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Brief Title: Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Official Title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Study ID: NCT02807636
Brief Summary: A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Highlands Oncology Group, Springdale, Arkansas, United States
Coastal Integrative Cancer Care, San Luis Obispo, California, United States
Yale School of Medicine, New Haven, Connecticut, United States
Norwalk Hospital, Norwalk, Connecticut, United States
Christina Care Institutional Review Board, Newark, Delaware, United States
Florida Cancer Specialists; Department of Oncology, Fort Myers, Florida, United States
UF Health Cancer Center at Orlando Health, Orlando, Florida, United States
Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building), Saint Petersburg, Florida, United States
Moffitt Cancer Center; GME Office, Tampa, Florida, United States
The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology, Chicago, Illinois, United States
Parkview Research Center, Fort Wayne, Indiana, United States
Norton Cancer Institute, Louisville, Kentucky, United States
East Jefferson Hematology Oncology; Hematology Oncology-Yenni Pavillion, Metairie, Louisiana, United States
Park Nicollet Clin-Cancer Ctr, Saint Louis Park, Minnesota, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Mount Sinai School of Medicine - Tisch Cancer Institute, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of North Carolina, Lineberger Cancer Ctr, Chapel Hill, North Carolina, United States
Bon Secours - St. Francis Hospital, Greenville, South Carolina, United States
Sarah Cannon Research Institute / Tennessee Oncology, Germantown, Tennessee, United States
Macquarie University Hospital, Macquarie Park, New South Wales, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Lyell McEwin Hospital, Adelaide, South Australia, Australia
Ashford Cancer Center Research, Kurralta Park, South Australia, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Cabrini Medical Centre; Oncology, Malvern, Victoria, Australia
Sunshine Hospital; Oncology Research, St Albans, Victoria, Australia
GHdC Site Notre Dame, Charleroi, , Belgium
AZ Sint Lucas (Sint Lucas), Gent, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
CHC MontLégia, Liege, , Belgium
University Clinical Centre of the Republic of Srpska, Banja Luka, , Bosnia and Herzegovina
Clinical center University of Sarajevo, Sarajevo, , Bosnia and Herzegovina
Hospital Luxemburgo; Oncologia, Belo Horizonte, MG, Brazil
CETUS Hospital Dia Oncologia, Uberaba, MG, Brazil
Clinicas Oncologicas Integradas - COI, Rio De Janeiro, RJ, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijui, RS, Brazil
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Clinica Viver, Santa Maria, RS, Brazil
Clinica de Neoplasias Litoral, Itajai, SC, Brazil
Hospital de Base de Sao Jose do Rio Preto, Sao Jose do Rio Preto, SP, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Beneficencia Portuguesa de Sao Paulo, São Paulo, SP, Brazil
Tom Baker Cancer Centre-Calgary; Clinical Research Unit, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer Agency, CSI, Kelowna, British Columbia, Canada
Dr. Georges L. Dumont University Hospital Centre, Moncton, New Brunswick, Canada
Juravinski Cancer Clinic; Clinical Trials Department, Hamilton, Ontario, Canada
Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center, Oshawa, Ontario, Canada
North York General Hospital, Toronto, Ontario, Canada
Bradford Hill Centro de Investigaciones Clinicas, Recoleta, , Chile
OrlandiOncología, Santiago, , Chile
Fundacion Arturo Lopez Perez, Santiago, , Chile
Clinica Alemana, Vitacura, , Chile
Peking Union Medical College Hospital, Beijing City, , China
Beijing Friendship Hospital, Beijing, , China
Chongqing Cancer Hospital, Chongqing, , China
Sun Yat-sen Memorial Hospital, Guangzhou, , China
Jiangsu Cancer Hospital, Nanjing City, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Zhongshan Hospital Fudan University, Shanghai, , China
Huadong Hospital Affiliated to Fudan University, Shanghai, , China
The 2nd Hospital of Tianjin Medical University, Tianjin, , China
Masarykuv onkologicky ustav, Brno, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
University Hospital Motol; Department of Urology, Praha 5, , Czechia
East Tallinn Central Hospital, Tallinn, , Estonia
North Estonia Medical Centre Foundation; Oncology Center, Tallinn, , Estonia
Oulu University Hospital; Oncology, Oulu, , Finland
Turku Uni Central Hospital; Oncology Clinics, Turku, , Finland
Research institute for Clinical Medicine, Tbilisi, , Georgia
