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    Summary
    EudraCT Number:2020-000854-85
    Sponsor's Protocol Code Number:CA045-020
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-02
    Trial 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 ConcernedItaly - Italian Medicines Agency
    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)
    Studio di fase 1/2 su Bempegaldesleukin in combinazione con Nivolumab in bambini, adolescenti e giovani adulti con neoplasie maligne ricorrenti o refrattarie (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)
    Studio su Bempegaldesleukin in combinazione con Nivolumab in bambini, adolescenti e giovani adulti con neoplasie maligne ricorrenti o resistenti al trattamento (PIVOT IO 020)
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    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 PlanP/273/2020
    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.5.6E-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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 name-
    D.3.2Product code [NKTR-214 - 1 mg vial]
    D.3.4Pharmaceutical form Powder for 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.3.9.1CAS 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Neoplasie maligne pediatriche ricorrenti o refrattarie
    E.1.1.1Medical condition in easily understood language
    Recurrent or Refractory Pediatric Malignancies
    Neoplasie maligne pediatriche ricorrenti o resistenti al trattamento
    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
    Primario - Parte A Lead-in di sicurezza
    • Lead-in di sicurezza: Stimare la sicurezza e la tollerabilità del trattamento dello studio nei partecipanti pediatrici con neoplasie maligne refrattarie, recidivanti o nei partecipanti per i quali mancano trattamenti curativi.
    • Caratterizzare la farmacocinetica (PK) di bempegaldesleukin e nivolumab nei partecipanti pediatrici con neoplasie maligne refrattarie, recidivanti o nei partecipanti per i quali mancano trattamenti curativi.
    Primario - Parte B Espansione
    • Stimare l’efficacia preliminare (ad es., l’ORR [tasso di risposta obiettivo] del trattamento dello studio separatamente nelle seguenti coorti di malattia):
    o B1: neuroblastoma
    o B2: sarcoma di Ewing
    o B3: rabdomiosarcoma
    o B4: vari tumori solidi
    o B5: linfoma non-Hodgkin
    (LNH)/leucemia
    o B6: glioma di alto grado
    o B7: medulloblastoma e tumori embrionali
    o B8: ependimoma
    o B9: vari tumori del sistema nervoso centrale (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.
    Secondario - Parte B Espansione
    • Stimare la sicurezza della terapia dello studio nei partecipanti pediatrici.
    • Stimare la PFS (sopravvivenza libera da progressione) e la OS (sopravvivenza complessiva) della terapia dello studio nei partecipanti pediatrici
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: CA045020/19-214-27
    Date: 08/10/2020
    Title: CLINICAL PROTOCOL CA045020/19-214-27 Phase 1/2 Study of Bempegaldesleukin in Combination with Nivolumab in Children, Adolescents, and Young Adults with Recurrent or Refractory Malignancies (PIVOT IO 020) Sez. 9.8.1 Additional Research Collection
    Objectives: Sez. 9.8.1 Additional Research Collection

    Pharmacogenomics
    Version: CA045020/19-214-27
    Date: 08/10/2020
    Title: CLINICAL PROTOCOL CA045020/19-214-27 Phase 1/2 Study of Bempegaldesleukin in Combination with Nivolumab in Children, Adolescents, and Young Adults with Recurrent or Refractory Malignancies (PIVOT IO 020) Sez. 9.8.1 Additional Research Collection
    Objectives: Sez. 9.8.1 Additional Research Collection

    Farmacogenetica
    Versione: CA045020/19-214-27
    Data: 08/10/2020
    Titolo: PROTOCOLLO CLINICO CA045020/19-214-27 Studio di fase 1/2 su Bempegaldesleukin in combinazione con Nivolumab in bambini, adolescenti e giovani adulti con neoplasie maligne ricorrenti o refrattarie (PIVOT IO 020) Sezione. 9.8.1 Raccolta per la Ricerca addizionale
    Obiettivi: Sezione. 9.8.1 Raccolta per la Ricerca addizionale

    Farmacogenomica
    Versione: CA045020/19-214-27
    Data: 08/10/2020
    Titolo: PROTOCOLLO CLINICO CA045020/19-214-27 Studio di fase 1/2 su Bempegaldesleukin in combinazione con Nivolumab in bambini, adolescenti e giovani adulti con neoplasie maligne ricorrenti o refrattarie (PIVOT IO 020) Sezione. 9.8.1 Raccolta per la Ricerca addizionale
    Obiettivi: Sezione. 9.8.1 Raccolta per la Ricerca addizionale
    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
    • Età inferiore a 18 anni a per la Parte A e la Parte B.
    • Età sino a 30 anni per la Parte B Coorti B2, B3 e B4
    • I partecipanti devono aver ricevuto la terapia standard e non deve essere disponibile alcun trattamento potenzialmente curativo.
    • Neoplasie maligne, confermate istologicamente, recidivanti o refrattarie, o per cui mancano trattamenti curativi
    • I partecipanti devono presentare malattia misurabile o valutabile in base ai Response Evaluation Criteria in Solid Tumors RECIST v1.1 per i tumori solidi, Response Assessment in Neuro-Oncology (RANO) o Response Assessment in Pediatric Neuro-Oncology (RAPNO) per i tumori del SNC, International Pediatric NonHodgkin Lymphoma Response Criteria per Lnforma non –Hodgkin (LNH), International Neuroblastoma Response Criteria (INCR) revisionati per il neuroblastoma, National Comprehensive Cancer Network Criteria (NCCN) modificati per la leucemia linfoblastica acuta e Cheson et al International Working Group Criteria modificati per la leucemia mieloide acuta.
    • Il punteggio di Lansky relativo alle attività di gioco per partecipanti di età =16 anni o il punteggio della scala di Karnofsky per partecipanti di età >16 anni, valutato entro 2 settimane dall’arruolamento, deve essere =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 a cellule T/cellule Natural Killer e linfoma di Hodgkin
    • Necessità di >2 farmaci antipertensivi per la gestione dell’ipertensione (compresi i diuretici)
    • Anamnesi cardiovascolare nota, inclusa malattia cardiaca instabile o in peggioramento, nei 12 mesi precedenti lo screening
    • Insufficienza surrenalica non trattata adeguatamente
    • Patologia che richiede il trattamento sistemico con corticosteroidi o altri farmaci immunosoppressori nei 14 giorni precedenti l’inizio del trattamento dello studio
    • Precedente trapianto allogenico di cellule staminali
    • Precedente infezione da SARS-CoV-2 (sindrome respiratoria acuta grave Coronavirus-2), sospetta o confermata, nelle 4 settimane precedenti lo screening
    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) Incidenza di tossicità dose-limitanti, eventi avversi (EA), EA seri (EAS), EA correlati al farmaco, EA che portano all’interruzione e al decesso
    2) Parametri PK: picco di concentrazione, concentrazione minima, concentrazione media nel tempo, clearance (CL) e volume di distribuzione (Vd)
    Parte B
    3) Tasso di risposta obiettiva valutato dallo sperimentatore
    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) Fino a 2 anni e 100 giorni
    2) Fino a 2 anni
    3) Fino a anni
    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
    • Incidenza di eventi avversi (EA), eventi avversi seri (EAS), EA correlati al farmaco, EA che determinano interruzione del trattamento e decesso.
    • Incidenza di anomalie di laboratorio: ematologici e chimici
    • Sopravvivenza libera da progressione (PFS)
    • Sopravvivenza complessiva (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 5 years
    Fino a 5 anni
    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 1b (dose finding)
    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 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 trial13
    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 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 Information not present in EudraCT
    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
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS (ultima visita dell’ultimo soggetto)
    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 days29
    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.1.1.1In 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.
    Soggetti impossibilitati a dare il proprio consenso scritto (es. ictus o soggetti con demenza o demenza grave) possono essere arruolati nello studio solo con il consenso di un rappresentante legalmente riconosciuto. Vedere l’appendice 2 del Protocoll
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    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 termine dello studio, i partecipanti che continuano a dimostrare un beneficio clinico saranno idonei a ricevere il trattamento di studio fornito da BMS per la durata massima del trattamento specificata nella Sezione 7.1 del Protocollo.
    Il trattamento dello studio sarà fornito tramite un'estensione dello studio, uno studio di rollover che richiede l'approvazione dell'autorità sanitaria responsabile e del comitato etico o attraverso un altro meccanismo a discrezione di 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 Decision2021-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-25
    P. End of Trial
    P.End of Trial StatusOngoing
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