Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

PHASE3CompletedINTERVENTIONAL
Enrollment

1,213

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

August 31, 2022

Study Completion Date

February 12, 2024

Conditions
Urothelial Carcinoma
Interventions
DRUG

Atezolizumab

Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.

DRUG

Carboplatin

Carboplatin will be administered at doses to achieve area under the concentration-time curve (AUC) of 4.5 milligram per milliliter into minute (mg/mL\*min) by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.

DRUG

Gemcitabine

Gemcitabine will be administered at a dose of 1000 milligrams per square meter (mg/m\^2) by IV infusion on Day 1 and Day 8 of each 21-day cycle, until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.

OTHER

Placebo

Placebo matched to atezolizumab will be administered by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.

DRUG

Cisplatin

Cisplatin will be administered at a dose of 70 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.

Trial Locations (204)

0

Clinica Alemana, Vitacura

333

Chang Gung Medical Foundation-Linkou, Urinary Oncology, Taoyuan District

407

Taichung Veterans General Hospital, Taichung

704

National Cheng Kung Uni Hospital, Tainan City

1000

Institute of Oncology Ljubljana, Ljubljana

2109

Macquarie University Hospital, Macquarie University

2196

Sandton Oncology Medical Group, Sandton

3000

UZ Leuven Gasthuisberg, Leuven

3128

Box Hill Hospital, Box Hill

3144

Cabrini Medical Centre, Malvern

4000

CHC MontLégia, Liège

4029

Royal Brisbane and Women's Hospital, Herston

5112

Lyell McEwin Hospital, Adelaide

6045

Cancercare, Port Elizabeth

9000

AZ Sint Lucas (Sint Lucas), Ghent

10003

Hospital San Pedro De Alcantara, Cáceres

10029

Mount Sinai School of Medicine - Tisch Cancer Institute, New York

10048

National Taiwan Uni Hospital, Taipei

10126

A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro, Turin

10138

East Tallinn Central Hospital, Tallinn

10300

Vajira Hospital, Bangkok

10330

Chulalongkorn Hospital, Bangkok

10700

Faculty of Med. Siriraj Hosp., Bangkok

11000

Clinical Center of Serbia, Belgrade

11528

Alexandras General Hospital of Athens, Athens

12002

Hospital Provincial de Castellon, Castellon

13419

North Estonia Medical Centre Foundation, Tallinn

14004

Hospital Universitario Reina Sofia, Córdoba

15006

University Hospital Motol, Prague

16132

Az. Osp. Uni Ria San Martino, Genoa

18000

Clinical Centre Nis, Clinic for Oncology, Niš

18014

Hospital Universitario Virgen de las Nieves, Granada

19713

Christina Care Institutional Review Board, Newark

20089

Istituto Clinico Humanitas, Rozzano

20133

Irccs Istituto Nazionale Dei Tumori (Int), Milan

20520

Turku Uni Central Hospital, Turku

21204

Oncology Institute of Vojvodina, Kamenitz

21565

Gachon University Gil Medical Center, Incheon

22030

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

23007

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico, Jaén

24071

Complejo Asistencial Universitario de Leon, León

27003

Hospital Universitario Lucus Augusti, Lugo

27599

University of North Carolina, Lineberger Cancer Ctr, Chapel Hill

28007

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Ramon y Cajal, Madrid

28040

Hospital Universitario Clínico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

