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

Muscle-invasive Bladder Cancer Clinical Trial

— IMvigor011  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04660344
• Other study ID #: BO42843
• Status: Recruiting
• Phase: Phase 3
• Start date: May 3, 2021
• Est. completion date: April 1, 2031

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: BO42843 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. and Canada)
• Email: global.rochegenentechtrials[@]roche.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 1, 2031
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle-invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Atezolizumab
Participants will receive 1680 mg intravenously every 4 weeks (Q4W) on Day 1 of each 28-day cycle.

Other:
• Placebo
Participants will receive placebo intravenously Q4W on Day 1 of each 28-day cycle

Locations

Country	Name	City	State
Argentina	Cemic; Oncologia Clinica	Buenos Aires
Argentina	Centro Medico Austral	Buenos Aires
Argentina	Instituto Alexander Fleming	Buenos Aires
Belgium	AZ KLINA	Brasschaat
Belgium	UZ Gent	Gent
Belgium	AZ Delta (Campus Rumbeke)	Roeselare
Brazil	*X*Fundação Pio XII Hospital de Câncer de Barretos	Barretos	SP
Brazil	Hospital Erasto Gaertner	Curitiba	PR
Brazil	Crio - Centro Regional Integrado de Oncologia	Fortaleza	CE
Brazil	Oncocentro Serviços Medicos E Hospitalares Ltda	Fortaleza	CE
Brazil	Hospital Amaral Carvalho	Jau	SP
Brazil	Hospital Moinhos de Vento	Porto Alegre	RS
Brazil	Hospital Nossa Senhora da Conceicao	Porto Alegre	RS
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Clinica Viver	Santa Maria	RS
Brazil	Hospital Alemao Oswaldo Cruz; Pesquisa Clinica	Sao Paulo	SP
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
Brazil	Beneficencia Portuguesa de Sao Paulo	São Paulo	SP
Brazil	CETUS Hospital Dia Oncologia	Uberaba	MG
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Health Sciences North	Sudbury	Ontario
Canada	Princess Margaret Cancer Center	Toronto	Ontario
Canada	Sunnybrook Research Institute	Toronto	Ontario
China	Friendship Hospital, Capital Medical University	Beijing
China	Peking University First Hospital	Beijing City
China	the First Hospital of Jilin University	Changchun
China	Hu Nan Provincial Cancer Hospital	Changsha
China	Chongqing Cancer Hospital	Chongqing
China	The First Affiliated Hospital of Fujian Medical University	Fu Zhou
China	Fujian Medical University Union Hospital	Fuzhou City
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Harbin Medical University Cancer Hospital	Harbin
China	Jiangsu Cancer Hospital	Nanjing City
China	Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)	Nanjing City
China	Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School	Nanjing City
China	Zhongshan Hospital Fudan University	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai City
China	Huashan Hospital Affiliated to Fudan University	Shanghai City
China	Liaoning cancer Hospital & Institute	Shenyang
China	The 2nd Hospital of Tianjin Medical University; Department of Urology	Tianjin
China	Tianjin Cancer Hospital	Tianjin
China	Xinjiang Medical University Cancer Hospital	Urumqi City
China	The First Affiliated Hospital of Xiamen University	Xiamen
China	Yantai Yu Huangding Hospital	Yantai
Colombia	Clinica del Country	Bogota
Colombia	Instituto Cancerologia Medellin; Clinica Las Americas	Medellin
Colombia	Oncomedica S.A.	Monteria
Czechia	Fakultni nemocnice Olomouc; Onkologicka klinika	Olomouc
Czechia	Fakultni Thomayerova nemocnice; Onkologicka klinika 1. LF UK a FTN	Praha 4 - Krc
Czechia	Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol	Praha 5
France	ICO Paul Papin; Oncologie Medicale.	Angers
France	Institut Sainte Catherine;Recherche Clinique	Avignon
France	CHU Besançon - Hôpital Jean Minjoz	Besançon Cedex
France	Hopital Saint Andre	Bordeaux
France	Centre Jean Perrin	Clermont Ferrand
France	Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes	Lyon
France	Centre D'Oncologie de Gentilly; Oncology	Nancy
France	Centre Antoine Lacassagne	Nice
France	Institut Mutualiste Montsouris; Oncologie	Paris
France	Hopital Foch; Oncologie	Suresnes
France	Institut Claudius Régaud	Toulouse
France	Institut Gustave Roussy; Departement Oncologie Medicale	Villejuif
Germany	Universitätsklinikum Düsseldorf; Urologische Klinik	Düsseldorf
Germany	Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie	Halle (Saale)
Germany	Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik	Herne
Germany	Universitätsklinikum Jena, Urologische Klinik und Poliklinik	Jena
Germany	Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik	München
