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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-000317-78
    Sponsor's Protocol Code Number:PV-10-MM-31
    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:2021-01-22
    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 number2016-000317-78
    A.3Full title of the trial
    PV-10 Intralesional Injection vs Systemic Chemotherapy or
    Intralesional Oncolytic Viral Therapy for Treatment of Locally
    Advanced Cutaneous Melanoma
    PV-10 Intralesional Injection vs Systemic Chemotherapy or
    Intralesional Oncolytic Viral Therapy for Treatment of Locally
    Advanced Cutaneous Melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of PV-10 to Chemotherapy or Oncolytic Viral Therapy for Treatment of Malignant Melanoma of the Skin
    Confronto tra PV-10 verso chemioterapia o terapia virale oncolitica per il trattamento del melanoma cutaneo localmente avanzato
    A.3.2Name or abbreviated title of the trial where available
    Comparison of PV-10 to Chemotherapy or Oncolytic Viral Therapy for Treatment of Malignant Melanoma o
    Confornto tra PV-10 verso Chemioterapia e immunoterapia virale oncolitica per il trattamento del mel
    A.4.1Sponsor's protocol code numberPV-10-MM-31
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12345678
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02288897
    A.5.3WHO Universal Trial Reference Number (UTRN)U1234-1234-1234
    A.5.4Other Identifiers
    Name:PV-10-MM-31Number:PV-10-MM-31
    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 SponsorPROVECTUS BIOPHARMACEUTICALS, 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 supportProvectus Biopharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProvecuts Biopharmaceuticals, Inc
    B.5.2Functional name of contact pointChief Technology Officer
    B.5.3 Address:
    B.5.3.1Street Address10025 Investment Drive, Suite 250
    B.5.3.2Town/ cityKnoxville, TN
    B.5.3.3Post code37932
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018657694011
    B.5.5Fax number0
    B.5.6E-mailwachter@pvct.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePV-10
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 632-69-9
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB15149MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 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 DACARBAZINA MEDAC - 200 MG POLVERE PER SOLUZIONE INIETTABILE O PER INFUSIONE 10 FLACONCINI IN VETRO
    D.2.1.1.2Name of the Marketing Authorisation holderMEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNDACARBAZINA
    D.3.9.1CAS number 4342-03-4
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB06882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Temodal 5 mg capsule rigide
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited EU/1/98/096/001-2,025
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameTemozolomide
    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 INNTEMOZOLOMIDE
    D.3.9.1CAS number 85622-93-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Imlygic 10^6 plaque forming units (PFU)/mL solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Yes
    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 DACARBAZINA MEDAC - 500 MG POLVERE PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO
    D.2.1.1.2Name of the Marketing Authorisation holderMEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameDacarbazine
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDACARBAZINA
    D.3.9.1CAS number 4342-03-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameDACARBAZINA
    D.3.9.4EV Substance CodeSUB06882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 TEMODAL - 20 MG - CAPSULA RIGIDA- USO ORALE- CAPSULE IN BUSTINE SIGILLATE INDIVIDUALMENTE 20 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP e DOHME LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTemodal 20 mg capsule rigide
