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    Summary
    EudraCT Number:2014-005330-58
    Sponsor's Protocol Code Number:SAKK06/14
    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:2016-03-04
    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 ConcernedGermany - PEI
    A.2EudraCT number2014-005330-58
    A.3Full title of the trial
    A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study in patients with bladder cancer
    A.4.1Sponsor's protocol code numberSAKK06/14
    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 SponsorSAKK (Schweizerische Arbeitsgemeinschaft für klinische Krebsforschung)
    B.1.3.4CountrySwitzerland
    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 supportSAKK CC
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSAKK CC
    B.5.2Functional name of contact pointMilica Enoiu, PhD
    B.5.3 Address:
    B.5.3.1Street AddressEffingerstrasse 33
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 31 508 41 48
    B.5.5Fax number+41 31 508 41 42
    B.5.6E-mailtrials@sakk.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 nameVPM1002BC
    D.3.2Product code VPM1002BC
    D.3.4Pharmaceutical form Lyophilisate and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVPM1002BC
    D.3.9.2Current sponsor codeVPM1002BC
    D.3.9.3Other descriptive nameRecombinant Mycobacterium bovis BCG∆ureC::Hly+
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 19.2
    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) Yes
    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 Yes
    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
    Treatment of patients with recurrent non-muscle invasive bladder cancer
    E.1.1.1Medical condition in easily understood language
    Bladder cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10005005
    E.1.2Term Bladder cancer recurrent
    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
    To investigate the efficacy, safety, tolerability and immunogenicity of intravesical VPM1002BC instillations in patients with recurrence of non-muscle-invasive bladder cancer (NMIBC) after TURB and standard BCG therapy.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Disease characteristics:

    -Histologically confirmed diagnosis of recurrent NMIBC (urothelial carcinoma) including repeat TURB confirming tumor-free state of the bladder (confirmed by TURB and biopsy) For patients with pure CIS of the bladder no repeat TURB is necessary.
    -Negative cytology before start of treatment, except for patients with concomitant CIS.
    -Planned treatment starts 2-6 weeks after last TURB
    -Pathological grading includes reporting according to WHO 1973 and 2004.
    -One previous cycle of intravesical BCG (induction phase with at least 5 instillations ± maintenance) not more than 5 years ago for NMIBC.
    -Patients have recurrent high-risk NMIBC for progression (score 7-23), based on the European Organization for Research and Treatment of Cancer scoring system, failing BCG therapy (EAU 2008 definition), for whom radical cystectomy or re-induction with standard BCG is indicated. This includes:
    o Patients with high-grade, non-muscle invasive tumor(s) present at both 3 and 6 months after start of the previous cycle of BCG therapy, and
    o Any worsening of the disease under BCG treatment, such as a higher number of recurrences, higher tumor category or higher grade, or appearance of CIS, including low grade tumors, in spite of an initial response.

    Patient characteristics:

    -Patient must give written informed consent before registration.
    -Baseline Quality of Life questionnaire has been completed.
    -WHO performance status 0-2
    -Age 18 - 85 years
    -Adequate hematological values: WBC ≥2.5 x 109/L, platelets ≥ 100 x 109/L
    -Adequate hepatic function: total bilirubin ≤ 2 x ULN, AST/ALT ≤ 5 x ULN
    -Adequate renal function: eGFR ≥ 30 mL/min/1.73m2, no need for dialysis
    -Women are not breastfeeding. Sexually active women must ensure that their partner wears a condom during intercourse. Women with child-bearing potential are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 6 months thereafter. A negative pregnancy test (serum or urine) before inclusion (within 7 days) into the trial is required for all women with child-bearing potential.
    Sexually active men must use a condom during intercourse and ensure that his partner practices contraception. Men agree not to father a child during participation in the trial and during 6 months thereafter.
    E.4Principal exclusion criteria
    Disease characteristics:

