Studie Atezolizumab versus Placebo jako adjuvantní terapie u pacientů s vysoce rizikovým svalově invazivním karcinomem močového měchýře, kteří jsou ctDNA pozitivní po cystektomii (IMvigor011)
Fáze III, dvojitě zaslepená, multicentrická, randomizovaná studie Atezolizumab (protilátka proti PDL1) versus placebo jako adjuvantní terapie u pacientů s vysoce rizikovým svalově invazivním karcinomem močového měchýře, kteří jsou po cystektomii pozitivní na 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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Buenos Aires, Argentina, 1019
- Centro Medico Austral
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Buenos Aires, Argentina, 1426
- Instituto Alexander Fleming
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Brasschaat, Belgie, 2930
- AZ KLINA
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Ghent, Belgie, 9000
- UZ Gent
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Ceará
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Fortaleza, Ceará, Brazílie, 60170-170
- Oncocentro Serviços Medicos E Hospitalares Ltda
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazílie, 30110022
- CETUS Hospital Dia Oncologia
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazílie, 91350-200
- Hospital Nossa Senhora da Conceicao
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Porto Alegre, Rio Grande do Sul, Brazílie, 90610-000
- Hospital Sao Lucas - PUCRS
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São Paulo
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Barretos, São Paulo, Brazílie, 14784-400
- *X*Fundação Pio XII Hospital de Câncer de Barretos
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Jaú, São Paulo, Brazílie, 17210-120
- Hospital Amaral Carvalho
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São Paulo, São Paulo, Brazílie, 01323-020
- Hospital Alemao Oswaldo Cruz
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São Paulo, São Paulo, Brazílie, 01246-000
- Instituto do Cancer do Estado de Sao Paulo - ICESP
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Angers, Francie, 49055
- ICO Paul Papin
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Avignon, Francie, 84918
- Institut Sainte Catherine
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Bordeaux, Francie, 33075
- Hopital Saint Andre
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Clermont-Ferrand, Francie, 63011
- Centre Jean Perrin
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Lyon, Francie, 69373
- Centre Léon Bérard
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Nancy, Francie, 54100
- Centre D'Oncologie de Gentilly
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Paris, Francie, 75674
- Institut Mutualiste Montsouris
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Suresnes, Francie, 92151
- Hopital Foch
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Toulouse, Francie, 31059
- Institut Claudius Régaud
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Villejuif, Francie, 94805
- Institut Gustave Roussy
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Hong Kong, Hongkong
- Queen Mary Hospital
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Cork, Irsko
- Cork Uni Hospital
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Dublin, Irsko, D24 NR0A
- Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital
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Campania
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Naples, Campania, Itálie, 80131
- Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico
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Naples, Campania, Itálie, 80131
- Istituto Nazionale Tumori Irccs Fondazione G. Pascale
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Emilia-Romagna
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Bologna, Emilia-Romagna, Itálie, 40138
- AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
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Lazio
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Rome, Lazio, Itálie, 00168
- Policlinico Universitario "Agostino Gemelli"
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Liguria
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Genoa, Liguria, Itálie, 16132
- A.O. Universitaria S. Martino Di Genova
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Lombardy
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Milan, Lombardy, Itálie, 20133
- Irccs Istituto Nazionale Dei Tumori (Int)
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Milan, Lombardy, Itálie, 20141
- Istituto Europeo Di Oncologia
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Milan, Lombardy, Itálie, 20132
- Irccs Ospedale San Raffaele
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Piedmont
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Orbassano, Piedmont, Itálie, 10043
- A.O. Universitaria S. Luigi Gonzaga
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Tuscany
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Arezzo, Tuscany, Itálie, 52100
- Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato
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Veneto
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Padova, Veneto, Itálie, 35128
- IOV - Istituto Oncologico Veneto - IRCCS
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Tel Aviv, Izrael, 6423906
- Tel Aviv Sourasky Medical Ctr
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Aichi, Japonsko, 466-8560
- Nagoya University Hospital
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Chiba, Japonsko, 260-8717
- Chiba Cancer Center
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Chiba, Japonsko, 285-8741
- Toho University Sakura Medical Center
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Ehime, Japonsko, 791-0280
- Shikoku Cancer Center
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Hiroshima, Japonsko, 730-8518
- Hiroshima City Hiroshima Citizens Hospital
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Hiroshima, Japonsko, 721-8511
- Fukuyama City Hospital
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Hokkaido, Japonsko, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Ibaraki, Japonsko, 305-8576
- University of Tsukuba Hospital
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Kanagawa, Japonsko, 216-8511
- St. Marianna University Hospital
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Kanagawa, Japonsko, 238-8558
- Yokosuka Kyosai Hospital
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Kyoto, Japonsko, 606-8507
