Badanie atezolizumabu w porównaniu z placebo jako terapii adjuwantowej u pacjentów z naciekającym mięśnie rakiem pęcherza moczowego wysokiego ryzyka, u których po cystektomii uzyskano dodatni wynik ctDNA (IMvigor011)
Wieloośrodkowe, randomizowane badanie fazy III z podwójnie ślepą próbą atezolizumabu (przeciwciało anty-PDL1) w porównaniu z placebo jako terapii uzupełniającej u pacjentów z rakiem pęcherza moczowego wysokiego ryzyka naciekającego mięśnie, u których po cystektomii uzyskano dodatni wynik ctDNA
This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are circulating tumour deoxyribonucleic acid (ctDNA) positive and are at high risk for recurrence following cystectomy.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Buenos Aires, Argentyna, 1019
- Centro Medico Austral
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Buenos Aires, Argentyna, 1426
- Instituto Alexander Fleming
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Brasschaat, Belgia, 2930
- AZ KLINA
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Ghent, Belgia, 9000
- UZ Gent
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Ceará
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Fortaleza, Ceará, Brazylia, 60170-170
- Oncocentro Serviços Medicos E Hospitalares Ltda
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazylia, 30110022
- CETUS Hospital Dia Oncologia
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazylia, 91350-200
- Hospital Nossa Senhora da Conceicao
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Porto Alegre, Rio Grande do Sul, Brazylia, 90610-000
- Hospital Sao Lucas - PUCRS
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São Paulo
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Barretos, São Paulo, Brazylia, 14784-400
- *X*Fundação Pio XII Hospital de Câncer de Barretos
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Jaú, São Paulo, Brazylia, 17210-120
- Hospital Amaral Carvalho
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São Paulo, São Paulo, Brazylia, 01323-020
- Hospital Alemao Oswaldo Cruz
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São Paulo, São Paulo, Brazylia, 01246-000
- Instituto do Cancer do Estado de Sao Paulo - ICESP
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Beijing, Chiny, 100050
- Friendship Hospital, Capital Medical University
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Changchun, Chiny, 130021
- the First Hospital of Jilin University
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Changsha, Chiny, 410006
- Hu Nan Provincial Cancer Hospital
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Fuzhou, Chiny, 350005
- The First Affiliated Hospital of Fujian Medical University
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Guangzhou, Chiny, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Nanjing, Chiny, 210009
- Jiangsu Cancer Hospital
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Nanjing, Chiny, 210029
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
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Nanjing, Chiny, 210029
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
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Shanghai, Chiny, 200032
- Zhongshan Hospital Fudan University
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Shanghai, Chiny, 200120
- Fudan University Shanghai Cancer Center
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Tianjin, Chiny, 300060
- Tianjin Cancer Hospital
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Yantai, Chiny, 264099
- Yantai Yu Huangding Hospital
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Olomouc, Czechy, 779 00
- Fakultni nemocnice Olomouc
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Prague, Czechy, 150 06
- Fakultni nemocnice v Motole
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Praha 4 - Krc, Czechy, 140 59
- Fakultni Thomayerova nemocnice
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Angers, Francja, 49055
- ICO Paul Papin
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Avignon, Francja, 84918
- Institut Sainte Catherine
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Bordeaux, Francja, 33075
- Hopital Saint Andre
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Clermont-Ferrand, Francja, 63011
- Centre Jean Perrin
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Lyon, Francja, 69373
- Centre Léon Bérard
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Nancy, Francja, 54100
- Centre D'Oncologie de Gentilly
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Paris, Francja, 75674
- Institut Mutualiste Montsouris
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Suresnes, Francja, 92151
- Hopital Foch
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Toulouse, Francja, 31059
- Institut Claudius Régaud
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Villejuif, Francja, 94805
- Institut Gustave Roussy
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Ahens, Grecja, 124 64
- Attikon University General Hospital
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Athens, Grecja, 115 28
