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AzTrials

Urinary Tract CancerPhase 3NCT02928406

A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

A Phase 3 study testing Atezolizumab in people with Urinary Tract Cancer, run by Hoffmann-La Roche at 175 sites in 32 countries.

Completed

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

Official record
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Trial summary

This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Tract Cancer
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
1,004 participants
Where
175 sitesin 32 countries
Study dates
30 Nov 2016to 12 Dec 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

  • Participants with histologically documented locally advanced (tumor [T] 4b, any node [N]; or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial carcinoma of the urinary tract
  • Participants with measurable and/or non-measurable disease according to RECIST v1.1
  • Participants must have progressed during or following treatment with at least one prior (and not more than 3) treatments for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
  • If available, a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block should be submitted
  • Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2

Who cannot join

  • Treatment with more than three prior lines of systemic therapy for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation
  • Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were not on active drug in that prior trial are eligible
  • Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were in the follow-up phase of that prior trial and had stopped receiving active drug 4 or more weeks before study treatment initiation are eligible
  • Malignancies other than the one studied in this protocol within 5 years prior to Cycle 1, Day 1
  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
  • Significant renal disorder indicating a need for renal transplant

Trial locations and contacts

175 sites in 32 countries.

175 sites in 32 countries

Spain32 sites

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Badalona, Barcelona, 08916

  • Hospital del Mar Barcelona

    Barcelona, 08003

  • Hospital Clínic i Provincial; Servicio de Oncología

    Barcelona, 08036

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

    Barcelona, 08041

  • Hospital Duran i Reynals; Oncologia

    Barcelona, 08907

  • Hospital de Basurto; Servicio de Oncologia

    Bilbao, Vizcaya, 48013

  • Hospital San Pedro De Alcantara; Servicio de Oncologia

    Cáceres, 10003

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

  • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

    Girona, 17007

  • Hospital General Universitario de Guadalajara; Servicio de Oncologia

    Guadalajara, 19002

  • Hospital Lucus Augusti; Servicio de Oncologia

    Lugo, 27003

  • 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

  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

    Madrid, 28050

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Complejo Hospitalario de Althaia; Servicio de Oncologia

    Manresa, Barcelona, 08243

  • Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

    Murcia, 30008

  • Hospital de Navarra; Servicio de Oncologia

    Navarra, Navarre, 31008

  • Complejo Hospitalario de Orense; Servicio de Oncologia

    Ourense, 32005

  • Hospital Univ. Central de Asturias; Servicio de Oncologia

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Son Espases; Servicio de Oncologia

    Palma de Mallorca, Balearic Islands, 07014

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 8208

  • Hospital Universitario de Canarias;servicio de Oncologia

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Sant Andreu de la Barca, Barcelona, 08740

  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia

    Seville, 41013

  • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

    Toledo, 45004

  • Hospital Clínico Universitario de Valencia; Servicio de Oncología

    Valencia, 46010

  • Hospital General Universitario de Valencia; Servicio de oncologia

    Valencia, 46014

  • Hospital La Fe

    Valencia

Other trials in Spain

Italy26 sites

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

    Arezzo, Tuscany, 52100

  • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

    Bari, Apulia, 70124

  • Asst Papa Giovanni XXIII; Oncologia Medica

    Bergamo, Lombardy, 24127

  • AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica

    Bologna, Emilia-Romagna, 40138

  • A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia

    Cagliari, Sardinia, 09100

  • Ospedale Cannizzaro, Oncologia

    Catania, Sicily, 95126

  • Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica

    Chieti, Abruzzo, 66100

  • ASST DI CREMONA; Dip. Medicina - S.C. Oncologia

    Cremona, Lombardy, 26100

  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

    Genoa, Liguria, 16132

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

    Meldola, Emilia-Romagna, 47014

  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

    Milan, Lombardy, 20133

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • A.O. Universitaria Policlinico Di Modena; Oncologia

    Modena, Emilia-Romagna, 41124

  • Azienda Ospedaliera Universitaria Federico II

    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

  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

    Padova, Veneto, 35128

  • Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

    Pisa, Tuscany, 56100

  • Arcispedale Santa Maria Nuova; Oncologia

    Reggio Emilia, Emilia-Romagna, 42100

  • Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica

    Rome, Lazio, 00128

  • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

    Rome, Lazio, 00152

  • Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

    Rome, Lazio, 00168

  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

    San Giovanni Rotondo, Apulia, 71013

  • Azienda Ospedaliera S. Maria - Terni; Oncologia

    Terni, Umbria, 05100

  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

    Udine, Friuli Venezia Giulia, 33100

  • Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Oncologia Medica

    Verona, Veneto, 37134

Other trials in Italy

Germany12 sites

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

    Dresden, 01307

  • Universitätsklinikum Erlangen; Medizinische Klinik 5 - Hämatound Internist Onko

