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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 After Surgical Resection [IMvigor010]

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02450331
First received: May 19, 2015
Last updated: August 1, 2017
Last verified: August 2017
  Purpose
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 urothelial carcinoma (UC) who are at high risk for recurrence following resection. Eligible participants will be randomized by a 1:1 ratio into atezolizumab group or control group.

Condition Intervention Phase
Carcinoma, Transitional Cell Drug: Atezolizumab Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Disease-Free Survival (DFS), as Assessed by Investigator [ Time Frame: Randomization up to first occurrence of DFS event (assessed at screening/randomization, every 12 weeks after randomization in first 3 years, every 24 weeks for Years 4 and 5, and at Year 6) ]
    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:
  • Overall Survival (OS) [ Time Frame: Randomization until death due to any cause (up to approximately 6.5 years) ]
  • Disease-Specific Survival (DSS), as Assessed by Investigator [ Time Frame: Randomization until death due to UC (up to approximately 6.5 years) ]
    DSS is defined as the time from randomization until the date of death from UC.

  • Distant Metastasis-Free Survival (DMFS) [ Time Frame: Randomization up to diagnosis of distant metastases or death from any cause (assessed at screening/randomization, every 12 weeks after randomization in first 3 years, every 24 weeks for Years 4 and 5, and at Year 6) ]
    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.

  • Non-Urinary Tract Recurrence-Free Survival (NURFS) [ Time Frame: Randomization up to time of first occurrence of a NURFS event (assessed at screening/randomization, every 12 weeks after randomization in first 3 years, every 24 weeks for Years 4 and 5, and at Year 6) ]
    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.

  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Screening up to approximately 1 year ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, and every 8 cycles from Cycle 8; at treatment discontinuation (up to 1 year); 90 days after last dose (last dose = up to 1 year) (Cycle length = 21 days) ]
  • European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score [ Time Frame: Day 1 of Cycle 1 up to 6 (detailed timeframe is provided in outcome description section) ]
    Detailed timeframe: Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 15, at treatment/observation period discontinuation (up to 1 year), thereafter every 12 weeks up to Year 3 and then every 24 weeks up to Year 5, at Year 6, additionally at 6, 12, 24 weeks after disease recurrence (any time up to 6 years) (Cycle length = 21 days)

  • 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 (up to 1 year), 120 days after treatment discontinuation (up to 1 year 4 months) ]
  • Maximum Observed Serum Atezolizumab Concentration (Cmax) [ Time Frame: Pre-dose (Hour 0) and 0.5 hours after end of infusion on Day 1 of Cycle 1 (infusion duration = 60 minutes, Cycle length = 21 days) ]

Estimated Enrollment: 700
Actual Study Start Date: October 5, 2015
Estimated Study Completion Date: April 30, 2022
Estimated Primary Completion Date: October 4, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma [TCC]) of the bladder or upper urinary tract (i.e., renal pelvis or ureters)
  • Participants who have not received prior platinum-based neoadjuvant chemotherapy, have refused or are ineligible ("unfit") for cisplatin-based adjuvant chemotherapy
  • Representative formalin-fixed paraffin-embedded (FFPE) 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 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 (MRI) 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 (ECOG) 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 (HIV) 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-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02450331

Contacts
Contact: Reference Study ID Number: WO29636 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Arizona Withdrawn
Phoenix, Arizona, United States, 85259
HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
CBCC Global Research Inc., at Comprehensive Blood and Cancer Center Not yet recruiting
Bakersfield, California, United States, 93309
UCLA Recruiting
Los Angeles, California, United States, 90024
USC Norris Cancer Center Recruiting
Los Angeles, California, United States, 90033
Central Coast Medical Oncology Not yet recruiting
Los Angeles, California, United States, 90095-1772
Torrance Heath Association DBA Torrance Memorial Physican Network / Cancer Care Associate Not yet recruiting
Redondo Beach, California, United States, 90277
Pacific Central Coast Health Centers SLO Oncology and Hematology Not yet recruiting
San Luis Obispo, California, United States, 93401
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
The Urology Center of Colorado Recruiting
Denver, Colorado, United States, 80211
United States, Connecticut
Yale Cancer Center; Medical Oncology Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
University Of Miami Hospital Recruiting
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University Feinberg School Of Medicine Recruiting
Chicago, Illinois, United States, 60611
University of Chicago; Hematology/Oncology Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospital & Clinic; Division of Hematology/Oncology Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Cancer Center of Kansas Not yet recruiting
Wichita, Kansas, United States, 67214
United States, Kentucky
Albert B. Chandler Medical Center; University of Kentucky Terminated
Lexington, Kentucky, United States, 40536
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40402
United States, Maine
New England Cancer Specialists Recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
John Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Chesapeake Urology Research Associates Completed
Towson, Maryland, United States, 21204
United States, Massachusetts
Massachusetts General Hospital. Recruiting
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Inst. Recruiting
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
University Of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Henry Ford Health System Not yet recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
United States, Nebraska
Southeast Nebraska Cancer Ctr Recruiting
Lincoln, Nebraska, United States, 68510
United States, New Jersey
MSK @Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Saint Barnbas Medical Center Cancer Center Not yet recruiting
Livingston, New Jersey, United States, 07039
United States, New York
MSKCC @ Commack Recruiting
Commack, New York, United States, 11725
MSKCC @ West Harrison Recruiting
Harrison, New York, United States, 10604
Monter Cancer Center Withdrawn
Lake Success, New York, United States, 11042
Laura and ISAAC Perlmutter Cancer Center at NYU Langone. Recruiting
New York, New York, United States, 10016
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
MSKC @ Rockville Recruiting
Rockville Centre, New York, United States, 11570
MSKCC at Sleepy Hollow Terminated
Sleepy Hollow, New York, United States, 10591
Associated Medical Professionals of NY, PLLC Recruiting
Syracuse, New York, United States, 13210-1155
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Wake Forest University Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Fairview Hospital; Cleveland Clinic Cancer Center Recruiting
Cleveland, Ohio, United States, 44111
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43212
Hillcrest Hospital; Hirsch Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Cleveland CL N Coast Cancer Cr Recruiting
Sandusky, Ohio, United States, 44870
United States, Pennsylvania
St. Luke's University Health network Terminated
Bethlehem, Pennsylvania, United States, 18015
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Abramson Cancer Center; Univ of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Kimmel Cancer Center Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Fox Chase-Temple Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Rhode Island
Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390-8897
Baylor College of Medicine; Gastroenterology Recruiting
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22906
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Australia, New South Wales
Macquarie University Hospital Recruiting
Macquarie University, New South Wales, Australia, 2109
Australia, Queensland
Royal Brisbane & Women's Hosp; Cancer Care Serv Recruiting
Herston, Queensland, Australia, 4029
Australia, Victoria
Monash Medical Centre; Oncology Recruiting
East Bentleigh, Victoria, Australia, VIC 3165
Austin and Repatriation Medical Centre; Cancer Services Recruiting
Melbourne, Victoria, Australia, 3084
Belarus
Healthcare Institution "Gomel Regional Clinical Oncologic Dispensary" Withdrawn
Gomel, Belarus, 246012
N.N. Alexandrov National Cancer Centre of Belarus Withdrawn
Minsk District, Belarus, 223040
Minsk City Clinical Oncologic Dispensary Withdrawn
Minsk, Belarus, BU-220013
Vitebsk Regional Clinical Oncology Dispensary Withdrawn
Vitebsk, Belarus, BU-210603
Belgium
ZNA Middelheim Terminated
Antwerpen, Belgium, 2020
Institut Jules Bordet Recruiting
Bruxelles, Belgium, 1000
Cliniques Universitaires St-Luc Recruiting
Bruxelles, Belgium, 1200
UZ Gent Recruiting
Gent, Belgium, 9000
UZ Leuven Gasthuisberg Recruiting
Leuven, Belgium, 3000
Sint Augustinus Wilrijk Terminated
Wilrijk, Belgium, 2610
Canada, Alberta
Cross Cancer Institute ; Dept of Medical Oncology Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA-Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
QEII HSC; Oncology Terminated
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Royal Victoria Hospital Recruiting
Barrie, Ontario, Canada, L4M 6M2
London Regional Cancer Centre Recruiting
London, Ontario, Canada, N6A 4L6
Lakeridge Health Oshawa; Oncology Recruiting
Oshawa, Ontario, Canada, L1G 2B9
The Ottawa Hospital Cancer Centre; Oncology Recruiting
Ottawa, Ontario, Canada, K1H 8L6
North York General Hospital Recruiting
Toronto, Ontario, Canada, M2K 1E1
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University; Glen Site; Oncology Recruiting
Montreal, Quebec, Canada, H4A 3J1
Canada
Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec Recruiting
Quebec, Canada, G1R 3S1
China
Cancer Hospital Chinese Academy of Medical Sciences. Not yet recruiting
Beijing, China, 100021
Peking University First Hospital Recruiting
Beijing, China, 100034
Friendship Hospital, Capital Medical University Recruiting
Beijing, China, 100050
Peking University Third Hospital Not yet recruiting
Beijing, China, 100083
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
the First Hospital of Jilin University Recruiting
Changchun, China, 130021
Hu Nan Provincial Cancer Hospital Not yet recruiting
Changsha, China, 410006
The Second Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou City, China, 510120
Sun Yet-sen University Cancer Center Withdrawn
Guangzhou, China, 510060
Jiangsu Cancer Hospital Recruiting
Nanjing, China, 210009
Jiangsu Province Hospital Recruiting
Nanjing, China, 210036
Huashan Hospital Affiliated to Fudan University Recruiting
Shanghai City, China, 200040
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Zhongshan Hospital Fudan University Recruiting
Shanghai, China, 200032
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200092
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, China, 200127
The 2nd Hospital of Tianjin Medical University Not yet recruiting
Tianjin, China, 201203
Tianjin Cancer Hospital; urologic tumor Not yet recruiting
Tianjin, China
Czechia
Masarykuv onkologicky ustav Recruiting
Brno, Czechia, 656 53
University Hospital Olomouc Recruiting
Olomouc, Czechia, 77520
Hospital Pardubice Recruiting
Pardubice, Czechia, 532 03
University Hospital Motol; Department of Urology Recruiting
Praha 5, Czechia, 15006
Finland
Helsinki University Central Hospital; Urology Clinics Recruiting
