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    Summary
    EudraCT Number:2015-003196-29
    Sponsor's Protocol Code Number:20120139
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-15
    Trial results View 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 number2015-003196-29
    A.3Full title of the trial
    A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects
    Who Previously Received Talimogene Laherparepvec in Amgen or BioVEXSponsored
    Clinical Trials
    Studio di registro per valutare la sopravvivenza e la sicurezza a lungo termine dei soggetti precedentemente trattati con talimogene laherparepvec in studi clinici sponsorizzati da Amgen o da BioVEX
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Registry study to evaluate the survival and long-term safety of subjects
    who have received at least one dose of talimogene laherparepvec in Amgen
    or BioVEX-sponsored clinical trial.
    Studio di registro per valutare la sopravvivenza e la sicurezza a lungo termine dei soggetti precedentemente trattati con talimogene
    laherparepvec in studi clinici sponsorizzati da Amgen o da BioVEX
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number20120139
    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 SponsorAMGEN 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 supportAmgen INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.r.l.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressVia Tazzoli 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number0039026241121
    B.5.5Fax number0039026241121
    B.5.6E-mailmedicalinformationitaly@amgen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name IMLYGIC - 1X 10E8 PFU/ML - SOLUZIONE INIETTABILE - USO INTRALESIONALE - FLACONCINO (POLIMERO CICLOOLEFINICO) 1 ML - 1 X 10E8 PFU/ML
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN EUROPE B.V.
    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 nameTalimogene Laherparepvec
    D.3.2Product code AMG 678
    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 codeAMG 678
    D.3.9.4EV Substance CodeSUB130338
    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 number1000000
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberGene Therapy Medicinal Product EMA/CAT/451866/2012
    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: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name IMLYGIC - 1X 10E8 PFU/ML - SOLUZIONE INIETTABILE - USO INTRALESIONALE - FLACONCINO (POLIMERO CICLOOLEFINICO) 1 ML - 1 X 10E8 PFU/ML
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN EUROPE B.V.
    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 nameTalimogene Laherparepvec
    D.3.2Product code AMG 678
    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 codeAMG 678
    D.3.9.4EV Substance CodeSUB130338
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberGene Therapy Medicinal Product EMA/CAT/451866/2012
    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
    Any tumor type eligible for treatment with talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial
    Qualsiasi tipo di tumore ammissibile al trattamento con talimogene laherparepvec in sperimentazione clinica sponsorizzata da Amgen o BioVEX
    E.1.1.1Medical condition in easily understood language
    Any tumor type eligible for treatment with talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial
    Qualsiasi tipo di tumore ammissibile al trattamento con talimogene laherparepvec in sperimentazione clinica sponsorizzata da Amgen o BioVEX
    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 LLT
    E.1.2Classification code 10053571
    E.1.2Term Melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety of talimogene laherparepvec
    ¿ To monitor subject overall survival
    ¿ To monitor use of subsequent anti-cancer therapy, for the tumor
    indication in the prior Amgen or BioVEX-sponsored clinical trial,
    including retreatment with marketed talimogene laherparepvec in subjects previously enrolled in Amgen or BioVEX-sponsored clinical trials
    Per valutare la sicurezza a lungo termine di talimogene laherparepvec:
    ¿ Monitorare la sopravvivenza complessiva del soggetto
    ¿ Monitorare l'uso della successiva terapia anti-cancro, per l¿indicazione del tumore
    nella precedente sperimentazione clinica sponsorizzata da Amgen o BioVEX,
    compreso il ritrattamento con talimogene laherparepvec commercializzato in
    soggetti precedentemente arruolati in studi clinici sponsorizzati da Amgen o BioVEX
    E.2.2Secondary objectives of the trial
    There are no secondary objectives
    Non vi sono obiettivi secondari
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. All subjects must provide informed consent prior to initiation of any
    study activities. When the subject is legally too young to provide
    informed consent/assent, subject's legally acceptable representative
    must provide informed consent/assent based on local regulations
    and/or guidelines prior to initiation of any study activities
    2. All subjects must have received at least one dose of talimogene
    laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any
    tumor type and must have discontinued treatment and participation,
    including long-term follow-up (if applicable) in that trial
    1. Tutti i soggetti devono fornire un consenso informato prima di iniziare qualsiasi
    attività dello studio. Quando il soggetto è legalmente troppo giovane per fornire
    consenso/assenso informato, il rappresentante legalmente accettabile del soggetto
    deve fornire consenso/assenso informato in base alle locali
    normative e/o linee guida prima di iniziare qualsiasi attività dello studio
    2. Tutti i soggetti devono avere ricevuto almeno una dose di talimogene
    laherparepvec in uno studio clinico sponsorizzato da Amgen o BioVEX
    per un qualsiasi tipo di tumore e devono aver interrotto il trattamento e la partecipazione,
    compreso il follow-up a lungo termine (se applicabile) in quello studio
    E.4Principal exclusion criteria
    1. Subjects currently receiving talimogene laherparepvec in Amgen or
    BioVEX-sponsored clinical trial
    2. Subject currently participating, including for long-term follow-up (if
    applicable), in other Amgen-sponsored talimogene laherparepvec clinical
    trial.
    1. Soggetti attualmente in terapia con laurparepvec talimogene in studi clinici sponsorizzati da Amgen o da BioVEX
    2. Soggetti attualmente partecipante, anche per follow-up a lungo termine (se
    applicabile), in altri studi clinici di lahnparepvec talimogene sponsorizzati da Amgen
    E.5 End points
    E.5.1Primary end point(s)
    laherparepvec treatment-related adverse events of any grade, grade . 3
    adverse events, serious adverse events, fatal adverse events, and
    adverse events of interest that begin after the defined reporting period
    has ended on the previous Amgen or BioVEX-sponsored talimogene
    laherparepvec clinical trial will be summarized. Treatment-related
    adverse events during the retreatment period with marketed talimogene
    laherparepvec and up to 30 days after the discontinuation of treatment
    will be reported separately.
    . Survival status: Time to death will be calculated from the first dose of
    talimogene laherparepvec from the earliest parent study.
    . Use of subsequent anti-cancer therapy for indicated tumor type in prior
    Amgen or BioVEX-sponsored talimogene laherparepvec clinical trial will be summarized.
    - Sicurezza a lungo termine, valutata per incidenza di tutti i casi di eventi avversi di talimogene di laherparepvec correlati al trattamento di qualsiasi grado, grado 3
    eventi avversi, gravi eventi avversi, eventi avversi fatali e
    eventi avversi di interesse che iniziano dopo il periodo di riferimento definito
    e finito del precedente studio clinico di talimogene laherparepvec sponsorizzato da Amgen o BioVEX che sarà sintetizzata. Eventi avversi correlati al trattamento
    durante il periodo di ripresa con il talimogene laherparepvec commercializzato
    e fino a 30 giorni dopo la sospensione del trattamento che verranno segnalati separatamente.
    - Stato di sopravvivenza: Il tempo a morte sarà calcolato dalla prima dose di
    talimogene laherparepvec dal primo studio genitore.
    - Uso della successiva terapia anti-cancro per il tipo di tumore indicato nel precedente
    studio clinico sponsorizzato da Amgen o BioVEX con talimogene laherparepvec che sarà sintetizzato.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis will be performed at the end of study. The registry
    study will end when the sponsor (in consultation with the regulatory
    authorities) has determined that the collection of long-term safety and
    survival data are no longer necessary.
    L'analisi primaria verrà eseguita alla fine dello studio. Il Registro dello
    studio terminerà quando lo sponsor (in consultazione con le autorità
    regolatorie) ha stabilito che la raccolta di sicurezza a lungo termine e
    i dati di sopravvivenza non sono più necessari.
    E.5.2Secondary end point(s)
    There are no secondary endpoints
    Non vi sono endpoints secondari
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Studio osservazionale di registro
    Observational registry study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA31
    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
    Canada
    Russian Federation
    United States
    Austria
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Poland
    Spain
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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
    The registry study will end when the sponsor (in consultation with the
    regulatory authorities) has determined that the collection of long-term safety and survival data are no longer necessary.
    Lo studio di registro terminer¿ quando lo sponsor (in consultazione con le autorit¿
    regolatorie) ha stabilito che la raccolta di sicurezza a lungo termine e i dati di sopravvivenza non sono pi¿ necessari.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years12
    E.8.9.2In all countries concerned by the trial months11
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 200
    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)
    NA
    NA
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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