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    The EU Clinical Trials Register currently displays   43854   clinical trials with a EudraCT protocol, of which   7284   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:2004-001937-40
    Sponsor's Protocol Code Number:EORTC 16032-18031
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-26
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-001937-40
    A.3Full title of the trial
    Randomized, open phase II study of immunization with the recombinant MAGE-3 protein combined with adjuvant AS02B or AS15 in patients with unresectable and progressive metastatic cutaneous melanoma
    A.4.1Sponsor's protocol code numberEORTC 16032-18031
    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 SponsorEuropean Organisation for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Information not present in EudraCT
    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 nameProteinD-MAGE-3/His recombinant protein formulated in AS02B adjuvant
    D.3.2Product code PD-MAGE3/AS02B
    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.3.9.2Current sponsor codeProteinD-MAGE-3/His recombinant protein
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.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 Information not present in EudraCT
    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 nameProteinD-MAGE-3/His recombinant protein formulated in AS15 adjuvant
    D.3.2Product code PD-MAGE3/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.3.9.2Current sponsor codeProteinD-MAGE-3/His recombinant protein
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Unresectable and progressive metastatic cutaneous melanoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10027155
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The observation that immunization with the protein MAGE 3 can induce tumor regression has generated the need to find out which immunological adjuvants can maximize the antigenicity of MAGE 3. This trial is aimed at evaluating in parallel the activity and toxicity of adjuvant AS02B with the more recent adjuvant AS15 (AS01B plus AS07A) in the treatment of metastatic cutaneous melanoma.
    This trial is expected to affect ongoing and future studies with cancer vaccines, because it will provide unique information on safety and clinical activity of repeated cycles of injections of tumor antigens combined with two adjuvants currently being tested in cancer patients. This randomized phase II clinical trial design is employed to be able to select one of the two adjuvant vaccines for inclusion in a subsequent phase III trial in comparison with the standard treatment.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. The patient has histologically proven measurable metastatic cutaneous melanoma.
    Patients with any skin, soft-tissue or lymph-node metastasis can be included in the study, provided the disease is not amenable to curative treatment with surgery. In terms of AJCC 2001 classification, this means that patients with unresectable stage III melanoma or with stage IV M1a melanoma are candidates for inclusion, whereas patients with stage IV M1b or IV M1c disease cannot be included in the study.
    The patient must present a documented progressive disease within 12 weeks before the first vaccine administration.
    2. The tumor sample expresses the MAGE-3 gene, as determined by RT-PCR analysis (more than 1% of the positive MAGE-3 control included in the assay).
    3. The patient is at least 18 years old.
    4. If the patient is a woman of childbearing potential, the urine pregnancy test should be done ≤ 1 week before randomization and should be negative.
    5. If the patient is a woman of childbearing potential, she must consent to use oral contraception or an IUD during the treatment and until three months have elapsed after the last injection.
    6. No previous systemic chemotherapy, except isolated limb perfusion which should be performed > 4 weeks from randomization.
    7. No previous vaccine containing a MAGE 3 antigen, and no previous vaccine for the metastatic stage.
    Prior adjuvant vaccine containing other tumor antigen than MAGE-3 is allowed if the last vaccine has been injected eight weeks before the randomization.
    8. Patient fully recovered from any previous surgery/biopsy.
    9. ECOG performance status of 0 or 1.
    10. The patient has normal organ functions as shown by all of the following:
    • Hemoglobin ≥ Lower Limit of Normal (LLN)
    • Leucocytes ≥ Lower Limit of Normal (LLN)
    • Lymphocytes ≥ Lower Limit of Normal (LLN)
    • Platelets ≥ Lower Limit of Normal (LLN)
    • Serum creatinine ≤ Upper Normal Limit (UNL)
    • Serum bilirubin ≤ Upper Normal Limit (UNL)
    • LDH ≤ Upper Normal Limit (UNL)
    • ASAT ≤ 2  Upper Normal Limit (UNL)
    • ALAT ≤ 2  Upper Normal Limit (UNL)
    • Prothrombin time (PT) within the Central laboratory’s normal range
    • Activated partial thromboplastin time (APTT) within the Central laboratory 's normal range
    11. Viral tests:
    • HIV (human immunodeficiency virus): antibody test should be negative.
    • HBV (hepatitis B virus): antigen test should be negative, whereas antibody test may be positive.
    • HCV (hepatitis C virus): antibody test should be negative.
    12. The patient has not received an organ allograft.
    13. Absence of autoimmune diseases (vitiligo is not an exclusion criterion).
    Patients without any clinical evidence of autoimmune disease but with a titer of Anti-Nuclear Antibody (by immunofluorescence on Hep2 cells)  1/320 or = 1/160 but with auto-antibodies directed against specific auto-antigens (by immunodot and/or ELISA) are not eligible.
    14. Absence of immunodeficiency.
    15. Patients should not receive anti-cancer treatment(s) during the study period such as chemotherapeutic agents, immune modulating agents such as BCG or immunosuppressive agents such as corticosteroids (except for prednisone, or equivalent, < 0.5 mg/kg/day [absolute maximum 40 mg/day, maximum duration of treatment 3 weeks], inhaled and topical steroids, which are allowed).
    16. Absence of splenectomy and/or radiation therapy to the spleen.
    17. Absence of any second malignancy(ies) in the previous 5 years, with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous carcinoma of the skin.
    18. Absence of serious acute or chronic illness(ies), e.g. active infections requiring antibiotics, bleeding disorders, clinically significant heart disease (CTC grade III–IV), or other conditions requiring concurrent medications not allowed during this study.
    19. Absence of psychological, familial, sociological and geographical conditions potentially hampering compliance with the study protocol and follow-up schedule.
    20. Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
    E.4Principal exclusion criteria
    see above
    E.5 End points
    E.5.1Primary end point(s)
    This phase II study is a one-stage toxicity/efficacy with two co-primary endpoints study design:
    1. The rate of vaccine-related grade 3 / 4 toxicity (other than skin toxicity and flu-like symptoms) according to the common toxicity criteria CTC version 3.0.
    2. The rate of objective clinical response (CR or PR).
    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 No
    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 Information not present in EudraCT
    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) 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    No comparator. Both combinations are being tested.
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    End of study occurs when all of the following criteria have been satisfied:

    1. The trial is mature for the analysis of the primary endpoint as defined in the protocol
    2. The database has been fully cleaned and frozen for this analysis
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-04-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 68
    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 Decision2005-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-31
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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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