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    Summary
    EudraCT Number:2015-002067-41
    Sponsor's Protocol Code Number:3475-158
    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:2015-10-30
    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 number2015-002067-41
    A.3Full title of the trial
    A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE 158)
    Ensayo clínico de evaluación de biomarcadores predictivos con pembrolizumab (MK-3475) en pacientes con tumores sólidos avanzados (KEYNOTE 158)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PhII Trial of Pembrolizumab in Advanced Solid Tumors
    Ensayo clínico de Fase II con pembrolizumab en pacientes con tumores sólidos avanzados
    A.3.2Name or abbreviated title of the trial where available
    KEYNOTE-158
    KEYNOTE-158
    A.4.1Sponsor's protocol code number3475-158
    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 Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 Yes
    D.2.1.1.1Trade name Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp and Dohme, 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 namePembrolizumab
    D.3.2Product code 1374853-91-4
    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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.3Other descriptive nameAnti-PD-1 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 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) Yes
    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
    A-Anal Squamous Cell Carcinoma (CA)
    B-Biliary Adenocarcinoma (Gallbladder&Biliary Tree but excluding Ampulla of Vater Cancers)
    C-Neuroendocrine Tumors (well&moderately-differentiated,including Carcinoid)
    D-Endometrial CA
    E-Cervical Squamous Cell CA
    F-Vulvar Squamous Cell CA
    G-Small Cell Lung CA
    H-Malignant Pleural Mesothelioma
    I-Thyroid CA (Papillary or Follicular Subtype)
    J-Salivary Gland CA OR
    K-Other advanced solid tumor (except CRC) which is MSI-H from a newly obtained tumor biopsy
    A-Carcinoma anal
    B-Carcinoma biliar
    C-Tumores neuroendocrinos (bien y moderadamente diferenciados, como el carcinoide),
    D-Carcinoma endometrial
    E-Carcinoma cervicouterino
    F-Carcinoma vulvar
    G-Carcinoma pulmonar microcítico,
    H-Mesotelioma,
    I-Carcinoma tiroideo
    J-Carcinoma de las glándulas salivales
    K-Cualquier otro tumor sólido avanzado, con excepción del CCR, con MSI-elevada basándose en el examen de una biopsia tumoral
    E.1.1.1Medical condition in easily understood language
    Advanced Solid Tumors
    tumores sólidos avanzados
    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 PT
    E.1.2Classification code 10061045
    E.1.2Term Colon neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objective 1: To evaluate the ORR to pembrolizumab, based on RECIST 1.1 as assessed by independent central radiologic review, in biomarker-unselected subjects with any one of multiple types of advanced (metastatic and/or unresectable) solid tumors (Groups A-J) for which prior standard of care (SOC) treatments have failed
    Objective 2: To evaluate the ORR to pembrolizumab, based on RECIST 1.1 as assessed by independent central radiologic review, in biomarker-selected subjects with any one of multiple types of advanced (metastatic and/or unresectable) solid tumors (Groups A-K) for which prior SOC treatments have failed. The primary biomarkers to be evaluated are (1) tumor expression of PD-L1 by IHC (Groups A-J), (2) tumor GEP by RNA analysis (Groups A-J), and (3) tumor MSI by DNA analysis (Groups A-J) or routine local testing (Group K).
    Objetivo 1: Determinar la TRO a pembrolizumab, basándose en los criterios RECIST 1.1 según la revisión radiológica central independiente, en pacientes no seleccionados por los biomarcadores con cualquiera de los múltiples tipos de tumores sólidos avanzados (metastásicos o irresecables) (grupos A-J)
    Objetivo 2: Determinar la TRO a pembrolizumab, basándose en los criterios RECIST 1.1 según la revisión radiológica central independiente, en pacientes seleccionados por los biomarcadores con cualquiera de los múltiples tipos de tumores sólidos avanzados (metastásicos o irresecables) (grupos A-K). Los biomarcadores primarios que se evaluarán son (1) expresión de PD-L1 en el tumor mediante IHQ (grupos A-J), (2) PEG en el tumor mediante análisis del ARN (grupos A-J) y (3) MSI-H en el tumor (grupos A-K).
