AzTrials
AzTrials

Carcinoma, Transitional CellPhase 3IMvigor010NCT02450331

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

A Phase 3 study testing Atezolizumab in people with Carcinoma, Transitional Cell, run by Hoffmann-La Roche at 186 sites in 24 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Transitional Cell
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
809 participants
Where
186 sitesin 24 countries
Study dates
5 Oct 2015to 14 Jun 2022
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

  • Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma) of the bladder or upper urinary tract (i.e., renal pelvis or ureters)
  • For participants treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-4a or ypN+ (ypT2-4 or ypN+ for participants with upper urinary tract UC) and M0
  • For participants who have not received prior neoadjuvant chemotherapy: tumor stage of pT3-4a or pN+ (pT3-4 or pN+ for participants with upper urinary tract UC) and M0
  • Representative formalin-fixed paraffin-embedded tumor specimens from surgical resection (i.e., radical cystectomy, nephroureterectomy, or lymph node dissection) in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor programmed death-ligand 1 (PD-L1) expression prior to study enrollment
  • Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging scan of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization
  • Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery
Show all 10Show fewer
  • Eastern Cooperative Oncology Group performance status of less than or equal to (</=) 2
  • Life expectancy greater than or equal to (>/=) 12 weeks
  • Adequate hematologic and end-organ function
  • For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab

Who cannot join

  • Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
  • Adjuvant chemotherapy or radiation therapy for UC following surgical resection
  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug prior to enrollment
  • Malignancies other than UC within 5 years prior to Cycle 1, Day 1
  • Pregnancy or breastfeeding
  • Significant cardiovascular disease
Show all 16Show fewer
  • Severe infections within 4 weeks prior to Cycle 1, Day 1
  • Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • History of autoimmune disease
  • Prior allogeneic stem cell or solid organ transplant
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Positive test for human immunodeficiency virus and/or active hepatitis B or hepatitis C or tuberculosis
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1
  • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-CD40, anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies

Trial locations and contacts

186 sites in 24 countries.

186 sites in 24 countries

United States41 sites

  • University Of Michigan

    Ann Arbor, Michigan, 48109

  • University Of Colorado

    Aurora, Colorado, 80045

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • MSK @Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Dana Farber Cancer Inst.

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Massachusetts General Hospital.

    Boston, Massachusetts, 2114

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22906

  • Northwestern University Feinberg School Of Medicine

    Chicago, Illinois, 60611

  • University of Chicago; Hematology/Oncology

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44106

  • Fairview Hospital; Cleveland Clinic Cancer Center

    Cleveland, Ohio, 44111

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43212

  • Memorial Sloan-Kettering Cancer Center

    Commack, New York, 11725

  • University of Texas Southwestern

    Dallas, Texas, 75390-8897

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke Cancer Center

    Durham, North Carolina, 27710

  • Baylor College of Medicine; Gastroenterology

    Houston, Texas, 77030

  • University of Iowa Hospital & Clinic; Division of Hematology/Oncology

    Iowa City, Iowa, 52242

  • Albert B. Chandler Medical Center; University of Kentucky

    Lexington, Kentucky, 40536

  • Saint Barnabas Medical Center Cancer Center

    Livingston, New Jersey, 07039

  • UCLA

    Los Angeles, California, 90024

  • USC Norris Cancer Center

    Los Angeles, California, 90033

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Yale Cancer Center; Medical Oncology

    New Haven, Connecticut, 06520

  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • Abramson Cancer Center; Univ of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Kimmel Cancer Center Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Fox Chase-Temple Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Cleveland CL N Coast Cancer Cr

    Sandusky, Ohio, 44870

  • HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network

    Scottsdale, Arizona, 85258

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan17 sites

  • Nagoya University Hospital; Urology

    Aichi, 466-8560

  • Hirosaki University School of Medicine & Hospital; Urology

    Aomori, 036-8563

  • Shikoku Cancer Center

    Ehime, 791-0280

  • Hiroshima City Hiroshima Citizens Hospital; Urology

    Hiroshima, 730-8518

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804

  • University of Tsukuba Hospital

    Ibaraki, 305-8576

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Iwate Medical University Hospital; Urology

    Numakunai, 028-3695

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka University Hospital; Urology

    Osaka, 565-0871

  • Kindai University Hospital; Urology

    Osaka, 589-8511

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

  • Shizuoka Cancer Center; Urology

    Shizuoka, 411-8777

  • National Cancer Center Hospital; Urology

    Tokyo, 104-0045

  • The University of Tokyo Hospital

    Tokyo, 113-8655

  • The Cancer Institute Hospital, JFCR; Urology

    Tokyo, 135-8550

  • Kyorin University Hospital

    Tokyo, 181-8611

Other trials in Japan

France14 sites

  • ICO Paul Papin; Oncologie Medicale.

    Angers, 49055

  • Institut Sainte Catherine;Recherche Clinique

    Avignon, 84918

  • Hopital Saint Andre

    Bordeaux, 33075

  • Centre Francois Baclesse; Recherche Clinique

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Leon Berard; Departement Oncologie Medicale

    Lyon, 69373

  • Centre D'Oncologie de Gentilly; Oncology

    Nancy, 54100

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital Cochin; Unite Fonctionnelle D Oncologie

    Paris, 75014

  • Hopital Saint Louis; Oncologie Medicale

    Paris, 75475

  • Institut Mutualiste Montsouris; Oncologie

    Paris, 75674

  • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

    Paris, 75908

  • ICO - Site René Gauducheau

    Saint-Herblain, 44805

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059

Other trials in France

Germany11 sites

  • Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie

    Berlin, 10117

  • Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin

    Bochum, 44791

  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

    Dresden, 01307

  • Universitätsklinikum Düsseldorf; Urologische Klinik

    Düsseldorf, 40225

  • Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik

    Herne, 44625

  • Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

    Mannheim, 68167

  • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

    München, 81675

  • Universitätsmedizin Rostock, Urologische Klinik und Poliklinik

    Rostock, 18057

  • Diakonie-Klinikum Stuttgart; Urologische Klinik

    Stuttgart, 70176

  • Universitätsklinikum Tübingen; Klinik für Urologie

    Tübingen, 72076

  • Universitätsklinikum Ulm; Klinik für Urologie

    Ulm, 89081

Other trials in Germany

Spain11 sites

  • Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

    Barcelona, 08041

  • Hospital de Donostia; Servicio de Oncologia Medica

    Donostia / San Sebastian, Guipuzcoa, 20080

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Clinico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 8208

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Sant Andreu de la Barca, Barcelona, 08740

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

Other trials in Spain

Canada10 sites

  • Royal Victoria Hospital

    Barrie, Ontario, L4M 6M2

  • Cross Cancer Institute ; Dept of Medical Oncology

    Edmonton, Alberta, T6G 1Z2

  • London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • McGill University; Glen Site; Oncology

    Montreal, Quebec, H4A 3J1

  • Lakeridge Health Oshawa; Oncology

    Oshawa, Ontario, L1G 2B9

  • The Ottawa Hospital Cancer Centre; Oncology

    Ottawa, Ontario, K1H 8L6

  • CHU de Quebec Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • North York General Hospital

    Toronto, Ontario, M2J 1V1

  • Sunnybrook Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

China10 sites

  • Peking University First Hospital

    Beijing, 100034

  • Friendship Hospital, Capital Medical University

    Beijing, 100050

  • Beijing Cancer Hospital

    Beijing, 100142

  • The Second Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510120

  • Jiangsu Province Hospital

    Nanjing, 210008

  • Jiangsu Cancer Hospital

    Nanjing, 211100

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, 200040

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200092

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

Other trials in China

Italy10 sites

  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

    Arezzo, Tuscany, 52100

  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

    Bologna, Emilia-Romagna, 40138

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

    Meldola, Emilia-Romagna, 47014

  • Irccs Ospedale San Raffaele;Oncologia Medica

    Milan, Lombardy, 20132

  • Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche

    Milan, Lombardy, 20141

  • Az. Osp. Cardarelli; Divisione Di Oncologia

    Naples, Campania, 80131

  • ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

    Naples, Campania, 80131

  • A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica

    Orbassano, Piedmont, 10043

  • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

    Rome, Lazio, 00152

  • Azienda Ospedaliera S. Maria - Terni; Oncologia

    Terni, Umbria, 05100

Other trials in Italy

United Kingdom8 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, BS2 8HW

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Barts Health NHS Trust - St Bartholomew's Hospital

