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

July 5, 2019 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

931

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital; Medical Oncology
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital; Oncology
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre; Oncology
      • Melbourne, Victoria, Australia, 3084
        • Austin and Repatriation Medical Centre; Cancer Services
  • Austria
      • Wien, Austria, 1090
        • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
      • Wien, Austria, 1100
        • Kaiser-Franz-Josef-Spital; Zent.Onkologie und Hamatologie
  • Belgium
      • Antwerpen, Belgium, 2020
        • ZNA Middelheim
      • Bruxelles, Belgium, 1000
        • Institut Jules Bordet
      • Gent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre-Calgary
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Bcca - Cancer Center Southern Interior
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA-Vancouver Cancer Centre
      • Victoria, British Columbia, Canada, V8R 6V5
        • Bcca - Vancouver Island Cancer Centre; Oncology
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa; Oncology
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre; Oncology
      • Sault Ste Marie, Ontario, Canada, P6A 2C4
        • Sault Area Hospitals
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
  • Czechia
      • Brno, Czechia, 656 53
        • Masarykuv onkologicky ustav
      • Olomouc, Czechia, 775 20
        • Fakultni Nemocnice Olomouc
      • Pardubice, Czechia, 532 03
        • MULTISCAN, s.r.o., Radiologicke centrum Pardubice
      • Praha, Czechia, 100 34
        • Fakultní Nemocnice Královské Vinohrady
      • Praha 2, Czechia, 128 08
        • Vseobecna Fakultni Nemocnice V Praze
  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital; Onkologisk afdeling
      • København Ø, Denmark, 2100
        • Rigshospitalet; Onkologisk Klinik
  • Finland
      • Helsinki, Finland, 00180
        • Docrates Cance Center
      • Turku, Finland, 20520
        • Turku University Central Hospital; Urology clinic
  • France
      • Angers, France, 49000
        • ICO - Paul Papin
      • Avignon, France, 84918
        • Institut Sainte Catherine;Recherche Clinique
      • Besancon, France, 25030
        • CHR de Besancon - Hopital Jean Minjoz
      • Bordeaux, France, 33075
        • Hopital Saint André
      • Bordeaux, France, 33076
        • Institut Bergonie; Oncologie
      • Caen, France, 14076
        • Centre Francois Baclesse; Recherche Clinique
      • Creteil, France, 94010
        • CHU Henri Mondor; Service d'Oncologie Medicale
      • Limoges, France, 87039
        • Clinique Chenieux; Oncology
      • Lyon, France, 69373
        • Centre Leon Berard; Departement Oncologie Medicale
      • Marseille, France, 13009
        • Institut J Paolii Calmettes
      • Montpellier, France, 34298
        • Institut Régional du Cancer Montpellier
      • Nancy, France, 54100
        • Centre D'Oncologie de Gentilly; Oncology
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Nimes, France, 30029
        • CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
      • Paris, France, 75014
        • Hopital Cochin; Unite Fonctionnelle D Oncologie
      • Paris, France, 75475
        • Hopital Saint Louis; Oncologie Medicale
      • Paris, France, 75908
        • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
      • Paris, France, 75231
        • Institut Curie; Recherche Clinique
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Rouen, France, 76031
        • CHU de Rouen - Hôpital Charles Nicolle
      • Saint Herblain, France, 44805
        • ICO - Site René Gauducheau
      • Strasbourg, France, 67098
        • Hopital Hautepierre; Hematologie Oncologie
      • Suresnes, France, 92151
        • Hopital Foch; Oncologie
      • Toulouse, France, 31059
        • Institut Claudius Regaud; Departement Oncologie Medicale
      • Villejuif, France, 94805
        • Institut Gustave Roussy; Departement Oncologie Medicale
  • Germany
      • Aachen, Germany, 52074
        • Uniklinik RWTH Aachen; Klinik für Urologie
      • Berlin, Germany, 12200
        • Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie
      • Dresden, Germany, 01307
        • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf; Urologische Klinik
      • Erlangen, Germany, 91054
        • Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
      • Göttingen, Germany, 37075
        • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
      • Heidelberg, Germany, 69120
        • Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
      • Homburg/Saar, Germany, 66424
        • Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie
      • Mannheim, Germany, 68167
        • Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
      • München, Germany, 81675
        • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen; Klinik für Urologie
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm; Klinik für Urologie
  • Greece
      • Athens, Greece, 115 28
        • Alexandras General Hospital of Athens; Oncology Department
      • Heraklion, Greece, 711 10
        • Univ General Hosp Heraklion; Medical Oncology
      • Patras, Greece, 265 04
        • University Hospital of Patras Medical Oncology
      • Thessaloniki, Greece, 546 45
        • Euromedical General Clinic of Thessaloniki; Oncology Department
  • Hungary
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Budapest, Hungary, 1082
        • Semmelwies University of Medicine; Urology Dept.
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
      • Kecskemét, Hungary, 6000
        • Kecskemeti Onkoradilogai Centrum
      • Szolnok, Hungary, 5004
        • Hetenyi Geza County Hospital; Onkologiai Kozpont
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
      • Modena, Emilia-Romagna, Italy, 41100
        • A.O. Universitaria Policlinico Di Modena; Oncologia
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy, 33100
        • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
    • Lazio
      • Roma, Lazio, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
        • Asst Papa Giovanni XXIII; Oncologia Medica
      • Cremona, Lombardia, Italy, 26100
        • ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
      • Milano, Lombardia, Italy, 20133
        • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
    • Piemonte
      • Candiolo, Piemonte, Italy, 10060
        • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
    • Puglia
      • San Giovanni Rotondo, Puglia, Italy, 71013
        • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
    • Sicilia
      • Palermo, Sicilia, Italy, 90146
        • Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
    • Toscana
      • Arezzo, Toscana, Italy, 52100
        • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
      • Firenze, Toscana, Italy, 50139
        • Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
  • Japan
      • Aichi, Japan, 466-8560
        • Nagoya University Hospital; Urology
      • Aomori, Japan, 036-8563
        • Hirosaki University School of Medicine & Hospital; Urology
      • Chiba, Japan, 260-8717
        • Chiba Cancer Center; Urology
      • Chiba, Japan, 277-8577
        • National Cancer Center Hospital East; Breast and Medical Oncology
      • Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center; Urology
      • Fukuoka, Japan, 812-0033
        • Harasanshin Hospital; Urology
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital; Urology
      • Gunma, Japan, 371-8511
        • Gunma University Hospital; Urology
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital; Urology
      • Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital; Urology
      • Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital; Urology
      • Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital; Urology
      • Iwate, Japan, 020-8505
        • Iwate Medical University Hospital; Urology
      • Kanagawa, Japan, 236-0004
        • Yokohama City University Hospital; Urology
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital; Urology
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital;Urology
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute; Urology
      • Osaka, Japan, 565-0871
        • Osaka University Hospital; Urology
      • Osaka, Japan, 589-8511
        • Kindai University Hospital; Urology
      • Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center; Urology
      • Tokushima, Japan, 770-8503
        • Tokushima University Hospital; Urology
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital; Medical Oncology
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital, JFCR; Urology
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital; Urology
      • Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital; Urology
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 6351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center - Oncology
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis
      • Hoofddorp, Netherlands, 2134 TM
        • Spaarne Ziekenhuis; Inwendige Geneeskunde
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Centre; Medical Oncology
      • Nieuwegein, Netherlands, 3430 EM
        • St. Antonius Ziekenhuis Nieuwegein
      • Zwolle, Netherlands, 8011 JW
        • Isala Klinieken
  • Norway
      • Kristiansand, Norway, 4604
        • Sørlandet Sykehus Kristiansand
      • Tromsø, Norway, 9019
        • Uni Hospital of Tromso; Dept. of Oncology
      • Trondheim, Norway, 7000
        • St. Olavs Hospital; Kreftavdelingen
  • Poland
      • Bialystok, Poland, 15-027
        • Medical University of Bialystok; Oncology clinic
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
      • Lublin, Poland, 20-090
        • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
      • Poznan, Poland, 60-569
        • Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
      • Warszawa, Poland, 02-781
        • Centrum onkologii Instytutu im. Marii Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego
      • Wroclaw, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Hospital de Santa Maria; Servico de Oncologia Medica
      • Loures, Portugal, 2674-514
        • Hospital Beatriz Angelo; Departamento de Oncologia
      • Porto, Portugal, 4200-072
        • IPO do Porto; Servico de Oncologia Medica
  • Romania
      • Baia Mare, Romania, 430031
        • Spitalul Judetean de Urgenta Dr Constantin Opris
      • Bucharest, Romania, 022338
        • Institute Of Oncology Bucharest; Medical Oncology
      • Cluj-napoca, Romania, 400015
        • Institut Oncologic Ion Chiricuta; Departament Radioterapie
      • Craiova, Romania, 200347
        • Oncology Center Sf. Nectarie
      • Iasi, Romania, 700106
        • Euroclinic Center of Oncology SRL
      • Targu Mures, Romania, 540142
        • Spital Clinic Judetean Mures; Oncologie
      • Timisoara, Romania, 300239
        • ONCOMED - Medical Centre
  • Russian Federation
      • Barnaul, Russian Federation, 656049
        • Altai Regional Oncological Center
      • Moscow, Russian Federation, 125284
        • Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology
      • St Petersburg, Russian Federation, 198255
        • St. Petersburg Oncology Hospital
      • Stavropol, Russian Federation, 355045
        • SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
    • Niznij Novgorod
      • Nizhni Novgorod, Niznij Novgorod, Russian Federation, 603001
        • GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Oncology and Radiology of Serbia; Medical Oncology
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia; Clinic of Urology
      • Sremska Kamenica, Serbia, 21204
        • Oncology Institute of Vojvodina
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana
  • Spain
      • Barcelona, Spain, 08908
        • Institut Catala d Oncologia Hospital Duran i Reynals
      • Barcelona, Spain, 08035
        • Hospital Univ Vall d'Hebron; Servicio de Oncologia
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial; Servicio de Farmacia
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
      • Caceres, Spain, 10003
        • Hospital San Pedro De Alcantara; Servicio de Oncologia
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal; Servicio de Oncologia
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre; Servicio de Oncologia
      • Madrid, Spain, 28040
        • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
      • Malaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
      • Navarra, Spain, 31008
        • Hospital de Navarra; Servicio de Oncologia
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia; Servicio de Oncología
      • Valencia, Spain, 41014
        • Hospital General Universitario de Valencia; Servicio de oncologia
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia; Servicio de Oncologia
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain, 07014
        • Hospital Universitario Son Espases; Servicio de Oncologia
    • LA Coruña
      • Santiago de Compostela, LA Coruña, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra; Servicio de Oncologia
  • Sweden
      • Göteborg, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset; Jubileumskliniken
      • Stockholm, Sweden, 171 76
        • Karolinska Hospital; Oncology - Radiumhemmet
      • Umea, Sweden, 090185
        • Norrlands Uni Hospital; Onkologi Avd.
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Bern; Universitätsklinik für medizinische Onkologie
      • Chur, Switzerland, 7000
        • Kantonsspital Graubünden;Onkologie und Hämatologie
      • Geneve, Switzerland, 1211
        • HUG; Oncologie
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen; Onkologie/Hämatologie
      • Zürich, Switzerland, 8091
        • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital; Urology
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital; Division of Urology
      • Taipei, Taiwan, 100
        • National Taiwan Uni Hospital; Dept of Oncology
      • Taipei, Taiwan, 11217
        • TAIPEI VETERANS GENERAL HOSPITAL, Urology
  • Turkey
      • Bursa, Turkey, 16059
        • Uludag Uni Hospital; Oncology
      • Edirne, Turkey, 22770
        • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
      • Istanbul, Turkey, 34300
        • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
      • Istanbul, Turkey, 34286
        • Bezmialem Vakif Univ Medical
      • Istanbul, Turkey, 34365
        • Istanbul VKV American Hospital; Medical Oncology
      • Izmir, Turkey, 35100
        • Ege Uni Medical Faculty Hospital; Oncology Dept
      • Malatya, Turkey, 44280
        • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
      • Sıhhiye, Ankara, Turkey, 06100
        • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • Cheltenham, United Kingdom, GL53 7AN
        • Cheltenham General Hospital
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital coventry; Oncology Department
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Hospital; Oncology Centre
      • Lancaster, United Kingdom, LA1 4RP
        • Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
      • Leeds, United Kingdom, LS9 7TF
        • St James Institute of Oncology
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary; Dept. of Medical Oncology
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital; Dept of Oncology
      • London, United Kingdom, EC1M 6BQ
        • Barts and The London
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Northern Centre for Cancer Care; Northern Centre for Cancer Care
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Oxford, United Kingdom, OX3 7LJ
        • Churchill Hospital
      • Scunthorpe, United Kingdom, DN16 7BH
        • Scunthorpe General Hospital; Dept of Oncology
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital; Medical Oncology
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital; Dept of Medical Oncology
      • Truro, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital
      • Wirral, United Kingdom, CH63 4JY
        • The Clatterbridge Cancer Centre NHS Foundation Trust
  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center Lombardi Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University; Winship Cancer Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Bon Secours - St. Francis Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Atezolizumab
Atezolizumab will be administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants will receive atezolizumab as long as they continue to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
Other Names:
  • Tecentriq
Active Comparator: Arm B: Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
Participants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m^2), paclitaxel 175 mg/m^2, or docetaxel 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Drug: Docetaxel
Docetaxel 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
Drug: Paclitaxel
Paclitaxel 175 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
Drug: Vinflunine
Vinflunine 320 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled
OS was defined as time from randomization to death from any cause.
Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1
Time Frame: Up to approximately 25 months after first participant enrolled
PFS was defined as the time between the date of randomization and the date of first documented progression of disease (PD) or death, whichever occurred first. PD was determined on the basis of investigator assessment with use of RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters had to demonstrate an absolute increase of >/= 5 millimeters (mm).
Up to approximately 25 months after first participant enrolled
Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1
Time Frame: Up to approximately 25 months after first participant enrolled
DOR was defined as the time from first occurrence of a CR or PR, whichever came first, to first documented PD or death, whichever occurred first. Disease progression was determined on the basis of investigator assessment with use of RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.
Up to approximately 25 months after first participant enrolled
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 46 months after first participant enrolled
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Up to approximately 46 months after first participant enrolled
Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab
Time Frame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)
Participants were considered post-baseline ATA positive if they had post-baseline ATAs to Atezolizumab that were treatment-induced or treatment-enhanced. Participants had treatment-induced ATAs if they had a baseline-negative ATA result and developed ATAs at any time after initial drug administration. Participants had treatment-enhanced ATAs if they had a baseline-positive ATA result that showed an enhanced signal that was >/= 0.60 titer units at any time after initial drug initiation.
Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Time Frame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)
Cmin was measured for all participants that received at least one dose of Atezolizumab.
Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)
Percentage of Participants With Unconfirmed Objective Response Rate (ORR) as Determined by the Investigator With Use of Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)
Time Frame: Up to approximately 25 months after first participant enrolled
ORR was defined as the percentage of participants, who had an objective response. Objective response was defined as either a complete response (CR) or partial response (PR) as determined by the investigator with use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). Objective response in this study did not need to be a confirmed response. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. ORR=CR+PR
Up to approximately 25 months after first participant enrolled
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Time Frame: 30 minutes post dose on Day 1 of Cycles 1
Cmax was measured for all participants that received at least one dose of Atezolizumab.
30 minutes post dose on Day 1 of Cycles 1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Global Health Status Scale
Time Frame: Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)
The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.
Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Physical Functioning Scale
Time Frame: Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)
The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.
Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Fatigue Symptom Scale
Time Frame: Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)
The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.
Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2015

Primary Completion (Actual)

March 13, 2017

Study Completion (Actual)

November 8, 2018

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO29294
  • 2014-003231-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bladder Cancer

Clinical Trials on Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe