Исследование атезолизумаба по сравнению с плацебо в качестве адъювантной терапии у пациентов с мышечно-инвазивным раком мочевого пузыря высокого риска, которые имеют положительный результат цДНК после цистэктомии (IMvigor011)
Фаза III, двойное слепое, многоцентровое, рандомизированное исследование атезолизумаба (антитела к PDL1) по сравнению с плацебо в качестве адъювантной терапии у пациентов с мышечно-инвазивным раком мочевого пузыря высокого риска, у которых после цистэктомии обнаружена цДНК
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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Buenos Aires, Аргентина, 1019
- Centro Medico Austral
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Buenos Aires, Аргентина, 1426
- Instituto Alexander Fleming
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Brasschaat, Бельгия, 2930
- AZ KLINA
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Ghent, Бельгия, 9000
- UZ Gent
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Ceará
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Fortaleza, Ceará, Бразилия, 60170-170
- Oncocentro Serviços Medicos E Hospitalares Ltda
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Minas Gerais
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Belo Horizonte, Minas Gerais, Бразилия, 30110022
- CETUS Hospital Dia Oncologia
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Бразилия, 91350-200
- Hospital Nossa Senhora da Conceicao
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Porto Alegre, Rio Grande do Sul, Бразилия, 90610-000
- Hospital Sao Lucas - PUCRS
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São Paulo
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Barretos, São Paulo, Бразилия, 14784-400
- *X*Fundação Pio XII Hospital de Câncer de Barretos
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Jaú, São Paulo, Бразилия, 17210-120
- Hospital Amaral Carvalho
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São Paulo, São Paulo, Бразилия, 01323-020
- Hospital Alemao Oswaldo Cruz
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São Paulo, São Paulo, Бразилия, 01246-000
- Instituto do Cancer do Estado de Sao Paulo - ICESP
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Düsseldorf, Германия, 40225
- Universitätsklinikum Düsseldorf
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Halle, Германия, 06120
- Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
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Herne, Германия, 44625
- Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
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Tübingen, Германия, 72076
- Universitätsklinikum Tübingen
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Ulm, Германия, 89081
- Universitätsklinikum Ulm
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Würzburg, Германия, 97080
- Universitätsklinikum Würzburg
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Hong Kong, Гонконг
- Queen Mary Hospital
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Ahens, Греция, 124 64
- Attikon University General Hospital
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Athens, Греция, 115 28
- Alexandras General Hospital of Athens
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Larissa, Греция, 411 10
- University Hospital of Larissa
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Pátrai, Греция, 265 04
- University Hospital of Patras Medical Oncology
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Thessaloniki, Греция, 54007
- Theageneio Hospital
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Tel Aviv, Израиль, 6423906
- Tel Aviv Sourasky Medical Ctr
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Cork, Ирландия
- Cork Uni Hospital
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Dublin, Ирландия, D24 NR0A
- Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital
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Barcelona, Испания, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Испания, 08041
- Hospital de la Santa Creu i Sant Pau
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Barcelona, Испания, 08036
- Hospital Clínic i Provincial
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Madrid, Испания, 28040
- Hospital Clinico San Carlos
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Madrid, Испания, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Испания, 28046
- Hospital Universitario La Paz
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Madrid, Испания, 28034
- Hospital Ramon y Cajal
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Valencia, Испания, 46009
- Instituto Valenciano Oncologia
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Valencia, Испания, 46010
- Hospital Clinico Universitario de Valencia
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Barcelona
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Sabadell, Barcelona, Испания, 08208
- Corporacio Sanitaria Parc Tauli
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Cantabria
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Santander, Cantabria, Испания, 39008
- Hospital Universitario Marques de Valdecilla
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Cordoba
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Córdoba, Cordoba, Испания, 14004
- Hospital Universitario Reina Sofia
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Guipuzcoa
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Donostia / San Sebastian, Guipuzcoa, Испания, 20080
- Hospital de Donostia
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Campania
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Naples, Campania, Италия, 80131
- Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico
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Naples, Campania, Италия, 80131
- Istituto Nazionale Tumori Irccs Fondazione G. Pascale
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Emilia-Romagna
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Bologna, Emilia-Romagna, Италия, 40138
- AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
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Lazio
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Rome, Lazio, Италия, 00168
- Policlinico Universitario "Agostino Gemelli"
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Liguria
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Genoa, Liguria, Италия, 16132
- A.O. Universitaria S. Martino Di Genova
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Lombardy
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Milan, Lombardy, Италия, 20133
