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    Summary
    EudraCT Number:2020-000295-38
    Sponsor's Protocol Code Number:IMPEDE
    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:2021-06-15
    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 number2020-000295-38
    A.3Full title of the trial
    Phase II trial, open label, single-arm, of Immune Checkpoint Inhibitor In High Risk Oral Premalignant Lesions
    Studio di fase II, in aperto, a braccio singolo su inibitore del checkpoint immunitario in lesioni orali premaligne ad alto rischio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II trial, open label, single-arm, of Immune Checkpoint Inhibitor In High Risk Oral Premalignant Lesions
    Studio di fase II, in aperto, a braccio singolo su inibitore del checkpoint immunitario in lesioni orali premaligne ad alto rischio
    A.3.2Name or abbreviated title of the trial where available
    IMPEDE
    IMPEDE
    A.4.1Sponsor's protocol code numberIMPEDE
    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 SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
    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 supportPfizer S.r.l.
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportAIRC
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street Addressvia S. Leonardo, trav. Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number089301545
    B.5.5Fax number0897724155
    B.5.6E-mailimpede@cr-technology.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 nameavelumab
    D.3.2Product code [MSB0010718C]
    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.3.9.1CAS number 1537032-82-8
    D.3.9.2Current sponsor codeMSB0010718C
    D.3.9.3Other descriptive nametrade name Bavencio
    D.3.9.4EV Substance CodeSUB180078
    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 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 Yes
    D.3.11.13.1Other medicinal product typefull human IgG1 antibody directed against PD-L1
    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
    Clinical and histological evidence of Oral Premalignant Lesions (OPL) with high risk of malignant transformation
    Pazienti con evidenza clinica ed istologica di lesioni orali premaligne (OPL) ad altro rischio di trasformazione maligna
    E.1.1.1Medical condition in easily understood language
    Premalignant oral lesions with high risk of malignant transformation
    Lesioni orali precancerose ad altro rischio di trasformazione maligna
    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 PT
    E.1.2Classification code 10078906
    E.1.2Term Oral soft tissue biopsy
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To revert the risk of malignant transformation of OPL through a short course of immunotherapy with avelumab. This objective will be evaluated both in its final endpoint (malignant transformation) and with an intermediate endpoint (reversal of loss of heterozygosity -LOH- status)
    Revertire il rischio di trasformazione maligna delle OPL attraverso un breve periodo di immunoterapia con avelumab. Questo obiettivo sarà valutato nel endpoint finale (trasformazione maligna) e con un endpoint intermedio (inversione della perdita dello stato di eterozigosi (LOH)).
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of immunotherapeutic approach in OPL
    • To assess the change of histological grade of OPL
    • To discover genomic and imaging predictive tools able to foresee response to avelumab
    • Valutare la sicurezza dell'approccio immunoterapico nelle OPL
    • Valutare il cambiamento del grado istologico delle OPL
    • Individuare strumenti predittivi, in termini di genomica e di imaging, in grado di prevedere la risposta ad all’immunoterapia con avelumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent;
    2. Male or female > 18 years of age;
    3. ECOG Performance status (PS) 0-1(see Appendix 2);
    4. Clinical and histological evidence of OPL with high risk of malignant transformation as defined by LOH at 3p14 and/or 9p21 plus at least at one additional chromosomal site (4q, 8p,11p,13q, or 17p) or patients with a prior oral cancer history and LOH at 3p14 and/or 9p21 (LOH defined according to EPOC trial - see Appendix 3). These conditions define “LOH positivity”;
    5. OPL with a histological definition of dysplasia and a minimum diameter of at least 20 mm;
    6. Be willing to provide tissue from newly obtained oral biopsies;
    7. Not receiving chronic systemic steroidal therapy or any immunosuppressive therapy within 7 days prior to the first treatment; absence of active autoimmune disease that required systemic treatment in the past 2 years, except the following:
    - Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra-articular injection);
    - Systemic corticosteroids at physiologic doses =10 mg/day of prednisone or equivalent;
    - Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication);
    8. Adequate bone marrow function: neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, haemoglobin > 9 g/dL;
    9. Adequate liver function: bilirubin < 2 X upper normal limit (except known medical reason not interfering with liver function, such as Gilbert disease), SGOT, SGPT, AP, GGT < 3 x ULN;
    10. Adequate renal function: calculated or analysed creatinine clearance > 60 mL/min;
    11. If of childbearing potential, willingness to use effective contraceptive method (Pearl Index < 1; e.g. oral contraceptive (pill), hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), sterilization, sexual abstinence for the study duration and 2 months post-dosing.
