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    Summary
    EudraCT Number:2015-003300-23
    Sponsor's Protocol Code Number:EMR100070-007
    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:2016-03-18
    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 number2015-003300-23
    A.3Full title of the trial
    A Phase III open-label, multicenter trial of maintenance therapy with avelumab (MSB0010718C) versus continuation of first-line chemotherapy in subjects with unresectable, locally advanced or metastatic, adenocarcinoma of the stomach, or of the gastro-esophageal junction
    Ensayo de fase III, multicéntrico y no enmascarado sobre el tratamiento de mantenimiento con avelumab (MSB0010718C) frente a la continuación de la quimioterapia de primera línea en sujetos con un adenocarcinoma gástrico, o de la zona de unión gastroesofágica, irresecable, localmente avanzado o metastásico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Avelumab in First-Line Gastric Cancer
    Avelumab en primera línea para cáncer gástrico
    A.3.2Name or abbreviated title of the trial where available
    Avelumab in First-Line Gastric Cancer
    Avelumab en primera línea para cáncer gástrico
    A.4.1Sponsor's protocol code numberEMR100070-007
    A.5.4Other Identifiers
    Name:JAVELINNumber:Gastric 100
    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 number34900 810 844
    B.5.5Fax number496151 72 2000
    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 Capecitabine Accord 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited, Sage house, 319, Pinner road, North Harrow, Middlesex HA1 4HF, United Kin
    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 nameCapecitabine
    D.3.2Product code Capecitabine
    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 INNCapecitabine
    D.3.9.1CAS number 154361-50-9
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Capecitabine Accord 150 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited, Sage house, 319, Pinner road, North Harrow, Middlesex HA1 4HF, United Kin
    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 nameCapecitabine
    D.3.2Product code Capecitabine
    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 INNCapecitabine
    D.3.9.1CAS number 154361-50-9
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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: 4
    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 Oxaliplatin Hospira
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited, Horizon; Honey Lane, Hurley,Maidenhead, SL6 6RJ, 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 nameOxaliplatin
    D.3.2Product code Oxaliplatin
    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 INNOXALIPLATIN
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 5
    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 Fluorouracil Hospira
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited, Queensway; Royal Leamington Spa; Warwick, 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 nameFluorouracil
    D.3.2Product code 5-FU
    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 INNFLUOROURACIL SODIUM
    D.3.9.1CAS number 51-21-8
    D.3.9.4EV Substance CodeSUB02225MIG
    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 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
    Advanced (unresectable, locally advanced or metastatic) adenocarcinoma of the stomach, or of the gastro-esophageal junction (GEJ)
    Adenocarcinoma del estómago o de la unión gastroesofágica (UGE) avanzado
    (no resecable, localmente avanzado o metastásico)
    E.1.1.1Medical condition in easily understood language
    Gastric cancer
    Cáncer 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 objectives of this trial are to demonstrate superiority of maintenance therapy with avelumab versus continuation of first-line chemotherapy with regard to Overall Survival (OS) or Progression-free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in subjects who have not progressed on firstline chemotherapy.
    El objetivo principal de este ensayo es demostrar la superioridad del tratamiento de
    mantenimiento con avelumab frente a la continuación de la quimioterapia de primera línea en relación con la supervivencia general (SG) o supervivencia sin progresión (SSP) de acuerdo a los Criterios de Evaluación de la Respuesta en Tumores Sólidos versión 1.1 (RECIST v1.1) en sujetos que no han experimentado progresión con la quimioterapia de primera línea
    E.2.2Secondary objectives of the trial
    ? To demonstrate superiority of maintenance therapy with avelumab
    versus continuation of first-line chemotherapy with regard to the
    objective response rate (ORR) as per RECIST v1.1
    ? To compare the subject-reported outcomes / quality of life of subjects
    when treated with avelumab versus continuation of first-line
    chemotherapy as assessed by the European Quality of Life (EuroQOL)
    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
    - Demostrar la superioridad del tratamiento de mantenimiento con avelumab frente a la
    continuación de la quimioterapia de primera línea en relación con la Tasa de Respuesta Objetiva (TRO) según RECIST v1.1
    - Comparar los resultados comunicados por el sujeto/la calidad de vida de los sujetos cuando
    se han tratado con avelumab frente a la continuación de la quimioterapia de primera línea,
    mediante el cuestionario Europeo de Calidad de Vida (EuroQoL) EQ-5D-5L y el de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC) QLQ-C30 y el módulo QLQ-STO22.
    - Determinar la seguridad y la tolerabilidad de avelumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male or female subjects aged greater than or equal to (>=) 18 years
    -Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
    -Subjects with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ)
    -Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
    -Estimated life expectancy of more than 12 weeks
    -Adequate haematological, 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 de 18 años de edad, de uno u otro sexo.
    - La enfermedad debe ser medible según RECIST v1.1.
    - Sujetos con adenocarcinoma del estómago o UGE no resecable, localmente avanzado o
    metastásico confirmado histológicamente.
    - EG ECOG de 0 a 1 en el momento de incorporación al ensayo.
    - Esperanza de vida estimada de más de 12 semanas.
    - Funciones hematológica, hepaticas y renales adecuadas definidas por el protocolo
    - Prueba de embarazo en sangre en la preselección para mujeres en edad fértil.
    - Métodos anticonceptivos altamente efectivos para hombres y mujeres si existe riesgo de concepción.
    - Otros criterios de aplicación definidos en el protocolo
    E.4Principal exclusion criteria
    ?Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
    ?Concurrent anticancer treatment
    ?Prior chemotherapy for unresectable locally advanced or metastatic adenocarcinoma of the stomach or GEJ
    ?Tumor shown to be HER2 possitive
    ?Major surgery for any reason, except diagnostic biopsy, within 4 weeks of enrolment and/or if the subject has not fully recovered from the surgery within 4 weeks of enrolment
    ?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 55 days 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 anterior con anticuerpos o fármacos dirigidos a las proteínas correguladoras de los linfocitos T
    ? Tratamiento concomitante contra el cáncer
    ? Quimioterapia anterior para el adenocarcinoma del estómago o UGE no resecable, localmente avanzado o metastásico.
    ? Tumor que se haya demostrado que es HER2+
    ? Intervención quirúrgica mayor por cualquier razón, excepto la biopsia diagnóstica, en las
    4 semanas anteriores a la inscripción o si el sujeto no se ha recuperado por completo de la
    cirugía en las 4 semanas anteriores a la inscripción
    ? Para los sujetos que reciben fármacos inmunodepresores (tales como los corticosteroides) 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 corticosteroides a una dosis de sustitución fisiológica, equivalente a < 10 mg de prednisona al día)
    ? Todos los sujetos con metástasis cerebral, salvo quienes cumplan los siguientes criterios:
    Metástasis cerebral tratada localmente. Ausencia de síntomas neurológicos en curso relacionados con la localización cerebral de la enfermedad (se aceptan secuelas que sean consecuencia del tratamiento de la metástasis cerebral).
    ? Neoplasia maligna previa (distinta del cáncer gástrico) en los 5 años anteriores, a excepción del carcinoma basocelular o epidermoide, o del carcinoma localizado (vesical, cervical, colorrectal, mamario).
    ? 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 en los anticuerpos monoclonales, cualquier antecedente de anafilaxia o asma no controlado (es decir, 3 o más características de asma parcialmente controlada).
    ? Toxicidad persistente relacionada con un tratamiento previo, excepto alopecia.
    ? Neuropatía de grado > 3.
    ? Embarazo o lactancia.
    ? Alcoholismo o toxicomanía conocidos.
    ? Antecedentes de enfermedades intercurrentes no controladas, incluyendo hipertensión, infección activa o diabetes no controlada.
