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
2 other identifiers
interventional
1,004
30 countries
163
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2016
Longer than P75 for phase_3
163 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedStudy Start
First participant enrolled
November 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2022
CompletedResults Posted
Study results publicly available
April 4, 2024
CompletedApril 4, 2024
March 1, 2024
6 years
October 7, 2016
December 11, 2023
March 6, 2024
Conditions
Outcome Measures
Primary Outcomes (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.
Baseline up to end of study (up to approximately 6 years)
Secondary Outcomes (11)
Overall Survival (OS)
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)
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)
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
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
Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
- +6 more secondary outcomes
Study Arms (1)
Atezolizumab
EXPERIMENTALParticipants 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).
Interventions
Atezolizumab 1200 milligrams (mg) will be administered by intravenous (IV) infusion Q3W.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (175)
Inst. Alexander Fleming; Oncologia
Buenos Aires, C1426ANZ, Argentina
Hospital Aleman
Caba, C1118AAT, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, C1284AEB, Argentina
Canberra Hospital; Medical Oncology
Canberra, Australian Capital Territory, 2606, Australia
Macquarie University Hospital
Macquarie Park, New South Wales, 2109, Australia
Prince of Wales Hospital; Oncology
Randwick, New South Wales, 2031, Australia
Northern Cancer Institute
St Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, 2298, Australia
Icon Cancer Foundation
South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Royal Hobart Hospital; Hematology/Oncology
Hobart, Tasmania, 7000, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Austin Hospital Olivia Newton John Cancer Centre
Heidelberg, Victoria, 3084, Australia
Medizinische Universität Innsbruck; Universitätsklinik für Urologie
Innsbruck, 6020, Austria
Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
Linz, 4020, Austria
Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU
Salzburg, 5020, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Vienna, 1090, Austria
Medizinische Universität Wien; Universitätsklinik für Urologie
Vienna, 1090, Austria
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Pronutrir - suporte nutricional e quimioterapia ltda.
Fortaleza, Ceará, 60810-180, Brazil
Centro Integrado de Oncologia de Curitiba
Curitiba, Paraná, 80810-050, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, 01308-050, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01323-903, Brazil
Complex Oncology Center (COC)-Plovidiv
Plovdiv, 4000, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, 1527, Bulgaria
SHATOD - Sofia
Sofia, 1784, Bulgaria
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, T6G 1Z2, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2, Canada
The Ottawa Hospital Cancer Center; General Campus
Ottawa, Ontario, K1H 1C4, Canada
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, 210008, China
Clinica del Country
Bogotá, 11001, Colombia
Clinical Hospital Centre Zagreb
Zagreb, 10000, Croatia
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni
Prague, 140 59, Czechia
Aalborg Universitetshospital; Onkologisk Afdeling
Aalborg, 9000, Denmark
Aarhus Universitetshospital; Kræftafdelingen
Aarhus N, 8200, Denmark
Herlev Hospital; Afdeling for Kræftbehandling
Herlev, 2730, Denmark
Rigshospitalet; Onkologisk Klinik
København Ø, 2100, Denmark
East Tallinn Central Hospital; Clinic of Internal Medicine
Tallinn, 11312, Estonia
North Estonia Medical Centre Foundation; Oncology Center
Tallinn, 13419, Estonia
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
Dresden, 01307, Germany
Universitätsklinikum Erlangen; Medizinische Klinik 5 - Hämatound Internist Onko
Erlangen, 91054, Germany
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie
Göttingen, 37075, Germany
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
Halle, 06120, Germany
Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie
Hanover, 30625, Germany
Onkologische Schwerpunktpraxis
Heidelberg, 69115, Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie
Lübeck, 23538, Germany
Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus
Mönchengladbach, 41063, Germany
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
München, 81675, Germany
Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie
Münster, 48149, Germany
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen, 72076, Germany
Universitätsklinikum Ulm; Klinik für Urologie
Ulm, 89081, Germany
Alexandras General Hospital of Athens; Oncology Department
Athens, 115 28, Greece
IASO General Hospital of Athens
Athens, 155 62, Greece
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
Kifissia, 145 64, Greece
Metropolitan Hospital; 2Nd Oncology Clinic
Piraeus, 185 47, Greece
Thermi Clinic; Oncology Clinic
Thermi Thessalonikis, 570 01, Greece
Euromedical General Clinic of Thessaloniki; Oncology Department
Thessaloniki, 546 45, Greece
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, 564 29, Greece
Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department
Budapest, 1062, Hungary
Semmelwies University of Medicine; Urology Dept.
