A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) 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 circulating tumour deoxyribonucleic acid (ctDNA) positive and are at high risk for recurrence following cystectomy.

Study Overview

• Status: Active, not recruiting
• Conditions: Muscle-invasive Bladder Cancer
• Intervention / Treatment: Drug: Atezolizumab; Other: Placebo; Device: Signatera

• Study Type: Interventional
• Enrollment (Actual): 761
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1019
    • Centro Medico Austral
  • Buenos Aires, Argentina, 1426
    • Instituto Alexander Fleming
• Belgium
  • Brasschaat, Belgium, 2930
    • AZ KLINA
  • Ghent, Belgium, 9000
    • UZ Gent
• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60170-170
      • Oncocentro Serviços Médicos e Hospitalares Ltda
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30110022
      • Cetus Hospital Dia Oncologia
  • Paraná
    • Curitiba, Paraná, Brazil, 81520-060
      • Hospital Erasto Gaertner
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceição
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
      • Hospital Moinhos de Vento
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas - PUCRS
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • *X*Fundação Pio XII Hospital de Câncer de Barretos
    • Jaú, São Paulo, Brazil, 17210-120
      • Hospital Amaral Carvalho
    • São Paulo, São Paulo, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
    • São Paulo, São Paulo, Brazil, 01323-020
      • Hospital Alemao Oswaldo Cruz
• China
  • Beijing, China, 100050
    • Friendship Hospital, Capital Medical University
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changsha, China, 410006
    • Hu Nan Provincial Cancer Hospital
  • Chongqing, China, 400030
    • Chongqing Cancer Hospital
  • Fuzhou, China, 350005
    • The First Affiliated Hospital Of Fujian Medical University
  • Guangzhou, China, 510120
    • The First Affiliated Hospital of Guangzhou Medical University
  • Nanjing, China, 210009
    • Jiangsu Cancer Hospital
  • Nanjing, China, 210029
    • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
  • Nanjing, China, 210029
    • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University
  • Shanghai, China, 200120
    • Fudan University Shanghai Cancer Center
  • Tianjin, China, 300060
    • Tianjin Cancer Hospital
  • Yantai, China, 264099
    • Yantai Yu Huangding Hospital
• Colombia
  • Bogotá, Colombia, 11001
    • Clinica del Country
  • Medellín, Colombia, 050024
    • Instituto Cancerología Medellin
  • Montería, Colombia, 230002
    • Oncomedica S.A.
• Czechia
  • Olomouc, Czechia, 779 00
    • Fakultni Nemocnice Olomouc
  • Prague, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Praha 4 - Krc, Czechia, 140 59
    • Fakultni Thomayerova nemocnice
• France
  • Angers, France, 49055
    • ICO Paul Papin
  • Avignon, France, 84918
    • Institut Sainte Catherine
  • Bordeaux, France, 33075
    • Hopital Saint Andre
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Lyon, France, 69373
    • Centre Leon Berard
  • Nancy, France, 54100
    • Centre d'oncologie de Gentilly
  • Paris, France, 75674
    • Institut Mutualiste Montsouris
  • Suresnes, France, 92151
    • Hopital Foch
  • Toulouse, France, 31059
    • Institut Claudius Regaud
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf
  • Halle, Germany, 06120
    • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
  • Herne, Germany, 44625
    • Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
  • Ulm, Germany, 89081
    • Universitatsklinikum Ulm
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg
• Greece
  • Ahens, Greece, 124 64
    • Attikon University General Hospital
  • Athens, Greece, 115 28
    • Alexandras General Hospital of Athens
  • Larissa, Greece, 411 10
    • University Hospital of Larissa
  • Pátrai, Greece, 265 04
    • University Hospital of Patras Medical Oncology
  • Thessaloniki, Greece, 54007
    • Theageneio Hospital
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
• Ireland
  • Cork, Ireland
    • Cork Uni Hospital
  • Dublin, Ireland, D24 NR0A
    • Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital
• Israel
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Ctr
• Italy
  • Campania
    • Naples, Campania, Italy, 80131
      • Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico
    • Naples, Campania, Italy, 80131
      • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
    • Meldola, Emilia-Romagna, Italy, 47014
      • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Policlinico Universitario "Agostino Gemelli"
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • A.O. Universitaria S. Martino Di Genova
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • IRCCS Ospedale San Raffaele
    • Milan, Lombardy, Italy, 20141
      • Istituto Europeo di Oncologia
    • Milan, Lombardy, Italy, 20133
      • Irccs Istituto Nazionale Dei Tumori (Int)
  • Piedmont
    • Orbassano, Piedmont, Italy, 10043
      • A.O. Universitaria S. Luigi Gonzaga
  • Tuscany
    • Arezzo, Tuscany, Italy, 52100
      • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato
  • Umbria
    • Terni, Umbria, Italy, 20089
      • Azienda Ospedaliera Santa Maria di Terni
  • Veneto
    • Padua, Veneto, Italy, 35128
      • IOV - Istituto Oncologico Veneto - IRCCS
• Japan
  • Aichi, Japan, 466-8560
    • Nagoya University Hospital
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Chiba, Japan, 285-8741
    • Toho University Sakura Medical Center
  • Ehime, Japan, 791-0280
    • Shikoku Cancer Center
  • Hiroshima, Japan, 730-8518
    • Hiroshima City Hiroshima Citizens Hospital
  • Hiroshima, Japan, 721-8511
    • Fukuyama City Hospital
  • Hokkaido, Japan, 003-0804
    • National Hospital Organization Hokkaido Cancer Center
  • Ibaraki, Japan, 305-8576
    • University of Tsukuba Hospital
  • Kanagawa, Japan, 216-8511
    • St. Marianna University Hospital
  • Kanagawa, Japan, 238-8558
    • Yokosuka Kyosai Hospital
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Nagano, Japan, 381-8551
    • Nagano Municipal Hospital
  • Numakunai, Japan, 028-3695
    • Iwate Medical University Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Saitama, Japan, 350-1298
    • Saitama Medical University International Medical Center
  • Saitama, Japan, 362-0806
    • Saitama Cancer Center
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital
  • Tokyo, Japan, 160-8582
    • Keio University Hospital
  • Toyama, Japan, 930-0194
    • Toyama University Hospital
• Mexico
  • Nuevo León
    • San Pedro Garza García, Nuevo León, Mexico, 66278
      • CUAN Hospital
• Poland
  • Krakow, Poland, 30-727
    • Pratia MCM Kraków
  • Poznan, Poland, 60-569
    • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu
  • Warsaw, Poland, 04-073
    • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
  • Wroclaw, Poland
    • Dolnoslaskie Centrum Onkologii
• Russia
  • Ivanovo, Russia, 153040
    • Ivanovo regional oncology dispensary
  • Leningrad
    • Kuzmolovo, Leningrad, Russia, 188663
      • St-Petersburg Regional Oncology Dispensary
  • Niznij Novgorod
    • Nizhny Novgorod, Niznij Novgorod, Russia, 603001
      • Privolzhsk Regional Medical Center
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 197758
      • FSI Russian Centre of Radiology and Surgical Technologies
• Singapore
  • Singapore, Singapore, 168583
    • National Cancer Centre
• South Korea
  • Goyang-si, South Korea, 10408
    • National Cancer Center
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, (0)6351
    • Samsung Medical Center
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08036
    • Hospital Clinic I Provincial
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28034
    • Hospital Ramon Y Cajal
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46009
    • Instituto Valenciano Oncologia
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia
  • Guipuzcoa
    • Donostia / San Sebastian, Guipuzcoa, Spain, 20080
      • Hospital de Donostia
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01230
    • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
  • Ankara, Turkey (Türkiye), 06800
    • Ankara City Hospital
  • Ankara, Turkey (Türkiye), 06700
    • Ankara University Faculty of Medicine Cebeci Hospital
  • Bakirkoy / Istanbul, Turkey (Türkiye), 34147
    • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
  • Cordaleo, Turkey (Türkiye), 35575
    • Medikal Park Izmir Hospital
  • Edirne, Turkey (Türkiye), 22030
    • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul University Cerrahpasa Faculty of Medicine
  • Istanbul, Turkey (Türkiye), 34730
    • Medeniyet University Goztepe Training and Research Hospital.
  • Samsun, Turkey (Türkiye), 55200
    • Medikal Park Samsun
• Ukraine
  • Dnipropetrovsk, Ukraine, 49102
    • CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
  • Kyiv, Ukraine, 03115
    • Kyiv City Clinical Oncological Center
  • KIEV Governorate
    • Dnipro, KIEV Governorate, Ukraine, 49005
      • ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
    • Lviv, KIEV Governorate, Ukraine, 79010
      • Lviv Regional Clinical Hospital
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61037
      • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital - London
  • London, United Kingdom, NW1 2PG
    • University College London NHS Foundation Trust
  • London, United Kingdom, EC1M 6BQ
    • Barts Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital
  • Preston, United Kingdom, PR2 9HT
    • Royal Preston Hospital
  • Sheffield, United Kingdom, S10 2SJ
    • Weston Park Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton University Hospitals NHS Trust
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital (Sutton)
• United States
  • Florida
    • Rockledge, Florida, United States, 32955
      • Cancer Care Centers of Brevard
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Optum Health Care
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • AHN Cancer Institute ? Allegheny General Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Atezolizumab; ctDNA positive participants will receive 1680 mg IV, every 4 weeks (Q4W) on Day 1 of each 28-day cycle.; Other Names: Tecentriq; Device: Signatera; 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.
Placebo Comparator: 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.	Other: Placebo; ctDNA positive participants will receive placebo IV, Q4W on Day 1 of each 28-day cycle; Device: Signatera; 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.
Experimental: 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.	Device: Signatera; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator-assessed (INV) - Disease-free Survival (DFS)	INV-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 49 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of ADAs to Atezolizumab	Prevalence of ADAs to atezolizumab at baseline.	Baseline
ctDNA Clearance	ctDNA clearance, defined as the proportion of participants 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)
Overall survival (OS)	OS, defined as the time from randomization to death from any cause.	Randomization up to death from any cause (up to approximately 6 years)
Independent Review Facility (IRF)-assessed DFS		Randomization up to first occurrence of DFS event (up to approximately 49 months)
INV Disease-specific Survival (DSS)	INV-DSS, 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 6 years)
INV Distant Metastasis-free Survival (DMFS)	INV-DMFS, 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 49 months)
Time to Confirmed Deterioration of Function and Health-related Quality of Life (HRQoL)	Time to confirmed deterioration of function and 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 49 months)
Percentage of Participants With Adverse Events (AEs)		Baseline up to approximately 6 years
Serum Concentration of Atezolizumab		At pre-defined intervals from first administration of study drug (up to approximately 49 months)
Incidence of Anti-Drug Antibodies (ADAs) to Atezolizumab	Incidence of ADAs to atezolizumab after initiation of study treatment (postbaseline incidence).	Baseline up to approximately 49 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Natera, Inc.
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): June 15, 2025
• Study Completion (Estimated): October 1, 2026

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): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Substandard Drugs; Pharmaceutical Preparations; atezolizumab
• Other Study ID Numbers: BO42843; 2020-004418-36 (EudraCT Number); 2022-502705-15-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

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