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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   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:2007-003993-24
    Sponsor's Protocol Code Number:CA186006
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-04
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-003993-24
    A.3Full title of the trial
    A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a
    Second-Line Monotherapy in Subjects with Previously Treated Unresectable Stage III or Stage IV Melanoma.

    And Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (Version 1.0, Date 26-Nov-2007).
    A.4.1Sponsor's protocol code numberCA186006
    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 nameAnti-CD137
    D.3.2Product code BMS-663513
    D.3.4Pharmaceutical form Concentrate for solution for 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.3.9.2Current sponsor codeBMS-663513
    D.3.9.3Other descriptive nameAnti-CD137
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 typeHuman monoclonal antibody (IgG4) produced in CHO cells
    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
    MELANOMA
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025671
    E.1.2Term Malignant melanoma stage IV
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine the 6-month PFS rate following treatment with BMS-663513 in each arm.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study include the following:
    • To estimate the PFS distribution and median PFS time in each arm
    • To estimate the tumor response rate in each arm
    • To estimate the disease control rate in each arm, ie, the proportion of subjects with a complete response (CR), a partial response (PR), or with stable disease (SD) that lasts for at least 24 weeks
    • To collect exploratory response data beyond disease progression
    • To estimate the overall survival distribution and 1-year survival rate in each arm
    • To estimate time to and duration of response for each arm
    • To evaluate the safety profile for each arm
    • To assess a population PK of BMS-663513 for each arm
    • To evaluate the exploratory pharmacodynamic and predictive biomarkers in serum, peripheral blood mononuclear cells (PBMCs), whole blood, or tumor tissue (if applicable)
    • To assess the immunogenicity of BMS-663513 on inducing serum Human Anti Human Antibodies (HAHA).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    * Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (Version 1.0, Date 26-Nov-2007).

    The objective of this Amendment is to permit the collection and storage of blood samples for use in future exploratory pharmacogenetic research studies. BMS will use DNA obtained from the blood sample and health information collected from the main clinical trial, CA186006 case report form, to study the association between genetic variation and drug response. BMS may also use the DNA to study the causes and further progression of melanoma. Samples from this and other clinical studies may also be used in conjunction to accomplish this objective.
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent
    a) Voluntary signed and dated IRB/IEC approved informed consent form in
    accordance with regulatory and institutional guidelines. This must be obtained
    before performing protocol-related procedures that are not part of standard subject
    care.

    2) Target Population
    a) Able to comply with visits/procedures required by the protocol.
    b) Life expectancy of at least 3 months from enrollment
    c) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    (Protocol Appendix 2)
    d) Histologically or cytologically confirmed cutaneous, mucosal or acral lentiginous
    melanoma that is radiographically assessable or clinically evaluable; however,
    measurable disease is not required for participation in this study
    e) Surgically incurable Stage III melanoma, and in-transit or satellite lesions or
    Stage IV disease, metastatic to one of the following sites: skin, subcutaneous
    tissues, or distant lymph nodes; lung or other visceral sites
    f) Subjects must have been previously treated with one line of systemic anti-cancer
    therapy (non-experimental or experimental) for metastatic disease, and relapsed,
    failed to respond (CR, PR or SD) or did not tolerate that regimen. If the treatment
    has been administered as an adjuvant and/or neoadjuvant therapy, the subject
    must have documented disease progression from the last treatment and also
    received one additional line of systemic therapy for metastatic disease
    g) Resolution of all prior therapy-related toxicities to ≤ Grade 1 or to baseline level
    h) Recovered from the reversible effects of prior antineoplastic therapy with at least
    4 weeks elapsed since the last exposure to cytotoxic chemotherapy, or to
    radiotherapy and at least 6 weeks elapsed since exposure to nitrosoureas or
    mitomycin C. Subjects treated with fully human anti-CTLA-4 monoclonal
    antibodies as immunotherapy regimens (eg, ipilimumab and tremelimumab) must
    not have received treatment with such antibodies for at least 8 weeks, and those
    treated with chimeric or other fully human monoclonal antibodies must not have
    received treatment with such antibodies for at least 4 weeks prior to
    randomization. Subjects treated with noncytotoxic small molecule drugs (eg,
    tyrosine kinase inhibitors) must not have received treatment with these drugs at
    the time of enrollment and at least 2 weeks prior to randomization.
    i) Suitable venous access for the conduct of blood sampling for candidate biomarker
    study
    j) Adequate organ function, as evidence by the following laboratory values:
    • Absolute neutrophil count (ANC) ≥ 1500/μL
    • Platelet count ≥ 100 x 103/μL
    • Hemoglobin ≥ 9 g/dL
    • Calculated creatinine clearance ≥ 40 mL/min based on Cockcroft-Gault or
    other available formula.
    • AST and ALT ≤ 2.5 x ULN
    • Total bilirubin ≤ 1.5 x ULN

    3) Age and Sex
    a) Men and women, who are at least 18 years of age.
    b) Male subjects must be willing to use an appropriate method of barrier
    contraception (eg, condoms) and inform any sexual partners that they must also
    use a reliable method of contraception (eg, birth control pills) during the study
    and for 60 days after the last dose of study treatment.
    c) Women of childbearing potential (WOCBP) must be using an adequate method of
    contraception to avoid pregnancy throughout the study and for up to 60 days after
    the last dose of investigational product in such a manner that the risk of pregnancy
    is minimized.
    E.4Principal exclusion criteria
    1) Sex and Reproductive Status
    a) WOCBP who are unwilling or unable to use an acceptable method to avoid
    pregnancy for the entire study and for up to 60 days after the last dose of
    investigational product.
    b) Women who are pregnant or breastfeeding
    c) Women with a positive pregnancy test on enrollment or prior to investigational
    product administration
    d) Sexually active fertile men not using effective birth control if their partners are
    WOCBP (eg, males unwilling to use a barrier method of contraception)
    2) Target Disease Exceptions
    a) Ocular melanoma
    b) Complete surgical resection of all identifiable sites of disease
    c) Clinical and/or radiographic evidence of cerebral or subdural metastases and/or
    progression of central nervous system (CNS) metastases within the past 4 weeks.
    Subjects who have a history of CNS metastasis but have no radiographic (eg,
    brain MRI or contrast CT) or clinical evidence of residual tumor (eg, following
    complete surgical resection) are excluded from participation in this study based
    on the following:
    – Required the use of corticosteroid therapy or DCVax®-Brain for this indication
    – Discontinue treatment for < 4 weeks before randomization in this study
    d) Any other malignancy for which the subject has been disease-free for less than 5
    years, with the exception of adequately treated basal or squamous cell skin cancer,
    superficial bladder cancer or carcinoma in situ of the cervix, breast or prostate
    3) Medical History and Concurrent Diseases
    a) Histories of autoimmune diseases including Inflammatory Bowel Disease,
    Systemic Lupus Erythematosus, vasculitis, infiltrating lung disease are excluded
    from this study. Note that not all autoimmune diseases are to be excluded, and
    subjects with a history of well-controlled and/or clinically manageable
    autoimmune disease (eg, vitiligo, well-controlled thyroid disease, or mild
    psoriasis) may be considered for inclusion in consultation with the Medical
    Monitor
    b) Known or suspected human immunodeficiency virus (HIV) infection or known or
    suspected active or chronic hepatitis B or hepatitis C infection. If false positive
    results are obtained, the subject can enter the study after discussion and agreement
    between the Investigator and the Medical Monitor.
    c) Any other diseases, metabolic dysfunction, physical examination finding, or
    clinical laboratory finding giving reasonable suspicion of a disease or condition
    that contraindicates the use of the investigational drug.
    d) Clinically significant abnormalities or serious cardiac arrhythmias on 12-lead
    electrocardiogram (ECG). Significant cardiovascular impairment (eg, history of
    congestive heart failure), New York Heart Association (NYHA) (Appendix 3)
    Class III and IV or history of myocardial infarction or unstable angina within the
    past six months or significant vascular disease (eg, aortic aneurysm or aortic
    dissection)
    e) History of abdominal fistula or gastrointestinal perforation within 6 months prior
    to randomization
    f) Prior treatment with radiation therapy within 4 weeks involving > 25% of the
    hematopoietically active bone marrow
    4) Physical and Laboratory Test Findings
    a) Evidence of organ dysfunction or any clinically significant deviation from normal
    in physical examination, vital signs, ECG or clinical laboratory determinations.
    b) Bodyweight of less then 85 lbs (38.5 Kg)
    5) Allergies and Adverse Drug Reactions
    a) History of allergy to BMS-663513 or related compounds
    6) Prohibited Treatments and/or Therapies
    a) Received more than one line of prior systemic therapies including cytotoxic
    chemotherapy; non-cytoxic small molecular drugs, biologics or radiation therapy
    for metastatic disease (note: adjuvant and/or neoadjuvant therapy is allowed and
    will not be counted as one line of prior therapy)
    b) Initiation of growth factor treatment such as granulocyte-colony stimulating factor
    (G-CSF), or granulocyte macrophage-colony stimulating factor (GM-CSF),
    erythropoietin, etc. within 28 days prior to randomization.
    c) Prior treatment with high-dose chemotherapy, defined as chemotherapy requiring
    the use of peripheral blood or bone marrow stem cell support for hematopoietic
    reconstitution or with organ allografts requiring immunosuppression
    7) Other Exclusion Criteria
    a) Prisoners or subjects who are involuntarily incarcerated
    b) Subjects who are compulsorily detained for treatment of either a psychiatric or
    physical (eg, infectious disease) illness
    c) Admission of current alcohol abuse or an inability to restrict consumption of
    alcohol to no more than 1 standard unit of alcohol per day during the study and
    for 30 days from the last dose of study treatment
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is PFS rate at 6 months. Kaplan-Meier methods,
    which account for censoring, will be used for analyses of the 6-month PFS rate.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenticity
    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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 94
    F.4.2.2In the whole clinical trial 160
    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)
    Subjects who have discontinued treatment due to study drug toxicity or
    any reason other than confirmed tumor progression will continue to have tumor
    assessments every 6 weeks through Week 48 post-randomization and then tumor
    assessments will be every 12 weeks until PD, death, or initiation of another anti-cancer therapy.
    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 Decision2008-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-12
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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