Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-002625-11
    Sponsor's Protocol Code Number:MO29983
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-002625-11
    A.3Full title of the trial
    AN OPEN LABEL, SINGLE ARM, MULTICENTER, SAFETY STUDY OF ATEZOLIZUMAB IN LOCALLY ADVANCED OR METASTATIC UROTHELIAL OR NON-UROTHELIAL CARCINOMA OF THE URINARY TRACT
    STUDIO IN APERTO, A BRACCIO SINGOLO, MULTICENTRICO, SULLA SICUREZZA DI ATEZOLIZUMAB NEL CARCINOMA UROTELIALE O NON UROTELIALE DELLE VIE URINARIE LOCALMENTE AVANZATO O METASTATICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non Urothelial Carcinoma of the Urinary Tract
    Uno studio con Atezolizumab nel carcinoma uroteliale o non uroteliale delle vie urinarie localmente avanzato o metastatico
    A.3.2Name or abbreviated title of the trial where available
    A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non Urothelial Carcinoma of
    UNO STUDIO CON ATEZOLIZUMAB NEL CARCINOMA UROTELIALE O NON UROTELIALE DELLE VIE URINARIE LOCALMENTE
    A.4.1Sponsor's protocol code numberMO29983
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041616881111
    B.5.5Fax number0041616919319
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAtezolizumab
    D.3.2Product code RO5541267/F03
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATEZOLIZUMAB
    D.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH - EU/1/17/1220/001
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAtezolizumab
    D.3.2Product code RO5541267/F03
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATEZOLIZUMAB
    D.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
    Carcinoma uroteliale o non uroteliale delle vie urinarie in stadio avanzato o metastatico
    E.1.1.1Medical condition in easily understood language
    Urothelial cancer is a type of cancer that affects the urinary tract. It includes cancer of the bladder, ureters, and renal pelvis.
    tumore uroteliale è un tipo di tumore che colpisce il tratto urinario. Esso comprende il cancro della vescica, ureteri, e pelvi renale.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064467
    E.1.2Term Urothelial carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety of atezolizumab
    valutare la sicurezza di atezolizumab
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of atezolizumab
    valutare l'efficacia di atezolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - 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
    - Patients with measurable and non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 are allowed
    - Must have received one prior combination chemotherapy regimen (e.g., methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], gemcitabine and cisplatin [GC], etc.) for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
    - Representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block available for submission at baseline
    - Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2
    - Life expectancy >= 12 weeks
    - Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 2 weeks prior to the first study treatment
    - Patients with treated, asymptomatic central nervous system (CNS) metastases are eligible (Note: Patients on stable doses of anticonvulsants or on prednisone doses [or dose equivalents] of <= 20 milligram/day are allowed)
    - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab
    - Età >/= 18 anni
    - Carcinoma uroteliale o non uroteliale delle vie urinarie istologicamente documentato come localmente avanzato (T4b, qualsiasi N; o qualsiasi T, N 2-3) o metastatico (M1, stadio IV)
    - È consentita la partecipazione di pazienti con malattia misurabile e non misurabile secondo i criteri RECIST v 1.1
    - Obbligo di precedente trattamento con un regime chemioterapico di combinazione (per es. MVAC, GC, ecc.) per un carcinoma uroteliale o non uroteliale delle vie urinarie inoperabile, localmente avanzato o metastatico
    - Disponibilità di un blocco di tessuto tumorale rappresentativo fissato in formalina e incluso in paraffina (Formalin-Fixed Paraffin-Embedded, FFPE)
    - Punteggio del performance status secondo l’Eastern Cooperative Oncology Group (ECOG) di 0, 1 o 2
    - Aspettativa di vita >/= 12 settimane
    - Adeguata funzione ematologica e degli organi terminali, definita dai seguenti valori delle analisi di laboratorio effettuate nelle 2 settimane precedenti la prima dose del trattamento in studio
    - I pazienti con metastasi del sistema nervoso centrale (SNC) asintomatiche sono eleggibili (NB: i pazienti che ricevono dosi stabili di anticonvulsivanti o dosi di prednisolone (o equivalenti di dose) </= 20 mg/die possono essere arruolati)
    - Per le donne potenzialmente fertili: consenso a praticare l’astinenza (astenersi dai rapporti eterosessuali) o a utilizzare metodi contraccettivi che siano caratterizzati da un tasso di insuccesso < 1% l’anno durante il periodo di trattamento e per almeno 5 mesi dopo l’ultima dose di atezolizumab
    E.4Principal exclusion criteria
    - Treatment with more than three prior line 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
    - Treatment with chemotherapy within 2 weeks prior to study treatment initiation
    - Treatment with radiotherapy ongoing at the time of study entry (for CNS-directed radiotherapy)
    - Pregnant or lactating, or intending to become pregnant during the study
    - Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
    - Significant cardiovascular disease, such as New York Heart Association cardiac disease >= Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina
    - Significant renal disorder requiring dialysis or indication for renal transplant
    - Signs or symptoms of severe infection within 2 weeks prior to initiation of study treatment, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
    - Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
    - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    - Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
    - History of autoimmune disease are allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks
    - Prior allogeneic stem cell or solid organ transplantation
    - History of idiopathic pulmonary fibrosis (including pneumonitis, drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
    - Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
    - Active tuberculosis
    - Administration of a live, attenuated vaccine within 4 weeks prior to study treatment initiation
    - Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, including anti- cytotoxic T lymphocyte-associated (CTLA)-4, anti- programmed cell death protein 1 (PD-1), and anti- programmed death-ligand 1 (PD-L1) therapeutic antibodies
    - Treatment with systemic immunostimulatory agents (including, but not limited to, interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment
    - Specifically for patients without autoimmune disease, treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to study treatment initiation or anticipated requirement for systemic immunosuppressive medications during the study treatment period. Note: For patients with autoimmune disease, immunosuppressive medications are permitted if the patient has controlled autoimmune disease and stable treatment (i.e., same treatment, same dose) for the previous 12 weeks
    -Trattamento con più di tre precedenti linee di terapia sistemica per il carcinoma uroteliale o non uroteliale delle vie urinarie, localmente avanzato o metastatico
    -Trattamento con altro agente sperimentale o partecipazione ad altro studio clinico con intento terapeutico nelle 4 settimane precedenti l’inizio del trattamento in studio
    -Trattamento con chemioterapia nelle 2 settimane precedenti l’inizio del trattamento in studio
    - Trattamento con radioterapia in atto al momento dell’ingresso nello studio (per radioterapia diretta contro il SNC)
    - Gravidanza, allattamento o pianificazione di una gravidanza durante lo studio
    - Evidenza di significativa patologia concomitante non controllata che potrebbe pregiudicare la compliance al protocollo, inclusa significativa epatopatia (quale cirrosi, disturbi di tipo epilettico maggiori non controllati o sindrome della vena cava superiore)
    - Malattia cardiovascolare significativa, quale cardiopatia di classe New York Heart Association III o superiore, infarto del miocardio negli ultimi 3 mesi, aritmie instabili o angina instabile
    - Significativo disordine renale con necessità di dialisi o indicazione per trapianto renale
    - Segni o sintomi di grave infezione nelle 2 settimane precedenti l’inizio del trattamento in studio, inclusi a titolo esemplificativo e non esaustivo ricovero per complicanze di un’infezione, batteriemia o polmonite grave
    - Procedura chirurgica maggiore nelle 4 settimane precedenti l’inizio del trattamento in studio o necessità prevista di una procedura chirurgica maggiore durante il corso dello studio, se non a scopo diagnostico
    - Antecedenti di gravi reazioni allergiche, anafilattiche o di altre reazioni di ipersensibilità agli anticorpi chimerici, umani o umanizzati o alle proteine di fusione
    - Nota ipersensibilità o allergia ai biofarmaci prodotti a partire da cellule di ovaio di hamster cinese o a uno qualsiasi dei componenti della formulazione di atezolizumab
    - Storia di malattia autoimmune consentita se controllata e in trattamento stabile (ossia, stesso trattamento, stessa dose) nelle ultime 12 settimane
    - Precedente trapianto allogenico di cellule staminali od organi solidi
    - Presenza in anamnesi di fibrosi polmonare idiopatica (compresa polmonite, polmonite indotta da farmaci, polmonite in organizzazione [bronchiolite obliterante, polmonite organizzata criptogenetica]) o evidenza di polmonite attiva alla tomografia computerizzata (TC) del torace effettuata allo screening
