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    Summary
    EudraCT Number:2016-005126-11
    Sponsor's Protocol Code Number:D419CC00002
    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:2017-10-20
    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 number2016-005126-11
    A.3Full title of the trial
    A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients with Unresectable Hepatocellular Carcinoma (HIMALAYA).
    Ensayo Fase III, aleatorizado, abierto, multicéntrico de durvalumab y
    tremelimumab como tratamiento en primera línea en pacientes con
    Carcinoma Hepatocelular Irresecable (HIMALAYA).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a randomized, open-label, multi-center, global, Phase III study to assess the effectiveness and safety of two Immune Therapy drugs, durvalumab given by itself or with tremelimumab versus sorafenib, the standard first line treatment, to treat patients with no prior systemic therapy for liver cancer (hepatocellular carcinoma) that cannot be removed by surgery (unresectable).
    Se trata de un ensayo clínico en fase III, multicéntrico, internacional, aleatorizado y abierto para evaluar la eficacia y la seguridad de la combinación de durvalumab y tremelimumab y durvalumab en monoterapia en comparación con sorafenib, siendo este la primera línea de tratamiento estándar en el tratamiento de pacientes que no han recibido tratamiento sistémico previo de cáncer de hígado (Carcinoma Hepatocelular) que no puede ser eliminado por cirugía (irresecable).
    A.3.2Name or abbreviated title of the trial where available
    HIMALAYA
    A.4.1Sponsor's protocol code numberD419CC00002
    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 number0034900200 444
    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 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 nametremelimumab
    D.3.2Product code MEDI1123
    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 INNtremelimumab
    D.3.9.1CAS number 745013-59-6
    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 number20
    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: 3
    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.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/364
    D.3 Description of the IMP
    D.3.1Product namesorafenib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNsorafenib
    D.3.9.1CAS number 284461-73-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    unresectable hepatocellular carcinoma (HCC)
    Carcinoma hepatocelular irresecable
    E.1.1.1Medical condition in easily understood language
    liver cancer that cannot be removed by surgery
    Cáncer de hígado en el que la cirugía no está indicada.
    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 plus tremelimumab compared with sorafenib.
    Evaluar la eficacia del tratamiento combinado de durvalumab tremelimumab en comparación con sorafenib.
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of durvalumab monotherapy and durvalumab plus tremelimumab combination therapy compared with sorafenib
    -To assess the efficacy of all immunotherapy arms compared with sorafenib by PD-L1 expression
    -To assess disease-related symptoms and health-related quality of life (HRQoL) in patients treated with all immunotherapy arms compared with sorafenib
    - To evaluate the population PK and pharmacodynamics of all immunotherapy arms
    - To investigate the immunogenicity of all immunotherapy arms
    - Evaluar la eficacia del tratamiento combinado de durvalumab y tremelimumab en comparación con sorafenib.
    - Evaluar la eficacia de todos los grupos de inmunoterapia en comparación con sorafenib según la expresión de PD-L1.
    - Evaluar los síntomas relacionados con la enfermedad y la calidad de vida relacionada con la salud (HRQoL) en pacientes tratados con todos los grupos de inmunoterapia en comparación con sorafenib.
    - Evaluar la farmacocinética poblacional y la farmacodinamia de todos los grupos de inmunoterapia.
    - Investigar la inmunogenicidad de todos los grupos de inmunoterapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - HCC (unresectable hepatocellular carcinoma) histopathological diagnosis confirmation based on tumor tissue
    - No prior systemic therapy for HCC
    - Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
    - Child-Pugh Score class A
    - ECOG performance status of 0 or 1 at enrollment
    - Carcinoma hepatocelular irresecable (HCC) de confirmación diagnóstica histopatológica basada en tejido tumoral.
    - No haber recibido terapia sistémica para HCC.
    - Estadio B según la clasificación BCLC (Barcelona Clinic Liver Cancer) no aptos para recibir tratamiento locorregional o en estadio C.
    - Clase A según la clasificación de Chil-Pugh.
    - Estado funcional del ECOG de 0 a 1 en la inclusión.
    E.4Principal exclusion criteria
    - Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
    - Ascites that requires ongoing paracentesis to control symptoms (within 6 weeks prior to the first scheduled dose)
    - Main portal vein thrombosis
    - Active or prior documented GI variceal bleed or history of upper GI bleeding, ulcers or esophageal varices with bleeding within 12 months
    - HBV and HCV co-infection
    - Encefalopatía hepática en los últimos 12 meses o medicamentos requeridos para prevenir o controlar la encefalopatía
    - Ascitis que requiere paracentesis continua para controlar los síntomas (dentro de las 6 semanas anteriores a la primera dosis programada)
    - Trombosis de la vena porta principal
    - Sangrado váricoso gastrointestinal activo o previamente referenciado o antecedentes de hemorragia gastrointestinal superior, úlceras o varices esofágicas con sangrado dentro de los 12 meses
    - Coinfección por VHB y VHC
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS) is defined as the time from the date of randomization until death due to any cause.
