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    Summary
    EudraCT Number:2017-003565-10
    Sponsor's Protocol Code Number:SAKK06/17
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-11-19
    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 ConcernedGermany - PEI
    A.2EudraCT number2017-003565-10
    A.3Full title of the trial
    Neoadjuvant and adjuvant durvalumab in combination with neoadjuvant chemotherapy in patients with operable urothelial cancer. A multicenter, single-arm phase II Trial.
    Neoadjuvante und adjuvante Kombinationstherapie von Durvalumab mit der neoadjuvanten Standardchemotherapie bei Patienten mit einem operablen Urothelkarzinom. Eine multizentrische einarmige Phase II Studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment to modulate the activity of the immune system in combination with chemotherapy treatment in patients with operable urothelial cancer
    Behandlung zur Beeinflussung der Aktivität des Immunsystems in Kombination mit einer Chemotherapiebehandlung bei Patienten mit operablen Urothelkarzinom
    A.4.1Sponsor's protocol code numberSAKK06/17
    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 SponsorSwiss Group for Clinical Cancer Research
    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 supportSwiss Group for Clinical Cancer Research
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCROLLL GmbH
    B.5.2Functional name of contact pointScientific Head
    B.5.3 Address:
    B.5.3.1Street AddressWörnitzstr. 115a
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90449
    B.5.3.4CountryGermany
    B.5.4Telephone number004991125268846
    B.5.5Fax number004991125268840
    B.5.6E-mailtobias.leidig@crolll.de
    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 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 drip use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDURVALUMAB
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.4EV Substance CodeSUB176342
    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) 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 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 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.2.5The 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 nameCisplatin
    D.3.4Pharmaceutical form 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 INNCISPLATIN
    D.3.9.1CAS number 15663-27-1
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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 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.IMP: 3
    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.2.5The 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 nameGemcitabin
    D.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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 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
    muscle invasive urothelial cancer (MIUC)
    muskelinvasives Urothelkarzinom
    E.1.1.1Medical condition in easily understood language
    muscle invasive urothelial cancer (MIUC)
    muskelinvasives Urothelkarzinom
    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 10064467
    E.1.2Term Urothelial carcinoma
    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 main objective is to demonstrate that the addition of neoadjuvant and adjuvant immunotherapy with durvalumab to standard neoadjuvant chemotherapy (with cisplatin/gemcitabine) and surgery in urothelial carcinoma could improve event-free survival.
    Ziel dieser Studie ist nachzuweisen, dass eine neoadjuvante und adjuvante Immuntherapie durch Durvalumab kombiniert mit neoadjuvanter Chemotherapie (mit Cisplatin/Gemcitabin) und Operation das ereignisfreie Überleben verbessert.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Translational Research - Determination of a pre- and post-therapeutic "Tumor immune profile"
    in this sub-study we aim to:
    - compare the tumor immunome before (treatment-naive) and after neoadjuvant chemo- and immunotherapy
    - investigate efficacy outcome parameters in relation to tissue expression of PD-L1
    - investiage biomarkers for anti-PD-L1 treatment and their relation to efficacy endpoints of interest (ypT0, EFS and OS) in urothelial carcinoma
    - investigate the role of DNA repair pathway alterations in urothelial carcinoma treated with neoadjuvant chemotherapy and immunotherapy
    2. Microbiome (optional)
    In this sub-study we aim to:
    - confirm the hypothesis that the gut microbiota is required for the anticancer effects of PD-L1 Blockade
    - validate the relevance of the gut microbiota composition for efficacy of immune checkpoint inhibitors
    - understand how immune checkpoint inhibition changes the host microbiome and how these changes correlate with the response of the disease to therapy
    1. Translationale Forschung - "Tumorimmunprofil"
    In dieser Substudie:
    - sollen das Tumorimmun vor (behandlungsnaiv) und nach der neoadjuvanten Chemo- und Immuntherapie verglichen werden.
    - sollen Parameter der Wirksamkeit im Verhältnis zur Gewebsexpression von PDL1 untersucht werden
    - sollen Biomarker der Anti-PD-L1 Behandlung und ihre Beziehung zu den Wirksamkeitsendpunkten (ypT0, EFS und OS) im Urothelkarzinom untersucht werden
    2. Mikrobiom (optional)
    In dieser Substudie:
    - Bestätigung der Hypothese, dass die Darmflora für den Antitumoreffekt der PD-L1 Blockade von Bedeutung ist
    - soll die Relevanz der Darmflorazusammensetzung für die Wirksamkeit des Immun-Checkpoint-Inhibitors gezeigt werden
    - soll untersucht werden, wie die Blockade des Immun-Checkpoints die Zusammensetzung des Mikrobioms verändert und wie diese Änderungen mit dem Ansprechen der Erkrankung auf die Therapie korrelieren
    E.3Principal inclusion criteria
    - histologically proven urothelial cell carcinoma of the bladder, urethra or upper urinary tract and considered suitable for curative multimodality treatment including surgery by a multidisciplinary tumor board
    - all histological subtypes eligible if urothelial carcinoma predominant
    - WHO performance Status 0-1
    - adequate bone marrow, hepatic, renal and cardiac function
    - Histologisch bestätigtes Urothelkarzinom ≥T2 (≤N1, M0) der Blase, Harnröhre, oder des oberen Harntrakts, als geeignet eingestuft für die kurative multimodale Behandlung inklusive Operation durch ein multidisziplinäres Tumor-Board
    - Alle histologischen Subtypen sind geeignet, wenn das Urothelkarzinom vorherrschend ist
    - WHO Performance Status (Allgemeinzustand) 0-1
    - adäquate Knochemarksfunktion, Leber- Nieren- Herzfunktion
    E.4Principal exclusion criteria
    - pathological evidence of small-cell carcinoma component
    - presence of distant metastasis
    - previous Treatment with a PD-1 or PD-L1 Inhibitor, including durvalumab
    - current or prior use of immunosuppressiva medication within 28 days prior to Registration
    - active or prior documented autoimmune or inflammatory disorders
    - known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B virus infection
    • pathologischer Nachweis einer kleinzelligen Karzinomkomponente
    • Vorhandensein von Fernmetastasen
    • Jegliche Vorbehandlung mit einem PD-1- oder PD-L1-Inhibitor, inklusive Durvalumab
    • Aktuelle oder frühere Therapie mit immunsupprimierenden Medikamenten innerhalb von 28 Tagen vor Registrierung
    • Aktive oder frühere dokumentierte Autoimmunerkrankungen oder entzündliche Erkrankungen
    • Medizinische Vorgeschichte einer Infektion mit Humanem Immundefizienz-Virus (HIV) oder aktiver chronischer Hepatitis C oder Hepatitis B Virusinfektion
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of the trial is event-free survival (EFS) at two years after trial treatment start (neoadjuvant). EFS is defined as the time from treatment start until one of the following events, whichever comes first:
    - progression during neoadjuvant treatment is leading to inoperability
    - recurrence of locoregional disease after surgery
    - appearance of metastases at any localization
    - death
    Der primäre Endpunkt ist das ereignisfreie Überleben (EFS) nach 2 Jahren Studienbehandlung (neoadjuvant).
    EFS ist definiert als Zeitraum vom Behandlungsbeginn bis zu einem der folgenden Ereignisse:
    • Progression während der neoadjuvanten Behandlung, die zu Inoperabilität führt
    • Rezidiv der lokoregionären Erkrankung nach Operation
    • Auftreten von Metastasen (jeglicher Lokalisation)
    • Tod
    E.5.1.1Timepoint(s) of evaluation of this end point
    two years after treatment start
    zwei Jahre nach Behandlungsstart
    E.5.2Secondary end point(s)
    - Event free survival (EFS)
    - recurrence-free survival (RFS) after R0 resection
    - Overall survival (OS)
    - Quality of resection
    - Pathological complete response rate (ypT0)
    - Pathological response rate (PaR) defined by pathological downstaging to ≤ypT1N0M0
    - Pattern of recurrence
    - Treatment feasibility
    - Adverse events
    • Ereignisfreies Überleben (EFS)
    • Progressionsfreies Überleben (RFS) nach R0-Resektion
    • Gesamtüberleben (OS)
    • Qualität der Resektion
    • Pathologische Gesamtansprechrate (ypT0)
    • Pathologische Ansprechrate (PaR) definiert durch pathologisches Downstaging bis ≤ypT1N0M0
    • Rezidivmuster
    • Durchführbarkeit der Behandlung
    • Unerwünschte Ereignisse
    E.5.2.1Timepoint(s) of evaluation of this end point
    at every study visit
    Bei jeder Studienvisite
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    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
    LPLV - last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 61
    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)
    Post-treatment examinations are in line with international guidelines for the follow-up of muscle invasive urothelial cancer patients
    Die Nachsorgeuntersuchungen entsprechen den üblichen Untersuchungen nach der Behandlung eines Muskel invasivem Urothelkarzinom nach internationalen Richtlinien
    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 Decision2018-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-13
    P. End of Trial
    P.End of Trial StatusOngoing
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