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    Summary
    EudraCT Number:2020-000854-85
    Sponsor's Protocol Code Number:CA045-020
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-02-09
    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 number2020-000854-85
    A.3Full title of the trial
    Phase 1/2 Study of Bempegaldesleukin in Combination with Nivolumab in Children, Adolescents, and Young Adults with Recurrent or Refractory Malignancies (PIVOT IO 020)
    Estudio fase 1/2 de bempegaldesleukin en combinación con nivolumab en niños, adolescentes y adultos jóvenes con neoplasias malignas recidivantes o refractarias (PIVOT IO 020)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Bempegaldesleukin in Combination with Nivolumab in Children, Adolescents and Young Adults with Recurrent or Treatment-resistant Cancer (PIVOT IO 020)
    Estudio de bempegaldesleukin en combinación con nivolumab en niños, adolescentes y adultos jóvenes con cáncer recidivante o resistente al tratamiento (PIVOT IO 020)
    A.4.1Sponsor's protocol code numberCA045-020
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1248-8239
    A.5.4Other Identifiers
    Name:18-214-13Number:Nektar Therapeutics
    A.7Trial is part of a Paediatric Investigation Plan Yes
    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 pointGSM-CT
    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 Yes
    D.2.1.1.1Trade name Opdivo (100 mg/10 ml)
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 nameNIVOLUMAB - 10ml vial - COMMERCIAL
    D.3.2Product code BMS-936558
    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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameMDX1106, ONO-4538
    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.3.2Product code NKTR-214 - 1 mg vial
    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 INNNot yet assigned
    D.3.9.1CAS number 1939126-74-5
    D.3.9.2Current sponsor codeNKTR-214
    D.3.9.3Other descriptive nameBMS986321
    D.3.9.4EV Substance CodeSUB192964
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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
    Recurrent or Refractory pediatric cancer
    Cáncer pediátrico recidivante o refractario
    E.1.1.1Medical condition in easily understood language
    Recurrent or Refractory Pediatric Malignancies
    Neoplasias malignas pediátricas recidivantes o refractarias
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029260
    E.1.2Term Neuroblastoma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10015560
    E.1.2Term Ewing's sarcoma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10039022
    E.1.2Term Rhabdomyosarcoma
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    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 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025322
    E.1.2Term Lymphomas non-Hodgkin's unspecified histology
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10024329
    E.1.2Term Leukemia
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10065443
    E.1.2Term Malignant glioma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10027107
    E.1.2Term Medulloblastoma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10014967
    E.1.2Term Ependymoma
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10007958
    E.1.2Term Central nervous system neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary - Part A Safety Lead-in:
    - Safety Lead-in: To estimate the safety and tolerability of study treatment in pediatric participants with malignant neoplasms that are refractory, relapsed, or participants for whom curative treatments are lacking.
    - To characterize the pharmacokinetics (PK) of bempegaldesleukin and nivolumab in pediatric participants with malignant neoplasms that are refractory, relapsed, or participants for whom curative treatments are lacking.

    Primary - Part B Expansion

    To estimate the preliminary efficacy (eg, ORR of study treatment separately in the following disease cohorts):
    B1: Neuroblastoma
    B2: Ewing sarcoma
    B3: Rhabdomyosarcoma
    B4: Miscellaneous solid tumors
    B5: Non-Hodgkin lymphoma (NHL)/leukemia 
    B6: High-grade glioma
    B7: Medulloblastoma and embryonal tumors 
    B8: Ependymoma
    B9: Miscellaneous central nervous system (CNS) tumors
    Principal - Parte A, Preinclusión de seguridad
    - Preinclusión de seguridad: estimar la seguridad y la tolerabilidad del tratamiento del estudio en participantes pediátricos con neoplasias malignas que sean refractarias, recidivantes o participantes para los que no haya tratamientos curativos.
    - Caracterizar la farmacocinética (FC) de bempegaldesleukin y nivolumab en participantes pediátricos con neoplasias malignas que sean refractarias, recidivantes o participantes para los que no haya tratamientos curativos.

    Principal – Parte B, expansión
    Estimar la eficacia preliminar (p. ej. TRO del tratamiento del estudio por separado en las siguientes cohortes de enfermedad):
    B1: Neuroblastoma
    B2: Sarcoma de Ewing
    B3: Rabdomiosarcoma
    B4: Tumores sólidos variados
    B5: Linfoma no Hodgkin (LNH)/leucemia
    B6: Glioma de alto grado
    B7: Meduloblastoma y tumores embrionarios
    B8: Ependimoma
    B9: Tumores variados del sistema nervioso central (SNC)
    E.2.2Secondary objectives of the trial
    Secondary - Part B Expansion
    - To estimate the safety of study therapy in pediatric participants.
    - To estimate the progression-free survival (PFS) and overall survival (OS) of study therapy in pediatric participants.
    Secundarios - Parte B, Expansión
    - Estimar la seguridad del tratamiento del estudio en participantes pediátricos.
    - Estimar la supervivencia libre de progresión (SLP) y la supervivencia global (SG) del tratamiento del estudio en participantes pediátricos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age < 18 years for Part A and Part B
    - Age up to 30 years for Part B Cohorts B2, B3 and B4
    - Must have received standard of care therapy and there must be no potentially curative treatment available
    - Histologically confirmed with malignant neoplasms that are refractory, relapsed, or curative treatments are lacking
    - Must have measurable or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for solid tumors, Response Assessment in Neuro-Oncology (RANO) or Response Assessment in Pediatric Neuro-Oncology (RAPNO) for central nervous system tumors, International Pediatric Non-Hodgkin Lymphoma Response Criteria for non-Hodgkin lymphoma (NHL), revised International Neuroblastoma Response Criteria (INRC) for neuroblastoma, modified National Comprehensive Cancer Network
    (NCCN) Criteria for acute lymphoblastic leukemia, and modified Cheson et al International Working Group criteria for acute myeloid leukemia
    - Lansky play score for age ≤ 16 years or Karnofsky performance score for age > 16 years assessed within 2 weeks of enrollment must be ≥ 60
    - Edad < 18 años para la Parte A y Parte B
    - Edad hasta 30 años para las Cohortes B2, B3 y B4 de la Parte B
    - Deben haber recibido el tratamiento de referencia actual y no debe haber tratamiento potencialmente curativo disponible
    - Neoplasias malignas confirmadas histológicamente que son refractarias, recidivantes o pacientes para los que faltan tratamientos curativos
    - Deben tener enfermedad medible o evaluable según los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST) v1.1 para tumores sólidos, Evaluación de la Respuesta en Neuro-Oncología (RANO) o Evaluación de la Respuesta en Neuro-Oncología Pediátrica (RAPNO) para tumores del sistema nervioso central, Criterios Internacionales de Respuesta en el Linfoma no Hodgkin Pediátrico (LNH) para el LNH, Criterios Internacionales de Respuesta en el Neuroblastoma (INRC) revisados para el neuroblastoma, Criterios de la National Comprehensive Cancer Network (NCCN) modificados para la leucemia linfoblástica aguda y criterios del Grupo de Trabajo Internacional de Cheson et al modificados para la leucemia mieloide aguda
    - Puntuación de Lansky para edades ≤ 16 años o puntuación de estado funcional de Karnofsky para edades > 16 años evaluada en el plazo de 2 semanas previas al reclutamiento debe ser ≥ 60
    E.4Principal exclusion criteria
    - Osteosarcoma, T-cell/NK-cell leukemia/lymphoma, and Hodgkin lymphoma
    - Need for > 2 antihypertensive medications for management of hypertension (including diuretics)
    - Known cardiovascular history, including unstable or deteriorating cardiac disease, within the previous 12 months prior to screening
    - Inadequately treated adrenal insufficiency
    - Active, known, or suspected autoimmune disease
    - Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
    - Prior allogeneic stem cell transplant
    - Previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection either suspected or confirmed within 4 weeks prior to screening
    - Osteosarcoma, leucemia/linfoma de células T/células NK y linfoma de Hodgkin
    - Necesidad de > 2 medicamentos antihipertensivos para el manejo de la hipertensión (incluidos diuréticos)
    - Antecedentes cardiovasculares conocidos, como enfermedad cardíaca inestable o en deterioro, dentro de los 12 meses previos a la selección
    - Insuficiencia suprarrenal tratada de forma inadecuada
    - Enfermedad autoinmunitaria activa conocida o sospecha de ella.
    - Problema que precise tratamiento sistémico con corticosteroides u otros medicamentos inmunodepresores dentro de los 14 días previos al comienzo del tratamiento del estudio
    - Trasplante alogénico de células progenitoras
    - Infección previa por SARS-CoV-2 ya sea de sospecha o confirmada dentro de las 4 semanas previas a la selección
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    1. Incidence of dose-limiting toxicities, adverse events (AEs), serious AEs (SAEs), drug-related AEs, AEs leading to discontinuation and death.
    2. Pharmacokinetic (PK) parameters: Peak concentration, trough concentration, time-averaged concentration, clearance (CL) and volume of distribution (Vd).

    Part B:
    3. Investigator-assessed objective response rate (ORR)
    Parte A:
    1. Incidencia de toxicidades limitantes de la dosis, acontecimientos adversos (AA), AA graves (AAG), AA relacionados con el fármaco, AA que condujeron a la suspensión y muerte.
    2. Parámetros farmacocinéticos FC: Concentración máxima, concentración valle, tiempo promedio de concentración, aclaramiento (CL) y volumen de distribución (Vd).

    Parte B:
    3. Tasa de respuestas objetivas (TRO) evaluada por el investigador
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 2 years and 100 days
    2. Up to 2 years
    3. Up to 5 years
    1. Hasta 2 años y 100 días
    2. Hasta 2 años
    3. Hasta 5 años
    E.5.2Secondary end point(s)
    Part B:
    - Incidence of AEs, SAEs, drug-related AEs, AEs leading to discontinuation and death.
    - Incidence of laboratory abnormalities: Hematology tests and clinical chemistry tests.
    - Progression-free survival (PFS)
    - Overall survival (OS)
    Parte B:
    - Incidencia de AA, AAG, AA relacionados con el fármaco, AA que conduzcan a la suspensión y muerte.
    - Incidencia de anomalías de laboratorio: pruebas de hematología y pruebas de química clínicas
    - Supervivencia libre de progresión (SLP)
    - Supervivencia global (SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 5 years
    Hasta 5 años
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 IB - Dose-finding study design
    Fase IB - Diseño de estudio de búsqueda de dosis
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    United States
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    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
    LVLS
    Última visita del último sujeto
    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 months4
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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 Yes
    F.1.1Number of subjects for this age range: 194
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 11
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 103
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 80
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 34
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects unable to give their written consent (e.g., stroke or subjects with or severe dementia) may only be enrolled in the study with the consent of a legally acceptable representative. See Appendix 2 of the protocol.
    Los sujetos que no puedan dar su consentimiento por escrito (por ej, accidente cerebrovascular o sujetos con demencia grave) sólo pueden incluirse con el consentimiento de un representante legalmente aceptable. Ver Apéndice 2 del Protocolo.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 228
    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, participants who continue to demonstrate clinical benefit will be eligible to receive BMS-supplied study treatment for the maximum treatment duration specified in Section 7.1 of the Protocol. Study treatment 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.
    Al final del estudio, los participantes que continúen demostrando beneficio clínico serán elegibles para recibir tratamiento de estudio proporcionado por BMS para la duración máxima del tratamiento especificada en la sección 7.1 del Protocolo. El tratamiento del estudio se proporcionará a través de una extensión del estudio, un estudio de rollover que requiere la aprobación por la Autoridad Sanitaria y comité de ética responsable o a través de otro mecanismo a discreción de BMS.
    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 Decision2021-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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