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    Summary
    EudraCT Number:2019-001906-61
    Sponsor's Protocol Code Number:20180115
    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:2021-06-14
    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 number2019-001906-61
    A.3Full title of the trial
    Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIBIVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy
    Studio di fase 2 su talimogene laherparepvec in associazione a pembrolizumab in soggetti con melanoma non resecabile/metastatico allo stadio IIIB-IVM1d, la cui malattia è progredita durante la precedente terapia a base di anti-PD-1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to Evaluate the efficacy of Talimogene Laherparepvec when it is used in combination with Pembrolizumab for subjects with Melanoma
    Studio per valutare l'efficacia di talimogene laherparepvec quando utilizzato in associazione a pembrolizumab in soggetti con melanoma
    A.3.2Name or abbreviated title of the trial where available
    MASTERKEY-115
    MASTERKEY-115
    A.4.1Sponsor's protocol code number20180115
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04068181
    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
    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.3.1Product 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 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 number10000000
    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 numberClassified as a Gene 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
    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.3.1Product 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 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 Yes
    D.3.11.3.5.1CAT classification and reference numberClassified as a Gene 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: 3
    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 Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    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 nameKeytruda
    D.3.2Product code [MK-3475]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Yes
    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 namePrednisone
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form 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 INNPREDNISONE
    D.3.9.1CAS number 53-02-2
    D.3.9.2Current sponsor codePREDNISONE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Unresectable/Metastatic Stage IIIB-IVM1d Melanoma
    Melanoma non resecabile/metastatico allo stadio IIIB-IVM1d
    E.1.1.1Medical condition in easily understood language
    A type of cancer that develops from the pigment-containing cells known as melanocytes
    tipologia di cancro che si sviluppa da cellule contenenti pigmento conosciute come melanociti
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of Talimogene laherparepvec in combination with pembrolizumab as assessed by objective response rate (ORR) in subjects with unresectable/metastatic stage IIIB-IVM1d melanoma who have progressed on prior anti-PD-1 therapy
    Valutare l’efficacia di talimogene laherparepvec in associazione a pembrolizumab, valutata tramite il tasso di risposta obiettiva (ORR) in soggetti con melanoma non resecabile/metastatico allo stadio IIIB-IVM1d, la cui malattia è progredita con la precedente terapia anti-PD-1
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab, as assessed by:
    o Complete response rate (CRR), best overall response, (BOR) durable response rate, (DRR) duration of response, (DOR) and disease control rate, (DCR)
    o ORR using modified irRC-RECIST
    o Progression free survival (PFS)
    o Overall survival (OS)

    -To evaluate the safety of talimogene laherparepvec in combination with pembrolizumab as assessed by incidence of treatment-emergent and treatment-related adverse events, and abnormal laboratory tests in patients who have progressed on prior anti-PD-1 therapy
    -To evaluate time to subsequent anti-cancer therapy
    - Valutare l’efficacia di talimogene laherparepvec in associazione a pembrolizumab, valutata mediante:
    o Tasso di risposta completa (CRR), migliore risposta globale (BOR), tasso di risposta durevole (DRR), durata della risposta (DOR) e tasso di controllo della
    malattia (DCR)
    o ORR utilizzando i criteri modificati irRC-RECIST
    o Sopravvivenza libera da progreprogressione (PFS)
    o Sopravvivenza globale (OS)

    - Valutare la sicurezza di talimogene laherparepvec in associazione a pembrolizumab in base all’incidenza degli eventi avversi emersi durante il trattamento e correlati al trattamento, e delle anomalie nei test di laboratorio dei pazienti la cui malattia è progredita con la precedente terapia anti-PD-1
    - Valutare il tempo trascorso prima della successiva terapia antitumorale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    This study will enroll subjects
    -who are male or female age > 18 years at the time of informed consent
    -with histologically confirmed diagnosis of melanoma (unresectable or metastatic stage IIIB, IIIC, IIID, IVM1a, IVM1b, IVM1c, or IVM1d melanoma).
    - Subjects with stage IVM1d and up to 3 cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, or gamma knife therapy, with no evidence of progression and not requiring steroids for at least 2 months prior to enrollment.
    -Subjects must have measurable disease and be a candidate for intralesional therapy.
    -Subjects must have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
    -Adequate hematologic, hepatic, renal, and coagulation function.
    - Subject must also have received prior anti-PD-1 therapy for at least 2 to 3 consecutive cycles within an 8 week period and have disease progression as defined by RECIST v1.1 criteria.
    Note: subjects with prior treatment and disease progression on more than 1 line of anti-PD-1 therapy are excluded.
    in questo studio verranno arruolati soggetti
    - di sesso maschile o femminile di età >18 anni al momento della firma del consenso informato
    - con diagnosi istologicamente confermata di melanoma (melanoma non resecabile o metastatico allo stadio IIIB, IIIC, IIID, IVM1a, IVM1b, IVM1c o IVM1d)
    - con stadio IVM1d e fino a 3 metastasi cerebrali possono essere arruolati, a condizione che tutte le lesioni siano state adeguatamente trattate con radioterapia stereotassica, craniotomia o trattamento con Gamma Knife, senza evidenze di progressione, e che non abbiano necessitato di steroidi per almeno 2 mesi prima dell’arruolamento
    - che devono presentare malattia misurabile ed essere candidati alla terapia intralesionale
    - che devono avere un performance status ECOG (Eastern Cooperative Oncology Group) pari a 0 o 1
    - che devono avere un’adeguata funzionalità ematologica, epatica, renale e coagulativa
    - che devono inoltre aver ricevuto una pregressa terapia anti-PD-1 per almeno 2-3 cicli consecutivi entro un periodo di 8 settimane e una progressione di malattia definita secondo i criteri RECIST v1.1.
    Nota. i soggetti con una precedente terapia e progressione di malattia su più di una linea di trattamento anti PD-1 sono esclusi.
    E.4Principal exclusion criteria
    -Subjects must not have clinically active cerebral melanoma metastases and/or carcinomatous meningitis.
    -Subjects must not have primary uveal or mucosal melanoma, history or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia), or history of other malignancy within the past 3 years with the exceptions noted in Section 6.2 of the protocol.
    -Subjects must not have been previously treated with talimogene laherparepvec, any other oncolytic viruses, or tumor vaccine (unless administered in the adjuvant setting).
    -Subjects must not have a history or evidence of symptomatic autoimmune glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, or active autoimmune disease or syndrome that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
    except vitiligo or resolved childhood asthma/atopy.
    -Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    -Subjects must not have active herpetic skin lesions or prior complications of herpetic infection (eg, herpetic keratitis or encephalitis) and must not require intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
    - I soggetti non devono presentare metastasi cerebrali clinicamente attive di melanoma e/o meningite carcinomatosa.
    - I soggetti non devono presentare melanoma primitivo uveale o delle mucose, anamnesi o evidenze di melanoma associato a stati di immunodeficienza (ad es. immunodeficienza ereditaria, trapianto d’organi o leucemia), o anamnesi positiva per altre neoplasie maligne negli ultimi 3 anni, escluse quelle indicate alla Sezione 6.2.
    - I soggetti non devono essere stati trattati in precedenza con talimogene laherparepvec, con qualsiasi altro virus oncolitico o vaccino antitumorale (a meno che non sia stato somministrato in ambito adiuvante).
    - I soggetti non devono presentare un’anamnesi o evidenze di glomerulonefrite o vasculite autoimmuni sintomatiche,
    oppure di altre patologie autoimmuni sintomatiche, o di malattie o sindromi autoimmuni attive che abbiano richiesto un trattamento sistemico negli ultimi 2 anni (ad es. con agenti modificanti la malattia, corticosteroidi o farmaci immunosoppressori) a eccezione della vitiligine o dell’asma/atopia infantile risolta
    - La terapia sostitutiva (ad es. terapia sostitutiva con tiroxina, insulina o corticosteroidi fisiologici per insufficienza surrenalica o ipofisaria, ecc.) non è considerata una forma di trattamento sistemico.
    - I soggetti non devono presentare lesioni cutanee erpetiche o complicanze pregresse di infezione erpetica (ad es. cheratite o encefalite erpetica) e non devono necessitare di un trattamento cronico o intermittente con un antierpetico (ad es. aciclovir), se non per uso topico intermittente.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response (complete response [CR]+partial response [PR]) (by investigator assessment using modified Response Evaluation Criteria in Solid Tumor [RECIST v1.1])
    Risposta globale (risposta completa [CR]+risposta parziale [PR]) (secondo la valutazione dello sperimentatore utilizzando i criteri
    di valutazione della risposta nei tumori solidi modificati [RECIST v1.1])
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Efficacy analysis will be performed on the Full Analysis Set (FAS) defined as all enrolled subjects who received at least 1 dose of talimogene laherparepvec and at least 1 dose of pembrolizumab in combination and the Per Protocol Analysis Set (PPAS). The PPAS is a subset of the FAS and includes subjects who do not have important protocol deviations that are considered to have an impact on efficacy outcomes.
    Analisi di efficacia verranno eseguite sul Full Analysis Set (FAS) definito come tutti i soggetti arruolati che hanno ricevuto almeno una dose di talimogene laherparepvec e una dose di pembrolizumab in associazione e il Per Protocol Analysis Set (PPAS). Il PPAS è un sottoinsieme del FAS e comprende soggetti che non hanno importanti deviazioni rispetto al protocollo e che si ritiene abbiano un impatto sui risultati di efficacia
    E.5.2Secondary end point(s)
    - Complete response, BOR, durable response, DOR, and disease control,, (investigator assessment using modified RECIST v1.1 and modified irRC-RECIST) and overall response using modified irRC-RECIST by investigator assessment
    -PFS (by investigator assessment using modified RECIST v1.1 and modified irRC-RECIST)
    -OS
    -Incidence of treatment-emergent and treatment-related adverse events (all adverse events, grade > = 3 adverse events, serious adverse events, fatal adverse events, adverse events defined as events of interest), and abnormal laboratory tests
    -Time to subsequent anti-cancer therapy
    - Risposta completa, BOR, risposta duratura, DOR e controllo della malattia (valutazione dello sperimentatore utilizzando i criteri RECIST v1.1 e irRC-RECIST modificati) e risposta globale utilizzando i criteri irRC-RECIST per la valutazione dello sperimentatore
    - PFS (valutazione dello sperimentatore utilizzando i criteri RECIST v1.1 e irRC-RECIST modificati)
    - OS
    - Incidenza degli eventi avversi emersi durante il trattamento e correlati al trattamento (tutti gli eventi avversi, eventi avversi di grado > = 3, eventi avversi seri, eventi avversi fatali ed eventi avversi definiti come eventi di interesse) e delle anomalie nei test di laboratorio
    - Tempo trascorso prima della successiva terapia anti-tumorale
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Efficacy analysis will be performed on the Full Analysis Set (FAS) defined as all enrolled subjects who received at least 1 dose of talimogene laherparepvec and at least 1 dose of pembrolizumab in combination and the Per Protocol Analysis Set (PPAS). The PPAS is a subset of the FAS and includes subjects who do not have important protocol deviations that are considered to have an impact on efficacy outcomes.
    - The Safety Analysis Set (SAS), defined as all enrolled subjects who received at least 1 dose of talimogene laherparepvec or pembrolizumab, will be used in the analysis of the safety endpoints.
    - Analisi di efficacia verranno eseguite sul Full Analysis Set (FAS) definito come tutti i soggetti arruolati che hanno ricevuto almeno una dose di talimogene laherparepvec e una dose di pembrolizumab in associazione e il Per Protocol Analysis Set (PPAS). Il PPAS è un sottoinsieme del FAS e comprende soggetti che non hanno importanti deviazioni rispetto al protocollo e che si ritiene abbiano un impatto sui risultati di efficacia.
    - La Safety Analysis Set (SAS), definita come tutti i soggetti arruolati che hanno ricevuto 1 dose di talimogene laherparepvec o pembrolizumab, verrà utilizzata nelle analisi di sicurezza degli endpoints
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 No
    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 EEA38
    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
    France
    Germany
    Greece
    Italy
    Netherlands
    Poland
    Spain
    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 end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), following any additional parts in the study (eg, long-term follow-up), as applicable.
    La data di fine studio è definita come la data in cui l'ultimo soggetto tra tutti i siti viene valutato o riceve un intervento per la valutazione nello studio (es LSLV), a seguito di eventuali parti aggiuntive nello studio (es follow-up a lungo termine), dove applicabile.
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 100
    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)
    None
    Nessuno
    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 Decision2020-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
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