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    Summary
    EudraCT Number:2014-001146-13
    Sponsor's Protocol Code Number:20110266
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-07
    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 ConcernedGreece - EOF
    A.2EudraCT number2014-001146-13
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Open-label Trial Assessing the Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Resectable, Stage IIIB to IVM1a Melanoma
    «Μία Πολυκεντρική, Τυχαιοποιημένη, Ανοιχτή Μελέτη Φάσης 2 για την Αξιολόγηση της Αποτελεσματικότητας και της Ασφάλειας της Προεγχειρητικής Θεραπείας με Talimogene Laherparepvec σε Συνδυασμό με Χειρουργική Επέμβαση Έναντι Μόνο της Χειρουργικής Επέμβασης για Εξαιρέσιμο Μελάνωμα Σταδίου IIIB έως IVM1a.»
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery versus Surgery alone for Melanoma
    «Αποτελεσματικότητα και ασφάλεια της Προεγχειρητικής Θεραπείας με Talimogene Laherparepvec σε Συνδυασμό με Χειρουργική Επέμβαση Έναντι Μόνο της Χειρουργικής Επέμβασης για Εξαιρέσιμο Μελάνωμα .»
    A.4.1Sponsor's protocol code number20110266
    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 (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@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 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 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.3.9.2Current sponsor codeAMG 678
    D.3.9.3Other descriptive nameTALIMOGENE LAHERPAREPVEC
    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 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 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 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.3.9.2Current sponsor codeAMG 678
    D.3.9.3Other descriptive nameTALIMOGENE LAHERPAREPVEC
    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 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.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
    Resectable, Stage IIIB to IVM1a Melanoma
    Eγχειρήσιμο μελάνωμα σταδίου IIIΒ έως IVM1a
    E.1.1.1Medical condition in easily understood language
    Melanoma
    Μελάνωμα
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10053571
    E.1.2Term 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 estimate the treatment effect of neoadjuvant talimogene laherparepvec plus surgery compared to surgery alone on recurrence-free survival (RFS).
    Η εκτίμηση της θεραπευτικής επίδρασης της προεγχειρητικής θεραπείας με talimogene laherparepvec σε συνδυασμό με χειρουργική επέμβαση σε σύγκριση με μόνο χειρουργική επέμβαση στην ελεύθερη υποτροπής επιβίωση (RFS).
    E.2.2Secondary objectives of the trial
    To estimate the effect of:
    - neoadjuvant talimogene laherparepvec plus surgery compared to surgery alone on 2-year, 3-year, and 5-year RFS
    - neoadjuvant talimogene laherparepvec plus surgery compared to surgery alone on rate of histopathological tumor-free margin (R0) surgical resection
    neoadjuvant talimogene laherparepvec on rate of pathological complete response (pCR)
    - neoadjuvant talimogene laherparepvec plus surgery compared to surgery alone on local recurrence-free survival (LRFS) and distant metastases-free survival (DMFS)
    - neoadjuvant talimogene laherparepvec plus surgery compared to surgery alone on 2-year, 3-year, 5-year, and overall survival (OS)
    To estimate response to neoadjuvant talimogene laherparepvec overall and separately in injected and uninjected lesions during treatment (arm 1 only)
    To evaluate the safety of neoadjuvant talimogene laherparepvec plus surgery compared to surgery alone
    Παρακαλούμε οπως αναφερθείτε στην Αρχική Αϊτηση για Έγκριση καθω΄ς ο χώρος δεν επαρκεί.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female ≥ 18 years of age with histologically confirmed diagnosis of stage IIIB, IIIC or IVM1a melanoma eligible for complete surgical resection. Prior systemic, regional and radiation anticancer therapies for melanoma must have been completed at least 3 months prior to randomization. Subject must have measurable disease and must be a candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion
    (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm. Also, subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and must have a serum lactate dehydrogenase (LDH) ≤ 1.0 X upper limit of normal and adequate hematologic, hepatic, renal, and coagulation organ function.
    Άνδρες ή γυναίκες ηλικίας ≥ 18 ετών με ιστολογικά επιβεβαιωμένη διάγνωση μελανώματος σταδίου IIIB, IIIC ή IVM1a, οι οποίοι είναι κατάλληλοι για πλήρη χειρουργική εκτομή. Οι προηγούμενες συστηματικές, τοπικές αντινεοπλασματικές θεραπείες και αντινεοπλασματικές ακτινοθεραπείες για το μελάνωμα θα πρέπει να έχουν ολοκληρωθεί τουλάχιστον 3 μήνες πριν από την τυχαιοποίηση. Ο ασθενής θα πρέπει να έχει μετρήσιμη νόσο και θα πρέπει να είναι υποψήφιος για χορήγηση θεραπείας εντός της βλάβης με τουλάχιστον μία δερματική, υποδόρια ή λεμφαδενική μελανωματική βλάβη στην οποία μπορούν να χορηγηθούν ενέσεις (≥ 10 mm στη μέγιστη διάμετρο) ή με πολλαπλές βλάβες στις οποίες μπορούν να χορηγηθούν ενέσεις, οι οποίες αθροιστικά έχουν μέγιστη διάμετρο ≥ 10 mm. Επίσης, ο ασθενής θα πρέπει να έχει κατάσταση απόδοσης 0 ή 1 σύμφωνα με τη Συνεργαζόμενη Ογκολογική Ομάδα της Ανατολικής Ακτής των ΗΠΑ (ECOG) και θα πρέπει να έχει επίπεδα γαλακτικής αφυδρογονάσης (LDH) ορού χαμηλότερα από το άνω όριο του φυσιολογικού εύρους και επαρκή αιματολογική, ηπατική, νεφρική και πηκτική οργανική λειτουργία.