    D.3.2Product code NA
    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 INNTemozolamide
    D.3.9.1CAS number 85622-93-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB10889MIG
    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: 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 TEMODAL - 100 MG - CAPSULA RIGIDA- USO ORALE- CAPSULE IN BUSTINE SIGILLATE INDIVIDUALMENTE 5 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP e DOHME LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTemodal 100 mg capsule rigide
    D.3.2Product code NA
    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 INNTEMOZOLAMIDE
    D.3.9.1CAS number 85622-93-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 TEMODAL - 140 MG - CAPSULA RIGIDA- USO ORALE- CAPSULE IN BUSTINE SIGILLATE INDIVIDUALMENTE 5 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP e DOHME LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTemozolamide
    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 INNTEMOZOLAMIDE
    D.3.9.1CAS number 85622-93-1
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameTEMOZOLAMIDE
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 TEMODAL - 180 MG - CAPSULA RIGIDA- USO ORALE- CAPSULE IN BUSTINE SIGILLATE INDIVIDUALMENTE 20 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP e DOHME LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTemozolamide
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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: 10
    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 TEMODAL - 250 MG - CAPSULA RIGIDA- USO ORALE- CAPSULE IN BUSTINE SIGILLATE INDIVIDUALMENTE 5 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP e DOHME LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTEMODAL
    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 INNTEMOZOLAMIDE
    D.3.9.1CAS number 85622-93-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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: 11
    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 Imlygic 10^8 plaque forming units (PFU)/mL solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.EU/1/15/1064/002
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTALIMOGENE LAHERPAREPVEC
    D.3.9.1CAS number 1187560-31-1
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameTALIMOGENE LAHERPAREPVEC
    D.3.9.4EV Substance CodeSUB168372
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Yes
    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
    Locally Advanced Cutaneous Melanoma
    Melanoma cutaneo localmente avanzato
    E.1.1.1Medical condition in easily understood language
    Malignant melanoma of skin
    Melanoma maligno della pelle
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025650
    E.1.2Term Malignant melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this randomized controlled trial (RCT) is to assess the effectiveness of intralesional (IL) PV-10 compared to the Investigator¿s choice of systemic chemotherapy or intralesional oncolytic viral therapy in treating locally advanced cutaneous melanoma.
    Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.
    L'obiettivo primario di questo studio controllato randomizzato (RCT) ¿ valutare l'efficacia del PV-10 intralesionale (IL) rispetto a una scelta da parte dello Sperimentatore tra chemioterapia sistemica e immunoterapia virale oncolitica intralesionale, nel trattamento del melanoma cutaneo localmente avanzato. L'efficacia sar¿ valutata tramite il confronto della sopravvivenza libera da progressione (PFS) tra tutti i soggetti intent-to-treat (ITT) nei due bracci di trattamento dello studio
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    ¿ Complete response rate (CRR).
    ¿ Duration of complete response.
    ¿ Overall survival (OS).
    ¿ Safety and tolerability.

    Exploratory Objectives
    ¿ Change from Baseline to each visit where the variable is assessed in each of the Skindex-16 self assessment instrument domain scores.
    ¿Change in Investigator assessed lesion bleeding from Baseline to each visit where clinical evaluation or assessment of progression status is performed.
    ¿Change in Investigator assessed lesion ulceration from Baseline.
    ¿Change in Investigator assessed lesion infection from Baseline to each visit where clinical evaluation or assessment of progression status is performed.
    Obiettivi secondari:
    ¿ Tasso di risposta completa (CRR).
    ¿ Durata della risposta completa.
    ¿ Sopravvivenza globale (OS).
    ¿ Sicurezza e tollerabilit¿.

    Obiettivi esploratori
    ¿Cambiamento rispetto ai punteggi del basale area-specifici con lo strumento Skindex-16.
    Cambiamento dal basale nel sanguinamento della lesione valutato dallo Sperimentatore.
    ¿Cambiamento dal basale nell'ulcerazione della lesione valutata dallo Sperimentatore.
    ¿Cambiamento dal basale nell'infezione della lesione valutata dallo Sperimentatore.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 years or older, male or female.
    2. Histologically or cytologically confirmed melanoma.
    3. Recurrent, satellite or in-transit locally advanced cutaneous or subcutaneous melanoma metastases (i.e., AJCC Stage IIIB, IIIC or Stage IV M1a with no active nodal metastases).
    4. At least 1 measurable Target Lesion that can be accurately measured by calipers or computed tomography (CT) consisting of:
    - at least one cutaneous lesion (each lesion = 10 mm in longest diameter or up to 5 lesions having a sum of longest diameters = 10 mm); and/or
    - at least one subcutaneous lesion (each lesion = 10 mm in longest diameter by CT);
    - where Target Lesions should be at least 10 mm from any other lesion.
    5. No lesion > 50 mm in longest diameter; and no more than 50 lesions.
    6. Calculated required PV-10 dose = 15 mL (based on total tumor burden).
    7. Performance Status: ECOG 0-2.
    8. Not a candidate for treatment with an immune checkpoint inhibitor (e.g., failed or did not tolerate prior therapy, or due to co-morbidities, pre-existing autoimmune disease, drug unavailability or standard of care).
    9. Not a candidate for targeted therapy with BRAF or combined BRAF/MEK inhibitors (e.g., failed or did not tolerate prior therapy, BRAF V600 wild-type or due to drug unavailability or standard of care).
    10. Clinical Laboratories: • Absolute neutrophil count (ANC) = 1.5 x 10 9
    /L and platelet count =100 x 10 9 /L. • Creatinine = 3 times the upper limit of normal (ULN). • Estimated creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) = 30 mL/min/1.73 m 2 . • Total bilirubin = 3 times the upper limit of normal (ULN). • Aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) = 5 times the upper limit of normal (ULN). • LDH = 2 times the upper limit of normal (ULN).
    11. Thyroid function abnormality = CTCAE Grade 2.
    12. Candidate for at least one comparator drug:
    • Subjects must be candidates for at least one of the designated comparator drugs.
    1. Età non inferiore a 18 anni, sesso maschile o femminile.
    2. Melanoma istologicamente o citologicamente confermato.
    3. Melanoma cutaneo o sottocutaneo localmente avanzato con metastasi ricorrenti, satellite o in-transit (ovvero AJCC Stadio IIIB, IIIC o Stadio IV M1a senza metastasi attive linfonodali).
    4. Almeno 1 Lesione target misurabile, che possa essere misurata con precisione tramite calibro o tomografia computerizzata (TAC), che consista:
    - di almeno una lesione cutanea (ogni lesion= 10 mm nel diametro più lungo, oppure fino a
    5 lesioni la cui somma totale dei diametri più lunghi sia = 10 mm) e/o
    - di almeno una lesione sottocutanea (ogni lesione >= 10 mm nel diametro più lungo in base alla TAC;
    -dove le Lesioni target devono essere ad almeno 10 mm da qualsiasi altra lesione.
    5. Nessuna lesione > 50 mm nel diametro più lungo; e non più di 50 lesioni.
    6. Dose calcolata necessaria di PV-10 = 15 ml (in base al carico tumorale totale).
    7. Condizioni generali di salute del paziente: ECOG 0-2.
    8. Non candidabilità al trattamento con un inibitore del checkpoint immunitario (ad esempio assenza di risposta o di tollerabilità a precedenti terapie, oppure a causa di comorbilità, preesistente malattia autoimmune, non disponibilità di farmaco o standard di cura).
    9. Non candidabilità a terapia mirata con inibitori di BRAF o inibitori combinati di BRAF/MEK (ad es. assenza di risposta o di tollerabilità a precedenti terapie BRAF V600 wild-type, o per non disponibilità di farmaco o standard di cura).
    10. Analisi di laboratorio:
    • conta assoluta dei neutrofili (ANC) = 1,5 x 109/l e conta piastrinica = 100 x 109/l.
    • Creatinina = 3 volte il limite superiore della norma (ULN).
    • Clearance della creatinina (CrCl) stimata o velocità di filtrazione glomerulare (eGFR)
    stimata = 30 ml/min/1,73 m2.
    •Bilirubina totale = 3 volte il limite superiore della norma (ULN).
    •Aspartato transaminasi (AST), alanina transaminasi (ALT) e fosfatasi alcalina (ALP) = 5 volte il limite superiore della norma (ULN).
    •LDH = 2 volte il limite superiore della norma (ULN).
    11. Anomalia della funzionalità tiroidea = CTCAE Grado 2.
    12. Candidabilità ad almeno un farmaco di confronto:
    •i soggetti devono essere candidati ad almeno uno dei farmaci di confronto indicati.

