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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

761

Participants

Timeline

Start Date

May 3, 2021

Primary Completion Date

June 15, 2025

Study Completion Date

September 13, 2026

Conditions
Muscle-invasive Bladder Cancer
Interventions
DRUG

Atezolizumab

ctDNA positive participants will receive 1680 mg intravenously every 4 weeks (Q4W) on Day 1 of each 28-day cycle.

OTHER

Placebo

ctDNA positive participants will receive placebo intravenously Q4W on Day 1 of each 28-day cycle

DEVICE

Signatera

Signatera will be used to evaluate whether circulating tumor DNA (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 follow-up.

Trial Locations (161)

1019

Centro Medico Austral, Buenos Aires

1426

Instituto Alexander Fleming, Buenos Aires

2930

AZ KLINA, Brasschaat

8800

AZ Delta (Campus Rumbeke), Roeselare

9000

UZ Gent, Ghent

10043

A.O. Universitaria S. Luigi Gonzaga, Orbassano

10408

National Cancer Center, Goyang-si

11001

Clinica del Country, Bogotá

14004

Hospital Universitario Reina Sofia, Córdoba

15212

AHN Cancer Institute ? Allegheny General Hospital, Pittsburgh

16132

A.O. Universitaria S. Martino Di Genova, Genoa

20080

Hospital de Donostia, Donostia / San Sebastian

20089

Azienda Ospedaliera Santa Maria di Terni, Terni

20132

Irccs Ospedale San Raffaele, Milan

20133

Irccs Istituto Nazionale Dei Tumori (Int), Milan

20141

Istituto Europeo Di Oncologia, Milan

22030

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

27157

Wake Forest Baptist Medical Center, Winston-Salem

28034

Hospital Ramon y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

31059

Institut Claudius Régaud, Toulouse

32955

Cancer Care Centers of Brevard, Rockledge

33075

Hopital Saint Andre, Bordeaux

34098

Istanbul University Cerrahpasa Faculty of Medicine, Istanbul

34147

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

34730

Medeniyet University Goztepe Training and Research Hospital., Istanbul

35128

IOV - Istituto Oncologico Veneto - IRCCS, Padua

35575

Medikal Park Izmir Hospital, Kar??yaka

39008

Hospital Universitario Marques de Valdecilla, Santander

40138

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

40225

Universitätsklinikum Düsseldorf, Düsseldorf

41013

Hospital Universitario Virgen del Rocio, Seville

44195

Cleveland Clinic, Cleveland

44625

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

46009

Instituto Valenciano Oncologia, Valencia

46010

Hospital Clinico Universitario de Valencia, Valencia

47014

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

49005

ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council, Dnipro

49055

ICO Paul Papin, Angers

49102

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

52100

Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato, Arezzo

54007

Theageneio Hospital, Thessaloniki

54100

Centre D'Oncologie de Gentilly, Nancy

55200

Medikal Park Samsun, Samsun

61037

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

63011

Centre Jean Perrin, Clermont-Ferrand

66278

CUAN Hospital, San Pedro Garza García

69373

Centre Léon Bérard, Lyon

72076

Universitätsklinikum Tübingen, Tübingen

75674

Institut Mutualiste Montsouris, Paris

79010

Lviv Regional Clinical Hospital, Lviv

80120

Rocky Mountain Cancer Center - Denver, Littleton

80131

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

Istituto Nazionale Tumori Irccs Fondazione G. Pascale, Napoli

81675

Klinikum rechts der Isar der TU München, München

84918

Institut Sainte Catherine, Avignon

89081

Universitätsklinikum Ulm, Ulm

89102

Optum Health Care, Las Vegas

90404

UCLA Department of Medicine, Santa Monica

92151

Hopital Foch, Suresnes

94805

Institut Gustave Roussy, Villejuif

97080

Universitätsklinikum Würzburg, Würzburg

100050

Friendship Hospital, Capital Medical University, Beijing

110042

Liaoning cancer Hospital & Institute, Shenyang

130021

the First Hospital of Jilin University, Changchun

153040

Ivanovo Regional Oncology Dispensary, Ivanovo

168583

National Cancer Centre, Singapore

183047

Murmansk Regional Clinical Hospital named after P.A. Bayandin, Murmansk

188663

St-Petersburg Regional Oncology Dispensary, Kuzmolovo

197758

FSI Russian Centre of Radiology and Surgical Technologies, Saint Petersburg

200032

Zhongshan Hospital Fudan University, Shanghai

200120

Fudan University Shanghai Cancer Center, Shanghai

210009

Jiangsu Cancer Hospital, Nanjing

