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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02302807
Recruitment Status : Completed
First Posted : November 27, 2014
Results First Posted : April 11, 2018
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody Drug: Docetaxel Drug: Paclitaxel Drug: Vinflunine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 931 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 13, 2015
Actual Primary Completion Date : March 13, 2017
Actual Study Completion Date : November 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  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) [ 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

  7. 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.

  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 [ 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.

  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 [ 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.

  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 [ 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.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302807


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

Documents provided by Hoffmann-La Roche:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02302807     History of Changes
Other Study ID Numbers: GO29294
2014-003231-19 ( EudraCT Number )
First Posted: November 27, 2014    Key Record Dates
Results First Posted: April 11, 2018
Last Update Posted: August 1, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Paclitaxel
Vinblastine
Docetaxel
Albumin-Bound Paclitaxel
Atezolizumab
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs