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Trial record 1 of 1 for:    NCT02450331
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A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection (IMvigor010)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02450331
Recruitment Status : Active, not recruiting
First Posted : May 21, 2015
Results First Posted : November 18, 2020
Last Update Posted : April 2, 2021
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.

Condition or disease Intervention/treatment Phase
Carcinoma, Transitional Cell Drug: Atezolizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 809 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection
Actual Study Start Date : October 5, 2015
Actual Primary Completion Date : November 30, 2019
Estimated Study Completion Date : May 10, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Atezolizumab
Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Drug: Atezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg).
Other Name: TECENTRIQ®; MPDL3280A

No Intervention: Observation
Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).

Primary Outcome Measures :
  1. Disease-Free Survival (DFS), as Assessed by Investigator [ Time Frame: Randomization up to first occurrence of DFS event (up to approximately 50 months) ]
    DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization until death due to any cause (up to approximately 50 months) ]
    Overall survival is defined as the time from randomization to the date of death from any cause, regardless of whether the death occurs during study treatment or following treatment discontinuation.

  2. Disease-Specific Survival (DSS), as Assessed by Investigator [ Time Frame: Randomization until death due to UC (up to approximately 50 months) ]
    DSS is defined as the time from randomization until the date of death from UC.

  3. Distant Metastasis-Free Survival (DMFS) [ Time Frame: Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months) ]
    DMFS is defined as the time from randomization to the date of diagnosis of distant (that is, non-locoregional) metastases or death from any cause. Tumor assessment will be performed using radiographic evaluations.

  4. Non-Urinary Tract Recurrence-Free Survival (NURFS) [ Time Frame: Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months) ]
    NURFS is defined as the time from randomization to the time of first occurrence of a NURFS event. NURFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.

  5. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Screening up to approximately 50 months ]
    Percentage of participants with at least one Adverse Event.

  6. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Baseline up to approximately 50 months ]
    Percentage of participants with anti-therapeutic antibodies to atezolizumab.

  7. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score [ Time Frame: Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days) ]
    The EQ-5D-5L is a generic preference-based HRQoL questionnaire that provides a single index value for health status and is used to inform pharmacoeconomic evaluations and to measure general health status. Visual analog scale (VAS) allows the patient to indicate, on a scale of 0-100, how his or her health is on the day of assessment, with 100 being the "best imaginable health state" and 0 being the "worst imaginable health state."

  8. Minimum Observed Serum Atezolizumab Concentration (Cmin) [ Time Frame: Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days) ]
    Minimum observed serum atezolizumab concentration (Cmin) prior to infusion on Day 1 of Cycles 1, 2, 3, and 4; every 8 cycles starting on Cycle 8; at treatment discontinuation; and at 120 days after the last dose of atezolizumab.

  9. Maximum Observed Serum Atezolizumab Concentration (Cmax) [ Time Frame: Day 1 of Cycle 1 (Cycle length = 21 days) ]
    Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma) of the bladder or upper urinary tract (i.e., renal pelvis or ureters)
  • For participants treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-4a or ypN+ (ypT2-4 or ypN+ for participants with upper urinary tract UC) and M0
  • For participants who have not received prior neoadjuvant chemotherapy: tumor stage of pT3-4a or pN+ (pT3-4 or pN+ for participants with upper urinary tract UC) and M0
  • Representative formalin-fixed paraffin-embedded tumor specimens from surgical resection (i.e., radical cystectomy, nephroureterectomy, or lymph node dissection) 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 programmed death-ligand 1 (PD-L1) expression prior to study enrollment
  • Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging scan of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization
  • Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery
  • Eastern Cooperative Oncology Group performance status of less than or equal to (</=) 2
  • Life expectancy greater than or equal to (>/=) 12 weeks
  • Adequate hematologic and end-organ function
  • For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab

Exclusion Criteria:

  • Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
  • Adjuvant chemotherapy or radiation therapy for UC following surgical resection
  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug prior to enrollment
  • Malignancies other than UC within 5 years prior to Cycle 1, Day 1
  • Pregnancy or breastfeeding
  • Significant cardiovascular disease
  • Severe infections within 4 weeks prior to Cycle 1, Day 1
  • Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • History of autoimmune disease
  • Prior allogeneic stem cell or solid organ transplant
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Positive test for human immunodeficiency virus and/or active hepatitis B or hepatitis C or tuberculosis
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1
  • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-CD40, anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02450331

