | 69500 | France |
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| Hopital de la Timone | Recruiting | Marseille | 13385 | France |
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| Hopital Saint-Louis | Recruiting | Paris | 75010 | France |
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| Groupe Hospitalier Pitie - Salpetriere | Recruiting | Paris | 75013 | France |
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| Institut Claudius Regaud | Recruiting | Toulouse | 31059 | France |
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| Charité Campus Virchow-Klinikum | Recruiting | Berlin | 10117 | Germany |
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| Universitätsklinikum Essen | Recruiting | Essen | 45147 | Germany |
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| University Hospital Frankfurt | Recruiting | Frankfurt | 60528 | Germany |
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| Rambam Medical Center | Recruiting | Haifa | 3109601 | Israel |
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| Rabin Medical Center- Beilinson Hospital | Recruiting | Petah Tikva | 4941492 | Israel |
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| Chaim Sheba Medical Center | Recruiting | Ramat Gan | 5265601 | Israel |
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| Tel-Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 64239 | Israel |
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| Neuro-Oncologia Clinica Ospedale Molinette - AOU Città della Salute e della Scienza di Torino | Recruiting | Torino | Torino | 10126 | Italy |
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| Ospedale Bellaria | Recruiting | Bologna | 40139 | Italy |
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| Fondazione IRCCS Istituto Neurologico Carlo Besta | Recruiting | Milan | 20133 | Italy |
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| Ospedale del Mare | Recruiting | Naples | 80147 | Italy |
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| UOC Oncologia Medica 1 Istituto Oncologico Veneto IOV-IRCCS | Recruiting | Padova | 35128 | Italy |
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| IRCCS Istituto Clinico Humanitas | Recruiting | Rozzano | 20089 | Italy |
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| U.O.C. Immunoterapia Oncologica A.O.U. Senese, Policlinico Santa Maria alle Scotte | Recruiting | Siena | 53100 | Italy |
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| Tokai University Hospital | Recruiting | Isehara | Kanagawa | 259-1193 | Japan |
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| Kyushu University Hospital | Recruiting | Fukuoka | 812-8582 | Japan |
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| Hokkaido University Hospital | Recruiting | Hokkaido | 060-8648 | Japan |
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| Kanazawa University Hospital | Recruiting | Ishikawa | 920-8641 | Japan |
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| Kumamoto University Hospital | Recruiting | Kumamoto | 860-8556 | Japan |
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| Kyoto University Hospital | Recruiting | Kyoto | 606-8507 | Japan |
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| Kyorin University Hospital | Recruiting | Mitaka | 181-8611 | Japan |
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| Nagoya University Hospital | Recruiting | Nagoya | 466-8560 | Japan |
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| Saitama Medical University International Medical Center | Recruiting | Saitama | 350-1298 | Japan |
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| Tohoku University Hospital | Recruiting | Sendai | 980-8574 | Japan |
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| National Cancer Center Hospital | Recruiting | Tokyo | 104-0045 | Japan |
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| Centrum Onkologii | Recruiting | Bydgoszcz | 85-796 | Poland |
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| Narodowy Instytut Onkologii | Recruiting | Gliwice | 44-102 | Poland |
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| Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika-Zakład Teleradioterapii | Recruiting | Lodz | 93-513 | Poland |
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| Hospital Universitario Clínico San Carlos | Enrolling by invitation | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario Clínico San Carlos | Recruiting | Madrid | Madrid | 28040 | Spain |
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| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
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| Institut Català d'Oncologia de L'Hospitalet (ICO L'Hospitalet) | Recruiting | Barcelona | 08908 | Spain |
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| Hospital Universitario Reina Sofia | Recruiting | Córdoba | 14004 | Spain |
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| Hospital Universitario Virgen de las Nieves | Recruiting | Granada | 18014 | Spain |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
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| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
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| Hospital Universitario Virgen del Rocio | Recruiting | Seville | 41013 | Spain |
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| Hospital Universitari i Politécnic La Fe | Recruiting | Valencia | 46026 | Spain |
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| University Hospital Basel Medical Oncology | Recruiting | Basel | 4031 | Switzerland |
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| Centre Hospitalier Universitaire Vaudois (CHUV) | Recruiting | Lausanne | 1005 | Switzerland |
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| University Hospital Zurich | Recruiting | Zurich | 8091 | Switzerland |
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| Queen Elizabeth | Recruiting | Birmingham | B15 2TH | United Kingdom |
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| Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust) | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
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| Velindre Cancer Centre | Recruiting | Cardiff | CF14 2TL | United Kingdom |
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| Western General Hospital | Recruiting | Edinburgh | EH4 2XU | United Kingdom |
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| The Clatterbridge Cancer Centre (Clatterbridge Cancer Centre NHS Foundation Trust) | Recruiting | Liverpool | L7 8YA | United Kingdom |
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| The Christie Hospital | Recruiting | Manchester | M20 4BX | United Kingdom |
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| Weston Park Hospital | Recruiting | Sheffield | S10 2SJ | United Kingdom |
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| Southampton General Hospital | Recruiting | Southampton | SO16 6YD | United Kingdom |
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| Royal Marsden | Recruiting | Sutton | SM2 5PT | United Kingdom |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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