    La Supervivencia Global (SG) es definida en el momento desde la fecha de la aleatorización hasta la muerte debida a cualquier causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patient level: Assessments for survival will be made every 4 weeks during treatment period and every 2 months following treatment discontinuation which will continue until the end of the study unless the patient has expressly withdrawn their consent to survival follow-up. In addition, all patients will be contacted in the week following data cutoff to confirm survival status.
    Nivel del paciente: Las evaluaciones de supervivencia se harán cada 4 semanas durante el período de tratamiento y cada 2 meses después de la interrupción del tratamiento que continuará hasta el final del estudio a menos que el paciente haya retirado expresamente su consentimiento para el seguimiento de la supervivencia. Además, todos los pacientes serán contactados en la semana siguiente al corte de datos para confirmar el estado de supervivencia.
    E.5.2Secondary end point(s)
    Other secondary efficacy endpoints include:
    OS (Overall survival),
    Time to progression (TTP),
    progression-free survival (PFS),
    objective response rate (ORR),
    disease control rate (DCR), and
    duration of response (DoR)
    Otras variables secundarias de eficacia incluyen:
    OS (supervivencia global),
    Tiempo hasta la progresión (TTP),
    Supervivencia libre de progresión (PFS),
    Tasa de respuesta objetiva (ORR),
    Tasa de control de la enfermedad (DCR), y
    Duración de la respuesta (DoR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    TTP, PFS, ORR, DoR, DCR - Patient level: Efficacy for all patients will be assessed by objective tumor assessments every 8 weeks (±1 week) for the first 48 weeks (relative to the date of randomization; then every 12 weeks (±1 week) thereafter until confirmed PD as defined by RECIST 1.1 or discontinuation from study participation.

    OS18 and OS24 - Patient level: Assessments for survival will be made every 4 weeks during treatment period and every 2 months following treatment discontinuation which will continue until the end of the study unless the patient has expressly withdrawn their consent to survival follow-up. In addition, all patients will be contacted in the week following data cutoff to confirm survival status.
    TTP, PFS, ORR, DoR, DCR-Nivel del pcnte: La eficacia para todos los pcntes se evaluará mediante evaluaciones objetivas del tumor cada 8 emanas (±1 semana) durante las primeras 48 semanas (con relación a la fecha de inclusión); después cada 12semanas (±1 semana) hasta que se confirme la PD como se define en RECIST 1.1 o la interrupción de la participación en el estudio. OS18 y OS24-Nivel del pcnte: Las evaluaciones de superv se realizarán cada 4 semanas durante el período de tto y cada 2 meses después de la suspensión del tto, que continuará hasta el final del estudio a menos que el pcnte haya retirado expresamente su consentimiento para el seguimiento de la superv. Además, todos los pcntes serán contactados en la semana siguiente al corte de datos para confirmar el estado de superv.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Healthcare resource utilization
    Quality of life
    Tolerailidad
    Utilización de los recursos sanitarios
    Calidad de vida
    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 No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Brazil
    Canada
    China
    France
    Germany
    Hong Kong
    India
    Italy
    Japan
    Korea, Republic of
    Russian Federation
    Spain
    Taiwan
    Thailand
    Ukraine
    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
    Last patients’ treatment discontinuation.
    El final del estudio se define como "la última visita del último sujeto que participe en el estudio"
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 960
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 640
    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.
    Cuando lo permitan las regulaciones locales, un representante legal puede dar su consentimiento en nombre de un paciente incapaz de dar su consentimiento de forma personal.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 348
    F.4.2.2In the whole clinical trial 1600
    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)
    After the final analysis, AstraZeneca will continue to supply open-label drug to patients receiving immunotherapy until confirmed PD, unacceptable toxicity, or any of the discontinuation criteria are met.
    Despues del análisis final, AstraZeneca continuará suministrando medicación abierta a los pacientes que estén recibiendo inmunoterapia hasta que confirmen su progresión, su toxicidad inaceptable o cualquier criterio de discontinuación que se presente.
    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 Decision2018-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-18
    P. End of Trial
    P.End of Trial StatusOngoing
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