Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
NCT ID: NCT02807636
Last Updated: 2025-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1213 participants
INTERVENTIONAL
2016-06-30
2024-02-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
Participants will receive blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
Atezolizumab
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
Carboplatin
Carboplatin will be administered at doses to achieve area under the concentration-time curve (AUC) of 4.5 milligram per milliliter into minute (mg/mL\*min) by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Gemcitabine
Gemcitabine will be administered at a dose of 1000 milligrams per square meter (mg/m\^2) by IV infusion on Day 1 and Day 8 of each 21-day cycle, until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Cisplatin
Cisplatin will be administered at a dose of 70 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Placebo+Gemcitabine+Carboplatin/Cisplatin
Participants will receive blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
Carboplatin
Carboplatin will be administered at doses to achieve area under the concentration-time curve (AUC) of 4.5 milligram per milliliter into minute (mg/mL\*min) by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Gemcitabine
Gemcitabine will be administered at a dose of 1000 milligrams per square meter (mg/m\^2) by IV infusion on Day 1 and Day 8 of each 21-day cycle, until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Placebo
Placebo matched to atezolizumab will be administered by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
Cisplatin
Cisplatin will be administered at a dose of 70 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Atezolizumab Monotherapy
Eligible participants will receive open-label atezolizumab as monotherapy.
Atezolizumab
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
Interventions
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Atezolizumab
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
Carboplatin
Carboplatin will be administered at doses to achieve area under the concentration-time curve (AUC) of 4.5 milligram per milliliter into minute (mg/mL\*min) by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Gemcitabine
Gemcitabine will be administered at a dose of 1000 milligrams per square meter (mg/m\^2) by IV infusion on Day 1 and Day 8 of each 21-day cycle, until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Placebo
Placebo matched to atezolizumab will be administered by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
Cisplatin
Cisplatin will be administered at a dose of 70 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (\</=) 2
* Histologically documented, locally advanced (T4b, any N; or any T, N2-3) or metastatic urothelial carcinoma (mUC) (M1, Stage IV) (also termed transitional cell carcinoma \[TCC\] or urothelial cell carcinoma \[UCC\] of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)
* Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment; participants who have fewer than 15 unstained slides available at baseline (but no less than \[\<\] 10) may be eligible following discussion with the Medical Monitor
* No prior chemotherapy for inoperable locally advanced or mUC
* For participants who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval more than (\>) 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment naive in the metastatic setting
* Prior local intravesical chemotherapy or immunotherapy is allowed if completed at least 4 weeks prior to the initiation of study treatment
* Measurable disease, as defined by RECIST v1.1
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent (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 6 months after the last dose of carboplatin, cisplatin, or gemcitabine or for 5 months after the last dose of atezolizumab
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm
Exclusion Criteria
* Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrolment
* Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic assessments
* Participants with treated asymptomatic central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: \* Evaluable or measurable disease outside the CNS \* No metastases to midbrain, pons, medulla, or within 10 mm of the optic apparatus (optic nerves and chiasm) \* No history of intracranial or spinal cord hemorrhage \* No ongoing requirement for corticosteroid as therapy for CNS disease; anti-convulsants at a stable dose are allowed \* No evidence of significant vasogenic edema \* No stereotactic radiation, whole-brain radiation or neurosurgical resection within 4 weeks prior to Cycle 1, Day 1 \* Radiographic demonstration of interim stability (i.e., no progression) between the completion of CNS-directed therapy and the screening radiographic study \* Screening CNS radiographic study \>/=4 weeks since completion of radiotherapy or surgical resection and \>/=2 weeks since discontinuation of corticosteroids
* Prior treatment with CD137 agonists, anti-CTLA-4, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
* Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[TNF\] agents) within 2 weeks prior to Cycle 1, Day 1 or anticipated requirement for systemic immunosuppressive medications during the study
* Leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
* Uncontrolled tumour-related pain or hypercalcemia
* Significant cardiovascular disease including known left ventricular ejection fraction (LVEF) \<40%
* Severe infections within 4 weeks before randomization or therapeutic oral or IV antibiotics within 2 weeks before randomization
* Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
* Malignancies other than urothelial carcinoma within 5 years prior to Cycle 1, Day 1
* Life expectancy of \<12 weeks
* Pregnant or lactating, or intending to become pregnant during the study
* Serum albumin \<25 gram per liter (g/L)
* 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
* Participants with prior allogeneic stem cell or solid organ transplantation
* History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
* Positive test for human immunodeficiency virus (HIV)
* Active hepatitis B or hepatitis C
* Active tuberculosis
* Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Highlands Oncology Group
Rogers, Arkansas, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Christina Care Institutional Review Board
Newark, Delaware, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States
Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
St. Petersburg, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
East Jefferson Hematology Oncology
Metairie, Louisiana, United States
Park Nicollet Clin-Cancer Ctr
Saint Louis Park, Minnesota, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Mount Sinai School of Medicine - Tisch Cancer Institute
New York, New York, United States
University of North Carolina, Lineberger Cancer Ctr
Chapel Hill, North Carolina, United States
Bon Secours - St. Francis Hospital
Greenville, South Carolina, United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, United States
Macquarie University Hospital
Macquarie University, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Lyell McEwin Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Cabrini Medical Centre
Malvern, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
GHdC Site Notre Dame
Charleroi, , Belgium
AZ Sint Lucas (Sint Lucas)
Ghent, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
CHC MontLégia
Liège, , Belgium
Clinical center University of Sarajevo
Sarajevo, , Bosnia and Herzegovina
CETUS Hospital Dia Oncologia
Belo Horizonte, Minas Gerais, Brazil
Hospital Luxemburgo
Belo Horizonte, Minas Gerais, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Clinica Viver
Santa Maria, Rio Grande do Sul, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Beneficencia Portuguesa de Sao Paulo
São Paulo, São Paulo, Brazil
Clinicas Oncologicas Integradas - COI
Rio de Janeiro, , Brazil
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer Agency, CSI
Kelowna, British Columbia, Canada
Dr. Georges L. Dumont University Hospital Centre
Moncton, New Brunswick, Canada
Juravinski Cancer Clinic
Hamilton, Ontario, Canada
Lakeridge Health Center
Oshawa, Ontario, Canada
North York General Hospital
Toronto, Ontario, Canada
Bradford Hill Centro de Investigaciones Clinicas
Recoleta, , Chile
OrlandiOncología
Santiago, , Chile
Fundacion Arturo Lopez Perez
Santiago, , Chile
Clinica Alemana
Vitacura, , Chile
Beijing Friendship Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Chongqing Cancer Hospital
Chongqing, , China
Sun Yat-sen Memorial Hospital
Guangzhou, , China
Jiangsu Cancer Hospital
Nanjing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Huadong Hospital Affiliated to Fudan University
Shanghai, , China
The 2nd Hospital of Tianjin Medical University
Tianjin, , China
Masarykuv onkologicky ustav
Brno, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
University Hospital Motol
Prague, , Czechia
East Tallinn Central Hospital
Tallinn, , Estonia
North Estonia Medical Centre Foundation
Tallinn, , Estonia
Oulu University Hospital
Oulu, , Finland
Turku Uni Central Hospital
Turku, , Finland
Research institute for Clinical Medicine
Tbilisi, , Georgia
National Center of Urology
Tbilisi, , Georgia
Alexandras General Hospital of Athens
Athens, , Greece
University Hospital of Patras Medical Oncology
Pátrai, , Greece
Princess Margaret Hospital
Hong Kong, , Hong Kong
Queen Elizabeth Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Rambam Health Care Campus
Haifa, , Israel
IRCCS Ospedale Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Apulia, Italy
Azienda Ospedaliera A. Cardarelli
Napoli, Campania, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna, Italy
Policlinico Umberto i di Roma
Rome, Lazio, Italy
Az. Osp. Uni Ria San Martino
Genoa, Liguria, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro
Turin, Piedmont, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato
Arezzo, Tuscany, Italy
Azienda Ospedaliera S. Maria - Terni
Terni, Umbria, Italy
IRCCS Istituto Oncologico Veneto (IOV)
Padua, Veneto, Italy
Nagoya University Hospital
Aichi, , Japan
Hirosaki University Hospital
Aomori, , Japan
National Hospital Organization Shikoku Cancer Center
Ehime, , Japan
Gunma University Hospital
Gunma, , Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido, , Japan
University of Tsukuba Hospital
Ibaraki, , Japan
Kanazawa University Hospital
Ishikawa, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Kindai University Hospital
Osaka, , Japan
Toranomon Hospital
Tokyo, , Japan
The Cancer Institute Hospital, JFCR
Tokyo, , Japan
Keio University Hospital
Tokyo, , Japan
Hospital Kuala Lumpur
Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia
Consultorio Médico
Zapopan, Jalisco, Mexico
Health Pharma Professional Research
CD Mexico, Mexico CITY (federal District), Mexico
IMSS Hospital General de Zona No. 48 S. Pedro Xalpa
Mexico CITY (federal District), Mexico CITY (federal District), Mexico
Cancerología
Querétaro, , Mexico
Martini Ziekenhuis
Groningen, , Netherlands
Hagaziekenhuis, locatie Leyweg
NL -DEN HAAG, , Netherlands
Zuyderland Medisch Centrum
Sittard-Geleen, , Netherlands
Isala Klinieken, Sophia
Zwolle, , Netherlands
Bialostockie Centrum Onkologii
Bialystok, , Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii
Lodz, , Poland
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
Poznan, , Poland
NU-MED Centrum Diagnostyki i Terapii Onkologicznej
Tomaszów Mazowiecki, , Poland
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
Warsaw, , Poland
Hospital de Santa Maria
Lisbon, , Portugal
IPO do Porto
Porto, , Portugal
Spitalul Judetean de Urgenta Dr Constantin Opris
Baia Mare, , Romania
Institute Of Oncology Bucharest
Bucharest, , Romania
Oncology Center Sf. Nectarie
Craiova, , Romania
SBEI of HPE ?Bashkir State Medical University? of MoH RF
Ufa, Bashkortostan Republic, Russia
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky
Krasnoyarsk, Krasnodarskiy Kray, Russia
Blokhin Cancer Research Center
Moscow, Moscow Oblast, Russia
Russian Scientific Center of Roentgenoradiology
Moscow, Moscow Oblast, Russia
P.A. Herzen Oncological Inst.
Moscow, Moscow Oblast, Russia
Privolzhsk Regional Medical Center
Nizhny Novgorod, Niznij Novgorod, Russia
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Saint Petersburg, Sankt-Peterburg, Russia
Sverdlovsk Regional Clinical Hospital 1
Yekaterinburg, Sverdlovsk Oblast, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, , Russia
Clinical Center of Serbia
Belgrade, , Serbia
Oncology Institute of Vojvodina
Kamenitz, , Serbia
Clinical Centre Nis, Clinic for Oncology
Niš, , Serbia
National University Hospital
Singapore, , Singapore
National Cancer Centre
Singapore, , Singapore
Oncocare Cancer Centre
Singapore, , Singapore
Institute of Oncology Ljubljana
Ljubljana, , Slovenia
Cancercare
Port Elizabeth, , South Africa
Wilgers Oncology Centre
Pretoria, , South Africa
Sandton Oncology Medical Group
Sandton, , South Africa
Kyungpook National University Medical Center
Daegu, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Complejo Hospitalario de Althaia
Manresa, Barcelona, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Provincial de Castellon
Castellon, Castellon, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, , Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, , Spain
Hospital Clinic de Barcelona. Unidad de Nuevas Terapias
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Institutio Catalan De Oncologia
Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, , Spain
Complejo Asistencial Universitario De Burgos
Burgos, , Spain
Hospital San Pedro De Alcantara
Cáceres, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
Jaén, , Spain
Complejo Asistencial Universitario de Leon
León, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario de Toledo
Toledo, , Spain
Hospital Universitario la Fe
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Chang Gung Medical Foundation - Kaohsiung
Kaohisung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung Uni Hospital
Tainan City, , Taiwan
National Taiwan Uni Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou, Urinary Oncology
Taoyuan District, , Taiwan
Vajira Hospital
Bangkok, , Thailand
Chulalongkorn Hospital
Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
Adana, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, , Turkey (Türkiye)
Bezmi Alem Vakif University Medical School
Istanbul, , Turkey (Türkiye)
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty
Istanbul, , Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital
S?hhiye, Ankara, , Turkey (Türkiye)
19 Mayis University Medical Faculty
Samsun, , Turkey (Türkiye)
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
Kharkiv, Kharkiv Governorate, Ukraine
CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
Dnipropetrovsk, , Ukraine
Zaporizhzhia Regional Clinic
Zaporizhzhia, , Ukraine
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
The York Hospital
York, , United Kingdom
Countries
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References
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Galsky MD, Guan X, Rishipathak D, Rapaport AS, Shehata HM, Banchereau R, Yuen K, Varfolomeev E, Hu R, Han CJ, Li H, Liang Y, Vucic D, Wang L, Zhu J, Yu H, Herbst RH, Hajaj E, Kiner E, Bamias A, De Santis M, Davis ID, Arranz JA, Kikuchi E, Bernhard S, Williams P, Lee C, Mellman I, Sanjabi S, Johnston R, Black PC, Grande E, Mariathasan S. Immunomodulatory effects and improved outcomes with cisplatin- versus carboplatin-based chemotherapy plus atezolizumab in urothelial cancer. Cell Rep Med. 2024 Feb 20;5(2):101393. doi: 10.1016/j.xcrm.2024.101393. Epub 2024 Jan 26.
Grande E, Arranz JA, De Santis M, Bamias A, Kikuchi E, Del Muro XG, Park SH, De Giorgi U, Alekseev B, Mencinger M, Izumi K, Schutz FA, Puente J, Li JR, O'Donnell PH, Kalebasty AR, Ye D, Mariathasan S, Bene-Tchaleu F, Bernhard S, Lee C, Davis ID, Galsky MD. Atezolizumab plus chemotherapy versus placebo plus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis results from a randomised, controlled, phase 3 study. Lancet Oncol. 2024 Jan;25(1):29-45. doi: 10.1016/S1470-2045(23)00540-5. Epub 2023 Dec 12.
Bamias A, Davis ID, Galsky MD, Arranz JA, Kikuchi E, Grande E, Del Muro XG, Park SH, De Giorgi U, Alekseev B, Mencinger M, Izumi K, Schutz FA, Puente J, Li JR, Panni S, Gumus M, Ozguroglu M, Mariathasan S, Poloz Y, Bene-Tchaleu F, Lee C, Bernhard S, De Santis M. Atezolizumab monotherapy versus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis from a randomised, controlled, phase 3 study. Lancet Oncol. 2024 Jan;25(1):46-61. doi: 10.1016/S1470-2045(23)00539-9. Epub 2023 Dec 12.
Grande E, Bamias A, Galsky MD, Kikuchi E, Davis ID, Arranz JA, Rezazadeh Kalebasty A, Garcia Del Muro X, Park SH, De Giorgi U, Alekseev B, Mencinger M, Izumi K, Puente J, Li JR, Bernhard S, Nicholas A, Telliez J, De Santis M. Overall Survival by Response to First-line Induction Treatment with Atezolizumab plus Platinum-based Chemotherapy or Placebo plus Platinum-based Chemotherapy for Metastatic Urothelial Carcinoma. Eur Urol Open Sci. 2023 Nov 4;58:28-36. doi: 10.1016/j.euros.2023.10.002. eCollection 2023 Dec.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000250-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WO30070
Identifier Type: -
Identifier Source: org_study_id
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