    Erlangen, 91054

  • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie

    Göttingen, 37075

  • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

    Halle, 06120

  • Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie

    Hanover, 30625

  • Onkologische Schwerpunktpraxis

    Heidelberg, 69115

  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie

    Lübeck, 23538

  • Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus

    Mönchengladbach, 41063

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

    München, 81675

  • Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie

    Münster, 48149

  • Universitätsklinikum Tübingen; Klinik für Urologie

    Tübingen, 72076

  • Universitätsklinikum Ulm; Klinik für Urologie

    Ulm, 89081

Other trials in Germany

Australia10 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Canberra Hospital; Medical Oncology

    Canberra, Australian Capital Territory, 2606

  • Austin Hospital Olivia Newton John Cancer Centre

    Heidelberg, Victoria, 3084

  • Royal Hobart Hospital; Hematology/Oncology

    Hobart, Tasmania, 7000

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2109

  • Prince of Wales Hospital; Oncology

    Randwick, New South Wales, 2031

  • Icon Cancer Foundation

    South Brisbane, Queensland, 4101

  • Northern Cancer Institute

    St Leonards, New South Wales, 2065

  • Calvary Mater Newcastle; Medical Oncology

    Waratah, New South Wales, 2298

Other trials in Australia

Greece7 sites

  • Alexandras General Hospital of Athens; Oncology Department

    Athens, 115 28

  • IASO General Hospital of Athens

    Athens, 155 62

  • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

    Kifissia, 145 64

  • Metropolitan Hospital; 2Nd Oncology Clinic

    Piraeus, 185 47

  • Thermi Clinic; Oncology Clinic

    Thermi Thessalonikis, 570 01

  • Euromedical General Clinic of Thessaloniki; Oncology Department

    Thessaloniki, 546 45

  • Papageorgiou General Hospital; Medical Oncology

    Thessaloniki, 564 29

Other trials in Greece

Switzerland7 sites

  • Universitaetsspital Basel; Onkologie

    Basel, 4031

  • Ospedale Regionale di Bellinzona Medizin Onkologie

    Bellinzona, 6500

  • Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit

    Bern, 3010

  • Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie

    Chur, 7000

  • Hôpitaux Universit. de Genève Médecine Oncologie; Oncologie

    Geneva, 1211

  • Luzerner Kantonsspital; Medizinische Onkologie

    Lucerne, 6004

  • Kantonsspital Winterthur; Medizinische Onkologie

    Winterthur, 8401

Other trials in Switzerland

Brazil6 sites

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Centro Integrado de Oncologia de Curitiba

    Curitiba, Paraná, 80810-050

  • Pronutrir - suporte nutricional e quimioterapia ltda.

    Fortaleza, Ceará, 60810-180

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01323-903

Other trials in Brazil

Austria5 sites

  • Medizinische Universität Innsbruck; Universitätsklinik für Urologie

    Innsbruck, 6020

  • Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

    Linz, 4020

  • Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU

    Salzburg, 5020

  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

    Vienna, 1090

  • Medizinische Universität Wien; Universitätsklinik für Urologie

    Vienna, 1090

Other trials in Austria

Canada5 sites

  • Royal Victoria Hospital

    Barrie, Ontario, L4M 6M2

  • Tom Baker Cancer Centre-Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute ; Dept of Medical Oncology

    Edmonton, Alberta, T6G 1Z2

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • The Ottawa Hospital Cancer Center; General Campus

    Ottawa, Ontario, K1H 1C4

Other trials in Canada

Hungary5 sites

  • Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department

    Budapest, 1062

  • Semmelwies University of Medicine; Urology Dept.

    Budapest, 1082

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

    Szeged, 6720

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály

    Szolnok, 5004

Other trials in Hungary

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

  • Maastricht University Medical Centre; Medical Oncology

    Maastricht, 6229 HX

  • St. Antonius locatie Leidsche Rijn

    Utrecht, 3543 AZ

Other trials in Netherlands

Romania5 sites

  • Oncopremium Team Srl

    Baia Mare, 430291

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Spital de zi-Parter

    Cluj-Napoca, 400015

  • Centrul de Oncologie Sfantul Nectarie

    Craiova, 200347

  • Centrul de Radioterapie AMETHYST

    Floreşti, 407280

  • Oncomed SRL; Oncologie

    Timișoara, 300239

Other trials in Romania

United Kingdom5 sites

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Raigmore Hospital; Dept of Radiotherapy & Oncology

    Inverness, IV1 3UJ

  • Leicester Royal Infirmary NHS Trust

    Leicester, LE1 5WW

  • Barts and the London NHS Trust.

    London, EC1A 7BE

  • Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

Belgium4 sites

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHU Sart-Tilman

    Liège, 4000

Other trials in Belgium

Denmark4 sites

  • Aalborg Universitetshospital; Onkologisk Afdeling

    Aalborg, 9000

  • Aarhus Universitetshospital; Kræftafdelingen

    Aarhus N, 8200

  • Herlev Hospital; Afdeling for Kræftbehandling

    Herlev, 2730

  • Rigshospitalet; Onkologisk Klinik

    København Ø, 2100

Other trials in Denmark

India4 sites

  • HealthCare Global Cancer Centre; Medical Oncology

    Ahmedabad, Gujarat, 380060

  • Artemis Health Institute

    Gurgaon, Haryana, 122001

  • TATA Medical Centre; Medical Oncology

    Kolkata, West Bengal, 700156

  • Max Super Speciality Hospital

    New Delhi, National Capital Territory of Delhi, 110017

Other trials in India

Poland4 sites

  • NZOZ Onko-Dent G. L. Slomian, Spolka Jawna

    ?ory, 44-240

  • Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

    Lublin, 20-090

  • Szpital Kliniczny Przemienienia Pa?skiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

    Poznan, 60-570

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

    Warsaw, 04-073

Other trials in Poland

Portugal4 sites

  • Hospital de Braga; Servico de Oncologia Medica X

    Braga, 4710-243

  • HUC; Servico de Urologia e Transplantacao Renal

    Coimbra, 3000-075

  • Hospital de Santa Maria; Servico de Oncologia Medica

    Lisbon, 1649-035

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Argentina3 sites

  • Inst. Alexander Fleming; Oncologia

    Buenos Aires, C1426ANZ

  • Hospital Aleman

    Caba, C1118AAT

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1284AEB

Other trials in Argentina

Bulgaria3 sites

  • Complex Oncology Center (COC)-Plovidiv

    Plovdiv, 4000

  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527

  • SHATOD - Sofia

    Sofia, 1784

Other trials in Bulgaria

Czechia3 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

    Prague, 140 59

Other trials in Czechia

Estonia2 sites

  • East Tallinn Central Hospital; Clinic of Internal Medicine

    Tallinn, 11312

  • North Estonia Medical Centre Foundation; Oncology Center

    Tallinn, 13419

Other trials in Estonia

Ireland2 sites

  • Cork University Hospital

    Cork

  • Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

    Dublin, D24 NR0A

Other trials in Ireland

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Endocrinology clinic

    Kaunas, 50009

  • National Cancer Institute

    Vilnius, 08660

Other trials in Lithuania

Russia2 sites

  • Blokhin Cancer Research Center; Urological Dept

    Moscow, Moscow Oblast, 115478

  • P.A. Herzen Oncological Inst. ; Oncology

    Moscow, Moscow Oblast, 125248

Other trials in Russia

Taiwan2 sites

  • National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

    Tainan, 704

  • Chang Gung Medical Foundation-Linkou, Urinary Oncology

    Taoyuan, 333

Other trials in Taiwan

China1 site

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210008

Other trials in China

Colombia1 site

  • Clinica del Country

    Bogotá, 11001

Other trials in Colombia

Croatia1 site

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Lebanon1 site

  • Hotel Dieu de France; Oncology

    Beirut, 2063 1111

Other trials in Lebanon

Saudi Arabia1 site

  • King Faisal Specialist Hospital & Research Centre; Oncology

    Riyadh, 11211

Other trials in Saudi Arabia

Slovakia1 site

  • Narodny onkologicky ustav

    Bratislava, 833 10

Other trials in Slovakia

About this study

Official title: An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab.

Being tested
Atezolizumab
Medical subject headings
Urologic Neoplasms

What participants receive

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

  • AtezolizumabDrug

    Also called MPDL3280A

    Atezolizumab 1200 milligrams (mg) will be administered by intravenous (IV) infusion Q3W.

Study groups in NCT02928406
Study groupRoleWhat they receive
AtezolizumabExperimentalParticipants will receive atezolizumab every 3 weeks (Q3W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Receives: Drug: Atezolizumab

What is being measured

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

  1. Percentage of Participants With Adverse Events (AEs)

    AEs were defined as any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. New disease, exacerbation of existing disease, recurrence of an intermittent medical condition not present at baseline, any deterioration in a laboratory value or other clinical test associated with symptoms or leading to a change in study/concomitant treatment or discontinuation from study drug as well as events related to protocol-mandated interventions are considered AEs.

