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    Summary
    EudraCT Number:2020-002075-35
    Sponsor's Protocol Code Number:MK-6482-011
    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:2021-05-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002075-35
    A.3Full title of the trial
    An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Second-line or Third-line Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy
    Studio clinico di fase 3 randomizzato, in aperto, con MK-6482 in combinazione con Lenvatinib (MK-7902) vs Cabozantinib nel trattamento di seconda linea o terza linea in pazienti con carcinoma renale avanzato che hanno progredito dopo la precedente terapia anti-PD-1/L1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of MK-6482 in Combination with Lenvatinib Versus Cabozantinib for Second-line or Third-line Treatment in Participants With Advanced Renal Cell Carcinoma (MK-6482-011)
    Studio di MK-6482 in combinazione con Lenvatinib versus Cabozantinib nel trattamento di seconda linea o terza linea in pazienti con carcinoma renale avanzato (MK-6482-011)
    A.3.2Name or abbreviated title of the trial where available
    Phase 3 Study of MK-6482 in Combination With Lenvatinib Versus Cabozantinib for Treatment of RCC
    Studio di fase 3 Con MK-6482 in combinazione con Lenvatinib rispetto a Cabozantinib per il trattamen
    A.4.1Sponsor's protocol code numberMK-6482-011
    A.5.4Other Identifiers
    Name:INDNumber:149,887
    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 SponsorMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Italia S.r.l.
    B.5.2Functional name of contact pointDivisione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Vitorchiano 151
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number00390636191371
    B.5.5Fax number00390636191371
    B.5.6E-mailgcto.italy@merck.com
    D. IMP Identification
    D.IMP: 1
    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 Cabometyx® (Cabozantinib)
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma - Num. AIC: EU/1/16/1136/004
    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 nameCabozantinib
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabozantinib
    D.3.9.1CAS number 849217-68-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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: 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 nameLenvatinib
    D.3.2Product code [E7080/MK-7902]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENVATINIB MESILATE
    D.3.9.1CAS number 857890-39-2
    D.3.9.2Current sponsor codeMK-7902
    D.3.9.3Other descriptive nameLENVATINIB MESILATE
    D.3.9.4EV Substance CodeSUB72971
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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: 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 Cabometyx® (Cabozantinib)
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma - Num. AIC: EU/1/16/1136/002
    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 nameCabozantinib
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabozantinib
    D.3.9.1CAS number 849217-68-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 nameLenvatinib
    D.3.2Product code [E7080/MK-7902]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENVATINIB MESILATE
    D.3.9.1CAS number 857890-39-2
    D.3.9.2Current sponsor codeMK-7902
    D.3.9.3Other descriptive nameLENVATINIB MESILATE
    D.3.9.4EV Substance CodeSUB72971
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Cabometyx® (Cabozantinib)
    D.2.1.1.2Name of the Marketing Authorisation holderExelixis, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCabozantinib
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabozantinib
    D.3.9.1CAS number 849217-68-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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 nameNA
    D.3.2Product code [MK-6482/PT2977]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMK-6482
    D.3.9.3Other descriptive nameMK-6482
    D.3.9.4EV Substance CodeSUB207909
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Cabometyx® (Cabozantinib)
    D.2.1.1.2Name of the Marketing Authorisation holderExelixis, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCabozantinib
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabozantinib
    D.3.9.1CAS number 849217-68-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Cabometyx® (Cabozantinib)
    D.2.1.1.2Name of the Marketing Authorisation holderExelixis, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCabozantinib
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabozantinib
    D.3.9.1CAS number 849217-68-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Yes
    D.2.1.1.1Trade name Cabometyx® (Cabozantinib)
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma - Num. AIC: EU/1/16/1136/006
    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 nameCabozantinib
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabozantinib
    D.3.9.1CAS number 849217-68-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    Renal cell carcinoma
    Carcinoma renale
    E.1.1.1Medical condition in easily understood language
    Confirmed diagnosis of locally advanced/metastatic Renal Cell Carcinoma with clear cell component
    Diagnosi confermata di carcinoma renale localmente avanzato/metastatico con componente a cellule chiare
    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 10038409
    E.1.2Term Renal cell carcinoma NOS
    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
    1. To compare MK-6482+lenvatinib to cabozantinib with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR)
    2. To compare MK-6482+lenvatinib to cabozantinib with respect to overall survival (OS)
    1. Confrontare MK-6482 + lenvatinib e cabozantinib rispetto alla sopravvivenza libera da progressione (PFS) in base ai criteri RECIST 1.1 come valutato mediante revisione centrale indipendente in cieco (BICR).
    2. Confrontare MK- 6482 + lenvatinib e cabozantinib in relazione alla sopravvivenza globale (OS).
    E.2.2Secondary objectives of the trial
    1. To compare MK-6482+lenvatinib to cabozantinib with respect to objective response rate (ORR) based on RECIST 1.1 as assessed by BICR
    2. To evaluate the duration of response (DOR) as assessed by BICR according to RECIST 1.1
    3. To evaluate the safety and tolerability of MK-6482+lenvatinib compared to cabozantinib
    1. Confrontare MK-6482 + lenvatinib e cabozantinib rispetto al tasso di risposta obiettiva (ORR) in base ai criteri RECIST 1.1 valutati mediante BICR.
    2. Valutare la durata della risposta (DOR) valutata mediante BICR secondo i criteri RECIST 1.1.
    3. Valutare la sicurezza e la tollerabilità di MK-6482 + lenvatinib rispetto a cabozantinib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must have a histologically confirmed diagnosis of unresectable, locally advanced/metastatic RCC with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per AJCC (8th Edition). Previous nephrectomy or metastasectomy is allowed.
    2. Has experienced disease progression on or after first- or second-line systemic treatment with an anti-PD-1/L1 therapy for locally advanced or metastatic RCC. The anti-PD-1/L1 therapy may have been monotherapy or in combination with other agent(s) such as anti- CTLA4 or VEGFtargeted- TKI. The immediately preceding line of treatment has to have been an anti-PD-1/L1 therapy.
    - Treatment progression is defined by meeting ALL of the following criteria: o Has received at least 2 doses of an anti-PD-1/L1 mAb. o Has shown radiographic disease progression during or after an anti-PD-1/L1 mAb as assessed by investigator.
    3. Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
    4. Has a KPS =70% [Karnofsky, D. A., et al 1948] assessed within 10 days before randomization.
    5. Submit an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. FFPE tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
    6. Has received no more than 2 prior systemic regimens for locally advanced or metastatic RCC.
    7. Has received only 1 prior anti-PD-1/L1 therapy for locally advanced or metastatic RCC.
    8. Have resolution of the toxic effect(s) of the most recent prior therapy to =Grade 1 (except alopecia or Grade 2 hypothyroidism) and if receiving systemic steroid therapy due to an irAE, the dose should not exceed 10 mg daily of prednisone or equivalent.
    9. If participants received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
    10. Is male or female, at least 18 years of age, at the time of signing the informed consent.
    11. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 5 days after the last dose of study intervention:
    • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent
    OR
    •Must agree to use contraception unless confirmed to be azoospermic.
    -Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    -If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
    For a full list of Inclusion criteria please refer to the Study Protocol.
    1. Deve presentare una diagnosi istologicamente confermata di RCC non resecabile localmente avanzato/metastatico con componente a cellule chiare (con o senza caratteristiche sarcomatoidi), ovvero RCC allo stadio IV secondo AJCC (8ª edizione). È consentita una precedente nefrectomia o metastasectomia.
    2. Ha manifestato progressione di malattia durante o dopo il trattamento sistemico di prima o seconda linea con una terapia anti-PD-1/L1 per RCC localmente avanzato o metastatico. La terapia anti-PD-1/L1 potrebbe essere stata in monoterapia o in combinazione con altri agenti come anti-CTLA4 o TKI mirato a VEGF. La linea di trattamento immediatamente precedente deve essere stata una terapia anti-PD-1/L1.
    • La progressione del trattamento è definita soddisfacendo TUTTI i seguenti criteri: o Ha ricevuto almeno 2 dosi di un mAb anti-PD-1/L1. o Ha mostrato progressione radiografica di malattia durante o dopo un mAb anti-PD-1/L1, come valutato dallo sperimentatore.
    3. Presenta una malattia misurabile secondo RECIST 1.1 valutata dallo sperimentatore/radiologia del centro locale. Le lesioni situate in un'area precedentemente irradiata sono considerate misurabili se la progressione è stata dimostrata in tali lesioni.
    4. Presenta una KPS =70% [Karnofsky, D. A., et al 1948] valutata nei 10 giorni precedenti alla randomizzazione.
    5. Ha fornito un campione di tessuto tumorale proveniente da archivio o fresco ottenuto tramite biopsia core o escissionale di una lesione tumorale non precedentemente irradiata. I blocchi di tessuto FFPE sono preferibili ai vetrini. Le biopsie di campioni freschi sono preferibili ai tessuti provenienti da archivio. I dettagli relativi all'invio del tessuto tumorale sono disponibili nel manuale del laboratorio.
    6. Ha ricevuto non più di 2 precedenti regimi sistemici per RCC localmente avanzato o metastatico.
    7. Ha ricevuto solo 1 precedente terapia anti-PD-1/L1 per RCC localmente avanzato o metastatico.
    8. Presenta una risoluzione degli effetti tossici derivanti dalla terapia precedente più recente a grado =1 (eccetto alopecia o ipotiroidismo di grado 2) e, se riceve una terapia steroidea sistemica a causa di un irAE, la dose non deve superare 10 mg al giorno di prednisone o equivalente.
    9. Se i partecipanti hanno ricevuto un intervento chirurgico importante o una radioterapia >30 Gy, devono essersi ripresi dalla tossicità e/o dalle complicanze dell’intervento.
    10. Il/La partecipante deve avere un'età minima di 18 anni al momento della firma del consenso informato.
    11. I partecipanti di sesso maschile sono idonei alla partecipazione se durante il periodo di intervento e per almeno 5 giorni dopo l'ultima dose dell'intervento dello studio accettano di:
    • Praticare l'astinenza dai rapporti eterosessuali come proprio stile di vita preferito e abituale (astinenza continuativa e a lungo termine) e acconsentire a rimanere astinenti
    OPPURE
    Acconsentire tassativamente a usare la contraccezione a eccezione degli individui con azoospermia confermata
    - L'uso del contraccettivo da parte degli uomini deve essere coerente con le normative locali relative ai metodi contraccettivi per coloro che partecipano agli studi clinici.
    - Se i requisiti di contraccezione riportati in etichetta locale per uno qualsiasi degli interventi dello studio sono più rigorosi dei requisiti di cui sopra, devono essere seguiti i requisiti riportati in etichetta locale.
    Per la lista completa dei criteri di inclusione fare riferimento al Protocollo di Studio
    E.4Principal exclusion criteria
    1. A WOCBP who has a positive urine pregnancy test within 24 hours before first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
    2. Has any of the following:
    - Hypoxia defined as a pulse oximeter reading <92% at rest, or
    - Requires intermittent supplemental oxygen, or
    - Requires chronic supplemental oxygen.
    3. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
    4. Has known CNS metastases and/or carcinomatous meningitis.
    5. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia.
    6. Prolongation of QTc interval to >480 ms.
    7. Has a LVEF below the institutional (or local laboratory) normal range as determined by MUGA or ECHO.
    8. Has urine protein =1 g/24 hours.
    9. Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain). A participant who is clinically stable after treatment
    for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
    10. Has pre-existing =Grade 3 gastrointestinal or nongastrointestinal fistula.
    11. Has moderate to severe hepatic impairment (Child-Pugh B or C).
    12. Has clinically significant hematuria, hematemesis or hemoptysis (>2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 3 months before randomization.
    13. Has other clinically significant disorders such as:
    a. Serious active nonhealing wound/ulcer/bone fracture
    b. Requirement for hemodialysis or peritoneal dialysis
    c. History of solid organ transplantation
    14. Received colony-stimulating factors (eg, G-CSF, GMCSF or recombinant EPO) within 28 days before randomization.
    15. Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
    16. Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, malabsorption).
    17. Has known hypersensitivity or allergy to the active pharmaceutical ingredient or any component of the study intervention (MK-6482, lenvatinib, or cabozantinib) formulations.
    18. Has received prior treatment with MK-6482 or another HIF-2a inhibitor.
    19. Has received prior treatment with lenvatinib.
    20. Has received prior treatment with cabozantinib.
    21. Has received any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization.
    22. Has received any type of systemic anticancer antibody (including investigational antibody) =28 days before randomization
    23. Has received prior radiotherapy within 2 weeks before randomization. Participants must have recovered from all radiationrelated toxicities and not require corticosteroids. A 1-week washout is required for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
    24. Has had major surgery within 3 weeks before randomization.
    25. Is receiving concomitant treatment, in therapeutic doses, with anticoagulants such as heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (eg, clopidogrel).
    For a full list of Exclusion criteria please refer to the Study Protocol
    1. Una donna in età fertile che riceve un test di gravidanza sulle urine positivo nelle 24 ore precedenti alla prima dose di trattamento dello studio. Se il test urinario è positivo o non è possibile confermare un risultato negativo, è necessario eseguire un test di gravidanza sierico.
    2. Presenta una delle seguenti condizioni:
    - Ipossia definita come un pulsossimetro con lettura <92% a riposo, o
    - Richiede ossigeno supplementare intermittente, o
    - Richiede ossigeno supplementare cronico.
    3. Ha un ulteriore tumore noto che sta progredendo o che ha richiesto trattamento attivo negli ultimi 3 anni.
    4. Ha metastasi note a livello del SNC e/o meningite carcinomatosa
    5. Presenta una malattia cardiovascolare clinicamente significativa entro 12 mesi dalla prima dose dell'intervento dello studio, inclusa insufficienza cardiaca congestizia di classe III o IV della New York Heart Association, angina instabile, infarto miocardico, evento cerebrovascolare o aritmia cardiaca.
    6. Prolungamento dell’intervallo QTc a >480 ms.
    7. Ha un LVEF al di sotto dell'intervallo normale istituzionale (o di laboratorio locale), come determinato da MUGA o ECHO.
    8. Presenta proteinuria =1 g/24 ore.
    9. Ha versamento della pleura sintomatico (ad esempio tosse, dispnea, dolore toracico pleuritico). È idoneo un partecipante clinicamente stabile a seguito del trattamento per queste condizioni (inclusa la toracoterapia o la paracentesi terapeutica).
    10. Ha una fistola gastrointestinale o non gastrointestinale di grado =3 preesistente.
    11. Presenta compromissione epatica da moderata a grave (Child-Pugh B o C).
    12. Presenta ematuria, ematemesi o emottisi (>2,5 ml) clinicamente significativa di sangue rosso o altra anamnesi di sanguinamento significativo (ad es. emorragia polmonare) nei 3 mesi precedenti alla randomizzazione.
    13. Presenta altri disturbi clinicamente significativi come:
    a. Ferite/ulcere/fratture ossee attive gravi non cicatrizzanti
    b. Necessità di emodialisi o dialisi peritoneale
    c. Anamnesi di trapianto di organo solido
    14. Ha ricevuto fattori stimolanti le colonie (ad es. G-CSF, GMCSF o EPO ricombinante) entro 28 giorni prima della randomizzazione.
    15. Ha un disturbo psichiatrico o di abuso di sostanza noto che interferirebbe con la capacità del partecipante di cooperare con i requisiti dello studio.
    16. Non è in grado di deglutire i farmaci somministrati per via orale o presenta un disturbo gastrointestinale che influisce sull'assorbimento (ad es. gastrectomia, ostruzione intestinale parziale, malassorbimento).
    17. Presenta ipersensibilità o allergia nota al principio attivo farmaceutico o a qualsiasi componente del trattamento dello studio (MK-6482, lenvatinib o cabozantinib).
    18. Ha ricevuto un precedente trattamento con MK-6482 o un altro inibitore di HIF-2a.
    19. Ha ricevuto un precedente trattamento con lenvatinib.
    20. Ha ricevuto un precedente trattamento con cabozantinib.
    21. Ha ricevuto qualsiasi tipo di inibitore della chinasi a piccole molecole (incluso l’inibitore della chinasi sperimentale) nelle 2 settimane precedenti alla randomizzazione.
    22. Ha ricevuto qualsiasi tipo di anticorpo antitumorale sistemico (incluso l'anticorpo sperimentale) =28 giorni prima della randomizzazione.
    23. Ha ricevuto una precedente radioterapia nelle 2 settimane precedenti alla randomizzazione. I partecipanti devono essersi ripresi da tutte le tossicità correlate alle radiazioni e non necessitare di corticosteroidi. È necessario un washout di 1 settimana per la radioterapia palliativa (=2 settimane di radioterapia) per la malattia non a livello del SNC.
    24. Ha subito un intervento chirurgico importante nelle 3 settimane precedenti alla randomizzazione.
    25. Riceve attualmente un trattamento concomitante, a dosi terapeutiche, con anticoagulanti come eparina, trombina o inibitori del fattore Xa o agenti antiaggreganti (ad es. clopidogrel).
    Per la lista completa dei criteri di esclusione fare riferimento al Protocollo di Studio
    E.5 End points
    E.5.1Primary end point(s)
    1. Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
    2. Overall Survival (OS)
    1. Sopravvivenza libera da progressione (PFS) in base ai criteri RECIST 1.1 come valutato mediante revisione centrale indipendente in cieco (BICR).
    2. Sopravvivenza globale (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 34 months
    2. Up to approximately 44 months
    1. Fino a circa 34 mesi
    2. Fino a circa 44 mesi
    E.5.2Secondary end point(s)
    3. Number of Participants Who Experienced One or More Adverse Events (AEs); 4. Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE); 1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR); 2. Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
    3. Numero di partecipanti che hanno presentato uno o più eventi avversi (AEs); 4. Numero di partecipanti che hanno interrotto il trattamento a causa di eventi avversi (AE); 1. Tasso di risposta obiettiva (ORR) in base ai criteri RECIST 1.1 come valutato mediante revisione centrale indipendente in cieco (BICR).; 2. Durata della risposta (DOR) in base ai criteri RECIST 1.1 come valutato mediante revisione centrale indipendente in cieco (BICR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    3. Up to approximately 44 months; 4. Up to approximately 44 months; 1. Up to approximately 24 months; 2. Up to approximately 44 months
    3. Fino a circa 44 mesi; 4. Fino a circa 44 mesi; 1. Fino a circa 24 mesi; 2. Fino a circa 44 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 Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Austria
    Belgium
    Brazil
    Canada
    France
    Germany
    Italy
    Japan
    Netherlands
    Spain
    Sweden
    Switzerland
    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
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 425
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 283
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 485
    F.4.2.2In the whole clinical trial 708
    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)
    Per local management guidelines.
    Secondo le linee guida locali
    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 Decision2021-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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