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


Condition: Urothelial Carcinoma

Intervention:

  • Drug: Atezolizumab
  • Drug: Carboplatin
  • Drug: Gemcitabine
  • Other: Placebo
  • Drug: Cisplatin

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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02807636

Sponsor: Hoffmann-La Roche

Primary Outcome Measures:

  • Measure: Progression-Free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Participants Treated with Atezolizumab Combination Therapy Compared With Placebo Arm
  • Time Frame: 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 44 months)
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: Baseline until death due to any cause (up to 44 months)
  • Safety Issue:
  • Measure: Percentage of Participants with Adverse Events (AEs) Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
  • Time Frame: Baseline up to 44 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) Assessed by Investigator Using RECIST v1.1
  • Time Frame: 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 44 months)
  • Safety Issue:
  • Measure: Duration of response (DOR) Assessed by Investigator Using RECIST v1.1
  • Time Frame: From first documented objective response (CR or PR) 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 44 months)
  • Safety Issue:
  • Measure: IRF-PFS as determined by blinded independent central review using RECIST v1.1
  • Time Frame: Randomization to first documented disease progression or death from any cause (up to 44 months)
  • Safety Issue:
  • Measure: Percentage of Participants Who Were Alive at Year 1
  • Time Frame: Year 1
  • Safety Issue:
  • Measure: Percentage of Participants Who Were Alive and Progression Free at Year 1 Using RECIST v1.1
  • Time Frame: Year 1
  • Safety Issue:
  • Measure: Median Time to Deterioration in Global Health Status as Measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score
  • Time Frame: Cycle 1 Day 1 (cycle length = 21 days), on Day 1 of each subsequent cycle up treatment discontinuation visit (up to 44 months)
  • Safety Issue:
  • Measure: Median Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score
  • Time Frame: Cycle 1 Day 1 (cycle length = 21 days), on Day 1 of each subsequent cycle up treatment discontinuation visit (up to 44 months)
  • Safety Issue:
  • Measure: Maximum Atezolizumab Serum Concentration
  • Time Frame: Pre-dose,30 min post-end of infusion(infusion length=60min) on Cycle 1 Day 1(1 cycle=21days), pre-dose on Day 1 of Cycles 2,3,4,8 and every 8th cycle thereafter(up to 44months),120 days after last dose or treatment discontinuation visit(up to 44 months)
  • Safety Issue:
  • Measure: Minimum Atezolizumab Serum Concentration
  • Time Frame: Pre-dose on Day 1 (1 cycle = 21 days) of Cycles 1,2,3,4,8 and every 8th cycle thereafter (up to 44 months)
  • Safety Issue:
  • Measure: Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs)
  • Time Frame: Baseline up to 44 months
  • Safety Issue:
  • Measure: Investigator-Assessed Progression-Free Survival (INV-PFS) Assessed by Investigator Using RECIST v1.1 in Participants Treated with Atezolizumab Montotherapy Compared With Placebo Arm
  • Time Frame: 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 44 months)
  • Safety Issue:

Estimated Enrollment: 1200

Study Start Date: June 30, 2016

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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 (
  • 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
  • Pregnant or lactating, or intending to become pregnant during the study
  • Serum albumin
  • 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

Contact:

  • Reference Study ID Number: WO30070 www.roche.com/about_roche/roche_worldwide.htm
  • 888-662-6728 (U.S. and Canada)

Locations:

  • Mayo Clinic Arizona
  • Scottsdale Arizona 85025 United States
  • Highlands Oncology Group
  • Fayetteville Arkansas 72703 United States
  • Comprehensive Blood & CA Ctr; Research
  • Bakersfield California 93309 United States
  • Los Angeles Hematology Oncology Medical Group
  • Los Angeles California 90017 United States
  • University of California Los Angeles (UCLA)
  • Los Angeles California 90095 United States
  • Cancer Care Associates
  • Redondo Beach California United States
  • Coastal Integrative Cancer Care
  • San Luis Obispo California 93401 United States
  • Central Coast Medical Oncology
  • Santa Maria California 93454 United States
  • St. Mary's Hospital Regional Cancer Center
  • Grand Junction Colorado 81501 United States
  • Danbury Hospital
  • Danbury Connecticut 06810 United States
  • Yale School of Medicine
  • New Haven Connecticut 06510 United States
  • Norwalk Hospital
  • Norwalk Connecticut 06856 United States
  • Christiana Care Health Srvcs
  • Newark Delaware 19713 United States
  • Florida Cancer Specialists; Department of Oncology
  • Fort Myers Florida 33901-8101 United States
  • UF Health Cancer Center at Orlando Health
  • Orlando Florida 32824 United States
  • Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
  • Saint Petersburg Florida 33705 United States
  • Moffitt Cancer Center; GME Office
  • Tampa Florida 33612 United States
  • The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology
  • Chicago Illinois 60637 United States
  • Parkview Research Center
  • Fort Wayne Indiana 46845 United States
  • Cancer Center of Kansas
  • Wichita Kansas 67214-3728 United States
  • Norton Cancer Institute
  • Louisville Kentucky 40241 United States
  • East Jefferson Hematology Oncology; Hematology Oncology-Yenni Pavillion
  • Metairie Louisiana 70006 United States
  • Park Nicollet Clin-Cancer Ctr
  • Saint Louis Park Minnesota 55426 United States
  • Jackson Oncology Associates, PLLC
  • Jackson Mississippi 39202 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89128 United States
  • MSK @Basking Ridge
  • Basking Ridge New Jersey 07920 United States
  • Memorial Sloan Kettering Cancer Center; MSK Monmouth
  • Middletown New Jersey 07748 United States
  • MSKCC @ Commack
  • Commack New York 11725 United States
  • MSKCC @ West Harrison
  • Harrison New York 10604 United States
  • Mount Sinai School of Medicine - Tisch Cancer Institute
  • New York New York 10029 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • MSKC @ Rockville
  • Rockville Centre New York 11570 United States
  • University of North Carolina, Lineberger Cancer Ctr
  • Chapel Hill North Carolina 27599 United States
  • Oregon Health & Science Uni
  • Portland Oregon 97239 United States
  • Fox Chase Cancer Center; Hematology/Oncology
  • Philadelphia Pennsylvania 19111 United States
  • Bon Secours - St. Francis Hospital
  • Greenville South Carolina 29607 United States
  • Sarah Cannon Cancer Center
  • Germantown Tennessee 38138 United States
  • Vanderbilt Ingram Cancer Clinic
  • Nashville Tennessee 37232 United States
  • Macquarie University Hospital
  • Sydney New South Wales 2109 Australia
  • Royal Brisbane and Women's Hospital
  • Herston Queensland 4029 Australia
  • Lyell McEwin Hospital
  • Adelaide South Australia 5112 Australia
  • Ashford Cancer Center Research
  • Kurralta Park South Australia 5037 Australia
  • Box Hill Hospital
  • Box Hill Victoria 3128 Australia
  • Cabrini Medical Centre; Oncology
  • Malvern Victoria 3144 Australia
  • Sunshine Hospital; Oncology Research
  • St Albans Victoria Australia
  • GHdC Site Notre Dame
  • Charleroi 6000 Belgium
  • AZ Sint Lucas (Sint Lucas)
  • Gent 9000 Belgium
  • UZ Leuven Gasthuisberg
  • Leuven 3000 Belgium
  • Clinique Saint-Joseph
  • Liège 4000 Belgium
  • University Clinical Centre of the Republic of Srpska
  • Banja Luka 78000 Bosnia and Herzegovina
  • Clinic of Oncology, University Clinical Center Sarajevo
  • Sarajevo 7100 Bosnia and Herzegovina
  • Cetus Hospital Dia Oncologia
  • Belo Horizonte MG 30150-270 Brazil
  • Hospital Luxemburgo; Oncologia
  • Belo Horizonte MG 31190-131 Brazil
  • Clinicas Oncologicas Integradas - COI
  • Rio De Janeiro RJ 22290-160 Brazil
  • Hospital de Caridade de Ijui; Oncologia
  • Ijui RS 98700-000 Brazil
  • Hospital das Clinicas - UFRGS
  • Porto Alegre RS 90035-003 Brazil
  • Hospital Sao Lucas - PUCRS
  • Porto Alegre RS 90610-000 Brazil
  • Hospital Nossa Senhora da Conceicao
  • Porto Alegre RS 91350-200 Brazil
  • Clinica Viver
  • Santa Maria RS 97015-373 Brazil
  • Clinica de Neoplasias Litoral
  • Itajai SC 88301-220 Brazil
  • Hospital de Base de Sao Jose do Rio Preto
  • Sao Jose do Rio Preto SP 15090-000 Brazil
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Sao Paulo SP 01246-000 Brazil
  • Hospital A. C. Camargo; Oncologia
  • Sao Paulo SP 01509-010 Brazil
  • Hospital Sao Jose
  • São Paulo SP CEP 01321-001 Brazil
  • Tom Baker Cancer Centre-Calgary; Clinical Research Unit
  • Calgary Alberta T2N 4N2 Canada
  • Cross Cancer Institute
  • Edmonton Alberta T6G 1Z2 Canada
  • BC Cancer Agency, CSI
  • Kelowna British Columbia V1Y 5L3 Canada
  • Dr. Léon-Richard Oncology Centre
  • Moncton New Brunswick E1C8X3 Canada
  • Juravinski Cancer Clinic; Clinical Trials Department
  • Hamilton Ontario L8V 5C2 Canada
  • Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center
  • Oshawa Ontario L1G 2B9 Canada
  • North York General Hospital
  • Toronto Ontario M2J 1V1 Canada
  • Princess Margaret Cancer Center
  • Toronto Ontario M5G 1Z5 Canada
  • Centro del Cáncer UC
  • Santiago de Chile 8330074 Chile
  • Health & Care SPA
  • Santiago 7500006 Chile
  • Fundacion Arturo Lopez Perez
  • Santiago 7500921 Chile
  • Hospital Clinico de La Universidad de Chile J.J.A.; Oncologia
  • Santiago 8380456 Chile
  • Centro Internacional de Estudios Clínicos (CIEC)
  • Santiago 8420383 Chile
  • Clinica Alemana
  • Vitacura Chile
  • Anhui Provincial Hospital
  • Anhui 230001 China
  • Peking Union Medical College Hospital
  • Beijing City 100032 China
  • CHINESE ACADEMY OF MEDICAL SCIENCE; CANCER INST. & HOSPITAL; Medical ward
  • Beijing 100021 China
  • Peking University First Hospital
  • Beijing 100034 China
  • Beijing Friendship Hospital
  • Beijing 100050 China
  • the First Hospital of Jilin University
  • Changchun 130021 China
  • Hu Nan Provincial Cancer Hospital
  • Changsha 410006 China
  • Chongqing Cancer Hospital
  • Chongqing 400030 China
  • Sun Yat-sen Memorial Hospital
  • Guangzhou 510000 China
  • Sun Yet-sen University Cancer Center
  • Guangzhou 510060 China
  • Zhejiang People's Hospital
  • Hangzhou City 310014 China
  • Zhejiang Cancer Hospital
  • Hangzhou 310022 China
  • Jiangsu Cancer Hospital
  • Nanjing 210009 China
  • Jiangsu Province Hospital
  • Nanjing 210036 China
  • Huashan Hospital Affiliated to Fudan University
  • Shanghai City 200040 China
  • Fudan University Shanghai Cancer Center
  • Shanghai 200032 China
  • Zhongshan Hospital Fudan University
  • Shanghai 200032 China
  • Huadong Hospital Affiliated to Fudan University
  • Shanghai 200040 China
  • Shanghai First People's Hospital
  • Shanghai 200080 China
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai 200092 China
  • The 2nd Hospital of Tianjin Medical University
  • Tianjin 201203 China
  • The First Affiliated Hospital of Xiamen University
  • Xiamen 361003 China
  • Masarykuv onkologicky ustav
  • Brno 656 53 Czechia
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Olomouc 779 00 Czechia
  • Vseobecna fakultni nemocnice v Praze
  • Praha 2 128 08 Czechia
  • University Hospital Motol; Department of Urology
  • Praha 5 15006 Czechia
  • East Tallinn Central Hospital
  • Tallinn 10138 Estonia
  • North Estonia Medical Centre Foundation; Oncology Center
  • Tallinn 13419 Estonia
  • Oulu University Hospital; Oncology
  • Oulu 90029 Finland
  • Turku Uni Central Hospital; Oncology Clinics
  • Turku 20520 Finland
  • Research institute for Clinical Medicine
  • Tbilisi 0112 Georgia
  • National Center of Urology
  • Tbilisi 0144 Georgia
  • Chemotherapy and Immunotherapy Clinic Medulla
  • Tbilisi 0186 Georgia
  • Alexandras General Hospital of Athens; Oncology Department
  • Athens 115 28 Greece
  • University Hospital of Patras Medical Oncology
  • Patras 265 04 Greece
  • Queen Mary Hospital; Dept. of Clinical Oncology
  • Hong Kong 852 Hong Kong
  • Princess Margaret Hospital; Oncology
  • Hong Kong Hong Kong
  • Queen Elizabeth Hospital; Clinical Oncology
  • Hong Kong Hong Kong
  • The Chinese University of Hong Kong; Department of Clinical Oncology
  • N.t. Hong Kong
  • Rambam Health Care Campus; Oncology
  • Haifa 3109601 Israel
  • Meir Medical Center; Oncology
  • Kfar-Saba 4428164 Israel
  • Assaf Harofeh; Oncology
  • Zerifin 6093000 Israel
  • 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
  • Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
  • Roma Lazio 00161 Italy
  • Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical
  • Genova Liguria 16132 Italy
  • ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
  • Cremona Lombardia 26100 Italy
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
  • Milano Lombardia 20133 Italy
  • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
  • Rozzano Lombardia 20089 Italy
  • A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro; Oncologia medica 2
  • Torino Piemonte 10126 Italy
  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
  • San Giovanni Rotondo Puglia 71013 Italy
  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
  • Arezzo Toscana 52100 Italy
  • Azienda Ospedaliera S. Maria - Terni; Oncologia
  • Terni Umbria 05100 Italy
  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
  • Padova Veneto 35128 Italy
  • Nagoya University Hospital
  • Aichi 466-8560 Japan
  • Hirosaki University Hospital
  • Aomori 036-8563 Japan
  • National Hospital Organization Shikoku Cancer Center
  • Ehime 791-0280 Japan
  • Gunma University Hospital
  • Gunma 371-8511 Japan
  • Hiroshima University Hospital
  • Hiroshima 734-8551 Japan
  • National Hospital Organization Hokkaido Cancer Center
  • Hokkaido 003-0804 Japan
  • University of Tsukuba Hospital
  • Ibaraki 305-8576 Japan
  • Kanazawa University Hospital
  • Ishikawa 920-8641 Japan
  • Kumamoto University Hospital
  • Kumamoto 860-8556 Japan
  • Niigata University Medical & Dental Hospital
  • Niigata 951-8520 Japan
  • Osaka City University Hospital
  • Osaka 545-8586 Japan
  • Kindai University Hospital
  • Osaka 589-8511 Japan
  • Toranomon Hospital
  • Tokyo 105-8470 Japan
  • The Cancer Institute Hospital, JFCR; Urology
  • Tokyo 135-8550 Japan
  • Keio University Hospital
  • Tokyo 160-8582 Japan
  • Kyungpook National University Medical Center
  • Daegu 41404 Korea, Republic of
  • Gachon University Gil Medical Center
  • Incheon 21565 Korea, Republic of
  • Korea University Anam Hospital
  • Seoul 02841 Korea, Republic of
  • Seoul National University Hospital
  • Seoul 03080 Korea, Republic of
  • Severance Hospital, Yonsei University Health System
  • Seoul 03722 Korea, Republic of
  • Asan Medical Center
  • Seoul 05505 Korea, Republic of
  • Samsung Medical Center
  • Seoul 6351 Korea, Republic of
  • Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
  • Kuala Lumpur 50586 Malaysia
  • University Malaya Medical Centre; Clinical Oncology Unit,
  • Kuala Lumpur 59100 Malaysia
  • Subang Jaya Medical Centre
  • Selangor 47500 Malaysia
  • Health Pharma Professional Research
  • CD Mexico Mexico CITY (federal District) 03810 Mexico
  • Medical Care & Research
  • Mérida Yucatan 97070 Mexico
  • IMSS Hospital General de Zona No. 48 S. Pedro Xalpa; Departamento de Urología
  • Ciudad De México DF 02710 Mexico
  • Hospital Angeles; Oncology
  • Leon 37150 Mexico
  • Hospital San Jose; Centro de investigacion y transferencia en salud del Tec de Monterrey
  • Monterrey, N.L 64710 Mexico
  • Cancerología
  • Queretaro 76090 Mexico
  • Clinica Sociedad Española de Beneficencia
  • Veracruz 91700 Mexico
  • Consultorio Médico
  • Zapopan, Jalisco 45040 Mexico
  • Martini Ziekenhuis; Dept of Internal Medicine
  • Groningen 9728 NT Netherlands
  • Hagaziekenhuis, locatie Leyweg
  • Nl -den Haag 2504 LN Netherlands
  • Zuyderland Medisch Centrum; Internal Diseases
  • Sittard-Geleen 6162 BG Netherlands
  • Isala Klinieken, Sophia
  • Zwolle 8025 AB Netherlands
  • Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
  • Bialystok 15-027 Poland
  • Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
  • Bydgoszcz 85-796 Poland
  • Szpital im. Stanislawa Leszczynskiego, Oddzial Onkologii
  • Katowice 40-074 Poland
  • Przychodnia Lekarska KOMED
  • Konin 62-500 Poland
  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
  • Krakow 31-531 Poland
  • Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
  • Lodz 93-513 Poland
  • Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
  • Lodz 93-513 Poland
  • Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
  • Poznan 60-569 Poland
  • NU-MED Centrum Diagnostyki i Terapii Onkologicznej
  • Tomaszów Mazowiecki 97-200 Poland
  • Centralny Szpital Kliniczny MSWiA; Klinika Urologii i Urologii Onkologicznej
  • Warsaw 02-507 Poland
  • Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.
  • Warszawa 02-616 Poland
  • Centrum Med. Ostrobramska NZOZ Magodent
  • Warszawa 04-125 Poland
  • Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology
  • Wroclaw 50-556 Poland
  • Centrum Medyczne Salve Medica
  • Łódź 91-211 Poland
  • Hospital de Santa Maria; Servico de Oncologia Medica
  • Lisboa 1649-035 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
  • Iasi 700106 Romania
  • ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic
  • Barnaul Altaj 656049 Russian Federation
  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
  • Sankt-peterburg Leningrad 197022 Russian Federation
  • Sverdlovsk Regional Clinical Hospital 1
  • Ekaterinburg 620102 Russian Federation
  • Ivanovo Regional Oncology Dispensary
  • Ivanovo 153040 Russian Federation
  • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
  • Krasnoyarsk 660133 Russian Federation
  • Blokhin Cancer Research Center; Urological Dept
  • Moscow 115478 Russian Federation
  • Russian Scientific Center of Roentgenoradiology
  • Moscow 117997 Russian Federation
  • P.A. Herzen Oncological Inst. ; Oncology
  • Moscow 125284 Russian Federation
  • Privolzhsk Regional Medical Center
  • Nizhny Novgorod 603001 Russian Federation
  • Scientific Research Oncology Institute named after N.N. Petrov; Oncology
  • St. Petersburg 197758 Russian Federation
  • SBEI of HPE "Bashkir State Medical University" of MoH RF
  • Ufa 450000 Russian Federation
  • Clinic for Urology, Clinical Center of Serbia; Clinic for Urology
  • Belgrade 11000 Serbia
  • Clinical Center of Serbia; Clinic of Urology
  • Belgrade 11000 Serbia
  • Clinical Centre Nis, Clinic for Oncology
  • Nis 18000 Serbia
  • Oncology Institute of Vojvodina
  • Sremska Kamenica 21204 Serbia
  • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • Singapore 119228 Singapore
  • National Cancer Centre; Medical Oncology
  • Singapore 169610 Singapore
  • Oncocare Cancer Centre; Gleneagles Medical Centre
  • Singapore Singapore
  • Institute of Oncology Ljubljana
  • Ljubljana 1000 Slovenia
  • GVI Oncology Outeniqua Unit; GVI Oncology Outeniqua Unit
  • George 6530 South Africa
  • Wits Donald Gordon Clinical Trial Site
  • Johannesburg 2041 South Africa
  • Cancercare
  • Port Elizabeth 6045 South Africa
  • Wilgers Oncology Centre
  • Pretoria 0001 South Africa
  • Steve Biko Academic Hospital; Oncology
  • Pretoria 0002 South Africa
  • Sandton Oncology Medical Group
  • Sandton 2196 South Africa
  • Hospital General Universitario de Elche; Servicio de Oncologia
  • Elche Alicante 03203 Spain
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Badalona Barcelona 08916 Spain
  • Complejo Hospitalario de Althaia; Servicio de Oncologia
  • Manresa Barcelona 08243 Spain
  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Sabadell Barcelona 08208 Spain
  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Santander Cantabria 39008 Spain
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Córdoba Cordoba 14004 Spain
  • Hospital Universitario Son Espases
  • Palma De Mallorca Islas Baleares 07014 Spain
  • Clinica Universitaria de Navarra; Servicio de Oncologia
  • Pamplona Navarra 31008 Spain
  • Hospital Alvaro Cunqueiro
  • Vigo Pontevedra 36312 Spain
  • Hospital de Basurto; Servicio de Oncologia
  • Bilbao Vizcaya 48013 Spain
  • Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia
  • Albacete 02006 Spain
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Barcelona 08035 Spain
  • Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department
  • Barcelona 08036 Spain
  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Barcelona 08041 Spain
  • Institutio Catalan De Oncologia
  • Barcelona 08908 Spain
  • Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
  • Burgos 09006 Spain
  • Hospital San Pedro De Alcantara; Servicio de Oncologia
  • Caceres 10003 Spain
  • Hospital Provincial de Castellon; Servicio de Oncologia
  • Castellon 12002 Spain
  • Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
  • Granada 18014 Spain
  • Hospital Juan Ramon Jimenez;Servicio de Oncologia
  • Huelva 21005 Spain
  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • Jaen 23007 Spain
  • Complejo Asistencial Universitario de Leon; Servicio de Oncologia
  • Leon 24071 Spain
  • Hospital Universitario Lucus Augusti
  • Lugo 27003 Spain
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Madrid 28007 Spain
  • MD Anderson Cancer Center
  • Madrid 28033 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 Universitario La Paz; Servicio de Oncologia
  • Madrid 28046 Spain
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Sevilla 41013 Spain
  • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
  • Toledo 45004 Spain
  • Hospital Clínico Universitario de Valencia; Servicio de Oncología
  • Valencia 46010 Spain
  • Hospital Universitario la Fe; Servicio de Oncologia
  • Valencia 46026 Spain
  • Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
  • Zaragoza 50009 Spain
  • Hospital Universitario Miguel Servet; Servicio de Oncologia Medica
  • Zaragoza 50009 Spain
  • Chang Gung Medical Foundation - Kaohsiung; Oncology
  • Kaohisung Taiwan
  • China Medical University Hospital; Urology
  • Taichung 40447 Taiwan
  • Taichung Veterans General Hospital; Division of Urology
  • Taichung 407 Taiwan
  • National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
  • Tainan 704 Taiwan
  • National Taiwan Uni Hospital; Dept of Oncology
  • Taipei 100 Taiwan
  • Chang Gung Medical Foundation-Linkou, Urinary Oncology
  • Taoyuan 333 Taiwan
  • Vajira Hospital
  • Bangkok 10300 Thailand
  • Chulalongkorn Hospital; Medical Oncology
  • Bangkok 10330 Thailand
  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
  • Bangkok 10400 Thailand
  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
  • Bangkok 10700 Thailand
  • Maharaj Nakorn Chiang Mai Hosp; Oncology Unit
  • Chiangmai 50200 Thailand
  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Adana 01250 Turkey
  • Yildirim Beyazit University Medical Faculty Ataturk Training and Research Hospital
  • Ankara 06800 Turkey
  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Edirne 22030 Turkey
  • Bezmi Alem Vakif University Medical School; Oncology
  • Istanbul 34093 Turkey
  • Istanbul University Cerrahpasa Medical Faculty; Medikal Onkoloji Departmani
  • Istanbul 34098 Turkey
  • Medeniyet University Goztepe Training and Research Hospital; Internal Diseases
  • Istanbul 34730 Turkey
  • Medikal Park Izmir Hospital
  • Karşıyaka 35575 Turkey
  • 19 Mayis University Medical Faculty; Medical Oncology Department
  • Samsun 55139 Turkey
  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • Sıhhiye, Ankara 06100 Turkey
  • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
  • Kharkiv Kharkiv Governorate 61037 Ukraine
  • CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
  • Dnipropetrovsk 49102 Ukraine
  • Zaporizhzhia Regional Clinic
  • Zaporizhzhia 69600 Ukraine
  • Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
  • Cambridge CB2 0QQ United Kingdom
  • Beatson West of Scotland Cancer Centre
  • Glasgow G12 0YN United Kingdom
  • University College London Hospitals NHS Foundation Trust - University College Hospital
  • London NW1 2PG United Kingdom
  • The Christie NHS Foundation Trust
  • Manchester M20 4BX United Kingdom
  • Nottingham University Hospitals NHS Trust
  • Nottingham NG7 2UH United Kingdom
  • The York Hospital
  • York YO31 8HE United Kingdom

View trial on ClinicalTrials.gov


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