A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy (IMvigor011)

A Phase III, Double-Blind, Multicenter, Randomized Study of Atezolizumab (Anti-PDL1 Antibody) Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

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 ctDNA positive and are at high risk for recurrence following cystectomy.

Study Overview

• Status: Recruiting
• Conditions: Muscle-invasive Bladder Cancer
• Intervention / Treatment: Drug: Atezolizumab; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: BO42843 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. and Canada); Email: global.rochegenentechtrials@roche.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1019
    • Recruiting
    • Centro Medico Austral
  • Buenos Aires, Argentina, 1426
    • Recruiting
    • Instituto Alexander Fleming
  • Buenos Aires, Argentina, C1431FWN
    • Withdrawn
    • Cemic; Oncologia Clinica
• Belgium
  • Brasschaat, Belgium, 2930
    • Recruiting
    • AZ Klina
  • Gent, Belgium, 9000
    • Recruiting
    • UZ Gent
  • Roeselare, Belgium, 8800
    • Recruiting
    • AZ Delta (Campus Rumbeke)
• Brazil
  • CE
    • Fortaleza, CE, Brazil, 60135-237
      • Recruiting
      • Oncocentro Serviços Medicos E Hospitalares Ltda
    • Fortaleza, CE, Brazil, 60336-232
      • Withdrawn
      • Crio - Centro Regional Integrado de Oncologia
  • MG
    • Uberaba, MG, Brazil, 38082-049
      • Recruiting
      • CETUS Hospital Dia Oncologia
  • PR
    • Curitiba, PR, Brazil, 81520-060
      • Recruiting
      • Hospital Erasto Gaertner
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Recruiting
      • Hospital Sao Lucas - PUCRS
    • Porto Alegre, RS, Brazil, 90035-000
      • Recruiting
      • Hospital Moinhos de Vento
    • Porto Alegre, RS, Brazil, 90040-373
      • Recruiting
      • Hospital Nossa Senhora da Conceicao
    • Santa Maria, RS, Brazil, 97015-373
      • Recruiting
      • Clinica Viver
  • SP
    • Barretos, SP, Brazil, 14784-400
      • Recruiting
      • *X*Fundação Pio XII Hospital de Câncer de Barretos
    • Jau, SP, Brazil, 17210-120
      • Recruiting
      • Hospital Amaral Carvalho
    • Sao Paulo, SP, Brazil, 01246-000
      • Recruiting
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
    • Sao Paulo, SP, Brazil, 01323-020
      • Recruiting
      • Hospital Alemao Oswaldo Cruz; Pesquisa Clinica
    • São Paulo, SP, Brazil, 01321-00
      • Recruiting
      • Beneficencia Portuguesa de Sao Paulo
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Withdrawn
      • Cross Cancer Institute
  • Ontario
    • Sudbury, Ontario, Canada, P3E 5J1
      • Withdrawn
      • Health Sciences North
    • Toronto, Ontario, Canada, M5G 1Z5
      • Withdrawn
      • Princess Margaret Cancer Center
    • Toronto, Ontario, Canada, M4N 3M5
      • Withdrawn
      • Sunnybrook Research Institute
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Withdrawn
      • Jewish General Hospital
• China
  • Beijing, China, 100050
    • Recruiting
    • Friendship Hospital, Capital Medical University
  • Beijing City, China, 100034
    • Active, not recruiting
    • Peking University First Hospital
  • Changchun, China, 130021
    • Recruiting
    • The First Hospital of Jilin University
  • Changsha, China, 410006
    • Recruiting
    • Hu Nan Provincial Cancer Hospital
  • Chongqing, China, 400030
    • Recruiting
    • Chongqing Cancer Hospital
  • Fu Zhou, China, 350005
    • Recruiting
    • The First Affiliated Hospital of Fujian Medical University
  • Fuzhou City, China, 350001
    • Recruiting
    • Fujian Medical University Union Hospital
  • Guangzhou, China, 510120
    • Recruiting
    • The First Affiliated Hospital of Guangzhou Medical University
  • Harbin, China, 150081
    • Withdrawn
    • Harbin Medical University Cancer Hospital
  • Nanjing City, China, 210029
    • Active, not recruiting
    • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
  • Nanjing City, China, 211100
    • Recruiting
    • Jiangsu Cancer Hospital
  • Nanjing City, China, 210008
    • Active, not recruiting
    • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
  • Shanghai, China, 200032
    • Recruiting
    • Zhongshan Hospital Fudan University
  • Shanghai City, China, 200120
    • Recruiting
    • Fudan University Shanghai Cancer Center
  • Shanghai City, China, 200040
    • Withdrawn
    • Huashan Hospital affiliated to Fudan University
  • Shenyang, China, 110042
    • Recruiting
    • Liaoning cancer Hospital & Institute
  • Tianjin, China, 300060
    • Recruiting
    • Tianjin cancer hospital
  • Tianjin, China, 300211
    • Active, not recruiting
    • The 2nd Hospital of Tianjin Medical University; Department of Urology
  • Urumqi City, China, 830011
    • Withdrawn
    • Xinjiang Medical University Cancer Hospital
  • Xiamen, China, 361003
    • Withdrawn
    • The First Affiliated Hospital of Xiamen University
  • Yantai, China, 264099
    • Recruiting
    • Yantai Yu Huangding Hospital
• Colombia
  • Bogota, Colombia, 11001
    • Recruiting
    • Clinica del Country
  • Medellin, Colombia, 050024
    • Recruiting
    • Instituto Cancerologia Medellin; Clinica Las Americas
  • Monteria, Colombia, 230002
    • Recruiting
    • Oncomedica S.A.
• Czechia
  • Olomouc, Czechia, 779 00
    • Recruiting
    • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Praha 4 - Krc, Czechia, 140 59
    • Recruiting
    • Fakultni Thomayerova nemocnice; Onkologicka klinika 1. LF UK a FTN
  • Praha 5, Czechia, 150 06
    • Recruiting
    • Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol
• France
  • Angers, France, 49055
    • Recruiting
    • ICO Paul Papin; Oncologie Medicale.
  • Avignon, France, 84918
    • Recruiting
    • Institut Sainte Catherine;Recherche Clinique
  • Besançon Cedex, France, 25030
    • Withdrawn
    • CHU Besançon - Hôpital Jean Minjoz
  • Bordeaux, France, 33075
    • Active, not recruiting
    • Hopital Saint André
  • Clermont Ferrand, France, 63011
    • Recruiting
    • Centre Jean Perrin
  • Lyon, France, 69373
    • Recruiting
    • Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes
  • Nancy, France, 54100
    • Recruiting
    • Centre D'Oncologie de Gentilly; Oncology
  • Nice, France, 06189
    • Recruiting
    • Centre Antoine Lacassagne
  • Paris, France, 75674
    • Recruiting
    • Institut Mutualiste Montsouris; Oncologie
  • Suresnes, France, 92151
    • Recruiting
    • Hopital Foch; Oncologie
  • Toulouse, France, 31059
    • Recruiting
    • Institut Claudius Regaud
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy; Departement Oncologie Medicale
• Germany
  • Düsseldorf, Germany, 40225
    • Recruiting
    • Universitätsklinikum Düsseldorf; Urologische Klinik
  • Halle (Saale), Germany, 06120
    • Recruiting
    • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
  • Herne, Germany, 44625
    • Recruiting
    • Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
  • Jena, Germany, 07743
    • Recruiting
    • Universitätsklinikum Jena, Urologische Klinik und Poliklinik
  • München, Germany, 81675
    • Recruiting
    • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
  • Münster, Germany, 48149
    • Recruiting
    • Universitatsklinikum Munster, Klinik fur Urologie und Kinderurologie
  • Tübingen, Germany, 72076
    • Recruiting
    • Universitätsklinikum Tübingen; Klinik für Urologie
  • Ulm, Germany, 89081
    • Recruiting
    • Universitätsklinikum Ulm; Klinik für Urologie
  • Würzburg, Germany, 97080
    • Recruiting
    • Universitätsklinikum Würzburg; Klinik und Poliklinik für Urologie und Kinderurologie
• Greece
  • Athens, Greece, 115 28
    • Recruiting
    • Alexandras General Hospital of Athens; Oncology Department
  • Chaidari, Greece, 124 62
    • Recruiting
    • Attikon University General Hospital
  • Larissa, Greece, 411 10
    • Recruiting
    • University Hospital of Larissa;Department of Medical Oncology
  • Patras, Greece, 265 04
    • Recruiting
    • University Hospital of Patras Medical Oncology
  • Thessaloniki, Greece, 546 39
    • Recruiting
    • Theageneio Hospital
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Tuen Mun Hospital; Clinical Oncology
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital; Dept. Of Haematology & Oncology
• Ireland
  • Cork, Ireland
    • Recruiting
    • Cork Uni Hospital; Oncology Dept
  • Dublin, Ireland, D04 T6F4
    • Recruiting
    • St Vincents University Hospital
  • Dublin, Ireland, D24 NR0A
    • Recruiting
    • Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
• Israel
  • Haifa, Israel, 3109601
    • Completed
