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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Cancer
• Intervention / Treatment: Drug: Atezolizumab

• Study Type: Interventional
• Enrollment (Actual): 1004
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ANZ
    • Inst. Alexander Fleming; Oncologia
  • Caba, Argentina, C1118AAT
    • Hospital Aleman
  • Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
    • Hospital Britanico de Buenos Aires
• Australia
  • Australian Capital Territory
    • Canberra, Australian Capital Territory, Australia, 2606
      • Canberra Hospital; Medical Oncology
  • New South Wales
    • Macquarie Park, New South Wales, Australia, 2109
      • Macquarie University Hospital
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital; Oncology
    • St Leonards, New South Wales, Australia, 2065
      • Northern Cancer Institute
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle; Medical Oncology
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Foundation
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital; Hematology/Oncology
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Heidelberg, Victoria, Australia, 3084
      • Austin Hospital Olivia Newton John Cancer Centre
• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck; Universitätsklinik für Urologie
  • Linz, Austria, 4020
    • Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU
  • Wien, Austria, 1090
    • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
  • Wien, Austria, 1090
    • Medizinische Universität Wien; Universitätsklinik für Urologie
• Belgium
  • Brussel, Belgium, 1090
    • UZ Brussel
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
• Brazil
  • CE
    • Fortaleza, CE, Brazil, 60810-180
      • Pronutrir - suporte nutricional e quimioterapia ltda.
  • PR
    • Curitiba, PR, Brazil, 80810-050
      • Centro Integrado de Oncologia de Curitiba
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital Sao Lucas - PUCRS
  • SP
    • Barretos, SP, Brazil, 14784-400
      • Hospital de Cancer de Barretos
    • Sao Paulo, SP, Brazil, 01308-050
      • Hospital Sirio-Libanes
    • Sao Paulo, SP, Brazil, 01323-903
      • Hospital Alemao Oswaldo Cruz
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Complex Oncology Center (COC)-Plovidiv
  • Sofia, Bulgaria, 1784
    • SHATOD - Sofia
  • Sofia, Bulgaria, 1527
    • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre-Calgary
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute ; Dept of Medical Oncology
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Hospital
    • Ottawa, Ontario, Canada, K1H 1C4
      • The Ottawa Hospital Cancer Center; General Campus
• China
  • Nanjing City, China, 210008
    • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
• Colombia
  • Bogota, Colombia, 11001
    • Clinica del Country
• Croatia
  • Zagreb, Croatia, 10000
    • Clinical Hospital Centre Zagreb
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny v Brne
  • Praha, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha, Czechia, 140 59
    • Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital; Onkologisk Afdeling
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital; Kræftafdelingen
  • Herlev, Denmark, 2730
    • Herlev Hospital; Afdeling for Kræftbehandling
  • København Ø, Denmark, 2100
    • Rigshospitalet; Onkologisk Klinik
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation; Oncology Center
  • Tallinn, Estonia, 11312
    • East Tallinn Central Hospital; Clinic of Internal Medicine
• Germany
  • Dresden, Germany, 01307
    • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen; Medizinische Klinik 5 - Hämatound Internist Onko
  • Göttingen, Germany, 37075
    • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie
  • Halle (Saale), Germany, 06120
    • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie
  • Heidelberg, Germany, 69115
    • Onkologische Schwerpunktpraxis
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie
  • Mönchengladbach, Germany, 41063
    • Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
  • Münster, Germany, 48149
    • Universitatsklinikum Munster, Klinik fur Urologie und Kinderurologie
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen; Klinik für Urologie
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm; Klinik für Urologie
• Greece
  • Athens, Greece, 155 62
    • IASO General Hospital of Athens
  • Athens, Greece, 115 28
    • Alexandras General Hospital of Athens; Oncology Department
  • Kifisia, Greece, 145 64
    • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
  • Piraeus, Greece, 185 47
    • Metropolitan Hospital; 2Nd Oncology Clinic
  • Thermi Thessalonikis, Greece, 570 01
    • Thermi Clinic; Oncology Clinic
  • Thessaloniki, Greece, 564 29
    • Papageorgiou General Hospital; Medical Oncology
  • Thessaloniki, Greece, 546 45
    • Euromedical General Clinic of Thessaloniki; Oncology Department
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet
  • Budapest, Hungary, 1062
    • Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department
  • Budapest, Hungary, 1082
    • Semmelwies University of Medicine; Urology Dept.
