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    Summary
    EudraCT Number:2020-003112-27
    Sponsor's Protocol Code Number:NORTH-REG-3
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-06-30
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-003112-27
    A.3Full title of the trial
    Nordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC Short title: NORTH-REG Dwell-Time Study
    Nordisk studie om reduceret påvirkningstid af BCG for højrisiko ikke-muskelinvasiv blæretumor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC Short title: NORTH-REG Dwell-Time Study
    Nordisk studie om reduceret påvirkningstid af BCG for højrisiko ikke-muskelinvasiv blæretumor
    A.3.2Name or abbreviated title of the trial where available
    DWELL-TIME
    DWELL-TIME
    A.4.1Sponsor's protocol code numberNORTH-REG-3
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04701151
    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 SponsorAarhus University
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University
    B.5.2Functional name of contact pointJørgen Bjerggaard Jensen
    B.5.3 Address:
    B.5.3.1Street AddressNordre Ringgade 1
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.4Telephone number004530915682
    B.5.6E-mailBjerggaard@skejby.rm.dk
    B.Sponsor: 2
    B.1.1Name of Sponsor
    B.1.3.4Country
    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 supportmedac GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointJørgen Bjerggaard Jensen
    B.5.3 Address:
    B.5.3.1Street AddressPalle-Juul Jensens Boulevard 99
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number004530915682
    B.5.6E-mailBjerggaard@skejby.rm.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name BCG medac
    D.2.1.1.2Name of the Marketing Authorisation holdermedac GmbH
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameBCG medac
    D.3.2Product code L03AX03
    D.3.4Pharmaceutical form Powder and solvent for intravesical suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for intravesical solution
    D.8.4Route of administration of the placeboIntravesical use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Reduced BCG dwell time in patients who are diagnosed with high risk non-muscle-invasive- bladder cancer
    Reduceret varighed af BCG behandlingstid ved patienter diagnostiseret med høj risiko ikke muskel invasiv blære tumorer
    E.1.1.1Medical condition in easily understood language
    Patients, who are diagnosed with non muscle invasive bladder cancer
    Patienter som har fået konstateret overfladiske tumorer i blæren med høj risiko for progression og tilbagefald
    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 LLT
    E.1.2Classification code 10005004
    E.1.2Term Bladder cancer NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The trial aims to evaluate the potential clinical impact of a new regimen with reduction of dwell-time during once-weekly BCG instillations for 6 weeks followed by maintenance therapy for 12 months in regards to side effects, adherence to instillation regimen and oncological outcome.
    Vi vil undersøge, om vi ved at reducere tiden hvor BCG skyllevæsken skal være i urinblæren, kan reducere bivirkninger ved BCG behandling, som giver af 6 ugentlige skyllebehandlinger, og efterfølgende vedligeholdelsesterapi i 12 måneder. Vi vil måle på om reduktionen i tiden baseret på løbende overvågning af bivirkninger kan gøre, at behandlingen er mere veltålt samt om flere patienter dermed gennemfører alle de planlagte behandlinger.
    E.2.2Secondary objectives of the trial
    • Recurrence rate within 24 months in Study Subjects with initial complete response
    • Progression rate within 24 months and 60 months
    • Disease specific survival within 24 months and 60 months
    • Overall survival within 24 months and 60 months
    • Total no. of BCG instillations per Study Subject
    • No. of Study Subjects completing all 6 induction instillations
    • Number of BCG instillations given with full dwell-time of 2 hours per Study Subject
    • Number of installations per Study Subject postponed 1 week or more because of side effect
    • Number of Study Subjects where instillations is stopped because of local side effects
    • Number of Study Subjects where instillations is stopped because of systemic side effects
    • Complete response rate following induction therapy defined as no recurrence at first cystoscopy after induction therapy
    • Number of Study Subjects undergoing re-induction therapy within 24 months because of recurrent or persistent disease
    • Recidivrate indenfor 24 måneder for patienten med komplet respons
    • Progressions rate indenfor 24 måneder og 60 måneder
    • Sygdomsspecifik overlevelse indenfor 24 måneder og 60 måneder
    • Samlet overlevelse indenfor 24 måneder og 60 måneder
    • Total antal BCG skyllebehandlinger pr studiedeltager
    • Antal studiedeltagere som gennemfører all 6 induktions skyllebehandlinger
    • Antal BCG skyllebehandlinger som gives med 2 timers fuld varighed pr. studiedeltager
    • Antal af skyllebehandlinger pr studiedeltager som udskydes en uge eller mere grundet bivirkninger
    • Antal deltagere hvor skyllebehandlingen stoppes pga lokale bivirkninger
    • Antal deltagere hvor skyllebehandlingen stoppes pga systemiske bivirkninger
    • Den komplette respons rate for induktions skyllebehandling defineret som ingen recidiv ved første cystoskopi efter induktions behandlingen.
    • Antal deltagere som får behov for en re-induktions skyllebehandling indenfor 24 måneder pga recidiv eller persisterende sygdom.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • ≥18 years of age at the time of signing the Informed Consent Form
    • Signed Informed Consent Form
    • Patients with NMIBC where BCG therapy including maintenance for 1 year is planned for one of the following histopathological findings:
    • Ta high grade without CIS
    • CIS with or without previous or concomitant Ta tumors
    • T1 with or without CIS
    • Is, according to the Investigator’s judgement, able to comply with the trial protocol
    • Ability to understand the Patient Information Sheet orally and in writing


    • Over 18 år
    • Afgivelse af informeret samtykke
    • Patienter med NMIBC hvor BCG behanding inkl vedligehold er planlagt for en af følgende histologisk fund
    o Ta high grade uden CIS
    o CIS med eller uden tidligere Ta tumorer
    o T1 med eller uden CIS
    • Ud fra investigators vurdering kan medvirke til studiet
    • Evne til at forstå patientinformation i skrift og tale

    E.4Principal exclusion criteria
    • Previous BCG instillation within the last 2 years, because of the risk of not having cleared potential previous side effects
    • T1 tumors where re-resection had not been performed
    • TUR-B, bladder biopsy or traumatic catheterization within 2 weeks.
    • Previous or current MIBC
    • Progression defined as progression to T1- tumour, T2+-tumour or cystectomy irrespectively of indication or development of metastatic urothelial
    cancer irrespectively of tumour stage
    • Contraindications to BCG
    • Incontinence
    • Bilateral nephrostomy catheters;
    Unilateral nephrostomy catheter is allowed if permanent for the duration of all instillations with BCG and a normally functioning kidney
    • Need for catheter at the time of instillation
    • Immune Suppressing medication (cancer therapy e.g cytostatic medicinal products, radiation, local and systemic steroids like e.g. prednisolone is permitted)
    • Reduced immune response (leukaemia, lymphoma)
    • Known allergy or sensitivity to BCG
    • HIV infection
    • Signs of active tuberculosis
    • Any type of previously radiation therapy involving the bladder
    • Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and prostate cancer without matastasis
    • Current urinary tract infection
    • Patient with visible hematuria
    • Current alcohol and/or drug abuse
    • Has a mental or legal incapacitation or another condition which impair the subject’s ability to participate
    • Has participated in another interventional clinical study and treatment with another investigational product 30 days days prior to randomization
    • For women study subjects: Pregnancy or breastfeeding
    • Tidligere BCG behandling
    • T1 tumorer hvor re resection ikke er udført
    • TURB, biopsi eller tramumatisk katerisering inden for 2 uger
    • Tidligere eller nuværende MIBC
    • Progression defineret som progression til T1-tumor, T2 + -tumor eller cystektomi uanset indikation eller udvikling af metastatisk urotelial
    kræft uanset tumorstadium
    • Kontraindikation for BCG
    • Inkontinent
    • Behov for permanent kateter samme tid som skyllebehandlingerne
    • Immunsupprimerende medicin (cancer terapi, ex. Cytostatika, strålebehandling, lokal eller systemisk steroider, prednisolon er tilladt
    • Reduceret immunrespons ( leukæmi, lymfom)
    • Kendt allergi eller sensitivitet overfor BCG
    • HIV infektion
    • Tegn på aktiv tuberkulose
    • Tidligere stråleterapi mod blæren
    • Kendt cancersygdom, pånær prostata cancer.
    • Pågående urinvejsinfektion
    • Patienter med makroskopisk hæmaturi
    • Nuværende alkohol eller stofmisbrug
    • Mental eller juridiske invaliditet eller en anden tilstand som påvirker patientens evne til at deltage
    • Deltagelse i et andet interventionsstudie og behandling med studiemedicin indenfor 30 dage før randomisering
    • For kvindelige deltagere: graviditet eller amning.
    E.5 End points
    E.5.1Primary end point(s)
    Number of Study Subjects completing all 6 induction instillations and subsequent maintenance installations for 12 months (6 + 3 x 3)
    Antal af studiedeltagere som gennemfører alle 6 induktions skyllebehandlinger og efterfølgende vedligeholdelsesskylningerne i 12 måneder ( 6 + 3 x 3)

    E.5.1.1Timepoint(s) of evaluation of this end point
    13 months after investigational treatment initiation
    13 måneder efter behandlingsstart med studiemedicin
    E.5.2Secondary end point(s)
    • Recurrence rate within 24 months in Study Subjects with initial complete response
    • Progression rate within 24 months and 60 months
    • Disease specific survival within 24 months and 60 months
    • Overall survival within 24 months and 60 months
    • Total number of BCG instillations per Study Subject
    • Number of Study Subjects completing all 6 induction instillations
    • Number of BCG instillations given with full dwell-time of 2 hours per Study Subject
    • Number of installations per Study Subject postponed 1 week or more because of side effect
    • Number of Study Subjects where instillations is stopped because of local side effects
    • Number of Study Subjects where instillations is stopped because of systemic side effects
    • Complete response rate following induction therapy defined as no recurrence at first cystoscopy after induction therapy
    • Number of Study Subjects undergoing re-induction therapy within 24 months because of recurrent or persistent disease
    • Recidivrate indenfor 24 måneder for patienten med komplet respons
    • Progressions rate indenfor 24 måneder og 60 måneder
    • Sygdomsspecifik overlevelse indenfor 24 måneder og 60 måneder
    • Samlet overlevelse indenfor 24 måneder og 60 måneder
    • Total antal BCG skyllebehandlinger pr studiedeltager
    • Antal studiedeltagere som gennemfører all 6 induktions skyllebehandlinger
    • Antal BCG skyllebehandlinger som gives med 2 timers fuld varighed pr. studiedeltager
    • Antal af skyllebehandlinger pr studiedeltager som udskydes en uge eller mere grundet bivirkninger
    • Antal studiedeltagere hvor skyllebehandlingen stoppes pga lokale bivirkninger
    • Antal studiedeltagere hvor skyllebehandlingen stoppes pga systemiske bivirkninger
    • Den komplette respons rate for induktions skyllebehandling defineret som ingen recidiv ved første cystoskopi efter induktions behandlingen.
    • Antal studiedeltagere som får behov for en re-induktions skyllebehandling indenfor 24 måneder pga recidiv eller persisterende sygdom.
    E.5.2.1Timepoint(s) of evaluation of this end point
    November 1, 2027
    1. november 2027
    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 No
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    BCG medac - der anvendes samme dosis i begge arme
    BCG medac - same dose in the two arms
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Dec. 1th. 2023 LVLS
    1. December 2023, sidste besøg for sidste projektdeltager
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 214
    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 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 state214
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 314
    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)
    standard care
    Standard behandling
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NORTH-REG
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-14
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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