    • Rambam Medical Center; Oncology
  • Jerusalem, Israel, 9112000
    • Recruiting
    • Hadassah Ein Karem Hospital; Oncology Dept
  • Petah Tikva, Israel, 4910000
    • Withdrawn
    • Rabin Medical Center; Oncology Dept
  • Tel Aviv, Israel, 6423906
    • Active, not recruiting
    • Tel Aviv Sourasky Medical Ctr; Oncology
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Recruiting
      • Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico
    • Napoli, Campania, Italy, 80131
      • Recruiting
      • ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Recruiting
      • AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
    • Meldola, Emilia-Romagna, Italy, 47014
      • Recruiting
      • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Recruiting
      • Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Recruiting
      • A.O. Universitaria S. Martino Di Genova
  • Lombardia
    • Milano, Lombardia, Italy, 20132
      • Recruiting
      • IRCCS Ospedale San Raffaele
    • Milano, Lombardia, Italy, 20141
      • Recruiting
      • Istituto Europeo di Oncologia
    • Milano, Lombardia, Italy, 20133
      • Recruiting
      • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
  • Piemonte
    • Orbassano, Piemonte, Italy, 10043
      • Recruiting
      • A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
  • Toscana
    • Arezzo, Toscana, Italy, 52100
      • Recruiting
      • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
  • Umbria
    • Terni, Umbria, Italy, 20089
      • Recruiting
      • Azienda Ospedaliera Santa Maria di Terni
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Recruiting
      • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
• Japan
  • Aichi, Japan, 466-8560
    • Recruiting
    • Nagoya University Hospital
  • Chiba, Japan, 260-8717
    • Recruiting
    • Chiba Cancer Center
  • Chiba, Japan, 285-8741
    • Recruiting
    • Toho University Sakura Medical Center
  • Ehime, Japan, 791-0280
    • Recruiting
    • Shikoku Cancer Center
  • Fukuoka, Japan, 812-8582
    • Recruiting
    • Kyushu University Hospital
  • Hiroshima, Japan, 730-8518
    • Recruiting
    • Hiroshima City Hiroshima Citizens Hospital
  • Hiroshima, Japan, 721-8511
    • Recruiting
    • Fukuyama City Hospital
  • Hokkaido, Japan, 003-0804
    • Recruiting
    • National Hospital Organization Hokkaido Cancer Center
  • Ibaraki, Japan, 305-8576
    • Recruiting
    • University of Tsukuba Hospital
  • Iwate, Japan, 028-3695
    • Recruiting
    • Iwate Medical University Hospital
  • Kanagawa, Japan, 216-8511
    • Recruiting
    • St. Marianna University Hospital
  • Kanagawa, Japan, 238-8558
    • Recruiting
    • Yokosuka Kyosai Hospital
  • Kyoto, Japan, 606-8507
    • Recruiting
    • Kyoto University Hospital
  • Nagano, Japan, 381-8551
    • Recruiting
    • Nagano Municipal Hospital
  • Okayama, Japan, 700-8558
    • Recruiting
    • Okayama University Hospital
  • Osaka, Japan, 541-8567
    • Recruiting
    • Osaka International Cancer Institute
  • Osaka, Japan, 565-0871
    • Recruiting
    • Osaka University Hospital
  • Saitama, Japan, 350-1298
    • Recruiting
    • Saitama Medical University International Medical Center
  • Saitama, Japan, 362-0806
    • Recruiting
    • Saitama Cancer Center
  • Shizuoka, Japan, 411-8777
    • Recruiting
    • Shizuoka Cancer Center
  • Tokushima, Japan, 770-8503
    • Recruiting
    • Tokushima University Hospital
  • Tokyo, Japan, 104-0045
    • Recruiting
    • National Cancer Center Hospital
  • Tokyo, Japan, 135-8550
    • Recruiting
    • The Cancer Institute Hospital of JFCR
  • Tokyo, Japan, 160-8582
    • Recruiting
    • Keio University Hospital
  • Toyama, Japan, 930-0194
    • Recruiting
    • Toyama University Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Completed
    • Kyungpook National University Chilgok Hospital
  • Goyang-si, Korea, Republic of, 10408
    • Recruiting
    • National Cancer Center
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
• Mexico
  • Mexico City, Mexico, 14080
    • Recruiting
    • Instituto Nacional de Cancerologia; Oncology
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 14000
      • Recruiting
      • Inst. Nacional de La Nutricion Salvador Zubiran; Oncology
    • Mexico City, Mexico CITY (federal District), Mexico, 06720
      • Recruiting
      • Centro Medico Nacional Siglo Xxi - Imss; Hospital de Oncologia
  • Nuevo LEON
    • San Pedro Garza García, Nuevo LEON, Mexico, 66278
      • Recruiting
      • CUAN Hospital; Centro de Urologia Avnazada del Noreste
• Poland
  • ?ód?, Poland, 93-513
    • Recruiting
    • Wojewódzki Szpital Specjalistyczny im. M. Kopernika w ?odzi
  • Brzozów, Poland, 36-200
    • Completed
    • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
  • Bydgoszcz, Poland, 85-094
    • Withdrawn
    • Szpital Uniwersytecki Nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy; Klinika Urologii i Onkologicznej
  • Kraków, Poland, 30-727
    • Recruiting
    • Pratia MCM Krakow
  • Pozna?, Poland, 60-569
    • Recruiting
    • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
  • Warszawa, Poland, 04-073
    • Recruiting
    • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
  • Wroc?aw, Poland, 53-413
    • Recruiting
    • Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii
• Russian Federation
  • Ivanovo, Russian Federation, 153040
    • Active, not recruiting
    • Ivanovo Regional Oncology Dispensary
  • Murmansk, Russian Federation, 183047
    • Active, not recruiting
    • Murmansk Regional Clinical Hospital named after P.A. Bayandin
  • Kaluga
    • Obninsk, Kaluga, Russian Federation, 249036
      • Withdrawn
      • FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER
  • Leningrad
    • Kuzmolovo, Leningrad, Russian Federation, 188663
      • Recruiting
      • St-Petersburg Regional Oncology Dispensary; Oncology
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 117997
      • Withdrawn
      • Russian Scientific Center of Roentgenoradiology
    • Moscow, Moskovskaja Oblast, Russian Federation, 115478
      • Withdrawn
      • FSBSI ?N. N. Blokhin Russian Cancer Research Center?
  • Niznij Novgorod
    • Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603001
      • Recruiting
      • Privolzhsk Regional Medical Center
  • Sankt Petersburg
    • Saint-Petersburg, Sankt Petersburg, Russian Federation, 197758
      • Recruiting
      • FSI Russian Centre of Radiology and Surgical Technologies
• Singapore
  • Singapore, Singapore, 119228
    • Recruiting
    • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • Singapore, Singapore, 168583
    • Recruiting
    • National Cancer Centre; Medical Oncology
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron; Oncology
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clínic i Provincial; Servicio de Oncología
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Ramon y Cajal; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos; Servicio de Oncologia
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz; Servicio de Oncologia
  • Madrid, Spain, 28007
    • Withdrawn
    • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Madrid, Spain, 28033
    • Withdrawn
    • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Valencia, Spain, 46009
    • Recruiting
    • Instituto Valenciano Oncologia; Oncologia Medica
  • Barcelona
    • Sabadell, Barcelona, Spain, 8208
      • Recruiting
      • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Recruiting
      • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Guipuzcoa
    • San Sebastian, Guipuzcoa, Spain, 20080
      • Recruiting
      • Hospital de Donostia; Servicio de Oncologia Medica
  • LAS Palmas
    • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
      • Recruiting
      • Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia
• Turkey
  • Adana, Turkey, 01230
    • Recruiting
    • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Ankara, Turkey, 06700
    • Recruiting
    • Ankara University Faculty of Medicine Cebeci Hospital
  • Ankara, Turkey, 06800
    • Recruiting
    • Ankara City Hospital; Oncology
  • Bakirkoy / Istanbul, Turkey, 34147
    • Recruiting
    • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
  • Edirne, Turkey, 22030
    • Recruiting
    • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Istanbul, Turkey, 34098
    • Recruiting
    • Istanbul University Cerrahpasa Faculty of Medicine
  • Kadiköy, Turkey, 34722
    • Recruiting
    • Medeniyet University Goztepe Training and Research Hospital.