29607

Bon Secours - St. Francis Hospital, Greenville

31008

Clinica Universitaria de Navarra, Pamplona

32824

UF Health Cancer Center at Orlando Health, Orlando

33612

Moffitt Cancer Center, Tampa

33705

Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building), St. Petersburg

33916

Florida Cancer Specialists, Fort Myers

34093

Bezmi Alem Vakif University Medical School, Istanbul

34098

Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty, Istanbul

35128

IRCCS Istituto Oncologico Veneto (IOV), Padua

36312

Hospital Alvaro Cunqueiro, Vigo

37203

Sarah Cannon Research Institute / Tennessee Oncology, Nashville

39008

Hospital Universitario Marques de Valdecilla, Santander

40402

Norton Cancer Institute, Louisville

40447

China Medical University Hospital, Taichung

41013

Hospital Universitario Virgen del Rocio, Seville

41100

A.O. Universitaria Policlinico Di Modena, Modena

41404

Kyungpook National University Medical Center, Daegu

45007

Hospital Universitario de Toledo, Toledo

45040

Consultorio Médico, Zapopan

46026

Hospital Universitario la Fe, Valencia

46845

Parkview Research Center, Fort Wayne

47014

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

48013

Hospital de Basurto, Bilbao

49102

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

50009

Hospital Clinico Universitario Lozano Blesa, Zaragoza

Hospital Universitario Miguel Servet, Zaragoza

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

50586

Hospital Kuala Lumpur, Kuala Lumpur

52100

Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato, Arezzo

55139

19 Mayis University Medical Faculty, Samsun

55426

Park Nicollet Clin-Cancer Ctr, Saint Louis Park

59100

University Malaya Medical Centre, Kuala Lumpur

61037

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

69600

Zaporizhzhia Regional Clinic, Zaporizhzhia

70006

East Jefferson Hematology Oncology, Metairie

71000

Clinical center University of Sarajevo, Sarajevo

71013

IRCCS Ospedale Casa Sollievo Della Sofferenza, San Giovanni Rotondo

72758

Highlands Oncology Group, Rogers

76090

Cancerología, Querétaro

80131

Azienda Ospedaliera A. Cardarelli, Napoli

89148

Comprehensive Cancer Centers of Nevada, Las Vegas

90029

Oulu University Hospital, Oulu

93401

Coastal Integrative Cancer Care, San Luis Obispo

100050

Beijing Friendship Hospital, Beijing

100730

Peking Union Medical College Hospital, Beijing

115478

Blokhin Cancer Research Center, Moscow

117997

Russian Scientific Center of Roentgenoradiology, Moscow

119228

National University Hospital, Singapore

125248

P.A. Herzen Oncological Inst., Moscow

153040

Ivanovo Regional Oncology Dispensary, Ivanovo

169610

National Cancer Centre, Singapore

197089

"SBEI HPE The First St.Petersburg State Medical University n.a. acad. I.P.Pavlovaof MoH of RF", Saint Petersburg

200032

Fudan University Shanghai Cancer Center, Shanghai

Zhongshan Hospital Fudan University, Shanghai

200040

Huadong Hospital Affiliated to Fudan University, Shanghai

200347

Oncology Center Sf. Nectarie, Craiova

201203

The 2nd Hospital of Tianjin Medical University, Tianjin

210009

Jiangsu Cancer Hospital, Nanjing

400030

Chongqing Cancer Hospital, Chongqing

430031

Spitalul Judetean de Urgenta Dr Constantin Opris, Baia Mare

450000

SBEI of HPE ?Bashkir State Medical University? of MoH RF, Ufa

510000

Sun Yat-sen Memorial Hospital, Guangzhou

603001

Privolzhsk Regional Medical Center, Nizhny Novgorod

620102

Sverdlovsk Regional Clinical Hospital 1, Yekaterinburg

660133

Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky, Krasnoyarsk

3109601

Rambam Health Care Campus, Haifa

7500713

OrlandiOncología, Santiago

8420383

Bradford Hill Centro de Investigaciones Clinicas, Recoleta

30110022

CETUS Hospital Dia Oncologia, Belo Horizonte

06520-8032

Yale School of Medicine, New Haven

06856

Norwalk Hospital, Norwalk

DUMMY_VALUE

Sunshine Hospital, St Albans

Princess Margaret Hospital, Hong Kong

Queen Elizabeth Hospital, Hong Kong

Queen Mary Hospital, Hong Kong

The Chinese University of Hong Kong, Hong Kong

Oncocare Cancer Centre, Singapore

Chang Gung Medical Foundation - Kaohsiung, Kaohisung

B6000

GHdC Site Notre Dame, Charleroi

31190-131

Hospital Luxemburgo, Belo Horizonte

98700-000

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijuí

90035-903

Hospital das Clinicas - UFRGS, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