    ? Enfermedad cardiovascular clínicamente significativa
    ? Cualquier otra enfermedad significativa que, en opinión del investigador, pudiera reducir la tolerancia del sujeto al tratamiento del ensayo.
    ? Todo trastorno psiquiátrico que impida la comprensión o la concesión del consentimiento informado y que limite el cumplimiento de los requisitos del estudio.
    ? La vacunación dentro de los 55 días desde la primera dosis de avelumab y durante el ensayo está prohibida, excepto la administración de vacunas inactivadas
    ? Incapacidad legal o capacidad legal limitada.
    ? Otros criterios de exclusión aplicables definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    1. Overall survival
    2. Progression-free Survival
    1. Supervivencia general.
    2. Supervivencia sin Progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 and 2: From the date of randomization up to 3 years
    1 y 2: Desde la fecha de inclusión hasta los 3 años posteriores.
    E.5.2Secondary end point(s)
    1 Best overall response (BOR)
    2 Change from baseline in European Quality Of Life 5-dimensions-5
    levels (EQ-5D-5L) Health Outcome Questionnaire
    3 Change from baseline in European Organization for the Research and
    Treatment of Cancer Quality of Life (EORTC QLQ-C30)
    4 Change from baseline in European Organization for Research and
    Treatment of Cancer Gastric Cancer Module QLQ-STO22
    5 Number of subjects with Treatment-Emergent Adverse Events (TEAEs)
    according to the National Cancer Institute Common Terminology Criteria
    for Adverse Events (NCI-CTCAE) Version 4.03
    1. Mejor RespuestaGeneral (MRG)
    2. Cambio desde el inicio en el cuestionario Europeo de Calidad de Vida 5 dimensiones-5 niveles sobre el estado de salud (EQ-5D-5L)
    3. Cambio desde el inicio en el cuestionario de Calidad de Vida de la Organización Europea para la Investigación y el tratamiento de Cáncer (EORTC QLQ-C30)
    4. Cambio desde el inicio en el Módulo de la Organización Europea pra la Investigación y Tratamiento de Cáncer Gástrico, QLQ-STO22
    5. Número de sujetos con Acontecimientos Adversos surgidos durante el Tratamiento (AAST) de acuerdo a los Criterios de terminología común del Instituto Nacional del Cáncer para Acontecimientos Adversos (NCI-CTCAE) Version 4.03
    E.5.2.1Timepoint(s) of evaluation of this end point
    Best response obtained among all tumor assessment visits after the date
    of randomization (preferably at the regularly scheduled 6-week
    assessment interval) until documented disease progression.
    1. Desde la fecha de inclusión hasta los siguientes 3 años.
    2, 3, y 4: Semana 4, 7, 13 y después cada 6 semanas hasta 12 semanas tras el último tratamiento, evaluado hasta los 3 años.
    5: Desde la primera dosis administrada del fármaco en estudio hasta 28 días después de la última dosis del mismo.
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Brazil
    Canada
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Romania
    Russian Federation
    Spain
    Taiwan
    Thailand
    Turkey
    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 5 years after the last subject receives the last dose of avelumab.
    Expected date for the primary endpoint is 25Nov2018 and the completion expected date is 25Nov2023.
    El seguimiento de la supervivencia continuará hasta 5 años después de que el último sujeto reciba la última dosis de avelumab.
    La fecha estimada para el primer criterio de valoración es 25Nov2018 y la fecha estimada de finalización es 25Nov2023
    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 months11
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months11
    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: 444
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 222
    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 200
    F.4.2.2In the whole clinical trial 666
    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 los sujetos hayan parado el tratamiento del ensayo, se administrará el tratamiento habitual. Si se requiere, de acuerdo con los cuidados estándar y la práctica médica aceptada del centro de ensayo dependiendo de las necesidades médicales individuales de los sujetos.
    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 Decision2016-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-03
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