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    Summary
    EudraCT Number:2005-002126-64
    Sponsor's Protocol Code Number:CA184-004
    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:2006-06-23
    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 number2005-002126-64
    A.3Full title of the trial
    A Randomized Phase II Study to Determine Potential Predictive Markers of Response to MDX-010 BMS-734016 in Patients with Unresectable Stage III or IV Malignant Melanoma
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberCA184-004
    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 SponsorBRISTOL-M.SQUIBB
    B.1.3.4CountryItaly
    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 Information not present in EudraCT
    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
    D.3.4Pharmaceutical form 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-734016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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
    Malignant unresectable melanoma, stage III or IV.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level HLT
    E.1.2Classification code 10027156
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To correlate pre-treatment characteristics of the patient and/or tumor with clinical tumor response in patients with unresectable Stage III and IV melanoma, in order to identify candidate markers predictive of response and/or serious toxicity to MDX-010 BMS-734016 in patients treated with MDX-010 BMS-734016 at 3 or 10 mg/kg q 3 weeks x 4.
    E.2.2Secondary objectives of the trial
    1 To evaluate the following in this patient population i Safety; ii Best objective response rate best response of CR or PR ; iii Progression Free Survival PFS Rate at Week 12; iv Disease control rate best response of CR PR SD ; v Progression free survival PFS ; vi Overall survival OS ; vii Duration of best objective response; and viii Time to best objective response. 2 To estimate the sensitivity and specificity of any candidate marker or combination of markers for prediction of clinical response and/or serious toxicity to MDX-010 BMS-734016 ; 3 To compare mRNA expression profiling, protein profiling and immunologic profiling in pre and post treatment tumor specimens in patients treated with MDX-010 BMS-734016 at 3 or 10 mg/kg q 3 weeks x 4; 4 To compare DTH response, antibody response, peripheral blood mRNA expression, and PBMCs functional attributes in pre and post treatment in patients treated with MDX-010 BMS-734016 at 3or 10 mg/kg q 3weeksX4
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Signed written informed consent Target population a Able to comply with visits/procedures required by the protocol b Life expectancy of at least 4 months. c ECOG performance status score 0-1. See Appendix 4 d Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma excluding ocular melanoma . e A pre- and post-treatment fresh core or excision tumor biopsy must be provided for biomarker and predictive marker analyses. It is preferred that the biopsies are obtained from the same organ. Note Site of tumor biopsy should not be the only site of measurable disease. f Measurable disease as defined in Section 3.3.2.2 g Required values for initial laboratory tests WBC 8805; 2500 x 103/mL ANC 8805; 1500 x 103/mL Platelets 8805; 100 x 106/mL Hemoglobin 8805; 10 g/dL Hematocrit 8805; 30 AST 8804; 2 x ULN Bilirubin 8804; 2 x ULN, except patients with Gilbert s Syndrome, who must have a total bilirubin less than 3.0 mg/mL; Serum creatinine 8804; 2.0 times the institutional ULN. At least 4 weeks must have elapsed since the last chemotherapy, immunotherapy, hormonal therapy, radiotherapy or major surgery and the beginning of protocol therapy. At least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin. i Toxicity related to prior therapy must either have returned to 8804; grade 1, baseline, or been deemed irreversible. Age and Sex a Men and women, ages 18 and above. Women of childbearing potential WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before dosing, and while women are on study and for up to 12 weeks after last dose of study drug. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization hysterectomy, bilateral tubal ligation or bilateral oophorectomy or is not postmenopausal defined as amenorrhea 8805; 12 consecutive months; or women on hormone replacement therapy HRT with documented serum follicle stimulating hormone FSH level 35mIU/mL . Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods diaphragm, condoms, spermicides to prevent pregnancy or practicing abstinence or where partner is sterile e.g., vasectomy , should be considered to be of child bearing potential. WOCBP must have a negative pregnancy test minimum sensitivity 25 IU/L or equivalent units of HCG within 72 hours prior to the start of study medication. Men must be willing and able to use an acceptable method of birth control, for at least 3 months after completion of the study, if their sexual partners are WOCBP.
    E.4Principal exclusion criteria
    Sex and Reproductive Status a WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the study; b WOCBP using a prohibited contraceptive method; c Women who are pregnant or breastfeeding; d Women with a positive pregnancy test on enrollment or prior to study drug administration; e Sexually active fertile men who are unwilling or unable to use an acceptable method of birth control, for the entire study period and for at least 3 months after completion of the study, if their sexual partners are WOCBP. 2 Target Disease Exclusion a Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix; b Ocular melanoma. 3 Medical History and Concurrent Diseases a Active, untreated central nervous system CNS metastasis including metastasis identified during screening MRI or contrast CT ; b Autoimmune disease Patients with a history of Inflammatory Bowel Disease are excluded from this study as are patients with a history of autoimmune disease e.g. Systemic Lupus Erythematosus, vasculitis, infiltrating lung disease whose possible progression during treatment would be considered by the Investigator to be unacceptable. Patients with a history of well-controlled and/or clinically manageable autoimmune disease e.g. vitiligo, well-controlled thyroid disease, mild psoriasis may be considered for inclusion in consultation with the CRO; c Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea; d Positive screening tests for HIV, HepB, and HepC. If positive results are not indicative of true active or chronic infection, the patient can be admitted after discussion with and agreement by the BMS Medical Monitor; e Uncontrolled or significant cardiovascular disease including 8722; myocardial infarction within 12 months 8722; uncontrolled angina within 6 months 8722; Class III-IV New York Heart Association NYHA congestive heart failure 8722; diagnosed or suspected congenital long QT syndrome Date 09-Dec-2005 59 Approved v4.0 930011706 3.0 Anti-CTLA-4 CA184004 BMS-734016 Clinical Protocol 8722; any history of clinically significant ventricular arrhythmias such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes . Any patient with a history of any arrhythmia should be discussed with the BMS Medical Monitor prior to entry into the study 8722; prolonged QTc interval on pre-entry electrocardiogram 450 msec 8722; any history of second or third degree heart block may be eligible if currently have a pacemaker 4 Prohibited Therapies and/or Medications a Prior exposure to an anti-CTLA4 antibody. b Use of any immunosuppressing treatments including corticosteroids patients on stable doses of hormone replacement therapy are exempt , cyclosporine, mycophenolate mofetil CellCept 63194; , chemotherapy, radiation, etc, within 4 weeks prior to Day 1 of treatment. c Exposure to any investigational drug or placebo within 4 weeks prior to Day 1 of treatment. d Drugs that are generally accepted to have a risk of causing Torsade de Pointes see Appendix 7 . Patients who have discontinued any of these medications must have a wash-out period of at least 5 days or at least 5 half-lives of the drug whichever is longer prior to the first dose of MDX-010 BMS-734016 . e Concomitant therapy with any of the following IL-2, interferon or other non-study anti-melanoma immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies..
    E.5 End points
    E.5.1Primary end point(s)
    To correlate pre-treatment characteristics of the patient and/or tumor with clinical tumor response in patients with unresectable Stage III and IV melanoma, in order to identify candidate markers predictive of response and/or serious toxicity to MDX-010 BMS-734016 in patients treated with MDX-010 BMS-734016 at 3 or 10 mg/kg q 3 weeks x 4. 1 To evaluate the following in this patient population i Safety; ii Best objective response rate best response of CR or PR ; iii Progression Free Survival PFS Rate at Week 12; iv Disease control rate best response of CR PR SD ; v Progression free survival PFS ; vi Overall survival OS ; vii Duration of best objective response; and viii Time to best objective response. 2 To estimate the sensitivity and specificity of any candidate marker or combination of markers for prediction of clinical response and/or serious toxicity to MDX-010 BMS-734016 ; 3 To compare mRNA expression profiling, protein profiling and immunologic profiling in pre and post treatment tumor specimens in patients treated with MDX-010 BMS-734016 at 3 or 10 mg/kg q 3 weeks x 4; 4 To compare DTH response, antibody response, peripheral blood mRNA expression, and PBMCs functional attributes in pre and post treatment in patients treated with MDX-010 BMS-734016 at 3or 10 mg/kg q 3weeksX4.
    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 Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo No
    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.8.5The 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 years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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 2006-06-23. 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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 90
    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 Decision2006-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-02-03
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