Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43976   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    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

    Summary
    EudraCT number
    2014-005330-58
    Trial protocol
    DE   NL  
    Global end of trial date
    07 Mar 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Jul 2023
    First version publication date
    30 Jul 2023
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    SAKK06/14
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02371447
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Swiss Group for Clinical Cancer Research (SAKK)
    Sponsor organisation address
    Effingerstrasse 33, Bern, Switzerland, 3008
    Public contact
    Head Regulatory Affairs, Swiss Group for Clinical Cancer Research (SAKK), +41 31389 91 91, sakkcc@sak.ch
    Scientific contact
    Head Regulatory Affairs, Swiss Group for Clinical Cancer Research (SAKK), +41 31389 91 91, sakkcc@sak.ch
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase I: To determine safety, tolerability and the recommended phase II dose (RP2D) of intravesical VPM1002BC instillations in patients with recurrence of non-muscle-invasive bladder cancer after transurethral resection of the bladder (TURB) and standard Bacille Calmette Guérin (BCG) therapy. Phase II: To investigate the efficacy, safety, tolerability and immunogenicity of intravesical VPM1002BC instillations in patients with recurrence of non-muscle-invasive bladder cancer after TURB and standard BCG therapy.
    Protection of trial subjects
    Protection of trial subjects was ensured by Safety Monitoring, i.e. assessment of adverse events, serious adverse events, adverse drug reactions, and the continous assessment of laboratory values and vital signs.
    Background therapy
    none
    Evidence for comparator
    not applicable
    Actual start date of recruitment
    08 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Switzerland: 34
    Worldwide total number of subjects
    42
    EEA total number of subjects
    8
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    8
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    42 patients at 14 sites in Switzerland (9 sites, 34 patients) and Germany (5 sites, 8 patients) have been enrolled from September 2015 to April 2018.

    Pre-assignment
    Screening details
    Eligibility criteria of a patient were checked by the investigator. Once a patient fullfils all inclusion criteria and not any of the exclusion criteria, he/she was enrolled.

    Period 1
    Period 1 title
    Phase I - Induction Phase
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    VPM1002BC
    Arm description
    Phase I: Dose finding.
    Arm type
    Experimental

    Investigational medicinal product name
    VPM1002BC
    Investigational medicinal product code
    Other name
    Mycobacterium bovis BCGΔureC::Hly+ for immunotherapy
    Pharmaceutical forms
    Intravesical suspension
    Routes of administration
    Instillation
    Dosage and administration details
    Dose level 1: 1-19.2x10E8 CFUs/50ml (CFU= colony forming units) per instillation (or dose level -1: 1-19.2x10E7 CFUs/46.4ml per instillation [not applied]) Induction: 6 instillations at weekly intervals (within 6 to 12 weeks). First instillation has to be done within 14 days after registration and corresponds to day 1 of the trial treatment schedule (= treatment start). After sterile transurethral insertion of a self-lubricating Charrière 12-16 catheter and after re-suspension of the dose of VPM1002BC in 50 ml of diluent, the dispersion is applied into the bladder wihout pressure.

    Number of subjects in period 1
    VPM1002BC
    Started
    6
    End of Phase I Induction
    6
    Completed
    42
    Joined
    36
         Phase II recruitment
    36
    Period 2
    Period 2 title
    Phase II - Baseline/Treatment Phase
    Is this the baseline period?
    Yes [1]
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    VPM1002BC
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    VPM1002BC
    Investigational medicinal product code
    Other name
    Mycobacterium bovis BCGΔureC::Hly+ for immunotherapy
    Pharmaceutical forms
    Intravesical suspension
    Routes of administration
    Instillation
    Dosage and administration details
    Dose level 1: 1-19.2x10E8 CFUs/50ml (CFU= colony forming units) per instillation Induction: 6 instillations at weekly intervals (within 6 to 12 weeks). First instillation has to be done within 14 days after registration and corresponds to day 1 of the trial treatment schedule (= treatment start). Maintenance: 3 instillations at weekly intervals starting at week 13 from day 1 followed by 3 instillations at weekly intervals starting at week 25 from day 1, followed by 3 instillations at weekly intervals starting at week 49 from day 1. After sterile transurethral insertion of a self-lubricating Charrière 12-16 catheter and after re-suspension of the dose of VPM1002BC in 50 ml of diluent, the dispersion is applied into the bladder wihout pressure.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: This was a combined PhaseI/II study. Period 1 refers to Phase I induction phase (dose finding), and Period 2 to Phase II baseline/treatment phase.
    Number of subjects in period 2
    VPM1002BC
    Started
    42
    Completed
    42
    Period 3
    Period 3 title
    Phase II - Follow-up Phase
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Follow-up
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    Follow-up
    Started
    42
    Completed
    19
    Not completed
    23
         Death
    12
         Lost to follow-up
    11