210029

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

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

230002

Oncomedica S.A., Montería

264099

Yantai Yu Huangding Hospital, Yantai

300060

Tianjin Cancer Hospital, Tianjin

350001

Fujian Medical University Union Hospital, Fujian

350005

The First Affiliated Hospital of Fujian Medical University, Fuzhou

400030

Chongqing Cancer Hospital, Chongqing

410006

Hu Nan Provincial Cancer Hospital, Changsha

510120

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

603001

Privolzhsk Regional Medical Center, Nizhny Novgorod

3109601

Rambam Medical Center, Haifa

6423906

Tel Aviv Sourasky Medical Ctr, Tel Aviv

30110022

CETUS Hospital Dia Oncologia, Belo Horizonte

DUMMY_VALUE

Oncocentro Serviços Medicos E Hospitalares Ltda, Fortaleza

Cork Uni Hospital, Cork

Dolnoslaskie Centrum Onkologii, Wroc?aw

81520-060

Hospital Erasto Gaertner, Curitiba

90035-001

Hospital Moinhos de Vento, Porto Alegre

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

14784-400

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

17210-120

Hospital Amaral Carvalho, Jaú

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

01323-020

Hospital Alemao Oswaldo Cruz, São Paulo

050024

Instituto Cancerología Medellin, Medellín

779 00

Fakultni nemocnice Olomouc, Olomouc

150 06

Fakultni nemocnice v Motole, Prague

140 59

Fakultni Thomayerova nemocnice, Praha 4 - Krc

06189

Centre Antoine Lacassagne, Nice

06120

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

124 64

Attikon University General Hospital, Ahens

115 28

Alexandras General Hospital of Athens, Athens

411 10

University Hospital of Larissa, Larissa

265 04

University Hospital of Patras Medical Oncology, Pátrai

Unknown

Queen Mary Hospital, Hong Kong

D24 NR0A

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

00168

"Policlinico Universitario Agostino Gemelli", Rome

466-8560

Nagoya University Hospital, Aichi

260-8717

Chiba Cancer Center, Chiba

285-8741

Toho University Sakura Medical Center, Chiba

791-0280

Shikoku Cancer Center, Ehime

812-8582

Kyushu University Hospital, Fukuoka

721-8511

Fukuyama City Hospital, Hiroshima

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

003-0804

National Hospital Organization Hokkaido Cancer Center, Hokkaido

305-8576

University of Tsukuba Hospital, Ibaraki

216-8511

St. Marianna University Hospital, Kanagawa

238-8558

Yokosuka Kyosai Hospital, Kanagawa

606-8507

Kyoto University Hospital, Kyoto

381-8551

Nagano Municipal Hospital, Nagano

028-3695

Iwate Medical University Hospital, Numakunai

700-8558

Okayama University Hospital, Okayama

541-8567

Osaka International Cancer Institute, Osaka

350-1298

Saitama Medical University International Medical Center, Saitama

362-0806

Saitama Cancer Center, Saitama

411-8777

Shizuoka Cancer Center, Shizuoka

770-8503

Tokushima University Hospital, Tokushima

104-0045

National Cancer Center Hospital, Tokyo

160-8582

Keio University Hospital, Tokyo

930-0194

Toyama University Hospital, Toyama

30-727

PRATIA MCM Kraków, Krakow

60-569

Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu, Późna

04-073

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

(0)6351

Samsung Medical Center, Seoul

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

08208

Corporacio Sanitaria Parc Tauli, Sabadell

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clínic i Provincial, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

01230

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

06700

Ankara University Faculty of Medicine Cebeci Hospital, Ankara

06800

Ankara City Hospital, Ankara

03115

Kyiv City Clinical Oncological Center, Kyiv

CB2 0QQ

Addenbrookes Hospital, Cambridge

EH4 2XU

Western General Hospital, Edinburgh

EC1M 6BQ

Barts Hospital, London

NW1 2PG

University College London NHS Foundation Trust, London

SW3 6JJ

Royal Marsden Hospital - London, London

W6 8RF

Charing Cross Hospital, London

PL6 8DH

Derriford Hospital, Plymouth

PR2 9HT

Royal Preston Hospital, Preston

S10 2SJ

Weston Park Hospital, Sheffield

SO16 6YD

Southampton University Hospitals NHS Trust, Southampton

SM2 5PT

Royal Marsden Hospital (Sutton), Sutton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Natera, Inc.

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY

NCT04660344 - A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy | Biotech Hunter | Biotech Hunter