    E.4Principal exclusion criteria
    1. Presence or history of visceral metastasis.
    2. Presence of active nodal metastases (e.g., radiologic or clinical evidence of current nodal disease).
    3. Presence of more than 50 melanoma lesions.
    4. Radiation therapy to any Study Lesion within 6 weeks of initial study treatment.
    5. Chemotherapy or other systemic cancer therapy within 4 weeks of initial study treatment (6
    weeks for nitrosoureas or mitomycin), or regional chemotherapy (limb infusion or perfusion)
    within 12 weeks of initial study treatment.
    6. Immunotherapy for cancer within 4 weeks of initial study treatment.
    7. Local treatment (e.g., surgery, cryotherapy, laser ablation) to any Study Lesion within 4
    weeks of initial study treatment.
    8. Anti-tumor vaccine therapy within 6 weeks of initial study treatment.
    9. Investigational agents within 4 weeks of initial study treatment.
    10. Concurrent or Intercurrent Illness:
    • Impaired wound healing or other extremity complications due to diabetes mellitus in
    subjects whose Study Lesions are located in an extremity.
    • Severe peripheral vascular disease in subjects whose Study Lesions are located in an
    extremity.
    • Significant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical
    dependence that would, in the opinion of the Investigator, compromise the subject’s
    safety or compliance or interfere with interpretation of study results.
    • Uncontrolled thyroid disease or cystic fibrosis.
    • Clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal,
    gastrointestinal, pulmonary, immunological, endocrine, or central nervous system
    disorders.
    11. Pregnancy: • Female subjects who are pregnant or lactating. • Female subjects who have positive serum pregnancy test taken within
    21 days of study treatment. • Female subjects of child-bearing potential who are unwilling to use highly effective contraception (e.g., combined (estrogen and progestogen containing) or progestogenonly hormonal contraceptives, intrauterine devices, bilateral tubal ligation, vasectomized partner, sexual abstinence or equivalent measures) for the duration of study treatment.
    12. Contraindication for all comparators:
    • Subjects with contraindications to all of the designated comparator drugs.
    1. Metastasi viscerali in atto o pregresse.
    2. Presenza di metastasi linfonodali attive (ad es. evidenza clinica o radiologica di malattia linfonodale).
    3. Presenza di più di 50 lesioni di melanoma.
    4. Radioterapia a qualsiasi Lesione in studio entro 6 settimane dall’inizio del trattamento in studio.
    5. Chemioterapia o altra terapia sistemica per il cancro entro 4 settimane dall’inizio del trattamento in studio (6 settimane per nitrosouree o mitomicina) o chemioterapia regionale (infusione o perfusione in arto) entro 12 settimane dall’inizio del trattamento in studio.
    6. Immunoterapia per il cancro entro 4 settimane dall’ inizio del trattamento in studio.
    7. Trattamento locale (ad es., chirurgia, crioterapia, ablazione laser) a ogni Lesione in studio entro 4 settimane dall’ inizio del trattamento in studio.
    8. Terapia con vaccino anti-tumorale entro 6 settimane dall’inizio del trattamento in studio.
    9. Agenti sperimentali entro 4 settimane dall’inizio del trattamento in studio.
    10. Malattia concomitante o intercorrente:
    •Alterazioni della cicatrizzazione o altre complicazioni agli arti a causa di diabete mellito nei soggetti le cui Lesioni in studio si trovano su un arto.
    •Malattia vascolare periferica grave in soggetti le cui Lesioni in studio si trovano su un arto.
    •Malattia significativa concomitante o intercorrente, disturbi psichiatrici o dipendenza da alcool o da sostanze chimiche che, a giudizio dello Sperimentatore, compromettano la sicurezza o la compliance del soggetto o interferiscano con l'interpretazione dei risultati dello studio.
    • Malattie della tiroide o fibrosi cistica non controllate.
    •Malattie clinicamente significative acute o instabili cardiovascolari, cerebrovascolari (ictus), renali, gastrointestinali, polmonari, immunologiche, endocrine o del sistema nervoso centrale.
    11. Gravidanza:
    •Soggetti di sesso femminile in stato di gravidanza o in allattamento.
    •Soggetti di sesso femminile con test di gravidanza su siero positivo effettuato entro 21 giorni dal trattamento di studio.
    •Soggetti di sesso femminile in età fertile che non siano disposte ad utilizzare metodi contraccettivi altamente efficaci (ad es., contraccettivi ormonali combinati (contenenti estrogeno e progestinico) oppure contraccetivi ormonali a base di solo progestinicoi, dispositivi intrauterini, legatura bilaterale delle tube, partner vasectomizzato, astinenza sessuale o misure equivalenti) per tutta la durata del trattamento in studio.
    12. Controindicazione a tutti i farmaci di confronto:
    •Soggetti con controindicazioni a tutti i farmaci di confronto indicati.

