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    Summary
    EudraCT Number:2011-001410-33
    Sponsor's Protocol Code Number:UZB-VUB-11-01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-05-09
    Trial 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 number2011-001410-33
    A.3Full title of the trial
    Randomized phase II clinical trial on mRNA electroporated autologous dendritic cells for stage III/IV melanoma in patients who are free from measurable tumor lesions following the local treatment of macro metastases
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized phase II clinical trial on mRNA electroporated autologous dendritic cells for stage III/IV melanoma in patients who are free from measurable tumor lesions following the local treatment of macro metastases
    A.3.2Name or abbreviated title of the trial where available
    DCMEL
    A.4.1Sponsor's protocol code numberUZB-VUB-11-01
    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 SponsorUZ BRUSSEL
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUZ BRUSSEL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Brussel
    B.5.2Functional name of contact pointProf Bart Neyns
    B.5.3 Address:
    B.5.3.1Street AddressLaarbeeklaan 101
    B.5.3.2Town/ cityJette
    B.5.3.3Post code1090
    B.5.3.4CountryBelgium
    B.5.4Telephone number0032024776415
    B.5.5Fax number0032024775460
    B.5.6E-mailbart.neyns@uzbrussel.be
    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 nameTriMix-DC
    D.3.2Product code TriMix-DC
    D.3.4Pharmaceutical form Solution for injection/infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTriMix-DC
    D.3.9.2Current sponsor codeTriMix-DC
    D.3.9.3Other descriptive nameTriMix-DC
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number24000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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 No
    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 melanoma in patients who are free from measurable tumor lesions following the local treatment of macro metastases
    E.1.1.1Medical condition in easily understood language
    stage III/IV melanoma in patients who are free from measurable tumor lesions following the local treatment of macro metastases
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10025671
    E.1.2Term Malignant melanoma stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the disease-free survival following therapeutic administration of autologous mRNA-electroporated monocyte derived DC in patients with stage III/IV melanoma who are free from measurable tumor lesions following the local treatment of macrometastases (e.g. by surgical resection, isolated limb perfusion, radiofrequency ablation, radiotherapy, …).
    E.2.2Secondary objectives of the trial
    Applicable to both arms of the study:
    1. To document the feasibility of manufacturing, and the product characteristics of the cellular IATMP (: autologous mRNA electroporated monocyte derived DC);
    2. To document the safety, and feasibility of therapeutic administration of autologous mRNA electroporated monocyte derived DC;
    3. To determine the recurrence-free survival (RFS), distant metastasis-free survival (DMFS), and overall survival (OS) using Kaplan-Meier survival estimates;
    Applicable to Arm B of the clinical trial only:
    4. To determine the best objective response according to the RECIST (v1.1), and the immune-related response criteria (irRC);
    5. To determine the progression-free survival (PFS) according to the RECIST (V1.1), and immune-related response criteria (irRC) using Kaplan-Meier survival estimates.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to give valid written informed consent before undergoing any study-related activities; patients must be willing to cooperate for the whole period of the study, and accept to be treated according to the study protocol regardless of the study arm the patient is allocated to following the randomization step;
    2. Histological documentation of AJCC stage III (Tx, N1b,-2b,-2c or -3, M0), or stage IV melanoma;
    3. Primary melanoma of the skin, unknown primary; patients with primary mucosal, or uveal melanoma (melanoma originating in the choroid, iris or ciliar body) are not eligible;
    4. At baseline tumor assessment by whole-body FDG-PET/CT, patients should be free from measurable tumor lesions (measurability is defined according to RECIST (v1.1)), and free from symptomatic non-measurable tumor lesions (e.g. bone metastasis, or pleural effusion);
    5. Prior local treatment of primary and metastatic tumor lesions is allowed (e.g. surgical resection, isolated limb perfusion, radiofrequency ablation, radiotherapy, cryotherapy, …). Treated tumor lesions should be free from progression at baseline assessment;
    6. Normal organ function and normal hematological parameters (as reflected by blood values); baseline laboratory parameters should be within normal range, except for the following laboratory parameters, which must be within the ranges specified:
    BLOOD PARAMETER RANGE
    HEMOGLOBIN ≥ 10 G/DL
    GRANULOCYTES ≥ 1,500/µL
    LYMPHOCYTES ≥ 500/µL
    PLATELETS ≥ 100,000/µL
    SERUM CREATININ ≤ 2.0 MG/DL
    SERUM BILIRUBIN ≤ 2.0 MG/DL
    AST AND ALT ≤ 2 X THE NORMAL UPPER LIMITS
    LDH ≤ 1,5X NORMAL UPPER LIMIT
    CRP ≤ 1,5X NORMAL UPPER LIMIT
    PROTHROMBIN TIME (PT) INTERNATIONAL NORMALIZED RATIO (INR) AND PARTIAL THROMBOPLASTIN TIME (PTT) WITHIN NORMAL LIMITS
    7. Negative serology for HCV, and HIV; absence of active infection with HBV, and Syphilis; If positive results for HepB or Syphilis indicate immunity and are not indicative of active infection, the patient can enter the study.