    E.2.2Secondary objectives of the trial
    The following secondary objectives will be evaluated across the ten specified tumor types (Groups A-J):
    -To evaluate DOR (based on RECIST 1.1 as assessed by independent central radiologic review) in subjects receiving pembrolizumab and the relationship between DOR and tumor PD-L1 expression and GEP score
    -To evaluate PFS (based on RECIST 1.1 as assessed by independent central radiologic review ) in subjects receiving pembrolizumab and the relationship between PFS and tumor PD-L1 expression and GEP score
    - To evaluate OS in subjects receiving pembrolizumab and the relationship between OS and tumor PD-L1 expression and GEP score
    The following secondary objectives will be evaluated across all tumor types (Groups A-K):
    -To determine the safety and tolerability of pembrolizumab
    Refer to protocol for complete list
    Se evaluarán los objetivos secundarios siguientes en los 10 tipos de tumores especificados (grupos A-J):
    -Determinar la DR (basándose en los criterios RECIST 1.1 según la revisión radiológica central independiente) en los pacientes que reciban pembrolizumab y la relación entre la DR y la expresión de PD-L1 y la puntuación del PEG en el tumor
    -Determinar la SSP (basándose en los criterios RECIST 1.1 según la revisión radiológica central independiente) en los pacientes que reciban pembrolizumab la relación entre la SSP y la expresión de PD-L1 y la puntuación del PEG en el tumor
    -Determinar la SG en los pacientes que reciban pembrolizumab y la relación entre la SG y la expresión de PD-L1 y la puntuación del PEG en el tumor
    Se evaluarán los objetivos secundarios siguientes en todos los tipos de tumor (grupos A-K):
    -Determinar la seguridad y la tolerabilidad de pembrolizumab
    Leer en el protocolo la lista completa
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    Merck llevará a cabo investigaciones biomédicas futuras con las
    muestras obtenidas específicamente con estos fines durante este ensayo
    clínico. Estas investigaciones tendrán por objeto el análisis de
    biomarcadores para abordar aspectos nuevos que no se describen en
    otras partes del protocolo (como parte del ensayo principal) y solo se
    llevarán a cabo en muestras de los sujetos que hayan otorgado el
    consentimiento correspondiente. El objetivo de la obtención de muestras
    para investigaciones biomédicas futuras consiste en estudiar e
    identificar biomarcadores que proporcionen información a los científicos
    sobre las enfermedades y sus tratamientos. El objetivo último es utilizar
    tal información para desarrollar fármacos más seguros y eficaces y/o
    para garantizar que los pacientes reciban la dosis correcta del fármaco
    adecuado en el momento preciso.
    E.3Principal inclusion criteria
    1.Have a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard first-line or later-line SOC treatments have failed. There is no limit to the number of prior treatment regimens.
    2.Have one of the following advanced (unresectable and/or metastatic) tumor types:
    (A)Anal Squamous Cell Carcinoma,
    (B)Biliary Adenocarcinoma (Gallbladder and Biliary Tree but excluding Ampulla of Vater Cancers),
    (C)Neuroendocrine Tumors (well- and moderately-differentiated, including Carcinoid),
    (D)Endometrial Carcinoma (a)
    (E)Cervical Squamous Cell Carcinoma,
    (F)Vulvar Squamous Cell Carcinoma,
    (G)Small Cell Lung Carcinoma,
    (H)Mesothelioma (Malignant Pleural Mesothelioma),
    (I)Thyroid Carcinoma (Papillary or Follicular Subtype),
    (J)Salivary Gland Carcinoma (a)
    OR
    (K)Any other advanced solid tumor (except CRC), which is MSI-H from a newly obtained tumor biopsy.

    (a)Note: All carcinoma subtypes are allowed; however, sarcomas or mesenchymal tumors are excluded.

    3.Have submitted an evaluable tissue sample for biomarker analysis from a newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated (exceptions may be considered after Sponsor consultation). Note: A newly obtained tumor specimen (i.e., collected since the completion of the most recent cancer therapy) for biomarker characterization will be required for enrollment of all subjects. Tissue from tumor progressing at a site of prior radiation may be allowed for biomarker characterization, based on the Sponsor?s approval.
    4.If enrollment in Groups A-J has moved to biomarker enrichment, have a tumor that is positive for one or more of the pre-specified primary biomarker(s), as assessed by the central laboratory. These enrichment biomarkers may be PD-L1 expression by IHC (at a percentage to be prespecified), a positive tumor RNA GEP score (at a prespecified cut-off), and/or tumor MSI-H.
    5.Have radiologically measurable disease based on RECIST 1.1. Independent central radiologic review must confirm the presence of radiologically measureable disease based on RECIST 1.1 for the subject to be eligible to participate in the trial (see Site Procedure Manual for detailed instructions). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

    Refer to protocol for complete list
    1.Presentar tumor sólido avanzado (metastásico y/o irresecable) documentado mediante histología o citología que sea incurable y no haya respondido a los tratamientos habituales de primera línea o líneas posteriores. No hay límite en el número de pautas de tratamiento previas.
    2.Presentar uno de los siguientes tipos de tumores avanzados (irresecables y/o metastásicos):
    A)Carcinoma epidermoide anal,
    (B)Adenocarcinoma de las vías biliares (vesícula biliar y árbol biliar, salvo los cánceres de la ampolla de Vater),
    (C)Tumores neuroendocrinos (bien y moderadamente diferenciados, como el carcinoide),
    (D)Carcinoma endometrial, a
    (E)Carcinoma epidermoide cervicouterino,
    (F)Carcinoma epidermoide vulvar,
    (G)Carcinoma pulmonar microcítico,
    (H)Mesotelioma (mesotelioma pleural maligno),
    (I)Carcinoma tiroideo (subtipos papilar o folicular),
    (J)Carcinoma de las glándulas salivales, a
    O
    (K)Cualquier otro tumor sólido avanzado (excepto el CCR), que tenga MSI-H, basándose en el examen de una biopsia tumoral recién obtenida.
    aNota: Se admitirán todos los subtipos de carcinoma; sin embargo, están excluidos los sarcomas o los tumores mesenquimatosos.
    3.Haber enviado una muestra de tejido evaluable para análisis de biomarcadores de una biopsia con aguja gruesa, de incisión o de escisión recién obtenida de una lesión tumoral no irradiada previamente (se podrán considerar excepciones después de consultar al promotor). Nota: Se exigirá una muestra tumoral "recién obtenida" (es decir, recogida desde la finalización del tratamiento antineoplásico más reciente) para caracterización de biomarcadores con vistas a la inscripción de todos los pacientes. Si lo aprueba el promotor, se permitirá la obtención de tumor que progrese en una zona radiada previamente para caracterización de biomarcadores.
    4.Si la inscripción en los grupos A-J ha llevado al enriquecimiento de biomarcadores, presentar un tumor que sea positivo para uno o más de los biomarcadores primarios especificados de antemano, según la evaluación del laboratorio central. Estos biomarcadores de enriquecimiento son la expresión de PD-L1 mediante IHQ (en un porcentaje que se especificará previamente), una puntuación del PEG del ARN positiva en el tumor (con un valor de corte preespecificado) y/o MSI-H del tumor.
    5.Tener enfermedad radiológicamente mensurable según los criterios RECIST 1.1. La revisión radiológica central independiente debe confirmar la presencia de enfermedad radiológicamente mensurable basándose en los criterios RECIST 1.1 para que el paciente pueda participar en el estudio (véanse instrucciones detalladas en el manual de imagen del centro). Las lesiones tumorales ubicadas en una zona previamente irradiada se considerarán mensurables siempre que se haya demostrado progresión en dichas lesiones.

    Léase en el protocolo la lista completa.
    E.4Principal exclusion criteria
    -Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
    -Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
    -Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., < or = to Grade 1 or at baseline) from AEs due to mAbs administered more than 4 weeks earlier.
    -Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., < or = to Grade 1 or at baseline) from adverse events due to a previously administered agent.
    Refer to protocol for complete list.
    -Tener un diagnóstico de inmunodeficiencia o haber recibido corticoterapia sistémica o algún tipo de tratamiento inmunosupresor en los 7 días previos a la primera dosis del tratamiento del ensayo. El uso de dosis fisiológicas de corticosteroides podrá autorizarse previa consulta con el promotor.
    -Presentar una enfermedad autoinmunitaria activa que haya necesitado tratamiento sistémico en los dos años anteriores (es decir, fármacos modificadores de la enfermedad, corticosteroides o inmunosupresores). El tratamiento de sustitución (p ej., tiroxina, insulina o corticosteroides en dosis fisiológicas para insuficiencia suprarrenal o hipofisaria, etc.) no se considera una forma de tratamiento sistémico.
    -Haber recibido un anticuerpo monoclonal (mAb) antineoplásico en las 4 semanas previas al día 1 del estudio o no haberse recuperado (es decir, a un grado < o = a 1 o a la situación basal) de los AA provocados por los mAb administrados más de 4 semanas antes.
    -Haber recibido quimioterapia, un tratamiento dirigido con moléculas pequeñas o radioterapia en las 2 semanas previas al día 1 del estudio o no haberse recuperado (es decir, a un grado < o = a 1 o a la situación basal) de los AA provocados por un fármaco administrado anteriormente.
    Léase en el protocolo la lista completa
    E.5 End points
    E.5.1Primary end point(s)
    ORR based on RECIST 1.1 as assessed by independent central radiologic review
    TRO conforme a los criterios RECIST 1.1 según la evaluación radiológica central
    E.5.1.1Timepoint(s) of evaluation of this end point
    The trial incorporates an adaptive design in which multiple interim analyses may be performed. Results will be reviewed by the study team. The cutoffs for the three primary biomarker assays will be selected and specified before the first interim analysis. Details regarding the timing and conduct of the initial interim analysis will be further clarified in the sSAP. The planned sample size may be modified based on the interim results. The timing of additional interim analyses, the final analysis as well as the analysis plan will be documented in the sSAP. The sSAP will also be updated as the trial evolves.
    The primary endpoint of ORR will be used for all interim analyses with or without a confirmatory assessment; however, a confirmatory assessment is required for the final analysis
    El estudio incorpora un diseño adaptativo, dónde se pueden realizar análisis intermedios. El equipo del estudio revisará los resultados. Se seleccionarán y especificarán valores de corte para los análisis de los 3 biomarcadores primarios antes del 1º análisis intermedio (AI). Se clarificarán en el sSAP detalles relativos al calendario y la realización del AI inicial. Se podrá modificar el tamaño previsto de la muestra en función de los resultados intermedios. Se documentarán en el sSAP el calendario de los AIs adicionales, el final y el plan de análisis. Se actualizará el sSAP a medida que avance el estudio. Se utilizará el criterio de valoración ppal de la TRO para los AIs con o sin evaluación de confirmación pero será necesaria la evaluación de confirmación para el análisis final.
    E.5.2Secondary end point(s)
    Safety and Tolerability
    Duration of response (DOR)
    Progression-free survival (PFS)
    Overall survival (OS)
    (PK) for the 200 mg iv Q3W fixed dosing regimen
    Seguridad y tolerabilidad
    Duración de la respuesta
    Supervivencia libre de progresión
    Supervivencia global
    PK para la dosis fijada de 200 mg iv Q3W
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoints will be summarized at the time that the primary analysis is conducted; however, these secondary endpoints are not likely to be mature at that time.
    Los criterios de valoración de eficacia secundarios se resumirán en el momento en el que se realice el análisis primario; sin embargo estos criterios de valoración secundarios no se cree que estén preparados en ese momento.
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Denmark
    France
    Germany
    Italy
    Netherlands
    Norway
    Spain
    United Kingdom
    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
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 260
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 520
    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)
    At the end of treatment, each subject will be followed for 30 days to monitor for AEs and events of clinical interest; subjects will be monitored for serious AEs for 90 days after the end of treatment. Subjects who discontinue for reasons other than PD will have follow-up for disease status until experiencing PD, initiating a non-study cancer treatment, withdrawing consent, or becoming lost to follow-up. All subjects will be followed by telephone for overall survival.
    Al fin del tto, se seguirá al paciente 30 días para vigilar AA y acontecimientos de interés clínico; AA graves se vigilarán 90 días al fin de tto. Los pacientes que se retiren por otros motivos a la progresión de la enfermedad serán objeto de un seguimiento después del tto hasta que experimenten progresión del tumor, inicien un tto antineoplásico que no sea el del estudio, retiren el CI o se pierdan para el seguimiento.Habrá seguimiento telefónico de los ptes para determinar supervivencia global
    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 Decision2016-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-25
    P. End of Trial
    P.End of Trial StatusOngoing
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