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    Summary
    EudraCT Number:2015-003301-42
    Sponsor's Protocol Code Number:EMR100070-008
    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:2016-02-17
    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 number2015-003301-42
    A.3Full title of the trial
    A Phase III open-label, multicenter trial of avelumab (MSB0010718C) as a third-line treatment of unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma
    Ensayo de fase III, abierto y multicéntrico de avelumab (MSB0010718C) como tratamiento de tercera línea del adenocarcinoma de la unión gastroesofágica o gástrico, metastásico, recurrente o irresecable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Avelumab in Third-Line Gastric Cancer
    Avelumab in tercera-linea de cancer gástrico
    A.3.2Name or abbreviated title of the trial where available
    Avelumab in Third-Line Gastric Cancer
    Avelumab in tercera linea de cancer gástrico
    A.4.1Sponsor's protocol code numberEMR100070-008
    A.5.4Other Identifiers
    Name:JAVELINNumber:Gastric 300
    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 Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Str. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post codeD-64293
    B.5.3.4CountryGermany
    B.5.4Telephone number0034657349874
    B.5.5Fax number0034657349874
    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 nameAvelumab
    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 INNAvelumab
    D.3.9.2Current sponsor codeMSB0010718C
    D.3.9.3Other descriptive nameAnti-PD-L1
    D.3.9.4EV Substance CodeSUB176547
    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 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.2.1.1.1Trade name Irinotecan Hospira
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited - Queensway Royal Leamington Spa, Warwickshire CV31 3RW , UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameIrinotecan
    D.3.2Product code Irinotecan
    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 INNIRINOTECAN
    D.3.9.1CAS number 97682-44-5
    D.3.9.4EV Substance CodeSUB08295MIG
    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 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.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.2.1.1.1Trade name Paclitaxel Hospira
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited - Queensway Royal Leamington Spa, Warwickshire CV31 3RW , UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePaclitaxel
    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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma
    Adenocarcinoma de la unión gastroesofágica o gástrico, metastásico, recurrente o irresecable
    E.1.1.1Medical condition in easily understood language
    Gastric cancer
    Cancer gástrico
    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 10017758
    E.1.2Term Gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10071114
    E.1.2Term Metastatic gastric adenocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10017761
    E.1.2Term Gastric cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 is to demonstrate superiority with regard to overall survival (OS) of avelumab plus best supportive care (BSC) versus physician?s choice (chosen from a pre-specified list of therapeutic options) plus BSC.
    El objetivo principal es demostrar la superioridad en relación con la supervivencia general (SG) del avelumab más el mejor tratamiento complementario (MTC) frente a la elección del médico (a partir de una lista específica de opciones de tratamiento) más el MTC.
    E.2.2Secondary objectives of the trial
    ? To compare avelumab plus BSC versus physician?s choice plus BSC in regard to the following:
    a.Progression-free survival based on an Independent Endpoint Review Committee (IRC) assessment
    b.ORR based on IRC assessment
    c.Subject-reported outcomes/quality of life (QoL) using the European Quality of Life (EuroQOL) 5-dimensions and 5-levels questionnaire (EQ 5D-5L), and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and module QLQ STO22.
    ? To determine the safety and tolerability of avelumab.
    ? Comparar el avelumab más el MTC frente a la elección del médico más el MTC en relación con lo siguiente:
    ? Supervivencia sin progresión (SSP) con base en la evaluación de un comité de revisión independiente (CRI).
    ? Tasa de respuesta objetiva (TRO) con base en la evaluación del CRI.
    ? Resultados comunicados por el sujeto/calidad de vida (CdV) mediante el cuestionario europeo de calidad de vida de 5 dimensiones y 5 niveles (EQ-5D-5L), el QLQ-C30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC) y el módulo QLQ-STO22.
    ? Determinar la seguridad y la tolerabilidad del avelumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Male or female subjects aged ? 18 years
    ?Disease must be measurable by RECIST 1.1
    ?Subjects with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or GEJ
    ?ECOG PS of 0 to 1 at trial entry
    ?Estimated life expectancy of more than 12 weeks
    ?Adequate hematological, hepatic and renal functions defined by the protocol
    ?Negative blood pregnancy test at Screening for women of childbearing potential.
    ? Highly effective contraception for both male and female subjects if the risk of conception exists
    ?Other protocol defined criteria could apply
    - Sujetos hombres o mujeres con edad ?18 años
    - Enfermedad mensurable por RECIST 1.1
    - Sujetos con adenocarcinoma del estómago o de la unión gastroesofágica recurrente, irresecable, localmente avanzado o metastásico confirmado histológicamente.
    - EG del ECOG de 0 a 1 en el momento de incorporación al ensayo.
    - Esperanza de vida estimada de más de 12 semanas
    - Funciones hematológicas, hepáticas y renales adecuadas definidas por el protocolo.
    - Test negativo de embarazo en la selección para mujers en edad fertil.
    -Metodos de contracepción altamente efectivos tanto para hombres como para mujeres en caso de que exista riesgo de concepción
    - Podrían aplicar otros criterios definidos en el protocolo
    E.4Principal exclusion criteria
    ?Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
    ?Concurrent anticancer treatment
    ?Major surgery
    ?Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to <10 mg prednisone daily).
    ?All subjects with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, and b. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
    ?Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)
    ?Prior organ transplantation, including allogeneic stem-cell transplantation
    ?Significant acute or chronic infections
    ?Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
    ?Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
    ?Persisting toxicity related to prior therapy except alopecia
    ?Neuropathy Grade > 3.
    ?Pregnancy or lactation
    ?Known alcohol or drug abuse
    ?History of uncontrolled intercurrent illness including hypertension, active infection, diabetes
    ?Clinically significant (i.e., active) cardiovascular disease
    ?All other significant diseases might impair the subject?s tolerance of trial treatment
    ?Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirements
    ?Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
    ?Legal incapacity or limited legal capacity
    ?Other protocol defined criteria could apply
    -- Tratamiento concomitante contra el cancer.
    - Intervención quirúrgica mayor.
    - Para los sujetos que reciben fármacos inmunodepresores (tales como los corticoesteroides) por cualquier razón, estos fármacos deben reducirse gradualmente antes del inicio del tratamiento del ensayo (con la excepción de sujetos con insuficiencia suprarrenal, que pueden seguir recibiendo corticoesteroides a una dosis de sustitución fisiológica, equivalente a <10 mg de prednisona al día).
    -Neoplasia maligna previa (distinta del cáncer gástrico) en los 5 años anteriores, a excepción del carcinoma basocelular o epidermoide de la piel o del carcinoma in situ (vesical, cervical, colorrectal, mamario).
    - Todos los sujetos con metástasis cerebral, salvo quienes cumplan los siguientes criterios: a. Las metástasis cerebrales que se han tratado localmente, y b. no hay síntomas neurológicos en curso relacionados con la localización cerebral de la enfermedad (se aceptan secuelas que sean consecuencia del tratamiento de la metástasis cerebral).
    - Tratamiento previo con cualquier anticuerpo o fármaco que tiene como objetivo las proteínas correguladoras de los linfocitos T.
    - Trasplante anterior de órganos, incluido el alotrasplante de células madre.
    - Infecciones agudas o crónicas significativas.
    - Enfermedad autoinmunitaria activa que pueda empeorar al recibir un inmunoestimulante.
    - Reacciones de hipersensibilidad intensas conocidas a los anticuerpos, cualquier antecedente de anafilaxia o asma no controlado (es decir, 3 o más cuadros clínicos de asma parcialmente controlado).
    - Toxicidad persistente relacionada con un tratamiento previo excepto alopecia.
    - Neuropatía grado ?3.
    - Embarazo o lactancia.
    - Alcoholismo o toxicomanía conocidos.
    - Antecedentes de enfermedad intercurrente no controlada, incluidas hipertensión, infección o diabetes no controlada.
    - Enfermedad cardiovascular clínicamente significativa (es decir, activa).
    - Cualquier otra enfermedad significativa que pudiera reducir la tolerancia del sujeto al tratamiento del ensayo
    - Cualquier afección psiquiátrica que pueda prohibir el entendimiento o la interpretación del consentimiento informado y que pueda limitar el cumplimiento con los requisitos del ensayo.
    - La vacunación dentro de las 4 semanas desde la primera dosis de avelumab y durante el ensayo está prohibida, excepto la administración de vacunas inactivadas.
    - Incapacidad legal o capacidad legal limitada.
    - Podrían aplicar otros criterios definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    Supervivencia general
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from date of randomization until death, assessed up to 3 years.
    Tiempo desde la fecha de aleatorización hasta la muerte, evaluado hasta 3 años.
    E.5.2Secondary end point(s)
    Secondary endpoints:
    1. Progression-free Survival (PFS)
    2. Best Overall Response (BOR)
    3. Change from baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire
    4- Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status.
    5- Change from baseline in European Organization for the Research and trarment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC STO22) Questionnaire Scores.
    Criterios de valoración secundarios:
    1- Supervivencia libre de progresión
    2- Mejor respuesta general.
    3- Cambio desde el momento basal en el Cuestionario europeo de calidad de vida de 5 dimensiones y de 5 niveles (EQ-5D-5L)
    4- Cambio desde el momento basal en el Cuestionario (EORTC-QLQ-C30) de la Organización Europea para la Investigación y el Tratamiento del Cáncer.
    5- Cambio desde el momento basal en el Cuestionario de calidad de vida específico de cáncer de estómago de la organización Europea para la Investigación y Tratamiento del cáncer (EORTC STO22)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 2: Time from date of randomization up to 3 years
    3 to 5: Baseline up to 3 years
    1 y 2: tiempo desde la aleatorización hasta los 3 años
    3-5: Basal hasta los 3 años
    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 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 trial2
    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 EEA70
    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
    Belgium
    Chile
    Colombia
    Czech Republic
    France
    Germany
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    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 survival follow-up will continue until up to 5 years after the last subject receives the last dose of avelumab or the last subject dies, whichever comes first.
    Se mantendrá el seguimiento de la supervivencia hasta 5 años después de que el último sujeto reciba la última dosis de avelumab o hasta que el sujeto muera, lo que ocurra primero
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days3
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 330
    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 stopped trial treatment, 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.
    Después de que un sujeto haya completado el tratamiento del ensayo, 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 Decision2016-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-14
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