Clinical trial NCT02420821: A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)
Official title: A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Cell Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-04-20
Enrollment: 915
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: This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.


Eligibility criteria: Inclusion Criteria:

* Definitive diagnosis of unresectable locally advanced or metastatic RCC with clear-cell histology and/or a component of sarcomatoid carcinoma, with no prior treatment in the metastatic setting
* Evaluable Memorial Sloan Kettering Cancer Center risk score
* Measurable disease, as defined by RECIST v1.1
* Karnofsky performance status greater than or equal to 70%
* Adequate hematologic and end-organ function prior to randomization

Exclusion Criteria:

Disease-Specific Exclusions:

* Radiotherapy for RCC within 14 days prior to treatment
* Active central nervous system disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites
* Uncontrolled hypercalcemia
* Any other malignancies within 5 years except for low-risk prostate cancer or those with negligible risk of metastasis or death

General Medical Exclusions:

* Life expectancy less than 12 weeks
* Participation in another experimental drug study within 4 weeks prior to treatment
* Pregnant or lactating women
* Known hypersensitivity to any component of atezolizumab or other study medication
* History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes mellitus
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
* Positive human immunodeficiency virus test
* Active or chronic hepatitis B or C
* Severe infections within 4 weeks prior to treatment
* Exposure to oral or IV antibiotics within 2 weeks prior to treatment
* Live attenuated vaccines within 4 weeks prior to treatment (for influenza vaccination participants must agree not to receive live, attenuated influenza vaccine within 4 weeks prior to treatment, during treatment or within 5 months following the last dose)
* Significant cardiovascular disease
* Prior allogeneic stem cell or solid organ transplantation

Exclusion Criteria Related to Medications:

* Prior treatment with cluster of differentiation 137 agonists, anti-cytotoxic T-lymphocyte associated protein-4, anti-programmed death (PD)-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
* Treatment with immunostimulatory agents for non-malignant conditions within 6 weeks or immunosuppressive agents within 2 weeks prior to treatment

Bevacizumab- and Sunitinib-Specific Exclusions:

* History of hypertensive crisis or hypertensive encephalopathy
* Baseline electrocardiogram showing corrected QT interval greater than 460 milliseconds

