A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] | NCT02302807 | Trialant

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] | NCT02302807 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra).

Representative tumor specimens as specified by the protocol

Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Life expectancy greater than or equal to (>/=) 12 weeks

Measurable disease, as defined by RECIST v1.1

Adequate hematologic and end organ function

For women of childbearing potential, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel.

For men, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel, and agreement to refrain from donating sperm

Exclusion Criteria:

Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment

Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment

Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments

Leptomeningeal disease

Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer

Pregnant and lactating women

Significant cardiovascular disease

Severe infections within 4 weeks prior to randomization

Major surgical procedure other than for diagnosis within 4 weeks prior to randomization

History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation

History of autoimmune disease

Prior allogeneic stem cell or solid organ transplant

History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan

Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis

Administration of a live, attenuated vaccine within 4 weeks prior to randomization

Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies

Georgetown University Medical Center Lombardi Cancer Center

Washington D.C., District of Columbia 20007, United States

Emory University; Winship Cancer Institute

Atlanta, Georgia 30308, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada 89128, United States

Duke Cancer Center

Durham, North Carolina 27710, United States

Bon Secours - St. Francis Hospital

Greenville, South Carolina 29607, United States

Vanderbilt-Ingram Cancer Ctr

Nashville, Tennessee 37232, United States

Royal Brisbane and Women's Hospital; Medical Oncology

Herston, Queensland 4029, Australia

Royal Adelaide Hospital; Oncology

Adelaide, South Australia 5000, Australia

Monash Medical Centre; Oncology

Clayton, Victoria 3168, Australia

Austin and Repatriation Medical Centre; Cancer Services

Melbourne, Victoria 3084, Australia

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

Vienna, 1090, Austria

Kaiser-Franz-Josef-Spital; Zent.Onkologie und Hamatologie

Vienna, 1100, Austria

ZNA Middelheim

Antwerp, 2020, Belgium

Institut Jules Bordet

Brussels, 1000, Belgium

UZ Gent

Ghent, 9000, Belgium

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Tom Baker Cancer Centre-Calgary

Calgary, Alberta T2N 4N2, Canada

Bcca - Cancer Center Southern Interior

Kelowna, British Columbia V1Y 5L3, Canada

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia V5Z 4E6, Canada

Bcca - Vancouver Island Cancer Centre; Oncology

Victoria, British Columbia V8R 6V5, Canada

Royal Victoria Hospital

Barrie, Ontario L4M 6M2, Canada

London Regional Cancer Centre

London, Ontario N6A 4L6, Canada

Lakeridge Health Oshawa; Oncology

Oshawa, Ontario L1G 2B9, Canada

The Ottawa Hospital Cancer Centre; Oncology

Ottawa, Ontario K1H 8L6, Canada

Sault Area Hospitals

Sault Ste. Marie, Ontario P6A 2C4, Canada

Sunnybrook Odette Cancer Centre

Toronto, Ontario M4N 3M5, Canada

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

Montreal, Quebec H3T 1E2, Canada

Masarykuv onkologicky ustav

Brno, 656 53, Czechia

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

MULTISCAN, s.r.o., Radiologicke centrum Pardubice

Pardubice, 532 03, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Herlev Hospital; Onkologisk afdeling

Herlev, 2730, Denmark

Rigshospitalet; Onkologisk Klinik

København Ø, 2100, Denmark

Docrates Cance Center

Helsinki, 00180, Finland

Turku University Central Hospital; Urology clinic

Turku, 20520, Finland

Ico - Paul Papin

Angers, 49000, France

Institut Sainte Catherine;Recherche Clinique

Avignon, 84918, France

Chr De Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Hopital Saint Andre

Bordeaux, 33075, France

Institut Bergonie; Oncologie

Bordeaux, 33076, France

Centre Francois Baclesse; Recherche Clinique

Caen, 14076, France

CHU Henri Mondor; Service d'Oncologie Medicale

Créteil, 94010, France

Clinique Chenieux; Oncology

Limoges, 87039, France

Centre Leon Berard; Departement Oncologie Medicale

Lyon, 69373, France

Institut J Paolii Calmettes

Marseille, 13009, France

Institut régional du Cancer Montpellier

Montpellier, 34298, France

Centre D'Oncologie de Gentilly; Oncology

Nancy, 54100, France

Centre Antoine Lacassagne

Nice, 06189, France

CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge

Nîmes, 30029, France

Hopital Cochin; Unite Fonctionnelle D Oncologie

Paris, 75014, France

Institut Curie; Recherche Clinique

Paris, 75231, France

Hopital Saint Louis; Oncologie Medicale

Paris, 75475, France

Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

Paris, 75908, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

CHU de Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

ICO - Site René Gauducheau

Saint-Herblain, 44805, France

Hopital Hautepierre; Hematologie Oncologie

Strasbourg, 67098, France

Hopital Foch; Oncologie

Suresnes, 92151, France

Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse, 31059, France

Institut Gustave Roussy; Departement Oncologie Medicale

Villejuif, 94805, France

Uniklinik RWTH Aachen; Klinik für Urologie

Aachen, 52074, Germany

Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie

Berlin, 12200, Germany

Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

Dresden, 01307, Germany

Universitätsklinikum Düsseldorf; Urologische Klinik

Düsseldorf, 40225, Germany

Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V

Erlangen, 91054, Germany

Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

Freiburg im Breisgau, 79106, Germany

Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie

Göttingen, 37075, Germany

Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

Hamburg, 20246, Germany

Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg

Heidelberg, 69120, Germany

Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie

Homburg/Saar, 66424, Germany

Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie

Magdeburg, 39120, Germany

Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

Mannheim, 68167, Germany

Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

München, 81675, Germany

Universitätsklinikum Tübingen; Klinik für Urologie

Tübingen, 72076, Germany

Universitätsklinikum Ulm; Klinik für Urologie

Ulm, 89081, Germany

Alexandras General Hospital of Athens; Oncology Department

Athens, 115 28, Greece

Univ General Hosp Heraklion; Medical Oncology

Heraklion, 711 10, Greece

University Hospital of Patras Medical Oncology

Pátrai, 265 04, Greece

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, 546 45, Greece

Semmelwies University of Medicine; Urology Dept.

Budapest, 1082, Hungary

Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

Budapest, 1122, Hungary

Uzsoki Utcai Korhaz

Budapest, 1145, Hungary

Kecskemeti Onkoradilogai Centrum

Kecskemét, 6000, Hungary

Hetenyi Geza County Hospital; Onkologiai Kozpont

Szolnok, 5004, Hungary

IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

San Giovanni Rotondo, Apulia 71013, Italy

Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico

Naples, Campania 80131, Italy

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

Meldola, Emilia-Romagna 47014, Italy

A.O. Universitaria Policlinico Di Modena; Oncologia

Modena, Emilia-Romagna 41100, Italy

A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

Udine, Friuli Venezia Giulia 33100, Italy

Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

Rome, Lazio 00152, Italy

Asst Papa Giovanni XXIII; Oncologia Medica

Bergamo, Lombardy 24127, Italy

ASST DI CREMONA; Dip. Medicina - S.C. Oncologia

Cremona, Lombardy 26100, Italy

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

Milan, Lombardy 20133, Italy

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

Candiolo, Piedmont 10060, Italy

Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello

Palermo, Sicily 90146, Italy

Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

Arezzo, Tuscany 52100, Italy

Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

Florence, Tuscany 50139, Italy

Nagoya University Hospital; Urology

Aichi, 466-8560, Japan

Hirosaki University School of Medicine & Hospital; Urology

Aomori, 036-8563, Japan

Chiba Cancer Center; Urology

Chiba, 260-8717, Japan

National Cancer Center Hospital East; Breast and Medical Oncology

Chiba, 277-8577, Japan

National Hospital Organization Shikoku Cancer Center; Urology

Ehime, 791-0280, Japan

Harasanshin Hospital; Urology

Fukuoka, 812-0033, Japan

Kyushu University Hospital; Urology

Fukuoka, 812-8582, Japan

Gunma University Hospital; Urology

Gunma, 371-8511, Japan

Hiroshima City Hiroshima Citizens Hospital; Urology

Hiroshima, 730-8518, Japan

Sapporo Medical University Hospital; Urology

Hokkaido, 060-8543, Japan

Hokkaido University Hospital; Urology

Hokkaido, 060-8648, Japan

University of Tsukuba Hospital; Urology

Ibaraki, 305-8576, Japan

Yokohama City University Hospital; Urology

Kanagawa, 236-0004, Japan

Kumamoto University Hospital; Urology

Kumamoto, 860-8556, Japan

Niigata Cancer Center Hospital;Urology

Niigata, 951-8566, Japan

Iwate Medical University Hospital; Urology

Numakunai, 020-8505, Japan

Osaka International Cancer Institute; Urology

Osaka, 541-8567, Japan

Osaka University Hospital; Urology

Osaka, 565-0871, Japan

Kindai University Hospital; Urology

Osaka, 589-8511, Japan

Shizuoka Cancer Center; Urology

Shizuoka, 411-8777, Japan

Tokushima University Hospital; Urology

Tokushima, 770-8503, Japan

National Cancer Center Hospital; Urology

Tokyo, 104-0045, Japan

Toranomon Hospital; Medical Oncology

Tokyo, 105-8470, Japan

Nippon Medical School Hospital; Urology

Tokyo, 113-8603, Japan

The Cancer Institute Hospital, JFCR; Urology

Tokyo, 135-8550, Japan

The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis

Amsterdam, 1066 CX, Netherlands

Spaarne Ziekenhuis; Inwendige Geneeskunde

Hoofddorp, 2134 TM, Netherlands

Maastricht University Medical Centre; Medical Oncology

Maastricht, 6229 HX, Netherlands

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, 3430 EM, Netherlands

Isala Klinieken

Zwolle, 8011 JW, Netherlands

Sørlandet Sykehus Kristiansand

Kristiansand, 4604, Norway

Uni Hospital of Tromso; Dept. of Oncology

Tromsø, 9019, Norway

St. Olavs Hospital; Kreftavdelingen

Trondheim, 7000, Norway

Medical University of Bialystok; Oncology clinic

Bialystok, 15-027, Poland

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, 80-214, Poland

COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

Lublin, 20-090, Poland

Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

Poznan, 60-569, Poland

Centrum onkologii Instytutu im. Marii Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego

Warsaw, 02-781, Poland

Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology

Wroclaw, 50-556, Poland

Hospital de Santa Maria; Servico de Oncologia Medica

Lisbon, 1649-035, Portugal

Hospital Beatriz Angelo; Departamento de Oncologia

Loures, 2674-514, Portugal

IPO do Porto; Servico de Oncologia Medica

Porto, 4200-072, Portugal

Spitalul Judetean de Urgenta Dr Constantin Opris

Baia Mare, 430031, Romania

Institute Of Oncology Bucharest; Medical Oncology

Bucharest, 022338, Romania

Institut Oncologic Ion Chiricuta; Departament Radioterapie

Cluj-Napoca, 400015, Romania

Oncology Center Sf. Nectarie

Craiova, 200347, Romania

Euroclinic Center of Oncology SRL

Iași, 700106, Romania

Spital Clinic Judetean Mures; Oncologie

Târgu Mureş, 540142, Romania

ONCOMED - Medical Centre

Timișoara, 300239, Romania

GBUZ Nizhegorodskay Region: Clinical Diagnostic Center

Nizhny Novgorod, Niznij Novgorod 603001, Russia

Altai Regional Oncological Center

Barnaul, 656049, Russia

Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology

Moscow, 125284, Russia

St. Petersburg Oncology Hospital

Saint Petersburg, 198255, Russia

SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

Stavropol, 355045, Russia

Clinical Center of Serbia; Clinic of Urology

Belgrade, 11000, Serbia

Institute for Oncology and Radiology of Serbia; Medical Oncology

Belgrade, 11000, Serbia

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Seoul National University Hospital

