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    Summary
    EudraCT Number:2017-003583-12
    Sponsor's Protocol Code Number:CA224-047
    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:2021-06-14
    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 number2017-003583-12
    A.3Full title of the trial
    A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined with
    Nivolumab versus Nivolumab in Participants with Previously Untreated
    Metastatic or Unresectable Melanoma
    Studio di fase 2/3 randomizzato, in doppio cieco, di Relatlimab in combinazione con Nivolumab rispetto a Nivolumab in partecipanti affetti da melanoma metastatico o non resecabile, non precedentemente trattato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Relatlimab plus Nivolumab Versus Nivolumab Alone in
    Participants with Advanced Melanoma
    studio di Relatlimab pi¿ Nivolumab rispetto a Nivolumab in monoterapia in partecipanti con melanoma in stadio avanzato
    A.3.2Name or abbreviated title of the trial where available
    ooo
    ooo
    A.4.1Sponsor's protocol code numberCA224-047
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1201-4386
    A.5.4Other Identifiers
    Name:oooNumber:000
    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 pointHead of the GSM-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 number000000
    B.5.5Fax number000000
    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 nameRelatlimab/ Nivolumab 1:3 Fixed Dose Combination
    D.3.2Product code BMS-986213
    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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameMDX-1106, 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 number12
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRelatlimab
    D.3.9.2Current sponsor codeBMS-986016
    D.3.9.3Other descriptive nameanti-LAG-3
    D.3.9.4EV Substance CodeSUB168199
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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.2.1.1.1Trade 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
    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 nameMDX-1106, ONO-4538
    D.3.9.4EV Substance CodeSUB32944
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name 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 nameMDX-1106, 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.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
    Previously Untreated Metastatic or Unresectable Melanoma
    melanoma metastatico o non resecabile non precedentemente trattato
    E.1.1.1Medical condition in easily understood language
    Advanced Melanoma
    Melanoma avanzato
    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 LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10053571
    E.1.2Term Melanoma
    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
    Phase 3 portion of the trial
    - To compare progression-free survival (PFS) of BMS-986213 to
    nivolumab monotherapy in participants with previously untreated,
    unresectable or metastatic melanoma.
    Phase 2 portion of the trial
    - To compare PFS of BMS-986213 to nivolumab monotherapy in
    participants with previously untreated, unresectable or metastatic
    melanoma.
    Fase 3 dello studio: - Confrontare la sopravvivenza libera da progressione (PFS) di
    BMS-986213 rispetto a nivolumab in monoterapia in partecipanti con melanoma non
    resecabile o metastatico precedentemente non trattati.
    Fase 2 dello studio: - Confrontare la PFS di BMS-986213 rispetto a
    nivolumab in monoterapia nei partecipanti melanoma non resecabile o metastatico
    E.2.2Secondary objectives of the trial
    Phase 3 portion of the trial
    - To compare OS of BMS-986213 to nivolumab monotherapy in subjects
    with previously untreated, unresectable or metastatic melanoma
    - To compare ORR of BMS-986213 to nivolumab in subjects with
    unresectable or metastatic melanoma
    Phase 2 portion of the trial
    Among subjects with unresectable or metastatic melanoma treated with
    BMS-986213 and those treated with nivolumab monotherapy:
    - To estimate the treatment effect, measured by ORR, as determined by
    BICR using RECISTv1.1 in all-comers and in subgroups based on
    combinations of LAG-3 expression and PDL-1 status
    - To evaluate DOR, PFS rates at pre-specified time points based on BICR
    assessments using RECIST v1.1 in the randomized population (for DOR)
    and in subgroups based on combinations of LAG-3 expression and PDL-1
    status
    - To assess the 1- and 2-year OS rate in the randomized population and
    in subgroups based on combinations of LAG-3 expression and PDL-1
    status
    - To assess safety and tolerability
    Fase 3 dello studio: - Confrontare la sopravvivenza globale (OS) di BMS-986213
    rispetto a nivolumab in soggetti con melanoma non resecabile o metastatico
    precedentemente non trattati –
    -Confrontare l'ORR di BMS-986213 rispetto a nivolumab in soggetti con melanoma non
    resecabile o metastatico
    Fase 2 dello studio: Tra soggetti con melanoma non resecabile o metastatico trattato
    con BMS-986213 e quelli trattati con nivolumab in monoterapia:
    - Stimare l'effetto del trattamento, misurato dall'ORR, come determinato dal BICR
    usando RECISTv1.1, in tutti i partecipanti ed in sottogruppi basati sulle combinazioni di
    espressione del LAG-3 e stato di PDL-1
    - Valutare i tassi DOR, PFS ai punti temporali pre-specificati in base alle valutazioni
    BICR utilizzando RECIST v1.1 nella popolazione randomizzata (per DOR) e nei
    sottogruppi basati sulle combinazioni di espressione del LAG-3 e stato di PDL-1
    per la descrizione completa fare riferimento al protocollo
    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: 1
    Date: 18/12/2017
    Title: A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined with
    Nivolumab versus Nivolumab in Participants with Previously Untreated
    Metastatic or Unresectable Melanoma
    Objectives: Additional research is optional for all study participants, except where retention and/or collection is prohibited by local laws or regulations, ethics committees, or institutional requirements.
    This collection for additional research is intended to expand the translational R&D capability at BMS, and will support as yet undefined research aims that will advance our understanding of disease and options for treatment. It may also be used to support health authority requests for analysis, and advancement of pharmacodiagnostic development to better target drugs to the right patients. This may also include genetic/genomic exploration aimed at exploring disease pathways, progression and response to treatment etc


    Pharmacogenomics
    Version: 1
    Date: 18/12/2017
    Title: A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined with
    Nivolumab versus Nivolumab in Participants with Previously Untreated
    Metastatic or Unresectable Melanoma
    Objectives: Additional research is optional for all study participants, except where retention and/or collection is prohibited by local laws or regulations, ethics committees, or institutional requirements.
    This collection for additional research is intended to expand the translational R&D capability at BMS, and will support as yet undefined research aims that will advance our understanding of disease and options for treatment. It may also be used to support health authority requests for analysis, and advancement of pharmacodiagnostic development to better target drugs to the right patients. This may also include genetic/genomic exploration aimed at exploring disease pathways, progression and response to treatment etc

    Farmacogenetica
    Versione: 1
    Data: 18/12/2017
    Titolo: Studio di fase 2/3 randomizzato, in doppio cieco, di Relatlimab in combinazione con Nivolumab rispetto a Nivolumab in partecipanti affetti da melanoma metastatico o non resecabile, non precedentemente trattato
    Obiettivi: La ricerca addizionale ¿ facoltativa per tutti i partecipanti allo studio, salvo dove la conservazione e / o la raccolta dei campioni siano vietate da leggi o regolamenti locali, dai Comitati etici o dai requisiti istituzionali.
    Questa raccolta per la ricerca addizionale ha lo scopo di espandere la capacit¿ traslazionale di ricerca e sviluppo di Bristol-Myers Squibb e supporter¿ scopi di ricerca non ancora definiti che miglioreranno la comprensione delle malattie e delle opzioni per il trattamento. Potrebbe anche essere utilizzata per sostenere le richieste dell'autorit¿ sanitaria per l'analisi e l'avanzamento dello sviluppo farmacodiagnostico, al fine di meglio identificare i farmaci migliori per i giusti pazienti. Questo pu¿ anche includere l'esplorazione genetica / genomica finalizzata ad esplorare i percorsi della malattia, la progressione e la risposta al trattamento


    Farmacogenomica
    Versione: 1
    Data: 18/12/2017
    Titolo: Studio di fase 2/3 randomizzato, in doppio cieco, di Relatlimab in combinazione con Nivolumab rispetto a Nivolumab in partecipanti affetti da melanoma metastatico o non resecabile, non precedentemente trattato
    Obiettivi: La ricerca addizionale ¿ facoltativa per tutti i partecipanti allo studio, salvo dove la conservazione e / o la raccolta dei campioni siano vietate da leggi o regolamenti locali, dai Comitati etici o dai requisiti istituzionali.
    Questa raccolta per la ricerca addizionale ha lo scopo di espandere la capacit¿ traslazionale di ricerca e sviluppo di Bristol-Myers Squibb e supporter¿ scopi di ricerca non ancora definiti che miglioreranno la comprensione delle malattie e delle opzioni per il trattamento. Potrebbe anche essere utilizzata per sostenere le richieste dell'autorit¿ sanitaria per l'analisi e l'avanzamento dello sviluppo farmacodiagnostico, al fine di meglio identificare i farmaci migliori per i giusti pazienti. Questo pu¿ anche includere l'esplorazione genetica / genomica finalizzata ad esplorare i percorsi della malattia, la progressione e la risposta al trattamento
    E.3Principal inclusion criteria
    - Participants must have histologically confirmed Stage III
    (unresectable) or Stage IV melanoma, per the AJCC staging system
    - Participants must not have had prior systemic anticancer therapy for
    unresectable or metastatic melanoma
    - Tumor tissue from an unresectable or metastatic site of disease must
    be provided for biomarker analyses
    - I partecipanti devono avere melanoma di stadio III (non resecabile) o stadio IV istologicamente confermato, secondo il sistema di stadiazione AJCC
    - I partecipanti non devono aver ricevuto una precedente terapia antitumorale sistemica per
    melanoma non resecabile o metastatico
    - deve essere fornito tessuto tumorale da un sito non resecabile o metastatico della malattia per analisi di biomarker
    E.4Principal exclusion criteria
    - Participants must not have active brain metastases or leptomeningeal
    metastases
    - Participants must not have uveal melanoma
    - Participants must not have an active, known, or suspected autoimmune
    disease
    - I partecipanti non devono avere metastasi cerebrali attive o metastasi leptomeningee
    - I partecipanti non devono avere il melanoma uveale
    - I partecipanti non devono avere una malattia autoimmune attiva, nota o sospetta
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Measures:
    1/ Progression Free Survival (PFS) Phase 3 portion of trial. Assessed by
    a Blinded Independent Central Review (BICR)
    2/ PFS Phase 2 portion of trial, assessed by a BICR
    Misure di outcome primarie:
    1 / sopravvivenza libera da progressione (PFS) Fase 3 dello studio. Valutato da una
    revisione centrale indipendente in cieco (BICR)
    2 / PFS Fase 2 dello studio, valutata mediante BICR
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame:
    1/ Up to 5 years
    2/ Up to 5 years
    Lasso di tempo:
    1 / Fino a 5 anni
    2 / Fino a 5 ann
    E.5.2Secondary end point(s)
    Secondary outcome measures:
    1/ Overall Survival (OS)
    Phase 3 portion of trial
    2/ ORR
    Phase 3 portion of trial, assessed by a BICR
    3/ ORR
    Phase 2 portion of trial, assessed by a BICR. In the randomized
    population and in subgroups
    4/ Duration of Response (DOR)
    Phase 2 portion of trial. In the randomized population and in subgroups
    5/ PFS
    Phase 2 portion of trial. In subgroups
    6/ OS
    Phase 2 portion of trial. In the randomized population and in subgroups
    7/ Number of Adverse Events (AEs)
    Phase 2 portion of the trial
    8/ Number of Serious Adverse Events (SAEs)
    Phase 2 portion of the trial
    9/ Number of AEs Leading to Discontinuation
    Phase 2 portion of the trial
    10/ Number of Deaths
    Phase 2 portion of the trial
    11/ Number of Laboratory Abnormalities
    Phase 2 portion of the trial
    Misure di outcome secondarie:
    1 / sopravvivenza complessiva (OS) - Fase 3 dello studio.
    2 / ORR Fase 3 dello studio, valutata mediante BICR
    3 / ORR Fase 2 dello studio, valutata mediante BICR nelle popolazione randomizzata e
    nei sottogruppi
    4 / Durata della risposta (DOR) Fase 2 dello studio. Nella popolazione randomizzata e
    in sottogruppi
    5/ PFS - Fase 2 dello studio. Nei sottogruppi
    6/ OS- Fase 2 dello studio. Nella popolazione randomizzata e in sottogruppi
    7 / Numero di eventi avversi (AE)- Fase 2 dello studio.
    8/ Numero di eventi avversi gravi (SAE)- Fase 2 dello studio.
    9/ Numero di eventi avversi che portano alla interruzione del trattamento- Fase 2 dello
    studio.
    10 / Numero di decessi - Fase 2 dello studio
    11/ Numero delle anormalità di laboratorio - Fase 2 dello studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/ Time Frame: Up to 5 years2/ Time Frame: Up to 5 years
    3/ Time Frame: Up to 5 years
    4/ Time Frame: Up to 5 years
    5/ Time Frame: Up to 5 years
    6/ Time Frame: Up to 5 years
    7/ Time Frame: Up to 5 years
    8/ Time Frame: Up to 5 years
    9/ Time Frame: Up to 5 years
    10/ Time Frame: Up to 5 years
    11/ Time Frame: Up to 5 years
    1 / Time Frame: fino a 5 anni
    2 / Time Frame: fino a 5 anni
    3 / Time Frame: fino a 5 anni
    4 / Time Frame: fino a 5 anni
    5 / Time Frame: fino a 5 anni
    6 / Time Frame: fino a 5 anni
    7 / Time Frame: fino a 5 anni
    8 / Time Frame: fino a 5 anni
    9/ Time Frame: fino a 5 anni
    10 / Time Frame: fino a 5 anni
    11 / Time Frame: 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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Brazil
    Canada
    Chile
    Colombia
    Israel
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Mexico
    New Zealand
    Russian Federation
    Taiwan
    United States
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Greece
    Italy
    Norway
    Poland
    Romania
    Spain
    Sweden
    United Kingdom
    Argentina
    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
    LPLV
    LPLV- ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days1
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 690
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 1000
    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 5.3. 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. Please refer to Section 7.8 of the Protocol for more
    details.
    Alla conclusione dello studio, i partecipanti che continuano a dimostrare beneficio clinico
    saranno idonei a ricevere il tratt. di studio fornito da BMS per la max durata
    del tratt. cfr sez. 5.3 del protocollo. Il tratt. di studio
    sarà fornito tramite estensione studio, uno studio di rollover che richiederà
    approvazione da parte dell'autorità sanitaria resp. e del CE, o
    attraverso altro meccanismo a discrezione di BMS. CFR sez. 7.8
    del protocollo per maggiori informazioni
    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 Decision2018-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
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