Spots Global Cancer Trial Database for A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
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Trial Identification
Brief Title: A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
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
Study ID: NCT02450331
Conditions
Interventions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network, Scottsdale, Arizona, United States
UCLA, Los Angeles, California, United States
USC Norris Cancer Center, Los Angeles, California, United States
Stanford University Medical Center, Palo Alto, California, United States
University Of Colorado, Aurora, Colorado, United States
The Urology Center of Colorado, Denver, Colorado, United States
Yale Cancer Center; Medical Oncology, New Haven, Connecticut, United States
Northwestern University Feinberg School Of Medicine, Chicago, Illinois, United States
University of Chicago; Hematology/Oncology, Chicago, Illinois, United States
University of Iowa Hospital & Clinic; Division of Hematology/Oncology, Iowa City, Iowa, United States
Albert B. Chandler Medical Center; University of Kentucky, Lexington, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Chesapeake Urology Research Associates, Towson, Maryland, United States
Dana Farber Cancer Inst., Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Massachusetts General Hospital., Boston, Massachusetts, United States
University Of Michigan, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
MSK @Basking Ridge, Basking Ridge, New Jersey, United States
Saint Barnabas Medical Center Cancer Center, Livingston, New Jersey, United States
Memorial Sloan-Kettering Cancer Center, Commack, New York, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone., New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Duke Cancer Center, Durham, North Carolina, United States
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Fairview Hospital; Cleveland Clinic Cancer Center, Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Cleveland CL N Coast Cancer Cr, Sandusky, Ohio, United States
Abramson Cancer Center; Univ of Pennsylvania, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Fox Chase-Temple Cancer Center, Philadelphia, Pennsylvania, United States
Miriam Hospital, Providence, Rhode Island, United States
University of Texas Southwestern, Dallas, Texas, United States
Baylor College of Medicine; Gastroenterology, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Macquarie University Hospital, Macquarie Park, New South Wales, Australia
Royal Brisbane & Women's Hosp; Cancer Care Serv, Herston, Queensland, Australia
Monash Medical Centre; Oncology, Clayton, Victoria, Australia
Austin and Repatriation Medical Centre; Cancer Services, Melbourne, Victoria, Australia
Institut Jules Bordet, Anderlecht, , Belgium
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Cross Cancer Institute ; Dept of Medical Oncology, Edmonton, Alberta, Canada
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Royal Victoria Hospital, Barrie, Ontario, Canada
London Regional Cancer Centre, London, Ontario, Canada
Lakeridge Health Oshawa; Oncology, Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre; Oncology, Ottawa, Ontario, Canada
North York General Hospital, Toronto, Ontario, Canada
Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada
McGill University; Glen Site; Oncology, Montreal, Quebec, Canada
CHU de Quebec Hotel-Dieu de Quebec, Quebec City, Quebec, Canada
Peking University First Hospital, Beijing City, , China
Friendship Hospital, Capital Medical University, Beijing, , China
Beijing Cancer Hospital, Beijing, , China
The Second Affiliated Hospital, Sun Yat-sen University, Guangzhou City, , China
Jiangsu Cancer Hospital, Nanjing City, , China
Jiangsu Province Hospital, Nanjing, , China
Huashan Hospital Affiliated to Fudan University, Shanghai City, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Zhongshan Hospital Fudan University, Shanghai, , China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Masarykuv onkologicky ustav, Brno, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, , Czechia
Multiscan s.r.o., Pardubice, , Czechia
University Hospital Motol; Department of Urology, Praha 5, , Czechia
Helsinki University Central Hospital; Urology Clinics, Helsinki, , Finland
Tampere University Hospital; Dept Of Urology, Tampere, , Finland
Turku University Central Hospital; Urology clinic, Turku, , Finland
ICO Paul Papin; Oncologie Medicale., Angers, , France
Institut Sainte Catherine;Recherche Clinique, Avignon, , France
Hopital Saint Andre, Bordeaux, , France
Centre Francois Baclesse; Recherche Clinique, Caen, , France
Centre Jean Perrin, Clermont Ferrand, , France
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Centre D'Oncologie de Gentilly; Oncology, Nancy, , France
Centre Antoine Lacassagne, Nice, , France
Hopital Cochin; Unite Fonctionnelle D Oncologie, Paris, , France
Hopital Saint Louis; Oncologie Medicale, Paris, , France
Institut Mutualiste Montsouris; Oncologie, Paris, , France
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale, Paris, , France
ICO - Site René Gauducheau, Saint Herblain, , France
Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse, , France
Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie, Berlin, , Germany
Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin, Bochum, , Germany
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie, Dresden, , Germany
Universitätsklinikum Düsseldorf; Urologische Klinik, Düsseldorf, , Germany
Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik, Herne, , Germany
Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie, Mannheim, , Germany
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik, München, , Germany
Universitätsmedizin Rostock, Urologische Klinik und Poliklinik, Rostock, , Germany
Diakonie-Klinikum Stuttgart; Urologische Klinik, Stuttgart, , Germany
Universitätsklinikum Tübingen; Klinik für Urologie, Tübingen, , Germany
Universitätsklinikum Ulm; Klinik für Urologie, Ulm, , Germany
Alexandras General Hospital of Athens; Oncology Department, Athens, , Greece
University Hospital of Patras Medical Oncology, Patras, , Greece
Rambam Health Care Campus; Oncology - Hafia, Hafia, , Israel
Hadassah Ein Karem Hospital; Oncology Dept, Jerusalem, , Israel
Meir Medical Center; Oncology, Kfar-Saba, , Israel
Rabin Medical Center; Oncology Dept, Petah Tikva, , Israel
Chaim Sheba Medical Center; Oncology Dept, Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center, Tel Aviv, , Israel
Assaf Harofeh; Oncology, Zerifin, , Israel
Az. Osp. Cardarelli; Divisione Di Oncologia, Napoli, Campania, Italy
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico, Napoli, Campania, Italy
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica, Bologna, Emilia-Romagna, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica, Roma, Lazio, Italy
Irccs Ospedale San Raffaele;Oncologia Medica, Milano, Lombardia, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche, Milano, Lombardia, Italy
A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica, Orbassano, Piemonte, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia, Arezzo, Toscana, Italy
Azienda Ospedaliera S. Maria - Terni; Oncologia, Terni, Umbria, Italy
Nagoya University Hospital; Urology, Aichi, , Japan
Hirosaki University School of Medicine & Hospital; Urology, Aomori, , Japan
Shikoku Cancer Center, Ehime, , Japan
Hiroshima City Hiroshima Citizens Hospital; Urology, Hiroshima, , Japan
National Hospital Organization Hokkaido Cancer Center, Hokkaido, , Japan
University of Tsukuba Hospital, Ibaraki, , Japan
Iwate Medical University Hospital; Urology, Iwate, , Japan
Kyoto University Hospital, Kyoto, , Japan
Okayama University Hospital, Okayama, , Japan
Osaka University Hospital; Urology, Osaka, , Japan
Kindai University Hospital; Urology, Osaka, , Japan
Saitama Medical University International Medical Center, Saitama, , Japan
Shizuoka Cancer Center; Urology, Shizuoka, , Japan
National Cancer Center Hospital; Urology, Tokyo, , Japan
The University of Tokyo Hospital, Tokyo, , Japan
The Cancer Institute Hospital, JFCR; Urology, Tokyo, , Japan
Kyorin University Hospital, Tokyo, , Japan
National Cancer Center, Goyang-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
NKI/AvL, Amsterdam, , Netherlands
VU MEDISCH CENTRUM; Dept. of Medical Oncology, Amsterdam, , Netherlands
Academ Ziekenhuis Groningen; Medical Oncology, Groningen, , Netherlands
Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie, Rotterdam, , Netherlands
St. Antonius locatie Leidsche Rijn, Utrecht, , Netherlands
KO-MED Centra Kliniczne Lublin II, Lublin, , Poland
Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii, Pozna?, , Poland
SpecjalistycznySzpital Miejski w Toruniu; Oddzia? Urologii Ogólnej i Onkologicznej, Toru?, , Poland
Szpital Kliniczny Dzieci?tka Jezus; Oddzia? Urologii, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii, Wroclaw, , Poland
SBEI of HPE ?Bashkir State Medical University? of MoH RF, UFA, Baskortostan, Russian Federation
P.A. Herzen Oncological Inst. ; Oncology, Moscow, Moskovskaja Oblast, Russian Federation
Privolzhsk Regional Medical Center, Nizhny Novgorod, Niznij Novgorod, Russian Federation
Sverdlovsk Regional Oncology Dispensary; Chemotherapy, Ekaterinburg, Sverdlovsk, Russian Federation
Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje", Belgrade, , Serbia
Clinical Center of Serbia; Clinic of Urology, Belgrade, , Serbia
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell, Barcelona, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de La Barca, Barcelona, Spain
Hospital de Donostia; Servicio de Oncologia Medica, San Sebastian, Guipuzcoa, Spain
Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico San Carlos; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Instituto Valenciano Oncologia; Oncologia Medica, Valencia, , Spain
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie, Zürich, , Switzerland
Taichung Veterans General Hospital; Division of Urology, Taichung, , Taiwan
National Taiwan University Hospital, Department of Urology, Taipei, , Taiwan
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana, , Turkey
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department, Edirne, , Turkey
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology, Istanbul, , Turkey
Medikal Park Izmir Hospital, Kar??yaka, , Turkey
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4, Kharkiv, Kharkiv Governorate, Ukraine
CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR, Dnipropetrovsk, , Ukraine
GU "Institution of urology of Academy Medical science of Ukraine", Kiev, , Ukraine
University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
University Hospitals Bristol NHS Foundation Trust, Bristol, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Barts Health NHS Trust - St Bartholomew's Hospital, London, , United Kingdom
Sarah Cannon Research Institute, London, , United Kingdom
James Cook Uni Hospital, Middlesborough, , United Kingdom
Royal Preston Hosptial, Preston, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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