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


Condition: Renal Cell Carcinoma

Intervention:

  • Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
  • Drug: Bevacizumab
  • Drug: Sunitinib

Purpose: This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02420821

Sponsor: Hoffmann-La Roche

Primary Outcome Measures:

  • Measure: Progression-Free Survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in Participants with Detectable Programmed Death-Ligand 1 (PD-L1)
  • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
  • Safety Issue:
  • Measure: Overall Survival (OS) in all Randomized Participants
  • Time Frame: Baseline until death due to any cause (up to 63 months)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: OS in Participants with Detectable PD-L1
  • Time Frame: Baseline until death due to any cause (up to 63 months)
  • Safety Issue:
  • Measure: PFS as Determined by an Independent Review Committee (IRC) According to RECIST v1.1
  • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
  • Safety Issue:
  • 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
  • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
  • Safety Issue:
  • Measure: Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
  • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
  • Safety Issue:
  • Measure: Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1
  • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
  • Safety Issue:
  • Measure: DOR as Determined by an IRC According to RECIST v1.1
  • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
  • Safety Issue:
  • Measure: PFS as Determined by the Investigator According to Modified RECIST
  • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
  • Safety Issue:
  • Measure: Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Modified RECIST
  • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
  • Safety Issue:
  • Measure: DOR as Determined by the Investigator According to Modified RECIST
  • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
  • Safety Issue:
  • Measure: PFS in All Randomized Participants as Determined by the Investigator According to RECIST v1.1
  • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
  • Safety Issue:
  • Measure: PFS in Participants With Sarcomatoid Histology as Determined by the Investigator According to RECIST v1.1
  • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
  • Safety Issue:
  • Measure: OS in Participants With Sarcomatoid Histology
  • Time Frame: Baseline until death due to any cause (up to 63 months)
  • Safety Issue:
  • Measure: Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II
  • Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days)
  • Safety Issue:
  • Measure: Change From Baseline in Symptom Severity as Determined by MDASI
  • Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days)
  • Safety Issue:
  • Measure: Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI)
  • Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle and weekly during the first 12 weeks, up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days)
  • Safety Issue:
  • Measure: Change From Baseline in Treatment Side Effects Subscale From Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19)
  • Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days)
  • Safety Issue:
  • Measure: Change From Baseline in Health-Related Quality of Life as Determined by European Quality of Life 5-Dimension (EQ-5D) Scores
  • Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days)
  • Safety Issue:
  • Measure: Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)
  • Time Frame: Baseline up to 63 months
  • Safety Issue:
  • Measure: Percentage of Participants With Anti--Therapeutic Antibodies (ATAs) Against Atezolizumab
  • Time Frame: Baseline up to 63 months (assessed at pre-dose [Hour 0] on Day 1 of Cycles 1, 2, 4, 8, and every 8 cycles thereafter up to treatment discontinuation [up to 63 months] , and 120 days after last dose [up to 63 months]) (Cycle = 42 days)
  • Safety Issue:
  • Measure: Maximum Serum Concentration (Cmax) for Atezolizumab
  • Time Frame: 30 minutes after the end of atezolizumab infusion (infusion duration: 30-60 minutes) on Cycle 1, Day 1 (Cycle = 42 days)
  • Safety Issue:
  • Measure: Minimum Serum Concentration (Cmin) for Atezolizumab
  • Time Frame: Pre-dose (Hour 0) on Days 1 and 22 of Cycles 1, 2, and 4; pre-dose (Hour 0) on Day 1 of Cycle 8 and every 8 cycles thereafter up to treatment discontinuation (up to 63 months), and 120 days after last dose (up to 63 months) (Cycle = 42 days)
  • Safety Issue:
  • Measure: Cmax for Bevacizumab
  • Time Frame: 30 minutes after the end of atezolizumab infusion (infusion duration: 30-90 minutes) on Cycle 1, Day 1 and Cycle 3, Day 1 (Cycle = 42 days)
  • Safety Issue:
  • Measure: Cmin for Bevacizumab
  • Time Frame: Pre-dose (Hour 0) on Cycle 1, Day 1 and Cycle 3, Day 1, at the treatment discontinuation (up to 63 months), and 120 days after last dose (up to 63 months) (Cycle = 42 days)
  • Safety Issue:

