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    Summary
    EudraCT Number:2011-004985-14
    Sponsor's Protocol Code Number:SP003
    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:2011-11-21
    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 number2011-004985-14
    A.3Full title of the trial
    Randomized, open-label, parallel-group, multi-centre phase II clinical trial of active cellular immunotherapy DCVAC/PCa in patients with localized prostate cancer after primary radical prostatectomy
    Randomizovaná, otevřená, multicentrická klinická studie fáze II s paralelními skupinami u pacientů s lokalizovaným karcinomem prostaty po primární radikální prostatektomii léčených pomocí aktivní buněčné imunoterapie přípravkem DCVAC/PCa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, open-label, parallel group, multi-centre Phase II clinical trial of active cellular immunotherapy DCVAC/PCa in patients with localized prostate cancer after primary radical prostatectomy
    Randomizovaná, otevřená, multicentrická klinická studie fáze II s paralelními skupinami u pacientů s lokalizovaným karcinomem prostaty po primární radikální prostatektomii léčených pomocí aktivní buněčné imunoterapie přípravkem DCVAC/PCa
    A.3.2Name or abbreviated title of the trial where available
    not applicable
    A.4.1Sponsor's protocol code numberSP003
    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/ cityPraha 7 - Holešovice
    B.5.3.3Post code170 00
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420224175111
    B.5.5Fax number+420227204958
    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.3.9.2Current sponsor codeDCVAC/PCa
    D.3.9.3Other descriptive nameDCVAC/PCa
    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 after primary radical prostatectomy
    E.1.1.1Medical condition in easily understood language
    Localized prostate cancer after primary radical prostatectomy
    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
    To evaluate the PSA doubling time in patients in immunotherapy group and in the control group in the treatment phase of the study.
    E.2.2Secondary objectives of the trial
    Other objectives are to compare the PSA doubling time measured in the treatment phase with the PSA doubling time prior to randomization in patients in both groups, to evaluate the PSA doubling time in patients in immunotherapy group and in the control group in the follow-up phase of the study, to monitor the incidence of adverse events, to determine the proportion of patients with a biochemical relapse, progressive increase in the PSA, objective disease progression or further anticancer therapy introduction within two years of randomization and to compare Overall Survival between the two groups.
    An exploratory objective is to search for potential biomarkers that could play a role as prognostic factors, indicate the biological effect of ACI on the immune-reponse or identify a subgroup of patients profiting from cancer immunotherapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inc-1) Men aged ≥ 18 years
    Inc-2) Histologically confirmed pT2 stage prostate cancer
    Inc-3) Post-radical prostatectomy (RPE) patients
    Inc-4) PSA increase which is defined as follows:
    Inc-4a) After salvage radiotherapy (or RPE, if patients did not undergo salvage radiotherapy), PSA level greater than 0.020 ng/mL was detected.
    Inc-4b) PSA values measured after the value greater than 0.020 ng/mL resulted in PSA doubling time (PSADT) equal or less than 12 months (It is possible to use also the initial value greater than 0.020 ng/mL for PSADT calculation). PSADT must be based on at least three increasing values (i.e. each value greater than the previous one).The interval between two subsequent measurements should be3 months (however, intervals of at least 4 weeks and at most 6 months, i.e. 26 weeks, may be accepted).If PSADT is based on more than 3 values, all the values measured between the first and the last one must be taken into account (fluctuation is allowed but the resulting trend should be increasing and fulfil the condition PSADT ≤12 months).
    Fulfilment of this inclusion criterion must be confirmed by the Sponsor before randomization of the patient.
    Inc-5) Patients who meet one of the following criteria:
    Inc-5a) Patients who did not undergo salvage radiotherapy, who had a PSA increase as defined in Inc-4) within 2 years of RPE.
    Inc-5b) Patients after the salvage radiotherapy indicated at the PSA under 1.0 ng/mL, who had a PSA increase as defined in Inc-4) at any time interval from salvage radiotherapy.
    Inc-6) 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 normal limit, bilirubin, AST and ALT under two times the upper limit of normal.
    Inc-7) ECOG 0-2 Performance Status
    Inc-8) Signed informed consent to participate in the study
    E.4Principal exclusion criteria
    E-1) Sexually active fertile men not using effective birth control, provided that 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 in previous 6 months, percutaneous coronary intervention or surgical revascularization within the previous 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 treatment
    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 medication used in this study
    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 prostate cancer treatment using androgen deprivation therapy at any time in the past (pharmacological treatment or bilateral orchiectomy)
    E-7) PSA > 1 ng/mL prior to starting salvage radiotherapy for biochemical relapse
    E-8) History of or ongoing chemotherapy for prostate cancer
    E-9) Participation in another clinical trial or administration of another investigational medicinal productwithin 30 days preceding the screening
    E-10) Immunotherapy other than specified in this protocol
    E-11) Unauthorized concomitant medication
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the PSA doubling time in the treatment phase (from randomization to Visit V10 at Week 40).
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    E.5.2Secondary end point(s)
    • Comparing the PSA doubling time measured in the treatment phase with the PSA doubling time prior to randomization
    • Value of the PSA doubling time in the follow-up phase (from completed visit at Week 40 to 2 years from randomization)
    • Incidence of adverse events
    • The proportion of patients with objective disease progression (metastatic disease development -Distant Failure-DF) within 2 years of randomization
    • The proportion of patients who required any further anticancer therapy within 2 years of randomization
    • For the subgroup of patients who did not undergo salvage radiotherapy (only RPE), the proportion of patients who had a biochemical relapse within 2 years of randomization
    • The proportion of patients who had a progressive increase in the PSA within 2 years of randomization
    • 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
    N/A
    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 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Patient group monitored according to standard treatment procedures
    E.8.2.4Number of treatment arms in the trial2
    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 concerned15
    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
    2 years after randomization of the last subject
    2 roky po randomizaci posledního subjektu
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state150
    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)
    not applicable
    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 Decision2012-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-22
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