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    The EU Clinical Trials Register currently displays   37219   clinical trials with a EudraCT protocol, of which   6124   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2008-001918-25
    Sponsor's Protocol Code Number:111714
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-12-11
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-001918-25
    A.3Full title of the trial
    An open Phase I/II study of immunization with the recMAGE-A3 + AS15 Antigen Specific Cancer Immunotherapeutic in association with dacarbazine in patients with MAGE-A3 positive unresectable and progressive metastatic cutaneous melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Safety and Clinical Activity of Cancer Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients
    A.3.2Name or abbreviated title of the trial where available
    MAGE3-AS15-MEL-002 (MET-chemo)
    A.4.1Sponsor's protocol code number111714
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00849875
    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.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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    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.5.4Telephone number442089904466
    B.5.5Fax number442089901234
    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 INNrecMAGE-A3
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Patients with unresectable and progressive metastatic cutaneous melanoma, whose tumor expresses MAGE-A3.
    E.1.1.1Medical condition in easily understood language
    Patients with 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
    Co-primary objectives of this study are to characterize in the overall population and in the gene signature subsets:
    • To assess the safety of recMAGE-A3 + AS15 in association with dacarbazine in patients with MAGE-A3-positive metastatic cutaneous melanoma, with emphasis on any possible toxic effects.
    • To assess the specific humoral and cellular immune response induced by the recMAGE-A3 + AS15 in association with dacarbazine in patients with MAGE-A3-positive metastatic cutaneous melanoma.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to characterize in the overall population and in the gene signature subsets
    • To assess the clinical activity of recMAGE-A3 + AS15 in association with dacarbazine in patients with MAGE-A3-positive metastatic cutaneous melanoma.
    • To assess other indicators of safety.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patient with histologically proven, measurable metastatic cutaneous melanoma.
    According to the American Joint Committee on Cancer 2002 classification, all melanoma patients with stage IV M1b and stage IV M1c with serum lactate dehydrogenase (LDH) <= 1.5 Upper Normal Limit and no involvement of the central nervous system (CNS) are candidates for inclusion.
    2. Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure. Note: Procedures performed before obtaining this informed consent and that are part of standard institution practices or of another clinical research study are accepted provided protocol intervals are observed.
    3. Patient is >= 18 years of age at the time of signature of the Informed Consent.
    4. The patient’s tumor shows expression of MAGE-A3 antigen, detected by Reverse-Transcription Polymerase Chain Reaction (RT-PCR). A tumor biopsy performed in the context of institution standard practice or another research study may be used for the MAGE-A3 testing (or the use of the result of the MAGE-A3 testing) provided this biopsy was preserved in RNAlater, was taken no more than 12 weeks before the first administration of study treatment and after obtention of the Sponsor’s agreement.
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    6. The patient has normal organ functions
    7. 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.
    8. In the view of the investigator, the patient can and will comply with all the study procedures
    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 the
    first study treatment administration).
    2. The patient is scheduled to receive any other anticancer treatments than those
    specified in the protocol, including but not limited to (bio-)chemotherapeutic,
    immunomodulating agents and radiotherapy.
    3. The patient requires concomitant treatment with systemic corticosteroids, or any
    other immunosuppressive agents.
    The use of prednisone, or equivalent, < 0.125 mg/kg/day (absolute maximum
    10 mg/day), or inhaled corticosteroids for chronic obstructive pulmonary disease
    (COPD), or topical steroids is permitted.
    4. The patient 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 8 weeks before the first study treatment administration.
    5. The patient has received any investigational or non-registered drug or vaccine other
    than the study medication within the 30 days preceding the first dose of study
    treatment, or plans to receive such a drug 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, multiple sclerosis,
    lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
    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 trial 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)
    The two co-primary endpoints are:
    • Safety of the ASCI injections assessed in terms of the:
    – Occurrence of ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
    – Occurrence of serious adverse events during the study.

    • Immunogenicity will be judged primarily after the fourth dose of ASCI:
    – The anti-MAGE-A3 seroconversion and concentration.
    – The anti-protein D seroconversion and concentration.
    – The MAGE-A3 cellular (T-cell) response.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Occurrence of ASCI-related grade 3/4 adverse events: After the concluding visit of the last patient

    Occurrence of serious adverse events during the study: After the concluding visit/contact of the last patient

    Immunogenicity:At regular intervals during the treatment period (9 assessments per patient) and after the concluding visit of the last patient
    E.5.2Secondary end point(s)
    Secondary Endpoints are to measure:

    -The rate of objective response (complete and partial)
    -The rate of stable disease
    -The rate of mixed response
    -Time to study treatment failure
    -Progression free survival time
    -Progression free survival time after initial Slow Progressive Disease
    -Occurrence of any adverse events (including abnormal laboratory values for haematology and biochemistry)
    -Overall survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    -The rate of objective response: After the concluding visit of the last patient
    -The rate of stable disease: After the concluding visit/contact of the last patient
    -The rate of mixed response: After the concluding visit/contact of the last patient
    -Time to study treatment failure: After the concluding visit/contact of the last patient
    -Progression free survival time: After the concluding visit/contact of the last patient
    -Progression free survival time after initial Slow Progressive Disease: -After the concluding visit/contact of the last patient
    -Occurrence of any adverse events: After the concluding visit of the last patient
    -Overall survival: After the concluding visit / contact of the last patient
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E. trial type description
    First administration to humans of combination of chemo- and immunotherapy
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 taking part in the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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: 30
    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. of subjects incapable of giving consent
    Consent may be given by 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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 immunotherapeutic in the metastatic setting. The cancer immunotherapeutic 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 Decision2008-12-12
    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 StatusPrematurely Ended
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