A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]
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
2 other identifiers
interventional
931
27 countries
212
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2015
Typical duration for phase_3
212 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2014
CompletedFirst Posted
Study publicly available on registry
November 27, 2014
CompletedStudy Start
First participant enrolled
January 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2017
CompletedResults Posted
Study results publicly available
April 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2018
CompletedAugust 1, 2019
July 1, 2019
2.2 years
November 25, 2014
March 13, 2018
July 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS was defined as time from randomization to death from any cause.
Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled
Secondary Outcomes (10)
Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1
Up to approximately 25 months after first participant enrolled
Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1
Up to approximately 25 months after first participant enrolled
Percentage of Participants With Adverse Events (AEs)
Up to approximately 46 months after first participant enrolled
Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab
Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)
- +5 more secondary outcomes
Study Arms (2)
Arm A: Atezolizumab
EXPERIMENTALAtezolizumab 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 B: Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
ACTIVE COMPARATORParticipants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Interventions
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
Docetaxel 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.
Paclitaxel 175 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.
Vinflunine 320 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (217)
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Emory University; Winship Cancer Institute
Atlanta, Georgia, 30308, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Bon Secours - St. Francis Hospital
Greenville, South Carolina, 29607, United States
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, 37232, United States
Royal Brisbane and Women's Hospital; Medical Oncology
Herston, Queensland, 4029, Australia
Royal Adelaide Hospital; Oncology
Adelaide, South Australia, 5000, Australia
Monash Medical Centre; Oncology
Clayton, Victoria, 3168, Australia
Austin and Repatriation Medical Centre; Cancer Services
Melbourne, Victoria, 3084, Australia
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Vienna, 1090, Austria
Kaiser-Franz-Josef-Spital; Zent.Onkologie und Hamatologie
Vienna, 1100, Austria
ZNA Middelheim
Antwerp, 2020, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, T2N 4N2, Canada
Bcca - Cancer Center Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Bcca - Vancouver Island Cancer Centre; Oncology
Victoria, British Columbia, V8R 6V5, Canada
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, L1G 2B9, Canada
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, K1H 8L6, Canada
Sault Area Hospitals
Sault Ste. Marie, Ontario, P6A 2C4, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, H3T 1E2, Canada
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Fakultni nemocnice Olomouc
Olomouc, 775 20, Czechia
MULTISCAN, s.r.o., Radiologicke centrum Pardubice
Pardubice, 532 03, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Herlev Hospital; Onkologisk afdeling
Herlev, 2730, Denmark
Rigshospitalet; Onkologisk Klinik
København Ø, 2100, Denmark
Docrates Cance Center
Helsinki, 00180, Finland
Turku University Central Hospital; Urology clinic
Turku, 20520, Finland
Ico - Paul Papin
Angers, 49000, France
Institut Sainte Catherine;Recherche Clinique
Avignon, 84918, France
Chr De Besancon - Hopital Jean Minjoz
Besançon, 25030, France
Hopital Saint Andre
Bordeaux, 33075, France
Institut Bergonie; Oncologie
Bordeaux, 33076, France
Centre Francois Baclesse; Recherche Clinique
Caen, 14076, France
CHU Henri Mondor; Service d'Oncologie Medicale
Créteil, 94010, France
Clinique Chenieux; Oncology
Limoges, 87039, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373, France
Institut J Paolii Calmettes
Marseille, 13009, France
Institut régional du Cancer Montpellier
Montpellier, 34298, France
Centre D'Oncologie de Gentilly; Oncology
Nancy, 54100, France
Centre Antoine Lacassagne
Nice, 06189, France
CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
Nîmes, 30029, France
Hopital Cochin; Unite Fonctionnelle D Oncologie
Paris, 75014, France
Institut Curie; Recherche Clinique
Paris, 75231, France
Hopital Saint Louis; Oncologie Medicale
Paris, 75475, France
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
Paris, 75908, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031, France
ICO - Site René Gauducheau
Saint-Herblain, 44805, France
Hopital Hautepierre; Hematologie Oncologie
Strasbourg, 67098, France
Hopital Foch; Oncologie
Suresnes, 92151, France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059, France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, 94805, France
Uniklinik RWTH Aachen; Klinik für Urologie
Aachen, 52074, Germany
Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie
Berlin, 12200, Germany
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
Dresden, 01307, Germany
Universitätsklinikum Düsseldorf; Urologische Klinik
Düsseldorf, 40225, Germany
Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V
Erlangen, 91054, Germany
Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
Freiburg im Breisgau, 79106, Germany
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie
Göttingen, 37075, Germany
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg, 20246, Germany
Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie
Homburg/Saar, 66424, Germany
Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie
Magdeburg, 39120, Germany
Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
Mannheim, 68167, Germany
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
München, 81675, Germany
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen, 72076, Germany
Universitätsklinikum Ulm; Klinik für Urologie
Ulm, 89081, Germany
Alexandras General Hospital of Athens; Oncology Department
Athens, 115 28, Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion, 711 10, Greece
University Hospital of Patras Medical Oncology
Pátrai, 265 04, Greece
Euromedical General Clinic of Thessaloniki; Oncology Department
Thessaloniki, 546 45, Greece
Semmelwies University of Medicine; Urology Dept.
Budapest, 1082, Hungary
Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
Budapest, 1122, Hungary
Uzsoki Utcai Korhaz
Budapest, 1145, Hungary
Kecskemeti Onkoradilogai Centrum
Kecskemét, 6000, Hungary
Hetenyi Geza County Hospital; Onkologiai Kozpont
Szolnok, 5004, Hungary
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
San Giovanni Rotondo, Apulia, 71013, Italy
Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico
Napoli, Campania, 80131, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, 41100, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
Udine, Friuli Venezia Giulia, 33100, Italy
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Rome, Lazio, 00152, Italy
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardy, 24127, Italy
ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
Cremona, Lombardy, 26100, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, 20133, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
Candiolo, Piedmont, 10060, Italy
Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
Palermo, Sicily, 90146, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo, Tuscany, 52100, Italy
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
Florence, Tuscany, 50139, Italy
Nagoya University Hospital; Urology
Aichi, 466-8560, Japan
Hirosaki University School of Medicine & Hospital; Urology
Aomori, 036-8563, Japan
Chiba Cancer Center; Urology
Chiba, 260-8717, Japan
National Cancer Center Hospital East; Breast and Medical Oncology
Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center; Urology
Ehime, 791-0280, Japan
Harasanshin Hospital; Urology
Fukuoka, 812-0033, Japan
Kyushu University Hospital; Urology
Fukuoka, 812-8582, Japan
Gunma University Hospital; Urology
Gunma, 371-8511, Japan
Hiroshima City Hiroshima Citizens Hospital; Urology
Hiroshima, 730-8518, Japan
Sapporo Medical University Hospital; Urology
Hokkaido, 060-8543, Japan
Hokkaido University Hospital; Urology
Hokkaido, 060-8648, Japan
University of Tsukuba Hospital; Urology
Ibaraki, 305-8576, Japan
Yokohama City University Hospital; Urology
Kanagawa, 236-0004, Japan
Kumamoto University Hospital; Urology
Kumamoto, 860-8556, Japan
Niigata Cancer Center Hospital;Urology
Niigata, 951-8566, Japan
Iwate Medical University Hospital; Urology
Numakunai, 020-8505, Japan
Osaka International Cancer Institute; Urology
Osaka, 541-8567, Japan
Osaka University Hospital; Urology
Osaka, 565-0871, Japan
Kindai University Hospital; Urology
Osaka, 589-8511, Japan
Shizuoka Cancer Center; Urology
Shizuoka, 411-8777, Japan
Tokushima University Hospital; Urology
Tokushima, 770-8503, Japan
National Cancer Center Hospital; Urology
Tokyo, 104-0045, Japan
Toranomon Hospital; Medical Oncology
Tokyo, 105-8470, Japan
Nippon Medical School Hospital; Urology
Tokyo, 113-8603, Japan
The Cancer Institute Hospital, JFCR; Urology
Tokyo, 135-8550, Japan
The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis
Amsterdam, 1066 CX, Netherlands
Spaarne Ziekenhuis; Inwendige Geneeskunde
Hoofddorp, 2134 TM, Netherlands
Maastricht University Medical Centre; Medical Oncology
Maastricht, 6229 HX, Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3430 EM, Netherlands
Isala Klinieken
Zwolle, 8011 JW, Netherlands
Sørlandet Sykehus Kristiansand
Kristiansand, 4604, Norway
Uni Hospital of Tromso; Dept. of Oncology
Tromsø, 9019, Norway
St. Olavs Hospital; Kreftavdelingen
Trondheim, 7000, Norway
Medical University of Bialystok; Oncology clinic
Bialystok, 15-027, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, 80-214, Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, 20-090, Poland
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
Poznan, 60-569, Poland
Centrum onkologii Instytutu im. Marii Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego
Warsaw, 02-781, Poland
Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology
Wroclaw, 50-556, Poland
Hospital de Santa Maria; Servico de Oncologia Medica
Lisbon, 1649-035, Portugal
Hospital Beatriz Angelo; Departamento de Oncologia
Loures, 2674-514, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072, Portugal
Spitalul Judetean de Urgenta Dr Constantin Opris
Baia Mare, 430031, Romania
Institute Of Oncology Bucharest; Medical Oncology
Bucharest, 022338, Romania
Institut Oncologic Ion Chiricuta; Departament Radioterapie
Cluj-Napoca, 400015, Romania
Oncology Center Sf. Nectarie
Craiova, 200347, Romania
Euroclinic Center of Oncology SRL
Iași, 700106, Romania
Spital Clinic Judetean Mures; Oncologie
Târgu Mureş, 540142, Romania
ONCOMED - Medical Centre
Timișoara, 300239, Romania
GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
Nizhny Novgorod, Niznij Novgorod, 603001, Russia
Altai Regional Oncological Center
Barnaul, 656049, Russia
Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology
Moscow, 125284, Russia
St. Petersburg Oncology Hospital
Saint Petersburg, 198255, Russia
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
Stavropol, 355045, Russia
Clinical Center of Serbia; Clinic of Urology
Belgrade, 11000, Serbia
Institute for Oncology and Radiology of Serbia; Medical Oncology
Belgrade, 11000, Serbia
Oncology Institute of Vojvodina
Kamenitz, 21204, Serbia
Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center - Oncology
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
Hospital Universitario Son Espases; Servicio de Oncologia
Palma de Mallorca, Balearic Islands, 07014, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, 14004, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, 15706, Spain
Hospital de Navarra; Servicio de Oncologia
Navarra, Navarre, 31008, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarre, 31008, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035, Spain
Hospital Clinic i Provincial; Servicio de Farmacia
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, 08041, Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia
Cáceres, 10003, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, 41013, Spain
Hospital General Universitario de Valencia; Servicio de oncologia
Valencia, 41014, Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología
Valencia, 46010, Spain
Sahlgrenska Universitetssjukhuset; Jubileumskliniken
Gothenburg, 413 45, Sweden
Karolinska Hospital; Oncology - Radiumhemmet
Stockholm, 171 76, Sweden
Norrlands Uni Hospital; Onkologi Avd.
Umeå, 090185, Sweden
Inselspital Bern; Universitätsklinik für medizinische Onkologie
Bern, 3010, Switzerland
Kantonsspital Graubünden;Onkologie und Hämatologie
Chur, 7000, Switzerland
HUG; Oncologie
Geneva, 1211, Switzerland
Kantonsspital St. Gallen; Onkologie/Hämatologie
Sankt Gallen, 9007, Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zurich, 8091, Switzerland
China Medical University Hospital; Urology
Taichung, 40447, Taiwan
Taichung Veterans General Hospital; Division of Urology
Taichung, 407, Taiwan
National Taiwan Uni Hospital; Dept of Oncology
Taipei, 100, Taiwan
TAIPEI VETERANS GENERAL HOSPITAL, Urology
Taipei, 11217, Taiwan
Uludag Uni Hospital; Oncology
Bursa, 16059, Turkey (Türkiye)
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, 22770, Turkey (Türkiye)
Bezmialem Vakif Univ Medical
Istanbul, 34286, Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, 34300, Turkey (Türkiye)
Istanbul VKV American Hospital; Medical Oncology
Istanbul, 34365, Turkey (Türkiye)
Ege Uni Medical Faculty Hospital; Oncology Dept
Izmir, 35100, Turkey (Türkiye)
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, 44280, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, Ankara, 06100, Turkey (Türkiye)
University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Cheltenham General Hospital
Cheltenham, GL53 7AN, United Kingdom
University Hospital coventry; Oncology Department
Coventry, CV2 2DX, United Kingdom
Royal Devon & Exeter Hospital; Oncology Centre
Exeter, EX2 5DW, United Kingdom
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
Lancaster, LA1 4RP, United Kingdom
St James Institute of Oncology
Leeds, LS9 7TF, United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester, LE1 5WW, United Kingdom
Barts and The London
London, EC1M 6BQ, United Kingdom
Royal Free Hospital; Dept of Oncology
London, NW3 2QG, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Northern Centre for Cancer Care; Northern Centre for Cancer Care
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Churchill Hospital
Oxford, OX3 7LJ, United Kingdom
Scunthorpe General Hospital; Dept of Oncology
Scunthorpe, DN16 7BH, United Kingdom
Southampton General Hospital; Medical Oncology
Southampton, SO16 6YD, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, SM2 5PT, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LQ, United Kingdom
Related Publications (7)
van der Heijden MS, Loriot Y, Duran I, Ravaud A, Retz M, Vogelzang NJ, Nelson B, Wang J, Shen X, Powles T. Atezolizumab Versus Chemotherapy in Patients with Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: A Long-term Overall Survival and Safety Update from the Phase 3 IMvigor211 Clinical Trial. Eur Urol. 2021 Jul;80(1):7-11. doi: 10.1016/j.eururo.2021.03.024. Epub 2021 Apr 23.
PMID: 33902955DERIVEDShemesh 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.
PMID: 33241650DERIVEDMorrissey 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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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2014
First Posted
November 27, 2014
Study Start
January 13, 2015
Primary Completion
March 13, 2017
Study Completion
November 8, 2018
Last Updated
August 1, 2019
Results First Posted
April 11, 2018
Record last verified: 2019-07