    - Pazienti con epatite B attiva (ossia con positività per l’antigene di superficie dell’epatite B [HBsAg] al test di screening) o epatite C attiva
    - Tubercolosi attiva
    - Somministrazione di un vaccino vivo attenuato nelle 4 settimane precedenti l’inizio del trattamento in studio
    - Precedente trattamento con agonisti di CD137 o con terapie di blocco del checkpoint immunitario, inclusi anticorpi terapeutici anti-CTLA-4, anti-PD-1 e anti-PD-L1
    - Trattamento con agenti immunostimolatori (inclusi a titolo esemplificativo e non esaustivo interferoni o interleuchina-2) nelle 4 settimane o cinque emivite del farmaco precedenti l’inizio del trattamento in studio (dei due il periodo più breve)
    - Specificamente per i pazienti senza malattia autoimmune: trattamento con corticosteroidi sistemici o altri farmaci immunosoppressori sistemici (inclusi a titolo esemplificativo e non esaustivo prednisone, desametasone, ciclofosfamide, azatioprina, metotressato, talidomide e agenti anti-fattore di necrosi tumorale) nelle 2 settimane precedenti l’inizio del trattamento in studio o prevista necessità di farmaci immunosoppressori sistemici durante lo studio
    NB: per i pazienti con malattia autoimmune, i farmaci immunosoppressori sono consentiti se il paziente presenta una malattia autoimmune controllata ed è in terapia stabile (stesso trattamento, stessa dose) da 12 settimane.
    E.5 End points
    E.5.1Primary end point(s)
    1.Nature, severity, duration, frequency and timing of adverse events
    2.Changes in vital signs, physical findings, and clinical laboratory results during and following atezolizumab administration
    1. Natura, gravità, durata, frequenza e tempistiche degli eventi avversi
    2. Variazioni dei parametri vitali, dei risultati dell’esame obiettivo e dei valori delle analisi di laboratorio durante e dopo la somministrazione di atezolizumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. Up to 6 years
    1-2. fino a 6 anni
    E.5.2Secondary end point(s)
    1.Overall survival (OS)
    2.Progression-free survival (PFS)
    3.Overall response rate (ORR)
    4.Disease control rate (DCR)
    5.Duration of response (DoR)
    6.Change from baseline in health-related quality of life (HRQoL), as assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30)
    7.EuroQol EQ-5D-5L-assessed health utility score
    1. Sopravvivenza globale (OS)
    2. Sopravvivenza libera da progressione (PFS)
    3. Il tasso di risposta complessiva (ORR)
    4. Il tasso di controllo della malattia (DCR)
    5. Durata della risposta (DoR)
    6. Variazione rispetto al basale della qualità di vita correlata alla salute (Health-Related Quality of Life, HRQoL), valutata mediante il questionario Core 30 dell'EORTC sulla qualità di vita (QLQ-C30)
    7. Utilità valutata mediante il questionario EuroQol EQ-5D-5L.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-7. Up to 6 years
    1-7. fino a 6 anni
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned26
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA140
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    China
    Colombia
    Egypt
    Russian Federation
    Saudi Arabia
    Austria
    Belgium
    Bulgaria
    Croatia
    Denmark
    Estonia
    Germany
    Greece
    Hungary
    Ireland
    Lithuania
    Netherlands
    Poland
    Portugal
    Romania
    Spain
    Switzerland
    United Kingdom
    Czechia
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    When all patients enrolled have either died, withdrawn consent, are lost to follow up, or have been followed for 48 months since the last study patient is enrolled, whichever occurs first
    quando tutti i pazienti arruolati saranno deceduti, avranno revocato il consenso o saranno persi al follow-up, oppure saranno stati seguiti per 48 mesi dall'arruolamento dell'ultimo paziente nello studio, a seconda di quale caso si verifichi per primo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 700
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state270
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 1000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    When appropriate, the Sponsor will offer access to atezolizumab to patients still benefiting from the treatment at the end of the study in accordance with the Roche
    Global Policy on Continued Access to Investigational Medicinal Product.
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    Se appropriato, lo Sponsor offrirà l'accesso a atezolizumab ai pazienti che beneficiano ancora del trattamento al termine dello studio in accordo con la politica aziendale di Roche in materia di prodotti sperimentali
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-18
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 21:13:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA