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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-004920-67
    Sponsor's Protocol Code Number:CA209-511
    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 number2015-004920-67
    A.3Full title of the trial
    Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma
    Estudio fase IIIb/IV, aleatorizado, a doble ciego, de nivolumab 3 mg/kg en combinación con ipilimumab 1 mg/kg frente a nivolumab 1 mg/kg en combinación con ipilimumab 3 mg/kg en sujetos con melanoma irresecable o metastásico, no tratado previamente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double Blinded, Study of Two Different Dose Combinations of Nivolumab in Combination with Ipilimumab in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma
    Estudio aleatorizado, a doble ciego, de dos combinaciones de dosis diferentes de nivolumab en combinación con ipilimumab 1en sujetos con melanoma irresecable o metastásico, no tratado previamente
    A.3.2Name or abbreviated title of the trial where available
    CheckMate 511: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 511
    CheckMate 511: vía de control y evaluación en ensayos clínicos de nivolumab
    A.4.1Sponsor's protocol code numberCA209-511
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1176-0309
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number900 150 160
    B.5.6E-mailclinical.trials@bms.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 nameNivolumab
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Solution for injection/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 INNNivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameBMS936558
    D.3.9.4EV Substance CodeSUB32944
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 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 nameIpilimumab
    D.3.2Product code BMS-734016
    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 INNIPILIMUMAB
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeBMS-734016
    D.3.9.3Other descriptive nameBMS734016
    D.3.9.4EV Substance CodeSUB22577
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with Previously Untreated, Unresectable or Metastatic Melanoma
    Sujetos con melanoma irresecable o metastásico, no tratado previamente
    E.1.1.1Medical condition in easily understood language
    Melanoma
    Melanoma
    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 10025671
    E.1.2Term Malignant melanoma stage IV
    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 10025670
    E.1.2Term Malignant melanoma stage III
    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 compare the incidence of drug-related Grade 3 - 5 AEs of nivolumab 3 mg/kg combined with ipilimumab 1 mg/kg to nivolumab 1 mg/kg combined with ipilimumab 3 mg/kg in treatment-naive subjects with unresectable or metastatic melanoma.
    El objetivo principal es comparar la incidencia de AA de grado 3 5 relacionados con el fármaco con nivolumab 3 mg/kg combinado con ipilimumab 1 mg/kg con la de nivolumab 1 mg/kg combinado con ipilimumab 3 mg/kg en sujetos con melanoma irresecable o metastásico que no hayan recibido tratamiento previo.
    E.2.2Secondary objectives of the trial
    -To evaluate the objective response rate (ORR), as determined by investigators, of nivolumab 3 mg/kg combined with ipilimumab 1 mg/kg and nivolumab 1 mg/kg combined with ipilimumab 3 mg/kg in treatment-naive subjects with unresectable or metastatic melanoma.
    -To evaluate progression free survival (PFS) of nivolumab 3 mg/kg combined with ipilimumab 1 mg/kg and nivolumab 1 mg/kg combined with ipilimumab 3 mg/kg in treatment-naive subjects with unresectable or metastatic melanoma.
    -To assess overall survival (OS)
    -To assess Health Related Quality of Life (HRQoL) using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30).
    - Evaluar la tasa de respuesta objetiva (TRO), determinada por los investigadores, de nivolumab 3 mg/kg combinado con ipilimumab 1 mg/kg y nivolumab 1 mg/kg combinado con ipilimumab 3 mg/kg en sujetos con melanoma irresecable o metastásico que no hayan recibido tratamiento previo.
    - Evaluar la supervivencia libre de progresión (SLP) de nivolumab 3 mg/kg combinado con ipilimumab 1 mg/kg y nivolumab 1 mg/kg combinado con ipilimumab 3 mg/kg en sujetos con melanoma irresecable o metastásico que no hayan recibido tratamiento previo.
    - Evaluar la supervivencia global (SG)
    - Evaluar la calidad de vida relacionada con la salud (CdVRS) usando el QLQ-C30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (QLQ-C30 de la EORTC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adult subjects (>=18 years) with histologically confirmed unresectable Stage III or Stage IV Melanoma as per AJCC staging system.
    -Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
    -No prior systemic anticancer therapy for unresectable or metastatic melanoma. Prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 6 weeks prior to date of first dose, and all related adverse events have either returned to baseline or stabilized.
    -Measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST) criteria
    -Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. In order to be randomized, a subject must be classified as PD-L1 positive, PD-L1 negative, or PD-L1 indeterminate. If an insufficient amount of tumor tissue from an unresectable or metastatic site is available prior to the start of the screening phase, subjects must consent to allow the acquisition of additional tumor tissue for performance of biomarker analyses.
    -Known BRAF V600 mutation status as determined by local institutional standard or subject to consent to BRAF V600 mutation testing per local institutional standards during the Screening Period, the results of which must be reported within 3 months of randomization. All BRAF statuses (BRAF wild-type or BRAF 600 mutation positive) are eligible.
    - Sujetos adultos (>=18 años) con melanoma confirmado histológicamente, irresecable en estadio III o IV según el sistema de estadificación del AJCC.
    - Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0?1
    - Ningún tratamiento oncológico sistémico previo para melanoma irresecable o metastásico. Se permite tratamiento previo adyuvante o neoadyuvante previo para el melanoma si se terminó al menos 6 semanas antes de la fecha de la primera dosis y todos los acontecimientos adversos relacionados han vuelto a la situación basal o se han estabilizado.
    - Enfermedad medible según los Criterios de Evaluación de la Respuesta en Tumores Sólidos, versión 1.1 (RECIST)
    - Debe facilitarse tejido tumoral de una localización irresecable o metastásica de la enfermedad para análisis de biomarcadores. Para ser aleatorizado, un sujeto debe ser clasificado como PD?L1 positivo, PD?L1 negativo o PD?L1 indeterminado. Si se dispone de una cantidad insuficiente de tejido tumoral de una localización irresecable o metastásica antes del comienzo de la fase de selección, los sujetos deben dar su consentimiento para permitir la obtención de tejido tumoral adicional para la realización de análisis de biomarcadores.
    - Estado conocido en cuanto a mutación BRAF V600 determinado por la norma institucional local o consentimiento del sujeto para una prueba de mutación de BRAF V600 según las normas del centro durante el periodo de selección, cuyos resultados deben notificarse en el plazo de 3 meses después de la aleatorización. Son elegibles todos los estados de BRAF (BRAF sin mutación o BRAF 600 con mutación).
    E.4Principal exclusion criteria
    - Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no evidence of progression via magnetic resonance imaging (MRI, except where contraindicated in which CT scan is acceptable) for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
    -Ocular melanoma
    -Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
    - Metástasis cerebrales activas o metástasis leptomeníngeas. Son elegibles los sujetos con metástasis cerebrales si han sido tratadas y no hay pruebas de progresión mediante resonancia magnética (RM, excepto cuando esté contraindicada, en cuyo caso es aceptable TC) durante al menos 8 semanas después de que se termine el tratamiento y en el plazo de 28 días antes de la administración de la primera dosis del fármaco del estudio. Tampoco debe haber requisito de dosis elevadas de corticosteroides sistémicos que puedan conducir a inmunosupresión (> 10 mg/día de prednisona o equivalente) durante al menos 2 semanas antes de la administración del fármaco del estudio.
    - Melanoma ocular
    - Sujetos con enfermedad autoinmunitaria activa, conocida o de sospecha. Se permite reclutar a sujetos con vitiligo, diabetes mellitus de tipo I, hipotiroidismo residual debido a un problema autoinmunitario que sólo precisa sustitución hormonal, psoriasis que no requiere tratamiento sistémico o problemas que no se espera que recurran en ausencia de un desencadenante externo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the incidence of drug-related Grade 3 - 5 AEs.
    El objetivo principal es la incidencia de AA de grado 3-5 relacionados con mediamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months from the first dose of study treatment
    Después de 6 meses desde la primera dosis del tratamiento en estudio
    E.5.2Secondary end point(s)
    -To evaluate the objective response rate (ORR), as determined by investigators, of nivolumab 3 mg/kg combined with ipilimumab 1 mg/kg and nivolumab 1 mg/kg combined with ipilimumab 3 mg/kg in treatment-naive subjects with unresectable or metastatic melanoma.
    -To evaluate progression free survival (PFS) of nivolumab 3 mg/kg combined with ipilimumab 1 mg/kg and nivolumab 1 mg/kg combined with ipilimumab 3 mg/kg in treatment-naive subjects with unresectable or metastatic melanoma.
    -To assess overall survival (OS)
    -To assess Health Related Quality of Life (HRQoL) using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30).
    - Evaluar la tasa de respuesta objetiva (TRO), determinada por los investigadores, de nivolumab 3 mg/kg combinado con ipilimumab 1 mg/kg y nivolumab 1 mg/kg combinado con ipilimumab 3 mg/kg en sujetos con melanoma irresecable o metastásico que no hayan recibido tratamiento previo.
    - Evaluar la supervivencia libre de progresión (SLP) de nivolumab 3 mg/kg combinado con ipilimumab 1 mg/kg y nivolumab 1 mg/kg combinado con ipilimumab 3 mg/kg en sujetos con melanoma irresecable o metastásico que no hayan recibido tratamiento previo.
    - Evaluar la supervivencia global (SG)
    - Evaluar la calidad de vida relacionada con la salud (CdVRS) usando el QLQ-C30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (QLQ-C30 de la EORTC).
    E.5.2.1Timepoint(s) of evaluation of this end point
    -After 6 months from the first dose of study treatment
    -The first date of documented progression
    -After 6 months from the first dose of study treatment
    -After 6 months from the first dose of study treatment
    - Después de 6 meses desde la primera dosis del tratamiento en estudio
    - La primera fecha documentada de progresión
    - Después de 6 meses desde la primera dosis del tratamiento en estudio
    - Después de 6 meses desde la primera dosis del tratamiento en estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity Assessments, Biomarker Assessments, Outcomes Research Assessments
    Evaluaciones de investigación de resultados, evaluaciones de inmunogenicidad y evaluaciones de biomarcadores
    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) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Diferentes dosis de la misma combinación de medicamentos
    different dosage of the same combination of drugs
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Canada
    Denmark
    France
    Germany
    Israel
    Italy
    Netherlands
    Poland
    Russian Federation
    Spain
    United Kingdom
    United States
    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
    Last follow-up visit of the last patient
    Última visita de seguimiento del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years6
    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: 322
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 138
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 460
    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 conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive BMS supplied study drug. Study drug will be provided via an extension of the study, a rollover study requiring approval by responsible health authority and ethics committee or through another mechanism at the discretion of BMS. Please refer to protocol section 3.2, Post Study Access Therapy, for more details.
    Cuando concluya el EC, los sujetos que sigan demostrando beneficio clínico serán elegibles para recibir el medicamento dado por BMS. Dicho medicamento se facilitará mediante una extensión del EC, un EC de continuación que requiriendo la aprobación de la autoridad sanitaria y Comité Ético competentes u otro mecanismo según el criterio de BMS. Ver sección 3.2 del protocolo "Acceso al tratamiento después del estudio" para más información
    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 Decision2016-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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