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    Summary
    EudraCT Number:2016-000250-35
    Sponsor's Protocol Code Number:WO30070
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-06-16
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-000250-35
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF ATEZOLIZUMAB (ANTI?PD-L1 ANTIBODY) IN COMBINATION WITH GEMCITABINE/CARBOPLATIN VERSUS GEMCITABINE/CARBOPLATIN ALONE IN
    PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO ARE INELIGIBLE FOR
    CISPLATIN-BASED THERAPY
    ESTUDIO DE FASE III MULTICÉNTRICO, DOBLE CIEGO, RANDOMIZADO, CONTROLADO CON PLACEBO DE ATEZOLIZUMAB (ANTICUERPO ANTI?PD-L1) EN COMBINACIÓN CON GEMCITABINA/CARBOPLATINO FRENTE A GEMCITABINA/CARBOPLATINO SOLO EN PACIENTES CON CARCINOMA UROTELIAL LOCALMENTE AVANZADO O METASTÁSICO NO TRATADO PREVIAMENTE, QUE NO SON APTOS PARA RECIBIR QUIMIOTERAPIA BASADA EN CISPLATINO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Atezolizumab in Combination With Gemcitabine/Carboplatin Versus Gemcitabine/Carboplatin plus placebo in Patients With Untreated Urothelial Carcinoma who are Ineligible for Cisplatin-Based Therapy
    Estudio de Atezolizumab en combinación con gemcitabina/carboplatino más placebo en pacientes con carcinoma de vejiga que sin elegibles para una quimioterapia basada en cisplatino.
    A.4.1Sponsor's protocol code numberWO30070
    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 SponsorRoche Farma, S.A., que representa en España a F. 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 number+3491325 73 00
    B.5.6E-mailwelwyn.eudract@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.3.9.3Other 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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: 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 Carboplatin-GRY®
    D.2.1.1.2Name of the Marketing Authorisation holderTeva GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 INNcarboplatin
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Gemcitabin Kabi
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Lyophilisate 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Urothelial Carcinoma, locally advanced or metastatic
    Carcinoma urotelial, localmente avanzado o metastásico
    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
    El cáncer urotelial es un tipo de cáncer que afecta al tracto urinario. Incluyendo cáncer de vejiga, uréteres y pelvis renal.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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 efficacy of atezolizumab plus gemcitabine/carboplatin compared with placebo plus gemcitabine/carboplatin based on progression-free survival (PFS) and overall survival (OS)
    Evaluar la eficacia de atezolizumab en combinación con gemcitabina/carboplatino comparado con placebo más gemcitabina/carboplatino, basándose en supervivencia libre de progresión (SLP) y supervivencia global (SG).
    E.2.2Secondary objectives of the trial
    ? To evaluate the efficacy of atezolizumab plus gemcitabine/carboplatin compared with placebo plus gemcitabine/carboplatin based on objective response rate (ORR), duration of response (DOR), PFS assessed by Independent Review Facility (IRF), OS rate, PFS rate, time to deterioration in global health status and in physical function as measured by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life (QLQ) Questionnaire Core 30
    ? To evaluate the safety and tolerability of atezolizumab plus gemcitabine/carboplatin compared with placebo plus gemcitabine/carboplatin
    ? To characterize the pharmacokinetics (PK) of atezolizumab when administered in combination with gemcitabine/carboplatin in patients who are treatment-naive and who are ineligible for cisplatin-based chemotherapy
    ? To evaluate the immune response to atezolizumab
    - Evaluar la eficacia de atezolizumab en combinación con gemcitabina/carboplatino comparado con placebo más gemcitabina/carboplatino, basándose en Índice de respuesta objetiva (IRO), Duración de la respuesta (DR), SLP evaluada por un Centro de Revisión Independiente (CRI), Tasa de SG, Tasa de SLP, Tiempo hasta el deterioro del estado de salud general, valorado mediante el cuestionario EORTC Quality-of-Life Questionnaire Core 30 (QLQ-C30).
    - El objetivo de seguridad de este estudio es evaluar la seguridad y tolerancia de
    atezolizumab en combinación con gemcitabina/carboplatino comparado con placebo más gemcitabina/carboplatino.
    - Definir la farmacocinética de atezolizumab cuando se administra en combinación con gemcitabina/carboplatino en pacientes no tratados previamente y que no son aptos para recibir quimioterapia basada en cisplatino.