    London, EC1A 7BE

  • Sarah Cannon Research Institute

    London, W1G 6AD

  • James Cook Uni Hospital

    Middlesbrough, TS4 3BW

  • Royal Preston Hosptial

    Preston, PR2 9HT

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Israel7 sites

  • Rambam Health Care Campus; Oncology - Hafia

    Hafia, 3109601

  • Hadassah Ein Karem Hospital; Oncology Dept

    Jerusalem, 9112000

  • Meir Medical Center; Oncology

    Kfar Saba, 4428164

  • Rabin Medical Center; Oncology Dept

    Petah Tikva, 4910000

  • Chaim Sheba Medical Center; Oncology Dept

    Ramat Gan, 5262100

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • Assaf Harofeh; Oncology

    Tsrifin, 6093000

Other trials in Israel

Netherlands5 sites

  • NKI/AvL

    Amsterdam, 1066 CX

  • VU MEDISCH CENTRUM; Dept. of Medical Oncology

    Amsterdam, 1081 HV

  • Academ Ziekenhuis Groningen; Medical Oncology

    Groningen, 9713 GZ

  • Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie

    Rotterdam, 3015AA

  • St. Antonius locatie Leidsche Rijn

    Utrecht, 3543 AZ

Other trials in Netherlands

Poland5 sites

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362

  • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii

    Późna, 60-569

  • SpecjalistycznySzpital Miejski w Toruniu; Oddzia? Urologii Ogólnej i Onkologicznej

    Toru?, 87-100

  • Szpital Kliniczny Dzieci?tka Jezus; Oddzia? Urologii

    Warsaw, 02-005

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii

    Wroclaw, 50-556

Other trials in Poland

Russia5 sites

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • P.A. Herzen Oncological Inst. ; Oncology

    Moscow, Moscow Oblast, 125248

  • Privolzhsk Regional Medical Center

    Nizhny Novgorod, Niznij Novgorod, 603001

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

    Ufa, Bashkortostan Republic, 450000

  • Sverdlovsk Regional Oncology Dispensary; Chemotherapy

    Yekaterinburg, Sverdlovsk Oblast, 620905

Other trials in Russia

Australia4 sites

  • Monash Medical Centre; Oncology

    Clayton, Victoria, 3168

  • Royal Brisbane & Women's Hosp; Cancer Care Serv

    Herston, Queensland, 4029

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2109

  • Austin and Repatriation Medical Centre; Cancer Services

    Melbourne, Victoria, 3084

Other trials in Australia

Belgium4 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Gent

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Czechia4 sites

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • Fakultni nemocnice Olomouc; Onkologicka klinika

    Olomouc, 779 00

  • Multiscan s.r.o.

    Pardubice, 532 03

  • University Hospital Motol; Department of Urology

    Prague, 15006

Other trials in Czechia

Turkey (Türkiye)4 sites

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

    Adana, 01230

  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

    Edirne, 22770

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

    Istanbul, 34300

  • Medikal Park Izmir Hospital

    Kar??yaka, 35575

Other trials in Turkey (Türkiye)

Finland3 sites

  • Helsinki University Central Hospital; Urology Clinics

    Helsinki, 00029

  • Tampere University Hospital; Dept Of Urology

    Tampere, 33520

  • Turku University Central Hospital; Urology clinic

    Turku, 20520

Other trials in Finland

South Korea3 sites

  • National Cancer Center

    Goyang-si, 10408

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

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

  • GU "Institution of urology of Academy Medical science of Ukraine"

    Kiev, 04053

Other trials in Ukraine

Greece2 sites

  • Alexandras General Hospital of Athens; Oncology Department

    Athens, 115 28

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

Other trials in Greece

Serbia2 sites

  • Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje"

    Belgrade, 11000

  • Clinical Center of Serbia; Clinic of Urology

    Belgrade, 11000

Other trials in Serbia

Taiwan2 sites

  • Taichung Veterans General Hospital; Division of Urology

    Taichung, 407

  • National Taiwan University Hospital, Department of Urology

    Taipei, 10048

Other trials in Taiwan

Switzerland1 site

  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection

This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.

Being tested
Atezolizumab
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

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

  • AtezolizumabDrug

    Also called TECENTRIQ®; MPDL3280A

    Atezolizumab will be administered at a dose of 1200 milligrams (mg).

Study groups in NCT02450331
Study groupRoleWhat they receive
AtezolizumabExperimentalParticipants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Receives: Drug: Atezolizumab
ObservationNo interventionParticipants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).

