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    Summary
    EudraCT Number:2013-003809-26
    Sponsor's Protocol Code Number:SP010
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-04
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2013-003809-26
    A.3Full title of the trial
    Open-label, one-arm, multi-centre phase II clinical trial with second cycle of active cellular immunotherapy DCVAC/PCa in patients with localized prostate cancer after primary radical prostatectomy and without objective progression on the first cycle of DCVAC/PCa
    Otevřená, jednoramenná, multicentrická klinická studie fáze II u pacientů s lokalizovaným karcinomem prostaty po primární radikální prostatektomii léčených druhým cyklem aktivní buněčné imunoterapie přípravkem DCVAC/PCa, u kterých v prvním cyklu léčby DCVAC/PCa nedošlo k objektivní progresi onemocnění
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial in patients with localized prostate cancer after primary radical prostatectomy treated with second cycle of active cellular immunotherapy with DCVAC/PCa and without objective progression on the first cycle of DCVAC/PCa
    Klinické hodnocení u pacientů s lokalizovaným karcinomem prostaty po primární radikální prostatektomii léčených druhým cyklem aktivní buněčné imunoterapie přípravkem DCVAC/PCa, u kterých v prvním cyklu léčby DCVAC/PCa nedošlo k objektivní progresi onemocnění
    A.4.1Sponsor's protocol code numberSP010
    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 SponsorSOTIO a.s.
    B.1.3.4CountryCzech Republic
    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 supportSOTIO a.s.
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSOTIO a.s.
    B.5.2Functional name of contact pointClinical Trials Sotio
    B.5.3 Address:
    B.5.3.1Street AddressJankovcova 1518/2
    B.5.3.2Town/ cityPrague 7
    B.5.3.3Post code17000
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420224175111
    B.5.5Fax number+420224175498
    B.5.6E-mailclinicaltrial@sotio.com
    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 nameDCVAC/PCa
    D.3.2Product code DCVAC/PCa
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDCVAC/PCa
    D.3.9.1CAS number DCVAC/PCa
    D.3.9.2Current sponsor codeDCVAC/PCa
    D.3.9.3Other descriptive nameCELL SUSPENSION CONTAINING DENDRITIC CELLS
    D.3.9.4EV Substance CodeSUB120526
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000
    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
    Localized prostate cancer
    Lokalizovaný karcinom prostaty
    E.1.1.1Medical condition in easily understood language
    Localized prostate cancer
    Lokalizovaný karcinom prostaty
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    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
    The clinical trial’s objective is to establish the safety profile of extended application of active cellular immunotherapy (ACI) prepared from repeated leukapheresis. The safety of the second cycle of active cellular immunotherapy involving second leukapheresis will be assessed in patients, who successfully received all doses of active cellular immunotherapy (ACI) in Study SP003, and who were without objective progression of the disease during Study SP003.
    E.2.2Secondary objectives of the trial
    Other objectives are to evaluate the PSA doubling time in the treatment phase of Study SP010, and compare it with the PSA doubling time in Study SP003, to evaluate the PSA doubling time in the follow-up phase of Study SP010 and to determine the proportion of patients who had a progressive increase in PSA, objective disease progression or received further anticancer therapy within 2 years of enrolment; and to evaluate overall survival.
    An exploratory objective is to search for potential biomarkers that could play a role as prognostic factors, indicate the biological effect of ACI on immune-response or identify a subgroup of patients profiting from cancer immunotherapy based on gene expression profiling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inc-1) Signed informed consent to the study
    Inc-2)Patients who were eligible and enrolled to Study SP003, received 10 doses of active cellular immunotherapy in Study SP003 and were without objective progression of the disease since the start of their participation in Study SP003
    Inc-3) Time from the last dose of first-cycle active cellular immunotherapy of study SP003 is not longer than 16 weeks at the time of screening
    Inc-4) The following laboratory values:
    WBC > 4 x 10(9)/L, platelet count > 100 x 10(9)/L,
    Hct > 30%, creatinine under 1.5 times the upper limit of normal,
    bilirubin, AST and ALT under two times the upper limit of normal.
    Inc-5) ECOG 0-2 Performance Status
    E.4Principal exclusion criteria
    E-1) Sexually active fertile men not using effective birth control, if their female partners are of fertile age and of child-bearing potential
    E-2) Comorbidities of the patient:
    E-2a) HIV positivity
    E-2b) Active hepatitis B or C
    E-2c) Active bacterial, viral or fungal infection requiring systemic treatment
    E-2d) Clinically significant cardiovascular disease (including myocardial infarction or ventricular tachyarrhythmia within last 6 months, percutaneous coronary intervention or surgical revascularization in the past 6 months, heart failure NYHA II-IV, known left ventricular dysfunction with ejection fraction < 40% or haemodynamically significant arrhythmias or conduction disorders) unless secured with permanent cardiac pacing.
    E-2e) Pleural or pericardial effusion of any CTC grade
    E-2f) Peripheral neuropathy CTC Grade ≥ 2
    E-2g) Other uncontrolled intercurrent condition, uncompensated psychiatric illness or social situation that would limit patient’s compliance
    E-2h) Patients with a history of malignancy other than non-melanoma skin cancer
    E-2i) Unresolved clinically significant urinary tract obstruction
    E-2j) Active autoimmune disease requiring therapy
    E-2k) History of primary immunodeficiency
    E-3) Allergies and adverse drug reactions
    E-3a) History of allergic reaction to a compound of the same or similar structure as the investigational medicinal product
    E-3b) History of anaphylaxis or other severe reaction following vaccination
    E-4) Any other serious reason the Investigator considers the patient should not participate in the study
    E-5) Any prostate cancer N and M stage other than N0 and M0
    E-6) History of or ongoing androgen deprivation therapy after radical prostatectomy
    E-7) History of or ongoing chemotherapy for prostate cancer
    E-8) Immunotherapy other than specified in this protocol
    E-9) Forbidden concomitant medication (other investigational drugs, products or instruments, any anti-tumour androgen deprivation therapy, bisphosphonate treatment)
    E-10) Indication for radiotherapy during Study SP003 or screening period for Study SP010
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study are safety measures such as incidence of Adverse Events, Serious Adverse Events, clinically significant laboratory abnormalities and changes in vital signs
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years after enrollment
    E.5.2Secondary end point(s)
    •PSA doubling time in the treatment phase, from Dose 1 to Dose 10 of the second immunotherapy cycle, i.e. in study SP010
    •Comparing the PSA doubling time measured in the treatment phase of the second immunotherapy cycle, i.e. in Study SP010, with the PSA doubling time measured in the first immunotherapy cycle, i.e. in Study SP003
    •PSA doubling time measured in the follow-up phase (from completed Visit 10 to 2 years from enrolment in the study
    •Comparing the PSA doubling time measured in the follow-up phase (from completed Visit 10 to 2 years from enrolment in the study) with the PSA doubling time in the treatment phase
    •The proportion of patients with objective clinical progression of the disease (evidence of metastases on bone scintigraphy or local progression or metastases on CT of the abdomen and small pelvis) within 2 years from the enrolment in the study
    •The proportion of patients who required any further anticancer therapy within 2 years from the enrolment in the study
    •The proportion of patients with progressive increase in PSA within 2 years from the enrolment in the study
    •Overall Survival

    Exploratory endpoints
    •Immune response
    •Gene expression profiling, and/or expression levels of a defined set of immune or cancer-related genes, respectively
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years after enrollment
    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 No
    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 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 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 concerned8
    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
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state24
    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)
    None
    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 Decision2013-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
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