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    Summary
    EudraCT Number:2005-006083-57
    Sponsor's Protocol Code Number:CA184-025
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-006083-57
    A.3Full title of the trial
    A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010) Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols

    Revised Protocol 09, incorporating Administrative Letter 01, 02, Amendments 01, 04, 05, 06, 07, 08, 09, 10 and 11 (version 10.0, dated 06-Dec-12)
    + administrative letter 03 dated 31-Jan-12
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies
    A.4.1Sponsor's protocol code numberCA184-025
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00162123
    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 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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Start Up Unit
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance, Avenue de Finlande 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.com
    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 nameIpilimumab
    D.3.2Product code BMS-734016 / MDX010
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 / MDX010
    D.3.9.3Other descriptive nameIPILIMUMAB
    D.3.9.4EV Substance CodeSUB29397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50 in 10 mL vial
    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.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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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) No
    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.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 nameIpilimumab
    D.3.2Product code BMS-734016 / MDX-010
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 / MDX010
    D.3.9.3Other descriptive nameIPILIMUMAB
    D.3.9.4EV Substance CodeSUB29397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200 in 40 mL vial
    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.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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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) No
    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
    Stage III, IV metastatic advanced melanoma
    E.1.1.1Medical condition in easily understood language
    Melanoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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 monitor the safety of ipilimumab (MDX-010) administered either as Re-Induction (10 mg/kg or 3 mg/kg) or as Maintenance therapy (0.3, 3 or 10 mg/kg) in this ipilimumab (MDX-010) clinical study.
    E.2.2Secondary objectives of the trial
    For all patients:
    1)OS from 1st dose of ipi. in parent study
    2)survival rate at 1 year from 1st dose of ipi. in parent study
    3)monitor patients (except in Group C Survival Follow-Up Only) who experience irAEs after ipi. treatment

    For patients receiving Re-Induction in this study at time of disease progression, following clinical benefit (SD, PR or CR) after ipi. treatment:
    4)Best ORR following 1st Re-Induction in this study
    5)Disease control rate following 1st Re-Induction in this study
    6)Duration of response following 1st Re-Induction in this study
    7)Time to resp. following 1st Re-Induction in this study
    8)OS following 1st Re-Induction in this study
    9)Repeat response following 2nd Re-Induction in this study

    For all patients receiving re-induction in this study, estimate:
    10)PFS from 1st Re-Induction in this study

    For the additional secondary objectives, please see section 2.3 of the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients eligible for this study must represent one of the three patient populations described in Section 3.2 of the Protocol and meet the inclusion/exclusion criteria detailed below.

    Group C (except Group C Survival Follow-Up Only) patients must meet Inclusion Criteria 1, 2, and 3 and Exclusion Criteria 1 and 2.
    Group C Survival Follow-Up Only patients must meet Inclusion Criteria 1, 2, 3 and Exclusion Criterion 2.

    1. Willing and able to give written informed consent;

    Target population
    2. Diagnosis of advanced melanoma;
    3. Prior treatment in one of the following studies: CA184008, CA184-022, CA184007, CA184004, MDX010-08 or MDX010-15; and meets criteria for Group A, B or C (see
    Section 3.2.)
    4. Accessible for treatment and Follow-Up;
    5. All patients entering the study as Group A to receive Re-Induction must have their case discussed with a BMS Medical Monitor prior to enrollment in the companion study;
    6. Patients who have not experienced IBE related to ipilimumab, or patients who have
    experienced a select IBE related to ipilimumab that has completely resolved with
    immunosuppressive therapy or controlled with hormone therapy (* see below for
    IBEs eligible for consideration, also refer to Section 3.2.2 for definition of select
    reversible IBEs):
    * List of IBEs eligible for consideration:
    a) Reversible autoimmune hepatitis
    b) Medically manageable endocrinopathy
    c) Reversible dermatological toxicity
    7. Have the complete set of baseline (i.e., Screening) images of lesions and radiographic images, including, but not limited to: brain, chest, abdomen pelvis and bone scans (bone scan only as applicable). All images must be of adequate quality;
    8. Life expectancy ≥16 weeks;
    9. ECOG performance status of 0 or 1 (Group A patients only, refer to Appendix 3);
    10. Required values for initial laboratory tests (Group A patients only):
    • WBC ≥ 2000/uL
    • ANC ≥ 1000/uL
    • Platelets ≥ 50 x 10³/uL
    • Hemoglobin ≥ 8 g/dL
    • Creatinine ≤ 3.0 x ULN
    • AST/ALT ≤ 2.5 x ULN for patients without liver metastasis ; ≤ 5 x ULN for patients with liver metastasis
    • Bilirubin ≤ 3.0 x ULN, (except patients with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL);
    11. No active or chronic infection with HIV, Hepatitis B or Hepatitis C;

    Age and Sex
    12. Men and women ≥18 years of age (or, ≥ 16, if allowable per local regulatory authority);
    Women of childbearing potential (WOCBP) must be using a highly effective method(s) of contraception (failure rate of less than 1% per year) to avoid pregnancy throughout the study and for up to 12 weeks after the last date of study treatment in such a manner that the risk of pregnancy is minimized.
    WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication and within 24 hours prior to each dose.
    E.4Principal exclusion criteria
    For Group A, B, and C patients:

    1) Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist, except for ipilimumab;
    2) Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled in this study.

    For Group A and Group B patients:

    Sex and Reproductive Status
    3) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study;
    4) Women who are pregnant or breastfeeding;
    5) Women with a positive pregnancy test on enrollment or prior to study drug administration;
    6) Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCBP must follow instructions for birth control when the half life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 12 weeks after dosing has been completed;

    Target Disease Exceptions
    7) Primary ocular melanoma;

    Medical History and Concurrent Diseases
    8) Any underlying medical or psychiatric condition or acute infection, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs (such as a condition associated with frequent diarrhea) or efficacy data (such as active lung infection that interferes with response assessments);
    8a) Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease are excluded from this study as are subjects with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [eg, Wegener’s Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (eg, Guillain-Barré Syndrome) are excluded from this study.

    Prohibited Therapies and/or Medications
    9) Concomitant therapy with any anti-cancer agent (for up to 30 days prior to 1st dose of ipilimumab in this study and except as defined in Section 6.2.8.5), immunosuppressive agents (for up to 30 days prior to 1st dose of ipilimumab in this study), surgery or radiotherapy (except as defined in Sections 6.2.8.3 and 6.2.8.4) (for up to 30 days prior to 1st dose of ipilimumab in this study); and chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses and for up to 30 days prior to 1st dose of ipilimumab in this study).
    10) Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 4 weeks prior to or after any dose of ipilimumab);
    11) Treatment with other investigational products within the last 4 weeks prior to or during this study.
    E.5 End points
    E.5.1Primary end point(s)
    To monitor safety of ipilimumab by evaluating the frequency of adverse
    events and laboratory abnormalities with corresponding severity.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study.
    E.5.2Secondary end point(s)
    1) To estimate overall survival from the first dose;
    2) To estimate 1 year survival rate from the 1st dose;
    3) To monitor Immune Breakthrough Events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) At the end of the study
    2) 1 year
    3) Throughout 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 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
    Immunogenicity testing
    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.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Norway
    Peru
    Poland
    Russian Federation
    South Africa
    Spain
    Sweden
    Ukraine
    United Kingdom
    United States
    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
    At the conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive study drug. Study drug will be provided via an extension of the study, a rollover study requiring approval by responsible health authority and ethics committee or through another mechanism at the discretion of BMS.
    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 months5
    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 months0
    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 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 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 Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.6.1Details of subjects incapable of giving consent
    Pregnant and nursing women are eligible only in Group C (Follow-Up Phase, no study drug administration in order to collect important safety information on all patients who were previously treated with ipilimumab).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 248
    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)
    - Even after ipilimumab is approved for clinical use, all patients who were enrolled onto the study prior to approval, will continue to receive treatment and follow-up on this study.
    - In the event a patient withdraws consent or discontinues from all other study procedures, the site may continue to contact the patient (with the patient’s agreement) for the collection of survival follow-up data only. The patient’s decision should be documented in the source records.
    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 Decision2006-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-18
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