Budapest, 1082, Hungary
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, 6720, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
Szolnok, 5004, Hungary
HealthCare Global Cancer Centre; Medical Oncology
Ahmedabad, Gujarat, 380060, India
Artemis Health Institute
Gurgaon, Haryana, 122001, India
Max Super Speciality Hospital
New Delhi, National Capital Territory of Delhi, 110017, India
TATA Medical Centre; Medical Oncology
Kolkata, West Bengal, 700156, India
Cork University Hospital
Cork, Ireland
Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
Dublin, D24 NR0A, Ireland
Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
Chieti, Abruzzo, 66100, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Apulia, 70124, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
San Giovanni Rotondo, Apulia, 71013, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, 80131, Italy
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
Napoli, Campania, 80131, Italy
AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
Bologna, Emilia-Romagna, 40138, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, 41124, Italy
Arcispedale Santa Maria Nuova; Oncologia
Reggio Emilia, Emilia-Romagna, 42100, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
Udine, Friuli Venezia Giulia, 33100, Italy
Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica
Rome, Lazio, 00128, Italy
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Rome, Lazio, 00152, Italy
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
Rome, Lazio, 00168, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genoa, Liguria, 16132, Italy
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardy, 24127, Italy
ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
Cremona, Lombardy, 26100, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, 20133, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, 20141, Italy
A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
Orbassano, Piedmont, 10043, Italy
A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia
Cagliari, Sardinia, 09100, Italy
Ospedale Cannizzaro, Oncologia
Catania, Sicily, 95126, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo, Tuscany, 52100, Italy
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
Pisa, Tuscany, 56100, Italy
Azienda Ospedaliera S. Maria - Terni; Oncologia
Terni, Umbria, 05100, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
Padua, Veneto, 35128, Italy
Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Oncologia Medica
Verona, Veneto, 37134, Italy
Hotel Dieu de France; Oncology
Beirut, 2063 1111, Lebanon
Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Endocrinology clinic
Kaunas, 50009, Lithuania
National Cancer Institute
Vilnius, 08660, Lithuania
NKI/AvL
Amsterdam, 1066 CX, Netherlands
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Amsterdam, 1081 HV, Netherlands
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, 9713 GZ, Netherlands
Maastricht University Medical Centre; Medical Oncology
Maastricht, 6229 HX, Netherlands
St. Antonius locatie Leidsche Rijn
Utrecht, 3543 AZ, Netherlands
NZOZ Onko-Dent G. L. Slomian, Spolka Jawna
?ory, 44-240, Poland
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
Lublin, 20-090, Poland
Szpital Kliniczny Przemienienia Pa?skiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan, 60-570, Poland
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
Warsaw, 04-073, Poland
Hospital de Braga; Servico de Oncologia Medica X
Braga, 4710-243, Portugal
HUC; Servico de Urologia e Transplantacao Renal
Coimbra, 3000-075, Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisbon, 1649-035, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072, Portugal
Oncopremium Team Srl
Baia Mare, 430291, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Spital de zi-Parter
Cluj-Napoca, 400015, Romania
Centrul de Oncologie Sfantul Nectarie
Craiova, 200347, Romania
Centrul de Radioterapie AMETHYST
Floreşti, 407280, Romania
Oncomed SRL; Oncologie
Timișoara, 300239, Romania
Blokhin Cancer Research Center; Urological Dept
Moscow, Moscow Oblast, 115478, Russia
P.A. Herzen Oncological Inst. ; Oncology
Moscow, Moscow Oblast, 125248, Russia
King Faisal Specialist Hospital & Research Centre; Oncology
Riyadh, 11211, Saudi Arabia
Narodny onkologicky ustav
Bratislava, 833 10, Slovakia
Hospital Universitario Son Espases; Servicio de Oncologia
Palma de Mallorca, Balearic Islands, 07014, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, 08916, Spain
Complejo Hospitalario de Althaia; Servicio de Oncologia
Manresa, Barcelona, 08243, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, 8208, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Sant Andreu de la Barca, Barcelona, 08740, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, 14004, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, 15706, Spain
Hospital de Navarra; Servicio de Oncologia
Navarra, Navarre, 31008, Spain
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Hospital de Basurto; Servicio de Oncologia
Bilbao, Vizcaya, 48013, Spain
Hospital del Mar Barcelona
Barcelona, 08003, Spain
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, 08041, Spain
Hospital Duran i Reynals; Oncologia
Barcelona, 08907, Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia
Cáceres, 10003, Spain
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
Girona, 17007, Spain
Hospital General Universitario de Guadalajara; Servicio de Oncologia
Guadalajara, 19002, Spain
Hospital Lucus Augusti; Servicio de Oncologia
Lugo, 27003, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034, Spain
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046, Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid, 28050, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010, Spain
Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
Murcia, 30008, Spain
Complejo Hospitalario de Orense; Servicio de Oncologia
Ourense, 32005, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, 41013, Spain
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
Toledo, 45004, Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología
Valencia, 46010, Spain
Hospital General Universitario de Valencia; Servicio de oncologia
Valencia, 46014, Spain
Hospital La Fe
Valencia, Spain
Universitaetsspital Basel; Onkologie
Basel, 4031, Switzerland
Ospedale Regionale di Bellinzona Medizin Onkologie
Bellinzona, 6500, Switzerland
Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit
Bern, 3010, Switzerland
Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
Chur, 7000, Switzerland
Hôpitaux Universit. de Genève Médecine Oncologie; Oncologie
Geneva, 1211, Switzerland
Luzerner Kantonsspital; Medizinische Onkologie
Lucerne, 6004, Switzerland
Kantonsspital Winterthur; Medizinische Onkologie
Winterthur, 8401, Switzerland
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
Tainan, 704, Taiwan
Chang Gung Medical Foundation-Linkou, Urinary Oncology
Taoyuan District, 333, Taiwan
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Raigmore Hospital; Dept of Radiotherapy & Oncology
Inverness, IV1 3UJ, United Kingdom
Leicester Royal Infirmary NHS Trust
Leicester, LE1 5WW, United Kingdom
Barts and the London NHS Trust.
London, EC1A 7BE, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
Related Publications (6)
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.
PMID: 36627145DERIVEDBamias 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.
PMID: 33984672DERIVEDMerseburger 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.
PMID: 33835866DERIVEDLoriot 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.
PMID: 32905959DERIVEDCathomas 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.
PMID: 32399958DERIVEDSternberg 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.
PMID: 30910346DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2016
First Posted
October 10, 2016
Study Start
November 30, 2016
Primary Completion
December 12, 2022
Study Completion
December 12, 2022
Last Updated
April 4, 2024
Results First Posted
April 4, 2024
Record last verified: 2024-03