A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
NCT ID: NCT02450331
Last Updated: 2023-06-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
809 participants
INTERVENTIONAL
2015-10-05
2022-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atezolizumab
Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Atezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg).
Observation
Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).
No interventions assigned to this group
Interventions
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Atezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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UCLA
Los Angeles, California, United States
HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network
Scottsdale, Arizona, 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
Brussels, , Belgium
UZ Gent
Ghent, , 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
Québec, Quebec, Canada
Peking University First Hospital
Beijing, , China
Friendship Hospital, Capital Medical University
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
The Second Affiliated Hospital, Sun Yat-sen University
Guangzhou, , China
Jiangsu Province Hospital
Nanjing, , China
Jiangsu Cancer Hospital
Nanjing, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Huashan Hospital Affiliated to Fudan University
Shanghai, , China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Fudan University Shanghai Cancer Center
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
Prague, , 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
Pátrai, , 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
Ẕerifin, , 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
Rome, Lazio, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milan, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
Milan, Lombardy, Italy
A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
Orbassano, Piedmont, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo, Tuscany, 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
Kyoto University Hospital
Kyoto, , Japan
Iwate Medical University Hospital; Urology
Numakunai, , 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
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
Późna, , Poland
SpecjalistycznySzpital Miejski w Toruniu; Oddzia? Urologii Ogólnej i Onkologicznej
Toru?, , Poland
Szpital Kliniczny Dzieci?tka Jezus; Oddzia? Urologii
Warsaw, , 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, Bashkortostan Republic, Russia
P.A. Herzen Oncological Inst. ; Oncology
Moscow, Moscow Oblast, Russia
Privolzhsk Regional Medical Center
Nizhny Novgorod, Niznij Novgorod, Russia
Sverdlovsk Regional Oncology Dispensary; Chemotherapy
Yekaterinburg, Sverdlovsk Oblast, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, , Russia
Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje"
Belgrade, , Serbia
Clinical Center of Serbia; Clinic of Urology
Belgrade, , Serbia
National Cancer Center
Goyang-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
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
Donostia / 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
Zurich, , 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 (Türkiye)
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, , Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, , Turkey (Türkiye)
Medikal Park Izmir Hospital
Kar??yaka, , Turkey (Türkiye)
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
Middlesbrough, , United Kingdom
Royal Preston Hosptial
Preston, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Powles T, Young A, Nimeiri H, Madison RW, Fine A, Zollinger DR, Huang Y, Xu C, Gjoerup OV, Aushev VN, Wu HT, Aleshin A, Carter C, Davarpanah N, Degaonkar V, Gupta P, Mariathasan S, Schleifman E, Assaf ZJ, Oxnard G, Hegde PS. Molecular residual disease detection in resected, muscle-invasive urothelial cancer with a tissue-based comprehensive genomic profiling-informed personalized monitoring assay. Front Oncol. 2023 Jul 31;13:1221718. doi: 10.3389/fonc.2023.1221718. eCollection 2023.
Bellmunt J, Hussain M, Gschwend JE, Albers P, Oudard S, Castellano D, Daneshmand S, Nishiyama H, Majchrowicz M, Degaonkar V, Shi Y, Mariathasan S, Grivas P, Drakaki A, O'Donnell PH, Rosenberg JE, Geynisman DM, Petrylak DP, Hoffman-Censits J, Bedke J, Kalebasty AR, Zakharia Y, van der Heijden MS, Sternberg CN, Davarpanah NN, Powles T; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):525-537. doi: 10.1016/S1470-2045(21)00004-8. Epub 2021 Mar 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-005603-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WO29636
Identifier Type: -
Identifier Source: org_study_id
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