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    Summary
    EudraCT Number:2016-003092-22
    Sponsor's Protocol Code Number:CO39385
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-11
    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 number2016-003092-22
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH ENZALUTAMIDE VERSUS ENZALUTAMIDE ALONE IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AFTER FAILURE OF AN ANDROGEN SYNTHESIS INHIBITOR AND FAILURE OF, INELIGIBILITY FOR, OR REFUSAL OF A TAXANE REGIMEN
    STUDIO DI FASE III MULTICENTRICO, RANDOMIZZATO, PER VALUTARE L¿EFFETTO DI ATEZOLIZUMAB (ANTICORPO ANTI-PD-L1) IN ASSOCIAZIONE A ENZALUTAMIDE RISPETTO A ENZALUTAMIDE IN MONOTERAPIA IN PAZIENTI CON TUMORE DELLA PROSTATA METASTATICO RESISTENTE ALLA CASTRAZIONE DOPO FALLIMENTO DI UN INIBITORE DELLA SINTESI DEGLI ANDROGENI E DOPO FALLIMENTO, INELEGGIBILIT¿ O RIFIUTO DI UN REGIME A BASE DI TAXANI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Atezolizumab (Anti PD L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostrate Cancer After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen
    Studio con Atezolizumab (Anticorpo Anti-PD L1) in combinazione don Enzalutamide rispetto al trattamento con il solo Enzalutamide in pazienti con tumore della prostata metastatico resistente alla castrazione, dopo fallimento di un inibitore della sintesi degli androgeni e dopo fallimento, ineleggibilit¿ o rifiuto di un regime a base di taxani.
    A.3.2Name or abbreviated title of the trial where available
    IMbassador250
    IMbassador250
    A.4.1Sponsor's protocol code numberCO39385
    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 code4047
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041616881111
    B.5.5Fax number0041616889391
    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
    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.3.9.2Current sponsor codeRO5541267
    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 RoleComparator
    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 XTANDI - "40 MG - CAPSULA MOLLE - USO ORALE - BLISTER (PVC/PCTFE/ALU)" 112 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA EUROPE B.V.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameEnzalutamide
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.2Current sponsor codeRO5251782
    D.3.9.4EV Substance CodeSUB77412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 3
    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 - AIC: 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 name-
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Concentrate for 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.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameSUB178312
    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
    Metastatic Castration-Resistant Prostrate Cancer (mCRPC)
    Tumore della prostata metastatico resistente alla castrazione (mCRPC)
    E.1.1.1Medical condition in easily understood language
    mCRPC is prostate cancer that is resistant to medical (e.g., hormonal) or surgical treatments that lower testosterone, and has spread to other parts of the body
    mCRPC è un tumore della prostata resistente a trattamenti medici (es. ormonali) o chirurgici che abbassano il livello di testosterone, e che si è diffuso in altre parti del corpo.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 efficacy of atezolizumab/enzalutamide compared with enzalutamide alone
    Valutare l¿efficacia di atezolizumab/enzalutamide rispetto a enzalutamide in monoterapia
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of atezolizumab/enzalutamide compared with enzalutamide alone
    To evaluate the safety and tolerability of atezolizumab/enzalutamide compared with enzalutamide alone
    To characterize the pharmacokinetics (PK)of atezolizumab when given in combination with enzalutamide
    To characterize the PK of enzalutamide and its active metabolite N-desmethyl enzalutamide when enzalutamide is administered alone or in combination with atezolizumab
    To evaluate the immune response to atezolizumab
    Valutare l¿efficacia di atezolizumab/enzalutamide rispetto a enzalutamide in monoterapia
    Valutare la sicurezza e la tollerabilit¿ di atezolizumab/enzalutamide rispetto a enzalutamide in monoterapia
    Caratterizzare la farmacocinetica di atezolizumab quando somministrato in associazione a enzalutamide
    Caratterizzare la farmacocinetica di enzalutamide e del suo metabolita attivo N-desmetil enzalutamide quando enzalutamide ¿ somministrata in monoterapia o in associazione ad atezolizumab
    Valutare la risposta immunitaria ad atezolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Eastern Cooperative Oncology Group performance status of 0 or 1
    - Life expectancy >= 3 months
    - Histologically confirmed adenocarcinoma of the prostate
    - Progressive, castrate-resistant disease prior to screening by prostate-specific antigen (PSA) or imaging per prostate cancer working group 3 (PCWG3) criteria during or following the direct prior line of therapy in the setting of medical or surgical castration
    - One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or ineligibility of a taxane-containing regimen
    - Progresion on prior regimen/line of an androgen synthesis inhibitor for prostate cancer
    - Availability of a representative tumor specimen from a site not previously irradiated that is suitable for determination of programmed death ligand 1 (PD L1) status via central testing
    - Adequate hematologic and end organ function
    • Performance status ECOG pari a 0 o 1
    • Aspettativa di vita = 3 mesi
    • Adenocarcinoma della prostata istologicamente confermato
    • Progressione della malattia prima dello screening, durante o dopo una linea di terapia precedente nell’ambito di una castrazione medica o chirurgica, definita in base ai valori del PSA o delle immagini radiologiche valutate secondo i criteri PCWG3
    • Una precedente linea di trattamento per l’mCRPC a base di taxani. Sono altresì arruolabili pazienti che hanno rifiutato o sono ineleggibili ad una linea di trattamento a base di Taxani
    • Progressione durante una precedente linea di trattamento/regime con un inibitore della sintesi degli androgeni per il trattamento del carcinoma prostatico
    • Disponibilità di un campione tumorale rappresentativo prelevato da una sede non precedentemente irradiata, che sia adatto per la determinazione dello stato del ligando di morte programmata-1 (PD L1) tramite analisi condotta a livello centrale
    • Adeguata funzione ematologica e degli organi
    E.4Principal exclusion criteria
    Cancer-specific exclusions
    - Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhibitor (e.g., apalutamide, ODM 201)
    - Treatment with any approved anti-cancer therapy, including chemotherapy, immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of abiraterone), within 4 weeks prior to initiation of study treatment
    - Treatment with abiraterone within 2 weeks prior to study treatment
    - Structurally unstable bone lesions suggesting impending fracture
    - Known or suspected brain metastasis or active leptomeningeal disease
    General medical exclusions
    - Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study
    Exclusion criteria related to atezolizumab
    - Active or history of autoimmune disease or immune deficiency
    - Prior allogeneic stem cell or solid organ transplantation
    - History of pulmonary fibrosis/inflammation
    - Positive HIV test, active hepatitis B or C virus infection, or active tuberculosis
    - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti Cytotoxic T Lymphocyte-Associated (CTLA) 4, anti programmed death 1 (PD 1), and anti PD L1 therapeutic antibodies
    - Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment
    - Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study
    Exclusion criteria related to enzalutamide
    - History of seizure or any condition that may predispose to seizure within 12 months prior to study treatment, including unexplained loss of consciousness or transient ischemic attack
    Criteri di esclusione specifici del tumore
    • Precedente trattamento con enzalutamide o qualunque altro inibitore dei recettori degli androgeni di nuova generazione (es: apalutamide, ODM-201).
    • Trattamento con qualsiasi terapia antineoplastica approvata, incluse chemioterapia, immunoterapia, terapia con radiofarmaci o terapia ormonale (con l’eccezione dell’abiraterone), nelle 4 settimane precedenti l’inizio del trattamento in studio
    • Trattamento con abiraterone nelle 2 settimane precedenti l’inizio del trattamento in studio
    • Lesioni ossee strutturalmente instabili che suggeriscono una frattura imminente
    • Metastasi cerebrali note o sospette o malattia leptomeningea attiva
    Criteri medico-generici di esclusione
    • Procedura chirurgica maggiore, se non a scopo diagnostico, nelle 4 settimane precedenti l’avvio del trattamento in studio o previsione della necessità di una procedura chirurgica maggiore durante il corso dello studio
    Criteri di esclusione correlati ad atezolizumab
    • Malattia autoimmune o deficit immunologico attivi o in anamnesi
    • Precedente trapianto allogenico di cellule staminali o organi solidi
    • Anamnesi di fibrosi polmonare idiopatica/polmonite
    • Positività al test per l’HIV, infezione attiva da virus dell’epatite B o C, o tubercolosi
    • Precedente trattamento con agonisti di CD137 o con terapie di blocco del checkpoint immunitario, inclusi anticorpi terapeutici anti-CTLA-4, anti-morte programmata 1 (PD-1) e anti-PD-L1
    • Trattamento con agenti immunostimolatori per via sistemica nelle 4 settimane o cinque emivite del farmaco precedenti l’avvio del trattamento in studio, a seconda di quale sia il periodo più lungo
    • Trattamento con medicinali immunosoppressori per via sistemica nelle 2 settimane precedenti l’avvio del trattamento in studio
    Criteri di esclusione correlati a enzalutamide
    • Precedenti di convulsioni o di qualsiasi altra patologia che potrebbe predisporre alle convulsioni, nei 12 mesi precedenti l’inizio del trattamento in studio, compresi precedenti di perdita di coscienza inspiegabile o attacco ischemico transitorio
    E.5 End points
    E.5.1Primary end point(s)
    1. Overall survival (OS)
    1. Sopravvivenza complessiva (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 42 months
    1. Fino a circa 42 mesi
    E.5.2Secondary end point(s)
    1. Time to first symptomatic skeletal event
    2. Radiographic progression-free survival (rPFS), as assessed by the investigator and adapted from the PCWG3 criteria
    3. PSA response rate
    4. Time to PSA progression
    5. Objective response rate determined by the investigator through use of PCWG3 criteria and immune modified response evaluation criteria in solid tumors criteria
    6. Incidence, nature, frequency, and severity of adverse events, with severity determined through use of the National Cancer Institute
    Common Terminology Criteria for Adverse Events Version 4
    7. Serum concentration of atezolizumab at specified timepoints
    8. Plasma concentration of enzalutamide and N-desmethyl enzalutamide at specified timepoints in the safety run in phase and in a
    PK cohort in the randomized phase
    9. Incidence of anti-therapeutic antibodies (ATAs) against
    atezolizumab
    1. Tempo al primo Evento Scheletrico Sintomatico
    2. Sopravvivenza libera da progressione radiografica (rPFS), valutata dallo sperimentatore e adattata dai criteri PCWG3
    3. Tasso di risposta del PSA
    4. Tempo alla progressione del PSA
    5. Tasso di risposta obiettiva rilevata dallo sperimentatore attraverso l'uso dei criteri PCWG3 e dei criteri RECIST modificati per l'immunoterapia
    6. Incidenza, natura, frequenza e severità degli eventi avversi, la cui gravità sarà stabilita mediante i criteri NCI CTCAE v 4.0
    7. Concentrazioni sieriche di atezolizumab in momenti temporali specifici
    8. Concentrazioni plasmatiche di enzalutamide e N desmetil enzalutamide in momenti temporali specifici nella fase di run-in di sicurezza e in una coorte di PK nella fase randomizzata
    9. Incidenza di anticorpi anti-terapeutici (ATA) diretti contro atezolizumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-6. Fino a circa 42 mesi
    7. Ciclo (C) 1 Giorno (D) 1, C2D1, C3D1, C4D1, C8D1, C12D1, C16D1; alla visita di discontinuazione di atezolizumab; e 120 giorni dopo l'ultima dose di atezolizumab
    8. C1D1, C3D1, e C8D1
    9. C1D1, C2D1, C3D1, C4D1, C8D1, C12D1, C16D1; alla visita di discontinuazione di atezolizumab; e 120 giorni dopo l'ultima dose di atezolizumab
    1-6. Up to approximately 42 months
    7. Cycle (C) 1 Day (D) 1, C2D1, C3D1, C4D1, C8D1, C12D1, C16D1; at atezolizumab discontinuation visit; and 120 days after last dose of atezolizumab
    8. C1D1, C3D1, and C8D1
    9. C1D1, C2D1, C3D1, C4D1, C8D1, C12D1, C16D1; at atezolizumab discontinuation visit; and 120 days after last dose of atezolizumab
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Enzalutamide
    Enzalutamide
    E.8.2.4Number of treatment arms in the trial2
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA97
    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
    Canada
    China
    Japan
    Korea, Republic of
    Russian Federation
    Taiwan
    United States
    Austria
    Belgium
    Denmark
    France
    Germany
    Greece
    Hungary
    Italy
    Poland
    Spain
    Switzerland
    European Union
    United Kingdom
    Czechia
    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
    The end of this study is defined as the earliest date of the following:
    ¿ Receipt of last data point from the last patient
    ¿ Sponsor decision to end the study
    La conclusione di questo studio coincider¿ con la manifestazione di uno dei seguenti eventi:
    ¿ Acquisizione degli ultimi dati dell¿ultimo paziente
    ¿ Decisione dello sponsor di porre fine allo studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months42
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months42
    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: 186
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 585
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 771
    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)
    The Sponsor will offer post-study access to Sponsor study drug (atezolizumab) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product.
    Lo Sponsor offrir¿ accesso gratuito al farmaco atezolizumab dopo la conclusione dello studio, ai pazienti eleggibili in accordo linee di condotta globali di Roche sull¿accesso continuato ai medicinali sperimentali
    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 Decision2017-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
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    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.

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