Clinical trial NCT02807636: Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urothelial Carcinoma
Keywords: Urothelial carcinoma
Bladder cancer
Anti-PD-L1
Transitional carcinoma
Tecentriq
Atezolizumab
IMvigor130
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 1213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.


Eligibility criteria: Inclusion Criteria

* Considered to be eligible to receive platinum-based chemotherapy, in the investigator's judgment
* 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:

* Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
* 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

Primary outcomes:
measure: Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
timeFrame: Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months)
measure: Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
timeFrame: Baseline until death due to any cause (up to approximately 73 months)
measure: Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
timeFrame: Baseline until death due to any cause (up to approximately 73 months)
Secondary outcomes:
measure: Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
timeFrame: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
measure: Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
timeFrame: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
measure: Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
timeFrame: From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
measure: Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
timeFrame: From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
measure: IRF-PFS
timeFrame: Randomization to first documented disease progression or death from any cause (up to 35 months)
measure: OS Event Free Rate Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
timeFrame: Year 1
measure: OS Event Free Rate in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
timeFrame: Year 1
measure: PFS Event Free Rate
timeFrame: Year 1
measure: Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
timeFrame: Up to approximately 73 months
measure: Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
timeFrame: Up to approximately 73 months
measure: Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
timeFrame: Up to approximately 73 months
measure: Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
timeFrame: Up to approximately 73 months
measure: Maximum Atezolizumab Serum Concentration
timeFrame: Cycle 1 Day 1
measure: Minimum Atezolizumab Serum Concentration
timeFrame: Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, Cycle 16 Day 1, Cycle 24 Day 1, Cycle 32 Day 1, Day 120 post dose of last blinded atezolizumab treatment, and study drug early discontinuation
measure: Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs)
timeFrame: Up to approximately 35 months
measure: Investigator-Assessed Progression-Free Survival (INV-PFS) in Participants Treated With Atezolizumab Monotherapy Arm Compared With Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
timeFrame: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 35 months)
measure: Percentage of Participants With Grade 3-4 Adverse Events (AEs)
timeFrame: Baseline up to 93 months
measure: Percentage of Participants With Grade 5 Adverse Events (AEs)
timeFrame: Baseline up to 93 months
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: Baseline up to 93 months
measure: Percentage of Participants With Adverse Events (AEs) Leading to Withdrawal of Any Study Treatment
timeFrame: Baseline up to 93 months
measure: Percentage of Participants With Atezolizumab-Specific Adverse Events of Special Interest (AESIs)
timeFrame: Baseline up to 93 months
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: San Luis Obispo
country: United States
facility: Coastal Integrative Cancer Care
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Newark
country: United States
facility: Christina Care Institutional Review Board
state: Delaware
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orlando
country: United States
facility: UF Health Cancer Center at Orlando Health
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Metairie
country: United States
facility: East Jefferson Hematology Oncology
state: Louisiana
city: Saint Louis Park
country: United States
facility: Park Nicollet Clin-Cancer Ctr
state: Minnesota
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: New York
country: United States
facility: Mount Sinai School of Medicine - Tisch Cancer Institute
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Lineberger Cancer Ctr
state: North Carolina
city: Greenville
country: United States
facility: Bon Secours - St. Francis Hospital
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute / Tennessee Oncology
state: Tennessee
city: Macquarie University
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Medical Centre
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Charleroi
country: Belgium
facility: GHdC Site Notre Dame
city: Gent
country: Belgium
facility: AZ Sint Lucas (Sint Lucas)
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liege
country: Belgium
facility: CHC MontLégia
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical center University of Sarajevo
city: Belo Horizonte
country: Brazil
facility: CETUS Hospital Dia Oncologia
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Hospital Luxemburgo
state: Minas Gerais
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: Rio Grande Do Sul
city: Santa Maria
country: Brazil
facility: Clinica Viver
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Clinica de Neoplasias Litoral
state: Santa Catarina
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Beneficencia Portuguesa de Sao Paulo
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Clinicas Oncologicas Integradas - COI
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Center-Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer Agency, CSI
state: British Columbia
city: Moncton
country: Canada
facility: Dr. Georges L. Dumont University Hospital Centre
state: New Brunswick
city: Hamilton
country: Canada
facility: Juravinski Cancer Clinic
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Center
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Recoleta
country: Chile
facility: Bradford Hill Centro de Investigaciones Clinicas
city: Santiago
country: Chile
facility: OrlandiOncología
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez
city: Vitacura
country: Chile
facility: Clinica Alemana
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
city: Tianjin
country: China
facility: The 2nd Hospital of Tianjin Medical University
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 5
country: Czechia
facility: University Hospital Motol
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Turku
country: Finland
facility: Turku Uni Central Hospital
city: Tbilisi
country: Georgia
facility: Research institute for Clinical Medicine
city: Tbilisi
country: Georgia
facility: National Center of Urology
city: Athens
country: Greece
facility: Alexandras General Hospital of Athens
city: Patras
country: Greece
facility: University Hospital of Patras Medical Oncology
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Napoli
country: Italy
facility: Azienda Ospedaliera A. Cardarelli
state: Campania
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico Umberto i di Roma
state: Lazio
city: Genova
country: Italy
facility: Az. Osp. Uni Ria San Martino
state: Liguria
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int)
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Torino
country: Italy
facility: A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro
state: Piemonte
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo Della Sofferenza
state: Puglia
city: Arezzo
country: Italy
facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato
state: Toscana
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria - Terni
state: Umbria
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto (IOV)
state: Veneto
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Aomori
country: Japan
facility: Hirosaki University Hospital
city: Ehime
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Gunma
country: Japan
facility: Gunma University Hospital
city: Hokkaido
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Ishikawa
country: Japan
facility: Kanazawa University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Osaka
country: Japan
facility: Kindai University Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital, JFCR
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: FED. Territory OF Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: FED. Territory OF Kuala Lumpur
city: Zapopan
country: Mexico
facility: Consultorio Médico
state: Jalisco
city: CD Mexico
country: Mexico
facility: Health Pharma Professional Research
state: Mexico CITY (federal District)
city: Mexico CITY (federal District)
country: Mexico
facility: IMSS Hospital General de Zona No. 48 S. Pedro Xalpa
city: Queretaro
country: Mexico
facility: Cancerología
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Nl -den Haag
country: Netherlands
facility: Hagaziekenhuis, locatie Leyweg
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala Klinieken, Sophia
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED, Roman Karaszewski
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Lodz
country: Poland
facility: Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii
city: Poznan
country: Poland
facility: Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
city: Tomaszów Mazowiecki
country: Poland
facility: NU-MED Centrum Diagnostyki i Terapii Onkologicznej
city: Warszawa
country: Poland
facility: Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: IPO do Porto
city: Baia Mare
country: Romania
facility: Spitalul Judetean de Urgenta Dr Constantin Opris
city: Bucharest
country: Romania
facility: Institute Of Oncology Bucharest
city: Craiova
country: Romania
facility: Oncology Center Sf. Nectarie
city: UFA
country: Russian Federation
facility: SBEI of HPE ?Bashkir State Medical University? of MoH RF
state: Baskortostan
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky
state: Krasnodar
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Roentgenoradiology
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: P.A. Herzen Oncological Inst.
state: Moskovskaja Oblast
city: Nizhny Novgorod
country: Russian Federation
facility: Privolzhsk Regional Medical Center
state: Niznij Novgorod
city: St Petersburg
country: Russian Federation
facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
state: Sankt Petersburg
city: Yekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital 1
state: Sverdlovsk
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: NIs
country: Serbia
facility: Clinical Centre Nis, Clinic for Oncology
city: Sremska Kamenica
country: Serbia
facility: Oncology Institute of Vojvodina
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Singapore
country: Singapore
facility: Oncocare Cancer Centre
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Port Elizabeth
country: South Africa
facility: Cancercare
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Manresa
country: Spain
facility: Complejo Hospitalario de Althaia
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Pontevedra
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Barcelona
country: Spain
facility: Vall d'Hebron Institute of Oncology (VHIO), Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Institutio Catalan De Oncologia
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Burgos
country: Spain
facility: Complejo Asistencial Universitario De Burgos
city: Caceres
country: Spain
facility: Hospital San Pedro De Alcantara
city: Castellon
country: Spain
facility: Hospital Provincial de Castellon
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
city: Valencia
country: Spain
facility: Hospital Universitario la Fe
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Kaohisung
country: Taiwan
facility: Chang Gung Medical Foundation - Kaohsiung
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung Uni Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan Uni Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou, Urinary Oncology
city: Bangkok
country: Thailand
facility: Vajira Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.
city: ChiangMai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Adana
country: Turkey
facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
city: Istanbul
country: Turkey
facility: Bezmi Alem Vakif University Medical School
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty
city: S?hhiye, Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital
city: Samsun
country: Turkey
facility: 19 Mayis University Medical Faculty
city: Kharkiv
country: Ukraine
facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
state: Kharkiv Governorate
city: Dnipropetrovsk
country: Ukraine
facility: CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
city: Zaporizhzhia
country: Ukraine
facility: Zaporizhzhia Regional Clinic
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust - University College Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: York
country: United Kingdom
facility: The York Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Galsky MD, Arija JAA, Bamias A, Davis ID, De Santis M, Kikuchi E, Garcia-Del-Muro X, De Giorgi U, Mencinger M, Izumi K, Panni S, Gumus M, Ozguroglu M, Kalebasty AR, Park SH, Alekseev B, Schutz FA, Li JR, Ye D, Vogelzang NJ, Bernhard S, Tayama D, Mariathasan S, Mecke A, Thastrom A, Grande E; IMvigor130 Study Group. Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2020 May 16;395(10236):1547-1557. doi: 10.1016/S0140-6736(20)30230-0.
citation: 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.