- Alexandras General Hospital of Athens
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Larissa, Grecja, 411 10
- University Hospital of Larissa
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Pátrai, Grecja, 265 04
- University Hospital of Patras Medical Oncology
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Thessaloniki, Grecja, 54007
- Theageneio Hospital
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Barcelona, Hiszpania, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Hiszpania, 08041
- Hospital de la Santa Creu i Sant Pau
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Barcelona, Hiszpania, 08036
- Hospital Clínic i Provincial
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Madrid, Hiszpania, 28040
- Hospital Clinico San Carlos
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Madrid, Hiszpania, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Hiszpania, 28046
- Hospital Universitario La Paz
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Madrid, Hiszpania, 28034
- Hospital Ramon y Cajal
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Valencia, Hiszpania, 46009
- Instituto Valenciano Oncologia
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Valencia, Hiszpania, 46010
- Hospital Clinico Universitario de Valencia
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Barcelona
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Sabadell, Barcelona, Hiszpania, 08208
- Corporacio Sanitaria Parc Tauli
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Cantabria
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Santander, Cantabria, Hiszpania, 39008
- Hospital Universitario Marques de Valdecilla
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Cordoba
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Córdoba, Cordoba, Hiszpania, 14004
- Hospital Universitario Reina Sofia
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Guipuzcoa
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Donostia / San Sebastian, Guipuzcoa, Hiszpania, 20080
- Hospital de Donostia
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Hong Kong, Hongkong
- Queen Mary Hospital
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Cork, Irlandia
- Cork Uni Hospital
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Dublin, Irlandia, D24 NR0A
- Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital
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Tel Aviv, Izrael, 6423906
- Tel Aviv Sourasky Medical Ctr
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Aichi, Japonia, 466-8560
- Nagoya University Hospital
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Chiba, Japonia, 260-8717
- Chiba Cancer Center
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Chiba, Japonia, 285-8741
- Toho University Sakura Medical Center
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Ehime, Japonia, 791-0280
- Shikoku Cancer Center
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Hiroshima, Japonia, 730-8518
- Hiroshima City Hiroshima Citizens Hospital
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Hiroshima, Japonia, 721-8511
- Fukuyama City Hospital
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Hokkaido, Japonia, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Ibaraki, Japonia, 305-8576
- University of Tsukuba Hospital
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Kanagawa, Japonia, 216-8511
- St. Marianna University Hospital
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Kanagawa, Japonia, 238-8558
- Yokosuka Kyosai Hospital
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Kyoto, Japonia, 606-8507
- Kyoto University Hospital
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Nagano, Japonia, 381-8551
- Nagano Municipal Hospital
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Numakunai, Japonia, 028-3695
- Iwate Medical University Hospital
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Osaka, Japonia, 541-8567
- Osaka International Cancer Institute
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Saitama, Japonia, 350-1298
- Saitama Medical University International Medical Center
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Saitama, Japonia, 362-0806
- Saitama Cancer Center
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Shizuoka, Japonia, 411-8777
- Shizuoka Cancer Center
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Tokushima, Japonia, 770-8503
- Tokushima University Hospital
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Tokyo, Japonia, 104-0045
- National Cancer Center Hospital
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Tokyo, Japonia, 160-8582
- Keio University Hospital
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Toyama, Japonia, 930-0194
- Toyama University Hospital
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Bogotá, Kolumbia, 11001
- Clinica del Country
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Medellín, Kolumbia, 050024
- Instituto Cancerología Medellin
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Montería, Kolumbia, 230002
- Oncomedica S.A.
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Goyang-si, Korea Południowa, 10408
- National Cancer Center
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Seoul, Korea Południowa, 03080
- Seoul National University Hospital
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Seoul, Korea Południowa, 05505
- Asan Medical Center
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Seoul, Korea Południowa, (0)6351
- Samsung Medical Center
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Düsseldorf, Niemcy, 40225
- Universitätsklinikum Düsseldorf
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Halle, Niemcy, 06120
- Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
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Herne, Niemcy, 44625
- Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
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Tübingen, Niemcy, 72076
- Universitätsklinikum Tübingen
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Ulm, Niemcy, 89081
- Universitätsklinikum Ulm
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Würzburg, Niemcy, 97080
- Universitätsklinikum Würzburg
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Krakow, Polska, 30-727
- PRATIA MCM Kraków
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Poznan, Polska, 60-569
- Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu
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Warsaw, Polska, 04-073
- Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
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Wroclaw, Polska
- Dolnoslaskie Centrum Onkologii
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Ivanovo, Rosja, 153040
- Ivanovo Regional Oncology Dispensary
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Leningrad
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Kuzmolovo, Leningrad, Rosja, 188663
- St-Petersburg Regional Oncology Dispensary
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Niznij Novgorod
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Nizhny Novgorod, Niznij Novgorod, Rosja, 603001
- Privolzhsk Regional Medical Center
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Rosja, 197758
- FSI Russian Centre of Radiology and Surgical Technologies
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Singapore, Singapur, 168583
- National Cancer Centre
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Florida
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Rockledge, Florida, Stany Zjednoczone, 32955
- Cancer Care Centers of Brevard
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44195
- Cleveland Clinic
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Pennsylvania
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15212
- AHN Cancer Institute ? Allegheny General Hospital
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Adana, Turcja (Türkiye), 01230
- Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
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Ankara, Turcja (Türkiye), 06700
- Ankara University Faculty of Medicine Cebeci Hospital
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Bakirkoy / Istanbul, Turcja (Türkiye), 34147
- Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
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Cordaleo, Turcja (Türkiye), 35575
- Medikal Park Izmir Hospital
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Edirne, Turcja (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Turcja (Türkiye), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
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Istanbul, Turcja (Türkiye), 34730
- Medeniyet University Goztepe Training and Research Hospital.
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Samsun, Turcja (Türkiye), 55200
- Medikal Park Samsun
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Dnipropetrovsk, Ukraina, 49102
- CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
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Kyiv, Ukraina, 03115
- Kyiv City Clinical Oncological Center
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KIEV Governorate
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Dnipro, KIEV Governorate, Ukraina, 49005
- ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
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Lviv, KIEV Governorate, Ukraina, 79010
- Lviv Regional Clinical Hospital
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Kharkiv Governorate
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Kharkiv, Kharkiv Governorate, Ukraina, 61037
- Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
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Campania
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Naples, Campania, Włochy, 80131
- Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico
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Naples, Campania, Włochy, 80131
- Istituto Nazionale Tumori Irccs Fondazione G. Pascale
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Emilia-Romagna
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Bologna, Emilia-Romagna, Włochy, 40138
- AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
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Lazio
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Rome, Lazio, Włochy, 00168
- Policlinico Universitario "Agostino Gemelli"
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Liguria
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Genoa, Liguria, Włochy, 16132
- A.O. Universitaria S. Martino Di Genova
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Lombardy
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Milan, Lombardy, Włochy, 20133
- Irccs Istituto Nazionale Dei Tumori (Int)
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Milan, Lombardy, Włochy, 20141
- Istituto Europeo Di Oncologia
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Milan, Lombardy, Włochy, 20132
- Irccs Ospedale San Raffaele
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Piedmont
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Orbassano, Piedmont, Włochy, 10043
- A.O. Universitaria S. Luigi Gonzaga
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Tuscany
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Arezzo, Tuscany, Włochy, 52100
- Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato
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Veneto
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Padova, Veneto, Włochy, 35128
- IOV - Istituto Oncologico Veneto - IRCCS
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Cambridge, Zjednoczone Królestwo, CB2 0QQ
- Addenbrookes Hospital
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Edinburgh, Zjednoczone Królestwo, EH4 2XU
- Western General Hospital
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London, Zjednoczone Królestwo, W6 8RF
- Charing Cross Hospital
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London, Zjednoczone Królestwo, SW3 6JJ
- Royal Marsden Hospital - London
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London, Zjednoczone Królestwo, NW1 2PG
- University College London NHS Foundation Trust
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London, Zjednoczone Królestwo, EC1M 6BQ
- Barts Hospital
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Plymouth, Zjednoczone Królestwo, PL6 8DH
- Derriford Hospital
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Preston, Zjednoczone Królestwo, PR2 9HT
- Royal Preston Hospital
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Sheffield, Zjednoczone Królestwo, S10 2SJ
- Weston Park Hospital
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Southampton, Zjednoczone Królestwo, SO16 6YD
- Southampton University Hospitals NHS Trust
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Sutton, Zjednoczone Królestwo, SM2 5PT
- Royal Marsden Hospital (Sutton)
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
Inclusion Criteria for the Surveillance Phase:
- Histologically confirmed MIUC (also termed transitional cell carcinoma [TCC]) of the bladder
- Tumor, nodes, and metastases (TNM) classification (based on American Joint Committee on Cancer [AJCC] Cancer Staging Manual, 8th Edition; Amin et al. 2016) at pathological examination of surgical resection specimen as follows: For participants treated with prior neoadjuvant chemotherapy (NAC): tumor stage of ypT2-4a or ypN+ and M0. For participants who have not received prior NAC: tumor stage of pT2-4a or pN+ and M0
- Surgical resection of MIUC of the bladder
- Participants who have not received prior platinum-based NAC must be ineligible for cisplatin-based adjuvant chemotherapy, have refused it, or will not receive it based on physician's decision
- ctDNA assay developed based on tumor tissue specimen and matched normal DNA from blood
- Tumor programmed death ligand (PD-L1) expression per immunohistochemistry (IHC) that is evaluable by central testing of a representative tumor tissue specimen
- Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 4 weeks prior to enrollment
- Full recovery from cystectomy and enrollment within 24 weeks following cystectomy. Minimum of 6 weeks must have elapsed from surgery
Additional Inclusion Criteria for the Treatment Phase:
- Blood for plasma ctDNA sample evaluated to be ctDNA positive, defined as the presence of two or more mutations out of the 16 mutations identified based on participant' whole exome sequencing (WES) evaluable (ctDNA assay designability) report
- Absence of residual disease and absence of metastasis, as confirmed by a negative baseline CT or MRI scan of the pelvis, abdomen, and chest no more than 28 days prior to randomization, as assessed by the investigator and Independent Review Facility
- Eastern cooperative oncology group (ECOG) performance status of ≤ 2
- Life expectancy ≥12 weeks
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
Exclusion Criteria:
General Medical Exclusion Criteria for the Surveillance Phase:
- Known PD-L1 IHC result for adjuvant therapy. The decision for the adjuvant therapy should not be based on the PD-L1 IHC result
- Pregnancy or breastfeeding
- Positive test for human immunodeficiency virus (HIV), with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy, have a cluster of differentiation 4 (CD4) count ≥ 200 per microliter (/µL), and have an undetectable viral load
- Participants with active hepatitis B virus (HBV) or hepatitis C virus (HCV). Participants with past HBV infection or resolved HBV infection are eligible. A negative HBV deoxyribonucleic acid (DNA) test must be obtained in these participants prior to enrollment. Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
- Active tuberculosis (TB) confirmed by a test performed within 3 months prior to treatment initiation
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- History of autoimmune disease. Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Participants with controlled type I diabetes mellitus (T1DM) on a stable dose of insulin regimen may be eligible for this study
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction (MI) within the previous 3 months, unstable arrhythmias, or unstable angina
Cancer-Specific Exclusion Criteria for the Surveillance Phase:
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to study enrollment
- Adjuvant chemotherapy or radiation therapy for UC following cystectomy
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lives of the drug, whichever is longer, prior to enrollment
- Malignancies other than UC within 5 years prior to study enrollment
Additional Exclusion Criteria for the Treatment Phase:
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to randomization to the treatment phase. Hormone-replacement therapy or oral contraceptives are allowed
- Adjuvant chemotherapy or radiation therapy for UC following cystectomy
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lives of the drug, whichever is longer, prior to randomization to the treatment phase
- Positive test for HIV, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy, have a CD4 count ≥200/μL, and have an undetectable viral load
- Participants with active HBV or HCV
- Active tuberculosis confirmed by a test performed within 3 months prior to treatment initiation
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Arm A: Atezolizumab
Atezolizumab will be administered intravenously (IV) at a dose of 1680 milligrams (mg) on Day 1 of each 28-day cycle for 12 cycles or up to 1 year (whichever occurs first). Atezolizumab will be discontinued in the event of disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor. |
ctDNA positive participants will receive 1680 mg IV, every 4 weeks (Q4W) on Day 1 of each 28-day cycle.
Inne nazwy:
Signatera will be used to evaluate whether ctDNA is detected during serial monitoring of peripheral blood samples for participants enrolled in surveillance. Participants with a ctDNA positive result will be screened for inclusion in the treatment phase. Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up. |
|
Komparator placebo: Arm B: Placebo
Placebo will be administered IV on Day 1 of each 28-day cycle. Placebo will be discontinued in the event of disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor. Following the primary analysis, participants randomized to the comparator arm might discontinue placebo and may receive treatment outside the study at the investigator's discretion. |
Signatera will be used to evaluate whether ctDNA is detected during serial monitoring of peripheral blood samples for participants enrolled in surveillance. Participants with a ctDNA positive result will be screened for inclusion in the treatment phase. Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up. ctDNA positive participants will receive placebo IV, Q4W on Day 1 of each 28-day cycle |
|
Eksperymentalny: Arm C: Surveillance Follow-Up
Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up. |
Signatera will be used to evaluate whether ctDNA is detected during serial monitoring of peripheral blood samples for participants enrolled in surveillance. Participants with a ctDNA positive result will be screened for inclusion in the treatment phase. Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
INV-assessed Disease-free Survival (DFS)
Ramy czasowe: From randomization to the first occurrence of a DFS event (Up to 48.2 months)
|
INV-assessed DFS was defined as the time from randomization to the first occurrence of a DFS event, defined as any of the following: local (pelvic) recurrence of urothelial carcinoma (UC) (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Participants without an INV-assessed DFS event were censored at the last date the participant was assessed to be alive and recurrence-free as determined with radiographic evidence. Kaplan-Meier (KM) methodology was used to estimate the median DFS. |
From randomization to the first occurrence of a DFS event (Up to 48.2 months)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Overall Survival (OS)
Ramy czasowe: From randomization to death from any cause (Up to 48.2 months)
|
OS was defined as the time from randomization to death from any cause. Data for participants who did not die at the time of analysis were censored at the date last known to be alive. Data for participants who did not have post-baseline information were censored at the date of randomization. KM methodology was used to estimate the median OS. |
From randomization to death from any cause (Up to 48.2 months)
|
|
Independent Review Facility (IRF)-Assessed DFS
Ramy czasowe: From randomization to the first occurrence of a DFS event (Up to 48.2 months)
|
IRF-assessed DFS was defined as the time from randomization to the first occurrence of a DFS event, defined as any of the following: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Participants without an IRF-assessed DFS event were censored at the last date the participant was assessed to be alive and recurrence-free as determined with radiographic evidence. KM methodology was used to estimate the median DFS. |
From randomization to the first occurrence of a DFS event (Up to 48.2 months)
|
|
INV-assessed Disease-specific Survival (DSS)
Ramy czasowe: From randomization to death from UC (Up to 48.2 months)
|
INV-assessed DSS was defined as the time from randomization to death from UC per investigator assessment of cause of death. Data for participants who did not die will be censored at the last date they were known to be alive. Data for participants who died from causes other than bladder cancer were censored at the date of death. KM methodology was used to estimate the median DSS. |
From randomization to death from UC (Up to 48.2 months)
|
|
INV-assessed Distant Metastasis-free Survival (DMFS)
Ramy czasowe: From randomization to the first occurrence of a DMFS event (Up to 48.2 months)
|
