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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2014-002834-30
    Sponsor's Protocol Code Number:20120328
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-28
    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 ConcernedAustria - BASG
    A.2EudraCT number2014-002834-30
    A.3Full title of the trial
    A Phase 3b, Multicenter, Open-label, Single-arm, Expanded Access Protocol
    of Talimogene Laherparepvec for the Treatment of Subjects in Europe With
    Unresected Stage IIIB to IVM1c Melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Expanded Access Study of Talimogene Laherparepvec of Subjects in Europe with late stage Melanoma
    A.4.1Sponsor's protocol code number20120328
    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
    Unresectable, Stage IIIB to IVM1c Melanoma
    E.1.1.1Medical condition in easily understood language
    Melanoma
    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 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 provide access of talimogene laherparepvec for subjects with unresected stage IIIB to IVM1c melanoma in select countries in Europe until marketing authorization approval by the European Commission for the treatment of melanoma
    E.2.2Secondary objectives of the trial
    - to describe the treatment-emergent and treatment-related adverse events (including all adverse events, grade ≥ 3 adverse events, serious adverse events, fatal adverse events, adverse events defined as events of interest, and adverse events requiring permanent discontinuation of protocol treatment)
    - to describe the incidence of talimogene laherparepvec DNA detection in lesions suspected to be herpetic in origin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    101 Subject has provided informed consent prior to initiation of any protocol-specific activities/procedures
    102 Male or female age ≥ 18 years at the time of informed consent
    103 Histologically confirmed diagnosis of melanoma
    104 Subject has unresected stage lllB to IVM1c melanoma regardless of prior therapy
    105 Subject who is not eligible for or cannot access ongoing talimogene
    laherparepvec clinical trials
    106 Subject does not qualify for, or cannot access, other comparable or satisfactory alternative therapy for stage IIIB to IVM1c melanoma
    107 Candidate for intralesional therapy (ie, disease is appropriate for direct injection or through the use of ultrasound guidance) defined as one of the following:
    • for a subject not previously treated with talimogene laherparepvec:
    − at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion ≥ 10 mm in longest diameter, or
    − multiple injectable melanoma lesions that in aggregate have a longest diameter of ≥ 10 mm
    • for a subject previously treated with talimogene laherparepvec:
    − at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion must be present (no minimal size criteria)
    108 Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    109 Adequate organ function determined within 35 days prior to enrollment, defined as follows:
    • absolute neutrophil count ≥ 1500/mm3
    • platelet count ≥ 75,000/mm3
    • hemoglobin ≥ 8 g/dL without need for hematopoietic growth factor or
    transfusion support
    • serum creatinine ≤ 1.5 x upper limit of normal (ULN)
    • serum bilirubin ≤ 1.5 x ULN
    • aspartate amino-transferase (AST) ≤ 2.5 x ULN
    • alanine amino-transferase (ALT) ≤ 2.5 x ULN
    • alkaline phosphatase ≤ 2.5 x ULN
    • serum albumin ≥ 2.5 g/dL
    • prothrombin time (PT) or international normalization ratio (INR)≤ 1.5 x ULN*
    • partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN*
    * prolongation in INR, PT, and PTT when the result is from therapeutic
    anticoagulation treatment are permitted for subjects whose injectable lesions are cutaneous and/or subcutaneous such that direct pressure could be applied in the event of excessive bleeding
    110 Serum LDH levels ≤ 1.5 ULN within 35 days prior to enrollment
    111 For a subject who previously received talimogene laherparepvec in another clinical trial, subject must have ended treatment for reason(s) other than disease progression or intolerability to talimogene laherparepvec
    E.4Principal exclusion criteria
    201 Clinically active cerebral metastases. Subjects with up to 3 (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, including Gamma Knife therapy, or craniotomy, with no evidence of progression, and have not required steroids, for at least 2 months prior to enrollment.
    202 Greater than 3 visceral metastases (this does not include lung metastases or nodal metastases associated with visceral organs). For subjects with ≤ 3 visceral metastases, no lesion > 3 cm, and liver lesions must meet RECIST criteria for stable disease for at least 1 month prior to enrollment.
    203 Bone metastases
    204 Primary ocular or mucosal melanoma
    205 History or evidence of symptomatic autoimmune pneumonitis,
    glomerulonephritis, vasculitis, or other symptomatic autoimmune disease
    206 Evidence of clinically significant immunosuppression such as the following:
    • primary immunodeficiency state such as Severe Combined
    Immunodeficiency Disease
    • concurrent opportunistic infection
    • receiving systemic immunosuppressive therapy (> 2 weeks), including oral steroid doses > 10 mg/day of prednisone or equivalent
    207 Active herpetic skin lesions or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis)
    208 Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
    209 Currently receiving treatment with another investigational device or drug study besides talimogene laherparepvec, or less than 28 days since ending treatment with another investigational device or drug study(s)
    210 Other investigational procedures while participating in this protocol are excluded
    211 Known to have acute or chronic active hepatitis B infection
    212 Known to have acute or chronic active hepatitis C infection
    213 Known to have human immunodeficiency virus infection
    214 History of other malignancy within the past 3 years with the following exceptions:
    • malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for
    recurrence by the treating physician
    • adequately treated non-melanoma skin cancer without evidence of disease
    • adequately treated cervical carcinoma in situ without evidence of disease
    • adequately treated breast ductal carcinoma in situ without evidence of disease
    • prostatic intraepithelial neoplasia without evidence of prostate cancer
    • adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
    215 Subject has known sensitivity to any of the products or components to be administered during dosing
    216 Subject likely to not be available to complete all protocol-required visits or procedures, and/or to comply with all required protocol procedures to the best of the subject’s and investigator’s knowledge
    217 History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen medical monitor, if consulted, would pose a risk to subject safety or interfere with the protocol evaluation, procedures or completion
    218 Subject has entered this protocol previously
    219 Female subject is pregnant or breast-feeding, or planning to become pregnant during protocol treatment and through 3 months after the last dose of talimogene laherparepvec
    220 Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during protocol treatment and through 3 months after the last dose of talimogene laherparepvec
    (please note: Women not of childbearing potential are defined as: Any female who is post-menopausal [age > 55 years with cessation of menses for 12 or more months or < than 55 years with postmenopausal status confirmed by follicle-stimulating hormone [FSH] in the postmenopausal range] or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
    E.5 End points
    E.5.1Primary end point(s)
    • incidence of treatment-emergent and treatment-related adverse events (including all adverse events, grade ≥ 3 adverse events, serious adverse events, fatal adverse events, adverse events defined as events of interest, and adverse events requiring permanent discontinuation of protocol drug)
    • incidence of talimogene laherparepvec DNA detection in lesions suspected to be herpetic in origin
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    E.6.5Efficacy No
    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 No
    E.8.1.1Randomised No
    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.8.2.4Number 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 EEA37
    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
    Switzerland
    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 protocol will end when the last subject has had the opportunity to complete the safety follow-up/end of protocol visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months27
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months27
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 125
    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
    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 Decision2015-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
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