Germany	Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie	Münster
Germany	Universitätsklinikum Tübingen; Klinik für Urologie	Tübingen
Germany	Universitätsklinikum Ulm; Klinik für Urologie	Ulm
Germany	Universitätsklinikum Würzburg; Klinik und Poliklinik für Urologie und Kinderurologie	Würzburg
Greece	Alexandras General Hospital of Athens; Oncology Department	Athens
Greece	Attikon University General Hospital	Chaidari
Greece	University Hospital of Larissa;Department of Medical Oncology	Larissa
Greece	University Hospital of Patras Medical Oncology	Patras
Greece	Theageneio Hospital	Thessaloniki
Hong Kong	Queen Mary Hospital; Dept. Of Haematology & Oncology	Hong Kong
Hong Kong	Tuen Mun Hospital; Clinical Oncology	Hong Kong
Ireland	Cork Uni Hospital; Oncology Dept	Cork
Ireland	Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit	Dublin
Ireland	St Vincents University Hospital	Dublin
Israel	Rambam Medical Center; Oncology	Haifa
Israel	Hadassah Ein Karem Hospital; Oncology Dept	Jerusalem
Israel	Rabin Medical Center; Oncology Dept	Petah Tikva
Israel	Tel Aviv Sourasky Medical Ctr; Oncology	Tel Aviv
Italy	Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia	Arezzo	Toscana
Italy	AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica	Bologna	Emilia-Romagna
Italy	A.O. Universitaria S. Martino Di Genova	Genova	Liguria
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2	Milano	Lombardia
Italy	Irccs Ospedale San Raffaele	Milano	Lombardia
Italy	Istituto Europeo Di Oncologia	Milano	Lombardia
Italy	Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico	Napoli	Campania
Italy	ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico	Napoli	Campania
Italy	A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica	Orbassano	Piemonte
Italy	IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II	Padova	Veneto
Italy	Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica	Roma	Lazio
Italy	Azienda Ospedaliera Santa Maria di Terni	Terni	Umbria
Japan	Nagoya University Hospital	Aichi
Japan	Chiba Cancer Center	Chiba
Japan	Toho University Sakura Medical Center	Chiba
Japan	Shikoku Cancer Center	Ehime
Japan	Kyushu University Hospital	Fukuoka
Japan	Fukuyama City Hospital	Hiroshima
Japan	Hiroshima City Hiroshima Citizens Hospital	Hiroshima
Japan	National Hospital Organization Hokkaido Cancer Center	Hokkaido
Japan	University of Tsukuba Hospital	Ibaraki
Japan	Iwate Medical University Hospital	Iwate
Japan	St. Marianna University Hospital	Kanagawa
Japan	Yokosuka Kyosai Hospital	Kanagawa
Japan	Kyoto University Hospital	Kyoto
Japan	Nagano Municipal Hospital	Nagano
Japan	Okayama University Hospital	Okayama
Japan	Osaka International Cancer Institute	Osaka
Japan	Osaka University Hospital	Osaka
Japan	Saitama Cancer Center	Saitama
Japan	Saitama Medical University International Medical Center	Saitama
Japan	Shizuoka Cancer Center	Shizuoka
Japan	Tokushima University Hospital	Tokushima
Japan	Keio University Hospital	Tokyo
Japan	National Cancer Center Hospital	Tokyo
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Japan	Toyama University Hospital	Toyama
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Mexico	Centro Medico Nacional Siglo Xxi - Imss; Hospital de Oncologia	Mexico City	Mexico CITY (federal District)
Mexico	Inst. Nacional de La Nutricion Salvador Zubiran; Oncology	Mexico City	Mexico CITY (federal District)
Mexico	Instituto Nacional de Cancerologia; Oncology	Mexico City
Mexico	CUAN Hospital; Centro de Urologia Avnazada del Noreste	San Pedro Garza García	Nuevo LEON
Poland	Wojewódzki Szpital Specjalistyczny im. M. Kopernika w ?odzi	?ód?
Poland	Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny	Brzozów
Poland	Szpital Uniwersytecki Nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy; Klinika Urologii i Onkologicznej	Bydgoszcz
Poland	PRATIA MCM Kraków	Kraków
Poland	Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii	Pozna?
Poland	Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.	Warszawa
Poland	Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii	Wroc?aw
Russian Federation	Ivanovo Regional Oncology Dispensary	Ivanovo
Russian Federation	St-Petersburg Regional Oncology Dispensary; Oncology	Kuzmolovo	Leningrad
Russian Federation	FSBSI ?N. N. Blokhin Russian Cancer Research Center?	Moscow	Moskovskaja Oblast
Russian Federation	Russian Scientific Center of Roentgenoradiology	Moscow	Moskovskaja Oblast
Russian Federation	Murmansk Regional Clinical Hospital named after P.A. Bayandin	Murmansk
Russian Federation	Privolzhsk Regional Medical Center	Nizhny Novgorod	Niznij Novgorod
Russian Federation	FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER	Obninsk	Kaluga
Russian Federation	FSI Russian Centre of Radiology and Surgical Technologies	Saint-Petersburg	Sankt Petersburg
Singapore	National Cancer Centre; Medical Oncology	Singapore
Singapore	National University Hospital; National University Cancer Institute, Singapore (NCIS)	Singapore
Spain	Hospital Clínic i Provincial; Servicio de Oncología	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia	Barcelona
Spain	Hospital Universitari Vall d'Hebron; Oncology	Barcelona
Spain	Hospital Universitario Reina Sofia; Servicio de Oncologia	Córdoba	Cordoba
Spain	Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia	Las Palmas de Gran Canaria	LAS Palmas
Spain	Centro Oncologico MD Anderson Internacional; Servicio de Oncologia	Madrid
Spain	Hospital Clinico San Carlos; Servicio de Oncologia	Madrid
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid
Spain	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	Corporacio Sanitaria Parc Tauli; Servicio de Oncologia	Sabadell	Barcelona
Spain	Hospital de Donostia; Servicio de Oncologia Medica	San Sebastian	Guipuzcoa
Spain	Hospital Universitario Marques de Valdecilla; Servicio de Oncologia	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocio; Servicio de Oncologia	Sevilla
Spain	Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia	Valencia
Spain	Instituto Valenciano Oncologia; Oncologia Medica	Valencia
Turkey	Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology	Adana
Turkey	Ankara City Hospital; Oncology	Ankara
Turkey	Ankara University Faculty of Medicine Cebeci Hospital	Ankara
Turkey	Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji	Bakirkoy / Istanbul
Turkey	Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi	Edirne
Turkey	Istanbul University Cerrahpasa Faculty of Medicine	Istanbul
Turkey	Medeniyet University Goztepe Training and Research Hospital.	Kadiköy
Turkey	Medikal Park Izmir Hospital	Kar??yaka
Turkey	Medikal Park Samsun	Samsun
Ukraine	ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council	Dnipro	KIEV Governorate
Ukraine	CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR	Dnipropetrovsk
Ukraine	Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4	Kharkiv	Kharkiv Governorate
Ukraine	Kyiv City Clinical Oncological Center	Kyiv
Ukraine	Lviv Regional Clinical Hospital	Lviv	KIEV Governorate
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	St James Hospital; Dept of Oncology/Hematology	Leeds
United Kingdom	Barts Hospital; Institute of Cancer	London
United Kingdom	Charing Cross Hospital	London
United Kingdom	Royal Marsden Hospital - London	London
United Kingdom	University College London NHS Foundation Trust	London
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Weston Park Hospital	Sheffield
United Kingdom	Southampton University Hospitals NHS Trust	Southampton
United Kingdom	Royal Marsden Hospital (Sutton)	Sutton
United States	Texas Oncology Cancer Center	Austin	Texas
United States	Cleveland Clinic	Cleveland	Ohio
United States	Texas Oncology-Medical City Dallas	Dallas	Texas
United States	Texas Oncology-Denton South	Denton	Texas
United States	Duke Cancer Institute	Durham	North Carolina
United States	Texas Oncology-Fort Worth 12th Ave	Fort Worth	Texas
United States	Texas Oncology - Houston (Gessner)	Houston	Texas
United States	Texas Oncology - Willowbrook	Houston	Texas
United States	Optum Health Care	Las Vegas	Nevada
United States	Rocky Mountain Cancer Center - Denver	Littleton	Colorado
United States	Texas Oncology P.A. (McKinney)	McKinney	Texas
United States	Woodlands Medical Specialists, P.A.	Pensacola	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Cancer Care Centers of Brevard	Rockledge	Florida
United States	Sansum Clinic	Santa Barbara	California
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  China,  Colombia,  Czechia,  France,  Germany,  Greece,  Hong Kong,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  Singapore,  Spain,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Independent Review Facility (IRF)-Assessed DFS		Randomization up to first occurrence of DFS event (up to approximately 40 months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Percentage of Participants With Adverse Events		Baseline up to approximately 10 years
Secondary	Serum Concentration of Atezolizumab		At pre-defined intervals from first administration of study drug up to approximately 10 years
Secondary	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
Secondary	Prevalence of ADAs to Atezolizumab	Prevalence of ADAs to atezolizumab at baseline.	Baseline