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    Summary
    EudraCT Number:2016-003881-14
    Sponsor's Protocol Code Number:CA209-901
    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:2021-06-17
    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 number2016-003881-14
    A.3Full title of the trial
    A Phase 3, Open-label, Randomized Study of Nivolumab Combined with
    Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of
    Care Chemotherapy in Participants with Previously Untreated Unresectable
    or Metastatic Urothelial Cancer
    Studio in fase 3, in aperto, randomizzato di Nivolumab combinato con Ipilimumab o con chemioterapia standard di cura, rispetto a chemioterapia standard di cura nei soggetti con carcinoma uroteliale precedentement non trattato, non resecabile o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Nivolumab combined with Ipilimumab or Standard of Care chemotherapy, versus standard of care chemotherapy in patients with previously untreated unresectable or metastatic urothelial cancer.
    Studio di nivolumab combinato ad ipilimumab o con chemioterapia standard di cura verso chemioterapia standard di cura in soggetti affetti da carcinoma uroteliale precedentemente non trattato, non reseabile o metastatico.
    A.3.2Name or abbreviated title of the trial where available
    CheckMate 901: CHECKpoint pathway and nivoluMAb clinical Trial
    CA209-901 (CheckMate 901)
    A.4.1Sponsor's protocol code numberCA209-901
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03036098
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1187-9637
    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.5.4Telephone number000
    B.5.5Fax number000
    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.3.4Pharmaceutical 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 Yes
    D.2.1.1.1Trade name Yervoy (200mg/40ml)
    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.3.4Pharmaceutical 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 INNipilimumab
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeBMS-734016
    D.3.9.3Other descriptive nameMDX010/MDX-CTLA-4
    D.3.9.4EV Substance CodeSUB22577
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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.2.1.1.1Trade name PARAPLATIN 450 mg/45 ml solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical 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 INNCARBOPLATINO
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 4
    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.2.1.1.1Trade name Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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 INNGEMCITABINA CLORIDRATO
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 5
    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.2.1.1.1Trade name Cisplatin NeoCorp¿ 1 mg/ml ¿ Concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 INNCISPLATINO
    D.3.9.2Current sponsor codeNot available
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 6
    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.2.1.1.1Trade name Cisplatin-Ebewe, 1 mg/ml, concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderEBEWE Pharma Ges.m.b.H. Nfg. KG
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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.3.4Pharmaceutical 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 INNCISPLATINO
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 7
    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.2.1.1.1Trade name Gemcitabine 1 g Powder for Solution for Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Powder 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 INNGEMCITABINA CLORIDRATO
    D.3.9.1CAS number 00-00-0
    D.3.9.2Current sponsor code000
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 8
    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.2.1.1.1Trade name Cisplatin TEVA, 1mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 9
    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 No
    D.2.1.1.1Trade name Carboplatin-Actavis 10mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf.
    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 nameNA
    D.3.2Product code [NA]
    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 INNCARBOPLATIN
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB06614MIG
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 Urothelial Cancer
    carcinoma uroteliale precedentemente non trattato, non resecabile o metastatico
    E.1.1.1Medical condition in easily understood language
    Untreated Inoperable or Metastatic Urothelial Cancer
    carcinoma uroteliale non trattato e inoperabile
    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 10064467
    E.1.2Term Urothelial carcinoma
    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
    To compare Overall Survival (OS), and Progression Free Survival (PFS) of nivolumab combined with ipilimumab versus standard of care (SOC) chemotherapy in cisplatin-ineligible participants with previously untreated, unresectable or metastatic urothelial carcinoma (UC).
    Confrontare La sopravvivenza complessiva (OS) e la sopravvivenza libera da progressione (PFS) , di nivolumab in combinazione con ipilimumab rispetto alla chemioterapia standard di cura (standard of care, SOC) in partecipanti non eleggibili a ricevere cisplatino, affetti da carcinoma uroteliale (UC) non pretrattato, non resecabile o metastatico
    E.2.2Secondary objectives of the trial
    To compare OS and PFS of nivolumab combined with ipilimumab versus SOC chemotherapy in all randomized participants with previously untreated, unresectable or metastatic UC. To evaluate changes from baseline in Health-Related QOL (HRQoL) of nivolumab combined with ipilimumab versus SOC chemotherapy in all randomized participants with previously untreated, unresectable or metastatic UC. To evaluate whether PD-L1 expression is a predictive biomarker of efficacy (PFS and OS) of nivolumab combined with ipilimumab as first-line therapy in participants with previously untreated, unresectable or metastatic UC.
    Confrontare OS e PFS di nivolumab in combinazione con ipilimumab rispetto alla chemioterapia SOC in tutti i partecipanti randomizzati affetti da UC non pretrattato, non resecabile o metastatico. Valutare le variazioni dal basale nel (quality of life, QOL ) correlata alla salute (HRQoL) di nivolumab in combinazione con ipilimumab rispetto alla chemioterapia SOC in tutti i partecipanti randomizzati affetti da UC non pretrattato, non resecabile o metastatico. Valutare se l¿espressione di PD-L1 sia un biomarcatore predittivo dell¿ efficacia (PSF e OS) di nivolumab combinato con ipilimumab come terapia di prima linea nei parteciapnti affetti da UC non pretrattato, non resecabile o metastatico
    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: Revised Protocol Number: 02
    Date: 21/04/2017
    Title: A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer.
    Objectives: This protocol will include both sample collection and residual sample
    storage for additional research (AR).
    For more details please refer to section 9.8.1 of the protocol.
    Main objective of the substudy as per revised protocol 02 dated 21-Apr-
    2017 (A Phase 3, Open-label, Randomized Study of Nivolumab Combined
    with Ipilimumab, or with Standard of Care Chemotherapy, versus
    Standard of Care Chemotherapy in Participants with Previously
    Untreated Unresectable or Metastatic Urothelial Cancer): To compare
    PFS of nivolumab combined with SOC chemotherapy versus SOC
    chemotherapy in cisplatin-eligible participants with previously
    untreated, unresectable or metastatic urothelial carcinoma (UC)
    Secondary Objectives of the substudy as per revised protocol 02 dated
    XML File Identifier: O9+soSeoLQPKS67UvV2dwGtVen4=
    Page 39/56
    21-Apr-2017:
    -To compare OS of nivolumab combined with SOC chemotherapy versus
    SOC chemotherapy in cisplatin-eligible participants with previously
    untreated, unresectable or metastatic UC
    -To evaluate changes from baseline in Health-Related QOL (HRQoL) of
    nivolumab combined with SOC chemotherapy versus SOC chemotherapy
    in cisplatin-eligible participants with previously untreated, unresectable
    or metastatic UC
    -To evaluate whether PD-L1 expression is a predictive biomarker of
    efficacy (PFS and OS) of nivolumab combined with SOC chemotherapy as
    first-line therapy in participants with previously untreated, unresectable
    or metastatic UC

    Pharmacogenomics
    Version: Revised Protocol Number: 01
    Date: 19/12/2016
    Title: A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer
    Objectives: This protocol will include both sample collection and residual sample storage for additional research (AR).
    Additional research is optional for all study articipants, 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 Bristol-Myers Squibb, 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.
    Prospective samples of tumor tissue (optional), whole blood, serum samples, PMBC, and MDSCs will be collected at selected time points.
    Residual tumor tissue from baseline tumor tissue collections will also be retained for additional research purposes.
    For more details please refer to section 9.8.1 of the protocol.

    Farmacogenetica
    Versione: Revised Protocol Number: 02
    Data: 21/04/2017
    Titolo: Studio in fase 3, in aperto, randomizzato di Nivolumab combinato con Ipilimumab o con chemioterapia standard di cura, rispetto a chemioterapia standard di cura nei soggetti con carcinoma uroteliale precedentement non trattato, non resecabile o metastatico
    Obiettivi: Il protocollo includer¿ raccolta e stoccaggio dei campioni residui per ulteriori ricerche (AR). Per maggiori dettagli, fare riferimento alla sezione 9.8.1 del protocollo.
    Obiettivo principale del sottostudio come da rev. prot. 02 del 21 aprile 2017 (Studio in fase 3, in aperto, randomizzato di Nivolumab combinato con Ipilimumab o con chemioterapia standard di cura, rispetto a chemioterapia standard di cura nei soggetti con carcinoma uroteliale precedentement non trattato, non resecabile o metastatico): confrontare PFS di nivolumab combinato con la chemioterapia SOC nei soggetti eleggibili al cisplatino con carcinoma uroteliale precedentement non trattato, non resecabile o metastatico. Obiettivi secondari del sottostudio come da rev. prot. 2.0 datato 21 Aprile 2017:
    Valutare l'OS di nivolumab in combinazione con la chemioterapia SOC rispetto alla chemioterapia SOC nei partecipanti eleggibili al cisplatino con con UC precedentement non trattato, non resecabile o metastatico. Valutare le variazioni dal basale nel QOL correlata alla salute (HRQoL) di nivolumab in combinazione con chemioterapia SOC rispetto alla chemioterapia SOC in tutti i partecipanti elegibbili al cisplatino affetti da UC non pretrattato, non resecabile o metastatico.
    Valutare se l¿espressione di PD-L1 sia un biomarcatore predittivo dell¿ efficacia (PSF e OS) di nivolumab combinato con chemioterapia SOC come terapia di prima linea nei partecipanti affetti da UC non pretrattato, non resecabile o metastatico

    Farmacogenomica
    Versione: Revised Protocol Number: 01
    Data: 19/12/2016
    Titolo: Studio di fase III, in aperto, randomizzato, sull¿uso di Nivolumab combinato con Ipilimumab verso chemioterapia standard di cura in soggetti con carcinoma uroteliale precedentemente non trattato, non resecabile o metastatico
    Obiettivi: Questo protocollo includer¿ sia la raccolta di nuovi campioni che l¿archiviazione di campioni residui per ricerca addizionale (AR). La ricerca addizionale ¿ facoltativa per tutti i partecipanti allo studio, salvo dove la ritenzione e/o la raccolta sono vietati da leggi o regolamenti locali, da Comitati etici o requisiti istituzionali.
    Questa raccolta per ulteriori ricerche ha lo scopo di espandere la capacit¿ di Ricerca e Sviluppo (R&D) di Bristol-Myers Squibb e supporter¿ non ancora definiti scopi di ricerca che faranno avanzare la comprensione della malattie e delle opzioni per il trattamento. Pu¿ anche essere utilizzata per sostenere richieste delle autorit¿ sanitarie per l'analisi e l'avanzamento dello sviluppo farmacodiagnostico per meglio mirare i farmaci ai pazienti. Questo pu¿ anche includere l'esplorazione genetica/genomica finalizzata all'esplorazione del decorso della malattia, la progressione e la risposta al trattamento, ecc.
    Campioni di tessuto tumorale prospettici (opzionali), sangue intero, campioni di siero, PMBC e MDSC saranno raccolti a definite tempistiche.
    Anche il tessuto tumorale residuo raccolto al baseline sar¿ conservato per ulteriori ricerche.
    Per maggiori dettagli, fare riferimento alla sezione 9.8.1 del protocollo.

    E.3Principal inclusion criteria
    - Metastatic or inoperable urothelial cancer
    - Must have at least 1 lesion with measurable disease
    - Must have full activity or, if limited, must be able to walk and carry out
    light activities such as light house work or office work
    - No prior systemic chemotherapy treatment in the metastatic setting
    - Carcinoma uroteliale metastatico o inoperabile
    - Deve avere almeno 1 lesione misurabile di malattia
    - Deve avere piena attività o, se limitata, deve poter camminare ed eseguire attività leggere come il lavoro a casa leggera o in ufficio
    - Nessun precedente trattamento chemioterapico sistemico in ambito metastatico
    E.4Principal exclusion criteria
    - Patients with disease that is suitable for local therapy administered
    with curative intent
    - Patients with active brain metastases or leptomeningeal metastases
    - Patients with active, known or suspected autoimmune disease
    - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
    - Pazienti con malattia idonei alla terapia locale somministrata con intento curativo
    - Pazienti con metastasi cerebrali attive o metastasi leptomeningee
    - Pazienti con malattia autoimmune attiva, conosciuta o sospetta
    - trattamento precedente con un anticorpo anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 o anti-CTLA-4 o qualsiasi altro anticorpo o farmaco specificamente destinato alla co-stimolazione delle cellule T o di checkpoint cellulari.
    E.5 End points
    E.5.1Primary end point(s)
    Main study: Co-primary endpoint of Overall Survival (OS), and Progression Free Survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1), in cisplatin-ineligible participants with previously untreated, unresectable or metastatic UC.
