Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42151   clinical trials with a EudraCT protocol, of which   6931   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-004792-36
    Sponsor's Protocol Code Number:CA209-017
    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:2012-07-25
    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 number2011-004792-36
    A.3Full title of the trial
    An Open-Label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC).
    Studio di fase III randomizzato in aperto di BMS-936558 verso Docetaxel in soggetti con carcinoma polmonare squamoso non a piccole cellule (NSCLC), in stadio avanzato o metastatico precedentemente trattato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of BMS-936558 compared to Docetaxel in previously treated advanced or metastatic Squamous cell NSCLC.
    Studio di confronto tra BMS-936558 e Docetaxel in soggetti con carcinoma polmonare squamoso non a piccole cellule (NSCLC) avanzato o metastatico precedentemente trattato.
    A.4.1Sponsor's protocol code numberCA209-017
    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.5.3.4CountryBelgium
    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.3.1Product nameNA
    D.3.2Product code BMS-936558
    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.3.9.1CAS number 946414-94-4
    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.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 Taxotere 160 mg (20 mg/mL)
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma S.A
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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 INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Squamous cell Non-small cell lung cancer
    Carcinoma polmonare squamoso non a piccole cellule (NSCLC)
    E.1.1.1Medical condition in easily understood language
    Squamous cell Non-small cell lung cancer
    Carcinoma Polmonare squamoso non a piccole cellule (NSCLC)
    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 10061873
    E.1.2Term Non-small cell lung cancer
    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
    The purpose of the study is to compare the change in tumor size, and overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy
    L’obiettivo principale dello studio è confrontare la variazione della dimensione del tumore e la sopravvivenza complessiva indotti da BMS-936558 rispetto a Docetaxel in soggetti con carcinoma polmonare squamoso non a piccole cellule che hanno fallito una precedente chemioterapia contenente platino.
    E.2.2Secondary objectives of the trial
    .To compare the progression-free survival (PFS) of BMS-936558 versus docetaxel 2.To evaluate clinical benefit in terms of ORR and OS of BMS-936558 versus docetaxel, in PD-L1 + versus PD-L1- protein expression subgroups 3.To evaluate durability of and time to objective response in BMS-936558 and docetaxel groups 4.To evaluate the proportion of subjects exhibiting disease-related symptom progression, as measured by LCSS, in BMS-936558 and docetaxel groups
    1.Confrontare la sopravvivenza libera da progressione (PFS) indotta da BMS-936558 rispetto a Docetaxel 2.Valutare il beneficio clinico in termini di percentuale di risposta obiettiva (ORR) e sopravvivenza complessiva (OS) indotte da BMS-936558 rispetto a Docetaxel nel sottogruppo di soggetti positivi all’espressione della proteina PD-L1 rispetto a quelli che non esprimono la proteina PD-L1 3.Valutare la durata e il tempo alla risposta obiettiva tra i due bracci, BMS-936558 e Docetaxel 4.Valutare la percentuale di soggetti che mostrano sintomi di progressione correlati alla malattia, misurati attraverso la specifica scala di valutazione LCSS, nei due bracci BMS-936558 e Docetaxel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) men & women ≥ 18 years of age 2) Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent disease following radiation therapy or surgical resection. 3) Disease recurrence or progression during/after one prior platinum-containing chemotherapy regimen for advanced or metastatic disease 4) Measurable disease by CT/MRI per RECIST 1.1 criteria 5) ECOG performance status ≤ 1 6) An FFPE tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient.
    1.Uomini e donne di età maggiore o uguale a 18 anni 2.Soggetti con carcinoma polmonare squamoso non a piccole cellule (NSCLC), documentato in termini istologici o citologici, con malattia allo stadio IIIB/IV o recidivante dopo radioterapia o rimozione chirurgica 3.Malattia recidivante o che è andata in progressione durante o dopo un precedente regime di chemioterapia contenente platino 4.Malattia misurabile tramite TAC/RMN sulla base dei criteri RECIST 1.1 5.Performance Status inferiore o uguale a 1 (ECOG) 6.Blocchetto di tessuto tumorale fissato in formalina e incluso in paraffina o vetrini non colorati contenenti sezioni di tessuto (di archivio o recenti) devono essere disponibili per l’analisi dei biomarker. Tali campioni devono essere ricevuti dal laboratorio centralizzato prima della randomizzazione. Il tessuto deve provenire da una biopsia escissionale, incisionale o ago aspirato profondo. L’ago aspirato sottile non è sufficiente.