    - Evaluar la respuesta inmune contra atezolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Eastern Cooperative Oncology Group performance status of <= 2
    - Histologically documented, locally advanced (T [tumor] 4b, any N [nodes]; or any T, N 2?3) or metastatic urothelial carcinoma (mUC) (M [metastasized] 1, Stage IV)
    - Representative formalin-fixed paraffin-embedded tumor specimens in paraffin blocks or at least 15 unstained slides
    - No prior chemotherapy for inoperable locally advanced or mUC
    - Ineligible for cisplatin-based chemotherapy
    - Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    - Adequate hematologic and end-organ function
    - 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 6 months after the last dose of carboplatin or gemcitabine or for 90 days after the last dose of atezolizumab
    - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of carboplatin or gemcitabine or for 90 days after the last dose of atezolizumab
    - Tener >= 18 años de edad
    - Estado funcional del Eastern Cooperative Oncology Group (ECOG) <= 2
    - Presentar carcinoma urotelial (CU) localmente avanzado (T [tumor] 4b, cualquier N [nodos] o cualquier T, N 2-3) o metastásico (M [metástasico] 1, estadio IV) documentado histológicamente
    - Disponibilidad de muestras de tumor representativas fijadas en formalina e
    incluidas en parafina (FFPE), preparadas en bloques de parafina o de un mínimo de 15 secciones no teñidas.
    - No haber recibido previamente quimioterapia para CU localmente avanzado o
    metastásico inoperable.
    - No ser elegibles para recibir quimioterapia basada en cisplatino.
    - Enfermedad medible, definida de acuerdo con los criterios RECIST v1.1
    - Función hematológica y de órganos diana adecuada
    - Las mujeres potencialmente fértiles deben comprometerse a practicar la
    abstinencia sexual (es decir, abstenerse de mantener relaciones heterosexuales) o a utilizar métodos anticonceptivos que tengan una tasa de fallos < 1% al año, durante el período de tratamiento y como mínimo hasta 6 meses después de la administración de la última dosis de carboplatino o gemcitabina o hasta 90 días después de que reciban la última dosis de atezolizumab.
    - Los varones deben comprometerse a practicar la abstinencia sexual (es decir,
    abstenerse de mantener relaciones heterosexuales) o a utilizar métodos
    anticonceptivos proporcionen una tasa de fallos < 1%, así como abstenerse de donar semen durante el período de tratamiento y como mínimo hasta
    6 meses después de la administración de la última dosis de gemcitabina y/o
    carboplatino o en los 90 días siguientes a la administración de la última dosis de
    atezolizumab.
    E.4Principal exclusion criteria
    - Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
    - Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrollment
    - Active or untreated central nervous system metastases as determined by computed tomography or magnetic resonance imaging evaluation during screening and prior radiographic assessments
    - Leptomeningeal disease
    - Uncontrolled hypercalcemia, tumor-related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
    - Malignancies other than urothelial carcinoma within 5 years prior to Cycle 1, Day 1
    General Medical Exclusions:
    - Life expectancy of < 12 weeks
    - Pregnant or lactating, or intending to become pregnant during the study
    - Serum albumin < 2.5 gram per deciliter
    Exclusion Criteria Related to Atezolizumab:
    - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    - History of autoimmune disease
    - Patients with prior allogeneic stem cell or solid organ transplantation
    - History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia or evidence of active pneumonitis
    - Significant cardiovascular disease
    - Known left ventricular ejection fraction < 40%
    - Positive test for HIV
    - Active hepatitis B or hepatitis C, tuberculosis
    - Severe infections within 4 weeks prior to randomization
    - Therapeutic oral or intravenous antibiotics within 2 weeks prior to randomization
    - Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
    - Prior treatment with Cluster of Differentiation (CD) 137 agonists, anti- cytotoxic T-lymphocyte-associated protein (CTLA)-4, anti? programmed cell death protein (PD)-1, or anti?PD-L1 therapeutic antibody or pathway-targeting agents
    - Treatment with systemic immunostimulatory agents, systemic corticosteroids or other systemic immunosuppressive medications
    - Known hypersensitivity to gemcitabine
    - History of severe allergic reactions to cisplatin or other platinum-containing compounds
    - Severe bone marrow depression or significant bleeding
    - Administración de cualquier terapia anticancerosa aprobada, incluyendo
    quimioterapia u hormonoterapia, en las 3 semanas previas al inicio del tratamiento
    del estudio.
    - Tratamiento con cualquier otro agente en investigación o participación en otro
    ensayo clínico con intención terapéutica en los 28 días previos a la inclusión en el estudio.
    - Metástasis del SNC activas o no tratadas, evidenciadas en la evaluación con
    tomografía computarizada o resonancia magnética realizada durante el período de selección y en estudios radiológicos previos.
    - Enfermedad leptomeníngea.
    - Hipercalcemia no controlada, dolor relacionado con el tumor, derrame pleural o pericárdico o ascitis no controlados que requieran drenaje repetido.
    - Neoplasias malignas distintas de carcinoma urotelial en los 5 años previos al día 1 del ciclo 1.

    Criterios de exclusión relacionados con condiciones médicas generales:
    - Esperanza de vida < 12 semanas
    - Mujeres embarazadas, en período de lactancia o que tengan intención de quedarse embarazadas durante el estudio.
    - Albúmina sérica < 2,5 g/dl

    Criterios de exclusión relacionados con atezolizumab:
    - Antecedentes de reacciones alérgicas severas, anafilácticas u otras reacciones de hipersensibilidad a anticuerpos quiméricos o humanizados o a proteínas de fusión.
    - Antecedentes de enfermedades autoinmunes
    - Trasplante alogénico de células madre o de órganos sólidos realizado previamente.
    - Antecedentes de fibrosis pulmonar idiopática , neumonitis inducida por fármacos, neumonía organizada o evidencia de neumonitis activa.
    - Enfermedad cardiovascular significativa.
    - Fracción de eyección ventricular izquierda (FEVI) documentada < 40%
    - Resultado positivo en la prueba del VIH
    - Hepatitis B activa or hepatitis C, tuberculosis
    - Infecciones severas en las 4 semanas previas a la randomización
    - Administración de antibióticos orales o IV con fines terapéuticos en las 2 semanas
    previas a la randomización.
    - Administración de vacunas vivas atenuadas en las 4 semanas previas al día 1 del ciclo 1
    - Tratamiento previo con agonistas de CD137, anticuerpos terapéuticos anti-CTLA-4,
    anti-PD-1 o anti-PD-L1 o agentes dirigidos contra vías específicas.
    - Tratamiento sistémico con agentes inmunoestimuladores , tratamiento sistémico con corticosteroides u otros inmunosupresores.
    - Hipersensibilidad conocida a la gemcitabina.
    - Antecedentes de reacciones alérgicas severas al cisplatino u otros compuestos que contengan platino.
    - Depresión severa de la médula ósea o sangrado significativo.
    E.5 End points
    E.5.1Primary end point(s)
    1. PFS as assessed by the investigator using RECIST v1.1
    2. OS
    1. SLP determinada por el investigador basándose en RECIST v1.1
    2. SG
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. Up to 33 months
    1-2. Hasta los 33 meses.
    E.5.2Secondary end point(s)
    1. Objective Response Rate (ORR)
    2. Duration of Response (DOR)
    3. PFS assessed by Independent Review Facility (IRF)
    4. OS rate
    5. PFS rate
    6. Time to deterioration in global health status and physical function as measured by the EORTC QLQ-C30
    Safety
    7. Incidence, nature and severity of adverse events
    8. Changes in vital signs and clinical laboratory results
    Pharmacokinetic
    9. Maximum and minimum serum concentration of atezolizumab
    Immunogenicity
    10. Incidence of anti-therapeutic antibodies (ATAs) during the study relative to the prevalence of ATAs at baseline
    1. Indice de Respuesta Objetiva (IRO)
    2. Duración de la respuesta (DOR)
    3. SLP evaluada por un Centro de Revisión Independiente (CRI)
    4. Tasa de SG
    5. Tasa de SLP
    6. Tiempo hasta el deterioro del estado de salud general, valorado mediante el cuestionario EORTC Quality-of-Life Questionnaire Core 30 (QLQ-C30).
    7. Incidencia, tipo y severidad de los acontecimientos adverson.
    8. Cambios producidos en las constantes vitales y los resultados de las pruebas de laboratorio clínico

    Farmacocinético
    9. concentración sérica máxima ymínima de atezolizumab.

    Inmunogenicidad
    10. Incidencia de anticuerpos antiterapéuticos (ATA) durante el estudio, en relación
    con su prevalencia en el período basal
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. Up to 33 months
    4-5. 1 year
    6-8. Up to 33 months
    9-10. Pre-dose Cycle (C) 1 Day (D) 1, D1 of C2, C3, C4, and C8, at treatment discontinuation, 120 days (+/- 30 days) after last dose of atezolizumab
    1-3. Hasta los 33 meses
    4-5. 1 año
    6-8. Hasta los 33 meses
    9-10. Pre-dosis Ciclo (C) 1 Día (D) 1, D1 de C2, C3, C4, y C8, a la discontinuación del tratamiento, 120 días (+/- 30 días) después de la última dosis de 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenicidad
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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 No
    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
    Chile
    China
    Czech Republic
    Estonia
    Greece
    Hong Kong
    Italy
    Korea, Republic of
    Mexico
    Poland
    Romania
    Russian Federation
    Serbia
    Slovenia
    South Africa
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    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 date when the required number of deaths has been observed for the final analysis of OS in the global study?s intend-to-treat population or when the required number of OS events in patients enrolled in China has occurred, whichever is later.
    Este estudio terminará en la fecha en la que se haya alcanzado el número de muertes requerido para el análisis final de la SG en la población por intención de tratar (IT) del estudio global (principal) o cuando se haya producido el número necesario de acontecimientos de SG en los pacientes incluidos en China, dependiendo de lo que ocurra antes.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 265
    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 Yes
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 435
    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 atezolizumab free of charge to eligible patients. The following conditions should be met:
    ? The patient has a life-threatening or severe medical condition and requires continued study drug treatment for his or her well-being
    ? There are no appropriate alternative treatments available to the patient
    ? The patient and his or her doctor comply with and satisfy any legal or regulatory
    requirements that apply to them
    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 Decision2016-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-26
    P. End of Trial
    P.End of Trial StatusOngoing
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