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    VPM1002BC
    Reporting group description
    -

    Reporting group values
    VPM1002BC Total
    Number of subjects
    42 42
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    8 8
        From 65-84 years
    34 34
    Gender categorical
    Units: Subjects
        Female
    4 4
        Male
    38 38

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    VPM1002BC
    Reporting group description
    Phase I: Dose finding.
    Reporting group title
    VPM1002BC
    Reporting group description
    -
    Reporting group title
    Follow-up
    Reporting group description
    -

    Subject analysis set title
    FAS
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full analysis ste including all registered patients, exluding two patients failing to satisfy major eligibilty criteria.

    Subject analysis set title
    PPS
    Subject analysis set type
    Per protocol
    Subject analysis set description
    PPS including all patients in the FAS and excluding 15 patients with serious protocol deviations.

    Primary: PE | Recurrence-free rate (90%CI)

    Close Top of page
    End point title
    PE | Recurrence-free rate (90%CI) [1]
    End point description
    The primary endpoint (PE) was analyzed using a test statistic based on the Kaplan-Meier (KM) estimator of the cumulative hazard function. The KM estimator was evaluated at 62 weeks as we allowed 2 weeks delay in the last assessment. The recurrence-free rate at 60 weeks together with a one-sided 90% as well a two-sided 95% confidence interval (CI) estimated using the KM estimator are shown. Note: Dummy data ("9999") entered for upper limit of 1-sided 90% CI due to database restrictions. Upper limit of 1-sided 90% CI not applicable. A single-stage design was applied with p0: recurrence-free rate at 60 weeks ≤15% and p1: recurrence-free rate at 60 weeks ≥30% with a 1-sided significance level of 10% and a power of 80%. The lower boundary of the 1-sided 90% CI is higher than p0 (15%) and even higher than p1 (30%), thus the null hypothesis can be rejected and the PE is clearly reached.
    End point type
    Primary
    End point timeframe
    60 weeks after registration.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses cannot be entered for single arm studies (database restriction): A single-stage design was applied with p0: recurrence-free rate at 60 weeks ≤15% and p1: recurrence-free rate at 60 weeks ≥ 30% with a 1-sided significance level of 10% and a power of 80%. As the lower boundary of the 1-sided 90% CI is higher than p0 (15%) the null hypothesis can be rejected. The lower boundary of the 1-sided 90% CI is even higher than p1 (30%). Thus, the primary endpoint is clearly reached.
    End point values
    FAS PPS
    Number of subjects analysed
    40
    25
    Units: Recurrence-free rate (%)
        number (confidence interval 90%)
    49.3 (38.1 to 9999)
    44.1 (30.7 to 9999)
    No statistical analyses for this end point

    Primary: PE | Recurrence-free rate (95% CI)

    Close Top of page
    End point title
    PE | Recurrence-free rate (95% CI) [2]
    End point description
    The primary endpoint (PE) was analyzed using a test statistic based on the Kaplan-Meier (KM) estimator of the cumulative hazard function. The KM estimator was evaluated at 62 weeks as we allowed 2 weeks delay in the last assessment. The recurrence-free rate at 60 weeks together with a one-sided 90% as well a two-sided 95% confidence interval (CI) estimated using the KM estimator are shown. A single-stage design was applied as described before for the 90% CI, except the use of a 2-sided 95% CI. Even with the 2-sided 95% CI the null hypothesis can be rejected.
    End point type
    Primary
    End point timeframe
    60 weeks after registration.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses cannot be entered for single arm studies (database restriction): A single-stage design was applied with p0: recurrence-free rate at 60 weeks ≤15% and p1: recurrence-free rate at 60 weeks ≥30% with a 2-sided significance level of 5% and a power of 80%. Even with the 2-sided 95% CI the null hypothesis can be rejected and the primary endpoint is clearly reached.
    End point values
    FAS PPS
    Number of subjects analysed
    40
    25
    Units: Recurrence-free rate (%)
        number (confidence interval 95%)
    49.3 (32.1 to 64.4)
    44.1 (23.8 to 62.8)
    No statistical analyses for this end point

    Secondary: SE | Time to recurrence in the bladder

    Close Top of page
    End point title
    SE | Time to recurrence in the bladder
    End point description
    23 patients experienced a confirmed recurrence in the bladder. The median time to recurrence in the bladder was estimated using the KM method. Note: Dummy data ("9999") entered for 95% CI upper limit of time to recurrence due to database restrictions. Upper limit of 95% CI not reached.
    End point type
    Secondary
    End point timeframe
    From registration to tumor recurrence in the bladder.
    End point values
    FAS
    Number of subjects analysed
    40
    Units: Time to recurrence (years)
        median (confidence interval 95%)
    1.3 (0.8 to 9999)
    No statistical analyses for this end point

    Secondary: SE | Recurrence-free rate in the bladder at 2, 3 and 4 years

    Close Top of page
    End point title
    SE | Recurrence-free rate in the bladder at 2, 3 and 4 years
    End point description
    The recurrence-free rate in the bladder at 2, 3, and 4 years were calculated using the KM estimator.
    End point type
    Secondary
    End point timeframe
    Two, three and four years after start of treatment.
    End point values
    FAS
    Number of subjects analysed
    40
    Units: Estimator (%)
    number (confidence interval 95%)
        2 years
    45.5 (28.9 to 60.7)
        3 years
    39.5 (23.6 to 54.9)
        4 years
    39.5 (23.6 to 54.9)
    No statistical analyses for this end point

    Secondary: SE | Time to recurrence

    Close Top of page
    End point title
    SE | Time to recurrence
    End point description
    Two events in addition to 23 recurrences in the bladder = 25 events. The median time to recurrence was estimated using the KM method.
    End point type
    Secondary
    End point timeframe
    From registration to recurrence at local, regional or distant site.
    End point values
    FAS
    Number of subjects analysed
    40
    Units: Time to recurrence (years)
        median (confidence interval 95%)
    1.3 (0.7 to 4.3)
    No statistical analyses for this end point

    Secondary: SE | Recurrence-free rate at 1, 2, 3 and 4 years

    Close Top of page
    End point title
    SE | Recurrence-free rate at 1, 2, 3 and 4 years
    End point description
    The recurrence-free rate in the bladder at 1, 2, 3, and 4 years were calculated using the KM estimator.
    End point type
    Secondary
    End point timeframe
    One, two, three and four years after start of treatment.
    End point values
    FAS
    Number of subjects analysed
    40
    Units: Estimator (%)
    number (confidence interval 95%)
        1 year
    52.7 (35.9 to 67.0)
        2 years
    44.5 (28.4 to 59.4)
        3 years
    36.2 (21.2 to 51.3)
        4 years
    36.2 (21.2 to 51.3)
    No statistical analyses for this end point