Helsinki, Finland, 00029
Tampere University Hospital; Dept Of Urology Recruiting
Tampere, Finland, 33520
Turku University Central Hospital; Urology clinic Recruiting
Turku, Finland, 20520
France
ICO Paul Papin; Oncologie Medicale. Active, not recruiting
Angers, France, 49055
Institut Sainte Catherine;Recherche Clinique Recruiting
Avignon, France, 84918
Hopital Saint Andre Recruiting
Bordeaux, France, 33075
Centre Francois Baclesse; Recherche Clinique Recruiting
Caen, France, 14076
Centre Jean Perrin Recruiting
Clermont Ferrand, France, 63011
Centre Leon Berard; Departement Oncologie Medicale Recruiting
Lyon, France, 69373
Centre D'Oncologie de Gentilly; Oncology Recruiting
Nancy, France, 54100
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Hopital Cochin; Unite Fonctionnelle D Oncologie Recruiting
Paris, France, 75014
Hopital Saint Louis; Oncologie Medicale Recruiting
Paris, France, 75475
Institut Mutualiste Montsouris; Oncologie Active, not recruiting
Paris, France, 75674
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale Active, not recruiting
Paris, France, 75908
ICO - Site René Gauducheau Completed
Saint Herblain, France, 44805
Institut Claudius Regaud; Departement Oncologie Medicale Active, not recruiting
Toulouse, France, 31059
Institut Gustave Roussy; Departement Oncologie Medicale Recruiting
Villejuif, France, 94805
Germany
Uniklinik RWTH Aachen; Klinik für Urologie Recruiting
Aachen, Germany, 52074
Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie Recruiting
Berlin, Germany, 12200
Augusta Kranken-Anstalt gGmbH Recruiting
Bochum, Germany, 44791
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie Recruiting
Dresden, Germany, 01307
Universitätsklinikum Düsseldorf; Urologische Klinik Recruiting
Düsseldorf, Germany, 40225
Uniklinik Essen; Urologische Klinik & Poliklinik Terminated
Essen, Germany, 45122
Asklepios Klinik Altona, Abteilung für Urologie Recruiting
Hamburg, Germany, 22763
Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik Recruiting
Herne, Germany, 44625
Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie Not yet recruiting
Homburg/Saar, Germany, 66424
Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie Recruiting
Mannheim, Germany, 68167
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik Recruiting
München, Germany, 81675
Universitätsmedizin Rostock, Urologische Klinik und Poliklinik Recruiting
Rostock, Germany, 18057
Diakonie-Klinikum Stuttgart, Urologische Klinik Recruiting
Stuttgart, Germany, 70176
Universitätsklinikum Tübingen; Klinik für Urologie Recruiting
Tübingen, Germany, 72076
Universitätsklinikum Ulm; Klinik für Urologie Recruiting
Ulm, Germany, 89075
Greece
Alexandras General Hospital of Athens; Oncology Department Recruiting
Athens, Greece, 115 28
University Hospital of Patras Medical Oncology Recruiting
Patras, Greece, 265 04
Israel
Ranbam Health Care Campus; Oncology - Hafia Recruiting
Hafia, Israel, 3109601
Shaare Zedek Medical Center; Oncology Dept Not yet recruiting
Jerusalem, Israel, 91031
Hadassah Ein Karem Hospital; Oncology Dept Recruiting
Jerusalem, Israel, 91120-01
Meir Medical Center; Oncology Recruiting
Kfar-Saba, Israel, 4428164
Rabin Medical Center; Oncology Dept Recruiting
Petach Tikva, Israel, 49100
Chaim Sheba Medical Center; Oncology Dept Recruiting
Ramat Gan, Israel, 5262100
Tel-Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 6423906
Assaf Harofeh; Oncology Recruiting
Zerifin, Israel, 6093000
Italy
Az. Osp. Cardarelli; Divisione Di Oncologia Recruiting
Napoli, Campania, Italy, 80131
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico Recruiting
Napoli, Campania, Italy, 80131
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica Recruiting
Bologna, Emilia-Romagna, Italy, 40138
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Recruiting
Meldola, Emilia-Romagna, Italy, 47014
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica Recruiting
Roma, Lazio, Italy, 00152
Irccs Ospedale San Raffaele;Oncologia Medica Recruiting
Milano, Lombardia, Italy, 20132
Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche Recruiting
Milano, Lombardia, Italy, 20141
A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica Recruiting
Orbassano, Piemonte, Italy, 10043
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia Recruiting
Arezzo, Toscana, Italy, 52100
Azienda Ospedaliera S. Maria - Terni; Oncologia Recruiting
Terni, Umbria, Italy, 05100
Japan
Nagoya University Hospital; Urology Recruiting
Aichi, Japan, 466-8560
Hirosaki University School of Medicine & Hospital; Urology Recruiting
Aomori, Japan, 036-8563
Hiroshima City Hiroshima Citizens Hospital; Urology Recruiting
Hiroshima, Japan, 730-8518
National Hospital Organization Hokkaido Cancer Center Recruiting
Hokkaido, Japan, 003-0804
University of Tsukuba Hospital Recruiting
Ibaraki, Japan, 305-8576
Iwate Medical University Hospital; Urology Recruiting
Iwate, Japan, 020-8505
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Shikoku Cancer Center Recruiting
Matsuyama-shi, Japan, 791-0280
Niigata University Medical & Dental Hospital Recruiting
Niigata, Japan, 951-8520
Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
Osaka University Hospital; Urology Recruiting
Osaka, Japan, 565-0871
Kindai University Hospital; Urology Recruiting
Osaka, Japan, 589-8511
Saitama Medical University International Medical Center Recruiting
Saitama, Japan, 350-1298
Shizuoka Cancer Center; Urology Recruiting
Shizuoka, Japan, 411-8777
National Cancer Center Hospital; Urology Recruiting
Tokyo, Japan, 104-0045
The University of Tokyo Hospital Recruiting
Tokyo, Japan, 113-8655
The Cancer Institute Hospital, JFCR; Urology Recruiting
Tokyo, Japan, 135-8550
Tokyo Women's Medical University Hospital Recruiting
Tokyo, Japan, 162-8666
Kyorin University Hospital Recruiting
Tokyo, Japan, 181-8611
Korea, Republic of
National Cancer Center Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Severance Hospital, Yonsei University Health System Terminated
Seoul, Korea, Republic of, 03722
Asan Medical Center Active, not recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Netherlands
NKI/AvL Recruiting
Amsterdam, Netherlands, 1066 CX
VU MEDISCH CENTRUM; Dept. of Medical Oncology Recruiting
Amsterdam, Netherlands, 1081 HV
Academ Ziekenhuis Groningen; Medical Oncology Recruiting
Groningen, Netherlands, 9713 GZ
UMC Radboud Nijmegen Withdrawn
Nijmegen, Netherlands, 6500 HB
Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie Recruiting
Rotterdam, Netherlands, 3075 EA
St. Antonius locatie Leidsche Rijn Recruiting
Utrecht, Netherlands, 3543 AZ
Poland
KO-MED Centra Kliniczne Lublin II Recruiting
Lublin, Poland, 20-362
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu Recruiting
Poznan, Poland, 60-569
SpecjalistycznySzpital Miejski w Toruniu; Oddział Urologii Ogólnej i Onkologicznej Recruiting
Toruń, Poland, 87-100
Szpital Kliniczny Dzieciątka Jezus; Oddział Urologii Recruiting
Warszawa, Poland, 02-005
Centralny Szpital Kliniczny Mswia; Klinika onkologii, hematologii i chorob wewnetrznych Withdrawn
Warszawa, Poland, 02-507
Międzyleski Szpital Specjalistyczny; Oddział Urologii Recruiting
Warszawa, Poland, 04-749
Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology Recruiting
Wroclaw, Poland, 50-556
Russian Federation
GBUZ Nizhegorodskay Region: Clinical Diagnostic Center Withdrawn
Nizhni Novgorod, Niznij Novgorod, Russian Federation, 603001
Sverdlovsk Regional Oncology Dispensary; Chemotherapy Recruiting
Ekaterinburg, Russian Federation, 620905
Ivanovo Regional Oncology Dispensary Recruiting
Ivanovo, Russian Federation, 153040
Ctr Clinical Hosptial of President'S Affairs Board; Oncology Not yet recruiting
Moscow, Russian Federation, 121356
P.A. Herzen Oncological Inst. ; Oncology Recruiting
Moscow, Russian Federation, 125284
Privolzhsk Regional Medical Center Recruiting
Nizhny Novgorod, Russian Federation, 603001
City Clinical Oncology Dispensary Terminated
Saint-Petersburg, Russian Federation, 197022
Regional Oncology Hospital; Oncology Not yet recruiting
Tumen, Russian Federation, 625047
SBEI of HPE "Bashkir State Medical University" of MoH RF Recruiting
Ufa, Russian Federation, 450000
Serbia
Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje" Completed
Belgrade, Serbia, 11000
Clinic for Urology; Military Medical Academy Terminated
Belgrade, Serbia, 11000
Clinical Center of Serbia; Clinic of Urology Active, not recruiting
Belgrade, Serbia, 11000
Clinical Center of Vojvodina Recruiting
Novi Sad, Serbia, 21000
Institute for Oncology of Vojvodina Withdrawn
Sremska Kamenica, Serbia, 21204
Spain
Hospital Univ. Central de Asturias; Servicio de Oncologia Terminated
Oviedo, Asturias, Spain, 33011
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia Recruiting
Sabadell, Barcelona, Spain, 08208
Hospital de Donostia; Servicio de Oncologia Medica Recruiting
San Sebastian, Guipuzcoa, Spain, 20080
Hospital Univ Vall d'Hebron; Servicio de Oncologia Recruiting
Barcelona, Spain, 08035
Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department Recruiting
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia Recruiting
Barcelona, Spain, 08041
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Recruiting
Madrid, Spain, 28007
Hospital Ramon y Cajal; Servicio de Oncologia Active, not recruiting
Madrid, Spain, 28034
Hospital Clinico San Carlos; Servicio de Oncologia Recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre; Servicio de Oncologia Recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Oncologia Recruiting
Madrid, Spain, 28046
Instituto Valenciano Oncologia; Oncologia Medica Recruiting
Valencia, Spain, 46009
Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie Recruiting
Zürich, Switzerland, 8091
Taiwan
Taichung Veterans General Hospital; Division of Urology Recruiting
Taichung, Taiwan, 407
National Taiwan University Hospital, Department of Urology Active, not recruiting
Taipei, Taiwan, 10048
Chang Gung Medical Foundation-Linkou, Urinary Oncology Recruiting
Taoyuan, Taiwan, 333
Turkey
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology Recruiting
Adana, Turkey, 01250
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department Recruiting
Edirne, Turkey, 22770
Bezmialem Vakif Univ Medical; Bezmialem Vakif Univ T Recruiting
Istanbul, Turkey, 34093
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology Recruiting
Istanbul, Turkey, 34300
Ege Uni Medical Faculty; Oncology Dept Recruiting
Izmir, Turkey, 35100
Medikal Park Izmir Hospital Active, not recruiting
Karşıyaka, Turkey, 35575
Hacettepe Uni Medical Faculty Hospital; Oncology Dept Terminated
Sıhhiye, ANKARA, Turkey, 06100
Ukraine
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4 Recruiting
Kharkiv, Kharkiv Governorate, Ukraine, 61037
CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR Recruiting
Dnipropetrovsk, Ukraine, 49102
GU "Institution of urology of Academy Medical science of Ukraine" Recruiting
Kiev, Ukraine, 04053
Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy Terminated
Lviv, Ukraine, 79031
Zaporozhye Regional Oncology Hospital; Dept of Oncology Terminated
Zaporozhye, Ukraine, 69104
United Kingdom
University Hospitals Birmingham NHS Foundation Trust Active, not recruiting
Birmingham, United Kingdom, B15 2TH
University Hospitals Bristol NHS Foundation Trust Active, not recruiting
Bristol, United Kingdom, BS2 8BJ
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom, G12 0YN
Barts Health NHS Trust - St Bartholomew's Hospital Active, not recruiting
London, United Kingdom, EC1A 7BE
Sarah Cannon Research Institute Recruiting
London, United Kingdom, W1G 6AD
James Cook Uni Hospital Recruiting
Middlesborough, United Kingdom, TS4 3BW
Churchill Hospital Recruiting
Oxford, United Kingdom, OX3 7LJ
Royal Preston Hosptial Active, not recruiting
Preston, United Kingdom, PR2 9HT
Southampton General Hospital Active, not recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02450331     History of Changes
Other Study ID Numbers: WO29636
2014-005603-25 ( EudraCT Number )
Study First Received: May 19, 2015
Last Updated: August 1, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017