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    The EU Clinical Trials Register currently displays   35554   clinical trials with a EudraCT protocol, of which   5841   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-001663-39
    Sponsor's Protocol Code Number:D4190C00022
    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:2015-10-05
    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 number2015-001663-39
    A.3Full title of the trial
    A Study of Safety, Tolerability, and Clinical Activity of MEDI4736 and Tremelimumab Administered as Monotherapy and in Combination to Subjects with Unresectable Hepatocellular Carcinoma
    Estudio de seguridad, tolerabilidad y actividad clínica de MEDI4736 y tremelimumab administrados en monoterapia y en combinación a pacientes con carcinoma hepatocelular no resecable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial in patients with liver cancer that cannot be removed by surgery, investigating the safety, tolerability, and clinical activity of investigational drugs MEDI4736 and tremelimumab. The study will look at the effect of these two drugs either as a single agents (monotherapy) or as combination therapy (when given together to patients).
    Ensayo clínico en pacientes con cáncer de hígado que no se puede extirpar mediante cirugía, en el que se investiga la seguridad, tolerabilidad y actividad clínica de los medicamentos en investigación MEDI4736 y tremelimumab. En el estudio se investigará el efecto de estos dos medicamentos administrados solos (monoterapia) o en combinación (cuando se administran los dos juntos a los pacientes).
    A.4.1Sponsor's protocol code numberD4190C00022
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02519348
    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 SponsorMedImmune
    B.1.3.4CountryUnited States
    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 supportMedimmune, Limited
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC
    B.5.2Functional name of contact pointClinical Trial Enquiries
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number00800-4573-0011
    B.5.6E-mailclinicaltrialenquiries@medimmune.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 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 codeMEDI1123
    D.3.9.3Other descriptive nameHuman cytotoxic T lymphocyte-associated antigen 4 monoclonal antibody
    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: 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.3.2Product 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.3.9.3Other descriptive nameImmunoglobulin G1, anti-(human CD antigen
    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.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
    Hepatocellular Carcinoma
    Carcinoma hepatocelular
    E.1.1.1Medical condition in easily understood language
    Liver Cancer
    Cancer de hígado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 safety and tolerability of MEDI4736 and tremelimumab administered as monotherapy and in combination to subjects with unresectable HCC
    Evaluar la seguridad y la tolerabilidad de MEDI4736 y tremelimumab administrados en monoterapia y en combinación a pacientes con carcinoma hepatocelular (CHC) no resecable.
    E.2.2Secondary objectives of the trial
    1. To evaluate the preliminary clinical activity of MEDI4736 and tremelimumab administered as monotherapy and in combination to subjects with unresectable HCC.
    2. To evaluate the relationship between candidate biomarkers (eg, programmed cell death ligand 1 [PD-L1] expression in the tumor microenvironment) and measures of clinical outcome of MEDI4736 and tremelimumab administered as monotherapy and in combination in subjects with unresectable HCC.
    1. Evaluar la actividad clínica preliminar de MEDI4736 y tremelimumab administrados en monoterapia y en combinación a pacientes con carcinoma hepatocelular (CHC) no resecable.
    2. Evaluar la relación entre los biomarcadores candidatos (p. ej., expresión del ligando de muerte celular programada 1 [PD-L1] en el microentorno tumoral) y las determinaciones de la respuesta clínica obtenida con MEDI4736 y tremelimumab administrados en monoterapia y en combinación a pacientes con carcinoma hepatocelular (CHC) no resecable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects
    2. 18 years and older
    3. Confirmed diagnosis of unresectable hepatocellular carcinoma with or without concomitant viral hepatits B or hepatitis C infection.
    4. Subjects must have either: progressed on, are intolerant to, or refused treatment with sorafenib.
    1. Pacientes hombres o mujeres 2. 18 años o más 3. Diagnóstico confirmado de carcinoma hepatocelular no resecable con o sin infección concomitante por el virus de la hepatitis B o la hepatitis C 4. Los pacientes deben bien presentar progresión de la enfermedad o intolerancia al sorafenib, o bien haber rechazado el tratamiento con sorafenib.
    E.4Principal exclusion criteria
    1. Prior exposure to immune-mediated therapy
    2. Hepatic encephalopathy characterized by asterixis
    3. Active or prior documented gastrointestinal variceal bleed
    4. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
    6. Active or prior documented autoimmune or inflammatory disease with some exceptions
    7. Current or prior use of immunosuppressive medication within 14 days with some exceptions
    1. Exposición previa a la inmunoterapia 2. Encefalopatía hepática caracterizada por asterixis 3. Hemorragia digestiva varicosa activa o anterior documentada 4. Cualquier quimioterapia, inmunoterapia o terapia biológica u hormonal concomitante para el tratamiento del cáncer 6. Trastornos autoinmunitarios o inflamatorios activos o anteriores documentados, con algunas excepciones 7. Uso previo o actual de medicamentos inmunosupresores en los 14 días anteriores, con algunas excepciones.
    E.5 End points
    E.5.1Primary end point(s)
    Number (percentage) of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events.
    Changes from baseline in laboratory parameters (including liver and viral laboratory tests),
    electrocardiograms and vital signs.
    Número (porcentaje) de pacientes que notifiquen acontecimientos adversos y número (porcentaje) de pacientes que notifiquen acontecimientos adversos graves. Cambios con respecto al momento basal en los parámetros de laboratorio (incluidas las pruebas de función hepática y detección de virus), electrocardiogramas y constantes vitales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of AEs, SAEs, discontinuation of IP, changes in Lab parameters, ECG etc will be assessed at Screening (baseline) AEs, SAEs and lab changes; Day1± 3 days every other week to week 25 then week 29,33,37,41,45 and 49, EoT & approx Day 30, 60 and 90 post last dose. ECG: baseline and week 9.

    Evaluación de los AA, AAG, interrupción del MI, cambios en los parámetros analíticos, ECG, etc. en la fase de selección (línea basal) AA, AAG y cambios en los parámetros analíticos; Día 1 ± 3 días, cada dos semanas hasta la semana 25 y en las semanas 29, 33, 37, 41, 45 y 49, en el FdT y aproximadamente en los días 30, 60 y 90 después de la última dosis. ECG: línea basal y semana 9.
    E.5.2Secondary end point(s)
    Objective response (OR), disease control (DC), duration of response (DoR), time to progression (TTP), and progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and overall survival (OS).
    La respuesta objetiva (RO), el control de la enfermedad (CE), la duración de la respuesta (DdR), el tiempo hasta la progresión (ThP)y la supervivencia sin progresión (SSP) de acuerdo con los criterios de evaluación de la respuesta en tumores sólidos (RECIST) v.1.1 y la supervivencia global (SG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Clinical outcome (OR, DC, DoR, TTP, PFS, and OS): Screening, weeks 9, 17, 25, 33, 41, 49 and then every 8 weeks until end of trial and then every 3 months to 12 months post last dose.
    1. Resultado clínico (RO, CE, DR, THP, SSP, SG): selección, semanas 9, 17, 25, 33, 41, 49 y cada 8 semanas hasta el final del ensayo y, posteriormente, cada 3 meses durante los 12 meses después de la última dosis.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Singapore
    Spain
    Taiwan
    United States
    E.8.7Trial has a data monitoring committee No
    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
    As per protocol: 'The end of the study (?study completion?) is 3 years after the final subject is enrolled or the date the study is closed by the sponsor, whichever occurs first.'
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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, where permitted.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 120
    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)
    None
    Ninguno
    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 Decision2015-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-13
    P. End of Trial
    P.End of Trial StatusOngoing
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