    Secondary: SE | Time to progression

    Close Top of page
    End point title
    SE | Time to progression
    End point description
    In the trial protocol, progression was defined as a recurrence with an increased stage (as compared to the stage at recurrence before inclusion into the trial) or increased grade or new occurrence of CIS. In case of several events, the first one was counted. To allow comparisons with literature, another definition for progression was used in addition, counting progression to muscle-invasive disease and increase in M or N stage as progression. According to the protocol definition, 16 patients experienced an event (12 increases in stage and 4 new occurrences of CIS). With the updated definition, 11 patients experienced an event; of those 3 and 4 were increase in M or N stage, respectively, and 4 were progressions to muscle-invasive disease. The median time to progression was not reached at the time of this analysis. Dummy data ("9999") entered due to database restrictions.
    End point type
    Secondary
    End point timeframe
    Time to progression was defined as time from registration to progression.
    End point values
    FAS
    Number of subjects analysed
    40
    Units: Time to progression (years)
        median (confidence interval 95%)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: SE | Progression-free rate in the bladder at 1, 2, 3 and 4 years

    Close Top of page
    End point title
    SE | Progression-free rate in the bladder at 1, 2, 3 and 4 years
    End point description
    The progression-free rate at 1, 2, 3 and 4 years (protocol definition or updated definition, see information provided for endpoint "Time to progression") was calculated using the KM estimator.
    End point type
    Secondary
    End point timeframe
    One, two, three and four years after start of treatment.
    End point values
    FAS
    Number of subjects analysed
    40
    Units: Estimator (%)
    number (confidence interval 95%)
        1 year (protocol definition)
    66.3 (48.3 to 79.3)
        2 years (protocol definition)
    63.2 (45.0 to 76.8)
        3 years (protocol definition)
    56.8 (38.7 to 71.4)
        4 years (protocol definition)
    56.8 (38.7 to 71.4)
        1 year (updated definition)
    78.7 (60.3 to 89.3)
        2 years (updated definition)
    78.7 (60.3 to 89.3)
        3 years (updated definition)
    78.7 (60.3 to 89.3)
        4 years (updated definition)
    71.0 (51.3 to 83.9)
    No statistical analyses for this end point

    Secondary: SE | Overall survival

    Close Top of page
    End point title
    SE | Overall survival
    End point description
    Eleven deaths have occurred in the FAS, five of these deaths were due to progressive disease. Eighteen patients were still alive and eleven were lost to follow-up. The median OS was not reached with a lower boundary of the 95% CI of 5 years. The median OS was not reached at the time of this analysis. Dummy data ("9999") entered due to database restrictions.
    End point type
    Secondary
    End point timeframe
    From registration until death from any cause.
    End point values
    FAS
    Number of subjects analysed
    40
    Units: Overall survival (years)
        median (confidence interval 95%)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: SE | Survival rate at 1, 2, 3 and 4 years

    Close Top of page
    End point title
    SE | Survival rate at 1, 2, 3 and 4 years
    End point description
    The survival rates at 1, 2, 3 and 4 years were calculated by the KM estimator.
    End point type
    Secondary
    End point timeframe
    One, two, three and four years after start of treatment.
    End point values
    FAS
    Number of subjects analysed
    40
    Units: Estimator (%)
    number (confidence interval 95%)
        1 year
    100 (100 to 100)
        2 years
    80.2 (62.9 to 90.0)
        3 years
    77.3 (59.7 to 88.0)
        4 years
    74.5 (56.7 to 85.8)
    No statistical analyses for this end point

    Secondary: SE | Tolerability

    Close Top of page
    End point title
    SE | Tolerability
    End point description
    Tolerability during induction phase was defined as finishing 5 instillations of VPM1002BC within 12 weeks after treatment start.
    End point type
    Secondary
    End point timeframe
    During induction phase.
    End point values
    FAS
    Number of subjects analysed
    40
    Units: Patients (%)
    number (not applicable)
        1 instillation during induction phase
    2.5
        3 instillations during induction phase
    2.5
        5 instillations during induction phase
    2.5
        6 instillations during induction phase
    92.5
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From registration until 12 weeks after last instillation for patients not completing the overall treatment or after week 60 for patients completing the entire maintenance phase.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    VPM1002BC - Safety Set
    Reporting group description
    -