    E.4Principal exclusion criteria
    1) Subjects with active CNS metastases are excluded. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10mg daily prednisone (or equivalent) 2) Subjects with carcinomatous meningitis. 3) Subjects with active, known or suspected autoimmune disease, or subjects with interstitial lung disease. 4) Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization. 5) Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). 6) Prior treatment on the first line study CA184104 first line NSCLC study 7) Prior treatment with docetaxel 8) Treatment with any investigational agent within 28 days of first administration of study treatment
    1.Soggetti con metastatasi attive del sistema nervoso centrale sono esclusi. Tali soggetti possono essere inclusi se le metastasi sono adeguatamente trattate e i soggetti sono rientrati nel basale neurologico da almeno 2 settimane prima dell’arruolamento. Inoltre tali soggetti devono essere fuori dal trattamento con corticosteroidi o in dose stabile o decrescente inferiore o uguale a 10 mg di prednisone (o equivalenti). 2.Soggetti con meningite carcinomatosa 3.Soggetti con malattia autoimmune attiva, nota o sospetta, o soggetti con malattia polmonare interstiziale 4.Soggetti con una condizione clinica che richieda trattamento sistemico sia con corticosteroidi o altri farmaci immunosoppressivi nell’arco dei 14 giorni precedenti alla randomizzazione 5.Precedente trattamento con terapia anti-PD-1, anti-PD-L1, anti-PD.L2, anti-CD137, o anticorpo anti-CTLA-4 (incluso ipilimumab o qualunque altro anticorpo o farmaco che abbia come target specifico la costimolazione delle cellule T) 6.Precedente trattamento nello studio BMS CA184-104, Ipilimumab prima linea nel tumore al polmone non a piccole cellule (NSCLC). 7.Precedente trattamento con Docetaxel 8.Trattamento con altri farmaci sperimentati nell’arco dei 28 giorni precedenti l’inizio della terapia con il farmaco in studio.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate, Overall Survival
    Percentuale di Risposta Obiettiva (ORR), Sopravvivenza Complessiva (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 MONTHS
    24 MESI
    E.5.2Secondary end point(s)
    1.To compare the progression-free survival (PFS) of BMS-936558 versus docetaxel 2.To evaluate clinical benefit in terms of ORR and OS of BMS-936558 versus docetaxel, in PD-L1 + versus PD-L1- protein expression subgroups 3.To evaluate durability of and time to objective response in BMS-936558 and docetaxel groups 4.To evaluate the proportion of subjects exhibiting disease-related symptom progression, as measured by LCSS, in BMS-936558 and docetaxel groups.
    1. Confrontare la sopravvivenza libera da progressione (PFS) indotta da BMS-936558 rispetto a Docetaxel 2. Valutare il beneficio clinico in termini di percentuale di risposta obiettiva (ORR) e sopravvivenza complessiva (OS) indotte da BMS-936558 rispetto a Docetaxel nel sottogruppo di soggetti positivi all’espressione della proteina PD-L1 rispetto a quelli che non esprimono la proteina PD-L1 3. Valutare la durata e il tempo alla risposta obiettiva tra i due bracci, BMS-936558 e Docetaxel 4. Valutare la percentuale di soggetti che mostrano sintomi di progressione correlati alla malattia, misurati attraverso la specifica scala di valutazione LCSS, nei due bracci BMS-936558 e Docetaxel
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 MONTHS
    24 MESI
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker,Immunogenicity,Outcomes Research Assessments:LCSS&EuroPRO Group’s EQ-5D
    Valutazione Biomarker, Immunogenicità, Risultati Ricerca: LCSS &EuroPRO Group’s EQ-5D
    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 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 EEA60
    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
    Argentina
    Australia
    Brazil
    Canada
    Chile
    Hong Kong
    Mexico
    Peru
    Russian Federation
    Singapore
    South Africa
    Turkey
    United States
    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
    This study will end when analysis of survival is complete. All subjects will be followed for overall survival every 3 months until death, lost to follow-up, or withdrawal of study consent. The duration of study will be approximately 2 years (24 months).
    Lo studio si concluderà dopo completamento dell'analisi della sopravvivenza.Tutti i soggetti saranno seguiti per la sopravvivenza complessiva ogni 3 mesi fino a decesso, perdita al follow up,ritiro del consenso. Durata dello studio: circa 2 anni
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.1Number 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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 320
    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. Study drug will be provided via an extension of the study, a rollover study requiring approval by responsible health authority and ethics committee, or through another mechanism at the discretion of the sponsor. See also Protocol, section 3.2 for more details.
    Al termine dello studio i pazienti che continueranno a dimostrare un beneficio clinico saranno idonei a ricevere ancora il farmaco in studio. Il farmaco sarà fornito attraverso una estensione del presente studio o tramite uno studio di roll-over che richiederà l’approvazione del comitato etico, o attraverso un altro procedimento consentito dalla legge a discrezione dello sponsor. Per ulteriori dettagli vedi protocollo sezione 3.2
    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 Decision2012-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-18
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA