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    Summary
    EudraCT Number:2015-005143-13
    Sponsor's Protocol Code Number:ONCOS-C719
    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:2016-02-24
    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 number2015-005143-13
    A.3Full title of the trial
    A randomised Phase II open-label study with a Phase Ib safety lead-in cohort of ONCOS-102, an immune-priming GM-CSF coding oncolytic adenovirus, and pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma
    Estudio abierto y aleatorizado de fase II con una cohorte de preinclusión de seguridad de fase Ib para evaluar ONCOS-102, un adenovirus oncolítico que codifica GM-CSF para la sensibilización inmunitaria, y pemetrexed/cisplatino en pacientes con mesotelioma pleural maligno irresecable.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Patients with unresectable malignant pleural mesothelioma
    Pacientes con mesotelioma pleural maligno irresecable
    A.3.2Name or abbreviated title of the trial where available
    MESOS
    A.4.1Sponsor's protocol code numberONCOS-C719
    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 SponsorTargovax Oy
    B.1.3.4CountryFinland
    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 supportTargovax Ltd.
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTargovax Ltd.
    B.5.2Functional name of contact pointCharlotta Backman
    B.5.3 Address:
    B.5.3.1Street AddressSaukonpaadenranta 2
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post codeFI-00180
    B.5.3.4CountryFinland
    B.5.4Telephone number00358 40 900 0415
    B.5.6E-mailcharlotta.backman@targovax.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/180/14
    D.3 Description of the IMP
    D.3.1Product nameONCOS-102
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNONCOS-102
    D.3.9.2Current sponsor codeONCOS-102
    D.3.9.4EV Substance CodeSUB87690
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms/ml billion organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cyclophosphamide
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Ltd
    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 nameCyclophosphamide
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNCyclophosphamide
    D.3.9.1CAS number 6055-19-2
    D.3.9.3Other descriptive nameCYCLOPHOSPHAMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB16414MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 Cisplatin
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    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 nameCisplatin
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNCisplatin
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 ALIMTA
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMETREXED DISODIUM
    D.3.9.1CAS number 150399-23-8
    D.3.9.3Other descriptive namePEMETREXED DISODIUM
    D.3.9.4EV Substance CodeSUB03669MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Patients with unresectable malignant pleural mesothelioma
    Pacientes con mesotelioma pleural maligno irresecable
    E.1.1.1Medical condition in easily understood language
    Patients with unresectable malignant pleural mesothelioma
    Pacientes con mesotelioma pleural maligno irresecable
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and tolerability of ONCOS-102 in combination with pemetrexed/cisplatin.
    Determinar la seguridad y tolerabilidad de ONCOS-102 en combinación con pemetrexed/cisplatino.
    E.2.2Secondary objectives of the trial
    ? To determine and compare tumour-specific immunological activation in the peripheral blood in the experimental group (ONCOS 102 in combination with pemetrexed/cisplatin) and the control group (pemetrexed/cisplatin).
    ? To determine and compare immunological activation in tumour mass in the experimental group and the control group.
    ? To determine and compare overall response rate and progression-free survival (PFS) in the experimental group and the control group.
    ? To determine and compare overall survival (OS) in the experimental group and the control group.
    ? To analyse the correlation between immunological activation and clinical outcome.
    ?? Determinar y comparar la activación inmunológica específica del tumor en sangre periférica en el grupo experimental (ONCOS-102 en combinación con pemetrexed/cisplatino) y el grupo de control (pemetrexed/cisplatino).
    ?? Determinar y comparar la activación inmunológica en la masa tumoral en el grupo experimental y el grupo de control.
    ?? Determinar y comparar la tasa de respuesta global y la supervivencia sin progresión (SSP) en el grupo experimental y el grupo de control.
    ?? Determinar y comparar la supervivencia global (SG) en el grupo experimental y el grupo de control.
    ?? Analizar la correlación entre la activación inmunológica y los resultados clínicos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.? Written informed consent.
    2.? Male or female, ?18 years of age.
    3.? Histologically confirmed unresectable (advanced) malignant pleural mesothelioma in patients who are not candidates for curative surgery and for whom therapy with pemetrexed/cisplatin is considered appropriate.
    o This includes patients who are naïve to chemotherapy,
    o and those who have already received pemetrexed/cisplatin to which their tumour initially responded, but they have relapsed after at least 6 months.
    4.? Measurable disease according to Response Evaluation in Solid Tumour (RECIST) 1.1.
    5.? Tumour must be accessible to intratumoural (i.t.) injections and to tumour core needle biopsy or thoracoscopy for tissue sampling and immunohistochemistry analysis.
    6.? Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance score 0 to 1.
    7.? Acceptable liver, renal, and haematological functions.
    8.? All women of childbearing potential must have a negative urine or serum pregnancy test at screening and all patients must agree to use barrier contraception (i.e. condom) during study treatment and for 2 months after the last virus treatment and 6 months after the last
    dose of pemetrexed/cisplatin.
    1.? Consentimiento informado por escrito.
    2.? Varones o mujeres con una edad mínima de 18 años.
    3.? Pacientes con mesotelioma pleural maligno irresecable (avanzado) confirmado mediante histología que no sean candidatos a cirugía curativa y para los que se considere adecuado un tratamiento con pemetrexed/cisplatino.
    o Esto incluye pacientes que no han sido previamente tratados con quimioterapia
    o y los que ya hayan recibido pemetrexed/cisplatino y hayan experimentado una respuesta tumoral inicial, pero hayan sufrido una recaída tras, por lo menos, 6 meses.
    4.? Enfermedad mensurable según los «Criterios de evaluación de la respuesta de tumores sólidos» (RECIST) 1.1.
    5.? El tumor debe ser accesible mediante inyecciones intratumorales (i.t.), punción biópsica con aguja gruesa del tumor o toracoscopia para la toma de muestras del tejido y los análisis inmunohistoquímicos.
    6.? Estado funcional 0-1 según la escala del Grupo Oncológico Cooperativo del Este [Eastern Cooperative Oncology Group (ECOG)]/ la Organización Mundial de la Salud (OMS).
    7.? Función hepática, renal y hematológica aceptables.
    8.? Las mujeres en edad fértil deberán tener resultados negativos en una prueba de embarazo en suero en la visita de selección y todos los pacientes deberán aceptar el uso de métodos anticonceptivos de barrera (p. ej., preservativos) durante el tratamiento del estudio y durante los 2 meses siguientes al último tratamiento con el virus y los 6 meses siguientes a la última dosis de pemetrexed/cisplatino.
    E.4Principal exclusion criteria
    1. Receipt of oncolytic virus treatment, or vaccination with a vaccine containing live virus within 4 weeks before Day 1.
    2. Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of >10 mg/day prednisone) within 4 weeks before Day 1.
    3. Patients who participated in a study with an investigational drug or device within 4 weeks prior to Day 1.
    4. Active bacterial, viral, or fungal infections, requiring systemic therapy.
    5. Severe arrhythmia, heart failure, previous cardiac infarction, or acute inflammatory heart disease.
    6. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient, if included in this study.
    7. Known infection with HIV, hepatitis B, or hepatitis C.
    8. Known brain metastases.
    9. History of organ transplant.
    10. Females who are pregnant or breast feeding.
    11. Unwillingness or inability to comply with the study protocol for any reason.
    12. Patients with pre-existing hearing loss or neuropathy that may worsen due to potential neurotoxicity from cisplatin.
    13. Patients with a history of hypersensitivity to cisplatin or pemetrexed or cyclophosphamide (or any of its metabolites).
    14. Patients who are taking phenytoin for prophylactic use.
    15. History of malignant tumour, unless the patient has been without evidence of disease for at least 3 years, or the tumour was a non-melanoma skin tumour, cervical carcinoma in situ, or prostatic carcinoma in situ.
    1. Tratamiento con virus oncolítico o vacuna con un virus vivo en las 4 semanas anteriores al día 1.
    2.? Uso significativo de inmunosupresores, incluida una dosis alta de corticoesteroides (definida como el equivalente a >10 mg/día de prednisona) en las 4 semanas anteriores al día 1.
    3. Participación en un estudio con un medicamento o producto sanitario en fase de investigación en las 4 semanas anteriores al día 1.
    4.? Infecciones bacterianas, víricas o micosis activas que requieran tratamiento sistémico.
    5.? Arritmia grave, insuficiencia cardíaca, infarto de miocardio previo o cardiopatía inflamatoria aguda.
    6.? Enfermedad o afección concomitante que pueda interferir con la realización del estudio o que pueda, en opinión del investigador, suponer un riesgo inaceptable para el paciente en caso de participación.
    7.? Infección conocida por el VIH, virus de la hepatitis B o de la hepatitis C.
    8.? Metástasis cerebrales conocidas.
    9.? Antecedentes de trasplante de órgano.
    10.? Mujeres embarazadas o lactantes.
    11.? Incapacidad o falta de disposición para cumplir los requisitos del protocolo del estudio por cualquier motivo.
    12.? Pacientes con hipoacusia o neuropatía preexistentes que puedan empeorar por la neurotoxicidad potencial del cisplatino.
    13.? Pacientes con antecedentes de hipersensibilidad al cisplatino, al pemetrexed o a la ciclofosfamida (o a cualquiera de sus metabolitos).
    14.? Pacientes que toman fenitoína para uso profiláctico.
    15.? Antecedentes de tumor maligno, salvo si el paciente lleva sin enfermedad por lo menos 3 años, o si el tumor consistió en un cáncer de piel diferente del melanoma, un carcinoma localizado de cuello uterino o un carcinoma localizado de próstata.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability profile of ONCOS 102 and pemetrexed/cisplatin after 2 cycles of chemotherapy (Day 64).
    Perfil de seguridad y tolerabilidad de ONCOS-102 y pemetrexed/cisplatino luego de 2 ciclos de quimioterapia (Día 64)
    E.5.1.1Timepoint(s) of evaluation of this end point
    This will be assessed in an ongoing basis
    Esto se evaluará de forma continua
    E.5.2Secondary end point(s)
    ? Biological correlates by means of cellular and humoral immune responses in blood as well as biological changes in tumour biopsies of injected and non-injected tumours.
    ? Response rate and PFS according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, modified immunologically relevant RECIST (iRECIST ) and PERCIST 1.0 PET criteria (PERCIST).
    ? Overall survival.
    ? Correlación biológica relacionada con la respuesta imunológica humoral y celular en sangre así como cambios biológicos dados en biopsias de tumor
    ? Tasa de respuesta global y la supervivencia sin progresión (SSP) según los «Criterios de evaluación de la respuesta de tumores sólidos» (RECIST) 1.1, RECIST inmunológicamente relevante modificado ( iRECIST ) y PERCIST 1.0 criterios de PET ( PERCIST ).
    ? Supervivencia total
    E.5.2.1Timepoint(s) of evaluation of this end point
    Points 1 and 2 will be done on an ongoing basis
    Third point ? will continue until the last treated patient has died.
    Los puntos 1 y 2 se hará de forma continua
    Tercer punto - continuará hasta que el último paciente tratado ha muerto .
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I to study safety of ONCOS-102 with standard chemotherapy in mesothelioma
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    End of trial is defined as last visit last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 4
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    Patients will be monitored regularly for immunological assessment (PBMCs) including Month 9 and Month 12 (i.e., after the end of study visit), and will be followed up for survival every 3 months until end of life.
    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 Opinion2016-05-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-08
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