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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Docetaxel
Paclitaxel
Vinflunine
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown University Medical Center Lombardi Cancer Center
  • Emory University; Winship Cancer Institute
  • Comprehensive Cancer Centers of Nevada
  • Duke Cancer Center
  • Bon Secours - St. Francis Hospital
  • Vanderbilt-Ingram Cancer Ctr
  • Royal Brisbane and Women's Hospital; Medical Oncology
  • Royal Adelaide Hospital; Oncology
  • Monash Medical Centre; Oncology
  • Austin and Repatriation Medical Centre; Cancer Services
  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
  • Kaiser-Franz-Josef-Spital; Zent.Onkologie und Hamatologie
  • ZNA Middelheim
  • Institut Jules Bordet
  • UZ Gent
  • UZ Leuven Gasthuisberg
  • Tom Baker Cancer Centre-Calgary
  • Bcca - Cancer Center Southern Interior
  • BCCA-Vancouver Cancer Centre
  • Bcca - Vancouver Island Cancer Centre; Oncology
  • Royal Victoria Hospital
  • London Regional Cancer Centre
  • Lakeridge Health Oshawa; Oncology
  • The Ottawa Hospital Cancer Centre; Oncology
  • Sault Area Hospitals
  • Sunnybrook Odette Cancer Centre
  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice Olomouc
  • MULTISCAN, s.r.o., Radiologicke centrum Pardubice
  • Vseobecna fakultni nemocnice v Praze
  • Fakultni nemocnice Kralovske Vinohrady
  • Herlev Hospital; Onkologisk afdeling
  • Rigshospitalet; Onkologisk Klinik
  • Docrates Cance Center
  • Turku University Central Hospital; Urology clinic
  • Ico - Paul Papin
  • Institut Sainte Catherine;Recherche Clinique
  • Chr De Besancon - Hopital Jean Minjoz
  • Hopital Saint Andre
  • Institut Bergonie; Oncologie
  • Centre Francois Baclesse; Recherche Clinique
  • CHU Henri Mondor; Service d'Oncologie Medicale
  • Clinique Chenieux; Oncology
  • Centre Leon Berard; Departement Oncologie Medicale
  • Institut J Paolii Calmettes
  • Institut régional du Cancer Montpellier
  • Centre D'Oncologie de Gentilly; Oncology
  • Centre Antoine Lacassagne
  • CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
  • Hopital Cochin; Unite Fonctionnelle D Oncologie
  • Institut Curie; Recherche Clinique
  • Hopital Saint Louis; Oncologie Medicale
  • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
  • Centre Hospitalier Lyon Sud
  • CHU de Rouen - Hôpital Charles Nicolle
  • ICO - Site René Gauducheau
  • Hopital Hautepierre; Hematologie Oncologie
  • Hopital Foch; Oncologie
  • Institut Claudius Regaud; Departement Oncologie Medicale
  • Institut Gustave Roussy; Departement Oncologie Medicale
  • Uniklinik RWTH Aachen; Klinik für Urologie
  • Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie
  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
  • Universitätsklinikum Düsseldorf; Urologische Klinik
  • Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V
  • Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
  • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie
  • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
  • Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
  • Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie
  • Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie
  • Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
  • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
  • Universitätsklinikum Tübingen; Klinik für Urologie
  • Universitätsklinikum Ulm; Klinik für Urologie
  • Alexandras General Hospital of Athens; Oncology Department
  • Univ General Hosp Heraklion; Medical Oncology
  • University Hospital of Patras Medical Oncology
  • Euromedical General Clinic of Thessaloniki; Oncology Department
  • Semmelwies University of Medicine; Urology Dept.
  • Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
  • Uzsoki Utcai Korhaz
  • Kecskemeti Onkoradilogai Centrum
  • Hetenyi Geza County Hospital; Onkologiai Kozpont
  • Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • A.O. Universitaria Policlinico Di Modena; Oncologia
  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
  • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
  • Asst Papa Giovanni XXIII; Oncologia Medica
  • ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
  • Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
  • Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
  • Nagoya University Hospital; Urology
  • Hirosaki University School of Medicine & Hospital; Urology
  • Chiba Cancer Center; Urology
  • National Cancer Center Hospital East; Breast and Medical Oncology
  • National Hospital Organization Shikoku Cancer Center; Urology
  • Harasanshin Hospital; Urology
  • Kyushu University Hospital; Urology
  • Gunma University Hospital; Urology
  • Hiroshima City Hiroshima Citizens Hospital; Urology
  • Sapporo Medical University Hospital; Urology
  • Hokkaido University Hospital; Urology
  • University of Tsukuba Hospital; Urology
  • Iwate Medical University Hospital; Urology
  • Yokohama City University Hospital; Urology
  • Kumamoto University Hospital; Urology
  • Niigata Cancer Center Hospital;Urology
  • Osaka International Cancer Institute; Urology
  • Osaka University Hospital; Urology
  • Kindai University Hospital; Urology
  • Shizuoka Cancer Center; Urology
  • Tokushima University Hospital; Urology
  • National Cancer Center Hospital; Urology
  • Toranomon Hospital; Medical Oncology
  • Nippon Medical School Hospital; Urology
  • The Cancer Institute Hospital, JFCR; Urology
  • Seoul National University Hospital
  • Asan Medical Center - Oncology
  • Samsung Medical Center
  • The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis
  • Spaarne Ziekenhuis; Inwendige Geneeskunde
  • Maastricht University Medical Centre; Medical Oncology
  • St. Antonius Ziekenhuis Nieuwegein
  • Isala Klinieken
  • Sørlandet Sykehus Kristiansand
  • Uni Hospital of Tromso; Dept. of Oncology
  • St. Olavs Hospital; Kreftavdelingen
  • Medical University of Bialystok; Oncology clinic
  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
  • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
  • Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
  • Centrum onkologii Instytutu im. Marii Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego
  • Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology
  • Hospital de Santa Maria; Servico de Oncologia Medica
  • Hospital Beatriz Angelo; Departamento de Oncologia
  • IPO do Porto; Servico de Oncologia Medica
  • Spitalul Judetean de Urgenta Dr Constantin Opris
  • Institute Of Oncology Bucharest; Medical Oncology
  • Institut Oncologic Ion Chiricuta; Departament Radioterapie
  • Oncology Center Sf. Nectarie
  • Euroclinic Center of Oncology SRL
  • Spital Clinic Judetean Mures; Oncologie
  • ONCOMED - Medical Centre
  • GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
  • Altai Regional Oncological Center
  • Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology
  • St. Petersburg Oncology Hospital
  • SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
  • Clinical Center of Serbia; Clinic of Urology
  • Institute for Oncology and Radiology of Serbia; Medical Oncology
  • Oncology Institute of Vojvodina
  • Institute of Oncology Ljubljana
  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Hospital Universitario Son Espases; Servicio de Oncologia
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Clinica Universitaria de Navarra; Servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital Clinic i Provincial; Servicio de Farmacia
  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Institut Catala d Oncologia Hospital Duran i Reynals
  • Hospital San Pedro De Alcantara; Servicio de Oncologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Hospital de Navarra; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Hospital General Universitario de Valencia; Servicio de oncologia
  • Hospital Clínico Universitario de Valencia; Servicio de Oncología
  • Sahlgrenska Universitetssjukhuset; Jubileumskliniken
  • Karolinska Hospital; Oncology - Radiumhemmet
  • Norrlands Uni Hospital; Onkologi Avd.
  • Inselspital Bern; Universitätsklinik für medizinische Onkologie
  • Kantonsspital Graubünden;Onkologie und Hämatologie
  • HUG; Oncologie
  • Kantonsspital St. Gallen; Onkologie/Hämatologie
  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • China Medical University Hospital; Urology
  • Taichung Veterans General Hospital; Division of Urology
  • National Taiwan Uni Hospital; Dept of Oncology
  • TAIPEI VETERANS GENERAL HOSPITAL, Urology
  • Uludag Uni Hospital; Oncology
  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
  • Bezmialem Vakif Univ Medical
  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
  • Istanbul VKV American Hospital; Medical Oncology
  • Ege Uni Medical Faculty Hospital; Oncology Dept
  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
  • Bristol Haematology and Oncology Centre
  • Addenbrooke's Hospital
  • Cheltenham General Hospital
  • University Hospital coventry; Oncology Department
  • Royal Devon & Exeter Hospital; Oncology Centre
  • Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
  • St James Institute of Oncology
  • Leicester Royal Infirmary; Dept. of Medical Oncology
  • Barts and The London
  • Royal Free Hospital; Dept of Oncology
  • Northern Centre for Cancer Care; Northern Centre for Cancer Care
  • Nottingham City Hospital
  • Churchill Hospital
  • Scunthorpe General Hospital; Dept of Oncology
  • Southampton General Hospital; Medical Oncology
  • Royal Marsden Hospital; Dept of Medical Oncology
  • Royal Cornwall Hospital
  • The Clatterbridge Cancer Centre NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Atezolizumab

Arm B: Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS was defined as time from randomization to death from any cause.

Secondary Outcome Measures

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).
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.
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.
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.
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Cmin was measured for all participants that received at least one dose of Atezolizumab.
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
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Cmax was measured for all participants that received at least one dose of Atezolizumab.
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.
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.
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.

Full Information

First Posted
November 25, 2014
Last Updated
July 5, 2019
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02302807
Brief Title
A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]
Official Title
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 13, 2015 (Actual)
Primary Completion Date
March 13, 2017 (Actual)
Study Completion Date
November 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
931 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Atezolizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B: Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 175 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Vinflunine
Intervention Description
Vinflunine 320 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as time from randomization to death from any cause.
Time Frame
Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1
Description
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).
Time Frame
Up to approximately 25 months after first participant enrolled
Title
Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1
Description
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.
Time Frame
Up to approximately 25 months after first participant enrolled
Title
Percentage of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 46 months after first participant enrolled
Title
Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab
Description
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.
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)
Title
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Description
Cmin was measured for all participants that received at least one dose of 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)
Title
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)
Description
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
Time Frame
Up to approximately 25 months after first participant enrolled
Title
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Description
Cmax was measured for all participants that received at least one dose of Atezolizumab.
Time Frame
30 minutes post dose on Day 1 of Cycles 1
Title
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
Description
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.
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)
Title
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
Description
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.
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)
Title
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
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra). Representative tumor specimens as specified by the protocol Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy greater than or equal to (>/=) 12 weeks Measurable disease, as defined by RECIST v1.1 Adequate hematologic and end organ function For women of childbearing potential, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel. For men, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel, and agreement to refrain from donating sperm Exclusion Criteria: Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments Leptomeningeal disease Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer Pregnant and lactating women Significant cardiovascular disease Severe infections within 4 weeks prior to randomization Major surgical procedure other than for diagnosis within 4 weeks prior to randomization History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation History of autoimmune disease Prior allogeneic stem cell or solid organ transplant History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis Administration of a live, attenuated vaccine within 4 weeks prior to randomization Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Georgetown University Medical Center Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Emory University; Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Bon Secours - St. Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Royal Brisbane and Women's Hospital; Medical Oncology
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Adelaide Hospital; Oncology
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Medical Centre; Oncology
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Austin and Repatriation Medical Centre; Cancer Services
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Kaiser-Franz-Josef-Spital; Zent.Onkologie und Hamatologie
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Tom Baker Cancer Centre-Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Bcca - Cancer Center Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
BCCA-Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Bcca - Vancouver Island Cancer Centre; Oncology
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
Royal Victoria Hospital
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Lakeridge Health Oshawa; Oncology
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre; Oncology
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sault Area Hospitals
City
Sault Ste Marie
State/Province
Ontario
ZIP/Postal Code
P6A 2C4
Country
Canada
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
MULTISCAN, s.r.o., Radiologicke centrum Pardubice
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Herlev Hospital; Onkologisk afdeling
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Rigshospitalet; Onkologisk Klinik
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Docrates Cance Center
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
Turku University Central Hospital; Urology clinic
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Ico - Paul Papin
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Institut Sainte Catherine;Recherche Clinique
City
Avignon
ZIP/Postal Code
84918
Country
France
Facility Name
Chr De Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Institut Bergonie; Oncologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Francois Baclesse; Recherche Clinique
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
CHU Henri Mondor; Service d'Oncologie Medicale
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Clinique Chenieux; Oncology
City
Limoges
ZIP/Postal Code
87039
Country
France
Facility Name
Centre Leon Berard; Departement Oncologie Medicale
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut J Paolii Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Institut régional du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre D'Oncologie de Gentilly; Oncology
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hopital Cochin; Unite Fonctionnelle D Oncologie
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Institut Curie; Recherche Clinique
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Hopital Saint Louis; Oncologie Medicale
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU de Rouen - Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
ICO - Site René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Hopital Hautepierre; Hematologie Oncologie
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hopital Foch; Oncologie
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Institut Claudius Regaud; Departement Oncologie Medicale
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave Roussy; Departement Oncologie Medicale
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Uniklinik RWTH Aachen; Klinik für Urologie
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf; Urologische Klinik
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie
City
Homburg/Saar
ZIP/Postal Code
66424
Country
Germany
Facility Name
Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Tübingen; Klinik für Urologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm; Klinik für Urologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Alexandras General Hospital of Athens; Oncology Department
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Univ General Hosp Heraklion; Medical Oncology
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
University Hospital of Patras Medical Oncology
City
Patras
ZIP/Postal Code
265 04
Country
Greece
Facility Name
Euromedical General Clinic of Thessaloniki; Oncology Department
City
Thessaloniki
ZIP/Postal Code
546 45
Country
Greece
Facility Name
Semmelwies University of Medicine; Urology Dept.
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Kecskemeti Onkoradilogai Centrum
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Hetenyi Geza County Hospital; Onkologiai Kozpont
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
A.O. Universitaria Policlinico Di Modena; Oncologia
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Asst Papa Giovanni XXIII; Oncologia Medica
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
City
Candiolo
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90146
Country
Italy
Facility Name
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
City
Arezzo
State/Province
Toscana
ZIP/Postal Code
52100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Facility Name
Nagoya University Hospital; Urology
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Hirosaki University School of Medicine & Hospital; Urology
City
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
Chiba Cancer Center; Urology
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Cancer Center Hospital East; Breast and Medical Oncology
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center; Urology
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Harasanshin Hospital; Urology
City
Fukuoka
ZIP/Postal Code
812-0033
Country
Japan
Facility Name
Kyushu University Hospital; Urology
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Gunma University Hospital; Urology
City
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital; Urology
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Sapporo Medical University Hospital; Urology
City
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Hokkaido University Hospital; Urology
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
University of Tsukuba Hospital; Urology
City
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Iwate Medical University Hospital; Urology
City
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Yokohama City University Hospital; Urology
City
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Kumamoto University Hospital; Urology
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Niigata Cancer Center Hospital;Urology
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka International Cancer Institute; Urology
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Osaka University Hospital; Urology
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Kindai University Hospital; Urology
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Shizuoka Cancer Center; Urology
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tokushima University Hospital; Urology
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
National Cancer Center Hospital; Urology
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Toranomon Hospital; Medical Oncology
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Nippon Medical School Hospital; Urology
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
The Cancer Institute Hospital, JFCR; Urology
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center - Oncology
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Spaarne Ziekenhuis; Inwendige Geneeskunde
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Maastricht University Medical Centre; Medical Oncology
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3430 EM
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
Facility Name
Sørlandet Sykehus Kristiansand
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
Facility Name
Uni Hospital of Tromso; Dept. of Oncology
City
Tromsø
ZIP/Postal Code
9019
Country
Norway
Facility Name
St. Olavs Hospital; Kreftavdelingen
City
Trondheim
ZIP/Postal Code
7000
Country
Norway
Facility Name
Medical University of Bialystok; Oncology clinic
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Centrum onkologii Instytutu im. Marii Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Hospital de Santa Maria; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital Beatriz Angelo; Departamento de Oncologia
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Spitalul Judetean de Urgenta Dr Constantin Opris
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
Institute Of Oncology Bucharest; Medical Oncology
City
Bucharest
ZIP/Postal Code
022338
Country
Romania
Facility Name
Institut Oncologic Ion Chiricuta; Departament Radioterapie
City
Cluj-napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Oncology Center Sf. Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Euroclinic Center of Oncology SRL
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Spital Clinic Judetean Mures; Oncologie
City
Targu Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
ONCOMED - Medical Centre
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
City
Nizhni Novgorod
State/Province
Niznij Novgorod
ZIP/Postal Code
603001
Country
Russian Federation
Facility Name
Altai Regional Oncological Center
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
St. Petersburg Oncology Hospital
City
St Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
City
Stavropol
ZIP/Postal Code
355045
Country
Russian Federation
Facility Name
Clinical Center of Serbia; Clinic of Urology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Oncology and Radiology of Serbia; Medical Oncology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Oncology Institute of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Oncologia
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Son Espases; Servicio de Oncologia
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial; Servicio de Farmacia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Institut Catala d Oncologia Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital San Pedro De Alcantara; Servicio de Oncologia
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital de Navarra; Servicio de Oncologia
City
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital General Universitario de Valencia; Servicio de oncologia
City
Valencia
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia; Servicio de Oncología
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset; Jubileumskliniken
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Karolinska Hospital; Oncology - Radiumhemmet
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Norrlands Uni Hospital; Onkologi Avd.
City
Umea
ZIP/Postal Code
090185
Country
Sweden
Facility Name
Inselspital Bern; Universitätsklinik für medizinische Onkologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kantonsspital Graubünden;Onkologie und Hämatologie
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
HUG; Oncologie
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Kantonsspital St. Gallen; Onkologie/Hämatologie
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
China Medical University Hospital; Urology
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital; Division of Urology
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; Dept of Oncology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
TAIPEI VETERANS GENERAL HOSPITAL, Urology
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Uludag Uni Hospital; Oncology
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
City
Edirne
ZIP/Postal Code
22770
Country
Turkey
Facility Name
Bezmialem Vakif Univ Medical
City
Istanbul
ZIP/Postal Code
34286
Country
Turkey
Facility Name
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
City
Istanbul
ZIP/Postal Code
34300
Country
Turkey
Facility Name
Istanbul VKV American Hospital; Medical Oncology
City
Istanbul
ZIP/Postal Code
34365
Country
Turkey
Facility Name
Ege Uni Medical Faculty Hospital; Oncology Dept
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Sıhhiye, Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Cheltenham General Hospital
City
Cheltenham
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
University Hospital coventry; Oncology Department
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Royal Devon & Exeter Hospital; Oncology Centre
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
St James Institute of Oncology
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary; Dept. of Medical Oncology
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Barts and The London
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Royal Free Hospital; Dept of Oncology
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Northern Centre for Cancer Care; Northern Centre for Cancer Care
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Scunthorpe General Hospital; Dept of Oncology
City
Scunthorpe
ZIP/Postal Code
DN16 7BH
Country
United Kingdom
Facility Name
Southampton General Hospital; Medical Oncology
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden Hospital; Dept of Medical Oncology
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33902955
Citation
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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.
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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.
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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. Erratum In: Lancet. 2017 Aug 26;390(10097):848.
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Learn more about this trial

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

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