AzTrials
AzTrials

Urothelial CarcinomaPhase 3IMvigor130NCT02807636

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

A Phase 3 study testing Atezolizumab, Carboplatin and Gemcitabine in people with Urothelial Carcinoma, run by Hoffmann-La Roche at 204 sites in 35 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
Atezolizumab, Carboplatin and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,213 participants
Where
204 sitesin 35 countries
Study dates
30 Jun 2016to 12 Feb 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

204 sites in 35 countries.

204 sites in 35 countries

Spain32 sites

  • Complejo Hospitalario Universitario de Albacete

    Albacete, 02006

  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035

  • Hospital Clinic de Barcelona. Unidad de Nuevas Terapias

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Institutio Catalan De Oncologia

    Barcelona, 08907

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Complejo Asistencial Universitario De Burgos

    Burgos, 09006

  • Hospital San Pedro De Alcantara

    Cáceres, 10003

  • Hospital Provincial de Castellon

    Castellon, Castellon, 12002

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

    Jaén, 23007

  • Complejo Asistencial Universitario de Leon

    León, 24071

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Complejo Hospitalario de Althaia

    Manresa, Barcelona, 08243

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07014

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario de Toledo

    Toledo, 45007

  • Hospital Universitario la Fe

    Valencia, 46026

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

United States18 sites

  • University of North Carolina, Lineberger Cancer Ctr

    Chapel Hill, North Carolina, 27599

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

  • Bon Secours - St. Francis Hospital

    Greenville, South Carolina, 29607

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Norton Cancer Institute

    Louisville, Kentucky, 40402

  • East Jefferson Hematology Oncology

    Metairie, Louisiana, 70006

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203

  • Yale School of Medicine

    New Haven, Connecticut, 06520-8032

  • Mount Sinai School of Medicine - Tisch Cancer Institute

    New York, New York, 10029

  • Christina Care Institutional Review Board

    Newark, Delaware, 19713

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • UF Health Cancer Center at Orlando Health

    Orlando, Florida, 32824

  • Highlands Oncology Group

    Rogers, Arkansas, 72758

  • Park Nicollet Clin-Cancer Ctr

    Saint Louis Park, Minnesota, 55426

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)

    St. Petersburg, Florida, 33705

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Japan14 sites

  • Nagoya University Hospital

    Aichi, 466-8560

  • Hirosaki University Hospital

    Aomori, 036-8563

  • National Hospital Organization Shikoku Cancer Center

    Ehime, 791-0280

  • Gunma University Hospital

    Gunma, 371-8511

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804

  • University of Tsukuba Hospital

    Ibaraki, 305-8576

  • Kanazawa University Hospital

    Ishikawa, 920-8641

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • Kindai University Hospital

    Osaka, 589-8511

  • Toranomon Hospital

    Tokyo, 105-8470

  • The Cancer Institute Hospital, JFCR

    Tokyo, 135-8550

  • Keio University Hospital

    Tokyo, 160-8582

Other trials in Japan

Italy12 sites

  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato

    Arezzo, Tuscany, 52100

  • Az. Osp. Uni Ria San Martino

    Genoa, Liguria, 16132

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133

  • A.O. Universitaria Policlinico Di Modena

    Modena, Emilia-Romagna, 41100

  • Azienda Ospedaliera A. Cardarelli

    Naples, Campania, 80131

  • IRCCS Istituto Oncologico Veneto (IOV)

    Padova, Veneto, 35128

  • Policlinico Umberto i di Roma

    Rome, Lazio, 00161

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

  • IRCCS Ospedale Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, Apulia, 71013

  • Azienda Ospedaliera S. Maria - Terni

    Terni, Umbria, 05100

  • A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro

    Turin, Piedmont, 10126

Other trials in Italy

Brazil11 sites

  • CETUS Hospital Dia Oncologia

    Belo Horizonte, Minas Gerais, 30110022

  • Hospital Luxemburgo

    Belo Horizonte, Minas Gerais, 31190-131

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Clinicas Oncologicas Integradas - COI