Seoul, 03080, South Korea

Asan Medical Center - Oncology

Seoul, 05505, South Korea

Samsung Medical Center

Seoul, 6351, South Korea

Hospital Universitario Son Espases; Servicio de Oncologia

Palma de Mallorca, Balearic Islands 07014, Spain

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona 08208, Spain

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba 14004, Spain

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

Santiago de Compostela, LA Coruña 15706, Spain

Hospital de Navarra; Servicio de Oncologia

Navarra, Navarre 31008, Spain

Clinica Universitaria de Navarra; Servicio de Oncologia

Pamplona, Navarre 31008, Spain

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, 08035, Spain

Hospital Clinic i Provincial; Servicio de Farmacia

Barcelona, 08036, Spain

Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

Barcelona, 08041, Spain

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, 08908, Spain

Hospital San Pedro De Alcantara; Servicio de Oncologia

Cáceres, 10003, Spain

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, 28007, Spain

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

Hospital Universitario Clínico San Carlos; Servicio de Oncologia

Madrid, 28040, Spain

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, 28041, Spain

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Málaga, 29010, Spain

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Seville, 41013, Spain

Hospital General Universitario de Valencia; Servicio de oncologia

Valencia, 41014, Spain

Hospital Clínico Universitario de Valencia; Servicio de Oncología

Valencia, 46010, Spain

Sahlgrenska Universitetssjukhuset; Jubileumskliniken

Gothenburg, 413 45, Sweden

Karolinska Hospital; Oncology - Radiumhemmet

Stockholm, 171 76, Sweden

Norrlands Uni Hospital; Onkologi Avd.

Umeå, 090185, Sweden

Inselspital Bern; Universitätsklinik für medizinische Onkologie

Bern, 3010, Switzerland

Kantonsspital Graubünden;Onkologie und Hämatologie

Chur, 7000, Switzerland

HUG; Oncologie

Geneva, 1211, Switzerland

Kantonsspital St. Gallen; Onkologie/Hämatologie

Sankt Gallen, 9007, Switzerland

UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

Zurich, 8091, Switzerland

China Medical University Hospital; Urology

Taichung, 40447, Taiwan

Taichung Veterans General Hospital; Division of Urology

Taichung, 407, Taiwan

National Taiwan Uni Hospital; Dept of Oncology

Taipei, 100, Taiwan

TAIPEI VETERANS GENERAL HOSPITAL, Urology

Taipei, 11217, Taiwan

Uludag Uni Hospital; Oncology

Bursa, 16059, Turkey (Türkiye)

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

Edirne, 22770, Turkey (Türkiye)

Bezmialem Vakif Univ Medical

Istanbul, 34286, Turkey (Türkiye)

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

Istanbul, 34300, Turkey (Türkiye)

Istanbul VKV American Hospital; Medical Oncology

Istanbul, 34365, Turkey (Türkiye)

Ege Uni Medical Faculty Hospital; Oncology Dept

Izmir, 35100, Turkey (Türkiye)

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

Malatya, 44280, Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sıhhiye, Ankara, 06100, Turkey (Türkiye)

University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Cheltenham General Hospital

Cheltenham, GL53 7AN, United Kingdom

University Hospital coventry; Oncology Department

Coventry, CV2 2DX, United Kingdom

Royal Devon & Exeter Hospital; Oncology Centre

Exeter, EX2 5DW, United Kingdom

Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

Lancaster, LA1 4RP, United Kingdom

St James Institute of Oncology

Leeds, LS9 7TF, United Kingdom

Leicester Royal Infirmary; Dept. of Medical Oncology

Leicester, LE1 5WW, United Kingdom

Barts and The London

London, EC1M 6BQ, United Kingdom

Royal Free Hospital; Dept of Oncology

London, NW3 2QG, United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Northern Centre for Cancer Care; Northern Centre for Cancer Care

Newcastle upon Tyne, NE7 7DN, United Kingdom

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Scunthorpe General Hospital; Dept of Oncology

Scunthorpe, DN16 7BH, United Kingdom

Southampton General Hospital; Medical Oncology

Southampton, SO16 6YD, United Kingdom

Royal Marsden Hospital; Dept of Medical Oncology

Sutton, SM2 5PT, United Kingdom

Royal Cornwall Hospital

Truro, TR1 3LQ, United Kingdom