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    Summary
    EudraCT Number:2011-002957-67
    Sponsor's Protocol Code Number:CA209-010
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-16
    Trial results View 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 number2011-002957-67
    A.3Full title of the trial
    A Randomized, Blinded, Phase 2 Dose-Ranging Study of BMS-936558 (MDX-1106) in Subjects With Progressive Advanced/Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy Revised Protocol 01 incorporating Administrative Letter 01 and Amendment 02
    Studio di fase 2 dose-ranging randomizzato, in cieco, di BMS-936558 (MDX-1106) nei soggetti con carcinoma a cellule renali a cellule chiare avanzato/metastatico in progressione che hanno ricevuto una precedente terapia anti-angiogenica. Protocollo revised 01 che incorpora l`™administrative Letter 01 e l`™emendamento 02
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Dose-Ranging Study of BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma
    Studio di fase 2 dose-ranging di BMS-936558 (MDX-1106) nei soggetti con carcinoma a cellule renali a cellule chiare avanzato/metastatico.
    A.4.1Sponsor's protocol code numberCA209-010
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01354431
    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 SponsorBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Study Start-Up Unit
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 8
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryItaly
    B.5.4Telephone number+32 2 352 7893
    B.5.5Fax number+32 2 352 7164
    B.5.6E-mailclinical.trials@bms.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.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Powder 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.3.9.2Current sponsor codeBMS-936558-01
    D.3.9.3Other descriptive nameAnti-PD-1 Human Monoclonal Antibody; MDX-1106
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.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
    Advanced/Metastatic renal cell carcinoma with a clear cell
    carcinoma a cellule renali a cellule chiare avanzato/metastatico
    E.1.1.1Medical condition in easily understood language
    Advanced/Metastatic renal cell carcinoma with a clear cell
    carcinoma a cellule renali a cellule chiare avanzato/metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10038410
    E.1.2Term Renal cell carcinoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10050513
    E.1.2Term Metastatic renal cell carcinoma
    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 evaluate the dose response relationship in the 0.3, 2, and 10 mg/kg BMS-936558 arms as measured by Progression-free survival (PFS).
    Valutare la correlazione tra la dose e la risposta nei tre bracci 0.3, 2 e 10 mg/kg di BMS-936558, misurata dalla sopravvivenza libera da progressione (PFS).
    E.2.2Secondary objectives of the trial
    To estimate PFS in the BMS-936558 arms • To estimate the response rate in the BMS-936558 arms • To estimate the Overall Survival (OS) in the BMS-936558 arms • To estimate the rate of adverse events in the BMS-936558 arms + Exploratory Objectives: • To evaluate changes in QTc in each treatment arm • To estimate the immune-related response rate (irRR) and irPFS in the 2 and 10 mg/kg BMS-936558 arms relative to the 0.3 mg/kg arm • To explore associations between PD-L1 expression in tumors and other immune response biomarkers on clinical outcome • To characterize the pharmacokinetics of BMS-936558 and to explore exposure-safety and exposure-efficacy relationships.
    o Definire la PFS nei bracci di trattamento con BMS-936558 o Determinare il tasso di risposta nei bracci di trattamento con BMS-936558 o Determinare la sopravvivenza totale (OS) nei bracci di trattamento con BMS-936558 o Determinare il tasso di eventi avversi nei bracci di trattamento con BMS-936558 Obiettivi esplorativi: o Valutare i cambiamenti del QTc in ogni braccio di trattamento o Determinare il tasso di risposta immuno-corretalo (irRR) e irPFS nei bracci 2.0 e 10mg/kg di BMS-936558 rispetto al braccio 0.3 mg/kg. o Determinare l’associazione tra l’espressione di PD-L1 nei tumori e di altri biomarcatori correlati alla risposta immunitaria con il risultato clinico o Caratterizzare la farmacocinetica di BMS-936558 ed definire la correlazione tra esposizione-sicurezza ed esposizione-efficacia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologic confirmation of RCC with a clear cell component. • Previous treatment with at least one anti-angiogenic agent • Progressed within 6 months of study enrollment • Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease. • Must have available tumor tissue for submission • Subjects must also meet various laboratory parameters for inclusion (see Protocol section 3.3.1 item 4)
    • conferma istologica di carcinoma a cellule renali (RCC) con la componente a cellule chiare • precedente trattamento con almeno una terapia anti-angiogenica • progressione entro 6 mesi dall’arruolamento nello studio . • I soggetti non devono aver ricevuto più di 3 regimi chemioterapici precedenti nella fase avanzata/metastatica • Tessuto tumorale deve essere disponibile per la sottomissione. • I soggetti devono rispettare dei paramenti di laboratorio per l’inclusione nello studio (si veda Protoclo sezione 3.3.1 punto 4).
    E.4Principal exclusion criteria
    • Active CNS metastases within 30 days of study enrollment • Subjects with any active autoimmune disease or a history of known autoimmune disease • Subjects with uncontrolled adrenal insufficiency • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
    • Metastasi cerebrali attive entro 30 giorni dall’arruolamento nello studio • Soggetti affetti da una malattia autoimmune attiva o con una storia di una nota malattia autoimmune • Soggetti con un’insuffficienza surrenalica non controllata • Precedente tumore attivo nei precedenti 3 anni ad eccezione dei tumori curabili localmente che sono stati appatentemente trattati
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival as measured by tumor assessments (radiographic scans) and the collection of death data. It will be compared to the doses given across the 3 treatment arms to see if a dose response exists.
    La sopravvivenza libera da progressione viene determinata dalle valutazioni del tumore (valutazione radiologica) e dalla raccolta dei dati sulla morte. Questa sarà confrontata alle dosi date nei 3 bracci di trattamento per vedere se esiste una correlazione dose-risposta.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor assessments (radiographic scans) will be done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression is documented. Subjects will be assessed for survival every 3 months.
    La valutazione del tumore (valutazione radiologica) viene condotta ogni 6 settimane per i primi 12 mesi dalla randomizzazione, e poi ogni 12 settimane fino ad una documentata progressione della malattia. I soggetti saranno valutati per la sopravvivenza ogni 3 mesi.
    E.5.2Secondary end point(s)
    • Progression free survival in the BMS-936558 arms • The tumor response rate in the BMS-936558 arms as assessed by the Investigator assessment of best overall response • The overall survival in the BMS-936558 arms as collected by death data.
    o La sopravvivenza libera da progressione nei bracci di trattamento con BMS-936558 o Il tasso di risposta nei bracci di trattamento con BMS-936558 valutato dallo sperimentatore come “best overall response” o La sopravvivenza nei bracci di trattamento con BMS-936558 valutata dalla raccolta dei dati sulla morte.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Progression free survival will be assessed in each individual treatment arm by tumor assessments every 6 weeks • The tumor response rate will be assessed on all subjects at the time they discontinue study treatment by the Investigators assessment of best overall response for a subject • The survival in each treatment arm will be assessed by the collection of death data every 3 months following the discontinuation of study therapy until a subjects death
    La sopravvivenza libera da progressione sarà determinata dalla valutazione del tumore ogni 6 settimane in ogni singolo braccio di trattamento Il tasso di risposta sarà valutata su tutti i pazienti una sola vota al momento della discontinuazione dal trattamento in studio a seguito della valutazione dello sperimentatore della “best overall response” per ogni soggetto
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    exploratory assessments
    Valutazioni di tipo esplorativo
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    dose-ranging
    dose-ranging
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Canada
    United States
    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
    The study will end when analysis of survival is complete. This analysis will be conducted after 75% of the subjects have died or 2 years of follow-up time from the analysis of PFS, whichever comes first.
    Lo studio si concluderà quando l’analisi della sopravvivenza sarà completa. Quest’analisi sarà condotta o dopo che il 75% dei soggetti sono morti o dopo 2 anni di follow up iniziato dall’analisi della PFS, a seconda di quale evento si verifica prima
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months46
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months46
    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.1.1Number of subjects for this age range: 0
    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: 136
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14
    F.4.2.2In the whole clinical trial 181
    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)
    At the conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive study drug. See Protocol section 3.2 Post Study Access to Therapy for further details.
    details Alla conclusione dello studio, i soggetti che continuano a ricevere un beneficio clinico saranno eleggibii a ricevere il farmaco in studio. Si faccia riferimento alla sezione 3.2 del protocollo (Post Study Access to therapy) per ulteriori dettagli.
    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 Decision2011-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-02
    P. End of Trial
    P.End of Trial StatusCompleted
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    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
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