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Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma (IMvigor130)

Primary Purpose

Urothelial Carcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Carboplatin
Gemcitabine
Placebo
Cisplatin
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Carcinoma focused on measuring Urothelial carcinoma, Bladder cancer, Anti-PD-L1, Transitional carcinoma, Tecentriq, Atezolizumab, IMvigor130

Eligibility Criteria

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

Inclusion Criteria

  • Considered to be eligible to receive platinum-based chemotherapy, in the investigator's judgment
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (</=) 2
  • Histologically documented, locally advanced (T4b, any N; or any T, N2-3) or metastatic urothelial carcinoma (mUC) (M1, Stage IV) (also termed transitional cell carcinoma [TCC] or urothelial cell carcinoma [UCC] of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)
  • Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment; participants who have fewer than 15 unstained slides available at baseline (but no less than [<] 10) may be eligible following discussion with the Medical Monitor
  • No prior chemotherapy for inoperable locally advanced or mUC
  • For participants who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval more than (>) 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment naive in the metastatic setting
  • Prior local intravesical chemotherapy or immunotherapy is allowed if completed at least 4 weeks prior to the initiation of study treatment
  • Measurable disease, as defined by RECIST v1.1
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose of carboplatin, cisplatin, or gemcitabine or for 5 months after the last dose of atezolizumab
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm

Exclusion Criteria:

  • Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
  • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrolment
  • Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic assessments
  • Participants with treated asymptomatic central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: * Evaluable or measurable disease outside the CNS * No metastases to midbrain, pons, medulla, or within 10 mm of the optic apparatus (optic nerves and chiasm) * No history of intracranial or spinal cord hemorrhage * No ongoing requirement for corticosteroid as therapy for CNS disease; anti-convulsants at a stable dose are allowed * No evidence of significant vasogenic edema * No stereotactic radiation, whole-brain radiation or neurosurgical resection within 4 weeks prior to Cycle 1, Day 1 * Radiographic demonstration of interim stability (i.e., no progression) between the completion of CNS-directed therapy and the screening radiographic study * Screening CNS radiographic study >/=4 weeks since completion of radiotherapy or surgical resection and >/=2 weeks since discontinuation of corticosteroids
  • Prior treatment with CD137 agonists, anti-CTLA-4, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
  • Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1 or anticipated requirement for systemic immunosuppressive medications during the study
  • Leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Uncontrolled tumour-related pain or hypercalcemia
  • Significant cardiovascular disease including known left ventricular ejection fraction (LVEF) <40%
  • Severe infections within 4 weeks before randomization or therapeutic oral or IV antibiotics within 2 weeks before randomization
  • Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
  • Malignancies other than urothelial carcinoma within 5 years prior to Cycle 1, Day 1
  • Life expectancy of <12 weeks
  • Pregnant or lactating, or intending to become pregnant during the study
  • Serum albumin <25 gram per liter (g/L)
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • History of autoimmune disease
  • Participants with prior allogeneic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
  • Positive test for human immunodeficiency virus (HIV)
  • Active hepatitis B or hepatitis C
  • Active tuberculosis
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1

Sites / Locations

  • Highlands Oncology Group
  • Coastal Integrative Cancer Care
  • Yale School of Medicine
  • Norwalk Hospital
  • Christina Care Institutional Review Board
  • Florida Cancer Specialists; Department of Oncology
  • UF Health Cancer Center at Orlando Health
  • Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
  • Moffitt Cancer Center; GME Office
  • The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology
  • Parkview Research Center
  • Norton Cancer Institute
  • East Jefferson Hematology Oncology; Hematology Oncology-Yenni Pavillion
  • Park Nicollet Clin-Cancer Ctr
  • Comprehensive Cancer Centers of Nevada
  • Mount Sinai School of Medicine - Tisch Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • University of North Carolina, Lineberger Cancer Ctr
  • Bon Secours - St. Francis Hospital
  • Sarah Cannon Cancer Center
  • Macquarie University Hospital
  • Royal Brisbane and Women's Hospital
  • Lyell McEwin Hospital
  • Ashford Cancer Center Research
  • Box Hill Hospital
  • Cabrini Medical Centre; Oncology
  • Sunshine Hospital; Oncology Research
  • GHdC Site Notre Dame
  • AZ Sint Lucas (Sint Lucas)
  • UZ Leuven Gasthuisberg
  • CHC MontLégia
  • University Clinical Centre of the Republic of Srpska
  • Clinic of Oncology, University Clinical Center Sarajevo
  • Hospital Luxemburgo; Oncologia
  • CETUS Hospital Dia Oncologia
  • Clinicas Oncologicas Integradas - COI
  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
  • Hospital das Clinicas - UFRGS
  • Hospital Sao Lucas - PUCRS
  • Hospital Nossa Senhora da Conceicao
  • Clinica Viver
  • Clinica de Neoplasias Litoral
  • Hospital de Base de Sao Jose do Rio Preto
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Beneficencia Portuguesa de Sao Paulo
  • Tom Baker Cancer Centre-Calgary; Clinical Research Unit
  • Cross Cancer Institute
  • BC Cancer Agency, CSI
  • Dr. Georges L. Dumont University Hospital Centre
  • Juravinski Cancer Clinic; Clinical Trials Department
  • Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center
  • North York General Hospital
  • Bradford Hill Centro de Investigaciones Clinicas
  • OrlandiOncología
  • Fundacion Arturo Lopez Perez
  • Clinica Alemana
  • Peking Union Medical College Hospital
  • Beijing Friendship Hospital
  • Chongqing Cancer Hospital
  • Sun Yat-sen Memorial Hospital
  • Jiangsu Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Zhongshan Hospital Fudan University
  • Huadong Hospital Affiliated to Fudan University
  • The 2nd Hospital of Tianjin Medical University
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Vseobecna fakultni nemocnice v Praze
  • University Hospital Motol; Department of Urology
  • East Tallinn Central Hospital
  • North Estonia Medical Centre Foundation; Oncology Center
  • Oulu University Hospital; Oncology
  • Turku Uni Central Hospital; Oncology Clinics
  • Research institute for Clinical Medicine
  • National Center of Urology
  • Chemotherapy and Immunotherapy Clinic Medulla
  • Alexandras General Hospital of Athens; Oncology Department
  • University Hospital of Patras Medical Oncology
  • Princess Margaret Hospital; Oncology
  • Queen Elizabeth Hospital; Clinical Oncology
  • Queen Mary Hospital; Dept. of Clinical Oncology
  • The Chinese University of Hong Kong; Department of Clinical Oncology
  • Rambam Health Care Campus; Oncology
  • Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • A.O. Universitaria Policlinico Di Modena; Oncologia
  • Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
  • Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical
  • ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
  • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
  • A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro; Oncologia medica 2
  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
  • Azienda Ospedaliera S. Maria - Terni; Oncologia
  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
  • Nagoya University Hospital
  • Hirosaki University Hospital
  • National Hospital Organization Shikoku Cancer Center
  • Gunma University Hospital
  • National Hospital Organization Hokkaido Cancer Center
  • University of Tsukuba Hospital
  • Kanazawa University Hospital
  • Kumamoto University Hospital
  • Niigata University Medical & Dental Hospital
  • Osaka Metropolitan University Hospital
  • Kindai University Hospital
  • Toranomon Hospital
  • The Cancer Institute Hospital, JFCR; Urology
  • Keio University Hospital
  • Kyungpook National University Medical Center
  • Gachon University Gil Medical Center
  • Severance Hospital, Yonsei University Health System
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
  • University Malaya Medical Centre; Clinical Oncology Unit,
  • Consultorio Médico
  • Health Pharma Professional Research
  • Hospital San Jose; Centro de investigacion y transferencia en salud del Tec de Monterrey
  • Cancerología
  • IMSS Hospital General de Zona No. 48 S. Pedro Xalpa; Departamento de Urología
  • Hagaziekenhuis, locatie Leyweg
  • Martini Ziekenhuis; Dept of Internal Medicine
  • Zuyderland Medisch Centrum; Internal Diseases
  • Isala Klinieken, Sophia
  • Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
  • Przychodnia Lekarska KOMED, Roman Karaszewski
  • Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna
  • Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
  • Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
  • NU-MED Centrum Diagnostyki i Terapii Onkologicznej
  • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii
  • Hospital de Santa Maria; Servico de Oncologia Medica
  • IPO do Porto; Servico de Oncologia Medica
  • Spitalul Judetean de Urgenta Dr Constantin Opris
  • Institute Of Oncology Bucharest; Medical Oncology
  • Oncology Center Sf. Nectarie
  • ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic
  • SBEI of HPE ?Bashkir State Medical University? of MoH RF
  • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
  • Blokhin Cancer Research Center; Urological Dept
  • Russian Scientific Center of Roentgenoradiology
  • P.A. Herzen Oncological Inst. ; Oncology
  • Privolzhsk Regional Medical Center
  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
  • Scientific Research Oncology Institute named after N.N. Petrov; Oncology
  • Sverdlovsk Regional Clinical Hospital 1
  • Ivanovo Regional Oncology Dispensary
  • Clinical Center of Serbia; Clinic of Urology
  • Clinical Centre Nis, Clinic for Oncology
  • Oncology Institute of Vojvodina
  • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • National Cancer Centre; Medical Oncology
  • Oncocare Cancer Centre; Gleneagles Medical Centre
  • Institute of Oncology Ljubljana
  • GVI Oncology Outeniqua Unit
  • Cancercare
  • Wilgers Oncology Centre
  • Steve Biko Academic Hospital; Oncology
  • Sandton Oncology Medical Group
  • Hospital General Universitario de Elche; Servicio de Oncologia
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Institutio Catalan De Oncologia
  • Complejo Hospitalario de Althaia; Servicio de Oncologia
  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Hospital Provincial de Castellon; Servicio de Oncologia
  • Hospital Universitario Son Espases
  • Clinica Universitaria de Navarra; Servicio de Oncologia
  • Hospital Alvaro Cunqueiro
  • Hospital de Basurto; Servicio de Oncologia
  • Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia
  • Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department
  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
  • Hospital San Pedro De Alcantara; Servicio de Oncologia
  • Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
  • Hospital Juan Ramon Jimenez;Servicio de Oncologia
  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • Complejo Asistencial Universitario de Leon; Servicio de Oncologia
  • Hospital Universitario Lucus Augusti
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Hospital Universitario de Toledo
  • Hospital Universitario la Fe; Servicio de Oncologia
  • Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
  • Hospital Universitario Miguel Servet; Servicio de Oncologia Medica
  • Chang Gung Medical Foundation - Kaohsiung; Oncology
  • China Medical University Hospital; Urology
  • Taichung Veterans General Hospital; Division of Urology
  • National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
  • National Taiwan Uni Hospital; Dept of Oncology
  • Chang Gung Medical Foundation-Linkou, Urinary Oncology
  • Vajira Hospital
  • Chulalongkorn Hospital; Medical Oncology
  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
  • Maharaj Nakorn Chiang Mai Hospital; Department of Medicine
  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Ankara Bilkent City Hospital
  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Bezmi Alem Vakif University Medical School; Oncology
  • Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
  • Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
  • Medikal Park Izmir Hospital
  • 19 Mayis University Medical Faculty; Medical Oncology Department
  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • 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
  • Zaporizhzhia Regional Clinic
  • Beatson West of Scotland Cancer Centre
  • University College London Hospitals NHS Foundation Trust - University College Hospital
  • The Christie NHS Foundation Trust
  • The York Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Atezolizumab+Gemcitabine+Carboplatin/Cisplatin

Placebo+Gemcitabine+Carboplatin/Cisplatin

Atezolizumab Monotherapy

Arm Description

Participants will receive blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

Participants will receive blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

Eligible participants will receive open-label atezolizumab as monotherapy.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Participants Treated with Atezolizumab Combination Therapy Compared With Placebo Arm
Overall Survival (OS)

Secondary Outcome Measures

Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) Assessed by Investigator Using RECIST v1.1
Duration of response (DOR) Assessed by Investigator Using RECIST v1.1
IRF-PFS as determined by blinded independent central review using RECIST v1.1
Percentage of Participants Who Were Alive at Year 1
Percentage of Participants Who Were Alive and Progression Free at Year 1 Using RECIST v1.1
Median Time to Deterioration in Global Health Status as Measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score
Median Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score
Maximum Atezolizumab Serum Concentration
Minimum Atezolizumab Serum Concentration
Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs)
Investigator-Assessed Progression-Free Survival (INV-PFS) Assessed by Investigator Using RECIST v1.1 in Participants Treated with Atezolizumab Montotherapy Compared With Placebo Arm
Percentage of Participants with Adverse Events (AEs) Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Full Information

First Posted
June 17, 2016
Last Updated
June 8, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02807636
Brief Title
Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Acronym
IMvigor130
Official Title
A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 30, 2016 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma
Keywords
Urothelial carcinoma, Bladder cancer, Anti-PD-L1, Transitional carcinoma, Tecentriq, Atezolizumab, IMvigor130

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
Arm Type
Experimental
Arm Description
Participants will receive blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
Arm Title
Placebo+Gemcitabine+Carboplatin/Cisplatin
Arm Type
Placebo Comparator
Arm Description
Participants will receive blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
Arm Title
Atezolizumab Monotherapy
Arm Type
Experimental
Arm Description
Eligible participants will receive open-label atezolizumab as monotherapy.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin will be administered at doses to achieve area under the concentration-time curve (AUC) of 4.5 milligram per milliliter into minute (mg/mL*min) by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine will be administered at a dose of 1000 milligrams per square meter (mg/m^2) by IV infusion on Day 1 and Day 8 of each 21-day cycle, until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to atezolizumab will be administered by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin will be administered at a dose of 70 mg/m^2 by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Participants Treated with Atezolizumab Combination Therapy Compared With Placebo Arm
Time Frame
Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 74 months)
Title
Overall Survival (OS)
Time Frame
Baseline until death due to any cause (up to 74 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) Assessed by Investigator Using RECIST v1.1
Time Frame
Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 90 months)
Title
Duration of response (DOR) Assessed by Investigator Using RECIST v1.1
Time Frame
From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 90 months)
Title
IRF-PFS as determined by blinded independent central review using RECIST v1.1
Time Frame
Randomization to first documented disease progression or death from any cause (up to 90 months)
Title
Percentage of Participants Who Were Alive at Year 1
Time Frame
Year 1
Title
Percentage of Participants Who Were Alive and Progression Free at Year 1 Using RECIST v1.1
Time Frame
Year 1
Title
Median Time to Deterioration in Global Health Status as Measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score
Time Frame
Cycle 1 Day 1 (cycle length = 21 days), on Day 1 of each subsequent cycle up treatment discontinuation visit (up to 90 months)
Title
Median Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score
Time Frame
Cycle 1 Day 1 (cycle length = 21 days), on Day 1 of each subsequent cycle up treatment discontinuation visit (up to 90 months)
Title
Maximum Atezolizumab Serum Concentration
Time Frame
Pre-dose,30 min post-end of infusion(infusion length=60min) on Cycle 1 Day 1(1 cycle=21days), pre-dose on Day 1 of Cycles 2,3,4,8 and every 8th cycle thereafter(up to 44months),120 days after last dose or treatment discontinuation visit(up to 90 months)
Title
Minimum Atezolizumab Serum Concentration
Time Frame
Pre-dose on Day 1 (1 cycle = 21 days) of Cycles 1,2,3,4,8 and every 8th cycle thereafter (up to 90 months)
Title
Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs)
Time Frame
Baseline up to 90 months
Title
Investigator-Assessed Progression-Free Survival (INV-PFS) Assessed by Investigator Using RECIST v1.1 in Participants Treated with Atezolizumab Montotherapy Compared With Placebo Arm
Time Frame
Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 90 months)
Title
Percentage of Participants with Adverse Events (AEs) Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time Frame
Baseline up to 90 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Considered to be eligible to receive platinum-based chemotherapy, in the investigator's judgment Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (</=) 2 Histologically documented, locally advanced (T4b, any N; or any T, N2-3) or metastatic urothelial carcinoma (mUC) (M1, Stage IV) (also termed transitional cell carcinoma [TCC] or urothelial cell carcinoma [UCC] of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra) Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment; participants who have fewer than 15 unstained slides available at baseline (but no less than [<] 10) may be eligible following discussion with the Medical Monitor No prior chemotherapy for inoperable locally advanced or mUC For participants who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval more than (>) 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment naive in the metastatic setting Prior local intravesical chemotherapy or immunotherapy is allowed if completed at least 4 weeks prior to the initiation of study treatment Measurable disease, as defined by RECIST v1.1 Adequate hematologic and end-organ function For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose of carboplatin, cisplatin, or gemcitabine or for 5 months after the last dose of atezolizumab For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm Exclusion Criteria: Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrolment Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic assessments Participants with treated asymptomatic central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: * Evaluable or measurable disease outside the CNS * No metastases to midbrain, pons, medulla, or within 10 mm of the optic apparatus (optic nerves and chiasm) * No history of intracranial or spinal cord hemorrhage * No ongoing requirement for corticosteroid as therapy for CNS disease; anti-convulsants at a stable dose are allowed * No evidence of significant vasogenic edema * No stereotactic radiation, whole-brain radiation or neurosurgical resection within 4 weeks prior to Cycle 1, Day 1 * Radiographic demonstration of interim stability (i.e., no progression) between the completion of CNS-directed therapy and the screening radiographic study * Screening CNS radiographic study >/=4 weeks since completion of radiotherapy or surgical resection and >/=2 weeks since discontinuation of corticosteroids Prior treatment with CD137 agonists, anti-CTLA-4, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1 or anticipated requirement for systemic immunosuppressive medications during the study Leptomeningeal disease Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Uncontrolled tumour-related pain or hypercalcemia Significant cardiovascular disease including known left ventricular ejection fraction (LVEF) <40% Severe infections within 4 weeks before randomization or therapeutic oral or IV antibiotics within 2 weeks before randomization Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis Malignancies other than urothelial carcinoma within 5 years prior to Cycle 1, Day 1 Life expectancy of <12 weeks Pregnant or lactating, or intending to become pregnant during the study Serum albumin <25 gram per liter (g/L) History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation History of autoimmune disease Participants with prior allogeneic stem cell or solid organ transplantation History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan Positive test for human immunodeficiency virus (HIV) Active hepatitis B or hepatitis C Active tuberculosis Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
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
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Coastal Integrative Cancer Care
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Christina Care Institutional Review Board
City
Newark
State/Province
Delaware
ZIP/Postal Code
18713
Country
United States
Facility Name
Florida Cancer Specialists; Department of Oncology
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-8101
Country
United States
Facility Name
UF Health Cancer Center at Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32824
Country
United States
Facility Name
Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Moffitt Cancer Center; GME Office
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
East Jefferson Hematology Oncology; Hematology Oncology-Yenni Pavillion
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Park Nicollet Clin-Cancer Ctr
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Mount Sinai School of Medicine - Tisch Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of North Carolina, Lineberger Cancer Ctr
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Bon Secours - St. Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
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 and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Lyell McEwin Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Ashford Cancer Center Research
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Cabrini Medical Centre; Oncology
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Sunshine Hospital; Oncology Research
City
St Albans
State/Province
Victoria
Country
Australia
Facility Name
GHdC Site Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
AZ Sint Lucas (Sint Lucas)
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHC MontLégia
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Clinic of Oncology, University Clinical Center Sarajevo
City
Sarajevo
ZIP/Postal Code
7100
Country
Bosnia and Herzegovina
Facility Name
Hospital Luxemburgo; Oncologia
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
31190-131
Country
Brazil
Facility Name
CETUS Hospital Dia Oncologia
City
Uberaba
State/Province
MG
ZIP/Postal Code
38082-049
Country
Brazil
Facility Name
Clinicas Oncologicas Integradas - COI
City
Rio De Janeiro
State/Province
RJ
ZIP/Postal Code
22290-160
Country
Brazil
Facility Name
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Clinica Viver
City
Santa Maria
State/Province
RS
ZIP/Postal Code
97015-373
Country
Brazil
Facility Name
Clinica de Neoplasias Litoral
City
Itajai
State/Province
SC
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Hospital de Base de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Beneficencia Portuguesa de Sao Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01321-00
Country
Brazil
Facility Name
Tom Baker Cancer Centre-Calgary; Clinical Research Unit
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BC Cancer Agency, CSI
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Dr. Georges L. Dumont University Hospital Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Juravinski Cancer Clinic; Clinical Trials Department
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
North York General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2J 1V1
Country
Canada
Facility Name
Bradford Hill Centro de Investigaciones Clinicas
City
Recoleta
ZIP/Postal Code
8420383
Country
Chile
Facility Name
OrlandiOncología
City
Santiago
ZIP/Postal Code
7500713
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Clinica Alemana
City
Vitacura
ZIP/Postal Code
0
Country
Chile
Facility Name
Peking Union Medical College Hospital
City
Beijing City
ZIP/Postal Code
100032
Country
China
Facility Name
Beijing Friendship Hospital
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Chongqing Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Sun Yat-sen Memorial Hospital
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing City
ZIP/Postal Code
211100
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
Huadong Hospital Affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
The 2nd Hospital of Tianjin Medical University
City
Tianjin
ZIP/Postal Code
201203
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
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
University Hospital Motol; Department of Urology
City
Praha 5
ZIP/Postal Code
15006
Country
Czechia
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
North Estonia Medical Centre Foundation; Oncology Center
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Oulu University Hospital; Oncology
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Facility Name
Turku Uni Central Hospital; Oncology Clinics
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Research institute for Clinical Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
National Center of Urology
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Chemotherapy and Immunotherapy Clinic Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
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
Princess Margaret Hospital; Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital; Clinical Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital; Dept. of Clinical Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
The Chinese University of Hong Kong; Department of Clinical Oncology
City
N.t.
Country
Hong Kong
Facility Name
Rambam Health Care Campus; Oncology
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
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
A.O. Universitaria Policlinico Di Modena; Oncologia
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro; Oncologia medica 2
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
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
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Nagoya University Hospital
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Hirosaki University Hospital
City
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Gunma University Hospital
City
Gunma
ZIP/Postal Code
371-8511
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
Kanazawa University Hospital
City
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
The Cancer Institute Hospital, JFCR; Urology
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Kyungpook National University Medical Center
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
003-722
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
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
Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
City
Kuala Lumpur
State/Province
FED. Territory OF Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
University Malaya Medical Centre; Clinical Oncology Unit,
City
Kuala Lumpur
State/Province
FED. Territory OF Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Consultorio Médico
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45040
Country
Mexico
Facility Name
Health Pharma Professional Research
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Hospital San Jose; Centro de investigacion y transferencia en salud del Tec de Monterrey
City
Monterrey, N.L
State/Province
Nuevo LEON
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Cancerología
City
Querétaro
State/Province
Queretaro
ZIP/Postal Code