National Center of Urology, Tbilisi, , Georgia
Chemotherapy and Immunotherapy Clinic Medulla, Tbilisi, , Georgia
Alexandras General Hospital of Athens; Oncology Department, Athens, , Greece
University Hospital of Patras Medical Oncology, Patras, , Greece
Princess Margaret Hospital; Oncology, Hong Kong, , Hong Kong
Queen Elizabeth Hospital; Clinical Oncology, Hong Kong, , Hong Kong
Queen Mary Hospital; Dept. of Clinical Oncology, Hong Kong, , Hong Kong
The Chinese University of Hong Kong; Department of Clinical Oncology, N.t., , Hong Kong
Rambam Health Care Campus; Oncology, Haifa, , Israel
Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico, Napoli, Campania, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia, Modena, Emilia-Romagna, Italy
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche, Roma, Lazio, Italy
Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical, Genova, Liguria, Italy
ASST DI CREMONA; Dip. Medicina - S.C. Oncologia, Cremona, Lombardia, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2, Milano, Lombardia, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano, Lombardia, Italy
A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro; Oncologia medica 2, Torino, Piemonte, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia, San Giovanni Rotondo, Puglia, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia, Arezzo, Toscana, Italy
Azienda Ospedaliera S. Maria - Terni; Oncologia, Terni, Umbria, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima, Padova, Veneto, Italy
Nagoya University Hospital, Aichi, , Japan
Hirosaki University Hospital, Aomori, , Japan
National Hospital Organization Shikoku Cancer Center, Ehime, , Japan
Gunma University Hospital, Gunma, , Japan
National Hospital Organization Hokkaido Cancer Center, Hokkaido, , Japan
University of Tsukuba Hospital, Ibaraki, , Japan
Kanazawa University Hospital, Ishikawa, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Niigata University Medical & Dental Hospital, Niigata, , Japan
Osaka Metropolitan University Hospital, Osaka, , Japan
Kindai University Hospital, Osaka, , Japan
Toranomon Hospital, Tokyo, , Japan
The Cancer Institute Hospital, JFCR; Urology, Tokyo, , Japan
Keio University Hospital, Tokyo, , Japan
Kyungpook National University Medical Center, Daegu, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi, Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia
University Malaya Medical Centre; Clinical Oncology Unit,, Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia
Consultorio Médico, Zapopan, Jalisco, Mexico
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
Hospital San Jose; Centro de investigacion y transferencia en salud del Tec de Monterrey, Monterrey, N.L, Nuevo LEON, Mexico
Cancerología, Querétaro, Queretaro, Mexico
IMSS Hospital General de Zona No. 48 S. Pedro Xalpa; Departamento de Urología, Mexico CITY (federal District), , Mexico
Hagaziekenhuis, locatie Leyweg, Den-Haag, , Netherlands
Martini Ziekenhuis; Dept of Internal Medicine, Groningen, , Netherlands
Zuyderland Medisch Centrum; Internal Diseases, Sittard-Geleen, , Netherlands
Isala Klinieken, Sophia, Zwolle, , Netherlands
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej, Bialystok, , Poland
Przychodnia Lekarska KOMED, Roman Karaszewski, Konin, , Poland
Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna, Kraków, , Poland
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii, Lodz, , Poland
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu, Poznan, , Poland
NU-MED Centrum Diagnostyki i Terapii Onkologicznej, Tomaszów Mazowiecki, , Poland
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o., Warszawa, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii, Wroclaw, , Poland
Hospital de Santa Maria; Servico de Oncologia Medica, Lisboa, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Spitalul Judetean de Urgenta Dr Constantin Opris, Baia Mare, , Romania
Institute Of Oncology Bucharest; Medical Oncology, Bucharest, , Romania
Oncology Center Sf. Nectarie, Craiova, , Romania
ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic, Barnaul, Altaj, Russian Federation
SBEI of HPE ?Bashkir State Medical University? of MoH RF, UFA, Baskortostan, Russian Federation
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy, Krasnoyarsk, Krasnodar, Russian Federation
Blokhin Cancer Research Center; Urological Dept, Moscow, Moskovskaja Oblast, Russian Federation
Russian Scientific Center of Roentgenoradiology, Moscow, Moskovskaja Oblast, Russian Federation
P.A. Herzen Oncological Inst. ; Oncology, Moscow, Moskovskaja Oblast, Russian Federation
Privolzhsk Regional Medical Center, Nizhny Novgorod, Niznij Novgorod, Russian Federation
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF, Sankt-peterburg, Sankt Petersburg, Russian Federation
Scientific Research Oncology Institute named after N.N. Petrov; Oncology, St. Petersburg, Sankt Petersburg, Russian Federation
Sverdlovsk Regional Clinical Hospital 1, Yekaterinburg, Sverdlovsk, Russian Federation
Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
Clinical Center of Serbia; Clinic of Urology, Belgrade, , Serbia
Clinical Centre Nis, Clinic for Oncology, Nis, , Serbia
Oncology Institute of Vojvodina, Sremska Kamenica, , Serbia
National University Hospital; National University Cancer Institute, Singapore (NCIS), Singapore, , Singapore
National Cancer Centre; Medical Oncology, Singapore, , Singapore
Oncocare Cancer Centre; Gleneagles Medical Centre, Singapore, , Singapore
Institute of Oncology Ljubljana, Ljubljana, , Slovenia
GVI Oncology Outeniqua Unit, George, , South Africa
Cancercare, Port Elizabeth, , South Africa
Wilgers Oncology Centre, Pretoria, , South Africa
Steve Biko Academic Hospital; Oncology, Pretoria, , South Africa
Sandton Oncology Medical Group, Sandton, , South Africa
Hospital General Universitario de Elche; Servicio de Oncologia, Elche, Alicante, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona, Barcelona, Spain
Institutio Catalan De Oncologia, Badalona, Barcelona, Spain
Complejo Hospitalario de Althaia; Servicio de Oncologia, Manresa, Barcelona, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell, Barcelona, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de La Barca, Barcelona, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia, Santander, Cantabria, Spain
Hospital Provincial de Castellon; Servicio de Oncologia, Castellon de La Plana, Castellon, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba, Cordoba, Spain
Hospital Universitario Son Espases, Palma De Mallorca, Islas Baleares, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital Alvaro Cunqueiro, Vigo, Pontevedra, Spain
Hospital de Basurto; Servicio de Oncologia, Bilbao, Vizcaya, Spain
Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia, Albacete, , Spain
Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia, Barcelona, , Spain
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia, Burgos, , Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia, Caceres, , Spain
Hospital Universitario Virgen de las Nieves; Servicio de Oncologia, Granada, , Spain
Hospital Juan Ramon Jimenez;Servicio de Oncologia, Huelva, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaen, , Spain
Complejo Asistencial Universitario de Leon; Servicio de Oncologia, Leon, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Hospital Universitario de Toledo, Toledo, , Spain
Hospital Universitario la Fe; Servicio de Oncologia, Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia, Zaragoza, , Spain
Hospital Universitario Miguel Servet; Servicio de Oncologia Medica, Zaragoza, , Spain
Chang Gung Medical Foundation - Kaohsiung; Oncology, Kaohisung, , Taiwan
China Medical University Hospital; Urology, Taichung, , Taiwan
Taichung Veterans General Hospital; Division of Urology, Taichung, , Taiwan
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology, Tainan, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology, Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou, Urinary Oncology, Taoyuan, , Taiwan
Vajira Hospital, Bangkok, , Thailand
Chulalongkorn Hospital; Medical Oncology, Bangkok, , Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc, Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Medicine, ChiangMai, , Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana, , Turkey
Ankara Bilkent City Hospital, Ankara, , Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne, , Turkey
Bezmi Alem Vakif University Medical School; Oncology, Istanbul, , Turkey
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani, Istanbul, , Turkey
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology, Kadiköy, , Turkey
Medikal Park Izmir Hospital, Kar??yaka, , Turkey
19 Mayis University Medical Faculty; Medical Oncology Department, Samsun, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara, , Turkey
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4, Kharkiv, Kharkiv Governorate, Ukraine
CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR, Dnipropetrovsk, , Ukraine
Zaporizhzhia Regional Clinic, Zaporizhzhia, , Ukraine
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
The York Hospital, York, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR