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

Primary Purpose

Carcinoma, Transitional Cell

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Transitional Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network
  • UCLA
  • USC Norris Cancer Center
  • Stanford University Medical Center
  • University Of Colorado
  • The Urology Center of Colorado
  • Yale Cancer Center; Medical Oncology
  • Northwestern University Feinberg School Of Medicine
  • University of Chicago; Hematology/Oncology
  • University of Iowa Hospital & Clinic; Division of Hematology/Oncology
  • Albert B. Chandler Medical Center; University of Kentucky
  • Norton Cancer Institute
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Chesapeake Urology Research Associates
  • Dana Farber Cancer Inst.
  • Beth Israel Deaconess Medical Center
  • Massachusetts General Hospital.
  • University Of Michigan
  • Karmanos Cancer Institute
  • Henry Ford Health System
  • MSK @Basking Ridge
  • Saint Barnabas Medical Center Cancer Center
  • Memorial Sloan-Kettering Cancer Center
  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
  • Columbia University Medical Center
  • Levine Cancer Institute
  • Duke Cancer Center
  • Wake Forest University Baptist Medical Center
  • Cleveland Clinic
  • Fairview Hospital; Cleveland Clinic Cancer Center
  • The Ohio State University Wexner Medical Center
  • Cleveland CL N Coast Cancer Cr
  • Abramson Cancer Center; Univ of Pennsylvania
  • Kimmel Cancer Center Thomas Jefferson University
  • Fox Chase-Temple Cancer Center
  • Miriam Hospital
  • University of Texas Southwestern
  • Baylor College of Medicine; Gastroenterology
  • University of Texas Health Science Center at San Antonio
  • University of Virginia
  • Seattle Cancer Care Alliance
  • Macquarie University Hospital
  • Royal Brisbane & Women's Hosp; Cancer Care Serv
  • Monash Medical Centre; Oncology
  • Austin and Repatriation Medical Centre; Cancer Services
  • Institut Jules Bordet
  • Cliniques Universitaires St-Luc
  • UZ Gent
  • UZ Leuven Gasthuisberg
  • Cross Cancer Institute ; Dept of Medical Oncology
  • BCCA-Vancouver Cancer Centre
  • Royal Victoria Hospital
  • London Regional Cancer Centre
  • Lakeridge Health Oshawa; Oncology
  • The Ottawa Hospital Cancer Centre; Oncology
  • North York General Hospital
  • Sunnybrook Odette Cancer Centre
  • McGill University; Glen Site; Oncology
  • CHU de Quebec Hotel-Dieu de Quebec
  • Peking University First Hospital
  • Friendship Hospital, Capital Medical University
  • Beijing Cancer Hospital
  • The Second Affiliated Hospital, Sun Yat-sen University
  • Jiangsu Cancer Hospital
  • Jiangsu Province Hospital
  • Huashan Hospital Affiliated to Fudan University
  • Fudan University Shanghai Cancer Center
  • Zhongshan Hospital Fudan University
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Multiscan s.r.o.
  • University Hospital Motol; Department of Urology
  • Helsinki University Central Hospital; Urology Clinics
  • Tampere University Hospital; Dept Of Urology
  • Turku University Central Hospital; Urology clinic
  • ICO Paul Papin; Oncologie Medicale.
  • Institut Sainte Catherine;Recherche Clinique
  • Hopital Saint Andre
  • Centre Francois Baclesse; Recherche Clinique
  • Centre Jean Perrin
  • Centre Leon Berard; Departement Oncologie Medicale
  • Centre D'Oncologie de Gentilly; Oncology
  • Centre Antoine Lacassagne
  • Hopital Cochin; Unite Fonctionnelle D Oncologie
  • Hopital Saint Louis; Oncologie Medicale
  • Institut Mutualiste Montsouris; Oncologie
  • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
  • ICO - Site René Gauducheau
  • Institut Claudius Regaud; Departement Oncologie Medicale
  • Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie
  • Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin
  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
  • Universitätsklinikum Düsseldorf; Urologische Klinik
  • Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
  • Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
  • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
  • Universitätsmedizin Rostock, Urologische Klinik und Poliklinik
  • Diakonie-Klinikum Stuttgart; Urologische Klinik
  • Universitätsklinikum Tübingen; Klinik für Urologie
  • Universitätsklinikum Ulm; Klinik für Urologie
  • Alexandras General Hospital of Athens; Oncology Department
  • University Hospital of Patras Medical Oncology
  • Rambam Health Care Campus; Oncology - Hafia
  • Hadassah Ein Karem Hospital; Oncology Dept
  • Meir Medical Center; Oncology
  • Rabin Medical Center; Oncology Dept
  • Chaim Sheba Medical Center; Oncology Dept
  • Tel-Aviv Sourasky Medical Center
  • Assaf Harofeh; Oncology
  • Az. Osp. Cardarelli; Divisione Di Oncologia
  • ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
  • Irccs Ospedale San Raffaele;Oncologia Medica
  • Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
  • A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
  • Azienda Ospedaliera S. Maria - Terni; Oncologia
  • Nagoya University Hospital; Urology
  • Hirosaki University School of Medicine & Hospital; Urology
  • Shikoku Cancer Center
  • Hiroshima City Hiroshima Citizens Hospital; Urology
  • National Hospital Organization Hokkaido Cancer Center
  • University of Tsukuba Hospital
  • Iwate Medical University Hospital; Urology
  • Kyoto University Hospital
  • Okayama University Hospital
  • Osaka University Hospital; Urology
  • Kindai University Hospital; Urology
  • Saitama Medical University International Medical Center
  • Shizuoka Cancer Center; Urology
  • National Cancer Center Hospital; Urology
  • The University of Tokyo Hospital
  • The Cancer Institute Hospital, JFCR; Urology
  • Kyorin University Hospital
  • National Cancer Center
  • Asan Medical Center
  • Samsung Medical Center
  • NKI/AvL
  • VU MEDISCH CENTRUM; Dept. of Medical Oncology
  • Academ Ziekenhuis Groningen; Medical Oncology
  • Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie
  • St. Antonius locatie Leidsche Rijn
  • KO-MED Centra Kliniczne Lublin II
  • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
  • SpecjalistycznySzpital Miejski w Toruniu; Oddzia? Urologii Ogólnej i Onkologicznej
  • Szpital Kliniczny Dzieci?tka Jezus; Oddzia? Urologii
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii
  • SBEI of HPE ?Bashkir State Medical University? of MoH RF
  • P.A. Herzen Oncological Inst. ; Oncology
  • Privolzhsk Regional Medical Center
  • Sverdlovsk Regional Oncology Dispensary; Chemotherapy
  • Ivanovo Regional Oncology Dispensary
  • Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje"
  • Clinical Center of Serbia; Clinic of Urology
  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital de Donostia; Servicio de Oncologia Medica
  • Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department
  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Clinico San Carlos; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Instituto Valenciano Oncologia; Oncologia Medica
  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • Taichung Veterans General Hospital; Division of Urology
  • National Taiwan University Hospital, Department of Urology
  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
  • Medikal Park Izmir Hospital
  • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
  • CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
  • GU "Institution of urology of Academy Medical science of Ukraine"
  • University Hospitals Birmingham NHS Foundation Trust
  • University Hospitals Bristol NHS Foundation Trust
  • Beatson West of Scotland Cancer Centre
  • Barts Health NHS Trust - St Bartholomew's Hospital
  • Sarah Cannon Research Institute
  • James Cook Uni Hospital
  • Royal Preston Hosptial
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Atezolizumab

Observation

Arm Description

Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).

Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).

Outcomes

Primary Outcome Measures

Disease-Free Survival (DFS), as Assessed by Investigator
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)
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.
Disease-Specific Survival (DSS), as Assessed by Investigator
DSS is defined as the time from randomization until the date of death from UC.
Distant Metastasis-Free Survival (DMFS)
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)
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)
Percentage of participants with at least one Adverse Event.
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Percentage of participants with anti-therapeutic antibodies to atezolizumab.
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score
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."
Minimum Observed Serum Atezolizumab Concentration (Cmin)
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.
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1.

Full Information

First Posted
May 19, 2015
Last Updated
May 22, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02450331
Brief Title
A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
Acronym
IMvigor010
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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decided to terminate the study early because the study did not meet its primary endpoint and because the study had met its goals of providing safety and additional exploratory efficacy information for atezolizumab monotherapy in MIBC.
Study Start Date
October 5, 2015 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
June 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Transitional Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
809 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab
Arm Type
Experimental
Arm Description
Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
TECENTRIQ®; MPDL3280A
Intervention Description
Atezolizumab will be administered at a dose of 1200 milligrams (mg).
Primary Outcome Measure Information:
Title
Disease-Free Survival (DFS), as Assessed by Investigator
Description
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.
Time Frame
Randomization up to first occurrence of DFS event (up to approximately 50 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
Randomization until death due to any cause (up to approximately 80 months)
Title
Disease-Specific Survival (DSS), as Assessed by Investigator
Description
DSS is defined as the time from randomization until the date of death from UC.
Time Frame
Randomization until death due to UC (up to approximately 50 months)
Title
Distant Metastasis-Free Survival (DMFS)
Description
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.
Time Frame
Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months)
Title
Non-Urinary Tract Recurrence-Free Survival (NURFS)
Description
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.
Time Frame
Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months)
Title
Percentage of Participants With Adverse Events (AEs)
Description
Percentage of participants with at least one Adverse Event.
Time Frame
Screening up to approximately 80 months
Title
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Description
Percentage of participants with anti-therapeutic antibodies to atezolizumab.
Time Frame
Baseline up to approximately 50 months
Title
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score
Description
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."
Time Frame
Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days)
Title
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Description
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.
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)
Title
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Description
Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1.
Time Frame
Day 1 of Cycle 1 (Cycle length = 21 days)

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
33721560
Citation
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.
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A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection

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