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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2007-001974-10
    Sponsor's Protocol Code Number:CA184-029
    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:2009-01-21
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-001974-10
    A.3Full title of the trial
    Adjuvant immunotherapy with anti-CTLA-4 monoclonal antibody (ipilimumab) versus
    placebo after complete resection of high-risk Stage III melanoma: A randomized, doubleblind Phase 3 trial of the EORTC Melanoma Group

    Inmunoterapia adyuvante con ipilimumab, un anticuerpo monoclonal anti-CTLA-4, frente a placebo tras la resección completa del melanoma en estadio III de alto riesgo: Ensayo de fase 3, aleatorizado y en doble ciego, del Grupo de Melanoma de la EORTC
    A.3.2Name or abbreviated title of the trial where available
    EORTC protocol 18071
    A.4.1Sponsor's protocol code numberCA184-029
    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 SponsorBristol-Myers Squibb International Corporation
    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 nameBMS-734016 / MDX-010 / Ipilimumab
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIpilimumab
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeBMS-734016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) No
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant protein
    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 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 nameBMS-734016 / MDX-010 / Ipilimumab
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIpilimumab
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeBMS-734016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) No
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant protein
    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 placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    High Risk Stage III melanoma

    Alto riesgo de melanoma en estadio III
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether post-operative adjuvant therapy with ipilimumab improves recurrence-free survival (RFS) as compared to placebo.
    E.2.2Secondary objectives of the trial
    - To determine whether post-operative adjuvant therapy with ipilimumab improves overall survival (OS) as compared to placebo.
    - To determine whether post-operative adjuvant therapy with ipilimumab improves distant metastases-free survival (DMFS) as compared to placebo.
    - To compare adverse event profiles between patients receiving ipilimumab versus patients receiving placebo.
    - To compare quality of life and quality-of-life-adjusted-survival between the two treatment groups (ipilimumab versus placebo).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent
    - Written informed consent required prior to clinical trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the trial registration, according to ICH/EU GCP, and national/local regulations

    2) Target Population
    - No mucosal or ocular melanoma, or melanoma with unknown origin of the primary
    - Complete resection of Stage III melanoma (AJCC R0) with histologically confirmed cutaneous melanoma metastatic to lymph node, classified as (AJCC, 2002): Stage IIIA with metastasis > 1mm; any Stage IIIB or IIIC (no in-transit metastases)
    - Adequate resection of Stage III lymph nodes per Criteria for adequate surgical procedures for complete lymph node dissection (CLND) as documented on the operating report and pathology report. Patients without documentation of adequate resection are not eligible
    - Recommendations for management of the lymph nodes are given in Appendix J and should include the following:
    a) Head and Neck
    - Minimum of 15 pathologically investigated nodes
    - Face, ear, and anterior scalp: parotidectomy plus modified radical neck dissection
    - Posterior scalp: modified radical neck dissection plus suboccipital
    nodes
    b) Upper Extremity
    - Minimum of 10 pathologically investigated nodes
    - Axillary node dissection included at least 10 nodes taken from Levels I and II
    - Level III nodes dissected if they were clinically involved
    - Pectoralis minor muscle was divided or sacrificed
    c) Lower Extremity
    - Minimum of 5 pathologically investigated nodes
    - Superficial inguinal node dissection was performed for non-palpable nodal involvement
    - If Cloquet?s node was positive, a deep inguinal node dissection was performed
    d) Lymph Node Dissection for Nodal Recurrence
    - Regional node recurrence was treated using the appropriate lymphadenectomy as above
    - Diagnosis of regional node recurrence was made by fine needle aspiration technique to avoid contaminating the region with tumor, followed by CLND as above


    - Full lymphadenectomy must be performed within 12 weeks (84 days) prior to randomization
    - Disease status for the post-surgery baseline assessment must be documented by full Chest/Abdomen/Pelvis CT and/or MRI with Neck CT and/or MRI (for Head and Neck primaries) and complete clinical examination after the informed consent and prior to randomization
    - The complete set of baseline radiographic images must be available before randomization and all images must be of adequate quality

    3) Physical and Laboratory Test Findings
    - Disease-free (no loco-regional relapse or distant metastasis); no clinical evidence for brain metastases
    - ECOG performance status of 0 or 1 (see Appendix B)
    - Adequate cardiac function (less or equal to NYHA II, see Appendix C)
    - Adequate hematologic, renal and liver function as defined by laboratory values performed within 4-6 weeks from enrollment
    - White blood count (WBC) greater than or equal to 2.5x10 (9)/L
    - Absolute neutrophil count (ANC) greater than or equal to 1x10 (9)/L
    - Platelet count greater than or equal to 75x10 (9)/L
    - Hemoglobin greater than or equal to 9 g/dL (5.6 mmol/L)
    - Serum creatinine less or equal to 2.5 times upper limit of laboratory normal range (ULN)
    - Total serum bilirubin, AST, ALT, alkaline phosphatase and LDH less or equal to 2 times ULN

    4) Age and Sex
    - At least 18 years of age
    - WOCBP (including women who are using oral implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods to prevent pregnancy or practicing abstinence or where partner is sterile) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) before randomization and within 72 hours prior to the start of study medication. It is the investigators responsibility to repeat the pregnancy test should start of treatment be delayed.
    E.4Principal exclusion criteria
    1) Sex and Reproductive Status
    - WOCBP unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last administration of the perfusion, women who are pregnant or breastfeeding, women with a positive pregnancy test on enrollment or prior to study drug administration, and sexually active fertile men whose partners are WOCBP, unless using an adequate method of birth control

    2) Medical History and Concurrent Diseases
    - No radiation therapy to the lymph node dissection field after surgery
    - No prior therapy for melanoma except surgery for primary melanoma lesions; patients who have previously received IFN are not eligible
    - No prior or concomitant therapy with any anti-cancer agents, immunosuppressive agents; other investigational anti-cancer therapies, or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses)
    - No non-oncology vaccine therapy can be used for prevention of infectious diseases (up-to) 4 weeks prior and after any dose of ipilimumab or placebo
    - No prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist
    - No previous participation in another ipilimumab (MDX-010) clinical trial
    - No treatment with other investigational products within the last 4 weeks prior to randomization into this study
    - No uncontrolled infectious disease including negative testing for HIV, HBV, HCV
    - No autoimmune disease: patients with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn?s disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, autoimmune thyroiditis (e.g. Hashimoto?s disease), autoimmune hepatitis, systemic progressive sclerosis (scleroderma), Systemic Lupus Erythematosus, autoimmune vasculitis (e.g., Wegener?s Granulomatosis)
    - Patients must not present immunodeficiency or previous splenectomy or radiation therapy to the spleen
    - No second malignancies in the past 5 years with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin

    6) Other Exclusion Criteria
    - Patients must have absence of any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs or efficacy, such as a condition associated with frequent diarrhea
    - No prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must be randomized into this study
    - Patients must have absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    E.5 End points
    E.5.1Primary end point(s)
    Recurrence-free survival (RFS)
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity sample testing (HAHA); QoL assessment
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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 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
    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 months8
    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 months8
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 530
    F.4.2.2In the whole clinical trial 1050
    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 Decision2009-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-26
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