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    Summary
    EudraCT Number:2012-002762-12
    Sponsor's Protocol Code Number:MESOT-TREM-2012
    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:2012-08-03
    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 number2012-002762-12
    A.3Full title of the trial
    A SECOND-LINE, SINGLE ARM, PHASE II CLINICAL STUDY WITH TREMELIMUMAB, A FULLY HUMANIZED ANTI-CTLA-4 MONOCLONAL ANTIBODY, AS MONOTHERAPY IN PATIENTS WITH UNRESECTABLE MALIGNANT MESOTHELIOMA
    Studio clinico di fase II a singolo braccio di trattamento con tremelimumab, un anticorpo monoclonale umano, in monoterapia in pazienti con mesotelioma maligno non resecabile. Codice dello Studio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MESOT-TREM-2012
    MESOT-TREM-2012
    A.3.2Name or abbreviated title of the trial where available
    MESOT-TREM-2012
    MESOT-TREM-2012
    A.4.1Sponsor's protocol code numberMESOT-TREM-2012
    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 SponsorAZIENDA OSPEDALIERA SENESE
    B.1.3.4CountryItaly
    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 supportMedImmune LLC, societa' a responsabilità limitata, regolata e costituita ai sensi della legge dello stato del Delaware
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera Universitaria Senese
    B.5.2Functional name of contact pointUOC Immunoterapia Oncologica
    B.5.3 Address:
    B.5.3.1Street AddressViale Bracci 14
    B.5.3.2Town/ citySiena
    B.5.3.3Post code53100
    B.5.3.4CountryItaly
    B.5.4Telephone number0577-586116 - 0577-586335
    B.5.5Fax number0577 586303
    B.5.6E-maill.calabro@ao-siena.toscana.it
    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 nametremelimumab
    D.3.2Product code NA
    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 745013-59-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number20
    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
    Patients affected by advanced malignant mesothelioma
    Pazienti affetti da mesotelioma maligno avanzato
    E.1.1.1Medical condition in easily understood language
    Pleural tumor disease
    Malattia tumorale della pleura
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 10035603
    E.1.2Term Pleural mesothelioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the rate of objective clinical complete response (CR) or partial response (PR)
    valutare il tasso di risposte cliniche obiettive (CR + PR)
    E.2.2Secondary objectives of the trial
    1) To define toxicity profile
    2) To assess the OS
    3) To estimate disease control rate (DCR) (proportion of patients with best response of CR+PR+SD)
    4) To assess the progression-free survival in treated patients
    5) To evaluate qualitative and quantitative changes in cellular and humoral immune responses
    1) definire il profilo di tossicità
    2) valutare il tasso di controllo della malattia (proporzione di soggetti con risposta completa [CR] + risposta parziale [PR] + malattia stabile [SD]);
    3) valutare la sopravvivenza globale
    4) valutare la sopravvivenza libera da progressione;
    5) valutare le variazioni qualitative e quantitative di risposte immuni, sia cellulare che umorale;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically or cytologically confirmed MM
    Have received only one prior systemic chemotherapy regimen for advanced MM
    Measurable disease, defined at least 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan (RECIST criteria).
    Disease not amenable to curative surgery
    No known brain metastasis
    Age 18 and over
    Performance status 0-2
    Life expectancy > 12 weeks
    Adequate hematologic, hepatic and renal function
    Platelet count > 100000/mm3
    Absolute granulocyte count > 1500/mm3
    Hemoglobin > 9 g/dL
    Bilirubin total < 2 x ULN (Upper limited normal)
    AST and ALT < 2.5 x ULN (< 5 x ULN if documented liver metastasis are present)
    Creatinine level < 2mg/dl or creatinine clearance > 50 mL/min
    Not pregnant or nursing
    Fertile patients must use effective contraception
    Patient must be willing and able to provide written informed consent, and the trial have to be approved by the institutional review board at each institution
    1)diagnosi istologica o citologica di MM;
    2)precedente trattamento con una sola linea di terapia medica sistemica per MM avanzato;
    3)malattia misurabile/valutabile (secondo i criteri RECIST modificati) entro i 28 giorni precedenti alla somministrazione della prima dose del farmaco oggetto dello studio;
    4)MM avanzato non operabile;
    5)assenza di metastasi cerebrali;
    6) uomini e donne di età ≥18 anni;
    7)Performance status ECOG di 0 o 2;
    8)aspettativa di vita di ≥ 12 settimane;
    9)valori richiesti per i test di laboratorio iniziali: piastrine ≥100 x 103/ul, neutrofili ≥ 1500/mm3 , emoglobina ≥ 9 g/dl, creatinina ≤ 2 x ULN, AST e ALT ≤ 2,5 x ULN per i pazienti senza metastasi al fegato, ≤ 5 x ULN per i pazienti con metastasi al fegato, Bilirubina totale ≤ 2 x ULN
    10)donne in età fertile che sono disposte o sono in grado di usare un metodo contraccettivo adeguato per l’intero periodo di studio;
    11)donne che non sono in gravidanza o che non allattano;
    12)volontà e capacità di concedere il consenso informato in forma scritta.
    E.4Principal exclusion criteria
    Symptomatic chronic inflammatory or autoimmune disease
    Active hepatitis B or C
    Prior treatment with tremelimumab or other anti-CTLA-4 antibody
    Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or non compensated chronic heart disease in NYHA class II or more
    History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent
    Uncontrolled active infections
    Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study
    Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents
    History of other malignancies except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma of cervix, unless the patient has been disease-free for at least 5 years
    1) pazienti con malattie infiammatorie dell’intestino, compresi la colite ulcerosa e il morbo di Crohn sono esclusi da questo studio, così come i pazienti con malattia autoimmunitaria clinicamente evidente.
    3)pazienti con epatite B e/o C attiva;
    4)pazienti con malattie cardiovascolari clinicamente rilevanti (quali, infarto del miocardio, severa coronaropatia nei precedenti 6 mesi, aritmie cardiache che richiedono trattamento medico, ipertensione arteriosa non controllata, insufficienza cardiaca non compensata di classe ≥ II secondo NYHA.
    5)pazienti con qualsiasi altra patologia maligna dalla quale risultano liberi da malattia da meno di 5 anni, con l’eccezione del carcinoma basocellulare o carcinoma a cellule squamose adeguatamente trattato e curato, cancro superficiale della vescica o carcinoma in situ della cervice;
    6)pazienti con qualsiasi condizione medica o psichiatrica concomitante che, secondo lo sperimentatore, può rendere rischiosa la somministrazione del farmaco in studio o incerta l’interpretazione degli eventi avversi.
    7)terapia concomitante con qualsiasi agente antitumorale, immunoterapico, radioterapia o altre terapie sperimentali antitumorali;
    8)pazienti con infezioni attive non controllate
    9) precedente trattamento con tremelimumab o altri anti-CTLA-4 mAb.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the rate of objective clinical complete response (CR) or partial response (PR)
    valutare il tasso di risposte cliniche obiettive (CR + PR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 months
    30 mesi
    E.5.2Secondary end point(s)
    1) To define toxicity profile
    2) To assess the OS
    3) To estimate disease control rate (DCR) (proportion of patients with best response of CR+PR+SD)
    4) To assess the progression-free survival in treated patients
    5) To evaluate qualitative and quantitative changes in cellular and humoral immune responses
    1) definire il profilo di tossicità
    2) valutare il tasso di controllo della malattia (proporzione di soggetti con risposta completa [CR] + risposta parziale [PR] + malattia stabile [SD]);
    3) valutare la sopravvivenza globale
    4) valutare la sopravvivenza libera da progressione;
    5) valutare le variazioni qualitative e quantitative di risposte immuni, sia cellulare che umorale;
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 mouths
    30 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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    LVLS
    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 months36
    E.8.9.1In the Member State concerned 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state29
    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)
    Third line of therapy or best supportive care
    Terza linea di terapia o terapia di supporto
    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 Decision2012-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-26
    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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