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
  • Szolnok, Hungary, 5004
    • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
• India
  • Delhi
    • New Delhi, Delhi, India, 110017
      • Max Super Speciality Hospital
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • HealthCare Global Cancer Centre; Medical Oncology
  • Haryana
    • Gurgaon, Haryana, India, 122001
      • Artemis Health Institute
  • WEST Bengal
    • Kolkata, WEST Bengal, India, 700156
      • TATA Medical Centre; Medical Oncology
• Ireland
  • Cork, Ireland
    • Cork University Hospital
  • Dublin, Ireland, D24 NR0A
    • Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
• Italy
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66100
      • Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
  • Campania
    • Napoli, Campania, Italy, 80131
      • Azienda Ospedaliera Universitaria Federico II
    • Napoli, Campania, Italy, 80131
      • ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
    • Meldola, Emilia-Romagna, Italy, 47014
      • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
    • Modena, Emilia-Romagna, Italy, 41124
      • A.O. Universitaria Policlinico Di Modena; Oncologia
    • Reggio Emilia, Emilia-Romagna, Italy, 42100
      • Arcispedale Santa Maria Nuova; Oncologia
  • Friuli-Venezia Giulia
    • Udine, Friuli-Venezia Giulia, Italy, 33100
      • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
  • Lazio
    • Roma, Lazio, Italy, 00152
      • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
    • Roma, Lazio, Italy, 00128
      • Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica
    • Roma, Lazio, Italy, 00168
      • Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
  • Liguria
    • Genova, Liguria, Italy, 16132
      • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
  • Lombardia
    • Bergamo, Lombardia, Italy, 24127
      • Asst Papa Giovanni XXIII; Oncologia Medica
    • Cremona, Lombardia, Italy, 26100
      • ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
    • Milano, Lombardia, Italy, 20141
      • Istituto Europeo di Oncologia
    • Milano, Lombardia, Italy, 20133
      • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
  • Piemonte
    • Orbassano, Piemonte, Italy, 10043
      • A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
  • Puglia
    • Bari, Puglia, Italy, 70124
      • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
    • San Giovanni Rotondo, Puglia, Italy, 71013
      • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
  • Sardegna
    • Cagliari, Sardegna, Italy, 09100
      • A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia
  • Sicilia
    • Catania, Sicilia, Italy, 95126
      • Ospedale Cannizzaro, Oncologia
  • Toscana
    • Arezzo, Toscana, Italy, 52100
      • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
    • Pisa, Toscana, Italy, 56100
      • Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
  • Umbria
    • Terni, Umbria, Italy, 05100
      • Azienda Ospedaliera S. Maria - Terni; Oncologia
  • Veneto
    • Padova, Veneto, Italy, 35128
      • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
    • Verona, Veneto, Italy, 37134
      • Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Oncologia Medica
• Lebanon
  • Beirut, Lebanon, 2063 1111
    • Hotel Dieu de France; Oncology
• Lithuania
  • Kaunas, Lithuania, 50009
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Endocrinology clinic
  • Vilnius, Lithuania, 08660
    • National Cancer Institute
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • NKI/AvL
  • Amsterdam, Netherlands, 1081 HV
    • VU MEDISCH CENTRUM; Dept. of Medical Oncology
  • Groningen, Netherlands, 9713 GZ
    • Academ Ziekenhuis Groningen; Medical Oncology
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Centre; Medical Oncology
  • Utrecht, Netherlands, 3543 AZ
    • St. Antonius locatie Leidsche Rijn
• Poland
  • ?ory, Poland, 44-240
    • NZOZ Onko-Dent G. L. Slomian, Spolka Jawna
  • Lublin, Poland, 20-090
    • Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
  • Poznan, Poland, 60-570
    • Szpital Kliniczny Przemienienia Pa?skiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
  • Warszawa, Poland, 04-073
    • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga; Servico de Oncologia Medica X
  • Coimbra, Portugal, 3000-075
    • HUC; Servico de Urologia e Transplantacao Renal
  • Lisboa, Portugal, 1649-035
    • Hospital de Santa Maria; Servico de Oncologia Medica
  • Porto, Portugal, 4200-072
    • IPO do Porto; Servico de Oncologia Medica
• Romania
  • Baia Mare, Romania, 430291
    • Oncopremium Team Srl
  • Cluj-Napoca, Romania, 400015
    • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Spital de zi-Parter
  • Craiova, Romania, 200347
    • Centrul de Oncologie Sfantul Nectarie
  • Floresti, Romania, 407280
    • Centrul de Radioterapie AMETHYST
  • Timisoara, Romania, 300239
    • Oncomed SRL; Oncologie
• Russian Federation
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 115478
      • Blokhin Cancer Research Center; Urological Dept
    • Moscow, Moskovskaja Oblast, Russian Federation, 125248
      • P.A. Herzen Oncological Inst. ; Oncology
• Saudi Arabia
  • Riyadh, Saudi Arabia, 11211
    • King Faisal Specialist Hospital & Research Centre; Oncology
• Slovakia
  • Bratislava, Slovakia, 833 10
    • Narodny onkologicky ustav
• Spain
  • Barcelona, Spain, 08907
    • Hospital Duran i Reynals; Oncologia
  • Barcelona, Spain, 08036
    • Hospital Clínic i Provincial; Servicio de Oncología
  • Barcelona, Spain, 08003
    • Hospital del Mar Barcelona
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Caceres, Spain, 10003
    • Hospital San Pedro De Alcantara; Servicio de Oncologia
  • Girona, Spain, 17007
    • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
  • Guadalajara, Spain, 19002
    • Hospital General Universitario de Guadalajara; Servicio de Oncologia
  • Lugo, Spain, 27003
    • Hospital Lucus Augusti; Servicio de Oncologia
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal; Servicio de Oncologia
  • Madrid, Spain, 28050
    • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos; Servicio de Oncologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz; Servicio de Oncologia
  • Malaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Murcia, Spain, 30008
    • Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
  • Navarra, Spain, 31008
    • Hospital de Navarra; Servicio de Oncologia
  • Orense, Spain, 32005
    • Complejo Hospitalario de Orense; Servicio de Oncologia
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Toledo, Spain, 45004
    • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia; Servicio de oncologia
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia; Servicio de Oncología
  • Valencia, Spain
    • Hospital La Fe
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Univ. Central de Asturias; Servicio de Oncologia
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
    • Manresa, Barcelona, Spain, 08243
      • Complejo Hospitalario de Althaia; Servicio de Oncologia
    • Sabadell, Barcelona, Spain, 8208
      • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
    • Sant Andreu de La Barca, Barcelona, Spain, 08740
      • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07014
      • Hospital Universitario Son Espases; Servicio de Oncologia
  • LA Coruña
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias;servicio de Oncologia
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital de Basurto; Servicio de Oncologia
• Switzerland
  • Basel, Switzerland, 4031
    • Universitaetsspital Basel; Onkologie
  • Bellinzona, Switzerland, 6500
    • Ospedale Regionale di Bellinzona Medizin Onkologie
  • Bern, Switzerland, 3010
    • Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit
  • Chur, Switzerland, 7000
    • Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
  • Geneve, Switzerland, 1211
    • Hôpitaux Universit. de Genève Médecine Oncologie; Oncologie
  • Luzern, Switzerland, 6004
    • Luzerner Kantonsspital; Medizinische Onkologie
  • Winterthur, Switzerland, 8401
    • Kantonsspital Winterthur; Medizinische Onkologie
• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou, Urinary Oncology
• United Kingdom
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Cancer Centre
  • Inverness, United Kingdom, IV1 3UJ
    • Raigmore Hospital; Dept of Radiotherapy & Oncology
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary NHS Trust
  • London, United Kingdom, EC1A 7BE
    • Barts and the London NHS Trust.
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

  1. 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
  2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atezolizumab; Participants 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).	Drug: Atezolizumab; Atezolizumab 1200 milligrams (mg) will be administered by intravenous (IV) infusion Q3W.; Other Names: MPDL3280A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to end of study (up to approximately 6 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Randomization until death from any cause (up to approximately 6 years)
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.	Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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	Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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.	Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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.	Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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.	Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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.	Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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).	Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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.	Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
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.	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)
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.	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)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2016
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimated): October 10, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Atezolizumab
• Other Study ID Numbers: MO29983; 2016-002625-11 (EudraCT Number)