    1. Consenso Informato scritto e firmato;
    2. Maschi e Femmine = 18 anni di età
    3. ECOG performance status di 0-1;
    4. Evidenza clinica e istologica di OPL con rischio elevato di trasformazione maligna definito come LOH in 3p14 e/o 9p21, e in almeno un altro sito cromosomico (4q, 8p,11p,13q, or 17p) o pazienti con precedente cancro alla cavità orale e LOH in 3p14 e/o 9p21 (LOH definito secondo lo studio EPOC). Queste condizioni definiscono "positività all’LOH";
    5. OPL con una definizione istologica di displasia e un diametro minimo di almeno 20 mm;
    6. Essere disposti a fornire tessuto da biopsie orali ottenute di recente;
    7. Non ricevere terapia steroidea sistemica cronica o terapia immunosoppressiva entro 7 giorni prima del primo trattamento; assenza di malattia autoimmune attiva che ha richiesto un trattamento sistemico negli ultimi 2 anni, eccetto:
    - Steroidi intranasali, inalati, topici o iniezioni di steroidi locali (ad es. Iniezione intra-articolare);
    - Corticosteroidi sistemici a dosi fisiologiche =10 mg/die di prednisone o l’equivalente;
    - Steroidi come premedicazione per reazioni di ipersensibilità (es. Premedicazione di scansione TC);
    8. Adeguata funzionalità del midollo osseo: neutrofili > 1.5 x 109/L, piastrine > 100 x 109/L, emoglobina > 9 g/dL;
    9. Adeguata funzionalità epatica: bilirubina < 2 X limite normale superiore (ULN) -eccetto motivi medici noti che non interferiscono con la funzionalità epatica, come la sindrome di Gilbert-, SGOT, SGPT, AP, GGT < 3 x ULN;
    10. Adeguata funzionalità renale: clearance della creatinina calcolata o analizzata > 60 mL/min;
    11. Se potenzialmente fertile, volontà di usare un metodo contraccettivo efficace (Indice Pearl < 1; es. contraccettivi orali -pillola-, spirale contracettiva, ormone impiantate, cerotto, una combinazione di due metodi di barriera -preservativo e diaframma-, sterilizzazione, assenza sessuale durante lo studio e fino a 2 mesi dopo l’ultimo dosaggio.
    E.4Principal exclusion criteria
    1. Previous immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint receptors);
    2. Oral lesions due to lichen planus;
    3. Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy, or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness;
    4. Any test for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating acute or chronic infection;
    5. Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for the administration of inactivated vaccines (for example, inactivated influenza vaccines);
    6. Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV (see Appendix 4), uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months;
    7. Significant neurologic or psychiatric disorders including dementia or seizures;
    8. Active uncontrolled infection (requiring IV antibiotics) or active tuberculosis;
    9. Active disseminated intravascular coagulation;
    10. Other serious underlying medical conditions which could impair the ability of the patient to participate into the study;
    11. Having participated in another clinical trial or having received any investigational agent in the preceding 30 days before study entry;
    12. Known allergic/hypersensitivity reaction to any of the components of the treatment;
    13. Pregnancy (absence confirmed by serum/urine beta HCG) or breastfeeding;
    14. Other active malignancy within 3 years, with the exception of a history of a previous, adequately treated:
    - basal cell carcinoma of the skin
    - pre-invasive carcinoma of the cervix
    - superficial bladder cancer
    - carcinoma in situ of the prostate, cervix or breast,
    - head and neck carcinoma surgically treated (radiotherapy treatment not allowed);
    15. Legal incapacity or limited legal capacity;
    16. Medical, psychological or socio-geographical condition or situation which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent;
    17. Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to be enrolled;
    18. Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of study drug administration. Inhaled or topical steroids, steroids as premedication for hypersensitivity reactions and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
    1. Precedente immunoterapia (anticorpi anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 o qualsiasi altro anticorpo o farmaco diretto specificamente alla co-stimolazione delle cellule T o ai recettori del checkpoint immunitario);
    2. Lesioni orali dovute al lichen planus;
    3. Diagnosi di precedente immunodeficienza o trapianto di organi che richiede terapia immunosoppressiva, o infezione da virus dell'immunodeficienza umana (HIV) o malattie correlate alla sindrome da immunodeficienza acquisita (AIDS);
    4. Indicazioni di infezione acuta o cronica causata dal virus dell'epatite B (HBV) dell'epatite C (HCV);
    5. Sono proibite vaccinazioni entro 4 settimane dalla prima dose di avelumab e durante la sperimentazione, con l’eccezione della somministrazione di vaccini inattivati (es. vaccini inattivati per l'influenza);
    6. Malattie cardiovascolari clinicamente significative: es. insufficienza cardiaca delle classi New-Heart Association III-IV (Appendice 4), malattia coronarica non controllata, cardiomiopatia, aritmia non controllata, ipertensione non controllata o infarto del miocardio negli ultimi 12 mesi;
    7. Disturbi neurologici o psichiatrici significativi tra cui demenza o convulsioni;
    8. Infezione attiva non controllata (che richiede antibiotici per via endovenosa) o tubercolosi attiva;
    9. Coagulazione intravascolare disseminata attiva;
    10. Altre gravi condizioni mediche di base che potrebbero compromettere la capacità del paziente di partecipare allo studio;
    11. Aver partecipato ad un'altra sperimentazione clinica o aver ricevuto un farmaco sperimentale nei 30 giorni prima dell'ingresso nello studio;
    12. Reazione allergica/di ipersensibilità nota a qualsiasi componente del trattamento;
    13. Gravidanza (assenza confermata da siero/urina beta HCG) o allattamento;
    14. Altre neoplasie attive entro 3 anni, ad eccezione di una storia di:
    - carcinoma basocellulare della pelle precedentemente adeguatamente trattato
    - carcinoma pre-invasivo della cervice
    - del carcinoma della vescica superficiale o carcinoma in situ della prostata, cervice, o al seno
    - carcinoma testa collo trattato chirurgicamente (radioterapia non consentita).
    15. Incapacità legale o capacità giuridica limitata;
    16. Condizione o situazione medica, psicologica o socio-geografica che, secondo l'opinione dello sperimentatore, non consentirebbe al paziente di completare lo studio o firmare un consenso informato significativo;
    17. Malattia autoimmune attiva, nota o sospetta. I pazienti con vitiligine, diabete mellito di tipo I, ipotiroidismo residuo a causa di condizioni autoimmuni che richiedono solo la sostituzione dell'ormone, la psoriasi che non richiede un trattamento sistemico o le condizioni che non dovrebbero ripresentarsi in assenza di un trigger esterno possono essere arruolati;
    18. Condizioni che richiedono un trattamento sistemico con corticosteroidi (> 10 mg equivalenti al prednisone al giorno) o altri farmaci immunosoppressori entro 7 giorni dalla somministrazione del farmaco in studio. Steroidi per via inalatoria o topica, steroidi come premedicazione per reazioni di ipersensibilità e dosi sostitutive surrenali> 10 mg equivalenti di prednisone al giorno sono consentiti in assenza di malattia autoimmune attiva.
    E.5 End points
    E.5.1Primary end point(s)
    1. To revert the risk of malignant transformation of OPL through a short course of immunotherapy with avelumab. This objective will be evaluated both in its final endpoint (malignant transformation) and with an intermediate endpoint (reversal of loss of heterozygosity -LOH- status)
    2. Change in LOH status (positive to negative) of OPL after 6 months since the start of immunotherapy. This is defined as disappearance of any high-risk LOH (and the nonappearance of any other high-risk LOH) in the site of the OPL at the histological sample after immunotherapy treatment
    1. Sopravvivenza libera da sviluppo maligno o ricorrenza dall’inizio dell’immunoterapia, in particolare gli eventi di interesse sono ricorrenza delle OPL con LOH o trasformazione maligna.
    2. Cambio di stato dell’LOH (da positivo a negativo) nelle OPL dopo 6 mesi dall’inizio dell’immunoterapia. Questo cambio è definito come la scomparsa di LOH ad alto rischio (e la non-comparsa di nessun’altro LOH ad alto.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 6 months after the start of treatment
    2. 6 months after the start of treatment
    1. 6 mesi dall'inizio del trattamento con avelumab
    2. 6 mesi dall'inizio del trattamento con avelumab
    E.5.2Secondary end point(s)
    • Grade 3-5 adverse events or any treatment interruption due to toxicities (safety)
    • Change of histological grading of OPL
    • Identification of multi-omic signatures associated with response to immunotherapy
    • Eventi avversi di grado 3-5 o interruzioni del trattamento dovute a tossicità (sicurezza).
    • Cambio nella classificazione istologica delle OPL.
    • Identificazione di strumenti predittivi in termini di genomica e di imaging per prevedere la risposta all'immunoterapia con avelumab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    continuosly
    6 months
    6 months and at malignant transformation
    in modo continuativo
    6 mesi
    6 mesi e a trasformazione maligna avvenuta
    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 No
    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 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 concerned7
    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 Information not present in EudraCT
    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 years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subject incapable of giving consent for physical reasons or reason linked to their medical condition
    Soggetto incapace di dare il consenso per motivi fisici o motivi legati alla loro condizione medica
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    Patients will be treated as per clinical practice
    I pazienti verranno seguiti secondo pratica clinica
    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 Decision2020-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-12-30
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