97015-450

Clinica Viver, Santa Maria

88301-220

Clinica de Neoplasias Litoral, Itajaí

15090-000

Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto

01246-000

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

01323-900

Beneficencia Portuguesa de Sao Paulo, São Paulo

22793-080

Clinicas Oncologicas Integradas - COI, Rio de Janeiro

T2N 4N2

Arthur J.E. Child Comprehensive Cancer Center-Calgary, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V1Y 5L3

BC Cancer Agency, CSI, Kelowna

E1C8X3

Dr. Georges L. Dumont University Hospital Centre, Moncton

L8V 5C2

Juravinski Cancer Clinic, Hamilton

L1G 2B9

Lakeridge Health Center, Oshawa

M2K 1E1

North York General Hospital, Toronto

Providencia

Fundacion Arturo Lopez Perez, Santiago

656 53

Masarykuv onkologicky ustav, Brno

779 00

Fakultni nemocnice Olomouc, Olomouc

128 08

Vseobecna fakultni nemocnice v Praze, Prague

0112

Research institute for Clinical Medicine, Tbilisi

0144

National Center of Urology, Tbilisi

265 04

University Hospital of Patras Medical Oncology, Pátrai

00161

Policlinico Umberto i di Roma, Rome

05100

Azienda Ospedaliera S. Maria - Terni, Terni

466-8560

Nagoya University Hospital, Aichi

036-8563

Hirosaki University Hospital, Aomori

791-0280

National Hospital Organization Shikoku Cancer Center, Ehime

371-8511

Gunma University Hospital, Gunma

003-0804

National Hospital Organization Hokkaido Cancer Center, Hokkaido

305-8576

University of Tsukuba Hospital, Ibaraki

920-8641

Kanazawa University Hospital, Ishikawa

860-8556

Kumamoto University Hospital, Kumamoto

951-8520

Niigata University Medical & Dental Hospital, Niigata

545-8586

Osaka Metropolitan University Hospital, Osaka

589-8511

Kindai University Hospital, Osaka

105-8470

Toranomon Hospital, Tokyo

135-8550

The Cancer Institute Hospital, JFCR, Tokyo

160-8582

Keio University Hospital, Tokyo

03810

Health Pharma Professional Research, CD Mexico

02710

IMSS Hospital General de Zona No. 48 S. Pedro Xalpa, Mexico CITY (federal District)

9728 NT

Martini Ziekenhuis, Groningen

2504 LN

Hagaziekenhuis, locatie Leyweg, NL -DEN HAAG

6162 BG

Zuyderland Medisch Centrum, Sittard-Geleen

8025 AB

Isala Klinieken, Sophia, Zwolle

15-027

Bialostockie Centrum Onkologii, Bialystok

62-500

Przychodnia Lekarska KOMED, Roman Karaszewski, Konin

31-501

Szpital Uniwersytecki w Krakowie, Krakow

93-513

Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii, Lodz

60-569

Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu, Poznan

97-200

NU-MED Centrum Diagnostyki i Terapii Onkologicznej, Tomaszów Mazowiecki

04-073

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

1649-035

Hospital de Santa Maria, Lisbon

4200-072

IPO do Porto, Porto

022338

Institute Of Oncology Bucharest, Bucharest

0001

Wilgers Oncology Centre, Pretoria

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

03203

Hospital General Universitario de Elche, Elche

07014

Hospital Universitario Son Espases, Palma de Mallorca

08243

Complejo Hospitalario de Althaia, Manresa

08208

Corporacio Sanitaria Parc Tauli, Sabadell

02006

Complejo Hospitalario Universitario de Albacete, Albacete

08035

Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Barcelona

08036

Hospital Clinic de Barcelona. Unidad de Nuevas Terapias, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

08907

Institutio Catalan De Oncologia, Barcelona

08916

Hospital Universitari Germans Trias i Pujol, Barcelona

09006

Complejo Asistencial Universitario De Burgos, Burgos

01250

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

06800

Ankara Bilkent City Hospital, Ankara

06100

Hacettepe Uni Medical Faculty Hospital, S?hhiye, Ankara

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

NW1 2BU

University College London Hospitals NHS Foundation Trust - University College Hospital, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

YO31 8HE

The York Hospital, York

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02807636 - Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma | Biotech Hunter | Biotech Hunter