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    Summary
    EudraCT Number:2021-001641-13
    Sponsor's Protocol Code Number:CA224-098
    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:2021-10-19
    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 number2021-001641-13
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy
    with Relatlimab and Nivolumab Fixed-dose Combination versus Nivolumab
    Monotherapy after Complete Resection of Stage III-IV Melanoma
    Studio di fase 3, randomizzato e in doppio cieco, di immunoterapia adiuvante con la combinazione a dose fissa di Relatlimab e Nivolumab rispetto alla monoterapia con Nivolumab, dopo resezione completa del melanoma allo stadio III-IV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose
    Combination versus Nivolumab Monotherapy after Complete Resection of
    Stage III-IV Melanoma
    Immunoterapia adiuvante con la combinazione a dose fissa di Relatlimab e Nivolumab rispetto alla monoterapia con Nivolumab, dopo resezione completa del melanoma allo stadio III-IV
    A.3.2Name or abbreviated title of the trial where available
    RELATIVITY 098
    RELATIVITY 098
    A.4.1Sponsor's protocol code numberCA224-098
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1266-6146
    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 support
    B.4.2Country
    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 number000000000000000
    B.5.5Fax number0000000000000000
    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 (Relatlimab 80 mg/Nivolumab 240 mg)
    D.3.2Product code [BMS-986213]
    D.3.4Pharmaceutical form 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 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 RoleComparator
    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.2.1.1.2Name 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 injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive 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
    participants with completely resected Stage III or Stage IV melanoma
    Partecipanti con melanoma allo stadio III o IV completamente resecato
    E.1.1.1Medical condition in easily understood language
    participants who had a stage 3 or 4 melanoma surgically removed
    Partecipanti con melanoma allo stadio III o IV rimosso chirurgicamente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025671
    E.1.2Term Malignant melanoma stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy, as measured by RFS, provided by relatlimab and
    nivolumab FDC vs nivolumab monotherapy in participants with
    completely resected Stage III/IV NED melanoma.
    Primario
    Confrontare l’efficacia, misurata mediante l’RFS, fornita dalla FDC di relatlimab e nivolumab rispetto a nivolumab in monoterapia in partecipanti con melanoma NED allo stadio III/IV completamente resecato
    E.2.2Secondary objectives of the trial
    -To compare the efficacy, as measured by distant metastasis-free
    survival (DMFS), provided by relatlimab and nivolumab FDC vs
    nivolumab monotherapy in participants with completely resected
    Stage III/IV NED melanoma.
    -To compare the OS provided by relatlimab and nivolumab FDC vs
    nivolumab monotherapy in participants with completely resected Stage
    III/IV NED melanoma.
    -To assess safety and toxicity of relatlimab and nivolumab FDC vs
    nivolumab monotherapy in participants with completely resected Stage
    III/IV NED melanoma.
    -To evaluate investigator-assessed outcomes on next-line therapies.
    Secondari
    • Confrontare l’efficacia, misurata mediante la distant metastasis-free survival (DMFS) fornita dalla FDC di relatlimab e nivolumab rispetto a nivolumab in monoterapia in partecipanti con melanoma NED allo stadio III/IV completamente resecato.
    • Confrontare l’OS fornita dalla FDC di relatlimab e nivolumab rispetto rispetto a nivolumab in monoterapia in partecipanti con melanoma NED allo stadio III/IV completamente resecato.
    • Valutare la sicurezza e la tossicità della FDC di relatlimab e nivolumab rispetto a nivolumab in monoterapia in partecipanti con melanoma NED allo stadio III/IV completamente resecato.
    • Valutare gli outcomes valutati dallo sperimentatore sulle terapie di linea successiva.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - All participants must have been diagnosed with either Stage IIIA (> 1
    mm tumor in lymph node)/B/C/D or Stage IV melanoma by AJCC v8 and
    have histologically confirmed melanoma that is completely surgically
    resected (free of disease) with negative margins in order to be eligible.
    All melanomas, except uveal melanoma, regardless of primary site of
    disease, will be allowed.
    - All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization
    and imaging studies within 35 days prior to randomization.
    - Tumor tissue obtained from surgical specimen or biopsy during
    resection collected within 3 months prior to randomization, with an
    associated pathology report, must be submitted to the central laboratory
    prior to randomization.
    - Eastern Cooperative Oncology Group (ECOG) performance status = 1.
    - Participant must be = 18 years of age inclusive at the time of signing
    the informed consent.
    • Per essere idonei, tutti i partecipanti devono aver ricevuto una diagnosi di melanoma allo stadio IIIA (tumore linfonodale >1 mm)/B/C/D o allo stadio IV secondo l’AJCC v8 e presentare un melanoma confermato istologicamente completamente resecato chirurgicamente (senza malattia) con margini negativi. Saranno consentiti tutti i tipi di melanoma, fatta eccezione per il melanoma uveale, a prescindere dalla sede primaria della malattia.
    • Tutti i partecipanti devono avere uno stato libero da malattia, documentato da esame obiettivo completo entro 14 giorni prima della randomizzazione e studi di diagnostica per immagini condotti entro i 35 giorni precedenti la randomizzazione.
    • Un blocchetto di tessuto tumorale ottenuto da campione chirurgico o biopsia durante la resezione prelevato nei 3 mesi precedenti la randomizzazione, con un referto patologico associato, deve essere inviato al laboratorio centrale prima della randomizzazione.
    • Eastern Cooperative Oncology Group (ECOG) performance status = 1.
    • I Participanti devono avere almeno 18 anni al momento della firma del consenso informato
    E.4Principal exclusion criteria
    - Prior immunotherapy treatment for any prior malignancy: No prior
    immunotherapies are permitted (such as, but not limited to, antiprogrammed
    death-1 (anti-PD-1), anti-programmed death ligand-1
    (anti-PD-L1), anti-programmed death ligand-2 (PD-L2), or any other
    antibody or drug specifically targeting T-cell costimulation or immune
    checkpoint pathways).
    - Prior treatment with LAG-3 targeted agents.
    - Prior therapy for melanoma except surgery for the melanoma lesion(s)
    and/or adjuvant radiation therapy for central nervous system lesions.
    - Participants with an active, known, or suspected autoimmune disease.
    Participants with type I diabetes mellitus, hypothyroidism only requiring
    hormone replacement, skin disorders (such as vitiligo, psoriasis, or
    alopecia) not requiring systemic treatment, or conditions not expected
    to recur in the absence of an external trigger are permitted to enroll.
    • Precedente trattamento immunoterapico per qualsiasi malignità precedente: non sono consentite immunoterapie precedenti (come, a titolo esemplificativo ma non esaustivo, anti-proteina di morte programmata 1 (anti-PD-1), anti-ligando di morte programmata 1 (anti-PD-L1), anti-ligando di morte programmata 2 (PD-L2) o qualsiasi altro anticorpo o farmaco specificamente mirato alla costimolazione delle cellule T o ai pathway del checkpoint immunitario)

    • Precedente trattamento con agenti mirati a LAG-3.
    • Precedente terapia per il melanoma eccetto intervento chirurgico della/e lesione/i del melanoma e/o radioterapia adiuvante per le lesioni a carico del SNC
    • Partecipanti con malattia autoimmune attiva, nota o sospetta. È consentito l’arruolamento di partecipanti con diabete mellito di tipo 1, ipotiroidismo che richiede soltanto terapia ormonale sostitutiva, disturbi cutanei (quali vitiligine, psoriasi o alopecia) che non richiedono il trattamento sistemico o con patologie di cui non si prevede la recidiva in assenza di un fattore scatenante esterno.
    E.5 End points
    E.5.1Primary end point(s)
    -RFS time as assessed by the investigator. RFS is defined as the time
    between the date of randomization and the first date of documented
    recurrence (local, regional, distant, new primary melanoma, including
    melanoma in situ), or death due to any cause, whichever occurs first.
    Comparison of relatlimab and nivolumab FDC vs nivolumab
    monotherapy.
    Tempo alla RFS, come valutato dallo sperimentatore. La RFS è definita come il tempo che intercorre tra la data della randomizzazione e la prima data di recidiva documentata (melanoma primario nuovo, locale, regionale, distante, compreso il melanoma in situ) o il decesso per qualsiasi causa, a seconda di quale evento si verifichi prima. Confronto tra la FDC relatlimab/nivolumab rispetto a nivolumab monoterapia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    approximately 56 months from the randomization of the first participant
    Circa 56 mesi dalla randomizzazione del primo partecipante
    E.5.2Secondary end point(s)
    1/DMFS, by investigator, is defined as the time between the
    date of randomization and the date of first distant metastasis
    or date of death due to any cause, whichever occurs first. Comparison of
    relatlimab and nivolumab FDC vs nivolumab
    monotherapy.
    2/OS is defined as the time between the date of randomization and the
    date of death due to any cause. Comparison of relatlimab and nivolumab
    FDC vs nivolumab monotherapy.
    3/ Incidence and severity of AE, SAEs, AEs leading to DC, IMAEs, drugrelated
    AEs, deaths, laboratory abnormalities, and other
    select AEs, in all treated participants.
    4/Duration of Treatment on next-line therapies, in all randomized
    subjects who received new anticancer therapy, tumor-directed
    radiotherapy, or tumor-directed surgery.
    5/PFS2 defined as time from randomization to second
    recurrence/objective disease progression per investigator, or death from
    any cause, whichever occurs first. Evaluation of relatlimab and
    nivolumab FDC vs nivolumab monotherapy.
    1) La DMFS, secondo lo sperimentatore, è definita come il tempo che intercorre tra la data della randomizzazione e la data della prima metastasi distante o la data del decesso per qualsiasi causa, a seconda di quale evento si verifichi prima. Confronto tra la FDC relatlimab/nivolumab rispetto a nivolumab monoterapia.
    2) L’OS è definita come l’intervallo di tempo tra la data di randomizzazione e la data di decesso per qualsiasi causa. Confronto tra la FDC relatlimab/nivolumab rispetto a nivolumab monoterapia.
    3) Incidenza e gravità di EA, SAE, EA che portano all’interruzione, IMAE, EA correlati al farmaco, decessi, anomalie di laboratorio, e altri EA selezionati, in tutti i partecipanti.
    4) Durata del trattamento con le terapie di linea successiva, in tutti i partecipanti randomizzati in tutti i soggetti randomizzati che hanno ricevuto una nuova terapia anticancro, radioterapia diretta contro il tumore o chirurgia diretta contro il tumore
    5) PFS2, definita come l’intervallo di tempo che va dalla randomizzazione alla seconda recidiva/progressione obiettiva della malattia secondo lo sperimentatore o al decesso per qualsiasi causa, in base a quale evento si verifichi prima. Confronto tra la FDC relatlimab/nivolumab rispetto a nivolumab monoterapia
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3, 4, and 5/ approximately 56 months from the randomization of the
    first participant
    2/ approximately 72 months after the first participant is randomized
    1, 3, 4, and 5) circa 56 mesi dalla randomizzazione del primo partecipante
    2) circa 72 mesi dopo che il primo partecipante è stato randomizzato
    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 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) No
    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 EEA6
    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
    China
    Israel
    Mexico
    United States
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Italy
    Norway
    Portugal
    Romania
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    Greece
    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
    last follow-up visit of the last participant
    ultima visita di follow up dell’ultimo partecipante
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months5
    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: 958
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 355
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 670
    F.4.2.2In the whole clinical trial 1313
    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 intervention to participants/ investigators unless BMS chooses to
    extend the study. The investigator should ensure that the participant
    receives appropriate standard of care to treat the condition under
    study. See protocol section 7.8 for more details.
    Al termine dello studio, BMS non continuerà a fornire il farmaco di studio ai partecipanti/ sperimentatori a meno che BMS non scelga di estendere lo studio. Lo sperimentatore deve assicurarsi che il partecipante riceva un adeguato standard di cura per trattare la sua condizione. Per maggiori dettagli, vedere la sezione 7.8 del protocollo.
    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 Decision2021-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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    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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