  • Kar??yaka, Turkey, 35575
    • Active, not recruiting
    • Medikal Park Izmir Hospital
  • Samsun, Turkey, 55200
    • Recruiting
    • Medikal Park Samsun
• Ukraine
  • Dnipropetrovsk, Ukraine, 49102
    • Recruiting
    • CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
  • Kyiv, Ukraine, 03115
    • Recruiting
    • Kyiv City Clinical Oncological Center
  • KIEV Governorate
    • Dnipro, KIEV Governorate, Ukraine, 49005
      • Recruiting
      • ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
    • Lviv, KIEV Governorate, Ukraine, 79010
      • Recruiting
      • Lviv Regional Clinical Hospital
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61037
      • Recruiting
      • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Withdrawn
    • Belfast City Hospital
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Addenbrookes Hospital
  • Edinburgh, United Kingdom, EH4 2XU
    • Recruiting
    • Western General Hospital
  • Leeds, United Kingdom, LS9 7TF
    • Active, not recruiting
    • St James Hospital; Dept of Oncology/Hematology
  • London, United Kingdom, W6 8RF
    • Recruiting
    • Charing Cross Hospital
  • London, United Kingdom, SW3 6JJ
    • Recruiting
    • Royal Marsden Hospital - London
  • London, United Kingdom, EC1M 6BQ
    • Recruiting
    • Barts Hospital; Institute of Cancer
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • University College London NHS Foundation Trust
  • Plymouth, United Kingdom, PL6 8BT
    • Recruiting
    • Derriford Hospital
  • Preston, United Kingdom, PR2 9HT
    • Recruiting
    • Royal Preston Hospital
  • Sheffield, United Kingdom, S10 2SJ
    • Recruiting
    • Weston Park Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • Southampton University Hospitals NHS Trust
  • Sutton, United Kingdom, SM2 5PT
    • Recruiting
    • Royal Marsden Hospital (Sutton)
• United States
  • California
    • Santa Barbara, California, United States, 93105
      • Withdrawn
      • Sansum Clinic
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Recruiting
      • Rocky Mountain Cancer Center - Denver
  • Florida
    • Pensacola, Florida, United States, 32503
      • Withdrawn
      • Woodlands Medical Specialists, P.A.
    • Rockledge, Florida, United States, 32955
      • Withdrawn
      • Cancer Care Centers of Brevard
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Recruiting
      • Optum Health Care
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • Allegheny General Hospital
  • Texas
    • Austin, Texas, United States, 78731
      • Withdrawn
      • Texas Oncology Cancer Center
    • Dallas, Texas, United States, 75230
      • Withdrawn
      • Texas Oncology-Medical City Dallas
    • Denton, Texas, United States, 76201
      • Withdrawn
      • Texas Oncology-Denton South
    • Fort Worth, Texas, United States, 76104
      • Withdrawn
      • Texas Oncology-Fort Worth 12th Ave
    • Houston, Texas, United States, 77024
      • Withdrawn
      • Texas Oncology - Houston (Gessner)
    • Houston, Texas, United States, 77070
      • Withdrawn
      • Texas Oncology - Willowbrook
    • McKinney, Texas, United States, 75071
      • Withdrawn
      • Texas Oncology P.A. (McKinney)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for the Surveillance Phase:

• Histologically confirmed MIUC (also termed TCC) of the bladder
• TNM classification (based on AJCC Cancer Staging Manual, 8th Edition; Amin et al. 2016) at pathological examination of surgical resection specimen as follows: For patients treated with prior NAC: tumor stage of ypT2-4a or ypN+ and M0. For patients who have not received prior NAC: tumor stage of pT2-4a or pN+ and M0
• Surgical resection of MIUC of the bladder
• Patients who have received prior platinum-based NAC.
• Patients who have not received prior platinum-based NAC, have refused, are ineligible ("unfit") for cisplatin-based adjuvant chemotherapy, or will not receive based on physicisan's decision.
• ctDNA assay developed based on tumor tissue specimen and matched normal DNA from blood.
• Tumor PD-L1 expression per 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 patient's 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
• ECOG Performance Status of <= 2
• Life expectancy >=12 weeks
• Adequate hematologic and end-organ function, investigator decision
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs

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. If a cap is in effect limiting enrollment of PD-L1 negative patients, this exclusion criterion will not apply.
• Pregnancy or breastfeeding
• Positive test for HIV, with the following exception: Patients 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
• Patients with active hepatitis B virus or hepatitis C. Patients with past HBV infection or resolved HBV infection are eligible. A negative HBV DNA test must be obtained in these patients prior to enrollment.

Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.

• Active tuberculosis 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. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with controlled Type I diabetes mellitus 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 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: Patients 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.
• Patients with active hepatitis B virus or hepatitis C
• Active tuberculosis confirmed by a test performed within 3 months prior to treatment initiation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Atezolizumab; Atezolizumab will be administered intravenously 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 IRF-assessed disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor.	Drug: Atezolizumab; Participants will receive 1680 mg intravenously every 4 weeks (Q4W) on Day 1 of each 28-day cycle.; Other Names: Tecentriq
Placebo Comparator: Arm B: Placebo; Placebo will be administered intravenously on Day 1 of each 28-day cycle. Placebo will be discontinued in the event of IRF-assessed disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor.	Other: Placebo; Participants will receive placebo intravenously Q4W on Day 1 of each 28-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator-assessed DFS	Investigator-assessed disease-free survival (DFS), 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; Death from any cause	Randomization up to first occurrence of DFS event (up to approximately 40 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of ADAs to Atezolizumab	Prevalence of ADAs to atezolizumab at baseline.	Baseline
Overall survival (OS)	Overall survival (OS), defined as the time from randomization to death from any cause.	Randomization up to death from any cause (up to approximately 10 years)
Independent Review Facility (IRF)-Assessed DFS		Randomization up to first occurrence of DFS event (up to approximately 40 months)
Investigator-Assessed Disease-Specific Survival	Investigator-assessed disease-specific survival, defined as the time from randomization to death from UC per investigator assessment of cause of death.	Randomization to death from UC (up to approximately 10 years)
Investigator-Assessed Distant Metastasis-Free Survival	Investigator-assessed distant metastasis-free survival, defined as the time from randomization to the diagnosis of distant (i.e., non-locoregional) metastases or death from any cause.	Randomization to diagnosis of distant metastases or death from any cause (up to approximately 10 years)
Time to Confirmed Deterioration of Function and Health Related Quality of Life (HRQoL)	Time to confirmed deterioration of function and health-related quality of life (HRQoL), defined as the time from randomization to the date of a participant's first score decrease of >= 10 points from baseline on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) physical function scale, role function scale, and the global health status (GHS)/QoL scale (separately), held for at least two consecutive time points or followed by death.	Randomization to participant's first score decrease of >=10 points from Baseline on EORTC QLQ-C30 physical function scale, role function scale, and the GHS/QoL Scale (up to approximately 10 years)
ctDNA Clearance	ctDNA clearance, defined as the proportion of patients who are ctDNA positive at baseline and ctDNA negative at Cycle 3, Day 1 or Cycle 5, Day 1.	Baseline, Cycle 3 Day 1 or Cycle 5 Day 1 (each cycle is 28 days)
Percentage of Participants With Adverse Events		Baseline up to approximately 10 years
Serum Concentration of Atezolizumab		At pre-defined intervals from first administration of study drug up to approximately 10 years
Incidence of Anti-Drug Antibodies (ADAs) to Atezolizumab	Incidence of anti-drug antibodies (ADAs) to atezolizumab after initiation of study treatment (postbaseline incidence).	Baseline up to approximately 10 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Atezolizumab
• Other Study ID Numbers: BO42843

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No