AzTrials
AzTrials

Bladder CancerPhase 3NCT02302807

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

A Phase 3 study testing Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Docetaxel and Paclitaxel in people with Bladder Cancer, run by Hoffmann-La Roche at 217 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Docetaxel and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
931 participants
Where
217 sitesin 29 countries
Study dates
13 Jan 2015to 8 Nov 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

217 sites in 29 countries.

217 sites in 29 countries

France25 sites

  • Ico - Paul Papin

    Angers, 49000

  • Institut Sainte Catherine;Recherche Clinique

    Avignon, 84918

  • Chr De Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Saint Andre

    Bordeaux, 33075

  • Institut Bergonie; Oncologie

    Bordeaux, 33076

  • Centre Francois Baclesse; Recherche Clinique

    Caen, 14076

  • CHU Henri Mondor; Service d'Oncologie Medicale

    Créteil, 94010

  • Clinique Chenieux; Oncology

    Limoges, 87039

  • Centre Leon Berard; Departement Oncologie Medicale

    Lyon, 69373

  • Institut J Paolii Calmettes

    Marseille, 13009

  • Institut régional du Cancer Montpellier

    Montpellier, 34298

  • Centre D'Oncologie de Gentilly; Oncology

    Nancy, 54100

  • Centre Antoine Lacassagne

    Nice, 06189

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

    Nîmes, 30029

  • Hopital Cochin; Unite Fonctionnelle D Oncologie

    Paris, 75014

  • Institut Curie; Recherche Clinique

    Paris, 75231

  • Hopital Saint Louis; Oncologie Medicale

    Paris, 75475

  • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

    Paris, 75908

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, 76031

  • ICO - Site René Gauducheau

    Saint-Herblain, 44805

  • Hopital Hautepierre; Hematologie Oncologie

    Strasbourg, 67098

  • Hopital Foch; Oncologie

    Suresnes, 92151

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059

  • Institut Gustave Roussy; Departement Oncologie Medicale

    Villejuif, 94805

Other trials in France

Japan25 sites

  • Nagoya University Hospital; Urology

    Aichi, 466-8560

  • Hirosaki University School of Medicine & Hospital; Urology

    Aomori, 036-8563

  • Chiba Cancer Center; Urology

    Chiba, 260-8717

  • National Cancer Center Hospital East; Breast and Medical Oncology

    Chiba, 277-8577

  • National Hospital Organization Shikoku Cancer Center; Urology

    Ehime, 791-0280

  • Harasanshin Hospital; Urology

    Fukuoka, 812-0033

  • Kyushu University Hospital; Urology

    Fukuoka, 812-8582

  • Gunma University Hospital; Urology

    Gunma, 371-8511

  • Hiroshima City Hiroshima Citizens Hospital; Urology

    Hiroshima, 730-8518

  • Sapporo Medical University Hospital; Urology

    Hokkaido, 060-8543

  • Hokkaido University Hospital; Urology

    Hokkaido, 060-8648

  • University of Tsukuba Hospital; Urology

    Ibaraki, 305-8576

  • Yokohama City University Hospital; Urology

    Kanagawa, 236-0004

  • Kumamoto University Hospital; Urology

    Kumamoto, 860-8556

  • Niigata Cancer Center Hospital;Urology

    Niigata, 951-8566

  • Iwate Medical University Hospital; Urology

    Numakunai, 020-8505

  • Osaka International Cancer Institute; Urology

    Osaka, 541-8567

  • Osaka University Hospital; Urology

    Osaka, 565-0871

  • Kindai University Hospital; Urology

    Osaka, 589-8511

  • Shizuoka Cancer Center; Urology

    Shizuoka, 411-8777

  • Tokushima University Hospital; Urology

    Tokushima, 770-8503

  • National Cancer Center Hospital; Urology

    Tokyo, 104-0045

  • Toranomon Hospital; Medical Oncology

    Tokyo, 105-8470

  • Nippon Medical School Hospital; Urology

    Tokyo, 113-8603

  • The Cancer Institute Hospital, JFCR; Urology

    Tokyo, 135-8550

Other trials in Japan

Spain19 sites

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital Clinic i Provincial; Servicio de Farmacia

