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    Summary
    EudraCT Number:2008-001301-42
    Sponsor's Protocol Code Number:111473
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-24
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-001301-42
    A.3Full title of the trial
    An open Phase II study to assess the clinical activity and safety of recMAGE-A3 + AS15 cancer immunotherapeutic in patients with metastatic cutaneous melanoma, and to explore its immunogenic properties, including their relation to tumor infiltration, genomics and proteomics
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study on the clinical activity of cancer immunotherapy in patients with inoperable metastatic cutaneous melanoma
    A.3.2Name or abbreviated title of the trial where available
    MAGE3-AS15-MEL-004 (MET)
    A.4.1Sponsor's protocol code number111473
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00896480
    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 SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge road
    B.5.3.2Town/ cityStockley Park, Uxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442089904466
    B.5.5Fax number442089901234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 namerecMAGE-A3 recombinant protein formulated in AS15 adjuvant
    D.3.2Product code recMAGE-A3 + AS15
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 949885-73-8
    D.3.9.2Current sponsor coderecMAGE-A3 recombinant protein
    D.3.9.3Other descriptive namerecMAGE-A3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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) Yes
    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.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
    Adult patients with histologically proven, measurable metastatic cutaneous melanoma (stage III in transit or unresectable, or stage IV M1a), with documented progressive disease within the 12 weeks before the first administration of study treatment
    E.1.1.1Medical condition in easily understood language
    Adult patients with unresectable metastatic cutaneous melanoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    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
    The clinical objectives of this study are to characterize in patients with MAGE-A3-positive metastatic cutaneous melanoma:
    1.The clinical activity of the study treatment in terms of objective response, stable disease and mixed response.
    2.The clinical activity of the study treatment recMAGE A3 + AS15 in terms of time to treatment failure.
    3.The safety of the study treatment

    The immunological objectivesof the trial are to document the humoral and cellular immune response induced by the study treatment recMAGE A3 + AS15.
    E.2.2Secondary objectives of the trial
    The objectives of the translational research are globally to assess the effects of the study treatment in terms of various biological variables. In detail:
    •To explore epitope spreading in the peripheral blood induced by the study treatment,
    •To explore the evolution of regulatory T cells in the peripheral blood during immunisation by the study treatment,
    •To profile by genetic (microarray) and proteomics evaluations the immunological response to the study treatment,
    •To explore the cross-talk between the patient’s immune system and tumor before and under the study treatment
    •To evaluate the concomitant expression of tumor antigen expression (MAGE A3, MAGE C2, NY ESO 1, LAGE-1, WT1 and PRAME) and of any potential gene profile expression and their evolution during immunization
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient (male or female) has histologically proven, measurable metastatic cutaneous melanoma in one of the following stages according to the American Joint Committee on Cancer classification of 2002:
    –Stage III in transit, or
    –Stage III unresectable, or
    –Stage IV M1a.
    2. There has been documented progression of the patient's disease within the 12 weeks before the first administration of study treatment.
    3. The patient presents at screening with at least three tumor lesions of diameter ≥0.5 mm.
    4. Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
    5. The patient is >18 years of age at the time of signature of informed consent.
    6. The patient's tumor shows expression of MAGE-A3 gene in at least one of the two tumor biopsies performed at baseline.
    7. The patient's ECOG performance status is 0 or 1.
    8. The patient has normal organ functions
    9. If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the treatment administration series.
    10. In the view of the investigator, the patient can and will comply with the requirements of the protocol.
    E.4Principal exclusion criteria
    1. The patient has at any time received systemic (bio-)chemotherapy (except for isolated limb perfusion, as long as this was performed at least 4 weeks before first study treatment administration).
    2. The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy and immunomodulating agents.
    3. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
    [Note: The use of prednisone, or equivalent, <0.125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids for chronic obstructive pulmonary disease or topical steroids is permitted and does not count as fulfilment of this exclusion criterion.]
    4. The patient has received any cancer immunotherapeutic containing a MAGE-A3 antigen or any cancer immunotherapeutic for his/her metastatic disease.
    [Note: Previous adjuvant treatment with a cancer immunotherapeutic containing a tumor antigen other than MAGE-A3 is allowed if the last administration took place at least eight weeks before the first ASCI administration in the present study.]
    5. Use of any investigational or non-registered product (drug or vaccine) other than the study treatment(s) within the 30 days preceding the first dose of study treatment, or planned use during the study period.
    6. The patient has (or has had) previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
    7. History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
    8. The patient has an autoimmune disease such as, but not limited to, neuroinflammatory autoimmune diseases, systemic lupus erythematosus, and inflammatory bowel disease. [Patients with vitiligo are not excluded by this criterion.]
    9. The patient has a family history of congenital or hereditary immunodeficiency.
    10. The patient is known to be positive for the human immunodeficiency virus (HIV).
    11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.
    12. The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
    13. For female patients: the patient is pregnant or lactating.
    14. The patient has an uncontrolled bleeding disorder.
    E.5 End points
    E.5.1Primary end point(s)
    Endpoints for assessment of clinical activity are:
    1. Tumor response (objective response, stable disease, mixed response)
    2. Time to treatment failure (patient withdrawn from study treatment)
    The safety of the study treatment will be assessed in terms of:
    1. Occurrence of ASCI related grade 3/4 adverse events
    2. Occurrence of serious adverse events during the study
    3. Documentation of any toxicity observed
    Endpoints for assessment of immunogenicity are:
    1. Anti-MAGE-A3 seroconversion
    2. Anti-MAGE-A3 antibody concentration
    3. The MAGE-A3 cellular (T-cell) CD4 and CD8 response
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Tumor response Time Frame: After the concluding visit of the last patient.
    2. Time to treatment failure Time Frame: After the concluding visit of the last patient.
    3. Occurrence of of ASCI related grade Grade 3 or 4 adverse events Time Frame: After the concluding visit of the last patient.
    4. Occurrence of serious adverse events Time Frame: After the concluding visit of the last patient.
    5. Occurrence of adverse events Time Frame: After the concluding visit of the last patient.
    6. Immunogenicity Time Frame: At specified time points during the immunization period (20 assessments per patient) and after the concluding visit of the last patient
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Translational research
    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.8.3 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 EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last visit of the last patient undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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.1.1Number of subjects for this age range: 0
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Informed consent may be given by a Legally Acceptable Representative of the patient
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    A plan for treatment after the patient has ended the participation in the trial is not provided for the cancer immunotherapeutics in the metastatic setting. The cancer immunotherapeutics is still under investigation in this study and there is as yet no scientific or clinical rationale for prolonging the immunization treatment
    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 Decision2008-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
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