Primary outcomes:
measure: Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population
timeFrame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population
timeFrame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: Percentage of Participants Who Died of Any Cause in ITT Population
timeFrame: Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)
measure: Overall Survival (OS) in ITT Population
timeFrame: Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)
Secondary outcomes:
measure: Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population
timeFrame: Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)
measure: OS in PD-L1-Selected Population
timeFrame: Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)
measure: Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population
timeFrame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: PFS as Determined by an IRC According to RECIST v1.1 in ITT Population
timeFrame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population
timeFrame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population
timeFrame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1 in Objective Response Rate (ORR)-Evaluable Population
timeFrame: Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 in DOR-Evaluable Population
timeFrame: Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1 in ORR-Evaluable Population
timeFrame: Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: DOR as Determined by an IRC According to RECIST v1.1 in DOR-Evaluable Population
timeFrame: Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: Percentage of Participants With PD as Determined by the Investigator According to Immune-Modified RECIST or Death From Any Cause in ITT Population
timeFrame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: PFS as Determined by the Investigator According to Immune-Modified RECIST in ITT Population
timeFrame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Immune-Modified RECIST in ORR-Evaluable Population
timeFrame: Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: DOR as Determined by the Investigator According to Immune-Modified RECIST in DOR-Evaluable Population
timeFrame: Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in ITT Population
timeFrame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: PFS as Determined by the Investigator According to RECIST v1.1 in ITT Population
timeFrame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in Participants With Sarcomatoid Histology
timeFrame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: PFS as Determined by the Investigator According to RECIST v1.1 in Participants With Sarcomatoid Histology
timeFrame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)
measure: Percentage of Participants Who Died of Any Cause in Participants With Sarcomatoid Histology
timeFrame: Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)
measure: OS in Participants With Sarcomatoid Histology
timeFrame: Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)
measure: Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score
timeFrame: Baseline (Day 1 Cycle 1); Day 22 Cycle 1; Day 1 and 22 of every cycle from Cycle 2 up to Cycle 19; Cycle length = 42 days
measure: Change From Baseline in Symptom Severity as Determined by MDASI Part I Score
timeFrame: Baseline; End of Treatment (EoT) visit (up to approximately 27 months)
measure: Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score
timeFrame: Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days
measure: Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item
timeFrame: Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days
measure: Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score
timeFrame: Day 1 and 22 of every cycle (Baseline = Day 1 Cycle 1) up to Cycle 19; Cycle length = 42 days
measure: Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
timeFrame: Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycles 2, 4, and 8, and every eight cycles thereafter up to EoT [up to approximately 27 months] and 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days)
measure: Number of Participants With ATAs Against Bevacizumab
timeFrame: Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycle 3, at EoT [up to approximately 27 months] and at 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days)
measure: Maximum Observed Serum Concentration (Cmax) for Atezolizumab
timeFrame: 30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days)
measure: Minimum Observed Serum Concentration (Cmin) for Atezolizumab
timeFrame: Predose (Hour 0) on Day 22 of Cycle 1; predose (Hour 0) on Day 1 of Cycles 2; Cycle length = 42 days
measure: Cmax for Bevacizumab
timeFrame: 30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days)
measure: Cmin for Bevacizumab
timeFrame: Pre-dose (Hour 0) on Day 1 of Cycle 3 (Cycle length = 42 days)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Orange
country: United States
facility: University of California at Irvine Medical Center; Department of Oncology
state: California
city: San Francisco
country: United States
facility: University of California
state: California
city: Aurora
country: United States
facility: University of Colorado; Anschutz Cancer Pavilion
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Center; Medical Oncology
state: Colorado
city: Washington
country: United States
facility: Georgetown U; Lombardi Comp Can
state: District of Columbia
city: Boca Raton
country: United States
facility: Lynn Cancer Institute/Boca Raton Regional Hospital
state: Florida
city: Port Charlotte
country: United States
facility: Florida Cancer Specialists - Port Charlotte
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialist, North Region
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Institute, PC
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Inst.
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology,P.C.-Albany
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation; Taussig Cancer Center
state: Ohio
city: Tigard
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Chattanooga
country: United States
facility: SCRI Tennessee Oncology Chattanooga
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center and Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Univ Medical Ctr
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology-Baylor Sammons Cancer Center
state: Texas
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of SW Virginia-Raonoke
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Camperdown
country: Australia
facility: Lifehouse
state: New South Wales
city: Macquarie Park
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle; Medical Oncology
state: New South Wales
city: South Brisbane
country: Australia
facility: Icon Cancer Foundation
state: Queensland
city: Kurralta Park
country: Australia
facility: Ashford Cancer Center Research
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Hospital; Medical Oncology
state: Victoria
city: Murdoch
country: Australia
facility: St John of God Hospital
state: Western Australia
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui; Oncologia
state: RS
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: SP
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre; Oncology
state: Nova Scotia
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa; Oncology
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre; Oncology
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Quebec Hotel-Dieu de Quebec
state: Quebec
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Praha 2
country: Czechia
facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
city: Praha 4 - Krc
country: Czechia
facility: Thomayerova nemocnice
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital; Kræftafdelingen
city: Herlev
country: Denmark
facility: Herlev Hospital; Afdeling for Kræftbehandling
city: Odense C
country: Denmark
facility: Odense Universitetshospital, Onkologisk Afdeling R
city: Angers
country: France
facility: ICO Paul Papin; Oncologie Medicale.
city: Bordeaux
country: France
facility: Hopital Saint Andre; Oncologie 2
city: Caen
country: France
facility: Centre Francois Baclesse; Urologie Gynecologie
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes; Oncologie Medicale
city: Nancy
country: France
facility: Centre D'Oncologie de Gentilly; Oncology
city: Paris
country: France
facility: APHP - Hospital Saint Louis
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
city: Saint Herblain
country: France
facility: ICO - Site René Gauducheau
city: Villejuif
country: France
facility: Institut Gustave Roussy; Departement Oncologie Medicale
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
city: Essen
country: Germany
facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
city: München
country: Germany
facility: Klinikum d.Universität München Campus Großhadern
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen; Klinik für Urologie
city: Napoli
country: Italy
facility: Az. Osp. Cardarelli; Divisione Di Oncologia
state: Campania
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Oncologia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
state: Lazio
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele;Oncologia Medica
state: Lombardia
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo, Oncologia
state: Lombardia
city: Arezzo
country: Italy
facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
state: Toscana
city: Aichi
country: Japan
facility: Nagoya University Hospital; Urology
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Gunma
country: Japan
facility: Gunma University Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital; Urology
city: Iwate
country: Japan
facility: Iwate Medical University Hospital
city: Kanagawa
country: Japan
facility: Yokohama City University Hospital
city: Kanagawa
country: Japan
facility: Kitasato University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute; Urology
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Kindai University Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital, JFCR; Urology
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Queretaro
country: Mexico
facility: Cancerología
city: Toluca
country: Mexico
facility: Centro Oncologico Estatal ISSEMYM
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
city: Poznan
country: Poland
facility: Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
city: Warsaw
country: Poland
facility: Saint Elizabeth's Hospital
city: Warsaw
country: Poland
facility: MAGODENT Sp. z o.o.
city: Barnaul
country: Russian Federation
facility: ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic
state: Altaj
city: Nizhni Novgorod
country: Russian Federation
facility: GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
state: Niznij Novgorod
city: Moscow
country: Russian Federation
facility: P.A. Herzen Oncological Inst. ; Oncology
city: Moscow
country: Russian Federation
facility: City Clinical Oncology Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre; Medical Oncology
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
state: Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
state: Cordoba
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Oncología
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals; Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital; Division of Urology
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; Dept of Oncology
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou, Urinary Oncology
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital; Medical Oncology
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
city: Chiangmai
country: Thailand
facility: Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital; Department of Oncology
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
city: Istanbul
country: Turkey
facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
city: Bebington
country: United Kingdom
facility: Clatterbridge Cancer Centre
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
city: London
country: United Kingdom
facility: Barts Health NHS Trust - St Bartholomew's Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital; Dept of Oncology
city: Manchester
country: United Kingdom
facility: Christie Hospital Nhs Trust; Medical Oncology
city: Oxford
country: United Kingdom
facility: Churchill Hospital; Oxford Cancer and Haematology Centre
city: Southampton
country: United Kingdom
facility: Southampton General Hospital; Medical Oncology
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Medical Oncology
city: Swansea
country: United Kingdom
facility: Singleton Hospital; Pharmacy Department
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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