    Barcelona, 08036

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

    Barcelona, 08041

  • Institut Catala d Oncologia Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital San Pedro De Alcantara; Servicio de Oncologia

    Cáceres, 10003

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Hospital de Navarra; Servicio de Oncologia

    Navarra, Navarre, 31008

  • Hospital Universitario Son Espases; Servicio de Oncologia

    Palma de Mallorca, Balearic Islands, 07014

  • Clinica Universitaria de Navarra; Servicio de Oncologia

    Pamplona, Navarre, 31008

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 08208

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

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia

    Seville, 41013

  • Hospital General Universitario de Valencia; Servicio de oncologia

    Valencia, 41014

  • Hospital Clínico Universitario de Valencia; Servicio de Oncología

    Valencia, 46010

Other trials in Spain

United Kingdom19 sites

  • University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Cheltenham General Hospital

    Cheltenham, GL53 7AN

  • University Hospital coventry; Oncology Department

    Coventry, CV2 2DX

  • Royal Devon & Exeter Hospital; Oncology Centre

    Exeter, EX2 5DW

  • Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

    Lancaster, LA1 4RP

  • St James Institute of Oncology

    Leeds, LS9 7TF

  • Leicester Royal Infirmary; Dept. of Medical Oncology

    Leicester, LE1 5WW

  • Barts and The London

    London, EC1M 6BQ

  • Royal Free Hospital; Dept of Oncology

    London, NW3 2QG

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral, CH63 4JY

  • Northern Centre for Cancer Care; Northern Centre for Cancer Care

    Newcastle upon Tyne, NE7 7DN

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Scunthorpe General Hospital; Dept of Oncology

    Scunthorpe, DN16 7BH

  • Southampton General Hospital; Medical Oncology

    Southampton, SO16 6YD

  • Royal Marsden Hospital; Dept of Medical Oncology

    Sutton, SM2 5PT

  • Royal Cornwall Hospital

    Truro, TR1 3LQ

Other trials in United Kingdom

Germany15 sites

  • Uniklinik RWTH Aachen; Klinik für Urologie

    Aachen, 52074

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

    Berlin, 12200

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

    Dresden, 01307

  • Universitätsklinikum Düsseldorf; Urologische Klinik

    Düsseldorf, 40225

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

    Erlangen, 91054

  • Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

    Freiburg im Breisgau, 79106

  • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie

    Göttingen, 37075

  • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

    Hamburg, 20246

  • Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie

    Homburg/Saar, 66424

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

    Magdeburg, 39120

  • Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

    Mannheim, 68167

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

    München, 81675

  • Universitätsklinikum Tübingen; Klinik für Urologie

    Tübingen, 72076

  • Universitätsklinikum Ulm; Klinik für Urologie

    Ulm, 89081

Other trials in Germany

Italy13 sites

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

    Arezzo, Tuscany, 52100

  • Asst Papa Giovanni XXIII; Oncologia Medica

    Bergamo, Lombardy, 24127

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

    Candiolo, Piedmont, 10060

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

    Cremona, Lombardy, 26100

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

    Florence, Tuscany, 50139

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

    Meldola, Emilia-Romagna, 47014

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

    Milan, Lombardy, 20133

  • A.O. Universitaria Policlinico Di Modena; Oncologia

    Modena, Emilia-Romagna, 41100

  • Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico

    Naples, Campania, 80131

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

    Palermo, Sicily, 90146

  • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

    Rome, Lazio, 00152

  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

    San Giovanni Rotondo, Apulia, 71013

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

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Canada11 sites

  • Royal Victoria Hospital

    Barrie, Ontario, L4M 6M2

  • Tom Baker Cancer Centre-Calgary

    Calgary, Alberta, T2N 4N2

  • Bcca - Cancer Center Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Centre

    London, Ontario, N6A 4L6

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

    Montreal, Quebec, H3T 1E2

  • Lakeridge Health Oshawa; Oncology

    Oshawa, Ontario, L1G 2B9

  • The Ottawa Hospital Cancer Centre; Oncology

    Ottawa, Ontario, K1H 8L6

  • Sault Area Hospitals

    Sault Ste. Marie, Ontario, P6A 2C4

  • Sunnybrook Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • Bcca - Vancouver Island Cancer Centre; Oncology

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Turkey (Türkiye)8 sites

  • Uludag Uni Hospital; Oncology

    Bursa, 16059

  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

    Edirne, 22770

  • Bezmialem Vakif Univ Medical

    Istanbul, 34286

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

    Istanbul, 34300

  • Istanbul VKV American Hospital; Medical Oncology

    Istanbul, 34365

  • Ege Uni Medical Faculty Hospital; Oncology Dept

    Izmir, 35100

  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

    Malatya, 44280

  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

    Sıhhiye, Ankara, 06100

Other trials in Turkey (Türkiye)

Romania7 sites

  • Spitalul Judetean de Urgenta Dr Constantin Opris

    Baia Mare, 430031

  • Institute Of Oncology Bucharest; Medical Oncology

    Bucharest, 022338

  • Institut Oncologic Ion Chiricuta; Departament Radioterapie

    Cluj-Napoca, 400015

  • Oncology Center Sf. Nectarie

    Craiova, 200347

  • Euroclinic Center of Oncology SRL

    Iași, 700106

  • Spital Clinic Judetean Mures; Oncologie

    Târgu Mureş, 540142

  • ONCOMED - Medical Centre

    Timișoara, 300239

Other trials in Romania

United States6 sites

  • Emory University; Winship Cancer Institute

    Atlanta, Georgia, 30308

  • Duke Cancer Center

    Durham, North Carolina, 27710

  • Bon Secours - St. Francis Hospital

    Greenville, South Carolina, 29607

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Vanderbilt-Ingram Cancer Ctr

    Nashville, Tennessee, 37232

  • Georgetown University Medical Center Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Poland6 sites

  • Medical University of Bialystok; Oncology clinic

    Bialystok, 15-027

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-214

  • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

    Lublin, 20-090

  • Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

    Poznan, 60-569

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

    Warsaw, 02-781

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

    Wroclaw, 50-556

Other trials in Poland

Czechia5 sites

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

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

    Pardubice, 532 03

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Hungary5 sites

  • Semmelwies University of Medicine; Urology Dept.