    Measured: Baseline up to end of study (up to approximately 6 years)

Secondary outcomes (11)

  1. Overall Survival (OS)

    OS was defined as date of death (due to any cause) or censoring minus date of start of study treatment plus 1.

    Measured: Randomization until death from any cause (up to approximately 6 years)

  2. Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    PFS was defined as the date of first occurrence of tumor progression (earliest of the dates of the RECIST component indicating tumor progression) or date of death (in the absence of tumor progression) by any cause, whichever occurred first, or date of censoring minus date of start of study treatment plus 1.

    Measured: Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)

  3. PFS as Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST)

    PFS as per Modified RECIST was defined as:

    • date of first occurrence of tumor progression after a modified confirmed response if the participant was a responder according to modified RECIST or
    • date of first occurrence of tumor progression in case the participant was not a responder according to modified RECIST or
    • date of death (in the absence of tumor progression) by any cause, or
    • date of censoring whichever occurred first, minus date of start of study treatment plus 1

    Measured: Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)

  4. Percentage of Participants With Best Overall Response (BOR) as Assessed by RECIST v1.1

    BOR was assessed by the investigators according to the RECIST v1.1. BOR was defined as a complete response (CR) or partial response (PR) determined on two consecutive investigator assessments >= 4 weeks apart in participants with measurable disease at baseline. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 millimeters (mm); PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must have demonstrated an absolute increase of at least 5 mm. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.

    Measured: Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)

  5. Percentage of Participants With BOR as Assessed by Modified RECIST

    BOR was assessed by the investigators according to the modified RECIST. BOR was defined as complete response (CR) or partial response (PR). CR includes complete disappearance of all tumor lesions and no new measurable or unmeasurable lesions confirmed by a consecutive assessment >=4 weeks from the first documented date. PR is a decrease in the sum of the diameters of all target and all new measurable lesions >=30%, relative to baseline, in the absence of CR confirmed by a consecutive assessment >=4 weeks from the first documented date. The assessment of BOR included post-screening RECIST assessments obtained up to: 1) death from any cause, 2) last evaluable RECIST assessment in the absence of death, 3) start of a subsequent anti-cancer therapy, whichever occurred first.

    Measured: Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)

  6. Percentage of Participants With Disease Control as Assessed by RECIST v1.1

    Disease control was determined separately on disease status using RECIST v1.1 by the investigator. Disease control rate was defined as the sum of the complete response, partial response, and stable disease rates.

    Measured: Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)

  7. Percentage of Participants With Disease Control as Assessed by Modified RECIST

    Disease control was determined separately on disease status using modified RECIST by the investigator. Disease control rate was defined as the sum of the complete response, partial response, and stable disease rates.

    Measured: Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)

  8. Duration of Response (DOR) as Assessed by RECIST v1.1

    Duration of response was determined separately on disease status using RECIST v1.1 by the investigator. For overall responders, DoR was defined as the time from the date of first occurrence of a confirmed response (complete response or partial response) to date of tumor progression or death from any cause, or to censoring date: 1) end of response coincided with the date of tumor progression or death (in the absence of tumor progression) used for the PFS endpoint, 2) for a participant without disease progression or death following a response, the censored end of response coincided with the PFS censoring date (that was latest RECIST assessment or start of subsequent cancer therapy, whichever occurred first).

    Measured: Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)

  9. DOR as Assessed by Modified RECIST

    Duration of response was determined separately on disease status using modified RECIST by the investigator. For overall responders, DoR was defined as the time from the date of first occurrence of a confirmed response (complete response or partial response) to date of tumor progression following that confirmed response or death from any cause, or to censoring date: 1) end of response was the date of tumor progression after that confirmed response or death (in the absence of tumor progression), 2) for a participant without disease progression or death following a response, the censored end of response was the latest RECIST assessment or start of subsequent cancer therapy, whichever occurred first.

    Measured: Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)

  10. Change From Baseline in Health-Related Quality of Life (HRQoL), as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score

    The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale. Higher scores on the global health status and functional scales indicated better health status/function. Higher scores on the symptoms scales and symptom items indicated greater symptom burden.

    Measured: Baseline, Day 1 of Cycles 1, 2, 3 and thereafter every 9 weeks for 54 weeks from study treatment start; and then every 12 weeks until progression/study discontinuation (up to approximately 6 years) (Cycle length = 21 days)

  11. Change From Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score

    The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) is a self-report health status questionnaire that consists of 6 questions used to calculate a health utility score for use in health economic analysis. There are two components to the EuroQol EQ-5D: 1) five health dimensions that assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; 2) a visual analogue scale (VAS) that measures health state. There are 5 response levels for each dimension (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems) with the highest level representing the worst outcome. The VAS is scored on a scale from 0 to 100, with 0 representing the worst imaginable health and 100 representing the best imaginable health.

    Measured: Baseline, Day 1 of Cycles 1, 2, 3 and thereafter every 9 weeks for 54 weeks from study treatment start; and then every 12 weeks until progression/study discontinuation (up to approximately 6 years) (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 posted10 Oct 2016 (estimated)
  2. Study start30 Nov 2016
  3. Primary completion12 Dec 2022
  4. Study completion12 Dec 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,004 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02928406
Sponsor's protocol ID
MO29983
Other IDs
2016-002625-11, 2016
Status last verified
Mar 2024
First submitted
7 Oct 2016
Last updated
4 Apr 2024

Publications

  • Bamias A, Merseburger A, Loriot Y, James N, Choy E, Castellano D, Lopez-Rios F, Calabro F, Kramer M, de Velasco G, Zakopoulou R, Tzannis K, Sternberg CN. New prognostic model in patients with advanced urothelial carcinoma treated with second-line immune checkpoint inhibitors. J Immunother Cancer. 2023 Jan;11(1):e005977. doi: 10.1136/jitc-2022-005977.

    PubMed 36627145

  • Bamias A, Merseburger AS, Loriot Y, James N, Choy E, Castellano D, Lopez-Rios F, Calabro F, Kramer M, de Velasco G, Zakopoulou R, Tzannis K, Sternberg CN. SAUL, a single-arm study of atezolizumab for chemotherapy-pretreated locally advanced or metastatic carcinoma of the urinary tract: outcomes by key baseline factors, PD-L1 expression and prior platinum therapy. ESMO Open. 2021 Jun;6(3):100152. doi: 10.1016/j.esmoop.2021.100152. Epub 2021 May 10.

    PubMed 33984672

  • Merseburger AS, Castellano D, Powles T, Loriot Y, Retz M, Voortman J, Huddart RA, Gedye C, Van Der Heijden MS, Gurney H, Ong M, de Ducla S, Pavlova J, Fear S, Sternberg CN. Safety and Efficacy of Atezolizumab in Understudied Populations with Pretreated Urinary Tract Carcinoma: Subgroup Analyses of the SAUL Study in Real-World Practice. J Urol. 2021 Aug;206(2):240-251. doi: 10.1097/JU.0000000000001768. Epub 2021 Apr 9.

    PubMed 33835866

  • Loriot Y, Sternberg CN, Castellano D, Oosting SF, Dumez H, Huddart R, Vianna K, Alonso Gordoa T, Skoneczna I, Fay AP, Nole F, Massari F, Brasiuniene B, Maroto P, Fear S, Di Nucci F, de Ducla S, Choy E. Safety and efficacy of atezolizumab in patients with autoimmune disease: Subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma. Eur J Cancer. 2020 Oct;138:202-211. doi: 10.1016/j.ejca.2020.07.023. Epub 2020 Sep 6.

    PubMed 32905959

  • Cathomas R, Schardt J, Pless M, Llado A, Mach N, Riklin C, Haefeli J, Fear S, Stenner F. Swiss experience of atezolizumab for platinum-pretreated urinary tract carcinoma: the SAUL study in real-world practice. Swiss Med Wkly. 2020 May 4;150:w20223. doi: 10.4414/smw.2020.20223. eCollection 2020 May 4.

    PubMed 32399958

  • Sternberg CN, Loriot Y, James N, Choy E, Castellano D, Lopez-Rios F, Banna GL, De Giorgi U, Masini C, Bamias A, Garcia Del Muro X, Duran I, Powles T, Gamulin M, Zengerling F, Geczi L, Gedye C, de Ducla S, Fear S, Merseburger AS. Primary Results from SAUL, a Multinational Single-arm Safety Study of Atezolizumab Therapy for Locally Advanced or Metastatic Urothelial or Nonurothelial Carcinoma of the Urinary Tract. Eur Urol. 2019 Jul;76(1):73-81. doi: 10.1016/j.eururo.2019.03.015. Epub 2019 Mar 23.

    PubMed 30910346

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab in people with Urinary Tract Cancer, run by Hoffmann-La Roche at 175 sites in 32 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 5 inclusion and 7 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 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in Spain, Italy, Germany, Australia, Greece and 27 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 4 Apr 2024). 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?

Percentage of Participants With Adverse Events (AEs) (time frame: Baseline up to end of study (up to approximately 6 years)). 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 NCT02928406, 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 4 Apr 2024.

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