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    The EU Clinical Trials Register currently displays   41465   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2018-001423-40
    Sponsor's Protocol Code Number:CA045-001
    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:2021-06-08
    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 number2018-001423-40
    A.3Full title of the trial
    A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma
    Studio di fase 3, randomizzato, in aperto, di NKTR-214 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 NKTR-214 Combined With Nivolumab vs Nivolumab Aone in
    Participants With Previously Untreated Inoperable or Metastatic Melanoma
    Studio di NKTR-214 combinato con Nivolumab vs Nivolumab Alone in Partecipanti affetti da melanoma metastatico o non resecabile, non precedentemente trattato.
    A.3.2Name or abbreviated title of the trial where available
    17-214-08
    17-214-08
    A.4.1Sponsor's protocol code numberCA045-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-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
    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 nameNA
    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 nameNKTR-214 - 1 mg vial
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Powder and solvent 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.3.9.1CAS number 1939126-74-5
    D.3.9.2Current sponsor codeNKTR-214
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB192964
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    Untreated unresectable or metastatic melanoma
    melanoma non resecabile o metastatico non precedentemente trattato
    E.1.1.1Medical condition in easily understood language
    Untreated inoperable or metastatic melanoma
    melanoma non operabile o metastatico non precedentemente trattato
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to determine whether an investigational immunotherapy NKTR-214, when combined with nivolumab, is more effective than nivolumab by itself in participants with unresectable or metastatic melanoma that is previously untreated
    Lo scopo di questo studio è di determinare se l’immunoterapia con NKTR-214, quando combinato con nivolumab, è più efficace di nivolumab da solo nei partecipanti con melanoma non resecabile o metastatico che non è stato precedentemente trattato
    E.2.2Secondary objectives of the trial
    - To evaluate efficacy of NKTR-214 combined
    with nivolumab and that of nivolumab
    monotherapy
    - To evaluate the association between PD-L1
    tumor expression on tumor cells (= 1% or < 1%/indeterminate) and efficacy measures
    including PFS and ORR by BICR and OS.
    -To evaluate the safety and tolerability of
    NKTR-214 combined with nivolumab and
    that of nivolumab monotherapy
    - Valutare l'efficacia di NKTR-214 combinato con nivolumab e quello di nivolumab in monoterapia
    - Valutare l'associazione tra l’espressione tumorale del PD-L1 sulle cellule tumorali (= 1% o <1% / indeterminato) e le misure di efficacia compresi PFS e ORR tramite BICR e OS.
    -Per valutare la sicurezza e la tollerabilità di NKTR-214 combinato con nivolumab e quello di Nivolumab in monoterapia
    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: 24/05/2018
    Title: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma
    Objectives: Ricerca addizionale facoltativa – vedere sez 9.8.1 del protocollo: questo protocollo includerà la conservazione dei campioni residui per la ricerca addizionale (AR) La ricerca addizionale è 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 capacità traslazionale di ricerca e sviluppo di Bristol-Myers Squibb e supporterà 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'autorità sanitaria per l'analisi e l'avanzamento dello sviluppo farmacodiagnostico, al fine di meglio identificare i farmaci migliori per i giusti pazienti. Questo può anche includere l'esplorazione genetica / genomica finalizzata ad esplorare i percorsi della malattia, la progressione e la risposta al trattamento - Eastern Cooperative Oncology Group (ECOG) performance status of </=1 (adults 18 years or older)/ Lansky Performance Score >/= 80% (minors ages 12-17 only) - Histologically confirmed stage III (unresectable) or stage IV melenoma - Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant treatment E.

    Farmacogenetica
    Versione: 1
    Data: 24/05/2018
    Titolo: Studio di fase 3, randomizzato, in aperto, di NKTR-214 in combinazione con Nivolumab rispetto a Nivolumab in partecipanti affetti da melanoma metastatico o non resecabile, non precedentemente trattato
    Obiettivi: Ricerca addizionale facoltativa – vedere sez 9.8.1 del protocollo: questo protocollo includerà la conservazione dei campioni residui per la ricerca addizionale (AR) La ricerca addizionale è 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 capacità traslazionale di ricerca e sviluppo di Bristol-Myers Squibb e supporterà 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'autorità sanitaria per l'analisi e l'avanzamento dello sviluppo farmacodiagnostico, al fine di meglio identificare i farmaci migliori per i giusti pazienti. Questo può anche includere l'esplorazione genetica / genomica finalizzata ad esplorare i percorsi della malattia, la progressione e la risposta al trattamento
    E.3Principal inclusion criteria
    - Eastern Cooperative Oncology Group (ECOG) performance status of
    </=1 (adults 18 years or older)/ Lansky Performance Score >/= 80%
    (minors ages 12-17 only)
    - Histologically confirmed stage III (unresectable) or stage IV melenoma
    - Treatment-naive participants (ie, no prior systemic anticancer therapy
    for unresectable or metastatic melanoma) with the exception of prior
    adjuvant and/or neoadjuvant treatment for melanoma with approved
    agents
    - Stato delle prestazioni del gruppo di oncologia della cooperativa orientale (ECOG)
    </ = 1 (adulti dai 18 anni in su) / Punteggio delle prestazioni di Lansky> / = 80%
    (solo minori di età compresa tra 12 e 17 anni)
    - Melanoma stadio III (non resecabile) o stadio IV confermato istologicamente
    - Partecipanti naive al trattamento (cioè nessuna precedente terapia antitumorale sistemica
    per melanoma non resecabile o metastatico) ad eccezione del precedente
    trattamento adiuvante e / o neoadiuvante per il melanoma con agenti approvati
    E.4Principal exclusion criteria
    - Active brain metastases or leptomeningeal metastases
    - Uveal melanoma
    - Participants with an active, known or suspected autoimmune disease
    - Metastasi cerebrali attive o metastasi leptomeningee
    - Melanoma uveale
    - Partecipanti con una malattia autoimmune attiva, nota o sospetta
    E.5 End points
    E.5.1Primary end point(s)
    1- Overall response rate (ORR) by Blinded Independent central review (BICR)
    2- Progression-free survival (PFS) by BICR
    3- Overall survival (OS)
    - Tasso di risposta generale (ORR) per revisione centrale indipendente in cieco (BICR)
    - Sopravvivenza libera da progressione (PFS) secondo BICR
    - Sopravvivenza globale (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1- Approximately 16 months
    2- Approximately 22 months
    3- Up to 59 months
    1- Circa 16 mesi
    2- Circa 22 mesi
    3- Fino a 59 mesi
    E.5.2Secondary end point(s)
    1- Clinical Benefit Rate (CBR)
    2- Duration of Response (DoR)
    3- Time To Response (TTR)
    4- ORR by investigator and in biomarker population
    5- PFS by investigator and in biomarker population
    6- OS in biomarker population
    7- Incidence of participants with non-serious Adverse Events (AEs)
    8- Incidence of participants with Serious Adverse Events (SAEs)
    9- Incidence of treatment-related AEs
    10- Incidence of treatment-related SAEs
    11- Incidence of laboratory abnormalities in blood, blood serum and
    urine
    1- Tasso di beneficio clinico (CBR)
    2- Durata della risposta (DoR)
    3- Tempo alla risposta (TTR)
    4- ORR da parte dello sperimentatore e nella popolazione di biomarcatori
    5- PFS da parte dello sperimentatore e nella popolazione di biomarcatori
    6- OS nella popolazione di biomarcatori
    7- Incidenza dì partecipanti con eventi avversi non gravi (eventi avversi)
    8- Incidenza di partecipanti con eventi avversi gravi (SAE)
    9- Incidenza di eventi avversi correlati al trattamento
    10- Incidenza di eventi avversi non gravi correlati al trattamento
    11- Incidenza di anomalie di laboratorio nel sangue, siero di sangue e
    urine
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4 Approximately 16 months
    5 - Approximately 22 months
    6 - Up to 59 months
    7-11 Up to 5 years
    1-4 Approssimativamente 16 months
    5 – Approssimativamente 22 months
    6 – superiore a 59 months
    7-11 superiore a 5 years
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Czechia
    France
    Germany
    Greece
    Ireland
    Israel
    Italy
    Netherlands
    New Zealand
    Poland
    Romania
    Russian Federation
    Spain
    Switzerland
    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 years6
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months7
    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 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: 51
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 561
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 408
    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
    Minors (adolescents) will be included in this study where locally permitted
    I minori (adolescenti) saranno inclusi in questo studio dove consentito dalle leggi locali
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state47
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 710
    F.4.2.2In the whole clinical trial 1020
    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 in Protocol
    Section 7.1. 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.
    Alla conclusione dello studio, i partecipanti che continuano a dimostrare beneficio clinico saranno idonei a ricevere il trattamento di studio fornito da BMS per la massima durata del trattamento specificato nella sezione 7.1 del protocollo. Il trattamento di studio sarà fornito tramite un'estensione dello studio, uno studio di rollover che richiederà approvazione da parte 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 Decision2018-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
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