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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)

Primary Purpose

Muscle-invasive Bladder Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle-invasive Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, or are ineligible ("unfit") for cisplatin-based adjuvant chemotherapy.
  • 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.
  • 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

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 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. HBV DNA 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 start.
  • 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

Sites / Locations

  • Sansum Clinic
  • Rocky Mountain Cancer Center - DenverRecruiting
  • Woodlands Medical Specialists, P.A.
  • Cancer Care Centers of Brevard
  • Optum Health CareRecruiting
  • Wake Forest Baptist Medical CenterRecruiting
  • Allegheny General HospitalRecruiting
  • Texas Oncology Cancer Center
  • Texas Oncology-Medical City Dallas
  • Texas Oncology-Denton South
  • Texas Oncology-Fort Worth 12th Ave
  • Texas Oncology - Houston (Gessner)
  • Texas Oncology - Willowbrook
  • Texas Oncology P.A. (McKinney)
  • Centro Medico AustralRecruiting
  • Instituto Alexander FlemingRecruiting
  • Cemic; Oncologia Clinica
  • AZ KLINA
  • UZ GentRecruiting
  • AZ Delta (Campus Rumbeke)Recruiting
  • Oncocentro Serviços Medicos E Hospitalares LtdaRecruiting
  • Crio - Centro Regional Integrado de Oncologia
  • CETUS Hospital Dia OncologiaRecruiting
  • Hospital Erasto GaertnerRecruiting
  • Hospital Moinhos de VentoRecruiting
  • Hospital Sao Lucas - PUCRSRecruiting
  • Hospital Nossa Senhora da ConceicaoRecruiting
  • Clinica ViverRecruiting
  • *X*Fundação Pio XII Hospital de Câncer de BarretosRecruiting
  • Hospital Amaral CarvalhoRecruiting
  • Instituto do Cancer do Estado de Sao Paulo - ICESPRecruiting
  • Hospital Alemao Oswaldo Cruz; Pesquisa ClinicaRecruiting
  • Beneficencia Portuguesa de Sao PauloRecruiting
  • Cross Cancer Institute
  • Health Sciences North
  • Sunnybrook Research Institute
  • Princess Margaret Cancer Center
  • Jewish General Hospital
  • Peking University First Hospital
  • Friendship Hospital, Capital Medical UniversityRecruiting
  • the First Hospital of Jilin UniversityRecruiting
  • Hu Nan Provincial Cancer HospitalRecruiting
  • Chongqing Cancer HospitalRecruiting
  • The First Affiliated Hospital of Fujian Medical UniversityRecruiting
  • Fujian Medical University Union HospitalRecruiting
  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Harbin Medical University Cancer Hospital
  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical SchoolRecruiting
  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)Recruiting
  • Jiangsu Cancer HospitalRecruiting
  • Huashan Hospital Affiliated to Fudan UniversityRecruiting
  • Fudan University Shanghai Cancer CenterRecruiting
  • Zhongshan Hospital Fudan UniversityRecruiting
  • Liaoning cancer Hospital & InstituteRecruiting
  • Tianjin Cancer HospitalRecruiting
  • The 2nd Hospital of Tianjin Medical University; Department of UrologyRecruiting
  • Xinjiang Medical University Cancer Hospital
  • The First Affiliated Hospital of Xiamen University
  • Yantai Yu Huangding HospitalRecruiting
  • Clinica del CountryRecruiting
  • Instituto Cancerologia Medellin; Clinica Las AmericasRecruiting
  • Oncomedica S.A.Recruiting
  • Fakultni nemocnice Olomouc; Onkologicka klinikaRecruiting
  • Fakultni Thomayerova nemocnice; Onkologicka klinika 1. LF UK a FTNRecruiting
  • Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN MotolRecruiting
  • ICO Paul Papin; Oncologie Medicale.Recruiting
  • Institut Sainte Catherine;Recherche CliniqueRecruiting
  • CHU Besançon - Hôpital Jean Minjoz
  • Hopital Saint Andre
  • Centre Jean PerrinRecruiting
  • Centre Léon Bérard; Centre régional; le cancer Rhône-AlpesRecruiting
  • Centre D'Oncologie de Gentilly; OncologyRecruiting
  • Centre Antoine LacassagneRecruiting
  • Institut Mutualiste Montsouris; OncologieRecruiting
  • Hopital Foch; OncologieRecruiting
  • Institut Claudius RégaudRecruiting
  • Institut Gustave Roussy; Departement Oncologie MedicaleRecruiting
