Spots Global Cancer Trial Database for A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]
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Trial Identification
Brief Title: A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]
Official Title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy
Study ID: NCT02302807
Conditions
Study Description
Brief Summary: This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Georgetown University Medical Center Lombardi Cancer Center, Washington, District of Columbia, United States
Emory University; Winship Cancer Institute, Atlanta, Georgia, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Duke Cancer Center, Durham, North Carolina, United States
Bon Secours - St. Francis Hospital, Greenville, South Carolina, United States
Vanderbilt-Ingram Cancer Ctr, Nashville, Tennessee, United States
Royal Brisbane and Women's Hospital; Medical Oncology, Herston, Queensland, Australia
Royal Adelaide Hospital; Oncology, Adelaide, South Australia, Australia
Monash Medical Centre; Oncology, Clayton, Victoria, Australia
Austin and Repatriation Medical Centre; Cancer Services, Melbourne, Victoria, Australia
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie, Wien, , Austria
Kaiser-Franz-Josef-Spital; Zent.Onkologie und Hamatologie, Wien, , Austria
ZNA Middelheim, Antwerpen, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Tom Baker Cancer Centre-Calgary, Calgary, Alberta, Canada
Bcca - Cancer Center Southern Interior, Kelowna, British Columbia, Canada
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Bcca - Vancouver Island Cancer Centre; Oncology, Victoria, British Columbia, Canada
Royal Victoria Hospital, Barrie, Ontario, Canada
London Regional Cancer Centre, London, Ontario, Canada
Lakeridge Health Oshawa; Oncology, Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre; Oncology, Ottawa, Ontario, Canada
Sault Area Hospitals, Sault Ste Marie, Ontario, Canada
Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada
Masarykuv onkologicky ustav, Brno, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
MULTISCAN, s.r.o., Radiologicke centrum Pardubice, Pardubice, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha, , Czechia
Herlev Hospital; Onkologisk afdeling, Herlev, , Denmark
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
Docrates Cance Center, Helsinki, , Finland
Turku University Central Hospital; Urology clinic, Turku, , Finland
Ico - Paul Papin, Angers, , France
Institut Sainte Catherine;Recherche Clinique, Avignon, , France
Chr De Besancon - Hopital Jean Minjoz, Besancon, , France
Hopital Saint Andre, Bordeaux, , France
Institut Bergonie; Oncologie, Bordeaux, , France
Centre Francois Baclesse; Recherche Clinique, Caen, , France
CHU Henri Mondor; Service d'Oncologie Medicale, Creteil, , France
Clinique Chenieux; Oncology, Limoges, , France
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Institut J Paolii Calmettes, Marseille, , France
Institut régional du Cancer Montpellier, Montpellier, , France
Centre D'Oncologie de Gentilly; Oncology, Nancy, , France
Centre Antoine Lacassagne, Nice, , France
CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge, Nimes, , France
Hopital Cochin; Unite Fonctionnelle D Oncologie, Paris, , France
Institut Curie; Recherche Clinique, Paris, , France
Hopital Saint Louis; Oncologie Medicale, Paris, , France
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
CHU de Rouen - Hôpital Charles Nicolle, Rouen, , France
ICO - Site René Gauducheau, Saint Herblain, , France
Hopital Hautepierre; Hematologie Oncologie, Strasbourg, , France
Hopital Foch; Oncologie, Suresnes, , France
Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse, , France
Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif, , France
Uniklinik RWTH Aachen; Klinik für Urologie, Aachen, , Germany
Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie, Berlin, , Germany
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie, Dresden, , Germany
Universitätsklinikum Düsseldorf; Urologische Klinik, Düsseldorf, , Germany
Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V, Erlangen, , Germany
Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie, Freiburg, , Germany
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie, Göttingen, , Germany
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II, Hamburg, , Germany
Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg, Heidelberg, , Germany
Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie, Homburg/Saar, , Germany
Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie, Magdeburg, , Germany
Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie, Mannheim, , Germany
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik, München, , Germany
Universitätsklinikum Tübingen; Klinik für Urologie, Tübingen, , Germany
Universitätsklinikum Ulm; Klinik für Urologie, Ulm, , Germany
Alexandras General Hospital of Athens; Oncology Department, Athens, , Greece
Univ General Hosp Heraklion; Medical Oncology, Heraklion, , Greece
University Hospital of Patras Medical Oncology, Patras, , Greece
Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki, , Greece
Semmelwies University of Medicine; Urology Dept., Budapest, , Hungary
Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály, Budapest, , Hungary
Uzsoki Utcai Korhaz, Budapest, , Hungary
Kecskemeti Onkoradilogai Centrum, Kecskemét, , Hungary
Hetenyi Geza County Hospital; Onkologiai Kozpont, Szolnok, , Hungary
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
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia, Udine, Friuli-Venezia Giulia, Italy
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica, Roma, Lazio, Italy
Asst Papa Giovanni XXIII; Oncologia Medica, Bergamo, Lombardia, 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
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico, Candiolo, Piemonte, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia, San Giovanni Rotondo, Puglia, Italy
Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello, Palermo, Sicilia, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia, Arezzo, Toscana, Italy
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1, Firenze, Toscana, Italy
Nagoya University Hospital; Urology, Aichi, , Japan
Hirosaki University School of Medicine & Hospital; Urology, Aomori, , Japan
Chiba Cancer Center; Urology, Chiba, , Japan
National Cancer Center Hospital East; Breast and Medical Oncology, Chiba, , Japan
National Hospital Organization Shikoku Cancer Center; Urology, Ehime, , Japan
Harasanshin Hospital; Urology, Fukuoka, , Japan
Kyushu University Hospital; Urology, Fukuoka, , Japan
Gunma University Hospital; Urology, Gunma, , Japan
Hiroshima City Hiroshima Citizens Hospital; Urology, Hiroshima, , Japan
Sapporo Medical University Hospital; Urology, Hokkaido, , Japan
Hokkaido University Hospital; Urology, Hokkaido, , Japan
University of Tsukuba Hospital; Urology, Ibaraki, , Japan
Iwate Medical University Hospital; Urology, Iwate, , Japan
Yokohama City University Hospital; Urology, Kanagawa, , Japan
Kumamoto University Hospital; Urology, Kumamoto, , Japan
Niigata Cancer Center Hospital;Urology, Niigata, , Japan
Osaka International Cancer Institute; Urology, Osaka, , Japan
Osaka University Hospital; Urology, Osaka, , Japan
Kindai University Hospital; Urology, Osaka, , Japan
Shizuoka Cancer Center; Urology, Shizuoka, , Japan
Tokushima University Hospital; Urology, Tokushima, , Japan
National Cancer Center Hospital; Urology, Tokyo, , Japan
Toranomon Hospital; Medical Oncology, Tokyo, , Japan
Nippon Medical School Hospital; Urology, Tokyo, , Japan
The Cancer Institute Hospital, JFCR; Urology, Tokyo, , Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center - Oncology, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands
Spaarne Ziekenhuis; Inwendige Geneeskunde, Hoofddorp, , Netherlands
Maastricht University Medical Centre; Medical Oncology, Maastricht, , Netherlands
St. Antonius Ziekenhuis Nieuwegein, Nieuwegein, , Netherlands
Isala Klinieken, Zwolle, , Netherlands
Sørlandet Sykehus Kristiansand, Kristiansand, , Norway
Uni Hospital of Tromso; Dept. of Oncology, Tromsø, , Norway
St. Olavs Hospital; Kreftavdelingen, Trondheim, , Norway
Medical University of Bialystok; Oncology clinic, Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Gdansk, , Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej, Lublin, , Poland
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu, Poznan, , Poland
Centrum onkologii Instytutu im. Marii Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology, Wroclaw, , Poland
Hospital de Santa Maria; Servico de Oncologia Medica, Lisboa, , Portugal
Hospital Beatriz Angelo; Departamento de Oncologia, Loures, , 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
Institut Oncologic Ion Chiricuta; Departament Radioterapie, Cluj-napoca, , Romania
Oncology Center Sf. Nectarie, Craiova, , Romania
Euroclinic Center of Oncology SRL, Iasi, , Romania
Spital Clinic Judetean Mures; Oncologie, Targu Mures, , Romania
ONCOMED - Medical Centre, Timisoara, , Romania
GBUZ Nizhegorodskay Region: Clinical Diagnostic Center, Nizhni Novgorod, Niznij Novgorod, Russian Federation
Altai Regional Oncological Center, Barnaul, , Russian Federation
Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology, Moscow, , Russian Federation
St. Petersburg Oncology Hospital, St Petersburg, , Russian Federation
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary, Stavropol, , Russian Federation
Clinical Center of Serbia; Clinic of Urology, Belgrade, , Serbia
Institute for Oncology and Radiology of Serbia; Medical Oncology, Belgrade, , Serbia
Oncology Institute of Vojvodina, Sremska Kamenica, , Serbia
Institute of Oncology Ljubljana, Ljubljana, , Slovenia
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell, Barcelona, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba, Cordoba, Spain
Hospital Universitario Son Espases; Servicio de Oncologia, Palma De Mallorca, Islas Baleares, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela, LA Coruña, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Hospital Clinic i Provincial; Servicio de Farmacia, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia, Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia, Caceres, , 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 Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Malaga, , Spain
Hospital de Navarra; Servicio de Oncologia, Navarra, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Hospital General Universitario de Valencia; Servicio de oncologia, Valencia, , Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología, Valencia, , Spain
Sahlgrenska Universitetssjukhuset; Jubileumskliniken, Göteborg, , Sweden
Karolinska Hospital; Oncology - Radiumhemmet, Stockholm, , Sweden
Norrlands Uni Hospital; Onkologi Avd., Umea, , Sweden
Inselspital Bern; Universitätsklinik für medizinische Onkologie, Bern, , Switzerland
Kantonsspital Graubünden;Onkologie und Hämatologie, Chur, , Switzerland
HUG; Oncologie, Geneve, , Switzerland
Kantonsspital St. Gallen; Onkologie/Hämatologie, St. Gallen, , Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie, Zürich, , Switzerland
China Medical University Hospital; Urology, Taichung, , Taiwan
Taichung Veterans General Hospital; Division of Urology, Taichung, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology, Taipei, , Taiwan
TAIPEI VETERANS GENERAL HOSPITAL, Urology, Taipei, , Taiwan
Uludag Uni Hospital; Oncology, Bursa, , Turkey
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department, Edirne, , Turkey
Bezmialem Vakif Univ Medical, Istanbul, , Turkey
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology, Istanbul, , Turkey
Istanbul VKV American Hospital; Medical Oncology, Istanbul, , Turkey
Ege Uni Medical Faculty Hospital; Oncology Dept, Izmir, , Turkey
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sıhhiye, Ankara, , Turkey
University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital, Birmingham, , United Kingdom
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
Cheltenham General Hospital, Cheltenham, , United Kingdom
University Hospital coventry; Oncology Department, Coventry, , United Kingdom
Royal Devon & Exeter Hospital; Oncology Centre, Exeter, , United Kingdom
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust, Lancaster, , United Kingdom
St James Institute of Oncology, Leeds, , United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology, Leicester, , United Kingdom
Barts and The London, London, , United Kingdom
Royal Free Hospital; Dept of Oncology, London, , United Kingdom
Northern Centre for Cancer Care; Northern Centre for Cancer Care, Newcastle Upon Tyne, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Scunthorpe General Hospital; Dept of Oncology, Scunthorpe, , United Kingdom
Southampton General Hospital; Medical Oncology, Southampton, , United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology, Sutton, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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