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    Summary
    EudraCT Number:2014-000445-79
    Sponsor's Protocol Code Number:EMR100070-003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-04
    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 number2014-000445-79
    A.3Full title of the trial
    A Phase II, open-label, multicenter trial to investigate the clinical activity and safety of MSB0010718C in subjects with Merkel cell
    carcinoma
    Ensayo de fase II, abierto y multicéntrico para investigar la actividad clínica y la seguridad de MSB0010718C en sujetos con carcinoma de células de Merkel
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MSB0010718C in Subjects With Skin Cancer
    MSB0010718C en sujetos con cancer de piel
    A.4.1Sponsor's protocol code numberEMR100070-003
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Centre Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+496151 725200
    B.5.5Fax number+496151 722000
    B.5.6E-mailservice@merckgroup.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 nameanti PD-L1
    D.3.2Product code MSB0010718C
    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 INNNot available
    D.3.9.2Current sponsor codeMSB0010718C
    D.3.9.3Other descriptive nameAnti PD-L1
    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 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
    Merkel Cell Carcinoma
    Carcinoma de células Merkel
    E.1.1.1Medical condition in easily understood language
    Skin cancer
    Cancer de Piel
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10064025
    E.1.2Term Merkel cell 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
    The primary objective of the trial is to assess the clinical activity of MSB0010718C as determined by the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in subjects with metastatic MCC after failing first-line chemotherapy.
    El objetivo principal del ensayo es evaluar la actividad clínica de MSB0010718C según lo determine un Comité de Revisión de Criterios de Valoración Independiente (Independent Endpoint Review Committee, IERC) mediante la tasa de respuesta objetiva (TRO) conforme a la versión 1.1 de los Criterios de evaluación de la respuesta en tumores sólidos (Response Evaluation Criteria In Solid Tumors, RECIST 1.1) en sujetos con carcinoma de células de Merkel (CCM) metastásico después del fracaso de la quimioterapia de primera línea.
    E.2.2Secondary objectives of the trial
    Secondary objectives are as follows:
    - To assess the duration of response
    - To assess the progression-free survival time (PFS)
    - To assess the safety profile of MSB0010718C in subjects with MCC
    - To assess overall survival (OS) time
    Los objetivos secundarios de este estudio son los siguientes:
    ? Evaluar la duración de la respuesta
    ? Evaluar el tiempo de supervivencia sin progresión (SSP)
    ? Evaluar el perfil de seguridad del MSB0010718C en sujetos con CCM
    ? Evaluar el tiempo de supervivencia general (SG)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Signed written informed consent
    ? Age 18 years and above
    ? Histologically proven MCC as defined in the protocol
    ? Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
    ? Adequate hematological, hepatic and renal function
    1. Consentimiento informado por escrito firmado
    2. Sujetos con edad ? 18 años, de ambos sexos
    3. CCM histológicamente demostrada tal y como se define en el protocolo
    4. Estado general según ECOG de 0 a 1 en el momento de incorporación al ensayo
    6. Función hematológica, hepática y renal adecuada
    E.4Principal exclusion criteria
    ? Prior therapy with any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-programmed death 1 (PD-1), anti-programmed death ligand 1 (anti-PD-L1), or anticytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody
    ? Subjects with active central nervous system (CNS) metastases are excluded. Subjects with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 2 months, and do not require continued steroid therapy
    ? Previous malignant disease (other than MCC) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ
    ? Significant acute or chronic infections (among others, positive test for human immunodeficiency virus [HIV] 1/2) or known acquired immunodeficiency syndrome or with active or history of any hepatitis)
    ? Active or history of any autoimmune disease (except for subjects with vitiligo) or immunodeficiencies that required treatment with systemic immunosuppressive drugs
    ? Known severe hypersensitivity reactions to monoclonal antibodies (Grade greater than or equal to [>=] 3 NCI-CTCAE Version 4.0), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
    - Tratamiento anterior con anticuerpos/fármacos que afecten a las proteínas correguladoras de los linfocitos T (puntos de control inmunitario) tales como los anticuerpos contra la muerte programada 1 (PD-1), contra PD-L1 o contra el antígeno 4 de los linfocitos T citotóxicos (CTLA-4)
    - Se excluye a los sujetos con metástasis activas en el sistema nervioso central (SNC). Los sujetos con antecedentes de metástasis en el SNC tratadas (por operación quirúrgica o radioterapia) no son idóneos a menos que se hayan recuperado totalmente del tratamiento, hayan demostrado no sufrir progresión alguna durante al menos dos meses y no requieran tratamiento con esteroides continuado
    - Enfermedad maligna anterior (distinta del CCM) en los cinco años anteriores, a excepción del carcinoma basocelular o escamocelular de la piel o del carcinoma cervicouterino in situ
    - Infecciones agudas o crónicas significativas (entre otras, un resultado positivo en la prueba de detección del VIH 1/2) o síndrome de la inmunodeficiencia adquirida conocido, o antecedentes de hepatitis o hepatitis activa, de cualquier tipo
    - Antecedentes de enfermedad autoinmunitaria o enfermedad autoinmunitaria activa (excepto por los sujetos con vitiligo) o inmunodeficiencias que hayan requerido tratamiento con fármacos inmunodepresores sistémicos
    - Reacciones de hipersensibilidad intensa conocidas a los anticuerpos monoclonales (grado ? 3 según los CTCAA del NCI v 4.0), cualquier antecedente de anafilaxia o asma no controlado (es decir, tres o más características del asma con control parcial)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the trial is the confirmed BOR, per RECIST 1.1, as determined by an IERC.
    El criterio principal de valoración para el ensayo es la MRG, conforme a RECIST 1.1, según lo determine el IERC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor assessments will be performed every 6 weeks
    Las evaluaciones tumorales se realizarán cada seis semanas
    E.5.2Secondary end point(s)
    ? Duration of response
    ? Progression-Free Survival (PFS) Time
    ? Safety
    ? Overall Survival (OS) Time
    ? duración de la respuesta
    ? tiempo de SSP
    ? Seguridad
    ? tiempo de SG
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor assessments will be performed every 6 weeks
    Las evaluaciones tumorales se realizarán cada seis semanas
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Austria
    France
    Germany
    Italy
    Japan
    Spain
    Switzerland
    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 the trial is defined as 1 year after the last subject receives the last dose of MSB0010718C.
    La finalizacion del estudio se considerará un año después de que el último paciente reciba la última dosis de MSB0010718C.
    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 months2
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days10
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 84
    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 a subject has completed the trial or has withdrawn early, usual treatment will be administered, if required, in accordance with the trial site?s standard of care and generally accepted medical practice and depending on the subject?s individual medical needs.
    Upon withdrawal from the trial, subjects may receive whatever care they and their physicians agree upon.
    Después de que un sujeto haya completado el ensayo o se haya retirado de forma anticipada, deberá recibir el tratamiento habitual, si es necesario, de conformidad con el tratamiento estándar del centro del ensayo y con la práctica médica generalmente aceptada, dependiendo de las necesidades médicas particulares de ese sujeto.
    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 Decision2014-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-07
    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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