    Serious adverse events
    VPM1002BC - Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 42 (23.81%)
         number of deaths (all causes)
    12
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Glioblastoma
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Small cell lung cancer
    Additional description: Neuro-endocrine (small cell) lung cancer
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Neuroendocrine tumour
    Additional description: Neuroendocrine tumor of the neobladder
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Urinary tract procedural complication
    Additional description: Traumatic catheterization due to sclerotic bladder neck
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Glaucoma surgery
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Hypersensitivity
    Additional description: Bcg-induced sytemic reaction
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    VPM1002BC - Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 42 (90.48%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences all number
    10
    Pyrexia
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    5
    Cystitis noninfective
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Pollakiuria
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences all number
    6
    Urinary tract pain
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Micturition urgency
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Infections and infestations
    Cystitis
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences all number
    14
    Urinary tract infection
         subjects affected / exposed
    14 / 42 (33.33%)
         occurrences all number
    19

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jan 2016
    The main reason for the amendment was the change of the immunology program in the Phase II part of the trial as follows: (1) reduction of the time points for immunology assessments from 9 to 4, (2) limitation of the immunology assessments to 10 patients (immunology cohort). Further changes: (1) Modification of inclusion criterion: “Planned treatment starts 2-5 weeks after last TURB” to “Planned treatment starts 2-6 weeks after last TURB”, (2) Modification of timeframe for computed tomography (CT) and other evaluations before registration from 8 weeks to 12 weeks, (3) Modification of timeframe for human immunodeficiency virus (HIV) testing from “within 7 days before or on registration” to “within 4 weeks before registration”, (4) Update of the timelines of the trial based on the effective trial activation date, (5) Minor adaptations concerning samples handling, (6) Administrative changes: correction of typos and wording
    08 Jul 2016
    The main reason for the amendment was the adaptation of the trial protocol according to the requests of the Competent Authority of Germany. The following changes were made: (1) Recommended Phase II Dose was specified in the protocol, (2) The timeframe for inactivation of VPM1002BC excreted in urine was the same in Phase II as in Phase I (1 week), (3) Any shortening of the 5 years follow-up period will have to be submitted to the ECs and to the competent authorities, (4) Update of the timelines of the trial, (5) Correction of inconsistency between exclusion criterion 6.2.27 "Psychiatric or neurological disorder precluding understanding of trial information, giving informed consent, filling out QoL forms" and chapter Quality of life, section patient selection: deletion of “mental problems” as a reason for noncompletion of QoL questionnaires, (6) Update of SAKK CC address and contact details, (7) Correction of typos and wording.
    20 Jul 2017
    The main reason for the amendment was the adaptation of the trial protocol according to the experience collected so far during trial conduct. The following changes were made: (1) Change of exclusion criterion 6.2.10 in order to allow inclusion of patients with low risk prostate cancer qualifying for active surveillance according to PRIAS criteria, (2) Duration of hospital stay after the instillation was reduced from 4 hours to time until first voiding (at least 1 hour), (3) Duration of follow-up period was reduced to 3 years, (4) Update of the timelines of the trial and addition of term “Primary completion date” in order to define the timeline of primary endpoint completion and study report preparation, (5) Update of chapter “Clinical experience with VPM1002” with data from ongoing /completed clinical trials, (6) Instructions for avoidance of traumatic catheterisation and postponing of VPM1002BC instillation in case of traumatic catheterisation, (7) Update of the table “BCG-related adverse events” and of “Precautions” according to the new Summary of Product Characteristics of BCG-medac, (8) Update of the table “Management options for side effects associated with intravesical VPM1002BC”, (9) Adaptation of the size of the immunology cohort in order to allow participation of more patients (at least 10 patients), (10) Update of chapter 18 with new analyses as part of the immunological assessments (translational research): multiplex analysis of serum and analysis of tumor material (including analysis of earlier tumor material from patient’s history of cancer, i.e. tumor material collected at the initial occurrence of the urothelial cancer)., (11) Update of contact details, (12) Removal of schedulers of assessments from the protocol (provided separately as useful tools), (13) Correction of typos, inconsistencies and orthographic mistakes.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/32363120
    http://www.ncbi.nlm.nih.gov/pubmed/35012889
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA