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New hope for bladder cancer: immunotherapy may delay recurrence in High-Risk patients

NCT ID NCT04660344

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the immunotherapy drug atezolizumab can delay or prevent bladder cancer from coming back after surgery. It includes 761 high-risk patients whose blood tests showed cancer DNA after bladder removal. Participants receive either atezolizumab or a placebo to see if the drug improves disease-free survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

761 people

The number who actually took part.

Started

May 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Muscle invasive bladder cancer

Contacts and locations

Locations

  • *X*Fundação Pio XII Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • A.O. Universitaria S. Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

  • A.O. Universitaria S. Martino Di Genova

    Genoa, Liguria, 16132, Italy

  • AHN Cancer Institute ? Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • AZ KLINA

    Brasschaat, 2930, Belgium

  • AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica

    Bologna, Emilia-Romagna, 40138, Italy

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital

    Dublin, D24 NR0A, Ireland

  • Alexandras General Hospital of Athens

    Athens, 115 28, Greece

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Ankara University Faculty of Medicine Cebeci Hospital

    Ankara, 06700, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Attikon University General Hospital

    Ahens, 124 64, Greece

  • Azienda Ospedaliera Santa Maria di Terni

    Terni, Umbria, 20089, Italy

  • Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico

    Naples, Campania, 80131, Italy

  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato

    Arezzo, Tuscany, 52100, Italy

  • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

    Bakirkoy / Istanbul, 34147, Turkey (Türkiye)

  • Barts Hospital

    London, EC1M 6BQ, United Kingdom

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital

    Adana, 01230, Turkey (Türkiye)

  • CETUS Hospital Dia Oncologia

    Belo Horizonte, Minas Gerais, 30110022, Brazil

  • CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR

    Dnipropetrovsk, 49102, Ukraine

  • CUAN Hospital

    San Pedro Garza García, Nuevo León, 66278, Mexico

  • Cancer Care Centers of Brevard

    Rockledge, Florida, 32955, United States

  • Centre D'Oncologie de Gentilly

    Nancy, 54100, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Léon Bérard

    Lyon, 69373, France

  • Centro Medico Austral

    Buenos Aires, 1019, Argentina

  • Charing Cross Hospital

    London, W6 8RF, United Kingdom

  • Chiba Cancer Center

    Chiba, 260-8717, Japan

  • Chongqing Cancer Hospital

    Chongqing, 400030, China

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica del Country

    Bogotá, 11001, Colombia

  • Cork Uni Hospital

    Cork, Ireland

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208, Spain

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Dolnoslaskie Centrum Onkologii

    Wroclaw, Poland

  • FSI Russian Centre of Radiology and Surgical Technologies

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Fakultni Thomayerova nemocnice

    Praha 4 - Krc, 140 59, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Fakultni nemocnice v Motole

    Prague, 150 06, Czechia

  • Friendship Hospital, Capital Medical University

    Beijing, 100050, China

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120, China

  • Fukuyama City Hospital

    Hiroshima, 721-8511, Japan

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518, Japan

  • Hopital Foch

    Suresnes, 92151, France

  • Hopital Saint Andre

    Bordeaux, 33075, France

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01323-020, Brazil

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-120, Brazil

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Clínic i Provincial

    Barcelona, 08036, Spain

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060, Brazil

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba, 14004, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital de Donostia

    Donostia / San Sebastian, Guipuzcoa, 20080, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Hu Nan Provincial Cancer Hospital

    Changsha, 410006, China

  • ICO Paul Papin

    Angers, 49055, France

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128, Italy

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014, Italy

  • Institut Claudius Régaud

    Toulouse, 31059, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Mutualiste Montsouris

    Paris, 75674, France

  • Institut Sainte Catherine

    Avignon, 84918, France

  • Instituto Alexander Fleming

    Buenos Aires, 1426, Argentina

  • Instituto Cancerología Medellin

    Medellín, 050024, Colombia

  • Instituto Valenciano Oncologia

    Valencia, 46009, Spain

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133, Italy

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Istanbul University Cerrahpasa Faculty of Medicine

