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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2008-004007-64
    Sponsor's Protocol Code Number:111476
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-31
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-004007-64
    A.3Full title of the trial
    An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma
    A.3.2Name or abbreviated title of the trial where available
    MAGE3-AS15-MEL-001 (MET)
    A.4.1Sponsor's protocol code number111476
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    First-line treatment for patients with unresectable, MAGE-A3-positive stage III or stage IVa melanoma
    MedDRA Classification
    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 clinical activity of the recMAGE-A3 + AS15 ASCI in terms of the 1-year overall survival rate (OSR) in patients with MAGE-A3 positive, unresectable stage III or stage IV M1a melanoma presenting with the gene signature identified as being associated with a clinical benefit in response to treatment with the MAGE-A3 + AS15 ASCI

    (in the remainder of this document this gene signature is referred to as the predictive gene signature)
    E.2.2Secondary objectives of the trial
    To evaluate the clinical activity of and the immunological response to the recMAGE-A3 + AS15 ASCI in the overall patient population and in the populations of patients presenting with and not presenting with, respectivley, the predictive gene signature. The clinical activity will be assessed in terms of the:
    •1-year OSR in the overall patient population and in patients not presenting the predictive gene signature;
    • progression-free survival (PFS);
    • 6-month and 1-year progression-free survival rate (PFSR);
    • median overall survival (OS);
    • Time to Treatment Failure (TTF);
    • overall clinical response rate and the duration of response;
    • The humoral and cellular immune response will be assessed in terms of the immunological response rate;
    • To assess the safety of the recMAGE-A3 + AS15 ASCI in the overall population.
    • To examine the correlation between test results obtained on fresh tumor tissue and on FFPE tissue
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable.
    2. Patients with regional or distant cutaneous, subcutaneous or lymph-node metastasis can be included in the study, provided the disease is not amenable to curative treatment with surgery. In terms of the AJCC 2002 classification, this includes patients with unresectable stage III melanoma including in-transit metastases or patient with stage IV M1a melanoma.
    3. Written informed consent obtained from the patient prior to performance of any study specific procedure.
    4. Patient is at least 18 years old at the time of signature of the informed consent form.
    5. The patient’s tumor expresses MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.
    6. Fresh tissue from the same lesion must be available for MAGE-A3 expression testing and for the testing of the predictive gene signature.
    7. Formalin-fixed paraffin-embedded (FFPE) tissue must be available for complementary MAGE-A3 and gene signature testing. This FFPE tissue should preferably come from the same (reference) lesion as the fresh tissue used for MAGE-A3 and gene signature testing but may be taken from a second lesion during the screening phase if the reference lesion does not provide sufficient tissue.
    8. Patient fully recovered from any previous intervention (i.e., biopsy).
    9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    10. Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria.
    11. 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 at least 30 days prior to registration in the trial, 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.
    12. In the opinion of the investigator, the patient can and will comply with the protocol requirements.
    E.4Principal exclusion criteria
    1. Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.
    2. The patient has at any time received any systemic anticancer treatment.
    • Prior systemic treatment with an immunomodulator (i.e., interferon or/and anti-CTL-A4 therapy) or loco-regional radiotherapy is permitted as prior adjuvant treatment provided that the last dose was administered at least 30 days before the registration into this trial;
    • Previous adjuvant treatment with a cancer vaccine containing a tumor antigen other than MAGE-A3 is allowed if the last administration took place at least 8 weeks before registration into the trial.
    • Prior isolated limb perfusion is permitted provided that the last dose was administered at least 30 days before registration into this trial.
    3. The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.
    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 no more than 0.125 mg/kg/day (absolute maximum 10 mg/day) or topical steroids is permitted.
    5. 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.
    6. The patient has a family history of congenital or hereditary immunodeficiency.
    7. The patient is known to be positive for Human Immunodeficiency Virus (HIV).
    8. History of allergic disease or reactions likely to be exacerbated by any component of the ASCI treatment.
    9. The patient has previous or concomitant malignancies at other sites, except
    • Effectively treated non-melanoma skin cancer or carcinoma in situ of the cervix
    • Effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
    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 an uncontrolled bleeding disorder.
    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. Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first dose of study treatment or planned use during the study period.
    14. Concurrently participating in another clinical study, at any time during the study period, in which the patient has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
    15. For female patients: the patient is pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be survival status 1 year after study entry.
    Secondary endpoints include:
    • Progression-free survival (PFS) defined as the time from the date of registration of the patient to either the date of disease progression or the date of death (for whatever reason), whichever comes first. Patients alive and without disease progression are censored at the date of the last visit/contact;
    • The progression status at 6 months (Week 23) and 1 year (Week 53) after study entry;
    • Overall survival (OS) defined as the time from registration of the patient until death. Patients alive at the time of analysis are censored at the time of the last visit/contact;
    • Time to Treatment Failure (TTF) defined as the time from registration of the patient until the date of the last treatment administration, irrespective of the reason for study treatment discontinuation.
    • Best clinical response;
    • The duration of response for patients with CR, PR or SD status.
    • Anti-MAGE-A3, anti-protein D and anti-CpG titres at the different collection time points;
    • Anti-MAGE-A3, anti-protein D and anti-CpG seropositivity at the different collection time points;
    • Anti-MAGE-A3, anti-protein D and anti-CpG seroconversion at the different collection time points;
    • The MAGE-A3 cellular (T-cell) response (a T-cell responder is defined as a patient with an increased amount of antigen-specific T-cells after immunization as compared to the baseline value). These specific T-cells include the CD4+ or CD8+ T-cells producing cytokines and/or presenting cytolytic activity, and/or specific CD4+ or CD8+ T-cells presenting a particular phenotype (effector/memory)).
    • Occurrence of adverse events up to 30 days after each study dose injection, including abnormal values of haematological and biochemical variables
    • Occurrence of serious adverse events and autoimmunity during the whole duration of the study (up to 30 days after the last administration of the study treatment).
    • The correlation between test results obtained on fresh tumor tissue and on FFPE tissue.
    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 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    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 taking part in 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 months7
    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 months7
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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
    A legally Acceptable Representative of the patient may give informed consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 110
    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 Decision2009-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-01
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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