    -Current or previous ≥ T2 urothelial carcinoma (UC) of the urinary bladder
    -Concomitant UC of upper urinary tract, prostate or urethra*, small cell carcinoma of the bladder (with or without neuroendocrine differentiation), micropapillary urothelial carcinoma, pure squamous cell carcinoma of the bladder, (UC with squamous differentiation is allowed), pure adenocarcinoma, lympho-vascular invasion (LVI) in the TURB specimen. * If a staged transurethral resection of the prostate (TURP) shows no histological evidence of UC in the deep resection layer of the prostate, the patient can be included.
    -Previous or current evidence of UC in a bladder diverticulum
    -Evidence of metastatic disease in the (thoraco-)abdominal CT scan at registration
    -Bladder surgery or traumatic catheterization or TURB within 2 weeks prior to the expected start of trial treatment
    -Administration of systemic cytotoxic agents within the past 3 years or administration of repeated cytostatic/cytotoxic drugs by intravesical instillations after a UC recurrence after the first BCG therapy (during the past 5 years). Exceptions are one immediate intravesical instillation (<24h) of a cytostatic/cytotoxic drug after TURB or repeated cytostatic/cytotoxic drugs by intravesical instillations before the first BCG therapy.

    Patient characteristics:

    -Stress urinary incontinence >I°, severe urge or urge urinary incontinence preventing the patient to keep the IMP in the bladder for at least 1 hour (anticholinergics and blocked catheter are allowed in order to achieve this criterion)
    -Residual urinary bladder volume after micturition (measured by ultrasound of bladder or inserted catheter) is > 150 ml.
    -Bladder diverticula or any other anatomical anomalies of the bladder that cannot be assessed by cystoscopy
    -Active concomitant malignant conditions except low risk prostate cancer qualifying for active surveillance according to PRIAS criteria, basal cell skin carcinoma and cervical carcinoma in situ. History of malignancy in the last 3 years except previous NMIBC.
    -Primary or secondary immunodeficiencies
    -Positive HIV test
    -Chronic administration (defined as more than 14 consecutive days) of immunosuppressive drugs or other immune modifying drugs within three months before instillation (for corticosteroids, this will mean prednisolone, or equivalent, 10mg/day). Inhaled and topical steroids are allowed.
    -Uncontrollable urinary tract infection, macroscopic haematuria, suspicion of bladder perforation, urethral strictures (if interfering with trial procedures)
    -Current and past pelvic radiation and brachytherapy
    -Active tuberculosis, suspicion of active tuberculosis, other ongoing mycobacterial infection.
    -Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last three months, significant arrhythmias, significant QT-prolongation).
    -History of anaphylaxis or severe allergic reactions, known allergies to any component of the investigational product, BCG intolerance
    -Local and severe allergy (e.g. ulceration, systemic reactions) to PPD test
    -Acute fever or fever (>38.5˚C) in the last 7 days before registration
    -Simultaneous administration of antituberculous agents and antibiotics that cannot be stopped until registration
    -Administration of immunoglobulins within the past 12 weeks
    -Suspected or known current drug and/or alcohol abuse preventing compliance with trial treatment
    -Patients who have participated in another clinical trial involving an investigational product within 30 days prior to trial entry
    -Any on-going uncontrolled chronic illness (e.g. active autoimmune disease, uncontrolled diabetes)
    -Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and
    follow-up.
    -Psychiatric or neurological disorder precluding understanding of trial information, giving informed consent, filling out QoL forms
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the phase II part is:
    -Recurrence-free rate in the bladder at 60 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    E.5.2Secondary end point(s)
    Secondary endpoints of the trial are:
    -Time to recurrence in the bladder
    -Time to recurrence
    -Time to progression
    -Overall survival
    -Adverse events
    -Tolerability
    -Quality of Life
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability and immunogenicity
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    Netherlands
    Switzerland
    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
    Last visit 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 days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 39
    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, there is no need for further use of the investigational product after end of 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 Decision2016-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-07
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