- Irccs Istituto Nazionale Dei Tumori (Int)
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Milan, Lombardy, Италия, 20141
- Istituto Europeo Di Oncologia
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Milan, Lombardy, Италия, 20132
- Irccs Ospedale San Raffaele
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Piedmont
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Orbassano, Piedmont, Италия, 10043
- A.O. Universitaria S. Luigi Gonzaga
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Tuscany
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Arezzo, Tuscany, Италия, 52100
- Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato
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Veneto
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Padova, Veneto, Италия, 35128
- IOV - Istituto Oncologico Veneto - IRCCS
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Beijing, Китай, 100050
- Friendship Hospital, Capital Medical University
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Changchun, Китай, 130021
- the First Hospital of Jilin University
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Changsha, Китай, 410006
- Hu Nan Provincial Cancer Hospital
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Fuzhou, Китай, 350005
- The First Affiliated Hospital of Fujian Medical University
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Guangzhou, Китай, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Nanjing, Китай, 210009
- Jiangsu Cancer Hospital
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Nanjing, Китай, 210029
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
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Nanjing, Китай, 210029
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
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Shanghai, Китай, 200032
- Zhongshan Hospital Fudan University
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Shanghai, Китай, 200120
- Fudan University Shanghai Cancer Center
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Tianjin, Китай, 300060
- Tianjin Cancer Hospital
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Yantai, Китай, 264099
- Yantai Yu Huangding Hospital
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Bogotá, Колумбия, 11001
- Clinica del Country
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Medellín, Колумбия, 050024
- Instituto Cancerología Medellin
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Montería, Колумбия, 230002
- Oncomedica S.A.
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Krakow, Польша, 30-727
- PRATIA MCM Kraków
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Poznan, Польша, 60-569
- Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu
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Warsaw, Польша, 04-073
- Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
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Wroclaw, Польша
- Dolnoslaskie Centrum Onkologii
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Ivanovo, Россия, 153040
- Ivanovo Regional Oncology Dispensary
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Leningrad
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Kuzmolovo, Leningrad, Россия, 188663
- St-Petersburg Regional Oncology Dispensary
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Niznij Novgorod
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Nizhny Novgorod, Niznij Novgorod, Россия, 603001
- Privolzhsk Regional Medical Center
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Россия, 197758
- FSI Russian Centre of Radiology and Surgical Technologies
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Singapore, Сингапур, 168583
- National Cancer Centre
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Cambridge, Соединенное Королевство, CB2 0QQ
- Addenbrookes Hospital
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Edinburgh, Соединенное Королевство, EH4 2XU
- Western General Hospital
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London, Соединенное Королевство, W6 8RF
- Charing Cross Hospital
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London, Соединенное Королевство, SW3 6JJ
- Royal Marsden Hospital - London
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London, Соединенное Королевство, NW1 2PG
- University College London NHS Foundation Trust
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London, Соединенное Королевство, EC1M 6BQ
- Barts Hospital
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Plymouth, Соединенное Королевство, PL6 8DH
- Derriford Hospital
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Preston, Соединенное Королевство, PR2 9HT
- Royal Preston Hospital
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Sheffield, Соединенное Королевство, S10 2SJ
- Weston Park Hospital
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Southampton, Соединенное Королевство, SO16 6YD
- Southampton University Hospitals NHS Trust
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Sutton, Соединенное Королевство, SM2 5PT
- Royal Marsden Hospital (Sutton)
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Florida
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Rockledge, Florida, Соединенные Штаты, 32955
- Cancer Care Centers of Brevard
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Ohio
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Cleveland, Ohio, Соединенные Штаты, 44195
- Cleveland Clinic
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Pennsylvania
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15212
- AHN Cancer Institute ? Allegheny General Hospital
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Adana, Турция (Туркие), 01230
- Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
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Ankara, Турция (Туркие), 06700
- Ankara University Faculty of Medicine Cebeci Hospital
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Bakirkoy / Istanbul, Турция (Туркие), 34147
- Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
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Cordaleo, Турция (Туркие), 35575
- Medikal Park Izmir Hospital
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Edirne, Турция (Туркие), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Турция (Туркие), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
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Istanbul, Турция (Туркие), 34730
- Medeniyet University Goztepe Training and Research Hospital.
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Samsun, Турция (Туркие), 55200
- Medikal Park Samsun
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Dnipropetrovsk, Украина, 49102
- CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
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Kyiv, Украина, 03115
- Kyiv City Clinical Oncological Center
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KIEV Governorate
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Dnipro, KIEV Governorate, Украина, 49005
- ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
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Lviv, KIEV Governorate, Украина, 79010
- Lviv Regional Clinical Hospital
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Kharkiv Governorate
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Kharkiv, Kharkiv Governorate, Украина, 61037
- Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
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Angers, Франция, 49055
- ICO Paul Papin
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Avignon, Франция, 84918
- Institut Sainte Catherine
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Bordeaux, Франция, 33075
- Hopital Saint Andre
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Clermont-Ferrand, Франция, 63011
- Centre Jean Perrin
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Lyon, Франция, 69373
- Centre Léon Bérard
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Nancy, Франция, 54100
- Centre D'Oncologie de Gentilly
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Paris, Франция, 75674
- Institut Mutualiste Montsouris
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Suresnes, Франция, 92151
- Hopital Foch
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Toulouse, Франция, 31059
- Institut Claudius Régaud
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Villejuif, Франция, 94805
- Institut Gustave Roussy
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Olomouc, Чехия, 779 00
- Fakultni nemocnice Olomouc
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Prague, Чехия, 150 06
- Fakultni nemocnice v Motole
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Praha 4 - Krc, Чехия, 140 59
- Fakultni Thomayerova nemocnice
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Goyang-si, Южная Корея, 10408
- National Cancer Center
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Seoul, Южная Корея, 03080
- Seoul National University Hospital
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Seoul, Южная Корея, 05505
- Asan Medical Center
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Seoul, Южная Корея, (0)6351
- Samsung Medical Center
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Aichi, Япония, 466-8560
- Nagoya University Hospital
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Chiba, Япония, 260-8717
- Chiba Cancer Center
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Chiba, Япония, 285-8741
- Toho University Sakura Medical Center
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Ehime, Япония, 791-0280
- Shikoku Cancer Center
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Hiroshima, Япония, 730-8518
- Hiroshima City Hiroshima Citizens Hospital
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Hiroshima, Япония, 721-8511
- Fukuyama City Hospital
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Hokkaido, Япония, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Ibaraki, Япония, 305-8576
- University of Tsukuba Hospital
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Kanagawa, Япония, 216-8511
- St. Marianna University Hospital
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Kanagawa, Япония, 238-8558
- Yokosuka Kyosai Hospital
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Kyoto, Япония, 606-8507
- Kyoto University Hospital
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Nagano, Япония, 381-8551
- Nagano Municipal Hospital
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Numakunai, Япония, 028-3695
- Iwate Medical University Hospital
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Osaka, Япония, 541-8567
- Osaka International Cancer Institute
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Saitama, Япония, 350-1298
- Saitama Medical University International Medical Center
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Saitama, Япония, 362-0806
- Saitama Cancer Center
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Shizuoka, Япония, 411-8777
- Shizuoka Cancer Center
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Tokushima, Япония, 770-8503
- Tokushima University Hospital
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Tokyo, Япония, 104-0045
- National Cancer Center Hospital
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Tokyo, Япония, 160-8582
- Keio University Hospital
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Toyama, Япония, 930-0194
- Toyama University Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
Другие имена:
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. |
|
Плацебо Компаратор: 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 |
|
Экспериментальный: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
INV-assessed Disease-free Survival (DFS)
Временное ограничение: 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)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall Survival (OS)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
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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)
Временное ограничение: Up to 11.8 months
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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
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Percentage of Participants With ctDNA Clearance
Временное ограничение: Baseline, Day 1 of Cycles 3 or 5 (Cycle length = 28 days)
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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)
Временное ограничение: From initiation of study treatment up to approximately 5 years
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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
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Maximum Serum Concentration (Cmax) of Atezolizumab
Временное ограничение: 30 minutes post dose on Cycle 1 Day 1 (Cycle length = 28 days)
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30 minutes post dose on Cycle 1 Day 1 (Cycle length = 28 days)
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Minimum Serum Concentration (Cmin) of Atezolizumab
Временное ограничение: Pre-dose on Day 1 of Cycles 2, 3, 4, 8 and 12 (Cycle length = 28 days)
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Pre-dose on Day 1 of Cycles 2, 3, 4, 8 and 12 (Cycle length = 28 days)
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Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
Временное ограничение: Up to 12.8 months
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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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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Директор по исследованиям: Clinical Trials, Hoffmann-La Roche
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- BO42843
- 2020-004418-36 (Номер EudraCT)
- 2022-502705-15-00 (Ктис)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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