    Substudy (revised protocol 02 dated 21Apr-2017): PFS by BICR (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC.
    Studio principale: Endpoint co-primario di OS e, PFS, valutate mediante revisione centrale indipendente in cieco (blinded independent central review, BICR) (utilizzando i criteri RECIST 1.1), in partecipanti non eleggibili a ricevere cisplatino, affetti da UC non pretrattato, non resecabile o metastatico.
    Sottostudio (revised protocol 02 datato 21 Aprile 2017): PFS valutato mediante BICR (utilizzando i criteri RECIST 1.1) in tutti i partecipanti affetti da UC precedentemente non pretrtattato, non resecabile o metastatico, elegibbili al cisplatino
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 42 months from the randomization of the first participant in main study.
    Substudy: Up to 43 months form the randomization of the first participant in the sub study.
    fino a 42 mesi dalla randomizzazione del primo partecipante nello studio principale
    Sottostudio: Fino a 43 mesi dalla randomizzazione del primo partecipante nel sottostudio.
    E.5.2Secondary end point(s)
    Secondary Endpoint Main Study: 1- OS, and PFS by BICR (using RECIST 1.1) in all randomized participants with previously untreated, unresectable or metastatic UC.
    2- European Organization for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score
    3- PFS by BICR (using RECIST 1.1) and OS by PD-L1 expression at = 1% expression by immunohistochemistry (IHC)
    Substudy (revised protocol 02 dated 21Apr2017):
    1- OS in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC
    2- European Organization for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score
    3- PFS by BICR (using RECIST 1.1) and OS by PD-L1 expression at = 1% expression by immunohistochemistry (IHC)
    Studio Principale:
    1- OS e PFS valutate mediante BICR (utilizzando i criteri RECIST 1.1) in tutti i partecipanti randomizzati affetti da UC precedentemente non pretrattato, non resecabile o metastatico
    2- Punteggio del questionario European Organization for Research and Treatment Care (EORTC) QLQ-C30 per la valutazione dello stato di salute generale
    3 - PFS valutato mediante BICR (utilizzando i criteri di RECIST 1.1) e OS valutato mediante l¿espressione di PD-L1 > 1% tramite immunoistochimica (IHC)
    Sottostudio: (revised protocol 02 datato 21-Aprile-2017)
    1- OS in tutti i partecipanti elegibbili al cisplatino affetti da UC precedentemente non pretrattato, non resecabile o metastatico
    2- Punteggio del questionario European Organization for Research and Treatment Care (EORTC) QLQ-C30 per la valutazione dello stato di salute generale
    3- PFS valutato mediante BICR (utilizzando i criteri di RECIST 1.1) e OS valutato mediante l¿espressione di PD-L1 > 1% tramite immunoistochimica (IHC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Main study (from the first participant¿s randomization date in main study)
    1-up to 42 months
    2-up to 28 months
    3-up to 42 months
    Substudy (from the randomization of the first participant in the sub study)
    1-up to 43 months
    2-up to 28 months
    3-up to 43 months
    Studio Principale: (dalla data del primo partecipante randomizzato nello studio principale)
    1- fino a 42 mesi
    2- fino a 28 mesi
    3- fino a 42 mesi
    Sottostudio (dalla randomizzazione del primo partecipante nel sottostudio)
    1-fino a 43 mesi
    2-fino a 28 mesi
    3-fino a 43 mesi
    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) 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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Brazil
    Canada
    Chile
    China
    Finland
    France
    Germany
    Greece
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Norway
    Peru
    Spain
    Sweden
    Switzerland
    Taiwan
    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
    End of trial is defined as last participant last visit on the Schedule of Activities.
    La fine dello studio clinico ¿ definita come l¿ultima visita dell¿ultimo partecipante.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months9
    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: 204
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1156
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 1360
    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. 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. See section 7.8 of the protocol
    Alla conclusione dello studio, i partecipanti che continuano a dimostrare il beneficio clinico saranno elegibili a ricevere il trattamento in studio fornito da BMS. Il trattamento in studio sar¿ fornito tramite un'estensione dello studio, uno studio di rollover che richiede l'approvazione da parte dell'autorit¿ sanitarie responsabili e dei comitati etici o attraverso un altro meccanismo a discrezione del BMS. 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 Decision2017-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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