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    Summary
    EudraCT Number:2008-002447-16
    Sponsor's Protocol Code Number:111482
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-11-13
    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 ConcernedSweden - MPA
    A.2EudraCT number2008-002447-16
    A.3Full title of the trial
    A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 ASCI as adjuvant therapy in patients with MAGE-A3 positive resected stage III melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III Study to Test the Benefit of a New Kind of Anti-cancer
    Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor.
    A.3.2Name or abbreviated title of the trial where available
    MAGE3-AS15-MEL-005 (ADJ)
    A.4.1Sponsor's protocol code number111482
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00796445
    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 Belgium
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithkline Biologicals Belgium
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street Addressrue de l'Institut 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number+442089904466
    B.5.5Fax number--------
    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.3.8INN - Proposed INN-
    D.3.9.1CAS number 949885-73-8
    D.3.9.2Current sponsor coderecMAGE-A3
    D.3.9.3Other descriptive namerecMAGE-A3 recombinant protein
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for suspension for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with histologically proven stage IIIB or IIIC cutaneous melanoma with macroscopic lymph node involvement suitable for surgical resection. Macroscopic lymph node involvement is defined as clinically detectable lymph node metastases confirmed by pathological examination following therapeutic lymphadenectomy
    E.1.1.1Medical condition in easily understood language
    Adult patients with resectable Melanoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    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 demonstrate the clinical efficacy in terms of disease-free survival (DFS) of the recMAGE-A3 + AS15 ASCI compared to placebo in the overall population of patients with completely resected stage III melanoma with macroscopic lymph node involvement
    -To demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favourable gene expression signature.
    E.2.2Secondary objectives of the trial
    To evaluate DFS in the population of patients who do not present he potentially favorable gene signature (GS);
    To evaluate overall survival in the overall and GS (sub-)populations;
    To evaluate the disease-free specific survival in the overall and GS (sub-)populations;
    To evaluate the distant metastasis-free survival in in the overall and GS (sub-)populations;
    To evaluate the 1-year, 2-year, 3-year and 4-year DFS rates in the overall and GS (sub-)populations;
    To validate the predictive value of the GS by evaluating the association between treatment outcome (DFS) and GS status;
    To evaluate the ASCI wrt safety and other clinical and biological indicators of efficacy in in the overall and GS (sub-)populations;
    To evaluate the immune response to the ASCI in in the overall and GS (sub-)populations;
    To evaluate and compare the changes in health-related quality of life in patients treated with recMAGE-A3 + AS15 ASCI to those treated with placebo using the EuroQoL-5D questionnaire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent for MAGE-A3 expression screening and gene expression profiling on resected tumor tissue has been obtained from the patient prior to shipment of the sample for expression testing and gene expression profiling, and written informed consent for the complete study has been obtained prior to the performance of any other protocol-specific procedure.
    2.Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery. In terms of the AJCC classification, this means that patients with T1-4a N1-2b M0 (stage IIIB with macroscopic nodal involvement) and patients with T1-4b N1-2bM0 or any TN3 macroscopic M0 (>= 4 macroscopic nodes or macroscopic matted nodes) may be enrolled. Macroscopic lymph-node involvement is defined as clinically detectable lymph node metastases confirmed by pathological examination following therapeutic lymphadenectomy (including nodal metastasis exhibiting gross extracapsular extension). Clinical detection includes the diagnosis by any imaging technique or physical examination and gross lymph node examination by a pathologist. Patients with unknown primaries are eligible for the study.
    3.The patient must have been surgically rendered free of disease no more than 9 weeks before the randomization. For patients undergoing an elective dissection followed by a lymphadenectomy, the date of the radical lymphadenectomy is considered the day when the patient is free of disease and will be taken as the reference point to count the 9-week interval. In the case where a first surgery does not render the patient free of disease a second surgery may be performed. The patient will still be eligible if a complete lymphadenectomy of the same lymphatic basin is performed.
    4.Patient is >= 18 years old at the time of signing the informed consent form.
    5.The patient’s lymph node tumor shows expression of the MAGE-A3 gene, as determined by RT-PCR analysis on formalin-fixed paraffin-embedded (FFPE) tissue.
    6.The patient has fully recovered from surgery.
    7.ECOG performance status of 0 or 1 at the time of randomization.
    8.The patient must have adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria.
    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 randomization, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the injection series.
    10.In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol.

    E.4Principal exclusion criteria
    1.The patient suffers from a mucosal or ocular melanoma.
    2.The patient has or has had any history of in-transit metastases(N2c or N3).
    3.The patient has been treated or is scheduled to be treated with an adjuvant anti-cancer therapy except for the following:
    •Prior systemic treatment with an immunomodulator (i.e., interferon and/or anti-CTL-A4) following a previous surgery, provided that a wash-out period of 30 days before randomization in the present trial is respected.
    •Previous radiotherapy, provided that the treatment has been completed before the lymphadenectomy that qualifies the patient for participation in the present trial
    4.The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents.
    The use of prednisone, or equivalent, at a dose of < 0.125 mg/kg/day (absolute maximum 10 mg/day) or topical steroids and inhaled corticosteroids is permitted.
    5.Use of any investigational or non-registered product (drug or vaccine) other than the study treatment within 30 days preceding the randomization or planned use during the study period.
    6.The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
    7.The patient has a family history of congenital or hereditary immunodeficiency.
    8.The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
    9.History of allergic disease or reactions likely to be exacerbated by any component of the treatments.
    10.The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
    11.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.
    12.The patient has previous or concomitant malignancies at other sites (including carcinoma in situ but not melanoma in situ), except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
    13.The patient has an uncontrolled bleeding disorder.
    14.For female patients: the patient is pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is Disease Free Survival (DFS), defined as the time from randomization to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurs first.
    •Types of recurrence to be considered as an event include loco-regional and distant metastases.
    •In addition, any death occurring without prior documentation of tumor recurrence will be considered as an event (and will not be censored in the statistical analysis) as this approach is less prone to introduce bias.
    •If no event has occurred by the time of the analysis, then the time to event will be censored at the date of the last assessment of the patient in question.
    •Any new primary cancer at another site, including second primary melanoma, will not be considered as a recurrence.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease Free Survival: Once the pre-defined number of events is reached
    E.5.2Secondary end point(s)
    •Overall Survival
    •Disease-free specific survival
    •Distant metastasis-free survival
    •Anti-MAGE-A3 and anti-protein D seropositivity status
    •Occurrence of adverse events including abnormal haematological and
    biochemical parameters.
    •Occurrence of serious adverse events and autoimmunity events
    •Health-related quality of life (utility) assessment using the EuroQoL 5D
    (EQ-5D) questionnaire.
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Overall Survival : At the time of analysis
    •Disease-free specific survival : At the time of analysis
    •Distant metastasis-free survival : At the time of analysis
    •Anti-MAGE-A3 and anti-protein D seropositivity status: Post-treatment
    and 1 year after concluding visit
    •Occurrence of adverse events including abnormal haematological and
    biochemical parameters.: Up to 30 days after each study dose.
    •Occurrence of serious adverse events and autoimmunity events: During
    the whole study duration up to 30 days after the last administration of
    study treatment
    •Health-related quality of life (utility) assessment using the EuroQoL 5D
    (EQ-5D) questionnaire : At regular intervals from Visit 1 (baseline) till 6
    months after the concluding visit or 1 year post-recurrence
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA161
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    Estonia
    France
    Germany
    Greece
    Ireland
    Israel
    Italy
    Japan
    Korea, Democratic People's Republic of
    Mexico
    Netherlands
    Norway
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Sweden
    Switzerland
    Taiwan
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 taking part in the trial
    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 months9
    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 months9
    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: 910
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 390
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 820
    F.4.2.2In the whole clinical trial 1300
    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)
    Expected normal 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 Decision2009-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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