Hide Hide 187 study locations
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United States, Arizona
HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network
Scottsdale, Arizona, United States, 85258
United States, California
Los Angeles, California, United States, 90024
USC Norris Cancer Center
Los Angeles, California, United States, 90033
Stanford University Medical Center
Palo Alto, California, United States, 94304
United States, Colorado
University Of Colorado
Aurora, Colorado, United States, 80045
The Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, Connecticut
Yale Cancer Center; Medical Oncology
New Haven, Connecticut, United States, 06520
United States, Illinois
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States, 60611
University of Chicago; Hematology/Oncology
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa Hospital & Clinic; Division of Hematology/Oncology
Iowa City, Iowa, United States, 52242
United States, Kentucky
Albert B. Chandler Medical Center; University of Kentucky
Lexington, Kentucky, United States, 40536
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
United States, Massachusetts
Massachusetts General Hospital.
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Inst.
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University Of Michigan
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New Jersey
MSK @Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Saint Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States, 07039
United States, New York
Memorial Sloan-Kettering Cancer Center
Commack, New York, United States, 11725
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10027
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Duke Cancer Center
Durham, North Carolina, United States, 27710
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44106
Fairview Hospital; Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44111
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43212
Cleveland CL N Coast Cancer Cr
Sandusky, Ohio, United States, 44870
United States, Pennsylvania
Abramson Cancer Center; Univ of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Kimmel Cancer Center Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Fox Chase-Temple Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390-8897
Baylor College of Medicine; Gastroenterology
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22906
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Australia, New South Wales
Macquarie University Hospital
Macquarie Park, New South Wales, Australia, 2109
Australia, Queensland
Royal Brisbane & Women's Hosp; Cancer Care Serv
Herston, Queensland, Australia, 4029
Australia, Victoria
Monash Medical Centre; Oncology
Clayton, Victoria, Australia, 3168
Austin and Repatriation Medical Centre; Cancer Services
Melbourne, Victoria, Australia, 3084
Institut Jules Bordet
Bruxelles, Belgium, 1000
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
UZ Gent
Gent, Belgium, 9000
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Canada, Alberta
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Royal Victoria Hospital
Barrie, Ontario, Canada, L4M 6M2
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, Canada, L1G 2B9
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, Canada, K1H 8L6
North York General Hospital
Toronto, Ontario, Canada, M2J 1V1
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University; Glen Site; Oncology
Montreal, Quebec, Canada, H4A 3J1
CHU de Quebec Hotel-Dieu de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Peking University First Hospital
Beijing City, China, 100034
Friendship Hospital, Capital Medical University
Beijing, China, 100050
Beijing Cancer Hospital
Beijing, China, 100142
The Second Affiliated Hospital, Sun Yat-sen University
Guangzhou City, China, 510120
Jiangsu Cancer Hospital
Nanjing City, China, 211100
Jiangsu Province Hospital
Nanjing, China, 210036
Huashan Hospital Affiliated to Fudan University
Shanghai City, China, 200040
Fudan University Shanghai Cancer Center
Shanghai City, China, 200120
Zhongshan Hospital Fudan University
Shanghai, China, 200032
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200092
Masarykuv onkologicky ustav
Brno, Czechia, 656 53
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, Czechia, 779 00
Multiscan s.r.o.
Pardubice, Czechia, 532 03
University Hospital Motol; Department of Urology
Praha 5, Czechia, 15006
Helsinki University Central Hospital; Urology Clinics
Helsinki, Finland, 00029
Tampere University Hospital; Dept Of Urology
Tampere, Finland, 33520
Turku University Central Hospital; Urology clinic
Turku, Finland, 20520
ICO Paul Papin; Oncologie Medicale.
Angers, France, 49055
Institut Sainte Catherine;Recherche Clinique
Avignon, France, 84918
Hopital Saint Andre
Bordeaux, France, 33075
Centre Francois Baclesse; Recherche Clinique
Caen, France, 14076
Centre Jean Perrin
Clermont Ferrand, France, 63011
Centre Leon Berard; Departement Oncologie Medicale
Lyon, France, 69373
Centre D'Oncologie de Gentilly; Oncology
Nancy, France, 54100
Centre Antoine Lacassagne
Nice, France, 06189
Hopital Cochin; Unite Fonctionnelle D Oncologie
Paris, France, 75014
Hopital Saint Louis; Oncologie Medicale
Paris, France, 75475
Institut Mutualiste Montsouris; Oncologie
Paris, France, 75674
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
Paris, France, 75908
ICO - Site René Gauducheau
Saint Herblain, France, 44805
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, France, 31059
Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie
Berlin, Germany, 10117
Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin
Bochum, Germany, 44791
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
Dresden, Germany, 01307
Universitätsklinikum Düsseldorf; Urologische Klinik
Düsseldorf, Germany, 40225
Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
Herne, Germany, 44625
Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
Mannheim, Germany, 68167
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
München, Germany, 81675
