Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma (IMvigor130)
February 6, 2025 updated by: Hoffmann-La Roche
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
A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1213
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Macquarie University, New South Wales, Australia, 2109
- Macquarie University Hospital
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Queensland
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Herston, Queensland, Australia, 4029
- Royal Brisbane and Women'S Hospital
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South Australia
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Adelaide, South Australia, Australia, 5112
- Lyell McEwin Hospital
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Victoria
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Box Hill, Victoria, Australia, 3128
- Box Hill Hospital
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Malvern, Victoria, Australia, 3144
- Cabrini Medical Centre
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St Albans, Victoria, Australia, DUMMY_VALUE
- Sunshine Hospital
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Charleroi, Belgium, B6000
- GHdC Site Notre Dame
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Gent, Belgium, 9000
- AZ Sint Lucas (Sint Lucas)
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Leuven, Belgium, 3000
- UZ Leuven Gasthuisberg
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Liege, Belgium, 4000
- CHC MontLegia
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Sarajevo, Bosnia and Herzegovina, 71000
- Clinical Center University of Sarajevo
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Rio de Janeiro, Brazil, 22793-080
- Clinicas Oncologicas Integradas - COI
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30110022
- Cetus Hospital Dia Oncologia
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Belo Horizonte, Minas Gerais, Brazil, 31190-131
- Hospital Luxemburgo
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Rio Grande Do Sul
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Ijui, Rio Grande Do Sul, Brazil, 98700-000
- Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
- Hospital Nossa Senhora da Conceicao
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
- Hospital das Clinicas - UFRGS
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Santa Maria, Rio Grande Do Sul, Brazil, 97015-450
- Clínica Viver
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Santa Catarina
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Itajai, Santa Catarina, Brazil, 88301-220
- Clinica de Neoplasias Litoral
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São Paulo
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Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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Sao Paulo, São Paulo, Brazil, 01323-900
- Beneficencia Portuguesa de Sao Paulo
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Sao Paulo, São Paulo, Brazil, 01246-000
- Instituto do Cancer do Estado de Sao Paulo - ICESP
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Arthur J.E. Child Comprehensive Cancer Center-Calgary
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
- BC Cancer Agency, CSI
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New Brunswick
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Moncton, New Brunswick, Canada, E1C8X3
- Dr. Georges L. Dumont University Hospital Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Clinic
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Oshawa, Ontario, Canada, L1G 2B9
- Lakeridge Health Center
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Toronto, Ontario, Canada, M2K 1E1
- North York General Hospital
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Recoleta, Chile, 8420383
- Bradford Hill Centro de Investigaciones Clinicas
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Santiago, Chile, 7500713
- Orlandioncologia
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Santiago, Chile, Providencia
- Fundacion Arturo Lopez Perez
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Vitacura, Chile
- Clinica Alemana
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Beijing, China, 100730
- Peking Union Medical College Hospital
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Beijing, China, 100050
- Beijing Friendship Hospital
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Chongqing, China, 400030
- Chongqing Cancer Hospital
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Guangzhou, China, 510000
- Sun Yat-sen Memorial Hospital
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Nanjing, China, 210009
- Jiangsu Cancer Hospital
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Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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Shanghai, China, 200032
- Zhongshan Hospital Fudan University
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Shanghai, China, 200040
- Huadong Hospital Affiliated to Fudan University
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Tianjin, China, 201203
- The 2nd Hospital of Tianjin Medical University
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Brno, Czechia, 656 53
- Masarykuv onkologicky ustav
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Olomouc, Czechia, 779 00
- Fakultni nemocnice Olomouc
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Praha 2, Czechia, 128 08
- Vseobecna fakultni nemocnice v Praze
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Praha 5, Czechia, 15006
- University Hospital Motol
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Tallinn, Estonia, 10138
- East Tallinn Central Hospital
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Tallinn, Estonia, 13419
- North Estonia Medical Centre Foundation
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Oulu, Finland, 90029
- Oulu University Hospital
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Turku, Finland, 20520
- Turku Uni Central Hospital
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Tbilisi, Georgia, 0112
- Research institute for Clinical Medicine
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Tbilisi, Georgia, 0144
- National Center of Urology
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Athens, Greece, 11528
- Alexandras General Hospital of Athens
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Patras, Greece, 265 04
- University Hospital of Patras Medical Oncology
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Hong Kong, Hong Kong, DUMMY_VALUE
- Princess Margaret Hospital
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Hong Kong, Hong Kong, DUMMY_VALUE
- Queen Elizabeth Hospital
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Hong Kong, Hong Kong, DUMMY_VALUE
- Queen Mary Hospital
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Hong Kong, Hong Kong, DUMMY_VALUE
- The Chinese University of Hong Kong
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Haifa, Israel, 3109601
- Rambam Health Care Campus
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Campania
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Napoli, Campania, Italy, 80131
- Azienda Ospedaliera A. Cardarelli
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Emilia-Romagna
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Meldola, Emilia-Romagna, Italy, 47014
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
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Modena, Emilia-Romagna, Italy, 41100
- A.O. Universitaria Policlinico Di Modena
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Lazio
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Roma, Lazio, Italy, 00161
- Policlinico Umberto i di Roma
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Liguria
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Genova, Liguria, Italy, 16132
- Az. Osp. Uni Ria San Martino
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Lombardia
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Milano, Lombardia, Italy, 20133
- Irccs Istituto Nazionale Dei Tumori (Int)
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Rozzano, Lombardia, Italy, 20089
- Istituto Clinico Humanitas
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Piemonte
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Torino, Piemonte, Italy, 10126
- A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro
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Puglia
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San Giovanni Rotondo, Puglia, Italy, 71013
- IRCCS Ospedale Casa Sollievo della Sofferenza
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Toscana
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Arezzo, Toscana, Italy, 52100
- Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato
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Umbria
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Terni, Umbria, Italy, 05100
- Azienda Ospedaliera S. Maria - Terni
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Veneto
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Padova, Veneto, Italy, 35128
- IRCCS Istituto Oncologico Veneto (IOV)
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Aichi, Japan, 466-8560
- Nagoya University Hospital
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Aomori, Japan, 036-8563
- Hirosaki University Hospital
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Ehime, Japan, 791-0280
- National Hospital Organization Shikoku Cancer Center
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Gunma, Japan, 371-8511
- Gunma University Hospital
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Hokkaido, Japan, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Ibaraki, Japan, 305-8576
- University of Tsukuba Hospital
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Ishikawa, Japan, 920-8641
- Kanazawa University Hospital
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Kumamoto, Japan, 860-8556
- Kumamoto University Hospital
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Niigata, Japan, 951-8520
- Niigata University Medical & Dental Hospital
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Osaka, Japan, 589-8511
- Kindai University Hospital
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Osaka, Japan, 545-8586
- Osaka Metropolitan University Hospital
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Tokyo, Japan, 160-8582
- Keio University Hospital
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Tokyo, Japan, 105-8470
- Toranomon Hospital
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Tokyo, Japan, 135-8550
- The Cancer Institute Hospital, JFCR
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Daegu, Korea, Republic of, 41404
- Kyungpook National University Medical Center
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Incheon, Korea, Republic of, 21565
- Gachon University Gil Medical Center
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System
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FED. Territory OF Kuala Lumpur
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Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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Mexico CITY (federal District), Mexico, 02710
- IMSS Hospital General de Zona No. 48 S. Pedro Xalpa
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Queretaro, Mexico, 76090
- Cancerología
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Jalisco
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Zapopan, Jalisco, Mexico, 45040
- Consultorio Medico
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Mexico CITY (federal District)
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CD Mexico, Mexico CITY (federal District), Mexico, 03810
- Health Pharma Professional Research
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Groningen, Netherlands, 9728 NT
- Martini Ziekenhuis
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Nl -den Haag, Netherlands, 2504 LN
- Hagaziekenhuis, locatie Leyweg
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Sittard-Geleen, Netherlands, 6162 BG
- Zuyderland Medisch Centrum
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Zwolle, Netherlands, 8025 AB
- Isala Klinieken, Sophia
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Bialystok, Poland, 15-027
- Bialostockie Centrum Onkologii
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Konin, Poland, 62-500
- Przychodnia Lekarska KOMED, Roman Karaszewski
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Kraków, Poland, 31-501
- Szpital Uniwersytecki w Krakowie
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Lodz, Poland, 93-513
- Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii
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Poznan, Poland, 60-569
- Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
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Tomaszów Mazowiecki, Poland, 97-200
- NU-MED Centrum Diagnostyki i Terapii Onkologicznej
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Warszawa, Poland, 04-073
- Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
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Lisboa, Portugal, 1649-035
- Hospital de Santa Maria
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Porto, Portugal, 4200-072
- IPO do Porto
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Baia Mare, Romania, 430031
- Spitalul Judetean de Urgenta Dr Constantin Opris
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Bucharest, Romania, 022338
- Institute of Oncology Bucharest
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Craiova, Romania, 200347
- Oncology Center Sf. Nectarie
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Ivanovo, Russian Federation, 153040
- Ivanovo Regional Oncology Dispensary
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Baskortostan
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UFA, Baskortostan, Russian Federation, 450000
- SBEI of HPE ?Bashkir State Medical University? of MoH RF
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Krasnodar
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Krasnoyarsk, Krasnodar, Russian Federation, 660133
- Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky
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Moskovskaja Oblast
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Moscow, Moskovskaja Oblast, Russian Federation, 117997
- Russian Scientific Center of Roentgenoradiology
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Moscow, Moskovskaja Oblast, Russian Federation, 115478
- Blokhin Cancer Research Center
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Moscow, Moskovskaja Oblast, Russian Federation, 125248
- P.A. Herzen Oncological Inst.
