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    Summary
    EudraCT Number:2015-004816-39
    Sponsor's Protocol Code Number:CA012-004
    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:2016-06-06
    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 number2015-004816-39
    A.3Full title of the trial
    A Phase 1/2a Study of BMS-986178 Administered Alone and in Combination with Nivolumab or Ipilimumab in Advanced Solid Tumors
    Estudio fase 1/2a de BMS-986178 administrado en monoterapia y en combinación con nivolumab o ipilimumab en tumores sólidos avanzados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of BMS-986178 Monotherapy or in Combination With Nivolumab or Ipilimumab in Subjects With Advanced Solid Tumors
    Estudio de BMS-986178 en monoterapia o en combinación con nivolumab o ipilimumab en tumores sólidos avanzados
    A.4.1Sponsor's protocol code numberCA012-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02737475
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1175-8335
    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 nameNA
    D.3.2Product code BMS-986178
    D.3.4Pharmaceutical form 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 INNNA
    D.3.9.2Current sponsor codeBMS-986178
    D.3.9.3Other descriptive nameBMS986178
    D.3.9.4EV Substance CodeSUB181367
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) 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 nameNIVOLUMAB - 10ml vial
    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-936558-01
    D.3.9.3Other descriptive nameBMS-936558, MDX1106, ONO-4538
    D.3.9.4EV Substance CodeSUB122750
    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: 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 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
    Advanced Solid Tumors
    Tumores sólidos avanzados
    E.1.1.1Medical condition in easily understood language
    Advanced Solid Tumors
    Tumores sólidos avanzados
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    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, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of BMS-986178 administered alone and in combination with nivolumab or ipilimumab in subjects with advanced malignant tumors.
    Determinar la seguridad, tolerabilidad, toxicidades limitantes de la dosis (TLD) y dosis máxima tolerada (DMT)/dosis recomendada para fase 2 (DRF2) de BMS-986178 administrado en monoterapia y en combinación con nivolumab o ipilimumab en sujetos con tumores malignos avanzados
    E.2.2Secondary objectives of the trial
    To investigate the preliminary anti-tumor activity of BMS-986178 administered alone and in combination with
    nivolumab or ipilimumab in subjects with advanced malignant tumors
    To characterize the pharmacokinetics (PK) of BMS-986178 administered alone and in combination with nivolumab or ipilimumab
    To characterize the immunogenicity of BMS-986178 administered alone and in combination with nivolumab or ipilimumab and the immunogenicity of nivolumab or ipilimumab administered with BMS-986178
    Investigar la actividad antitumoral preliminar de BMS-986178 administrado en monoterapia y en combinación con nivolumab o ipilimumab en sujetos con tumores malignos avanzados
    Caracterizar la farmacocinética (FC) de BMS-986178 administrado en monoterapia y en combinación con nivolumab o ipilimumab
    Caracterizar la inmunogenicidad de BMS-986178 administrado en monoterapia y en combinación con nivolumab o ipilimumab y la inmunogenicidad de nivolumab o ipilimumab administrado con BMS-986178
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients must have at least 1 standard treatment regimen in the advanced, recurrent or metastatic setting
    • ECOG (Eastern Cooperative Oncology Group) 0-1
    • Men and women 18 years old or older
    • At least one measurable lesion at baseline by CT (computed tomography) or MRI (magnetic resonance imaging) as per RECIST (Response Evaluation Criteria In Solid Tumors) v1.1
    • Pacientes con al menos 1 régimen estándar de tratamiento en el tumor avanzado, recurrente o metastásica
    • ECOG (Eastern Cooperative Oncology Group) 0-1
    • Hombres y mujeres de 18 años o más
    • Al menos una lesión medible al inicio del estudio por TAC (tomografía axial computarizada) o MRI (imágenes por resonancia magnética) de acuerdo con los criterios RECIST (Criterios de evaluación de respuesta en tumores sólidos) v1.1
    E.4Principal exclusion criteria
    • Known central nervous system metastases or central nervous system as the only source of disease
    • Concomitant malignancies
    • Active known or suspected autoimmune disease
    • Uncontrolled or significant cardiovascular disease
    • Major surgery less than 4 weeks before the start of the study
    • Metástasis conocida en el sistema nervioso central o sistema nervioso central como la única fuente de la enfermedad
    • Neoplasias concomitantes
    • Enfermedad autoinmune activa conocida o sospechada
    • Enfermedad cardiovascular significativa o no controlada
    • Cirugía mayor previa realizada con menos de 4 semanas antes de iniciar el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of AE's (adverse events) and SAE's (serious adverse events), AE's leading to discontinuation, deaths and clinical laboratory test abnormalities
    Incidencia de acontecimientos adversos (AA) y acontecimientos adversos graves (AAG), AA que provocan la discontinuación, muertes y anomalías en las pruebas clínicas de laboratorio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over 4 years
    Durante 4 años
    E.5.2Secondary end point(s)
    • Cmax (maximum observed serum concentration) for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits
    • Tmax (time of maximum observed concentration) for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits
    • AUC(0-t) (area under the concentration-time curve from time zero to the time) for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits
    • AUC(TAU) (area under the concentration-time curve in 1 dosing interval) for BMS-986178 alone and in
    combination with nivolumab or ipilimumab, if data permits
    • Ctau (the observed concentration at the end of a dosing interval) for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits
    • CLT (total body clearance) for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits
    • Css-avg [average concentration over a dosing interval (AUC(TAU)/tau)] for BMS-986178 alone and in
    combination with nivolumab or ipilimumab, if data permits
    • AI [ratio of an exposure measure at steady state to that after the first dose (exposure measure includes AUC (TAU), Cmax and Ctau)] for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits
    • T-HALFeff [effective elimination half-life to explain degree of accumulation for a specific exposure measure (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits
    • Ctrough [trough observed plasma concentrations (this includes pre-dose concentrations (C0) and Ctau)] for BMS-986178 alone and in combination with nivolumab or ipilimumab, if data permits
    • Immunoassay of anti-nivolumab antibody in combination with anti-BMS-986178 antibody
    • Immunoassay of anti-ipilimumab antibody in combination with anti-BMS-986178 antibody
    • Objective Response Rate (ORR)
    • Progression Free Survival Rate (PFSR)
    • Immunoassay of anti-BMS-986178 antibody alone
    • Cmax (concentración máxima en suero observada) de BMS-986178 en monoterapia y en combinación con nivolumab o ipilimumab, si se dispone de datos
    • Tmáx (tiempo de concentración máxima observada) de BMS-986178 en monoterapia y en combinación con nivolumab o ipilimumab, si se dispone de datos
    • AUC (0-t) (área bajo la curva de concentración-tiempo desde el tiempo cero al tiempo) de BMS-986178 en monoterapia y en combinación con nivolumab o ipilimumab, si se dispone de datos
    • AUC (TAU) (área bajo la curva de concentración-tiempo en el intervalo de dosificación 1) de BMS-986178 en monoterapia y en combinación con nivolumab o ipilimumab, si se dispone de datos
    • Ctau (la concentración observada al final de un intervalo de dosificación) de BMS-986178 en monoterapia y en combinación con nivolumab o ipilimumab, si se dispone de datos
    • CLT (aclaramiento corporal total) de BMS-986178 en monoterapia y en combinación con nivolumab o ipilimumab, si se dispone de datos
    • Ceq‑prom [concentración media en un intervalo de dosis (AUC (TAU) / tau)] de BMS-986178 en monoterapia y en combinación con nivolumab o ipilimumab, si se dispone de datos
    • AI [relación de una medida de la exposición en estado estacionario y después de la primera dosis (medida de la exposición incluye AUC (TAU), Cmax y Ctau)] de BMS-986178 en momonterapia y en combinación con nivolumab o ipilimumab, si se dispone de datos
    • T-MEDIAef [semivida de eliminación eficaz para explicar grado de acumulación de una medida específica de exposición (medida de la exposición incluye AUC (TAU), Cmax y Ctau)] de BMS-986178 en monoterapia y en combinación con nivolumab o ipilimumab, si se dispone de datos
    • Cvalle [concentraciones mínimas plasmáticas (esto incluye las concentraciones pre-dosis (C0) y Ctau)] de BMS-986178 solo y en combinación con nivolumab o ipilimumab, si se dispone de datos
    • Inmunoensayo de anticuerpo anti-nivolumab en combinación con anticuerpo anti-BMS-986178
    • Inmunoensayo de anticuerpo anti-ipilimumab en combinación con anticuerpo anti-BMS-986178
    • Tasa de respuesta objetiva (TRO)
    • Tasa de supervivencia libre de progresión (TSLP)
    • Inmunoensayo de anticuerpos anti-BMS-986178 solo
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Cmax; Tmax; AUC(0-t); AUC(TAU); Ctau; CLT; Css-avg; AI; T-HALFeff; Ctrough; Immunoassay of anti-nivolumab antibody in combination with anti-BMS-986178 antibody; Immunoassay of anti-ipilimumab antibody in combination with anti-BMS-986178 antibody : Approximately 100 days after the final study drug administration (end of treatment)
    • ORR; PFSR: Approximately 2 years
    • Immunoassay of anti-BMS-986178 antibody alone: Approximately 100 days after 6 months of treatment
    • Cmax; Tmax; AUC(0-t); AUC(TAU); Ctau; CLT; Ceq-prom; índice de acumulación (IA); semivida de eliminación efectiva (T-MEDIAef); Cvalle; Inmunoensayo de anticuerpo anti-nivolumab en combinación con anticuerpo anti-BMS-986178; Inmunoensayo de anticuerpo anti-ipilimumab en combinación con anticuerpo anti-BMS-986178: aproximadamente 100 días después de la administración del medicamento en estudio final (final del tratamiento)
    • TRO; TSLP: Aproximadamente 2 años
    • Inmunoensayo de anticuerpo anti-BMS-986178 solo: aproximadamente 100 días después de 6 meses de tratamiento
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity: The secondary objective of immunogenicity will be assessed by the frequency of positive ADA to BMS-986178 or nivolumab or ipilimumab.
    Inmunogenicidad: el objetivo secundario de la inmunogenicidad se evaluará por la frecuencia de AAF positivos frente a BMS-986178 o nivolumab o ipilimumab.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA2
    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
    Canada
    France
    Germany
    Israel
    Italy
    Netherlands
    Spain
    Switzerland
    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
    LPLV
    Última vistita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 145
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 245
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of the study, BMS will not continue to provide BMS-supplied study drug to subjects and investigators unless BMS chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.
    Cuando concluya el estudio, BMS no proporcionará el medicamento en estudio a los sujetos e investigadores a no ser que BMS opte por extender el estudio.
    El investigador debe asegurarse de que el sujeto recibe el cuidado estándar apropiado para tratar la afección en estudio.
    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 Decision2016-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
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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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