    8. Adequate venous access that allows to undergo leukapheresis;
    9. No prior systemic therapy for melanoma;
    10. Full recovery from all prior therapies. A minimal period of 4 weeks following major surgery, radiation therapy, or ILP, or any other major invasive procedure is required;
    11. Baseline WHO performance status of 0, or 1 (see Appendix D);
    12. Male and female patients ≥ 18 years of age;
    13. No need for uninterrupted therapeutic anticoagulation (e.g. for recent thrombo-embolism, or cardiac valve prosthesis)
    14. No prior history of a serious autoimmune disorder
    15. No concomitant medication with immune suppressive drugs (e.g. oral corticosteroids).
    16. 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 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 ≥ 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 serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) prior to the start of study.
    E.4Principal exclusion criteria
    1. Evidence of immunodeficiency. Autoimmune disease requiring medical treatment (e.g. corticosteroids or other immunosuppressive drugs). Vitiligo (skin depigmentation) is not an exclusion criterion;
    2. Any serious acute or chronic illnesses (e.g. heart disease NYHA Class III or IV, renal-, liver- or pulmonary insufficiency) or other conditions requiring concurrent medications not allowed during this study (e.g. active chronic infections requiring antibiotics).
    3. History of malignancy. Subjects with curatively treated cervical carcinoma in situ, or squamous-, or basal cell carcinoma of the skin, or subjects who have been treated and recurrence-free of other malignancies for  5 years following the diagnosis are eligible for this study;
    4. Inability to undergo FDG-PET/CT, or MRI examination;
    5. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study;
    6. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment;
    7. Subject is pregnant (positive serum beta human chorionic gonadotropin [-HCG] test at screening) or is currently breast-feeding, anticipates becoming pregnant/ impregnating their partner during the study or within 6 months after study participation, or subject does not agree to follow acceptable methods of birth control, such as hormonal contraception, intra-uterine pessar, condoms or sterilization, to avoid conception during the study and for at least 6 months after receiving the last dose of study treatment;
    8. Current alcohol dependence or drug abuse;
    9. Known hypersensitivity to the study treatment;
    10. Legal incapacity or limited legal capacity;
    11. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
    12. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
    E.5 End points
    E.5.1Primary end point(s)
    percentage of patients who are alive and free from melanoma macrometastases at 1 year (: 52 weeks) following randomization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52 following the initiation of study treatment
    E.5.2Secondary end point(s)
    Applicable to both arms of the study:
    1. the IATMP will be characterized for: the number of DC, purity and viability, electroporation efficiency (measured by the % of cells expressing CD70), the immunophenotype (including CD40, CD80, CD83, CCR7, CD14 expression), and functional characterization by IL-12p70 secretion at 0-24h and 24-48h. DC samples will be analyzed for sterility by long-term microbiological culture. The results will be tabulated, analyzed and summarized using descriptive statistics.
    2. Safety will be evaluated for all treated patients using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0 (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 be from the date of the first leukapheresis until the end of study visit.
    3. time of recurrence (locoregional and/or distant), time of death; median values with 95% confidence intervals will be determined using Kaplan-Meier survival estimates;

    Applicable to Arm B of the clinical trial only:
    Secondary endpoints: time of progression (according to irRC, and RECIST), or death.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuous during the conduct of 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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.2.3.1Comparator description
    Follow-up without therpeutic intervention
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of the trial will occur at the date of the last study visit (= up to the week 52 visit in the Arm-A and –B DC-treatment Phase) 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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state88
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 88
    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)
    the expected normal treatment of that condition
    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 Decision2011-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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