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    Summary
    EudraCT Number:2014-004420-22
    Sponsor's Protocol Code Number:UCC-EMMIE
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-01-08
    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 ConcernedIreland - HPRA
    A.2EudraCT number2014-004420-22
    A.3Full title of the trial
    Enhancing malignant melanoma immunological engagement using sequential therapy with ipilimumab and electrochemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of skin cancer using a different approach than surgery using an electroporation device that makes the tumour absorb more drug while leaving the healthy tissue alone combined with an immune modulator that enhances the anti-tumour immune response.
    A.3.2Name or abbreviated title of the trial where available
    EMMIE-IP
    A.4.1Sponsor's protocol code numberUCC-EMMIE
    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 SponsorUniversity College Cork
    B.1.3.4CountryIreland
    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 supportUniversity College Cork
    B.4.2CountryIreland
    B.4.1Name of organisation providing supportBristol Myers Squibb
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College Cork
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressCork University Hospital, Wilton
    B.5.3.2Town/ cityCork
    B.5.3.3Post code000
    B.5.3.4CountryIreland
    B.5.4Telephone number353021493 5362
    B.5.6E-mailderek.power1@hse.ie
    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 Yes
    D.2.1.1.1Trade name 1. Yervoy
    D.2.1.1.2Name of the Marketing Authorisation holder1. Bristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 L01XC11
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) 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 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
    Advanced Melanoma Cancer
    E.1.1.1Medical condition in easily understood language
    Advanced Melanoma Cancer
    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
    The Primary objective of this study is an assessment of the tolerability and safety of ipilimumab delivered systemically with electrochemotherapy delivered locally to the tumour.
    E.2.2Secondary objectives of the trial
    The Secondary objectives of this study are to investigate change to the total systemic tumour volume and structure as measured and evaluated radiologically: 12, and 24 weeks post the start of the procedure.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically verified melanoma.
    2. Patient must have a node/cutaneous lesion which is amenable to ECT.
    3. Patient must have at least one measurable lesion on a CT scan as defined by Modified RECIST.
    4. Unresectable, locally advanced, or metastatic melanoma with disease progression and no curable options with the standard of care.
    5. Men or women aged at least 18 years.
    6. Life expectancy of at least 3 months.
    7. Performance status (ECOG < or equal to 2).
    8. Treatment free interval of at least 2 weeks after previously applied therapy.
    9. WBC greater than or equal to 4.4 x 10 ^9/L, ANC great than or equal to 1.4x 10^9/L
    10. Platelets greater than or equal to 140 x 10^9/L
    11. Hemoglobin greater than or equal to 9g/dL
    12. Serum creatinine less than or equal to 1.5 times the upper limit of normal or creatinine clearance greater than or equal to 40 mls/min (using the Cockcroft-Gault Equation)
    13. AST and ALT less than or equal to 3 times ULN or less than or equal to 5 times ULN for subjects with liver metastasis
    14. Total bilirubin: less than or equal to 3 x ULN, [except subjects with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL]
    15. Patients must not have any physical, social or psychological condition that in the opinion of the investigator would impair the patients ability to provide informed consent.
    16. a) A female of Non-Childbearing potential (i.e. physiologically incapable of becoming pregnant) is eligible to participate in the study if she:
    - has had a hysterectomy
    - has had a bilateral oophorectomy (ovariectomy)
    - has had a bilateral tubal ligation
    - Is post-menopausal:
    [Post Menopausal definition: Patients not using hormone replacement therapy (HRT) must have experienced total cessation of menses for ≥ 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an oestradiol value < 40pg/mL (<140 pmol/L).
    Patients using HRT must have experienced total cessation of menses for > or = 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and oestradiol concentrations prior to initiation of HRT.]

    b) A female of Childbearing potential is eligible to participate in the study only if she has had a negative serum or urine pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible.

    c) Women of Childbearing potential and Men must agree to use adequate contraception since signing of the informed consent form until at least 6 months after the last study drug administration. The investigator or a designated associate is requested to advise the patient how to achieve an adequate birth control.
    18. Subjects with brain metastasis are eligible if these have been treated and there is no MRI (MRI -except where contraindicated in which case CT Scan is acceptable) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior or the first dose of study drug administration. There must be no requirement for immunosupressive doses of systemic corticosteroids (>10mg/day prednisolone equivalents) for at least 2 weeks prior to study drug administration.
    E.4Principal exclusion criteria
    1. Coagulation disorder
    2. Patients with a clinically manifested arrhythmia or with a pacemaker
    3. Patients with epilepsy.
    4. Pregnancy or lactation/breastfeeding.
    5. History of or current active autoimmune diseases, [e.g. including but not limited to inflammatory bowel diseases [IBD], rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (such as Guillain-Barre syndrome). Vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism are not exclusionary.]
    6. No known active infectious disease including including HIV, HBV and HCV.
    7. Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation.
    8. History of or current immunodeficiency disease [e.g. splenectomy or splenic irradiation];
    9. Prior allogeneic stem cell transplantation;
    10. 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.
    11. Concomitant therapy [e.g.: anti-cancer agent, potent immunosuppressive agents, surgery or radiotherapy or other investigational anti-cancer therapies or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses) with the exception of low dose steroids for AE management as deemed clinically appropriate.
    12. Prior therapies with systemic immunosuppressive agents [within prior 2 years (excluding episodic low dose corticosteroids, eg, for treatment of allergic dermatologic conditions); prior therapies with cytotoxic or investigational drugs within 2 weeks of randomization;]
    13. Prior immunotherapy within the previous 4 weeks.
    14. Treatment with any other investigational products/chemotherapy/RT, etc. within 2 weeks prior to inclusion into this study.
    15. Participation in another clinical study.
    16. Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
    17. Contraindications for bleomycin use including acute pulmonary infection and severe pulmonary disease.
    18. Contraindication for bleomycin use: allergic reactions to bleomycin observed in previous treatment.
    19. Contraindication for bleomycin use: if cumulative dose of 250mg BLM/m2 was previously exceeded.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point : Continuous assessment of safety by reviewing adverse events as they arise. The investigation will be put on hold if unacceptable safety issues are outstanding.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuous assessment of AEs and SAEs as they occur

    Safety End points:
    - Evaluation of any adverse events reported.
    - Evaluation of any severe adverse events reported.
    - Evaluation of the safety profile of treatment
    E.5.2Secondary end point(s)
    - Continuous assessment of safety by reviewing adverse events as they arise. The investigation will be put on hold if unacceptable safety issues are outstanding.

    - Evaluation of tumour regression / reduction in volume
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measured via CT or MRI scan at 12, or 24 weeks post the initial procedure.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 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.8.2.4Number of treatment arms in the trial1
    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 trial is defined as the follow up visit at week 24
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 10
    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)
    Patients will return to the standard or care available for advanced /metastatic melanoma cancer patients
    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 Decision2015-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-03-20
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