    Istanbul, 34098, Turkey (Türkiye)

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141, Italy

  • Istituto Nazionale Tumori Irccs Fondazione G. Pascale

    Naples, Campania, 80131, Italy

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040, Russia

  • Iwate Medical University Hospital

    Numakunai, 028-3695, Japan

  • Jiangsu Cancer Hospital

    Nanjing, 210009, China

  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

    Nanjing, 210029, China

  • Keio University Hospital

    Tokyo, 160-8582, Japan

  • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

    Halle, 06120, Germany

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115, Ukraine

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • Lviv Regional Clinical Hospital

    Lviv, KIEV Governorate, 79010, Ukraine

  • ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

    Dnipro, KIEV Governorate, 49005, Ukraine

  • Medeniyet University Goztepe Training and Research Hospital.

    Istanbul, 34730, Turkey (Türkiye)

  • Medikal Park Izmir Hospital

    Cordaleo, 35575, Turkey (Türkiye)

  • Medikal Park Samsun

    Samsun, 55200, Turkey (Türkiye)

  • Nagano Municipal Hospital

    Nagano, 381-8551, Japan

  • Nagoya University Hospital

    Aichi, 466-8560, Japan

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210029, China

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Cancer Centre

    Singapore, 168583, Singapore

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804, Japan

  • Oncocentro Serviços Medicos E Hospitalares Ltda

    Fortaleza, Ceará, 60170-170, Brazil

  • Oncomedica S.A.

    Montería, 230002, Colombia

  • Optum Health Care

    Las Vegas, Nevada, 89102, United States

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • PRATIA MCM Kraków

    Krakow, 30-727, Poland

  • Policlinico Universitario "Agostino Gemelli"

    Rome, Lazio, 00168, Italy

  • Privolzhsk Regional Medical Center

    Nizhny Novgorod, Niznij Novgorod, 603001, Russia

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

    Kharkiv, Kharkiv Governorate, 61037, Ukraine

  • Royal Marsden Hospital (Sutton)

    Sutton, SM2 5PT, United Kingdom

  • Royal Marsden Hospital - London

    London, SW3 6JJ, United Kingdom

  • Royal Preston Hospital

    Preston, PR2 9HT, United Kingdom

  • Saitama Cancer Center

    Saitama, 362-0806, Japan

  • Saitama Medical University International Medical Center

    Saitama, 350-1298, Japan

  • Samsung Medical Center

    Seoul, (0)6351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shikoku Cancer Center

    Ehime, 791-0280, Japan

  • Shizuoka Cancer Center

    Shizuoka, 411-8777, Japan

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD, United Kingdom

  • St-Petersburg Regional Oncology Dispensary

    Kuzmolovo, Leningrad, 188663, Russia

  • St. Marianna University Hospital

    Kanagawa, 216-8511, Japan

  • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

    Warsaw, 04-073, Poland

  • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu

    Poznan, 60-569, Poland

  • Tel Aviv Sourasky Medical Ctr

    Tel Aviv, 6423906, Israel

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350005, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120, China

  • Theageneio Hospital

    Thessaloniki, 54007, Greece

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • Toho University Sakura Medical Center

    Chiba, 285-8741, Japan

  • Toyama University Hospital

    Toyama, 930-0194, Japan

  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

    Edirne, 22030, Turkey (Türkiye)

  • UZ Gent

    Ghent, 9000, Belgium

  • University College London NHS Foundation Trust

    London, NW1 2PG, United Kingdom

  • University Hospital of Larissa

    Larissa, 411 10, Greece

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04, Greece

  • University of Tsukuba Hospital

    Ibaraki, 305-8576, Japan

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

  • Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik

    Herne, 44625, Germany

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Weston Park Hospital

    Sheffield, S10 2SJ, United Kingdom

  • Yantai Yu Huangding Hospital

    Yantai, 264099, China

  • Yokosuka Kyosai Hospital

    Kanagawa, 238-8558, Japan

  • Zhongshan Hospital Fudan University

    Shanghai, 200032, China

  • the First Hospital of Jilin University

    Changchun, 130021, China

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