- Kyoto University Hospital
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Nagano, Japonsko, 381-8551
- Nagano Municipal Hospital
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Numakunai, Japonsko, 028-3695
- Iwate Medical University Hospital
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Osaka, Japonsko, 541-8567
- Osaka International Cancer Institute
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Saitama, Japonsko, 350-1298
- Saitama Medical University International Medical Center
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Saitama, Japonsko, 362-0806
- Saitama Cancer Center
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Shizuoka, Japonsko, 411-8777
- Shizuoka Cancer Center
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Tokushima, Japonsko, 770-8503
- Tokushima University Hospital
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Tokyo, Japonsko, 104-0045
- National Cancer Center Hospital
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Tokyo, Japonsko, 160-8582
- Keio University Hospital
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Toyama, Japonsko, 930-0194
- Toyama University Hospital
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Goyang-si, Jižní Korea, 10408
- National Cancer Center
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Seoul, Jižní Korea, 03080
- Seoul National University Hospital
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Seoul, Jižní Korea, 05505
- Asan Medical Center
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Seoul, Jižní Korea, (0)6351
- Samsung Medical Center
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Bogotá, Kolumbie, 11001
- Clinica del Country
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Medellín, Kolumbie, 050024
- Instituto Cancerología Medellin
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Montería, Kolumbie, 230002
- Oncomedica S.A.
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Düsseldorf, Německo, 40225
- Universitätsklinikum Düsseldorf
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Halle, Německo, 06120
- Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
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Herne, Německo, 44625
- Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
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Tübingen, Německo, 72076
- Universitätsklinikum Tübingen
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Ulm, Německo, 89081
- Universitätsklinikum Ulm
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Würzburg, Německo, 97080
- Universitätsklinikum Würzburg
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Krakow, Polsko, 30-727
- PRATIA MCM Kraków
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Poznan, Polsko, 60-569
- Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu
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Warsaw, Polsko, 04-073
- Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
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Wroclaw, Polsko
- Dolnoslaskie Centrum Onkologii
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Ivanovo, Rusko, 153040
- Ivanovo Regional Oncology Dispensary
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Leningrad
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Kuzmolovo, Leningrad, Rusko, 188663
- St-Petersburg Regional Oncology Dispensary
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Niznij Novgorod
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Nizhny Novgorod, Niznij Novgorod, Rusko, 603001
- Privolzhsk Regional Medical Center
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Rusko, 197758
- FSI Russian Centre of Radiology and Surgical Technologies
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Singapore, Singapur, 168583
- National Cancer Centre
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Cambridge, Spojené království, CB2 0QQ
- Addenbrookes Hospital
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Edinburgh, Spojené království, EH4 2XU
- Western General Hospital
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London, Spojené království, W6 8RF
- Charing Cross Hospital
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London, Spojené království, SW3 6JJ
- Royal Marsden Hospital - London
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London, Spojené království, NW1 2PG
- University College London NHS Foundation Trust
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London, Spojené království, EC1M 6BQ
- Barts Hospital
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Plymouth, Spojené království, PL6 8DH
- Derriford Hospital
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Preston, Spojené království, PR2 9HT
- Royal Preston Hospital
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Sheffield, Spojené království, S10 2SJ
- Weston Park Hospital
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Southampton, Spojené království, SO16 6YD
- Southampton University Hospitals NHS Trust
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Sutton, Spojené království, SM2 5PT
- Royal Marsden Hospital (Sutton)
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Florida
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Rockledge, Florida, Spojené státy, 32955
- Cancer Care Centers of Brevard
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Ohio
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic
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Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15212
- AHN Cancer Institute ? Allegheny General Hospital
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Adana, Turecko (Türkiye), 01230
- Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
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Ankara, Turecko (Türkiye), 06700
- Ankara University Faculty of Medicine Cebeci Hospital
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Bakirkoy / Istanbul, Turecko (Türkiye), 34147
- Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
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Cordaleo, Turecko (Türkiye), 35575
- Medikal Park Izmir Hospital
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Edirne, Turecko (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Turecko (Türkiye), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
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Istanbul, Turecko (Türkiye), 34730
- Medeniyet University Goztepe Training and Research Hospital.