INV-assessed DMFS was defined as the time from randomization to the first occurrence of a DMFS event, defined as diagnosis of distant (i.e., non-locoregional) metastasis or death from any cause. Data for participants without a DMFS event were censored at the last date the participant was assessed to be alive and free of distant metastasis. Data for participants with no post-baseline disease assessment were censored at the randomization date. KM methodology was used to estimate the median DMFS. |
From randomization to the first occurrence of a DMFS event (Up to 48.2 months)
|
|
Time to Confirmed Deterioration (TTCD) in Physical Functioning, Role Functioning & Global Health Status/Quality of Life (GHS/QoL), Assessed by European Organisation for Research & Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Ramy czasowe: Up to 11.8 months
|
TTCD of physical functioning (PF), role functioning (RF) & health-related quality of life (HRQoL) was defined as time from randomization to first documented confirmed deterioration. Confirmed deterioration=participant's first ≥10-point score decrease from baseline on EORTC QLQ C30 PF, RF or GHS/QoL scale that must be held for ≤2 consecutive time points or followed by death due to cancer progression within 8 weeks from last patient-reported outcomes (PRO) assessment. EORTC QLQ-C30 has 30 questions assessing 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). Functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much) & GHS/QoL on a 7-point scale (1=very poor to 7=excellent). Scores are linearly transformed on a scale of 0 to 100. High score=better functioning/better QoL. |
Up to 11.8 months
|
|
Percentage of Participants With ctDNA Clearance
Ramy czasowe: Baseline, Day 1 of Cycles 3 or 5 (Cycle length = 28 days)
|
ctDNA clearance was defined as the percentage of participants who were ctDNA positive at baseline and ctDNA negative at Cycle 3, Day 1 or Cycle 5, Day 1. Percentages have been rounded off. |
Baseline, Day 1 of Cycles 3 or 5 (Cycle length = 28 days)
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Number of Participants With Adverse Events (AEs)
Ramy czasowe: From initiation of study treatment up to approximately 5 years
|
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
From initiation of study treatment up to approximately 5 years
|
|
Maximum Serum Concentration (Cmax) of Atezolizumab
Ramy czasowe: 30 minutes post dose on Cycle 1 Day 1 (Cycle length = 28 days)
|
30 minutes post dose on Cycle 1 Day 1 (Cycle length = 28 days)
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|
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Minimum Serum Concentration (Cmin) of Atezolizumab
Ramy czasowe: Pre-dose on Day 1 of Cycles 2, 3, 4, 8 and 12 (Cycle length = 28 days)
|
Pre-dose on Day 1 of Cycles 2, 3, 4, 8 and 12 (Cycle length = 28 days)
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|
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Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
Ramy czasowe: Up to 12.8 months
|
Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here. |
Up to 12.8 months
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: Clinical Trials, Hoffmann-La Roche
Publikacje i pomocne linki
Publikacje ogólne
- Jackson-Spence F, Toms C, O'Mahony LF, Choy J, Flanders L, Szabados B, Powles T. IMvigor011: a study of adjuvant atezolizumab in patients with high-risk MIBC who are ctDNA+ post-surgery. Future Oncol. 2023 Mar;19(7):509-515. doi: 10.2217/fon-2022-0868. Epub 2023 Apr 21.
- Powles T, Kann AG, Castellano D, Gross-Goupil M, Nishiyama H, Bracarda S, Bjerggaard Jensen J, Makaroff L, Jiang S, Ku JH, Park SH, Reig Torras O, Ye D, Maruzzo M, Necchi A, Morales-Barrera R, Giunta EF, Lee JL, Tortora G, Urun Y, Dolowy L, Erdem D, Pinto A, Grando F, Zou W, Assaf ZJ, Vuky J, Degaonkar V, Steinberg EE, Bellmunt J, Gschwend JE; IMvigor011 Investigators. ctDNA-Guided Adjuvant Atezolizumab in Muscle-Invasive Bladder Cancer. N Engl J Med. 2025 Dec 18;393(24):2395-2408. doi: 10.1056/NEJMoa2511885. Epub 2025 Oct 20.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BO42843
- 2020-004418-36 (Numer EudraCT)
- 2022-502705-15-00 (Ctis)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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