    Rio de Janeiro, 22793-080

  • Clinica Viver

    Santa Maria, Rio Grande do Sul, 97015-450

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Beneficencia Portuguesa de Sao Paulo

    São Paulo, São Paulo, 01323-900

Other trials in Brazil

China9 sites

  • Beijing Friendship Hospital

    Beijing, 100050

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Chongqing Cancer Hospital

    Chongqing, 400030

  • Sun Yat-sen Memorial Hospital

    Guangzhou, 510000

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, 200040

  • The 2nd Hospital of Tianjin Medical University

    Tianjin, 201203

Other trials in China

Russia9 sites

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky

    Krasnoyarsk, Krasnodarskiy Kray, 660133

  • Blokhin Cancer Research Center

    Moscow, Moscow Oblast, 115478

  • Russian Scientific Center of Roentgenoradiology

    Moscow, Moscow Oblast, 117997

  • P.A. Herzen Oncological Inst.

    Moscow, Moscow Oblast, 125248

  • Privolzhsk Regional Medical Center

    Nizhny Novgorod, Niznij Novgorod, 603001

  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

    Saint Petersburg, Sankt-Peterburg, 197089

  • SBEI of HPE ?Bashkir State Medical University? of MoH RF

    Ufa, Bashkortostan Republic, 450000

  • Sverdlovsk Regional Clinical Hospital 1

    Yekaterinburg, Sverdlovsk Oblast, 620102

Other trials in Russia

Canada7 sites

  • Arthur J.E. Child Comprehensive Cancer Center-Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Clinic

    Hamilton, Ontario, L8V 5C2

  • BC Cancer Agency, CSI

    Kelowna, British Columbia, V1Y 5L3

  • Dr. Georges L. Dumont University Hospital Centre

    Moncton, New Brunswick, E1C8X3

  • Lakeridge Health Center

    Oshawa, Ontario, L1G 2B9

  • North York General Hospital

    Toronto, Ontario, M2K 1E1

Other trials in Canada

Poland7 sites

  • Bialostockie Centrum Onkologii

    Bialystok, 15-027

  • Przychodnia Lekarska KOMED, Roman Karaszewski

    Konin, 62-500

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii

    Lodz, 93-513

  • Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

    Poznan, 60-569

  • NU-MED Centrum Diagnostyki i Terapii Onkologicznej

    Tomaszów Mazowiecki, 97-200

  • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

    Warsaw, 04-073

Other trials in Poland

Turkey (Türkiye)7 sites

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital

    Adana, 01250

  • Ankara Bilkent City Hospital

    Ankara, 06800

  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

    Edirne, 22030

  • Bezmi Alem Vakif University Medical School

    Istanbul, 34093

  • Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty

    Istanbul, 34098

  • Hacettepe Uni Medical Faculty Hospital

    S?hhiye, Ankara, 06100

  • 19 Mayis University Medical Faculty

    Samsun, 55139

Other trials in Turkey (Türkiye)

Australia6 sites

  • Lyell McEwin Hospital

    Adelaide, South Australia, 5112

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Macquarie University Hospital

    Macquarie University, New South Wales, 2109

  • Cabrini Medical Centre

    Malvern, Victoria, 3144

  • Sunshine Hospital

    St Albans, Victoria, DUMMY_VALUE

Other trials in Australia

Taiwan6 sites

  • Chang Gung Medical Foundation - Kaohsiung

    Kaohisung, DUMMY_VALUE

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Cheng Kung Uni Hospital

    Tainan, 704

  • National Taiwan Uni Hospital

    Taipei, 10048

  • Chang Gung Medical Foundation-Linkou, Urinary Oncology

    Taoyuan, 333

Other trials in Taiwan

Belgium4 sites

  • GHdC Site Notre Dame

    Charleroi, B6000

  • AZ Sint Lucas (Sint Lucas)