    E.4Principal exclusion criteria
    Subject must not have primary ocular or mucosal melanoma, or history or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia). Subject must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease. Subject must not have evidence of clinically significant immunosuppression or active herpetic skin lesions or prior complications of herpes simplex type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis) and must not require intermittent or chronic systemic treatment with an antiherpetic drug
    (eg, acyclovir), other than intermittent topical use. Subject known to have acute or chronic active hepatitis B, hepatitis C, or human immunodeficiency virus infection will also be excluded. Subject must not have been treated previously with talimogene laherparepvec or tumor vaccine.
    Ο ασθενής δεν θα πρέπει να έχει πρωτοπαθές οφθαλμικό μελάνωμα ή μελάνωμα των βλεννογόνων ή ιστορικό ή ενδείξεις μελανώματος σχετιζόμενου με καταστάσεις ανοσολογικής ανεπάρκειας (π.χ. κληρονομική ανοσολογική ανεπάρκεια, μεταμόσχευση οργάνου ή λευχαιμία). Ο ασθενής δεν θα πρέπει να έχει ιστορικό ή ενδείξεις συμπτωματικής αυτοάνοσης πνευμονίτιδας, σπειραματονεφρίτιδας, αγγειίτιδας ή άλλης συμπτωματικής αυτοάνοσης νόσου. Ο ασθενής δεν θα πρέπει να έχει ενδείξεις κλινικά σημαντικής ανοσοκαταστολής ή ενεργών ερπητικών δερματικών βλαβών ή προηγούμενων επιπλοκών λοίμωξης απλού έρπητα τύπου 1 (HSV-1) (π.χ. ερπητική κερατίτιδα ή εγκεφαλίτιδα) και δεν θα πρέπει να χρειάζονται διαλείπουσα ή χρόνια συστηματική θεραπεία με ένα αντιερπητικό φάρμακο (ασυκλοβίρη), εκτός από διαλείπουσα τοπική χρήση. Θα αποκλείονται επίσης οι ασθενείς που είναι γνωστό ότι έχουν οξεία ή χρόνια ενεργό ηπατίτιδα Β, ηπατίτιδα C ή λοίμωξη από τον ιό της ανθρώπινης ανοσολογικής ανεπάρκειας. Ο ασθενής δεν θα πρέπει να έχει λάβει θεραπεία στο παρελθόν με talimogene laherparepvec ή αντινεοπλασματικό εμβόλιο.
    E.5 End points
    E.5.1Primary end point(s)
    Recurrence-free survival (RFS)
    RFS
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analyses for RFS will occur at the later time of either the occurrence of approximately 64 events (local or distant recurrence of melanoma or death) or approximately 2 years after end of randomization. The final analyses will occur approximately 5 years after end of randomization.
    Το χρονικό σημείο της πρωταρχικής ανάλυσης για το RFS θα είναι σε μετέπειτα χρονικό σημείο είτε στην στιγμή εμφάνισης 64 βλαβών (τοπικών ή σε άλλο σημείο του μελανώματος ή θάνατος) είτε περίπου 2 έτη μετά το τέλος της τυχαιοποίησης. Η τελική ανάλυση θα τελεστεί περίπου 5 έτη μετά το τέλος της τυχαιοποίησης.
    E.5.2Secondary end point(s)
    2-year, 3-year, and 5-year RFS
    Rate of histopathology tumor-free margin (R0) surgical resection
    Rate of pCR
    LRFS
    DMFS
    2-year, 3-year and 5-year, and overall survival
    Overall tumor response and tumor response in injected and uninjected lesions
    Subject incidence of treatment-emergent and treatment-related adverse events
    • 2ετής, 3ετής και 5ετής RFS
    • Δείκτης χειρουργικής εκτομής των ιστοπαθολογικά ελεύθερων όγκου ορίων (R0)
    • Δείκτης pCR
    • LRFS
    • DMFS
    • 2ετής, 3ετής, 5ετής και συνολική επιβίωση
    • Συνολική ανταπόκριση όγκου και ανταπόκριση όγκου σε βλάβες στις οποίες χορηγήθηκαν και σε βλάβες στις οποίες δεν χορηγήθηκαν ενέσεις (σκέλος 1 μόνο)
    • Επίπτωση ανεπιθύμητων συμβαμάτων κατά τη διάρκεια της θεραπείας και σχετιζόμενων με τη θεραπεία ανεπιθύμητων συμβαμάτων στους ασθενείς.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis for certain secondary endpoints will be performed using the data from the second interim analysis. The final analyses will occur approximately 5 years after end of randomization.
    Το χρονικό σημείο της πρωταρχικής ανάλυσης για συγκεκριμένα τελικά σημεία θα τελεστεί χρησιμοποιώντας τα δεδομένα από την δευτερεύουσα ενδιάμεση ανάλυση. Η τελική ανάλυση θα τλελεστεί περίπου 5 έτη μετά το τέλος της τυχαιοποίησης.
    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) 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 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 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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Russian Federation
    United States
    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 time when the last subject is assessed or receives an intervention for evaluation in the study. The end of trial will occur when the last subject has had the opportunity to complete the long-term follow-up.
    Όταν ο τελευταίος ασθενής αξιολογηθεί ή λάβει παρέμβαση προς αξιολόγηση στη δοκιμή. Το τέλος της μελέτης θα επέλθει όταν ο τελευταίος ασθενής ολοκληρώσει την τελευταία επίσκεψη μακροχρόνιας παρακολούθησης.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 76
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 102
    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
    Κανένα
    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 Decision2015-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-28
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