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    Summary
    EudraCT Number:2012-000552-33
    Sponsor's Protocol Code Number:LUMC_2012
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-11-29
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-000552-33
    A.3Full title of the trial
    Adoptive T cell therapy plus vaccination in metastatic melanoma patients
    Adoptieve T cel therapie in combinatie met autologe tumor cel vaccinaties als behandeling voor patiënten met gemetastaseerd melanoom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    T lymphocyte infusions plus vaccination as treatment for melanoma.
    Infusie van T lymfocyten plus vaccinatie als behandeling van melanoom patiënten.
    A.3.2Name or abbreviated title of the trial where available
    ACT in melanoma.
    A.4.1Sponsor's protocol code numberLUMC_2012
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportLeiden University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointClinical Oncology
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31715263486
    B.5.5Fax number31715266760
    B.5.6E-mailH.W.Kapiteijn@lumc.nl
    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 nameMelanoma-reactive T cells and autologous whole tumor cell vaccine
    D.3.2Product code ACT and tumor cell vaccination
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtumor-reactive T cells
    D.3.9.2Current sponsor codetumor-reactive T cells
    D.3.9.3Other descriptive nametumor-reactive T cells
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number3000000000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNirradiated autologous tumor cells
    D.3.9.2Current sponsor codeautologous whole tumor cell vaccine
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number60000000
    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) 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
    Metastasized melanoma
    Gemetastaseerd melanoom
    E.1.1.1Medical condition in easily understood language
    Metastasized melanoma
    Gemetastaseerd melanoom
    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 to demonstrate safety of ACT plus low does IFN-alpha followed by vaccination with autologous tumor cells. Toxicity and adverse events will be evaluated according to common terminology criteria for adverse events (CTCAE) version 4.0, published June, 2010, Website: http://evs.nci.nih.gov/ftp1/CTCAE/About.html
    E.2.2Secondary objectives of the trial
    The secondary objective includes evaluation of the clinical response after treatment. Clinical outcome after treatment includes the overall survival and tumor response after treatment that will be assessed by physical examination and imaging studies (CT and MRI) and that will be evaluated according to RECIST version 1.1 and the immune response criteria irRC. As additional objective exploratory immune related parameters in patient’s serum, blood and transferred T cells will be evaluated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. Age ≥ 18 years.
    2. Histologically proven melanoma.
    3. Melanoma must be at one of the following AJCC 2009 stages:
    -Irresectable (or residual) regional metastatic melanoma, i.e. in terms of AJCC 2009 classification irresectable stage III melanoma, or
    -Stage IV melanoma, i.e. distant metastatic disease (any T, any N, M1a, M1b or M1c), and normal LDH.
    4. Patients with brain metastases have to be neurologically stable for at least 2 months and should not use dexamethasone.
    5. Presence of measurable progressive disease according to RECIST version 1.1.
    6. Expected survival of at least 3 months.
    7. WHO performance status ≤1.
    8. Within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified :
    Lab Parameter Range
    Hemoglobin ≥ 6,0 mmol/l
    Granulocytes ≥ 1,500/µl
    Lymphocytes ≥ 700/µl
    Platelets ≥ 100,000/µl
    Creatinine clearance ≥ 60 min/ml
    Serum bilirubin ≤ 40 µmol/l
    ASAT and ALAT ≤ 5 x the normal upper limit
    LDH ≤ 2 x the normal upper limit

    9. Viral tests:
    -Negative for HIV type 1/2, HTLV and TPHA
    -No HBV (hepatitis B virus) antigen or antibodies against HBc in the serum
    -No antibodies against HCV (hepatitis C virus) in the serum

    10. Able and willing to give valid written informed consent.
    11. Successful production of melanoma reactive T cells and autologous tumor cells that meet the release criteria
    E.4Principal exclusion criteria
    Patients will be excluded from the study for any of the following reasons:
    1. Prior treatment, including immunotherapy e.g. with Ipilimumab, is not an exclusion criterion. Systemic therapy must have been discontinued for at least four weeks before study entry. Radiotherapy and MEK-inhibitor/BRAF-inhibitor should be discontinued for at least two weeks before study entry. Patients should have PD after treatment. After treatment with Ipilimumab initial PD should be confirmed by repeated imaging studies evaluated according to irRC to exclude late effects of Ipilimumab treatment.
    2. Patients with brain metastases who are neurologically unstable and/or on use of dexamethasone.
    3. Clinically significant heart disease (NYHA Class III or IV).
    4. Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.
    5. Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion.
    6. Other malignancy within 2 years prior to entry into the study, except for treated non-melanoma skin cancer and in situ cervical carcinoma.
    7. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
    8. Lack of availability for follow-up assessments.
    9. Pregnancy or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    The study is stopped when at least 3 patients experience treatment limiting toxicity.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The study is stopped when at least 3 patients experience treatment limiting toxicity. If no treatment limiting toxicity occurs the primary endpoint is evaluated after completing treatment of 10 patients, which is anticipated to be finalized 3-4 years after initiation of the study.
    E.5.2Secondary end point(s)
    There is an interim analysis of the secondary objective after treatment of 15 patients. The study is stopped when after treating 15 patients less than 2 patients show clinical benefit (defined as CR, PR or SD according to RECIST 1.1).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The clinical response is evaluated and stopped when after completing treatment of 15 patients less than 2 patients show clinical benefit. This evaluation is anticipated to be finalized 4 years after initiation of the study.
    If more than 2 of the 15 treated patients show clinical benefit the study enters the second stage (Simon's two stage approach) and a maximum of 25 patients will be included for final evaluation of the secondary endpoint and of additional immune related parameters.
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    tumor-reactive T cell infusions and whole tumor cell vaccinations are administerde before to humans,
    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.8.2.4Number 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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state25
    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 subjects that have ended participation in the trial will be treated acoording to standard treatment for 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 Decision2012-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-27
    P. End of Trial
    P.End of Trial StatusOngoing
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