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    Summary
    EudraCT Number:2005-006083-57
    Sponsor's Protocol Code Number:CA184-025
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-29
    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 ConcernedUK - MHRA
    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 01, Incorporates Administrative Letter 01 and Amendment 01
    A.4.1Sponsor's protocol code numberCA184-025
    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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    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
    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 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 ipilimumab in prior/parent study
    2)survival rate at 1 year from 1st dose of ipilimumab in prior/parent study
    3)monitor patients who experience IBEs after ipilimumab treatment

    For patients receiving Re-Induction in this study at time of disease progression, following clinical benefit (SD, PR or CR) after ipilimumab treatment:
    4)BORR following 1st Re-Induction in this study
    5)Disease control rate following 1st Re-Induction in this study
    6)Duration of BOR following 1st Re-Induction in this study
    7)Time to BOR 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 or Maintenance treatment with ipilimumab in this study, estimate:
    10)PFS from 1st Re-Induction in this study
    11)continued PFS from 1st dose ipilimumab in prior/parent study
    12)duration of BOR following 1st dose ipilimumab in prior/parent study
    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.

    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;
    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. Tolerating ipilimumab treatment (i.e., no unacceptable toxicity requiring study drug discontinuation - refer to Protocl Section 6.2.4);
    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 (refer to Protocol Appendix 3);
    10. Required values for initial laboratory tests:
    - WBC ≥ 2500/uL
    - ANC ≥ 1000/uL
    - Platelets ≥ 75 x 103/uL
    - Hemoglobin ≥ 9 g/dL
    - Creatinine ≤ 2.5x ULN
    - AST ≤ 3 x ULN for patients without liver metastasis; ≤ 5 x ULN for patients with liver metastasis
    - Bilirubin ≤ 3x ULN, (except patients with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/mL);
    11. Negative Screening tests for HIV, HepB, and HepC. If positive results are not indicative of true active or chronic infection, the patient can enter the study after discussion and agreement between the Investigator and the Medical Monitor;

    Age and Sex
    12. Men and women ≥18 years of age (or, ≥ 16, if allowable per local regulatory authority);
    13. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study 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.
    E.4Principal exclusion criteria
    A/ 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.

    B/ 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. Sexually active fertile men whose partners are WOCBP, unless using an adequate method of birth control;

    Target Disease Exceptions
    7. Primary ocular or mucosal melanoma;

    Medical History and Concurrent Diseases
    8. 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 such as a condition associated with frequent diarrhea;

    Prohibited Therapies and/or Medications
    9. Prior or concomitant therapy with any anti-cancer agent, immunosuppressive agents, surgery or radiotherapy (except as defined in Protocol Sections 6.2.8.3 and 6.2.8.4); and chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses).
    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)
    Efficacy Measures:
    The Investigator will make all tumor evaluations based on modified World Health Organization (WHO) criteria (Refer to Protocol Section 3.3.2). Throughout the study each respective Investigator will determine disease status of patients at the protocol-defined time points and as clinically indicated.

    Safety Measures:
    Safety will be evaluated for all patients using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Safety assessments will be based on medical review of adverse event (AE) reports and the results of vital sign measurements, physical examinations and clinical laboratory tests. The incidence of AEs will be tabulated and reviewed for potential significance and clinical importance. The reporting period for safety data will either be: 1) from the date of the first dose of ipilimumab received in this study (Group A and B patients) to 70 days (5 half-lives) following the last dose received; or 2) 70 days from the last dose of ipilimumab received in the prior/parent study (Group C patients).
    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 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 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.8.3 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 concerned7
    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 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 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
    This study will continue to enroll new patients until/if ipilimumab becomes commercially available at all open sites or the Investigational New Drug Application (IND) is closed by the Sponsor. It will remain open until the last enrolled patient discontinues from any study Phase, including Follow-Up or the study is otherwise terminated by the Sponsor.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    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 Yes
    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) Yes
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 200
    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.
    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 Decision2006-10-04
    N.Ethics Committee Opinion of the trial applicationWithdrawn
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    Other
    N.Date of Ethics Committee Opinion2007-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-18
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