  • Universitätsklinikum Düsseldorf; Urologische KlinikRecruiting
  • Krankenhaus Martha-Maria Halle-Dölau, Klinik für UrologieRecruiting
  • Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische KlinikRecruiting
  • Universitätsklinikum Jena, Urologische Klinik und PoliklinikRecruiting
  • Klinikum rechts der Isar der TU München; Urologische Klinik und PoliklinikRecruiting
  • Universitätsklinikum Münster, Klinik für Urologie und KinderurologieRecruiting
  • Universitätsklinikum Tübingen; Klinik für UrologieRecruiting
  • Universitätsklinikum Ulm; Klinik für UrologieRecruiting
  • Universitätsklinikum Würzburg; Klinik und Poliklinik für Urologie und KinderurologieRecruiting
  • Alexandras General Hospital of Athens; Oncology DepartmentRecruiting
  • Attikon University General HospitalRecruiting
  • University Hospital of Larissa;Department of Medical OncologyRecruiting
  • University Hospital of Patras Medical OncologyRecruiting
  • Theageneio HospitalRecruiting
  • Queen Mary Hospital; Dept. Of Haematology & OncologyRecruiting
  • Tuen Mun Hospital; Clinical OncologyRecruiting
  • Cork Uni Hospital; Oncology DeptRecruiting
  • St Vincents University HospitalRecruiting
  • Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day UnitRecruiting
  • Rambam Medical Center; Oncology
  • Hadassah Ein Karem Hospital; Oncology DeptRecruiting
  • Rabin Medical Center; Oncology Dept
  • Tel Aviv Sourasky Medical Ctr; OncologyRecruiting
  • Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital OncologicoRecruiting
  • ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-GinecologicoRecruiting
  • AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia MedicaRecruiting
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia MedicaRecruiting
  • Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia MedicaRecruiting
  • A.O. Universitaria S. Martino Di GenovaRecruiting
  • Irccs Ospedale San RaffaeleRecruiting
  • Istituto Europeo Di OncologiaRecruiting
  • A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia MedicaRecruiting
  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. OncologiaRecruiting
  • Azienda Ospedaliera Santa Maria di TerniRecruiting
  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica IIRecruiting
  • Nagoya University HospitalRecruiting
  • Chiba Cancer CenterRecruiting
  • Toho University Sakura Medical CenterRecruiting
  • Shikoku Cancer CenterRecruiting
  • Kyushu University HospitalRecruiting
  • Fukuyama City HospitalRecruiting
  • Hiroshima City Hiroshima Citizens HospitalRecruiting
  • National Hospital Organization Hokkaido Cancer CenterRecruiting
  • University of Tsukuba HospitalRecruiting
  • Iwate Medical University HospitalRecruiting
  • St. Marianna University HospitalRecruiting
  • Yokosuka Kyosai HospitalRecruiting
  • Kyoto University HospitalRecruiting
  • Nagano Municipal HospitalRecruiting
  • Okayama University HospitalRecruiting
  • Osaka International Cancer InstituteRecruiting
  • Osaka University HospitalRecruiting
  • Saitama Medical University International Medical CenterRecruiting
  • Saitama Cancer CenterRecruiting
  • Shizuoka Cancer CenterRecruiting
  • Tokushima University HospitalRecruiting
  • National Cancer Center HospitalRecruiting
  • The Cancer Institute Hospital of JFCRRecruiting
  • Keio University HospitalRecruiting
  • Toyama University HospitalRecruiting
  • Kyungpook National University Chilgok Hospital
  • National Cancer CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Instituto Nacional de Cancerologia; OncologyRecruiting
  • Wojewódzki Szpital Specjalistyczny im. M. Kopernika w ?odziRecruiting
  • Szpital Specjalistyczny Podkarpacki O?rodek OnkologicznyRecruiting
  • Szpital Uniwersytecki Nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy; Klinika Urologii i Onkologicznej
  • PRATIA MCM KrakówRecruiting
  • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? ChemioterapiiRecruiting
  • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.Recruiting
  • Dolno?l?skie Centrum Onkologii, Pulmonologii i HematologiiRecruiting
  • FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER
  • St-Petersburg Regional Oncology Dispensary; OncologyRecruiting
  • Russian Scientific Center of Roentgenoradiology
  • Privolzhsk Regional Medical CenterRecruiting
  • FSI Russian Centre of Radiology and Surgical TechnologiesRecruiting
  • Ivanovo Regional Oncology DispensaryRecruiting
  • Murmansk Regional Clinical Hospital named after P.A. Bayandin
  • National Cancer Centre; Medical OncologyRecruiting
  • Corporacio Sanitaria Parc Tauli; Servicio de OncologiaRecruiting
  • Hospital Universitario Marques de Valdecilla; Servicio de OncologiaRecruiting
  • Hospital Universitario Reina Sofia; Servicio de OncologiaRecruiting
  • Hospital de Donostia; Servicio de Oncologia MedicaRecruiting
  • Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de OncologiaRecruiting
  • Hospital Universitari Vall d'Hebron; OncologyRecruiting
  • Hospital Clínic i Provincial; Servicio de OncologíaRecruiting
  • Hospital de la Santa Creu i Sant Pau; Servicio de OncologiaRecruiting
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de OncologiaRecruiting
  • Hospital Clinico San Carlos; Servicio de OncologiaRecruiting
  • Hospital Universitario 12 de Octubre; Servicio de OncologiaRecruiting
  • Hospital Universitario La Paz; Servicio de OncologiaRecruiting
  • Hospital Universitario Virgen del Rocio; Servicio de OncologiaRecruiting
  • Instituto Valenciano Oncologia; Oncologia MedicaRecruiting
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologiaRecruiting
  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical OncologyRecruiting
  • Ankara University Faculty of Medicine Cebeci HospitalRecruiting
  • Ankara City Hospital; OncologyRecruiting
  • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi OnkolojiRecruiting
  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan YerleskesiRecruiting
  • Istanbul University Cerrahpasa Faculty of MedicineRecruiting
  • Medeniyet University Goztepe Training and Research Hospital.Recruiting
  • Medikal Park Izmir HospitalRecruiting
  • Medikal Park SamsunRecruiting
  • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4Recruiting
  • ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional CouncilRecruiting
  • Lviv Regional Clinical HospitalRecruiting
  • CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MRRecruiting
  • Kyiv City Clinical Oncological CenterRecruiting
  • Belfast City Hospital
  • Addenbrookes HospitalRecruiting
  • Western General HospitalRecruiting
  • St James Hospital; Dept of Oncology/HematologyRecruiting
  • Barts Hospital; Institute of CancerRecruiting
  • University College London NHS Foundation TrustRecruiting
  • Royal Marsden Hospital - LondonRecruiting
  • Charing Cross HospitalRecruiting
  • Derriford HospitalRecruiting
  • Royal Preston HospitalRecruiting
  • Weston Park HospitalRecruiting
  • Southampton University Hospitals NHS TrustRecruiting
  • Royal Marsden Hospital (Sutton)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A: Atezolizumab

Arm B: Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Investigator-assessed DFS in Participants Who Are ctDNA Positive Within 24 Weeks of Cystectomy
Investigator-assessed disease-free survival (DFS) in participants who are ctDNA positive within 24 weeks of cystectomy (primary analysis population), 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

Secondary Outcome Measures

Overall survival (OS) in Participants Who Are ctDNA Positive Within 24 weeks After Cystectomy
Overall survival (OS) in participants who are ctDNA positive within 24 weeks after cystectomy (primary analysis population), defined as the time from randomization to death from any cause.
Investigator-assessed DFS in All Randomized Participants
Independent Review Facility (IRF)-Assessed DFS in Primary Analysis Population
IRF-Assessed DFS in All Randomized Participants
Investigator-Assessed Disease-Specific Survival in Primary Analysis Population
Investigator-assessed disease-specific survival in the primary analysis population, defined as the time from randomization to death from UC per investigator assessment of cause of death.
Investigator-Assessed Distant Metastasis-Free Survival in Primary Analysis Population
Investigator-assessed distant metastasis-free survival in the primary analysis population, defined as the time from randomization to the diagnosis of distant (i.e., non-locoregional) metastases or death from any cause.
Time to Deterioration of Function and Quality of Life (QoL) in Primary Analysis Population and in All Randomized Population
Time to deterioration of function and quality of life (QoL) in the primary analysis population and in the all randomized population, defined as the time from randomization to the date of a participants'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).
ctDNA Clearance in Primary Analysis Population
ctDNA clearance in the primary analysis population, 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.
Percentage of Participants With Adverse Events
Serum Concentration of Atezolizumab
Incidence of Anti-Drug Antibodies (ADAs) to Atezolizumab
Incidence of anti-drug antibodies (ADAs) to atezolizumab during the study.
Prevalence of ADAs to Atezolizumab
Prevalence of ADAs to atezolizumab at baseline.

Full Information

First Posted
December 1, 2020
Last Updated
October 6, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04660344
Brief Title
A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
November 22, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle-invasive Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Atezolizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B: Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Participants will receive 1680 mg intravenously every 4 weeks (Q4W) on Day 1 of each 28-day cycle.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo intravenously Q4W on Day 1 of each 28-day cycle
Primary Outcome Measure Information:
Title
Investigator-assessed DFS in Participants Who Are ctDNA Positive Within 24 Weeks of Cystectomy
Description
Investigator-assessed disease-free survival (DFS) in participants who are ctDNA positive within 24 weeks of cystectomy (primary analysis population), 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
Time Frame
Randomization up to first occurrence of DFS event (up to approximately 46 months)
Secondary Outcome Measure Information:
Title
Overall survival (OS) in Participants Who Are ctDNA Positive Within 24 weeks After Cystectomy
Description
Overall survival (OS) in participants who are ctDNA positive within 24 weeks after cystectomy (primary analysis population), defined as the time from randomization to death from any cause.
Time Frame
Randomization up to death from any cause (up to approximately 81 months)
Title
Investigator-assessed DFS in All Randomized Participants
Time Frame
Randomization up to first occurrence of DFS event (up to approximately 44 months)
Title
Independent Review Facility (IRF)-Assessed DFS in Primary Analysis Population
Time Frame
Randomization up to first occurrence of DFS event (up to approximately 81 months)
Title
IRF-Assessed DFS in All Randomized Participants
Time Frame
Randomization up to first occurrence of DFS event (up to approximately 81 months)
Title
Investigator-Assessed Disease-Specific Survival in Primary Analysis Population
Description
Investigator-assessed disease-specific survival in the primary analysis population, defined as the time from randomization to death from UC per investigator assessment of cause of death.
Time Frame
Randomization to death from UC (up to approximately 81 months)
Title
Investigator-Assessed Distant Metastasis-Free Survival in Primary Analysis Population
Description
Investigator-assessed distant metastasis-free survival in the primary analysis population, defined as the time from randomization to the diagnosis of distant (i.e., non-locoregional) metastases or death from any cause.
Time Frame
Randomization to diagnosis of distant metastases or death from any cause (up to approximately 81 months)
Title
Time to Deterioration of Function and Quality of Life (QoL) in Primary Analysis Population and in All Randomized Population
Description
Time to deterioration of function and quality of life (QoL) in the primary analysis population and in the all randomized population, defined as the time from randomization to the date of a participants'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).
Time Frame
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 81 months)
Title
ctDNA Clearance in Primary Analysis Population
Description
ctDNA clearance in the primary analysis population, 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.
Time Frame
Baseline, Cycle 3 Day 1 or Cycle 5 Day 1 (each cycle is 28 days)
Title
Percentage of Participants With Adverse Events
Time Frame
Baseline up to approximately 81 months
Title
Serum Concentration of Atezolizumab
Time Frame
At pre-defined intervals from first administration of study drug up to approximately 81 months
Title
Incidence of Anti-Drug Antibodies (ADAs) to Atezolizumab
Description
Incidence of anti-drug antibodies (ADAs) to atezolizumab during the study.
Time Frame
Baseline up to approximately 81 months
Title
Prevalence of ADAs to Atezolizumab
Description
Prevalence of ADAs to atezolizumab at baseline.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, or are ineligible ("unfit") for cisplatin-based adjuvant chemotherapy. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BO42843 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global.rochegenentechtrials@roche.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Withdrawn
Facility Name
Rocky Mountain Cancer Center - Denver
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Name
Woodlands Medical Specialists, P.A.
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cancer Care Centers of Brevard
City
Rockledge
State/Province
Florida
ZIP/Postal Code
32955
Country
United States
Individual Site Status
Withdrawn
Facility Name
Optum Health Care
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology-Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology-Denton South
City
Denton
State/Province
Texas
ZIP/Postal Code
76201
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology-Fort Worth 12th Ave
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology - Houston (Gessner)
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology - Willowbrook
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology P.A. (McKinney)
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Withdrawn
Facility Name
Centro Medico Austral
City
Buenos Aires
ZIP/Postal Code
1019
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Alexander Fleming
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cemic; Oncologia Clinica
City
Buenos Aires
ZIP/Postal Code
C1431FWN
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
AZ KLINA
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Delta (Campus Rumbeke)
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Oncocentro Serviços Medicos E Hospitalares Ltda
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60135-237
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Crio - Centro Regional Integrado de Oncologia
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60336-232
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
CETUS Hospital Dia Oncologia
City
Uberaba
State/Province
MG
ZIP/Postal Code
38082-049
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Erasto Gaertner
City
Curitiba
State/Province
PR
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Clinica Viver
City
Santa Maria
State/Province
RS
ZIP/Postal Code
97015-373
Country
Brazil
Individual Site Status
Recruiting
Facility Name
*X*Fundação Pio XII Hospital de Câncer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Amaral Carvalho
City
Jau
State/Province
SP
ZIP/Postal Code
17210-120
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Alemao Oswaldo Cruz; Pesquisa Clinica
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01323-020
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Beneficencia Portuguesa de Sao Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01321-00
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Health Sciences North
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Peking University First Hospital
City
Beijing City
ZIP/Postal Code
100034
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Friendship Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
the First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Hu Nan Provincial Cancer Hospital
City
Changsha
ZIP/Postal Code
410006
Country
China
Individual Site Status
Recruiting
Facility Name
Chongqing Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fu Zhou
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou City
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
City
Nanjing City
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
City
Nanjing City
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Cancer Hospital
City
Nanjing City
ZIP/Postal Code
211100
Country
China
Individual Site Status
Recruiting
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai City
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Liaoning cancer Hospital & Institute
City
Shenyang
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
The 2nd Hospital of Tianjin Medical University; Department of Urology
City
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Name
Xinjiang Medical University Cancer Hospital
City
Urumqi City
ZIP/Postal Code
830011
Country
China
Individual Site Status
Withdrawn
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
ZIP/Postal Code
361003
Country
China
Individual Site Status
Withdrawn
Facility Name
Yantai Yu Huangding Hospital
City
Yantai
ZIP/Postal Code
264099
Country
China
Individual Site Status
Recruiting
Facility Name
Clinica del Country
City
Bogota
ZIP/Postal Code
11001
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Instituto Cancerologia Medellin; Clinica Las Americas
City
Medellin
ZIP/Postal Code
050024
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Oncomedica S.A.
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Olomouc; Onkologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni Thomayerova nemocnice; Onkologicka klinika 1. LF UK a FTN
City
Praha 4 - Krc
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
ICO Paul Papin; Oncologie Medicale.
City
Angers
ZIP/Postal Code
49055
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Sainte Catherine;Recherche Clinique
City
Avignon
ZIP/Postal Code
84918
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besançon Cedex
ZIP/Postal Code
25030
Country
France
Individual Site Status
Withdrawn
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Centre D'Oncologie de Gentilly; Oncology
City
Nancy
ZIP/Postal Code
54100
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Mutualiste Montsouris; Oncologie
City
Paris
ZIP/Postal Code
75674
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Foch; Oncologie
City
Suresnes
ZIP/Postal Code
92151
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Claudius Régaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy; Departement Oncologie Medicale
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Düsseldorf; Urologische Klinik
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Name
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
City
Herne
ZIP/Postal Code
44625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Jena, Urologische Klinik und Poliklinik
City
Jena
ZIP/Postal Code
07743
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
City
München
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Tübingen; Klinik für Urologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Ulm; Klinik für Urologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Würzburg; Klinik und Poliklinik für Urologie und Kinderurologie
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Alexandras General Hospital of Athens; Oncology Department
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Name
Attikon University General Hospital
City
Chaidari
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of Larissa;Department of Medical Oncology
City
Larissa
ZIP/Postal Code
411 10
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of Patras Medical Oncology
City
Patras
ZIP/Postal Code
265 04
Country
Greece
Individual Site Status
Recruiting
Facility Name
Theageneio Hospital
City
Thessaloniki
ZIP/Postal Code
546 39
Country
Greece
Individual Site Status
Recruiting
Facility Name
Queen Mary Hospital; Dept. Of Haematology & Oncology
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Tuen Mun Hospital; Clinical Oncology
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Cork Uni Hospital; Oncology Dept
City
Cork
Country
Ireland
Individual Site Status
Recruiting
Facility Name
St Vincents University Hospital
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
City
Dublin
ZIP/Postal Code
D24 NR0A
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center; Oncology
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Hadassah Ein Karem Hospital; Oncology Dept
City
Jerusalem
ZIP/Postal Code
9112000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center; Oncology Dept
City
Petah Tikva
ZIP/Postal Code
4910000
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Tel Aviv Sourasky Medical Ctr; Oncology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. Universitaria S. Martino Di Genova
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Ospedale San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Europeo Di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
City
Arezzo
State/Province
Toscana
ZIP/Postal Code
52100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Santa Maria di Terni
City
Terni
State/Province
Umbria
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba Cancer Center
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toho University Sakura Medical Center
City
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shikoku Cancer Center
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuyama City Hospital
City
Hiroshima
ZIP/Postal Code
721-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima City Hiroshima Citizens Hospital
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Tsukuba Hospital
City
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Name
Iwate Medical University Hospital
City
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Recruiting
Facility Name
St. Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokosuka Kyosai Hospital
City
Kanagawa
ZIP/Postal Code
238-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagano Municipal Hospital
City
Nagano
ZIP/Postal Code
381-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University International Medical Center
City
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toyama University Hospital
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Cancerologia; Oncology
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w ?odzi
City
?ód?
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
City
Brzozów
ZIP/Postal Code
36-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Uniwersytecki Nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy; Klinika Urologii i Onkologicznej
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
PRATIA MCM Kraków
City
Kraków
ZIP/Postal Code
30-727
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
City
Pozna?
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
City
Warszawa
ZIP/Postal Code
04-073
Country
Poland
Individual Site Status
Recruiting
Facility Name
Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii
City
Wroc?aw
ZIP/Postal Code
53-413
Country
Poland
Individual Site Status
Recruiting
Facility Name
FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER
City
Obninsk
State/Province
Kaluga
ZIP/Postal Code
249036
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
St-Petersburg Regional Oncology Dispensary; Oncology
City
Kuzmolovo
State/Province
Leningrad
ZIP/Postal Code
188663
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Russian Scientific Center of Roentgenoradiology
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
117997
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Privolzhsk Regional Medical Center
City
Nizhny Novgorod
State/Province
Niznij Novgorod
ZIP/Postal Code
603001
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
FSI Russian Centre of Radiology and Surgical Technologies
City
Saint-Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Murmansk Regional Clinical Hospital named after P.A. Bayandin
City
Murmansk
ZIP/Postal Code
183047
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
8208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia; Servicio de Oncologia
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de Donostia; Servicio de Oncologia Medica
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20080
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia
City
Las Palmas de Gran Canaria
State/Province
LAS Palmas
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron; Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínic i Provincial; Servicio de Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Valenciano Oncologia; Oncologia Medica
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara University Faculty of Medicine Cebeci Hospital
City
Ankara
ZIP/Postal Code
06700
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara City Hospital; Oncology
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
City
Bakirkoy / Istanbul
ZIP/Postal Code
34147
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul University Cerrahpasa Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medeniyet University Goztepe Training and Research Hospital.
City
Kadiköy
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medikal Park Izmir Hospital
City
Kar??yaka
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medikal Park Samsun
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61037
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
City
Dnipro
State/Province
KIEV Governorate
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
State/Province
KIEV Governorate
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Kyiv City Clinical Oncological Center
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St James Hospital; Dept of Oncology/Hematology
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Barts Hospital; Institute of Cancer
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College London NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Marsden Hospital - London
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8BT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Southampton University Hospitals NHS Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Marsden Hospital (Sutton)
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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