Clinical trial NCT02928406: A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Tract Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-10-10
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 atezolizumab.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline up to end of study (up to approximately 6 years)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization until death from any cause (up to approximately 6 years)
measure: Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
measure: PFS as Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST)
timeFrame: Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
measure: Percentage of Participants With Best Overall Response (BOR) as Assessed by RECIST v1.1
timeFrame: Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
measure: Percentage of Participants With BOR as Assessed by Modified RECIST
timeFrame: Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
measure: Percentage of Participants With Disease Control as Assessed by RECIST v1.1
timeFrame: Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
measure: Percentage of Participants With Disease Control as Assessed by Modified RECIST
timeFrame: Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
measure: Duration of Response (DOR) as Assessed by RECIST v1.1
timeFrame: Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
measure: DOR as Assessed by Modified RECIST
timeFrame: Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
measure: 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
timeFrame: 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)
measure: Change From Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score
timeFrame: 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)
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Inst. Alexander Fleming; Oncologia
city: Caba
country: Argentina
facility: Hospital Aleman
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Canberra
country: Australia
facility: Canberra Hospital; Medical Oncology
state: Australian Capital Territory
city: Macquarie Park
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital; Oncology
state: New South Wales
city: St Leonards
country: Australia
facility: Northern Cancer Institute
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle; Medical Oncology
state: New South Wales
city: South Brisbane
country: Australia
facility: Icon Cancer Foundation
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital; Hematology/Oncology
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital Olivia Newton John Cancer Centre
state: Victoria
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck; Universitätsklinik für Urologie
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
city: Wien
country: Austria
facility: Medizinische Universität Wien; Universitätsklinik für Urologie
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Fortaleza
country: Brazil
facility: Pronutrir - suporte nutricional e quimioterapia ltda.
state: CE
city: Curitiba
country: Brazil
facility: Centro Integrado de Oncologia de Curitiba
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Sírio-Libanês
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
state: SP
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center (COC)-Plovidiv
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
city: Sofia
country: Bulgaria
facility: SHATOD - Sofia
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre-Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute ; Dept of Medical Oncology
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Center; General Campus
state: Ontario
city: Nanjing City
country: China
facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
city: Bogota
country: Colombia
facility: Clinica del Country
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha
country: Czechia
facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital; Onkologisk Afdeling
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital; Kræftafdelingen
city: Herlev
country: Denmark
facility: Herlev Hospital; Afdeling for Kræftbehandling
city: København Ø
country: Denmark
facility: Rigshospitalet; Onkologisk Klinik
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital; Clinic of Internal Medicine
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation; Oncology Center
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen; Medizinische Klinik 5 - Hämatound Internist Onko
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie
city: Heidelberg
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen; Klinik für Urologie
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm; Klinik für Urologie
city: Athens
country: Greece
facility: Alexandras General Hospital of Athens; Oncology Department
city: Athens
country: Greece
facility: IASO General Hospital of Athens
city: Kifisia
country: Greece
facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
city: Piraeus
country: Greece
facility: Metropolitan Hospital; 2Nd Oncology Clinic
city: Thermi Thessalonikis
country: Greece
facility: Thermi Clinic; Oncology Clinic
city: Thessaloniki
country: Greece
facility: Euromedical General Clinic of Thessaloniki; Oncology Department
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital; Medical Oncology
city: Budapest
country: Hungary
facility: Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department
city: Budapest
country: Hungary
facility: Semmelwies University of Medicine; Urology Dept.