Universitätsmedizin Rostock, Urologische Klinik und Poliklinik
Rostock, Germany, 18057
Diakonie-Klinikum Stuttgart; Urologische Klinik
Stuttgart, Germany, 70176
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen, Germany, 72076
Universitätsklinikum Ulm; Klinik für Urologie
Ulm, Germany, 89081
Alexandras General Hospital of Athens; Oncology Department
Athens, Greece, 115 28
University Hospital of Patras Medical Oncology
Patras, Greece, 265 04
Rambam Health Care Campus; Oncology - Hafia
Hafia, Israel, 3109601
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, Israel, 9112000
Meir Medical Center; Oncology
Kfar-Saba, Israel, 4428164
Rabin Medical Center; Oncology Dept
Petach Tikva, Israel, 4941492
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, Israel, 5262100
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Assaf Harofeh; Oncology
Zerifin, Israel, 6093000
Az. Osp. Cardarelli; Divisione Di Oncologia
Napoli, Campania, Italy, 80131
Napoli, Campania, Italy, 80131
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, Italy, 40138
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy, 47014
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Roma, Lazio, Italy, 00152
Irccs Ospedale San Raffaele;Oncologia Medica
Milano, Lombardia, Italy, 20132
Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
Milano, Lombardia, Italy, 20141
Orbassano, Piemonte, Italy, 10043
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo, Toscana, Italy, 52100
Azienda Ospedaliera S. Maria - Terni; Oncologia
Terni, Umbria, Italy, 05100
Nagoya University Hospital; Urology
Aichi, Japan, 466-8560
Hirosaki University School of Medicine & Hospital; Urology
Aomori, Japan, 036-8563
Shikoku Cancer Center
Ehime, Japan, 791-0280
Hiroshima City Hiroshima Citizens Hospital; Urology
Hiroshima, Japan, 730-8518
National Hospital Organization Hokkaido Cancer Center
Hokkaido, Japan, 003-0804
University of Tsukuba Hospital
Ibaraki, Japan, 305-8576
Iwate Medical University Hospital; Urology
Iwate, Japan, 028-3695
Kyoto University Hospital
Kyoto, Japan, 606-8507
Okayama University Hospital
Okayama, Japan, 700-8558
Osaka University Hospital; Urology
Osaka, Japan, 565-0871
Kindai University Hospital; Urology
Osaka, Japan, 589-8511
Saitama Medical University International Medical Center
Saitama, Japan, 350-1298
Shizuoka Cancer Center; Urology
Shizuoka, Japan, 411-8777
National Cancer Center Hospital; Urology
Tokyo, Japan, 104-0045
The University of Tokyo Hospital
Tokyo, Japan, 113-8655
The Cancer Institute Hospital, JFCR; Urology
Tokyo, Japan, 135-8550
Kyorin University Hospital
Tokyo, Japan, 181-8611
Korea, Republic of
National Cancer Center
Goyang-si, Korea, Republic of, 10408
Samsung Medical Center
Seoul, Korea, Republic of, (0)6351
Asan Medical Center
Seoul, Korea, Republic of, 05505
Amsterdam, Netherlands, 1066 CX
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Amsterdam, Netherlands, 1081 HV
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, Netherlands, 9713 GZ
Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie
Rotterdam, Netherlands, 3015AA
St. Antonius locatie Leidsche Rijn
Utrecht, Netherlands, 3543 AZ
KO-MED Centra Kliniczne Lublin II
Lublin, Poland, 20-362
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
Poznan, Poland, 60-569
SpecjalistycznySzpital Miejski w Toruniu; Oddział Urologii Ogólnej i Onkologicznej
Toruń, Poland, 87-100
Szpital Kliniczny Dzieciątka Jezus; Oddział Urologii
Warszawa, Poland, 02-005
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii
Wroclaw, Poland, 50-556
Russian Federation
Sverdlovsk Regional Oncology Dispensary; Chemotherapy
Ekaterinburg, Russian Federation, 620905
Ivanovo Regional Oncology Dispensary
Ivanovo, Russian Federation, 153040
Ctr Clinical Hosptial of President'S Affairs Board; Oncology
Moscow, Russian Federation, 121356
P.A. Herzen Oncological Inst. ; Oncology
Moscow, Russian Federation, 125284
Privolzhsk Regional Medical Center
Nizhny Novgorod, Russian Federation, 603001
SBEI of HPE "Bashkir State Medical University" of MoH RF
Ufa, Russian Federation, 450000
Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje"
Belgrade, Serbia, 11000
Clinical Center of Serbia; Clinic of Urology
Belgrade, Serbia, 11000
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain, 8208
Hospital de Donostia; Servicio de Oncologia Medica
San Sebastian, Guipuzcoa, Spain, 20080
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, Spain, 08041
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, Spain, 28007
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, Spain, 46009
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zürich, Switzerland, 8091
Taichung Veterans General Hospital; Division of Urology
Taichung, Taiwan, 407
National Taiwan University Hospital, Department of Urology
Taipei, Taiwan, 10048
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, Turkey, 01250
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, Turkey, 22770
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, Turkey, 34300
Medikal Park Izmir Hospital
Karşıyaka, Turkey, 35575
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
Kharkiv, Kharkiv Governorate, Ukraine, 61037
CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
Dnipropetrovsk, Ukraine, 49102
GU "Institution of urology of Academy Medical science of Ukraine"
Kiev, Ukraine, 04053
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom, BS2 8HW
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Barts Health NHS Trust - St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
James Cook Uni Hospital
Middlesborough, United Kingdom, TS4 3BW
Royal Preston Hosptial
Preston, United Kingdom, PR2 9HT
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
Study Protocol  [PDF] April 13, 2020
Statistical Analysis Plan  [PDF] February 1, 2019

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche Identifier: NCT02450331    
Other Study ID Numbers: WO29636
2014-005603-25 ( EudraCT Number )
First Posted: May 21, 2015    Key Record Dates
Results First Posted: November 18, 2020
Last Update Posted: April 2, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents