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    Summary
    EudraCT Number:2011-004986-34
    Sponsor's Protocol Code Number:SP002
    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:2011-11-10
    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 number2011-004986-34
    A.3Full title of the trial
    Randomized, open-label, parallel-group, multi-centre phase II clinical trial with active cellular immunotherapy DCVAC/PCa in combination with hormone therapy in patients with metastatic prostate cancer
    Randomizovaná, otevřená, multicentrická klinická studie fáze II s paralelními skupinami s metasatickým karcinomem prostaty léčených pomocí aktivní buněčné imunoterapie přípravkem DCVAC/PCa v kombinaci s hormonální terapií
    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 with active cellular immunotherapy DCVAC/PCa in combination with hormone therapy in patients with metastatic prostate cancer
    A.3.2Name or abbreviated title of the trial where available
    not applicable
    A.4.1Sponsor's protocol code numberSP002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02107391
    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
    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 Solution 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.3.10 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
    metastatic prostate cancer
    metastatický karcinom prostaty
    E.1.1.1Medical condition in easily understood language
    metastatic prostate cancer
    metastatický 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 10036909
    E.1.2Term Prostate cancer metastatic
    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 estimate the proportion of patients with PSA progression within two years after randomization.
    Cílem klinického hodnocení je odhad podílu pacientů, u kterých dojde k PSA progresi do dvou let po randomizaci.
    E.2.2Secondary objectives of the trial
    The clinical trial’s objective is to estimate the proportion of patients with a disease progression within two years of randomization, quality of life and the influence on the pain scale scoring using the standardized EORTC QLQ-C30 (v3.0) questionnaire, the incidence of adverse events and overall survival.
    An exploratory objective is to search for potential biomarkers that could play 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.
    Cílem klinického hodnocení je odhad podílu pacientů s progresí onemocnění do dvou let od randomizace, hodnocení kvality života a ovlivnění škály bolesti za použití standardizovaného dotazníku EORTC QLQ-C30 (v3.0), četnost výskytu nežádoucích příhod a celkové doby přežití.
    Explorativním cílem je definovat potenciální biomarkery, které by mohly hrát roli jako prognostické faktory, indikovat biologický vliv ACI na imunitní odpověď nebo umožnit identifikaci subpopulací pacientů profitujících z protinádorové imunoterapie (profilování na základě genové exprese).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inc-1) Men aged ≥ 18 years
    Inc-2) Histologically confirmed prostate carcinoma
    Inc-3) Bone or soft-tissue (other than brain or leptomeningeal) metastases confirmed by CT of the abdomen and small pelvis and/or bone scintigraphy
    Inc-4) The androgen deprivation therapy with LHRH analogs started not less than 1 month and not more than 3 months prior to the screening, or orchiectomy performed not less than 1 month and not more than 3 months prior to the screening
    Inc-5) ECOG 0-2 Performance Status
    Inc-6) The following laboratory values: WBC > 4 x 10(9)/L, ANC ≥ 1.5 x 10(9)/L, platelet count > 100 x 10(9)/L, Hb ≥ 90 g/L, Hct > 30%, Creatinine under 1.5 times the upper limit of normal, bilirubin, AST and ALT under 1.5 times the upper limit of normal.
    Inc-7) Castrate level of serum testosterone at screening (≤ 1.7 nmol/L, or ≤ 50 ng/dL)
    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, if their partners are of fertile age and of child-bearing potential
    E-2) Comorbidities of the patient
    E-2a) HIV-positive
    E-2b) Active hepatitis B or C
    E-2c) Active bacterial, viral or mycotic 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 in the past 6 months, heart failure NYHA II-IV, known left ventricular dysfunction with ejection fraction < 40% or haemodynamically significant arrhythmias or conduction problems, unless treated 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 coexisting condition, uncompensated psychiatric illness or social situation that would limit patient’s compliance.
    E-2h) Patients with a history of second malignancy other than non-melanoma skin cancer.
    E-2i) Unresolved ongoing clinically significant urinary tract obstruction
    E-2j) Active autoimmune disease requiring therapy
    E-2k) History of primary immunodeficiency
    E-3) Allergy 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) History of or ongoing chemotherapy for prostate cancer
    E-6) Patients with brain metastases or leptomeningeal metastases
    E-7) Ongoing unresolved post-operative complication of orchiectomy, which either requires treatment or restricts patient’s everyday activities
    E-8) Participation in another clinical trial or administration of another investigational medicinal product within 30 days preceding the screening
    E-9) Immunotherapy other than specified in this protocol
    E-10) Prohibited concomitant medication
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with a PSA progression within two years after randomization
    Podíl pacientů, u kterých dojde k progresi onemocnění do dvou let po randomizaci
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years after randomization
    2 roky po randomizaci
    E.5.2Secondary end point(s)
    The proportion of patients with disease progression within two years of randomization; Incidence of adverse events; Overall survival; Quality of life; Pain scale influence scoring; Exploratory endpoints - Immune response; Gene expression profiling, and/or expression levels of defined set of immune or cancer related genes, respectively
    Podíl pacientů, u kterých dojde k progresi onemocnění do dvou let po randomizaci; Četnost výskytu nežádoucích příhod; Celková doba přežití; Kvalita života; Hodnocení ovlivnění škály bolesti; Explorativní veličiny - Imunitní odpověď; Profilování na základě genové exprese a/nebo úrovně genové exprese u definované sady genů související s imunitou nebo karcinomem.
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 receiving only standard of care androgen deprivation therapy
    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 concerned18
    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 main part of the study will be terminated by the Sponsor as soon as the last patient undergoes the EOS visit. However, the study and collection of PSA and survival data (i.e. PSA and survival follow-up) will continue until sufficient data to evaluate overall survival are available. The current estimate is that the data will be available approximately 2 years after the EOS visit of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state60
    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 Decision2011-12-29
    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 trial2016-06-27
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