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
city: New Delhi
country: India
facility: Max Super Speciality Hospital
state: Delhi
city: Ahmedabad
country: India
facility: HealthCare Global Cancer Centre; Medical Oncology
state: Gujarat
city: Gurgaon
country: India
facility: Artemis Health Institute
state: Haryana
city: Kolkata
country: India
facility: TATA Medical Centre; Medical Oncology
state: WEST Bengal
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
city: Chieti
country: Italy
facility: Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
state: Abruzzo
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
state: Campania
city: Napoli
country: Italy
facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
state: Campania
city: Bologna
country: Italy
facility: AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
state: Emilia-Romagna
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Oncologia
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova; Oncologia
state: Emilia-Romagna
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
state: Lazio
city: Roma
country: Italy
facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
state: Lazio
city: Genova
country: Italy
facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
state: Liguria
city: Bergamo
country: Italy
facility: Asst Papa Giovanni XXIII; Oncologia Medica
state: Lombardia
city: Cremona
country: Italy
facility: ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Orbassano
country: Italy
facility: A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
state: Piemonte
city: Bari
country: Italy
facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
state: Puglia
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
state: Puglia
city: Cagliari
country: Italy
facility: A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia
state: Sardegna
city: Catania
country: Italy
facility: Ospedale Cannizzaro, Oncologia
state: Sicilia
city: Arezzo
country: Italy
facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
state: Toscana
city: Pisa
country: Italy
facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
state: Toscana
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria - Terni; Oncologia
state: Umbria
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
state: Veneto
city: Verona
country: Italy
facility: Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Oncologia Medica
state: Veneto
city: Beirut
country: Lebanon
facility: Hotel Dieu de France; Oncology
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Endocrinology clinic
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Amsterdam
country: Netherlands
facility: NKI/AvL
city: Amsterdam
country: Netherlands
facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology
city: Groningen
country: Netherlands
facility: Academ Ziekenhuis Groningen; Medical Oncology
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre; Medical Oncology
city: Utrecht
country: Netherlands
facility: St. Antonius locatie Leidsche Rijn
city: ?ory
country: Poland
facility: NZOZ Onko-Dent G. L. Slomian, Spolka Jawna
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Pa?skiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
city: Warszawa
country: Poland
facility: Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
city: Braga
country: Portugal
facility: Hospital de Braga; Servico de Oncologia Medica X
city: Coimbra
country: Portugal
facility: HUC; Servico de Urologia e Transplantacao Renal
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Oncologia Medica
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Baia Mare
country: Romania
facility: Oncopremium Team Srl
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Spital de zi-Parter
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie
city: Floresti
country: Romania
facility: Centrul de Radioterapie AMETHYST
city: Timisoara
country: Romania
facility: Oncomed SRL; Oncologie
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center; Urological Dept
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: P.A. Herzen Oncological Inst. ; Oncology
state: Moskovskaja Oblast
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre; Oncology
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias; Servicio de Oncologia
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
state: Barcelona
city: Manresa
country: Spain
facility: Complejo Hospitalario de Althaia; Servicio de Oncologia
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
state: Barcelona
city: Sant Andreu de La Barca
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
state: Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
state: Cordoba
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases; Servicio de Oncologia
state: Islas Baleares
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
state: LA Coruña
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias;servicio de Oncologia
state: Tenerife
city: Bilbao
country: Spain
facility: Hospital de Basurto; Servicio de Oncologia
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital del Mar Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Oncología
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals; Oncologia
city: Caceres
country: Spain
facility: Hospital San Pedro De Alcantara; Servicio de Oncologia
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
city: Guadalajara
country: Spain
facility: Hospital General Universitario de Guadalajara; Servicio de Oncologia
city: Lugo
country: Spain
facility: Hospital Lucus Augusti; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Madrid
country: Spain
facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
city: Murcia
country: Spain
facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
city: Navarra
country: Spain
facility: Hospital de Navarra; Servicio de Oncologia
city: Orense
country: Spain
facility: Complejo Hospitalario de Orense; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia; Servicio de oncologia
city: Valencia
country: Spain
facility: Hospital La Fe
city: Basel
country: Switzerland
facility: Universitaetsspital Basel; Onkologie
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale di Bellinzona Medizin Onkologie
city: Bern
country: Switzerland
facility: Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
city: Geneve
country: Switzerland
facility: Hôpitaux Universit. de Genève Médecine Oncologie; Oncologie
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital; Medizinische Onkologie
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur; Medizinische Onkologie
city: Tainan
country: Taiwan
facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou, Urinary Oncology
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Inverness
country: United Kingdom
facility: Raigmore Hospital; Dept of Radiotherapy & Oncology
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary NHS Trust
city: London
country: United Kingdom
facility: Barts and the London NHS Trust.
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.