What is being measured

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

  1. Disease-Free Survival (DFS), as Assessed by Investigator

    DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.

    Measured: Randomization up to first occurrence of DFS event (up to approximately 50 months)

Secondary outcomes (9)

  1. Overall Survival (OS)

    Overall survival is defined as the time from randomization to the date of death from any cause, regardless of whether the death occurs during study treatment or following treatment discontinuation.

    Measured: Randomization until death due to any cause (up to approximately 80 months)

  2. Disease-Specific Survival (DSS), as Assessed by Investigator

    DSS is defined as the time from randomization until the date of death from UC.

    Measured: Randomization until death due to UC (up to approximately 50 months)

  3. Distant Metastasis-Free Survival (DMFS)

    DMFS is defined as the time from randomization to the date of diagnosis of distant (that is, non-locoregional) metastases or death from any cause. Tumor assessment will be performed using radiographic evaluations.

    Measured: Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months)

  4. Non-Urinary Tract Recurrence-Free Survival (NURFS)

    NURFS is defined as the time from randomization to the time of first occurrence of a NURFS event. NURFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.

    Measured: Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months)

  5. Percentage of Participants With Adverse Events (AEs)

    Percentage of participants with at least one Adverse Event.

    Measured: Screening up to approximately 80 months

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

    Percentage of participants with anti-therapeutic antibodies to atezolizumab.

    Measured: Baseline up to approximately 50 months

  7. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score

    The EQ-5D-5L is a generic preference-based HRQoL questionnaire that provides a single index value for health status and is used to inform pharmacoeconomic evaluations and to measure general health status. Visual analog scale (VAS) allows the patient to indicate, on a scale of 0-100, how his or her health is on the day of assessment, with 100 being the "best imaginable health state" and 0 being the "worst imaginable health state."

    Measured: Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days)

  8. Minimum Observed Serum Atezolizumab Concentration (Cmin)

    Minimum observed serum atezolizumab concentration (Cmin) prior to infusion on Day 1 of Cycles 1, 2, 3, and 4; every 8 cycles starting on Cycle 8; at treatment discontinuation; and at 120 days after the last dose of atezolizumab.

    Measured: Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days)

  9. Maximum Observed Serum Atezolizumab Concentration (Cmax)

    Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1.

    Measured: Day 1 of Cycle 1 (Cycle length = 21 days)

Timeline

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

  1. First posted21 May 2015 (estimated)
  2. Study start5 Oct 2015
  3. Primary completion30 Nov 2019
  4. Study completion14 Jun 2022

Why it stopped: Sponsor decided to terminate the study early because the study did not meet its primary endpoint and because the study had met its goals of providing safety and additional exploratory efficacy information for atezolizumab monotherapy in MIBC.

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
None (open label)
Enrolment
809 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02450331
Sponsor's protocol ID
WO29636
Other IDs
2014-005603-25, 2014
Acronym
IMvigor010
Status last verified
May 2023
First submitted
19 May 2015
Last updated
18 Jun 2023

Publications

  • Landon BV, Huang J, Evangelopoulou EG, Anagnostou V, Canzoniero JV. Liquid biopsy approaches to capture minimal residual disease and therapy response in patients with early stage cancers. Int Rev Cell Mol Biol. 2026;399:113-143. doi: 10.1016/bs.ircmb.2024.12.002. Epub 2024 Dec 14.

    PubMed 41720562

  • Elias R, Aragaki AK, Hoffman-Censits JH, Hahn NM, McConkey DJ, Johnson BA 3rd. Intratumoral Expression of a Composite B Cell / CD8 T Cell Biomarker Stratifies Overall Survival by Circulating Tumor DNA Status and Benefit From Adjuvant Immunotherapy in High-Risk Muscle-Invasive Urothelial Carcinoma. J Urol. 2026 Mar;215(3):294-304. doi: 10.1097/JU.0000000000004828. Epub 2025 Oct 27.

    PubMed 41144872

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab in people with Carcinoma, Transitional Cell, run by Hoffmann-La Roche at 186 sites in 24 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 10 inclusion and 16 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: stopped early, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 186 sites in United States, Japan, France, Germany, Spain and 19 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. 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 18 Nov 2020). 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?

Disease-Free Survival (DFS), as Assessed by Investigator (time frame: Randomization up to first occurrence of DFS event (up to approximately 50 months)). 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 NCT02450331, which also lists 5 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 18 Jun 2023.

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