76090
Country
Mexico
Facility Name
IMSS Hospital General de Zona No. 48 S. Pedro Xalpa; Departamento de Urología
City
Mexico CITY (federal District)
ZIP/Postal Code
02710
Country
Mexico
Facility Name
Hagaziekenhuis, locatie Leyweg
City
Den-Haag
ZIP/Postal Code
2545 AA
Country
Netherlands
Facility Name
Martini Ziekenhuis; Dept of Internal Medicine
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum; Internal Diseases
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Isala Klinieken, Sophia
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Przychodnia Lekarska KOMED, Roman Karaszewski
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
NU-MED Centrum Diagnostyki i Terapii Onkologicznej
City
Tomaszów Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Facility Name
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
City
Warszawa
ZIP/Postal Code
04-073
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
Hospital de Santa Maria; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Spitalul Judetean de Urgenta Dr Constantin Opris
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
Institute Of Oncology Bucharest; Medical Oncology
City
Bucharest
ZIP/Postal Code
022338
Country
Romania
Facility Name
Oncology Center Sf. Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic
City
Barnaul
State/Province
Altaj
ZIP/Postal Code
656049
Country
Russian Federation
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
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
City
Krasnoyarsk
State/Province
Krasnodar
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center; Urological Dept
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Russian Scientific Center of Roentgenoradiology
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
117997
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
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Scientific Research Oncology Institute named after N.N. Petrov; Oncology
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Sverdlovsk Regional Clinical Hospital 1
City
Yekaterinburg
State/Province
Sverdlovsk
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
Clinical Center of Serbia; Clinic of Urology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Centre Nis, Clinic for Oncology
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Oncology Institute of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
National University Hospital; National University Cancer Institute, Singapore (NCIS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Facility Name
Oncocare Cancer Centre; Gleneagles Medical Centre
City
Singapore
Country
Singapore
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
GVI Oncology Outeniqua Unit
City
George
ZIP/Postal Code
6530
Country
South Africa
Facility Name
Cancercare
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Wilgers Oncology Centre
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Steve Biko Academic Hospital; Oncology
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Sandton Oncology Medical Group
City
Sandton
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Hospital General Universitario de Elche; Servicio de Oncologia
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Institutio Catalan De Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Complejo Hospitalario de Althaia; Servicio de Oncologia
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
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 Universitario Marques de Valdecilla; Servicio de Oncologia
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Provincial de Castellon; Servicio de Oncologia
City
Castellon de La Plana
State/Province
Castellon
ZIP/Postal Code
12002
Country
Spain
Facility Name
Hospital Universitario Son Espases
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Alvaro Cunqueiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
Hospital de Basurto; Servicio de Oncologia
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia
City
Albacete
ZIP/Postal Code
02006
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
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital San Pedro De Alcantara; Servicio de Oncologia
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Juan Ramon Jimenez;Servicio de Oncologia
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
City
Leon
ZIP/Postal Code
24071
Country
Spain
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
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 Universitario Clínico 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
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario de Toledo
City
Toledo
ZIP/Postal Code
45007
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Oncologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio de Oncologia Medica
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Chang Gung Medical Foundation - Kaohsiung; Oncology
City
Kaohisung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital; Urology
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital; Division of Urology
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; Dept of Oncology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Medical Foundation-Linkou, Urinary Oncology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Vajira Hospital
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Facility Name
Chulalongkorn Hospital; Medical Oncology
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital; Department of Medicine
City
ChiangMai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01230
Country
Turkey
Facility Name
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Bezmi Alem Vakif University Medical School; Oncology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
City
Kadiköy
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Medikal Park Izmir Hospital
City
Kar??yaka
ZIP/Postal Code
35575
Country
Turkey
Facility Name
19 Mayis University Medical Faculty; Medical Oncology Department
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Sihhiye/Ankara
ZIP/Postal Code
06230
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
Zaporizhzhia Regional Clinic
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust - University College Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
The York Hospital
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32416780
Citation
Galsky MD, Arija JAA, Bamias A, Davis ID, De Santis M, Kikuchi E, Garcia-Del-Muro X, De Giorgi U, Mencinger M, Izumi K, Panni S, Gumus M, Ozguroglu M, Kalebasty AR, Park SH, Alekseev B, Schutz FA, Li JR, Ye D, Vogelzang NJ, Bernhard S, Tayama D, Mariathasan S, Mecke A, Thastrom A, Grande E; IMvigor130 Study Group. Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2020 May 16;395(10236):1547-1557. doi: 10.1016/S0140-6736(20)30230-0.
Results Reference
derived
PubMed Identifier
27939400
Citation
Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Duran I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thastrom A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8. Erratum In: Lancet. 2017 Aug 26;390(10097):848.
Results Reference
derived

Learn more about this trial

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

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