    Budapest, 1082

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

    Budapest, 1122

  • Uzsoki Utcai Korhaz

    Budapest, 1145

  • Kecskemeti Onkoradilogai Centrum

    Kecskemét, 6000

  • Hetenyi Geza County Hospital; Onkologiai Kozpont

    Szolnok, 5004

Other trials in Hungary

Netherlands5 sites

  • The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis

    Amsterdam, 1066 CX

  • Spaarne Ziekenhuis; Inwendige Geneeskunde

    Hoofddorp, 2134 TM

  • Maastricht University Medical Centre; Medical Oncology

    Maastricht, 6229 HX

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3430 EM

  • Isala Klinieken

    Zwolle, 8011 JW

Other trials in Netherlands

Russia5 sites

  • Altai Regional Oncological Center

    Barnaul, 656049

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

    Moscow, 125284

  • GBUZ Nizhegorodskay Region: Clinical Diagnostic Center

    Nizhny Novgorod, Niznij Novgorod, 603001

  • St. Petersburg Oncology Hospital

    Saint Petersburg, 198255

  • SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

    Stavropol, 355045

Other trials in Russia

Switzerland5 sites

  • Inselspital Bern; Universitätsklinik für medizinische Onkologie

    Bern, 3010

  • Kantonsspital Graubünden;Onkologie und Hämatologie

    Chur, 7000

  • HUG; Oncologie

    Geneva, 1211

  • Kantonsspital St. Gallen; Onkologie/Hämatologie

    Sankt Gallen, 9007

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

    Zurich, 8091

Other trials in Switzerland

Australia4 sites

  • Royal Adelaide Hospital; Oncology

    Adelaide, South Australia, 5000

  • Monash Medical Centre; Oncology

    Clayton, Victoria, 3168

  • Royal Brisbane and Women's Hospital; Medical Oncology

    Herston, Queensland, 4029

  • Austin and Repatriation Medical Centre; Cancer Services

    Melbourne, Victoria, 3084

Other trials in Australia

Belgium4 sites

  • ZNA Middelheim

    Antwerp, 2020

  • Institut Jules Bordet

    Brussels, 1000

  • UZ Gent

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Greece4 sites

  • Alexandras General Hospital of Athens; Oncology Department

    Athens, 115 28

  • Univ General Hosp Heraklion; Medical Oncology

    Heraklion, 711 10

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

  • Euromedical General Clinic of Thessaloniki; Oncology Department

    Thessaloniki, 546 45

Other trials in Greece

Taiwan4 sites

  • China Medical University Hospital; Urology

    Taichung, 40447

  • Taichung Veterans General Hospital; Division of Urology

    Taichung, 407

  • National Taiwan Uni Hospital; Dept of Oncology

    Taipei, 100

  • TAIPEI VETERANS GENERAL HOSPITAL, Urology

    Taipei, 11217

Other trials in Taiwan

Norway3 sites

  • Sørlandet Sykehus Kristiansand

    Kristiansand, 4604

  • Uni Hospital of Tromso; Dept. of Oncology

    Tromsø, 9019

  • St. Olavs Hospital; Kreftavdelingen

    Trondheim, 7000

Other trials in Norway

Portugal3 sites

  • Hospital de Santa Maria; Servico de Oncologia Medica

    Lisbon, 1649-035

  • Hospital Beatriz Angelo; Departamento de Oncologia

    Loures, 2674-514

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Serbia3 sites

  • Clinical Center of Serbia; Clinic of Urology

    Belgrade, 11000

  • Institute for Oncology and Radiology of Serbia; Medical Oncology

    Belgrade, 11000

  • Oncology Institute of Vojvodina

    Kamenitz, 21204

Other trials in Serbia

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center - Oncology

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 6351

Other trials in South Korea

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset; Jubileumskliniken

    Gothenburg, 413 45

  • Karolinska Hospital; Oncology - Radiumhemmet

    Stockholm, 171 76

  • Norrlands Uni Hospital; Onkologi Avd.

    Umeå, 090185

Other trials in Sweden

Austria2 sites

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

    Vienna, 1090

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

    Vienna, 1100

Other trials in Austria

Denmark2 sites

  • Herlev Hospital; Onkologisk afdeling

    Herlev, 2730

  • Rigshospitalet; Onkologisk Klinik

    København Ø, 2100

Other trials in Denmark

Finland2 sites

  • Docrates Cance Center

    Helsinki, 00180

  • Turku University Central Hospital; Urology clinic

    Turku, 20520

Other trials in Finland

Slovenia1 site

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

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

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.

Conditions
Bladder Cancer
Being tested
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Docetaxel, Paclitaxel, Vinflunine
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibodyDrug

    Also called Tecentriq

    Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.

  • DocetaxelDrug

    Docetaxel 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.

  • PaclitaxelDrug

    Paclitaxel 175 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.

  • VinflunineDrug

    Vinflunine 320 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.

Study groups in NCT02302807
Study groupRoleWhat they receive
Arm A: AtezolizumabExperimentalAtezolizumab 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.
Receives: Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Arm B: Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)Active comparatorParticipants 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.
Receives: Drug: Docetaxel; Drug: Paclitaxel; Drug: Vinflunine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS was defined as time from randomization to death from any cause.

    Measured: Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled

Secondary outcomes (10)

  1. Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1

    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).

    Measured: Up to approximately 25 months after first participant enrolled

  2. Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1

    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.

    Measured: Up to approximately 25 months after first participant enrolled

  3. Percentage of Participants With Adverse Events (AEs)

    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.

    Measured: Up to approximately 46 months after first participant enrolled

  4. Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab

    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.

    Measured: 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)

  5. Minimum Observed Serum Atezolizumab Concentration (Cmin)

    Cmin was measured for all participants that received at least one dose of Atezolizumab.

    Measured: 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)

  6. 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)

    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

    Measured: Up to approximately 25 months after first participant enrolled

  7. Maximum Observed Serum Atezolizumab Concentration (Cmax)

    Cmax was measured for all participants that received at least one dose of Atezolizumab.

    Measured: 30 minutes post dose on Day 1 of Cycles 1

  8. 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

    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.

    Measured: 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)

  9. 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

    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.

    Measured: 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)

  10. 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

    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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2014 (estimated)
  2. Study start13 Jan 2015
  3. Primary completion13 Mar 2017
  4. Study completion8 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
931 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02302807
Sponsor's protocol ID
GO29294
Other IDs
2014-003231-19, 2014
Status last verified
Jul 2019
First submitted
25 Nov 2014
Last updated
1 Aug 2019

Publications

  • van der Heijden MS, Loriot Y, Duran I, Ravaud A, Retz M, Vogelzang NJ, Nelson B, Wang J, Shen X, Powles T. Atezolizumab Versus Chemotherapy in Patients with Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: A Long-term Overall Survival and Safety Update from the Phase 3 IMvigor211 Clinical Trial. Eur Urol. 2021 Jul;80(1):7-11. doi: 10.1016/j.eururo.2021.03.024. Epub 2021 Apr 23.

    PubMed 33902955

  • Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

    PubMed 33241650

  • Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.

    PubMed 31542806

  • Rassy EE, Bakouny Z, Aoun F, Haddad FG, Sleilaty G, Assi T, Kattan J. A network meta-analysis of the PD(L)-1 inhibitors in the salvage treatment of urothelial bladder cancer. Immunotherapy. 2018 Jun;10(8):657-663. doi: 10.2217/imt-2017-0190. Epub 2018 Mar 22.

    PubMed 29562804

  • Powles T, Duran I, van der Heijden MS, Loriot Y, Vogelzang NJ, De Giorgi U, Oudard S, Retz MM, Castellano D, Bamias A, Flechon A, Gravis G, Hussain S, Takano T, Leng N, Kadel EE 3rd, Banchereau R, Hegde PS, Mariathasan S, Cui N, Shen X, Derleth CL, Green MC, Ravaud A. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018 Feb 24;391(10122):748-757. doi: 10.1016/S0140-6736(17)33297-X. Epub 2017 Dec 18.

    PubMed 29268948

  • Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Duran I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thastrom A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8.

    PubMed 27939400

  • Kim YS, Lee SI, Park SH, Park S, Hwang IG, Lee SC, Sun JM, Lee J, Lim HY. A Phase II Study of Weekly Docetaxel as Second-Line Chemotherapy in Patients With Metastatic Urothelial Carcinoma. Clin Genitourin Cancer. 2016 Feb;14(1):76-81. doi: 10.1016/j.clgc.2015.09.008. Epub 2015 Sep 25.

    PubMed 26454620

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Docetaxel and Paclitaxel in people with Bladder Cancer, run by Hoffmann-La Roche at 217 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 217 sites in France, Japan, Spain, United Kingdom, Germany and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02302807, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.

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