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    Summary
    EudraCT Number:2009-014799-23
    Sponsor's Protocol Code Number:PH-L19IL2-03/09
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-08-18
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-014799-23
    A.3Full title of the trial
    A phase II study of intratumoral application of L19IL2 in patients with stage III/IV melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study of L19IL2 injected directly into the tumor in patients with stage III/IV melanoma
    A.3.2Name or abbreviated title of the trial where available
    L19IL2 intratumoral
    A.4.1Sponsor's protocol code numberPH-L19IL2-03/09
    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 SponsorPhilogen S.p.A
    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 supportPhilogen S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPhilogen S.p.A
    B.5.2Functional name of contact pointProduct Manager
    B.5.3 Address:
    B.5.3.1Street AddressLibernstrasse 3
    B.5.3.2Town/ cityOtelfingen
    B.5.3.3Post code8112
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041435448802
    B.5.5Fax number0041435448809
    B.5.6E-mailmanuela.kaspar@philochem.ch
    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 nameL19IL2
    D.3.2Product code L19IL2
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameL19-IL2
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number20
    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) 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 Yes
    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
    Cancer- Patients with histopathologically-proven malignant melanoma with presence of measurable and injectable dermal or subcutaneous metastases either in clinical stage III or stage IV
    E.1.1.1Medical condition in easily understood language
    locally advanced melanoma without metastases to inner organs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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 14.0
    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
    Rate of patients with complete response (CR) of L19IL2 treated metastases at week 12
    E.2.2Secondary objectives of the trial
    Safety of intratumoral administration of L19IL2
    Rate of patients with CR, partial response (PR) and stable disease (SD) of L19IL2 treated metastases at week 12 (objective response rate and disease control rate of L19IL2 treated metastases)
    Duration of objective response and disease control of L19IL2 treated metastases
    Rate of patients with CR, PR and SD of all metastases at week 12 (objective response rate and disease control rate of all metastases)
    Duration of objective response and disease control of all metastases
    Overall survival (OS)
    Objective response rate of all metastases at week 24 and 36 according to RECIST vs. 1.1
    Disease control rate of all metastases at week 24 and 36 according to RECIST vs. 1.1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histopathologically proven malignant melanoma
    • Presence of measurable and injectable soft tissue metastases either in clinical stage III or stage IV M1a without visceral metastases
    • Males or females, age > 18 years
    • Either without or after one line of prior systemic treatment for metastatic disease.
    • ECOG performance status < 2
    • LDH < 2 x the upper limit of normal
    • Life expectancy of at least 12 weeks
    • Absolute neutrophil count > 1.5 x 109/L, hemoglobin > 9.0 g/dL and platelets > 100 x 109/L
    • Negative serum pregnancy test (for women of child-bearing potential only) at screening
    • If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug.
    • Able to provide written Informed Consent.
    • Willingness and ability to comply with the scheduled visits, treatment plan,
    laboratory tests and other study procedures.
    E.4Principal exclusion criteria
    • Primary ocular melanoma
    • Presence of visceral metastases at screening
    • Evidence of active brain metastases at screening.
    • History of HIV infection or infectious hepatitis B or C
    • Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
    • Inadequately controlled cardiac arrhythmias including atrial fibrillation
    • Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria)
    • Uncontrolled hypertension
    • Ischemic peripheral vascular disease (Grade IIb-IV)
    • Active autoimmune disease
    • History of organ allograft or stem cell transplantation
    • Known history of allergy to IL2, or other intravenously administered human proteins/peptides/antibodies.
    • Breast feeding female
    • Growth factors or immunomodulatory agents within 7 days of the administration of study treatment
    • Patients in need of systemic treatment for rapidly progressive systemic disease during study treatment and up to 2 weeks after injection of L19IL2.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of patients with complete response(CR) of L19IL2 treated metastases at week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    Safety of intratumoral administration of L19IL2
    - Rate of patients with CR, partial response (PR) and stable disease (SD) of L19IL2 treated metastases at week 12 (objective response rate and disease control rate of L19IL2 treated metastases)
    - Duration of objective response and disease control of L19IL2 treated metastases
    - Rate of patients with CR, PR and SD of all metastases at week 12 (objective response rate and disease control rate of all metastases)
    - Duration of objective response and disease control of all metastases
    - Overall survival (OS)


    Objective response rate of all metastases at week 24 and 36 according to RECIST vs. 1.1
    Disease control rate of all metastases at week 24 and 36 according to RECIST vs. 1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    For objective response rates at week 12
    For OS and Duration of response up to 1 year
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.2Open No
    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.8.3 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 EEA5
    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
    End of Trial: corresponds to the last visit (end of study visit) of the last patient 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 months0
    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 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.1.1.1In 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    according to normal treatment
    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 Decision2010-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
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