    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is progression-free survival (PFS) in the intent-to-treat (ITT) population. Evaluation of progression will be performed by an Independent Review Committee (IRC) based on RECIST ver. 1.1 criteria. Events signaling progression include increase in size and/or number of Study Lesions, distant or nodal disease progression or death.

    L'endpoint primario dello studio è la sopravvivenza libera da progressione (PFS) nella popolazione intent-to-treat (ITT). La valutazione della progressione verrà effettuata da un Comitato di revisione indipendente (IRC) in base ai criteri del RECIST ver. 1.1. Eventi di segnalazione della progressione includono aumento delle dimensioni e/o del numero di Lesioni in studio, progressione della malattia a distanza o linfonodale o morte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    La valutazione clinica sarà eseguita a intervalli di 28 giorni durante la fase di trattamento dello studio, a partire dalla fine del primo Ciclo di trattamento e a tutte le visite non programmate durante il follow-up. La valutazione complessiva dello stato della progressione verrà eseguita alla fine del Ciclo di trattamento iniziale e ogni 12 settimane, fino a quando non si verifica una progressione della malattia o la sospensione dello studio.
    Clinical evaluation of progression status will be performed at 28-day intervals during the treatment phase of the study, commencing at the end of the first Treatment Cycle, and at any unscheduled visits during follow-up. Comprehensive assessment of progression status will be
    performed at the end of the Initial Treatment Course and every 12 weeks thereafter until disease progression or study discontinuation occurs.
    E.5.2Secondary end point(s)
    Secondary Endpoint Assessments
    Efficacy
    All secondary endpoints involving disease response and progression will be based on the IRC determination.

    ¿ Complete response rate (CRR) of all ITT subjects will be assessed according to RECIST ver. 1.1 criteria [73] at the end of the Initial Treatment Course and every 12 weeks thereafter until disease progression or study discontinuation occurs.

    ¿ Duration of complete response, for all ITT subjects who achieve a complete response, will be assessed based on the time from first documentation of complete response until disease progression.

    ¿ Overall survival (OS) status of all ITT subjects will be assessed by telephone, personal contact (e.g., clinic visit) or other unequivocal documentation of subject status at 12-week intervals commencing at the time of subject transition to Survival Follow-up.
    Tutti gli endpoint secondari che coinvolgono la risposta e la progressione della malattia si baseranno sulla determinazione dell'IRC.

    ¿ Tasso di risposta completa (CRR) valutato secondo i criteri del RECIST ver. 1.1 al termine del Ciclo di trattamento iniziale e ogni 12 settimane fino a progressione della malattia o sospensione dello studio.
    ¿ Durata della risposta completa valutata sulla base del tempo che intercorre tra la prima documentazione di risposta completa e la progressione della malattia.
    ¿ Sopravvivenza globale (OS).

    Per una specifica maggiore vedere la sinossi
    E.5.2.1Timepoint(s) of evaluation of this end point
    see the protocol
    Vedere protocollo
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 No
    E.8.1.6Cross over Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Mexico
    United States
    France
    Germany
    Italy
    Poland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 225
    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)
    Survival Follow-up will be done at 12 week intervals commencing at
    the date of the subject's termination and will continue every 12 weeks
    thereafter until the subject's death or study
    termination.
    La sopravvivenza follow-up sar¿ effettuato a 12 settimane ad intervalli a partire dalla data di fino studio del soggetto e continuer¿ ogni 12 settimane
    da allora in poi fino alla morte o termine dello studio da parte del soggetto.
    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 Decision2017-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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