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    The EU Clinical Trials Register currently displays   39799   clinical trials with a EudraCT protocol, of which   6533   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-002134-20
    Sponsor's Protocol Code Number:D933GC00001
    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:2019-05-27
    Trial 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 number2018-002134-20
    A.3Full title of the trial
    A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination with either Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in Patients with Locoregional Hepatocellular Carcinoma.
    Ensayo fase III, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la combinación de quimioembolización transarterial (TACE) con durvalumab en monoterapia o con durvalumab más bevacizumab en pacientes con carcinoma hepatocelular que requieran tratamiento locorregional.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma.
    Un ensayo global para evaluar la quimioembolización transarterial (TACE) en combinación con durvalumab y terapia con bevacizumab en pacientes con carcinoma hepatocelular locorregional.
    A.3.2Name or abbreviated title of the trial where available
    EMERALD-1
    EMERALD-1
    A.4.1Sponsor's protocol code numberD933GC00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Edificio Álamo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number003491900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.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 namedurvalumab
    D.3.2Product code MEDI4736
    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 INNdurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 AVASTIN
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    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 nameBevacizumab
    D.3.2Product code RO487-6646/F02
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO487-6646
    D.3.9.3Other descriptive namerhuMAb VEGF, anti-VEGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant humanised monoclonal antibody
    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
    Locoregional Hepatocellular Carcinoma (HCC)
    Carcinoma Hepatocelular Locorregional
    E.1.1.1Medical condition in easily understood language
    Liver Cancer patients who only have cancer in their livers, but who cannot receive surgery
    Pacientes con cáncer de hígado que solo tienen cáncer en el hígado, pero que no pueden recibir cirugía.
    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 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    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 assess the efficacy of durvalumab monotherapy when given with transarterial chemoembolization (TACE) compared to TACE + placebo
    Evaluar la eficacia durvalumab en monoterapia cuando se administra con quimioembolización transarterial (TACE) en comparación con TACE + placebo
    E.2.2Secondary objectives of the trial
    - To assess the efficacy and safety of durvalumab and bevacizumab when given with TACE compared to TACE + placebo

    -To assess the efficacy of all immunotherapy arms and TACE compared with placebo by PD-L1 expression and AFP expression level

    -To assess disease-related symptoms and health-related quality of life (HRQoL) in patients treated with all immunotherapy arms and TACE compared with placebo

    - To evaluate the PK and immunogenicities of all immunotherapy arms with TACE
    - Evaluar la eficacia y seguridad de durvalumab y bevacizumab cuando se administra con TACE en comparación con TACE + placebo.

    - Evaluar la eficacia de todos los brazos de inmunoterapia y TACE en comparación con el placebo por la expresión de PD-L1 y el nivel de expresión de AFP.

    - Evaluar los síntomas relacionados con la enfermedad y la calidad de vida relacionada con la salud (CVRS) en pacientes tratados con todos los brazos de inmunoterapia y TACE en comparación con placebo.

    - Evaluar la FC y la inmunogenicidad de todos los brazos de inmunoterapia con TACE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - No evidence of extrahepatic disease on baseline imaging
    - Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
    - Child-Pugh score class A to B7 and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
    - Measurable disease by mRECIST criteria
    - Adequate organ and marrow function
    - No hay evidencia de enfermedad extrahepática en las imágenes de referencia.
    - Enfermedad no susceptible de cirugía curativa o trasplante o ablación curativa, pero enfermedad susceptible de TACE
    - Puntuación de Child-Pugh clase A a B7 y estado funcional de Eastern Cooperative Oncology Group (ECOG) de 0 o 1 en el momento de la inclusión.
    - Enfermedad medible por criterios mRECIST.
    - Función adecuada de órgano y médula.
    E.4Principal exclusion criteria
    - Any history of nephrotic or nephritic syndrome
    - Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction
    - Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days
    - History of abdominal fistula or GI perforation, non healed gastric ulcer, or active GI bleeding within 6 months prior to enrollment
    - Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded
    - Cualquier antecedente de síndrome nefrótico o nefrítico.
    - Enfermedad cardiovascular clínicamente significativa o antecedentes de evento arterioembólico, incluido un accidente cerebrovascular o un infarto de miocardio
    - Cualquier evidencia previa o actual de coagulopatía o diátesis hemorrágica o pacientes que hayan tenido algún tipo de cirugía en los últimos 28 días
    - Antecedentes de fístula abdominal o perforación gastrointestinal, úlcera gástrica no curada o sangrado gastrointestinal activo dentro de los 6 meses anteriores al reclutamiento
    - Se excluyen los pacientes con trombosis de la vena porta Vp3 y Vp4 en la imagen de referencia.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR
    Supervivencia sin progresión (SSP) evaluada mediante los criterios RECIST 1.1 empleando la RCIE
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessments for PFS will be collected regularly at predefined time points until disease progression
    Las evaluaciones de SSP se recopilarán regularmente en puntos de tiempo predefinidos hasta la progresión de la enfermedad
    E.5.2Secondary end point(s)
    Overall Survival (OS)

    Objective Response Rate (ORR)

    Disease Control Rate (DCR)

    Duration of Response (DoR)

    Time to progression (TTP)

    Time from Randomization to Second Progression PFS (PFS2)

    Health-related quality of life (HRQoL) patient reported outcomes
    Supervivencia global (SG)

    Tasa de Respuesta Objetiva (TRO)

    Tasa de Control de la Enfermedad (TCE)

    Duración de la Respuesta (DR)

    Tiempo hasta la Progresión (THP)

    Tiempo desde la Aleatorización hasta la Segunda Progresión (SSP2)

    Resultados de calidad de vida relacionada con la salud (CVRS) informados por los pacientes
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessments will be made regularly until disease progression or until the end of the study
    Se realizarán evaluaciones regularmente hasta la progresión de la enfermedad o hasta el final del ensayo
    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 Yes
    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 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 trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Canada
    China
    France
    India
    Italy
    Japan
    Korea, Republic of
    Mexico
    Spain
    Taiwan
    Thailand
    United States
    Vietnam
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 270
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A legal representative may provide consent on behalf of a subject incapable of giving consent personally, where permitted by local regulations.
    Un representante legal puede otorgar el consentimiento en nombre de un sujeto incapaz de dar su consentimiento personalmente, cuando lo permitan las regulaciones locales.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 600
    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)
    Patients may continue to receive active treatment for as long as they are receiving benefit, providing no discontinuation criteria are met. Any treatment decisions following the cessation of study treatment are at the discretion of the treating physician.
    Los pacientes pueden seguir recibiendo un tratamiento activo mientras reciban beneficio, siempre que no se cumplan los criterios de interrupción. Cualquier decisión sobre el tratamiento posterior al cese del tratamiento del ensayo queda a criterio del médico del ensayo.
    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 Decision2019-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-10
    P. End of Trial
    P.End of Trial StatusOngoing
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