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHC MontLégia

    Liège, 4000

Other trials in Belgium

Chile4 sites

  • Bradford Hill Centro de Investigaciones Clinicas

    Recoleta, 8420383

  • OrlandiOncología

    Santiago, 7500713

  • Fundacion Arturo Lopez Perez

    Santiago, Providencia

  • Clinica Alemana

    Vitacura, 0

Other trials in Chile

Czechia4 sites

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • University Hospital Motol

    Prague, 15006

Other trials in Czechia

Hong Kong4 sites

  • Princess Margaret Hospital

    Hong Kong, DUMMY_VALUE

  • Queen Elizabeth Hospital

    Hong Kong, DUMMY_VALUE

  • Queen Mary Hospital

    Hong Kong, DUMMY_VALUE

  • The Chinese University of Hong Kong

    Hong Kong, DUMMY_VALUE

Other trials in Hong Kong

Mexico4 sites

  • Health Pharma Professional Research

    CD Mexico, Mexico CITY (federal District), 03810

  • IMSS Hospital General de Zona No. 48 S. Pedro Xalpa

    Mexico CITY (federal District), Mexico CITY (federal District), 02710

  • Cancerología

    Querétaro, 76090

  • Consultorio Médico

    Zapopan, Jalisco, 45040

Other trials in Mexico

Netherlands4 sites

  • Martini Ziekenhuis

    Groningen, 9728 NT

  • Hagaziekenhuis, locatie Leyweg

    NL -DEN HAAG, 2504 LN

  • Zuyderland Medisch Centrum

    Sittard-Geleen, 6162 BG

  • Isala Klinieken, Sophia

    Zwolle, 8025 AB

Other trials in Netherlands

South Korea4 sites

  • Kyungpook National University Medical Center

    Daegu, 41404

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

Other trials in South Korea

Thailand4 sites

  • Vajira Hospital

    Bangkok, 10300

  • Chulalongkorn Hospital

    Bangkok, 10330

  • Faculty of Med. Siriraj Hosp.

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

Other trials in Thailand

United Kingdom4 sites

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, NW1 2BU

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • The York Hospital

    York, YO31 8HE

Other trials in United Kingdom

Romania3 sites

  • Spitalul Judetean de Urgenta Dr Constantin Opris

    Baia Mare, 430031

  • Institute Of Oncology Bucharest

    Bucharest, 022338

  • Oncology Center Sf. Nectarie

    Craiova, 200347

Other trials in Romania

Serbia3 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Oncology Institute of Vojvodina

