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    Summary
    EudraCT Number:2021-003031-29
    Sponsor's Protocol Code Number:D4191C00137
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-003031-29
    A.3Full title of the trial
    Roll Over Study for Patients Who Have Completed a Previous Oncology Study with Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
    Studio principale di roll-over per pazienti che hanno completato uno studio oncologico precedente con Durvalumab e che secondo lo sperimentatore possono trarre un beneficio clinico dalla continuazione del trattamento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Roll Over Study for Patients Who Have Completed a Previous Oncology Study with Durvalumab
    Studio di roll-over per pazienti che hanno completato uno studio oncologico precedente con Durvalumab
    A.3.2Name or abbreviated title of the trial where available
    ROSY-D
    ROSY-D
    A.4.1Sponsor's protocol code numberD4191C00137
    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
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.centre@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 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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.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
    Post-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract
    Carcinoma uroteliale e non uroteliale post-chemioterapico delle vie urinarie
    E.1.1.1Medical condition in easily understood language
    Urinary Tract Cancer
    Carcinoma del tratto urinario
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061272
    E.1.2Term Malignant urinary tract neoplasm
    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 provide continuous study treatment to patients who continue to benefit at the end of a clinical study, while monitoring safety and
    tolerability.
    Fornire un trattamento dello studio continuo ai pazienti che continuano a ricevere un beneficio al termine di una sperimentazione clinica, monitorando allo stesso tempo sicurezza e tollerabilità.
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated, written ICF.
    2. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an
    AZ compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent study's protocol.
    1. Consegna del Modulo di consenso informato (ICF) scritto firmato e datato.
    2. Il paziente sta attualmente traendo un beneficio clinico, secondo il giudizio dello sperimentatore, dalla prosecuzione del trattamento in uno studio originario AZ che utilizza un composto AZ che ha soddisfatto i suoi endpoint, o che ha altrimenti interrotto, o il paziente ha raggiunto la durata massima del trattamento consentita dal protocollo dello studio originario.
    E.4Principal exclusion criteria
    1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
    2. Currently receiving treatment with any prohibited medication(s).
    3. Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    4. Permanent discontinuation from the parent study due to toxicity or disease progression.
    5. Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation
    6. Active infection including COVID-19 (PCR confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive HBsAg result), hepatitis C, or HIV (positive HIV 1/2 antibodies).
    7. Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy.
    8. Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of <= 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, as per Toxicity Dose Modification and TMGs for Immune-mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.
    1. Tossicità in corso, irrisolta, di grado 3 o superiore che richieda l’interruzione del trattamento al momento dell’interruzione dello studio originario.
    2. Attualmente in trattamento con eventuale/i farmaco/i proibito/i.
    3. Arruolamento simultaneo in qualsiasi altro tipo di ricerca medica ritenuta non scientificamente o clinicamente compatibile con questo studio.
    4. Interruzione permanente dello studio originario a causa di tossicità o progressione della malattia.
    5. Accesso locale al farmaco disponibile in commercio senza alcun costo per il paziente, come consentito dalle normative locali/nazionali.
    6. Infezione attiva, tra cui COVID-19 (confermata mediante reazione a catena della polimerasi [PCR] e/o clinicamente sospetta), tubercolosi, epatite B (risultato dell’antigene di superficie dell’epatite B [HBsAg] positivo noto), epatite C o virus dell’immunodeficienza umana (HIV) (positività agli anticorpi anti-HIV 1/2).
    7. Pazienti di sesso maschile o femminile potenzialmente fertili che non sono disposti ad adottare un metodo contraccettivo efficace a partire dall’inclusione nello studio fino a 90 giorni dopo l’ultima dose di durvalumab in monoterapia.
    8. Tossicità in corso, irrisolta, di grado 2 con incapacità di ridurre i corticosteroidi a una dose <=10 mg di prednisone al giorno (o equivalente) entro 12 settimane dopo l’ultima dose del trattamento dello studio/regime dello studio, in base alle linee guida per la modifica della dose di tossicità e le linee guida per la gestione della tossicità (TMG) per le reazioni immuno-mediate, correlate all’infusione e non immuno-mediate dello studio originario.
    E.5 End points
    E.5.1Primary end point(s)
    SAEs reported until 90 days after the last dose of study treatment.
    SAEs riportati fino a 90 giorni dopo l'ultima dose del trattamento in studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study.
    Nel corso dello studio
    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 No
    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) Yes
    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 No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Germany
    Italy
    Korea, Republic of
    United Kingdom
    United States
    France
    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
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 68
    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)
    All new SAEs and adverse events of special interest (AESIs) occurring during the 90 calendar days after the last dose of durvalumab must be reported and followed to resolution.
    Tutte le nuove SAEs ed eventi avversi di speciale interesse (AESIs) avvenuti durante i 90 giorni di calendario dopo la prima dose di durvalumab devono essere comunicati e seguiti fino a risoluzione
    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 Decision2022-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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