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    Summary
    EudraCT Number:2017-002979-26
    Sponsor's Protocol Code Number:D419JC00001
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-21
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2017-002979-26
    A.3Full title of the trial
    A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non Muscle Invasive Bladder Cancer Patients (POTOMAC)
    Randomizované, otvorené, multicentrické globálne klinické skúšanie vo fáze III na porovnanie kombinovanej liečby durvalumabom + BCG (Bacillus Calmette-Guerin) oproti monoterapii BCG u vysokorizikových BCG-naivných pacientov s neinvazívnym karcinómom močového mechúra (POTOMAC).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy and safety of Durvalumab (MEDI4736) in combination with intravesical BCG for the treatment of patients diagnosed with early stage bladder cancer (non-muscle invasive) compared to the standard therapy of intravesical BCG alone.
    Štúdia vyhodnocujúca efektívnosť a bezpečnosť Durvalumabu (MEDI4736) v kombinácii s intravezikálnou BCG pre liečbu pacientov s diagnostikovaným skorým štádiom rakoviny močového mechúra (svalovo neinvazívneho) v porovnaní so štandardnou liečbou samotnou intravezikálnou BCG.
    A.3.2Name or abbreviated title of the trial where available
    POTOMAC
    A.4.1Sponsor's protocol code numberD419JC00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astaallen
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.6E-mailinformation.center@astrazeneca.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 Yes
    D.2.1.1.1Trade name IMFINZI
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namedurvalumab
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) No
    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 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.IMP: 2
    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
    D.2.1.2Country which granted the Marketing AuthorisationSlovakia
    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.3.4Pharmaceutical form Intravesical solution
    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 INNBCG (Bacillus Calmette-Guérin) bacteria
    D.3.9.3Other descriptive nameBCG (BACILLUS CALMETTE-GUÉRIN) BACTERIA
    D.3.9.4EV Substance CodeSUB20565
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number50
    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 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
    Non-muscle invasive bladder cancer
    E.1.1.1Medical condition in easily understood language
    Bladder Cancer in early stages/ Stage 0/1 or cancer in situ
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10005008
    E.1.2Term Bladder cancer stage I, with cancer in situ
    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 assess the efficacy of durvalumab + BCG combination therapy compared to BCG alone in terms of Disease Free Survival (DFS).
    E.2.2Secondary objectives of the trial
    To assess the efficacy of the combination therapy (Durvalumab plus BCG) compared to SoC in terms of disease free at 24 months (DFS24), overall survival at 5 years (OS5), any disease-free survival (aDFS), time to muscle-invasive bladder cancer or metastatic disease, time to cystectomy and time to development of upper track urothelial carcinoma
    To assess the efficacy of the combination therapy (Durvalumab plus BCG) compared to SoC for patients with CIS prior to study entry or at
    baseline in terms of Complete response rate (CRR) at 6 month
    To assess disease-related symptoms and HRQoL in patients treated with durvalumab plus BCG combination therapy compared to SoC using EORTC QLQ-C30 and EORTC QLQ NMIBC24
    Tolerability using patient-reported PRO CTCAE symptoms
    To assess PK of durvalumab and Immunogenicity of durvalumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -BCG-naïve (patients who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry are eligible).
    -Local histological confirmation (based on pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high risk tumor is defined as one of the following:
     T1 tumor
     High grade/G3 tumor
     CIS
     Multiple and recurrent and large (with diameter of largest evaluable node ≥3 cm) tumors (all conditions must be met in this point)
    -Complete resection of all Ta/T1 papillary disease prior to randomization, with the TURBT removing high-risk NMIBC performed not more than 4 months before randomization in the study. Patients with residual CIS after TURBT are eligible.
    -No prior radiotherapy for bladder cancer.
    -No prior exposure to immune-mediated therapy of cancer including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 antibodies. Patients who have been treated with anticancer vaccines will be excluded.
    E.4Principal exclusion criteria
    -Evidence of muscle-invasive, locally advanced, metastatic, and/or extra vesical bladder cancer (ie, T2, T3, T4, and / or stage IV).
    -Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive transitional cell carcinoma of the urothelium.
    -Previous investigational product (IP) assignment in the present study.
    -Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer related conditions (eg, hormone replacement therapy) is acceptable. Chemotherapy for previous instances of NMIBC is acceptable. Patients who have received a single instillation of Mitomycin C or equivalent chemotherapy agent immediately after TURBT can be enrolled in the study.
    -Active infection including TB, hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (HIV [positive HIV] 1/2) antibodies. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). Appropriate TB tests (e.g. skin or interferon gamma tests) should be performed to exclude TB infection requiring treatment. Additional clinical evaluations including clinical history, physical examination, radiographic findings, and other diagnostic procedures and specialist consultations should be performed if necessary.
    -Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
     Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection)
     Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
     Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication)
    -Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
    − Patients with vitiligo or alopecia
    − Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
    − Any chronic skin condition that does not require systemic therapy
    − Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician
    − Patients with celiac disease controlled by diet alone
    -History of another primary malignancy except for
    − Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of IP and of low potential risk for recurrence during study period
    − Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease
    − Adequately treated CIS without evidence of disease
    − Prostate cancer (tumor/node/metastasis stage) of stage ≤ T2cN0M0 without biochemical recurrence or progression that in the opinion of the Investigator does not require active intervention
    E.5 End points
    E.5.1Primary end point(s)
    Disease-free survival (DFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be assessed by investigator tumor assessments every 3 months relative to the date of randomization until month 36, and then every 6 months according to standard of care or until disease progression.
    E.5.2Secondary end point(s)
    Disease free at 24 months (DFS24)

    Survival at 5 years (OS5)

    Complete response rate (CRR)

    Any disease-free survival (aDFS)

    Time to muscle-invasive bladder (MIBC) cancer or metastasis

    Time to cystectomy.

    Time to development of upper track urothelial carcinoma (UTUC)

    Disease related symptoms

    Patient reported treatment tolerability

    Assessment of PK of Durvalumab

    Immunogenicity of Durvalumab (ADA) in combination with BCG
    E.5.2.1Timepoint(s) of evaluation of this end point
    DFS24, OS5, aDFS, Time to MIBC, metastasis, cystectomy and UTUC will be assessed by disease assessments every 3 months until month 36 and then every 6 months. CRR will be assessed at 6 month.
    Disease related symptoms will be assessed with EORTC QLQ-C30 and EORTC QLQ NMIBC24 questionnaires at the 1st week of treatment and every 4 and 8 weeks until the end of the disease assessment period.
    Patient reported treatment tolerability will be assessed by PRO-CTCAE questionnaires every 4 weeks until the end of the disease assessment period. Concentration of Durvalumab (PK) will be assessed 5 times: pre- dose and post- dose for week 1, pre-dose at week 5 and week 25 and at week 12 of the follow-up period
    ADA and nAB will be assessed 4 times: week 1, week 5, week 25 and week 12 of follow-up period
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    Health Care resource utilization
    Tolerability
    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) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA94
    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
    Australia
    Austria
    Belgium
    Canada
    France
    Germany
    Japan
    Netherlands
    Poland
    Russian Federation
    Slovakia
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    LSLV
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    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: 292
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 683
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 415
    F.4.2.2In the whole clinical trial 975
    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)
    None
    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 Decision2019-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
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