Estimated Enrollment: 915

Study Start Date: May 31, 2015

Phase: Phase 3

Eligibility:

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

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, 28 days prior to randomization, during treatment, or within 5 months following last dose of atezolizumab
  • Significant cardiovascular disease
  • Prior allogeneic stem cell or solid organ transplantation

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, 28 days prior to randomization, during treatment, or within 5 months following last dose of atezolizumab
  • 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

Contact:

  • Reference Study ID Number: WO29637 www.roche.com/about_roche/roche_worldwide.htm
  • 888-662-6728 (U.S. and Canada)

Locations:

  • University of Arizona Cancer Center
  • Tucson Arizona 85719 United States
  • Univ of Calif, Los Angeles; Hematology/Oncology
  • Los Angeles California 90095 United States
  • University of California at Irvine Medical Center; Department of Oncology
  • Orange California 92868 United States
  • University of California
  • San Francisco California 94158 United States
  • University of Colorado; Anschutz Cancer Pavilion
  • Aurora Colorado 80045 United States
  • Rocky Mountain Cancer Center; Medical Oncology
  • Denver Colorado 80218 United States
  • Yale School of Medicine
  • New Haven Connecticut 06510 United States
  • Washington Cancer Institute at MedStar Washington Hospital Center.
  • Washington District of Columbia 20010 United States
  • Georgetown U; Lombardi Comp Can
  • Washington District of Columbia 20016-1468 United States
  • Lynn Cancer Institute/Boca Raton Regional Hospital
  • Boca Raton Florida 33486 United States
  • Florida Cancer Specialists - Port Charlotte
  • Port Charlotte Florida 33980 United States
  • Florida Cancer Specialist, North Region
  • Saint Petersburg Florida 33705 United States
  • Florida Cancer Specialists
  • West Palm Beach Florida 33401 United States
  • Piedmont Cancer Institute, PC
  • Atlanta Georgia 30318 United States
  • Central Georgia Cancer Care PC
  • Macon Georgia 31201 United States
  • Northwest Georgia Oncology Centers PC - Marietta
  • Marietta Georgia 30060 United States
  • University of Hawaii Cancer Center
  • Honolulu Hawaii 96813 United States
  • The University of Chicago
  • Chicago Illinois 60637 United States
  • Norton Cancer Institute
  • Louisville Kentucky 40241 United States
  • Johns Hopkins Uni; Oncology Center
  • Baltimore Maryland 21231 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02114 United States
  • Dana Farber Cancer Inst.
  • Boston Massachusetts 02115 United States
  • Beth Israel Deaconess Medical Center
  • Boston Massachusetts 02215 United States
  • Comprehensive Cancer Centers of Nevada - Eastern Avenue
  • Las Vegas Nevada 89169 United States
  • Hackensack University Medical Center
  • Hackensack New Jersey 07601 United States
  • Hematology Oncology Associates; Carol G. Simon Ctr
  • Morristown New Jersey 07960 United States
  • New York Oncology Hematology,P.C.-Albany
  • Albany New York 12208 United States
  • Memorial Sloan-Kettering Cancer Center
  • New York New York United States
  • Oncology Hematology Care Inc
  • Cincinnati Ohio 45242 United States
  • Cleveland Clinic Foundation; Taussig Cancer Center
  • Cleveland Ohio 44195 United States
  • Compass Oncology, The Northwest Cancer Specialists - Compass Oncology Tualatin
  • Tualatin Oregon 97062 United States
  • Allegheny Cancer Center
  • Pittsburgh Pennsylvania 15212 United States
  • SCRI Tennessee Oncology Chattanooga
  • Chattanooga Tennessee 37404 United States
  • Sarah Cannon Cancer Center and Research Institute
  • Nashville Tennessee 37203 United States
  • Vanderbilt Univ Medical Ctr
  • Nashville Tennessee 37232 United States
  • Texas Oncology-Baylor Sammons Cancer Center
  • Dallas Texas 75246 United States
  • The Center for Cancer and Blood Disorders - Fort Worth
  • Fort Worth Texas 76104 United States
  • University of Virginia
  • Charlottesville Virginia 22906 United States
  • Oncology and Hematology Associates of SW Virginia-Raonoke
  • Roanoke Virginia 24014 United States
  • Seattle Cancer Care Alliance
  • Seattle Washington 98109 United States
  • Lifehouse
  • Camperdown New South Wales 2050 Australia
  • Macquarie University Hospital
  • Sydney New South Wales 2109 Australia
  • Calvary Mater Newcastle; Medical Oncology
  • Waratah New South Wales 2298 Australia
  • Icon Cancer Foundation
  • South Brisbane Queensland 4101 Australia
  • Ashford Cancer Center Research
  • Kurralta Park South Australia 5037 Australia
  • Austin Hospital; Medical Oncology
  • Heidelberg Victoria 3084 Australia
  • St John of God Hospital
  • Murdoch Western Australia WA6150 Australia
  • University Clinical Centre of the Republic of Srpska
  • Banja Luka 78000 Bosnia and Herzegovina
  • Clinic of Oncology, University Clinical Center Sarajevo
  • Sarajevo 71000 Bosnia and Herzegovina
  • Hospital de Caridade de Ijui; Oncologia
  • Ijui RS 98700-000 Brazil
  • Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre RS 90020-090 Brazil
  • Hospital Sao Lucas - PUCRS
  • Porto Alegre RS 90610-000 Brazil
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Sao Paulo SP 01246-000 Brazil
  • Queen Elizabeth II Health Sciences Centre; Oncology
  • Halifax Nova Scotia B3H 2Y9 Canada
  • Royal Victoria Hospital
  • Barrie Ontario L4M 6M2 Canada
  • Hamilton Health Sciences - Juravinski Cancer Centre
  • Hamilton Ontario L8V 5C2 Canada
  • London Regional Cancer Centre
  • London Ontario N6A 4L6 Canada
  • Lakeridge Health Oshawa; Oncology
  • Oshawa Ontario L1G 2B9 Canada
  • The Ottawa Hospital Cancer Centre; Oncology
  • Ottawa Ontario K1H 8L6 Canada
  • Sunnybrook Odette Cancer Centre
  • Toronto Ontario M4N 3M5 Canada
  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
  • Toronto Ontario M5G 2M9 Canada
  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
  • Montreal Quebec H3T 1E2 Canada
  • Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec
  • Quebec G1R 3S1 Canada
  • Masarykuv onkologicky ustav
  • Brno 656 53 Czechia
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Olomouc 779 00 Czechia
  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
  • Praha 2 128 08 Czechia
  • Thomayerova nemocnice
  • Praha 4 - Krc 140 59 Czechia
  • Aarhus Universitetshospital; Kræftafdelingen
  • Aarhus N 8200 Denmark
  • Herlev Hospital; Onkologisk afdeling
  • Herlev 2730 Denmark
  • Odense Universitetshospital, Onkologisk Afdeling R
  • Odense 5000 Denmark
  • ICO Paul Papin; Oncologie Medicale.
  • Angers 49055 France
  • Hopital Saint Andre; Oncologie 2
  • Bordeaux 33075 France
  • Centre Francois Baclesse; Urologie Gynecologie
  • Caen 14076 France
  • Centre Oscar Lambret
  • Lille 59020 France
  • Centre Léon Bérard
  • Lyon 69373 France
  • Institut Paoli Calmettes; Oncologie Medicale
  • Marseille 13273 France
  • Centre D'Oncologie de Gentilly; Oncology
  • Nancy 54100 France
  • APHP - Hospital Saint Louis
  • Paris 75475 France
  • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
  • Paris 75908 France
  • ICO - Site René Gauducheau
  • Saint Herblain 44805 France
  • Institut Claudius Regaud; Departement Oncologie Medicale
  • Toulouse 31059 France
  • Institut Gustave Roussy; Departement Oncologie Medicale
  • Villejuif 94805 France
  • Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie
  • Berlin 10117 Germany
  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
  • Dresden 01307 Germany
  • Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
  • Essen 45122 Germany
  • Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
  • Heidelberg 69120 Germany
  • Klinikum d.Universität München Campus Großhadern
  • München 81377 Germany
  • Universitätsklinikum Tübingen; Klinik für Urologie
  • Tübingen 72076 Germany
  • Az. Osp. Cardarelli; Divisione Di Oncologia
  • 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
  • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
  • Roma Lazio 00152 Italy
  • Irccs Ospedale San Raffaele;Oncologia Medica
  • Milano Lombardia 20132 Italy
  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
  • Milano Lombardia 20162 Italy
  • Fondazione IRCCS Policlinico San Matteo, Oncologia
  • Pavia Lombardia 27100 Italy
  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
  • Arezzo Toscana 52100 Italy
  • Nagoya University Hospital; Urology
  • Aichi 466-8560 Japan
  • Chiba Cancer Center
  • Chiba 260-8717 Japan
  • Kyushu University Hospital
  • Fukuoka 812-8582 Japan
  • Gunma University Hospital
  • Gunma 371-8511 Japan
  • Hokkaido University Hospital
  • Hokkaido 060-8648 Japan
  • University of Tsukuba Hospital; Urology
  • Ibaraki 305-8576 Japan
  • Iwate Medical University Hospital
  • Iwate 020-8505 Japan
  • Yokohama City University Hospital
  • Kanagawa 236-0004 Japan
  • Kitasato University Hospital
  • Kanagawa 252-0375 Japan
  • Kumamoto University Hospital
  • Kumamoto 860-8556 Japan
  • Niigata University Medical & Dental Hospital
  • Niigata 951-8520 Japan
  • Okayama University Hospital
  • Okayama 700-8558 Japan
  • Osaka International Cancer Institute; Urology
  • Osaka 541-8567 Japan
  • Osaka City University Hospital
  • Osaka 545-8586 Japan
  • Osaka University Hospital
  • Osaka 565-0871 Japan
  • Kindai University Hospital
  • Osaka 589-8511 Japan
  • Saitama Medical University International Medical Center
  • Saitama 350-1298 Japan
  • Tokushima University Hospital
  • Tokushima 770-8503 Japan
  • Toranomon Hospital
  • Tokyo 105-8470 Japan
  • Tokyo Medical & Dental University Hospital
  • Tokyo 113-8519 Japan
  • Nippon Medical School Hospital
  • Tokyo 113-8603 Japan
  • The Cancer Institute Hospital, JFCR; Urology
  • Tokyo 135-8550 Japan
  • Keio University Hospital
  • Tokyo 160-8582 Japan
  • Tokyo Women's Medical University
  • Tokyo 162-0054 Japan
  • Chungnam National University Hospital
  • Daejeon 35015 Korea, Republic of
  • National Cancer Center
  • Gyeonggi-do 10408 Korea, Republic of
  • Seoul National University Bundang Hospital
  • Gyeonggi-do 13620 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 06351 Korea, Republic of
  • Hospital General de Mexico; Jefatura de Investigacion
  • Mexico City 06726 Mexico
  • Accelerium S. de R.L. de C.V.
  • Monterrey 64000 Mexico
  • Cancerología
  • Queretaro 76090 Mexico
  • Centro Oncologico Estatal ISSEMYM
  • Toluca 50180 Mexico
  • Hospital Regional de Alta Especialidad de Veracruz; Oncology
  • Veracruz 91700 Mexico
  • Consultorio Médico
  • Zapopan, Jalisco 45040 Mexico
  • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
  • Bydgoszcz 85-796 Poland
  • Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Oddział Chemioterapii
  • Lodz 93-513 Poland
  • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
  • Lublin 20-090 Poland
  • Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
  • Poznan 60-569 Poland
  • Saint Elizabeth's Hospital
  • Warsaw 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
  • ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic
  • Barnaul Altaj 656049 Russian Federation
  • GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
  • Nizhni Novgorod Niznij Novgorod 603001 Russian Federation
  • P.A. Herzen Oncological Inst. ; Oncology
  • Moscow 125284 Russian Federation
  • Moscow city oncology hospital #62 of Moscow Healthcare Department
  • Moscow 143423 Russian Federation
  • Clinic for Urology, Clinical Center of Serbia; Clinic for Urology
  • Belgrade 11000 Serbia
  • Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje"
  • Belgrade 11000 Serbia
  • Institute For Oncology Sremska Kamenica; Internal Medicine Department
  • Sremska Kamenica 21204 Serbia
  • National University Hospital
  • Singapore 119074 Singapore
  • National Cancer Centre; Medical Oncology
  • Singapore 169610 Singapore
  • Oncocare Cancer Centre
  • Singapore 258499 Singapore
  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Sabadell Barcelona 08208 Spain
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Córdoba Cordoba 14004 Spain
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Barcelona 08035 Spain
  • Hospital Clínic i Provincial; Servicio de Oncología
  • Barcelona 08036 Spain
  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Barcelona 08041 Spain
  • Hospital Duran i Reynals; Oncologia
  • Barcelona 08907 Spain
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Madrid 28007 Spain
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Madrid 28034 Spain
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Madrid 28041 Spain
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Sevilla 41013 Spain
  • Taichung Veterans General Hospital; Division of Urology
  • Taichung 407 Taiwan
  • National Taiwan Uni Hospital; Dept of Oncology
  • Taipei 100 Taiwan
  • Chang Gung Medical Foundation-Linkou, Urinary Oncology
  • Taoyuan 333 Taiwan
  • 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 Chiangmai Hospital; Department of Surgery/ Urology unit
  • Chiangmai 50200 Thailand
  • Prince of Songkla Uni ; Unit of Medical Oncology
  • Songkhla 90110 Thailand
  • Hacettepe University Medical Faculty
  • Ankara 6100 Turkey
  • Uludag Uni Hospital; Oncology
  • Bursa 16059 Turkey
  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
  • Edirne 22770 Turkey
  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
  • Istanbul 34300 Turkey
  • CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
  • Dnipropetrovsk 49102 Ukraine
  • GU "Institution of urology of Academy Medical science of Ukraine"
  • Kiev 04053 Ukraine
  • Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy
  • Lviv 79031 Ukraine
  • Zaporizhzhia Regional Clinic
  • Zaporizhzhia 69600 Ukraine
  • Clatterbridge Cancer Centre
  • Bebington CH63 4JY United Kingdom
  • Queen Elizabeth Hospital
  • Birmingham B15 2TH United Kingdom
  • Royal Blackburn Hospital
  • Blackburn BB2 3HH United Kingdom
  • Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
  • Cambridge CB2 0QQ United Kingdom
  • Barts Health NHS Trust - St Bartholomew's Hospital
  • London EC1A 7BE United Kingdom
  • Royal Free Hospital; Dept of Oncology
  • London NW3 2QG United Kingdom
  • Royal Marsden Hospital; Dept of Med-Onc
  • London SW3 6JJ United Kingdom
  • Christie Hospital Nhs Trust; Medical Oncology
  • Manchester M2O 4BX United Kingdom
  • Churchill Hospital; Oxford Cancer and Haematology Centre
  • Oxford OX3 7LJ United Kingdom
  • Southampton General Hospital; Medical Oncology
  • Southampton SO16 6YD United Kingdom
  • Royal Marsden Hospital; Dept of Medical Oncology
  • Sutton SM2 5PT United Kingdom
  • Singleton Hospital; Pharmacy Department
  • Swansea SA2 8QA United Kingdom

View trial on ClinicalTrials.gov


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