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

May 22, 2023 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

809

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2109
        • Macquarie University Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane & Women's Hosp; Cancer Care Serv
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre; Oncology
      • Melbourne, Victoria, Australia, 3084
        • Austin and Repatriation Medical Centre; Cancer Services
  • Belgium
      • Anderlecht, Belgium, 1070
        • Institut Jules Bordet
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Gent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute ; Dept of Medical Oncology
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA-Vancouver Cancer Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa; Oncology
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre; Oncology
      • Toronto, Ontario, Canada, M2J 1V1
        • North York General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University; Glen Site; Oncology
      • Quebec City, Quebec, Canada, G1R 2J6
        • CHU de Quebec Hotel-Dieu de Quebec
  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 100050
        • Friendship Hospital, Capital Medical University
      • Beijing City, China, 100034
        • Peking University First Hospital
      • Guangzhou City, China, 510120
        • The Second Affiliated Hospital, Sun Yat-Sen University
      • Nanjing, China, 210008
        • Jiangsu Province Hospital
      • Nanjing City, China, 211100
        • Jiangsu Cancer Hospital
      • Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
      • Shanghai, China, 200092
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shanghai City, China, 200120
        • Fudan University Shanghai Cancer Center
      • Shanghai City, China, 200040
        • Huashan Hospital affiliated to Fudan University
  • Czechia
      • Brno, Czechia, 656 53
        • Masarykuv onkologicky ustav
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc; Onkologicka klinika
      • Pardubice, Czechia, 532 03
        • Multiscan s.r.o.
      • Praha 5, Czechia, 15006
        • University Hospital Motol; Department of Urology
  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital; Urology Clinics
      • Tampere, Finland, 33520
        • Tampere University Hospital; Dept Of Urology
      • Turku, Finland, 20520
        • Turku University Central Hospital; Urology clinic
  • France
      • Angers, France, 49055
        • ICO Paul Papin; Oncologie Medicale.
      • Avignon, France, 84918
        • Institut Sainte Catherine;Recherche Clinique
      • Bordeaux, France, 33075
        • Hôpital Saint André
      • Caen, France, 14076
        • Centre Francois Baclesse; Recherche Clinique
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin
      • Lyon, France, 69373
        • Centre Leon Berard; Departement Oncologie Medicale
      • Nancy, France, 54100
        • Centre D'Oncologie de Gentilly; Oncology
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75014
        • Hopital Cochin; Unite Fonctionnelle D Oncologie
      • Paris, France, 75475
        • Hopital Saint Louis; Oncologie Medicale
      • Paris, France, 75674
        • Institut Mutualiste Montsouris; Oncologie
      • Paris, France, 75908
        • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
      • Saint Herblain, France, 44805
        • ICO - Site René Gauducheau
      • Toulouse, France, 31059
        • Institut Claudius Regaud; Departement Oncologie Medicale
  • Germany
      • Berlin, Germany, 10117
        • Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie
      • Bochum, Germany, 44791
        • Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin
      • Dresden, Germany, 01307
        • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf; Urologische Klinik
      • Herne, Germany, 44625
        • Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
      • Mannheim, Germany, 68167
        • Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
      • München, Germany, 81675
        • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
      • Rostock, Germany, 18057
        • Universitätsmedizin Rostock, Urologische Klinik und Poliklinik
      • Stuttgart, Germany, 70176
        • Diakonie-Klinikum Stuttgart; Urologische Klinik
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen; Klinik für Urologie
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm; Klinik für Urologie
  • Greece
      • Athens, Greece, 115 28
        • Alexandras General Hospital of Athens; Oncology Department
      • Patras, Greece, 265 04
        • University Hospital of Patras Medical Oncology
  • Israel
      • Hafia, Israel, 3109601
        • Rambam Health Care Campus; Oncology - Hafia
      • Jerusalem, Israel, 9112000
        • Hadassah Ein Karem Hospital; Oncology Dept
      • Kfar-Saba, Israel, 4428164
        • Meir Medical Center; Oncology
      • Petah Tikva, Israel, 4910000
        • Rabin Medical Center; Oncology Dept
      • Ramat Gan, Israel, 5262100
        • Chaim Sheba Medical Center; Oncology Dept
      • Tel Aviv, Israel, 6423906
        • Tel-Aviv Sourasky Medical Center
      • Zerifin, Israel, 6093000
        • Assaf Harofeh; Oncology
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Az. Osp. Cardarelli; Divisione Di Oncologia
      • Napoli, Campania, Italy, 80131
        • ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
    • Lazio
      • Roma, Lazio, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Irccs Ospedale San Raffaele;Oncologia Medica
      • Milano, Lombardia, Italy, 20141
        • Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
    • Piemonte
      • Orbassano, Piemonte, Italy, 10043
        • A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
    • Toscana
      • Arezzo, Toscana, Italy, 52100
        • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
    • Umbria
      • Terni, Umbria, Italy, 05100
        • Azienda Ospedaliera S. Maria - Terni; Oncologia
  • Japan
      • Aichi, Japan, 466-8560
        • Nagoya University Hospital; Urology
      • Aomori, Japan, 036-8563
        • Hirosaki University School of Medicine & Hospital; Urology
      • Ehime, Japan, 791-0280
        • Shikoku Cancer Center
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital; Urology
      • Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
      • Ibaraki, Japan, 305-8576
        • University of tsukuba hospital
      • Iwate, Japan, 028-3695
        • Iwate Medical University Hospital; Urology
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Osaka, Japan, 565-0871
        • Osaka University Hospital; Urology
      • Osaka, Japan, 589-8511
        • Kindai University Hospital; Urology
      • Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center
      • Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center; Urology
      • Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital
      • Tokyo, Japan, 181-8611
        • Kyorin University Hospital
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital, JFCR; Urology
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital; Urology
  • Korea, Republic of
      • Goyang-si, Korea, Republic of, 10408
        • National Cancer Center
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • NKI/AvL
      • Amsterdam, Netherlands, 1081 HV
        • VU MEDISCH CENTRUM; Dept. of Medical Oncology
      • Groningen, Netherlands, 9713 GZ
        • Academ Ziekenhuis Groningen; Medical Oncology
      • Rotterdam, Netherlands, 3015AA
        • Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie
      • Utrecht, Netherlands, 3543 AZ
        • St. Antonius locatie Leidsche Rijn
  • Poland
      • Lublin, Poland, 20-362
        • KO-MED Centra Kliniczne Lublin II
      • Pozna?, Poland, 60-569
        • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
      • Toru?, Poland, 87-100
        • SpecjalistycznySzpital Miejski w Toruniu; Oddzia? Urologii Ogólnej i Onkologicznej
      • Warszawa, Poland, 02-005
        • Szpital Kliniczny Dzieci?tka Jezus; Oddzia? Urologii
      • Wroclaw, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii
  • Russian Federation
      • Ivanovo, Russian Federation, 153040
        • Ivanovo Regional Oncology Dispensary
    • Baskortostan
      • UFA, Baskortostan, Russian Federation, 450000
        • SBEI of HPE ?Bashkir State Medical University? of MoH RF
    • Moskovskaja Oblast
      • Moscow, Moskovskaja Oblast, Russian Federation, 125248
        • P.A. Herzen Oncological Inst. ; Oncology
    • Niznij Novgorod
      • Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603001
        • Privolzhsk Regional Medical Center
    • Sverdlovsk
      • Ekaterinburg, Sverdlovsk, Russian Federation, 620905
        • Sverdlovsk Regional Oncology Dispensary; Chemotherapy
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia; Clinic of Urology
      • Belgrade, Serbia, 11000
        • Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje"
  • Spain
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal; Servicio de Oncologia
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos; Servicio de Oncologia
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre; Servicio de Oncologia
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz; Servicio de Oncologia
      • Valencia, Spain, 46009
        • Instituto Valenciano Oncologia; Oncologia Medica
    • Barcelona
      • Sabadell, Barcelona, Spain, 8208
        • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
      • Sant Andreu de La Barca, Barcelona, Spain, 08740
        • Hospital Univ Vall d'Hebron; Servicio de Oncologia
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20080
        • Hospital de Donostia; Servicio de Oncologia Medica
  • Switzerland
      • Zürich, Switzerland, 8091
        • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • Taiwan
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital; Division of Urology
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital, Department of Urology
  • Turkey
      • Adana, Turkey, 01230
        • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
      • Edirne, Turkey, 22770
        • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
      • Istanbul, Turkey, 34300
        • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
      • Kar??yaka, Turkey, 35575
        • Medikal Park Izmir Hospital
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
      • Kiev, Ukraine, 04053
        • GU "Institution of urology of Academy Medical science of Ukraine"
    • Kharkiv Governorate
      • Kharkiv, Kharkiv Governorate, Ukraine, 61037
        • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust
      • Bristol, United Kingdom, BS2 8HW
        • University Hospitals Bristol NHS Foundation Trust
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute
      • London, United Kingdom, EC1A 7BE
        • Barts Health NHS Trust - St Bartholomew's Hospital
      • Middlesborough, United Kingdom, TS4 3BW
        • James Cook Uni Hospital
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hosptial
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network
    • California
      • Los Angeles, California, United States, 90033
        • USC Norris Cancer Center
      • Los Angeles, California, United States, 90024
        • UCLA
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Denver, Colorado, United States, 80211
        • The Urology Center of Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Cancer Center; Medical Oncology
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
      • Chicago, Illinois, United States, 60637
        • University of Chicago; Hematology/Oncology
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital & Clinic; Division of Hematology/Oncology
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Albert B. Chandler Medical Center; University of Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
      • Towson, Maryland, United States, 21204
        • Chesapeake Urology Research Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Inst.
      • Boston, Massachusetts, United States, 2114
        • Massachusetts General Hospital.
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • MSK @Basking Ridge
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center Cancer Center
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10016
        • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44111
        • Fairview Hospital; Cleveland Clinic Cancer Center
      • Columbus, Ohio, United States, 43212
        • The Ohio State University Wexner Medical Center
      • Sandusky, Ohio, United States, 44870
        • Cleveland CL N Coast Cancer Cr
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase-Temple Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Kimmel Cancer Center Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center; Univ of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital
    • Texas
      • Dallas, Texas, United States, 75390-8897
        • University of Texas Southwestern
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine; Gastroenterology
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Virginia
      • Charlottesville, Virginia, United States, 22906
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • TECENTRIQ®; MPDL3280A
No Intervention: Observation
Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Randomization up to first occurrence of DFS event (up to approximately 50 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Randomization until death due to UC (up to approximately 50 months)
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.
Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months)
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.
Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months)
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.
Baseline up to approximately 50 months
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."
Day 1 of Cycle 1 up to approximately 50 months (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, 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.
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)
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.
Day 1 of Cycle 1 (Cycle length = 21 days)
Overall Survival (OS)
Time Frame: Randomization until death due to any cause (up to approximately 80 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.
Randomization until death due to any cause (up to approximately 80 months)
Percentage of Participants With Adverse Events (AEs)
Time Frame: Screening up to approximately 80 months
Percentage of participants with at least one Adverse Event.
Screening up to approximately 80 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2015

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

June 14, 2022

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 19, 2015

First Posted (Estimated)

May 21, 2015

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WO29636
  • 2014-005603-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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