    Kamenitz, 21204

  • Clinical Centre Nis, Clinic for Oncology

    Niš, 18000

Other trials in Serbia

Singapore3 sites

  • National University Hospital

    Singapore, 119228

  • National Cancer Centre

    Singapore, 169610

  • Oncocare Cancer Centre

    Singapore, DUMMY_VALUE

Other trials in Singapore

South Africa3 sites

  • Cancercare

    Port Elizabeth, 6045

  • Wilgers Oncology Centre

    Pretoria, 0001

  • Sandton Oncology Medical Group

    Sandton, 2196

Other trials in South Africa

Ukraine3 sites

  • CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR

    Dnipropetrovsk, 49102

  • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

    Kharkiv, Kharkiv Governorate, 61037

  • Zaporizhzhia Regional Clinic

    Zaporizhzhya, 69600

Other trials in Ukraine

Estonia2 sites

  • East Tallinn Central Hospital

    Tallinn, 10138

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

Other trials in Estonia

Finland2 sites

  • Oulu University Hospital

    Oulu, 90029

  • Turku Uni Central Hospital

    Turku, 20520

Other trials in Finland

Georgia2 sites

  • Research institute for Clinical Medicine

    Tbilisi, 0112

  • National Center of Urology

    Tbilisi, 0144

Other trials in Georgia

Greece2 sites

  • Alexandras General Hospital of Athens

    Athens, 11528

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

Other trials in Greece

Malaysia2 sites

  • Hospital Kuala Lumpur

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 59100

Other trials in Malaysia

Portugal2 sites

  • Hospital de Santa Maria

    Lisbon, 1649-035

  • IPO do Porto

    Porto, 4200-072

Other trials in Portugal

Bosnia and Herzegovina1 site

  • Clinical center University of Sarajevo

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Israel1 site

  • Rambam Health Care Campus

    Haifa, 3109601

Other trials in Israel

Slovenia1 site

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

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

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

Keywords
Urothelial carcinoma, Bladder cancer, Anti-PD-L1, Transitional carcinoma, Tecentriq, Atezolizumab, IMvigor130
Medical subject headings
Carcinoma, Transitional Cell, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    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.

  • CarboplatinDrug

    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.

  • GemcitabineDrug

    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.

  • PlaceboOther

    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.

  • CisplatinDrug

    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.

Study groups in NCT02807636
Study groupRoleWhat they receive
Atezolizumab+Gemcitabine+Carboplatin/CisplatinExperimentalParticipants will receive blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
Receives: Drug: Atezolizumab; Drug: Carboplatin; Drug: Gemcitabine; Drug: Cisplatin
Placebo+Gemcitabine+Carboplatin/CisplatinPlacebo comparatorParticipants will receive blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
Receives: Drug: Carboplatin; Drug: Gemcitabine; Other: Placebo; Drug: Cisplatin
Atezolizumab MonotherapyExperimentalEligible participants will receive open-label atezolizumab as monotherapy.
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm

    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.

    Measured: Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months)

  2. Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

    OS is defined as the time from randomization to death due to any cause.

    Measured: Baseline until death due to any cause (up to approximately 73 months)

  3. Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

    OS is defined as the time from randomization to death due to any cause.

    Measured: Baseline until death due to any cause (up to approximately 73 months)

Secondary outcomes (21)

  1. Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

    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.

    Measured: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)

  2. Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

    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.

    Measured: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)

  3. Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

    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.

    Measured: 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)

  4. Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

    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.

    Measured: 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)

  5. IRF-PFS

    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.

    Measured: Randomization to first documented disease progression or death from any cause (up to 35 months)

  6. OS Event Free Rate Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

    Overall Survival (OS) Event Free Rate at 1 Year.

    Measured: Year 1

  7. OS Event Free Rate in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

    Overall Survival (OS) Event Free Rate at 1 Year.

    Measured: Year 1

  8. PFS Event Free Rate

    Progression Free Survival (PFS) Event Free Rate at Year 1

    Measured: Year 1

  9. 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 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.

    Measured: Up to approximately 73 months

  10. 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 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.

    Measured: Up to approximately 73 months

  11. 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

    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.

    Measured: Up to approximately 73 months

  12. 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

    Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab Monotherapy Arm.

    Measured: Up to approximately 73 months

  13. Maximum Atezolizumab Serum Concentration

    Maximum atezolizumab serum concentration.

    Measured: Cycle 1 Day 1

  14. Minimum Atezolizumab Serum Concentration

    Minimum atezolizumab serum concentration.

    Measured: 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

  15. Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs)

    Percentage of participants with Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs).

    Measured: Up to approximately 35 months

  16. Investigator-Assessed Progression-Free Survival (INV-PFS) in Participants Treated With Atezolizumab Monotherapy Arm Compared With Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

    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.

    Measured: 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)

  17. Percentage of Participants With Grade 3-4 Adverse Events (AEs)

    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.

    Measured: Baseline up to 93 months

  18. Percentage of Participants With Grade 5 Adverse Events (AEs)

    Percentage of participants with Grade 5 Adverse Events (AEs) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

    Measured: Baseline up to 93 months

  19. Percentage of Participants With Serious Adverse Events (SAEs)

    Percentage of participants with Serious Adverse Events (SAEs) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

    Measured: Baseline up to 93 months

  20. Percentage of Participants With Adverse Events (AEs) Leading to Withdrawal of Any Study Treatment

    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.

    Measured: Baseline up to 93 months

  21. Percentage of Participants With Atezolizumab-Specific Adverse Events of Special Interest (AESIs)

    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.

    Measured: Baseline up to 93 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2016 (estimated)
  2. Study start30 Jun 2016
  3. Primary completion31 Aug 2022
  4. Study completion12 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02807636
Sponsor's protocol ID
WO30070
Other IDs
2016-000250-35, 2016
Acronym
IMvigor130
Status last verified
Feb 2025
First submitted
17 Jun 2016
Last updated
24 Feb 2025
Data monitoring committee
Yes

Publications

  • Galsky MD, Guan X, Rishipathak D, Rapaport AS, Shehata HM, Banchereau R, Yuen K, Varfolomeev E, Hu R, Han CJ, Li H, Liang Y, Vucic D, Wang L, Zhu J, Yu H, Herbst RH, Hajaj E, Kiner E, Bamias A, De Santis M, Davis ID, Arranz JA, Kikuchi E, Bernhard S, Williams P, Lee C, Mellman I, Sanjabi S, Johnston R, Black PC, Grande E, Mariathasan S. Immunomodulatory effects and improved outcomes with cisplatin- versus carboplatin-based chemotherapy plus atezolizumab in urothelial cancer. Cell Rep Med. 2024 Feb 20;5(2):101393. doi: 10.1016/j.xcrm.2024.101393. Epub 2024 Jan 26.

    PubMed 38280376

  • Grande E, Arranz JA, De Santis M, Bamias A, Kikuchi E, Del Muro XG, Park SH, De Giorgi U, Alekseev B, Mencinger M, Izumi K, Schutz FA, Puente J, Li JR, O'Donnell PH, Kalebasty AR, Ye D, Mariathasan S, Bene-Tchaleu F, Bernhard S, Lee C, Davis ID, Galsky MD. Atezolizumab plus chemotherapy versus placebo plus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis results from a randomised, controlled, phase 3 study. Lancet Oncol. 2024 Jan;25(1):29-45. doi: 10.1016/S1470-2045(23)00540-5. Epub 2023 Dec 12.

    PubMed 38101433

  • Bamias A, Davis ID, Galsky MD, Arranz JA, Kikuchi E, Grande E, Del Muro XG, Park SH, De Giorgi U, Alekseev B, Mencinger M, Izumi K, Schutz FA, Puente J, Li JR, Panni S, Gumus M, Ozguroglu M, Mariathasan S, Poloz Y, Bene-Tchaleu F, Lee C, Bernhard S, De Santis M. Atezolizumab monotherapy versus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis from a randomised, controlled, phase 3 study. Lancet Oncol. 2024 Jan;25(1):46-61. doi: 10.1016/S1470-2045(23)00539-9. Epub 2023 Dec 12.

    PubMed 38101431

  • Grande E, Bamias A, Galsky MD, Kikuchi E, Davis ID, Arranz JA, Rezazadeh Kalebasty A, Garcia Del Muro X, Park SH, De Giorgi U, Alekseev B, Mencinger M, Izumi K, Puente J, Li JR, Bernhard S, Nicholas A, Telliez J, De Santis M. Overall Survival by Response to First-line Induction Treatment with Atezolizumab plus Platinum-based Chemotherapy or Placebo plus Platinum-based Chemotherapy for Metastatic Urothelial Carcinoma. Eur Urol Open Sci. 2023 Nov 4;58:28-36. doi: 10.1016/j.euros.2023.10.002. eCollection 2023 Dec.

    PubMed 37954037

  • 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.

    PubMed 32416780

  • 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.

    PubMed 27939400

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Carboplatin and Gemcitabine in people with Urothelial Carcinoma, run by Hoffmann-La Roche at 204 sites in 35 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 204 sites in Spain, United States, Japan, Italy, Brazil and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02807636, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.

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