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Samsun, Turecko (Türkiye), 55200
- Medikal Park Samsun
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Dnipropetrovsk, Ukrajina, 49102
- CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
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Kyiv, Ukrajina, 03115
- Kyiv City Clinical Oncological Center
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KIEV Governorate
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Dnipro, KIEV Governorate, Ukrajina, 49005
- ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
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Lviv, KIEV Governorate, Ukrajina, 79010
- Lviv Regional Clinical Hospital
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Kharkiv Governorate
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Kharkiv, Kharkiv Governorate, Ukrajina, 61037
- Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
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Olomouc, Česko, 779 00
- Fakultni nemocnice Olomouc
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Prague, Česko, 150 06
- Fakultni nemocnice v Motole
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Praha 4 - Krc, Česko, 140 59
- Fakultni Thomayerova nemocnice
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Beijing, Čína, 100050
- Friendship Hospital, Capital Medical University
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Changchun, Čína, 130021
- the First Hospital of Jilin University
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Changsha, Čína, 410006
- Hu Nan Provincial Cancer Hospital
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Fuzhou, Čína, 350005
- The First Affiliated Hospital of Fujian Medical University
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Guangzhou, Čína, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Nanjing, Čína, 210009
- Jiangsu Cancer Hospital
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Nanjing, Čína, 210029
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
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Nanjing, Čína, 210029
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
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Shanghai, Čína, 200032
- Zhongshan Hospital Fudan University
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Shanghai, Čína, 200120
- Fudan University Shanghai Cancer Center
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Tianjin, Čína, 300060
- Tianjin Cancer Hospital
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Yantai, Čína, 264099
- Yantai Yu Huangding Hospital
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Ahens, Řecko, 124 64
- Attikon University General Hospital
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Athens, Řecko, 115 28
- Alexandras General Hospital of Athens
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Larissa, Řecko, 411 10
- University Hospital of Larissa
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Pátrai, Řecko, 265 04
- University Hospital of Patras Medical Oncology
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Thessaloniki, Řecko, 54007
- Theageneio Hospital
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Barcelona, Španělsko, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Španělsko, 08041
- Hospital de la Santa Creu i Sant Pau
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Barcelona, Španělsko, 08036
- Hospital Clínic i Provincial
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Madrid, Španělsko, 28040
- Hospital Clinico San Carlos
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Madrid, Španělsko, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Španělsko, 28046
- Hospital Universitario La Paz
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Madrid, Španělsko, 28034
- Hospital Ramon y Cajal
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Valencia, Španělsko, 46009
- Instituto Valenciano Oncologia
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Valencia, Španělsko, 46010
- Hospital Clinico Universitario de Valencia
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Barcelona
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Sabadell, Barcelona, Španělsko, 08208
- Corporacio Sanitaria Parc Tauli
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Cantabria
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Santander, Cantabria, Španělsko, 39008
- Hospital Universitario Marques de Valdecilla
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Cordoba
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Córdoba, Cordoba, Španělsko, 14004
- Hospital Universitario Reina Sofia
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Guipuzcoa
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Donostia / San Sebastian, Guipuzcoa, Španělsko, 20080
- Hospital de Donostia
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
Ostatní jména:
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. |
|
Komparátor placeba: 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 |
|
Experimentální: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
INV-assessed Disease-free Survival (DFS)
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Overall Survival (OS)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
|
|
Number of Participants With Adverse Events (AEs)
Časové okno: 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
Časové okno: 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)
|
|
|
Minimum Serum Concentration (Cmin) of Atezolizumab
Časové okno: 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)
|
|
|
Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Clinical Trials, Hoffmann-La Roche
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BO42843
- 2020-004418-36 (Číslo EudraCT)
- 2022-502705-15-00 (Ctis)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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