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    Summary
    EudraCT Number:2006-004777-10
    Sponsor's Protocol Code Number:107240
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-004777-10
    A.3Full title of the trial
    A Phase I/II study to assess the safety and immunogenicity of recMAGE-A3+AS15 cancer immunotherapeutic given as adjuvant therapy, with or without adjuvant chemo(-radio)therapy, to patients with MAGE-A3-positive Non-Small Cell Lung cancer (stage IB, II or III)
    A.3.2Name or abbreviated title of the trial where available
    MAGE3-AS15-NSC-001
    A.4.1Sponsor's protocol code number107240
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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.3.9.2Current sponsor coderecMAGE-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) 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
    Non-Small Cell Lung Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the specific humoral and cellular immune response induced by the cancer immunotherapeutic recMAGE-A3+AS15 in patients with MAGE-A3-positive NSCLC. - To evaluate the safety of recMAGE-A3+AS15 in patients with MAGE-A3-positive NSCLC.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Written informed consent obtained before performance of any protocol-specific procedure. 2.Patient is at least 18 years of age . 3.Pathologically proven stage IB, II or III NSCLC. 4.Patient's tumor shows expression of MAGE-A3 antigen, detected by RT-PCR. 5.Patient is free of any distant metastasis, as shown by standard procedures at the site. 6.Patients to be included in Cohort 1, all of the following. 6a.Resected stage IB, II or IIIA NSCLC. 6b.Operative technique for resection of the patient's tumor is anatomical, involving at least a lobectomy, and with a level of nodal sampling corresponding to the standard procedures at the center. 6c.ECOG performance status = 0 or 1 at the time of screening. 6d.Patient is due to receive adjuvant chemotherapy as permitted in this protocol. 6e.Patient has not received, is not receiving, and is not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III). 6f.First administration of chemotherapy can be scheduled to take place within the time-window of 4–8 weeks after surgery. 7.For patients to be included in Cohort 2, all of the following. 7a.Resected stage IB, II or IIIA NSCLC. 7b.The operative technique for resection of the patient's tumor is anatomical, involving at least a lobectomy, and with a level of nodal sampling corresponding to the standard procedures at the center. 7c.ECOG performance status = 0 or 1 at the time of screening. 7d.The patient is due to receive, or is already receiving, adjuvant chemotherapy as permitted in this protocol. 7e.The patient has not received, is not receiving, and is not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III). 7f. First administration of recMAGE A3+AS15 ASCI study treatment can be scheduled to take place within the time-window of 2–4 weeks after the last administration of chemotherapy 7g.The patient has received at least two cycles of standard chemotherapy before study treatment with recMAGE A3 ASCI is initiated, whereafter no further chemotherapy is planned. 8.For patients to be included in Cohort 3, all of the following. 8a.Resected stage IB, II or IIIA NSCLC. 8b.The operative technique for resection of the patient's tumor is anatomical, involving at least a lobectomy, and with a level of nodal sampling corresponding to the standard procedures at the center. 8c.ECOG performance status = 0 or 1 or 2 at the time of screening. 8d.The patient has not received, is not receiving, and is not due to receive, adjuvant chemotherapy. 8e.The patient has not received, is not receiving, and is not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III). 8f.First administration of recMAGE A3+AS15 ASCI study treatment can be scheduled to take place within the time-window of 4–8 weeks after surgery. 9.For patients to be included in Cohort 4, all of the following. 9a.Unresectable stage III NSCLC. 9b.ECOG performance status = 0 or 1 or 2 at the time of screening. 9c.The patient is due to receive, or is already receiving, chemo- and radiotherapy according to standard practice at the institution. 9d.The patient has received at least two cycles of standard chemotherapy before the initiation of study treatment with recMAGE A3+AS15 ASCI, whereafter no further chemo-/radiotherapy is planned. 9e.The patient has stable disease or objective response (confirmed by CT scan) after standard chemo-/radiotherapy. 9f.Administration of recMAGE A3+AS15 ASCI study treatment can be scheduled to take place within the time-window of 2–4 weeks after the last administration of chemo-/radiotherapy. 10.Laboratory criteria (all of the following must be fulfilled at the time when study treatment is commenced): adequate bone-marrow reserve, adequate renal function and adequate hepatic function. 11.(For female patients): EITHER the patient is not of child-bearing potential
    E.4Principal exclusion criteria
    1. 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. 2. The patient is pregnant or lactating. 3. The patient has a history of anaphylaxis or severe allergic reaction. 4. 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. 5. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures. 6. The patient is known to be HIV-positive. 7. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents. [Notes: 1. The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for COPD or topical steroids is permitted. 2. The use of corticosteroids as anti-emetic treatment is permitted.] 8. The patient needs home oxygenation. 9. 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 medication, or plans to receive such a drug during the study period. 10. The patient has a history of chronic alcohol consumption and/or drug abuse.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity Immunogenicity will be judged primarily after the fourth dose of ASCI, on the basis of: The anti-MAGE-A3 seroconversion. The anti-protein D seroconversion. The MAGE-A3 cellular (T-cell) response. Additionally, these antibody and cellular T-cell responses will be evaluated at the end of treatment. Safety The safety of the cancer immunotherapeutic recMAGE-A3+AS15, combined or not with standard chemotherapy, will be judged on the basis of: Occurrence of adverse events during the study, including abnormal hematological and biochemical laboratory values. Occurrence of serious adverse events during the study.
    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 Information not present in EudraCT
    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) 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 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 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=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 2007-11-21. 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 72
    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 Decision2007-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-08
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