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Niznij Novgorod
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Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603001
- Privolzhsk Regional Medical Center
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Sankt Petersburg
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St Petersburg, Sankt Petersburg, Russian Federation, 197089
- SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
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Sverdlovsk
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Yekaterinburg, Sverdlovsk, Russian Federation, 620102
- Sverdlovsk Regional Clinical Hospital 1
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Belgrade, Serbia, 11000
- Clinical Center of Serbia
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NIs, Serbia, 18000
- Clinical Centre Nis, Clinic for Oncology
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Sremska Kamenica, Serbia, 21204
- Oncology Institute of Vojvodina
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Singapore, Singapore, 169610
- National Cancer Centre
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Singapore, Singapore, 119228
- National University Hospital
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Singapore, Singapore, DUMMY_VALUE
- OncoCare Cancer Centre
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Ljubljana, Slovenia, 1000
- Institute of Oncology Ljubljana
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Port Elizabeth, South Africa, 6045
- Cancercare
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Pretoria, South Africa, 0001
- Wilgers Oncology Centre
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Sandton, South Africa, 2196
- Sandton Oncology Medical Group
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Albacete, Spain, 02006
- Complejo Hospitalario Universitario de Albacete
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Barcelona, Spain, 08041
- Hospital de La Santa Creu I Sant Pau
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Barcelona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol
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Barcelona, Spain, 08035
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona
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Barcelona, Spain, 08036
- Hospital Clinic de Barcelona. Unidad de Nuevas Terapias
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Barcelona, Spain, 08907
- Institutio Catalan De Oncologia
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Burgos, Spain, 09006
- Complejo Asistencial Universitario De Burgos
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Caceres, Spain, 10003
- Hospital San Pedro De Alcantara
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Castellon, Spain, 12002
- Hospital Provincial de Castellon
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Cordoba, Spain, 14004
- Hospital Universitario Reina Sofia
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Granada, Spain, 18014
- Hospital Universitario Virgen de las Nieves
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Jaen, Spain, 23007
- Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
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Leon, Spain, 24071
- Complejo Asistencial Universitario de Leon
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Lugo, Spain, 27003
- Hospital Universitario Lucus Augusti
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spain, 28046
- Hospital Universitario La Paz
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Madrid, Spain, 28034
- Hospital Ramon y Cajal
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Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañon
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Madrid, Spain, 28040
- Hospital Universitario Clinico San Carlos
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocío
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Toledo, Spain, 45007
- Hospital Universitario de Toledo
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Valencia, Spain, 46026
- Hospital Universitario La Fe
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Zaragoza, Spain, 50009
- Hospital Clinico Universitario Lozano Blesa
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Zaragoza, Spain, 50009
- Hospital Universitario Miguel Servet
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Alicante
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Elche, Alicante, Spain, 03203
- Hospital General Universitario de Elche
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Barcelona
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Manresa, Barcelona, Spain, 08243
- Complejo Hospitalario de Althaia
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Sabadell, Barcelona, Spain, 08208
- Corporacio Sanitaria Parc Tauli
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Cantabria
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Santander, Cantabria, Spain, 39008
- Hospital Universitario Marques De Valdecilla
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Islas Baleares
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Palma De Mallorca, Islas Baleares, Spain, 07014
- Hospital Universitario Son Espases
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Navarra
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Pamplona, Navarra, Spain, 31008
- Clinica Universitaria de Navarra
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Pontevedra
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Vigo, Pontevedra, Spain, 36312
- Hospital Alvaro Cunqueiro
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Vizcaya
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Bilbao, Vizcaya, Spain, 48013
- Hospital de Basurto
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Kaohisung, Taiwan, DUMMY_VALUE
- Chang Gung Medical Foundation - Kaohsiung
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taichung, Taiwan, 407
- Taichung Veterans General Hospital
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Tainan, Taiwan, 704
- National Cheng Kung Uni Hospital
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Taipei City, Taiwan, 10048
- National Taiwan Uni Hospital
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Taoyuan, Taiwan, 333
- Chang Gung Medical Foundation-Linkou, Urinary Oncology
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Bangkok, Thailand, 10330
- Chulalongkorn Hospital
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Bangkok, Thailand, 10300
- Vajira Hospital
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Bangkok, Thailand, 10700
- Faculty of Med. Siriraj Hosp.
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ChiangMai, Thailand, 50200
- Maharaj Nakorn Chiang Mai Hospital
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Adana, Turkey, 01250
- Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
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Ankara, Turkey, 06800
- Ankara Bilkent City Hospital
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Edirne, Turkey, 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Turkey, 34098
- Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty
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Istanbul, Turkey, 34093
- Bezmi Alem Vakif University Medical School
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S?hhiye, Ankara, Turkey, 06100
- Hacettepe Uni Medical Faculty Hospital
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Samsun, Turkey, 55139
- 19 Mayis University Medical Faculty
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Dnipropetrovsk, Ukraine, 49102
- CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
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Zaporizhzhia, Ukraine, 69600
- Zaporizhzhia Regional Clinic
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Kharkiv Governorate
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Kharkiv, Kharkiv Governorate, Ukraine, 61037
- Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
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Glasgow, United Kingdom, G12 0YN
- Beatson West of Scotland Cancer Centre
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London, United Kingdom, NW1 2BU
- University College London Hospitals NHS Foundation Trust - University College Hospital
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Manchester, United Kingdom, M20 4BX
- The Christie NHS Foundation Trust
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York, United Kingdom, YO31 8HE
- The York Hospital
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Arkansas
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Rogers, Arkansas, United States, 72758
- Highlands Oncology Group
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California
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San Luis Obispo, California, United States, 93401
- Coastal Integrative Cancer Care
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Connecticut
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New Haven, Connecticut, United States, 06520-8032
- Yale School of Medicine
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Norwalk, Connecticut, United States, 06856
- Norwalk Hospital
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Delaware
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Newark, Delaware, United States, 19713
- Christina Care Institutional Review Board
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Florida
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Fort Myers, Florida, United States, 33916
- Florida Cancer Specialists
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Orlando, Florida, United States, 32824
- UF Health Cancer Center at Orlando Health
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Saint Petersburg, Florida, United States, 33705
- Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center
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Indiana
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Fort Wayne, Indiana, United States, 46845
- Parkview Research Center
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Kentucky
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Louisville, Kentucky, United States, 40402
- Norton Cancer Institute
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Louisiana
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Metairie, Louisiana, United States, 70006
- East Jefferson Hematology Oncology
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Minnesota
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Saint Louis Park, Minnesota, United States, 55426
- Park Nicollet Clin-Cancer Ctr
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Nevada
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Las Vegas, Nevada, United States, 89148
- Comprehensive Cancer Centers of Nevada
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New York
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New York, New York, United States, 10029
- Mount Sinai School of Medicine - Tisch Cancer Institute
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina, Lineberger Cancer Ctr
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South Carolina
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Greenville, South Carolina, United States, 29607
- Bon Secours - St. Francis Hospital
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute / Tennessee Oncology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
Participants will receive blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
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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.
Other Names:
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.
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.
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.
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Placebo Comparator: Placebo+Gemcitabine+Carboplatin/Cisplatin
Participants will receive blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
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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.
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.
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.
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.
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Experimental: Atezolizumab Monotherapy
Eligible participants will receive open-label atezolizumab as monotherapy.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
Time Frame: Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months)
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PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever occurs first.
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Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months)
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Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Time Frame: Baseline until death due to any cause (up to approximately 73 months)
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OS is defined as the time from randomization to death due to any cause.
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Baseline until death due to any cause (up to approximately 73 months)
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Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Time Frame: Baseline until death due to any cause (up to approximately 73 months)
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OS is defined as the time from randomization to death due to any cause.
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Baseline until death due to any cause (up to approximately 73 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Time Frame: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
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Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments >= 28 days apart per RECIST v1.1, based on investigator assessment.
