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

NCT ID: NCT02928406

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1004 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2022-12-12

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.

Conditions

Urinary Tract Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

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

Interventions

Atezolizumab

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

Intervention Type: DRUG

Other Intervention Names

MPDL3280A

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Inst. Alexander Fleming; Oncologia

Buenos Aires, , Argentina

Hospital Aleman

Caba, , Argentina

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, , Argentina

Canberra Hospital; Medical Oncology

Canberra, Australian Capital Territory, Australia

Macquarie University Hospital

Macquarie Park, New South Wales, Australia

Prince of Wales Hospital; Oncology

Randwick, New South Wales, Australia

Northern Cancer Institute

St Leonards, New South Wales, Australia

Calvary Mater Newcastle; Medical Oncology

Waratah, New South Wales, Australia

Icon Cancer Foundation

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Royal Hobart Hospital; Hematology/Oncology

Hobart, Tasmania, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Austin Hospital Olivia Newton John Cancer Centre

Heidelberg, Victoria, Australia

Medizinische Universität Innsbruck; Universitätsklinik für Urologie

Innsbruck, , Austria

Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

Linz, , Austria

Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU

Salzburg, , Austria

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

Vienna, , Austria

Medizinische Universität Wien; Universitätsklinik für Urologie

Vienna, , Austria

UZ Brussel

Brussels, , Belgium

Cliniques Universitaires St-Luc

Brussels, , Belgium

UZ Leuven Gasthuisberg

Leuven, , Belgium

CHU Sart-Tilman

Liège, , Belgium

Pronutrir - suporte nutricional e quimioterapia ltda.

Fortaleza, Ceará, Brazil

Centro Integrado de Oncologia de Curitiba

Curitiba, Paraná, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

Hospital Sírio-Libanês

São Paulo, São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, Brazil

Complex Oncology Center (COC)-Plovidiv

Plovdiv, , Bulgaria

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

Sofia, , Bulgaria

SHATOD - Sofia

Sofia, , Bulgaria

Tom Baker Cancer Centre-Calgary

Calgary, Alberta, Canada

Cross Cancer Institute ; Dept of Medical Oncology

Edmonton, Alberta, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Royal Victoria Hospital

Barrie, Ontario, Canada

The Ottawa Hospital Cancer Center; General Campus

Ottawa, Ontario, Canada

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

Nanjing, , China

Clinica del Country

Bogotá, , Colombia

Clinical Hospital Centre Zagreb

Zagreb, , Croatia

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

Prague, , Czechia

Aalborg Universitetshospital; Onkologisk Afdeling

Aalborg, , Denmark

Aarhus Universitetshospital; Kræftafdelingen

Aarhus N, , Denmark

Herlev Hospital; Afdeling for Kræftbehandling

Herlev, , Denmark

Rigshospitalet; Onkologisk Klinik

København Ø, , Denmark

East Tallinn Central Hospital; Clinic of Internal Medicine

Tallinn, , Estonia

North Estonia Medical Centre Foundation; Oncology Center

Tallinn, , Estonia

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

Dresden, , Germany

Universitätsklinikum Erlangen; Medizinische Klinik 5 - Hämatound Internist Onko

Erlangen, , Germany

Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie

Göttingen, , Germany

Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

Halle, , Germany

Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie

Hanover, , Germany

Onkologische Schwerpunktpraxis

Heidelberg, , Germany

Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie

Lübeck, , Germany

Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus

Mönchengladbach, , Germany

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

München, , Germany

Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie

Münster, , Germany

Universitätsklinikum Tübingen; Klinik für Urologie

Tübingen, , Germany

Universitätsklinikum Ulm; Klinik für Urologie

Ulm, , Germany

Alexandras General Hospital of Athens; Oncology Department

Athens, , Greece

IASO General Hospital of Athens

Athens, , Greece

Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

Kifissia, , Greece

Metropolitan Hospital; 2Nd Oncology Clinic

Piraeus, , Greece

Thermi Clinic; Oncology Clinic

Thermi Thessalonikis, , Greece

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, , Greece

Papageorgiou General Hospital; Medical Oncology

Thessaloniki, , Greece

Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department

Budapest, , Hungary

Semmelwies University of Medicine; Urology Dept.

Budapest, , Hungary

Orszagos Onkologiai Intezet

Budapest, , Hungary

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

Szeged, , Hungary

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

Szolnok, , Hungary

HealthCare Global Cancer Centre; Medical Oncology

Ahmedabad, Gujarat, India

Artemis Health Institute

Gurgaon, Haryana, India

Max Super Speciality Hospital

New Delhi, National Capital Territory of Delhi, India

TATA Medical Centre; Medical Oncology

Kolkata, West Bengal, India

Cork University Hospital

Cork, , Ireland

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

Dublin, , Ireland

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

Chieti, Abruzzo, Italy

Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

Bari, Apulia, Italy

IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

San Giovanni Rotondo, Apulia, Italy

Azienda Ospedaliera Universitaria Federico II

Napoli, Campania, Italy

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

Napoli, Campania, Italy

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

Bologna, Emilia-Romagna, Italy

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

Meldola, Emilia-Romagna, Italy

A.O. Universitaria Policlinico Di Modena; Oncologia

Modena, Emilia-Romagna, Italy

Arcispedale Santa Maria Nuova; Oncologia

Reggio Emilia, Emilia-Romagna, Italy

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

Udine, Friuli Venezia Giulia, Italy

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

Rome, Lazio, Italy

Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

Rome, Lazio, Italy

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

Rome, Lazio, Italy

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

Genoa, Liguria, Italy

Asst Papa Giovanni XXIII; Oncologia Medica

Bergamo, Lombardy, Italy

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

Cremona, Lombardy, Italy

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

Milan, Lombardy, Italy

Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

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

Orbassano, Piedmont, Italy

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

Cagliari, Sardinia, Italy

Ospedale Cannizzaro, Oncologia

Catania, Sicily, Italy

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

Arezzo, Tuscany, Italy

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

Pisa, Tuscany, Italy

Azienda Ospedaliera S. Maria - Terni; Oncologia

Terni, Umbria, Italy

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

Padua, Veneto, Italy

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

Verona, Veneto, Italy

Hotel Dieu de France; Oncology

Beirut, , Lebanon

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

Kaunas, , Lithuania

National Cancer Institute

Vilnius, , Lithuania

NKI/AvL

Amsterdam, , Netherlands

VU MEDISCH CENTRUM; Dept. of Medical Oncology

Amsterdam, , Netherlands

Academ Ziekenhuis Groningen; Medical Oncology

Groningen, , Netherlands

Maastricht University Medical Centre; Medical Oncology

Maastricht, , Netherlands

St. Antonius locatie Leidsche Rijn

Utrecht, , Netherlands

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

?ory, , Poland

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

Lublin, , Poland

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

Poznan, , Poland

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

Warsaw, , Poland

Hospital de Braga; Servico de Oncologia Medica X

Braga, , Portugal

HUC; Servico de Urologia e Transplantacao Renal

Coimbra, , Portugal

Hospital de Santa Maria; Servico de Oncologia Medica

Lisbon, , Portugal

IPO do Porto; Servico de Oncologia Medica

Porto, , Portugal

Oncopremium Team Srl

Baia Mare, , Romania

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

Cluj-Napoca, , Romania

Centrul de Oncologie Sfantul Nectarie

Craiova, , Romania

Centrul de Radioterapie AMETHYST

Floreşti, , Romania

Oncomed SRL; Oncologie

Timișoara, , Romania

Blokhin Cancer Research Center; Urological Dept

Moscow, Moscow Oblast, Russia

P.A. Herzen Oncological Inst. ; Oncology

Moscow, Moscow Oblast, Russia

King Faisal Specialist Hospital & Research Centre; Oncology

Riyadh, , Saudi Arabia

Narodny onkologicky ustav

Bratislava, , Slovakia

Hospital Universitario Son Espases; Servicio de Oncologia

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

Badalona, Barcelona, Spain

Complejo Hospitalario de Althaia; Servicio de Oncologia

Manresa, Barcelona, Spain

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, Spain

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Sant Andreu de la Barca, Barcelona, Spain

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, Spain

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

Santiago de Compostela, LA Coruña, Spain

Hospital de Navarra; Servicio de Oncologia

Navarra, Navarre, Spain

Hospital Univ. Central de Asturias; Servicio de Oncologia

Oviedo, Principality of Asturias, Spain

Hospital Universitario de Canarias;servicio de Oncologia

San Cristóbal de La Laguna, Tenerife, Spain

Hospital de Basurto; Servicio de Oncologia

Bilbao, Vizcaya, Spain

Hospital del Mar Barcelona

Barcelona, , Spain

Hospital Clínic i Provincial; Servicio de Oncología

Barcelona, , Spain

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

Barcelona, , Spain

Hospital Duran i Reynals; Oncologia

Barcelona, , Spain

Hospital San Pedro De Alcantara; Servicio de Oncologia

Cáceres, , Spain

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

Girona, , Spain

Hospital General Universitario de Guadalajara; Servicio de Oncologia

Guadalajara, , Spain

Hospital Lucus Augusti; Servicio de Oncologia

Lugo, , Spain

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, , Spain

Hospital Clinico San Carlos; Servicio de Oncologia

Madrid, , Spain

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, , Spain

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, , Spain

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

Madrid, , Spain

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Málaga, , Spain

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

Murcia, , Spain

Complejo Hospitalario de Orense; Servicio de Oncologia

Ourense, , Spain

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Seville, , Spain

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

Toledo, , Spain

Hospital Clínico Universitario de Valencia; Servicio de Oncología

Valencia, , Spain

Hospital General Universitario de Valencia; Servicio de oncologia

Valencia, , Spain

Hospital La Fe

Valencia, , Spain

Universitaetsspital Basel; Onkologie

Basel, , Switzerland

Ospedale Regionale di Bellinzona Medizin Onkologie

Bellinzona, , Switzerland

Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit

Bern, , Switzerland

Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie

Chur, , Switzerland

Hôpitaux Universit. de Genève Médecine Oncologie; Oncologie

Geneva, , Switzerland

Luzerner Kantonsspital; Medizinische Onkologie

Lucerne, , Switzerland

Kantonsspital Winterthur; Medizinische Onkologie

Winterthur, , Switzerland

National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

Tainan City, , Taiwan

Chang Gung Medical Foundation-Linkou, Urinary Oncology

Taoyuan District, , Taiwan

Velindre Cancer Centre

Cardiff, , United Kingdom

Raigmore Hospital; Dept of Radiotherapy & Oncology

Inverness, , United Kingdom

Leicester Royal Infirmary NHS Trust

Leicester, , United Kingdom

Barts and the London NHS Trust.

London, , United Kingdom

Royal Marsden NHS Foundation Trust

Sutton, , United Kingdom

Countries

Argentina; Australia; Austria; Belgium; Brazil; Bulgaria; Canada; China; Colombia; Croatia; Czechia; Denmark; Estonia; Germany; Greece; Hungary; India; Ireland; Italy; Lebanon; Lithuania; Netherlands; Poland; Portugal; Romania; Russia; Saudi Arabia; Slovakia; Spain; Switzerland; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36627145 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33984672 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33835866 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32905959 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32399958 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30910346 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-002625-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MO29983

Identifier Type: -

Identifier Source: org_study_id