The analysis population for ORR will be all randomized participants with measurable disease at baseline.
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Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
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Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Time Frame: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
|
Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments >= 28 days apart per RECIST v1.1, based on investigator assessment.
The analysis population for ORR will be all randomized participants with measurable disease at baseline.
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Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
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Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Time Frame: From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
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Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first.
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From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
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Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Time Frame: From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
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Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first.
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From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
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IRF-PFS
Time Frame: Randomization to first documented disease progression or death from any cause (up to 35 months)
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Independent review facility PFS (IRF-PFS) is defined as the time from randomization to the first documented disease progression as determined by blinded independent central review with use of RECIST v1.1, or death due to any cause, whichever occurs first.
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Randomization to first documented disease progression or death from any cause (up to 35 months)
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OS Event Free Rate Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Time Frame: Year 1
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Overall Survival (OS) Event Free Rate at 1 Year.
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Year 1
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OS Event Free Rate in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Time Frame: Year 1
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Overall Survival (OS) Event Free Rate at 1 Year.
|
Year 1
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PFS Event Free Rate
Time Frame: Year 1
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Progression Free Survival (PFS) Event Free Rate at Year 1
|
Year 1
|
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Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
Time Frame: Up to approximately 73 months
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Time to deterioration in global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm.
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Up to approximately 73 months
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Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
Time Frame: Up to approximately 73 months
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Time to deterioration in global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 in the Placebo+Chemo Arm versus Atezolizumab Monotherapy Arm.
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Up to approximately 73 months
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Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
Time Frame: Up to approximately 73 months
|
Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm.
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Up to approximately 73 months
|
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Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
Time Frame: Up to approximately 73 months
|
Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab Monotherapy Arm.
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Up to approximately 73 months
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Maximum Atezolizumab Serum Concentration
Time Frame: Cycle 1 Day 1
|
Maximum atezolizumab serum concentration.
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Cycle 1 Day 1
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Minimum Atezolizumab Serum Concentration
Time Frame: Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, Cycle 16 Day 1, Cycle 24 Day 1, Cycle 32 Day 1, Day 120 post dose of last blinded atezolizumab treatment, and study drug early discontinuation
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Minimum atezolizumab serum concentration.
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Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, Cycle 16 Day 1, Cycle 24 Day 1, Cycle 32 Day 1, Day 120 post dose of last blinded atezolizumab treatment, and study drug early discontinuation
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Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs)
Time Frame: Up to approximately 35 months
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Percentage of participants with Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs).
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Up to approximately 35 months
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Investigator-Assessed Progression-Free Survival (INV-PFS) in Participants Treated With Atezolizumab Monotherapy Arm Compared With Placebo+Gemcitabine+Carboplatin/Cisplatin 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 35 months)
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PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever occurs first.
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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 35 months)
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Percentage of Participants With Grade 3-4 Adverse Events (AEs)
Time Frame: Baseline up to 93 months
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Percentage of participants with Grade 3-4 Adverse Events (AEs) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
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Baseline up to 93 months
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Percentage of Participants With Grade 5 Adverse Events (AEs)
Time Frame: Baseline up to 93 months
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Percentage of participants with Grade 5 Adverse Events (AEs) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
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Baseline up to 93 months
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Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame: Baseline up to 93 months
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Percentage of participants with Serious Adverse Events (SAEs) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
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Baseline up to 93 months
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Percentage of Participants With Adverse Events (AEs) Leading to Withdrawal of Any Study Treatment
Time Frame: Baseline up to 93 months
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Percentage of participants with Adverse Events (AEs) leading to withdrawal of any study treatment assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
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Baseline up to 93 months
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Percentage of Participants With Atezolizumab-Specific Adverse Events of Special Interest (AESIs)
Time Frame: Baseline up to 93 months
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Percentage of participants with atezolizumab-specific Adverse Events of Special Interest (AESIs) Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
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Baseline up to 93 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. doi: 10.1016/S0140-6736(17)32213-4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2016
Primary Completion (Actual)
August 31, 2022
Study Completion (Actual)
February 12, 2024
Study Registration Dates
First Submitted
June 17, 2016
First Submitted That Met QC Criteria
June 20, 2016
First Posted (Estimated)
June 21, 2016
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 6, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Carcinoma
- Carcinoma, Transitional Cell
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Antineoplastic Agents
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Atezolizumab
- Gemcitabine
- Carboplatin
Other Study ID Numbers
- WO30070
- 2016-000250-35 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.