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    Summary
    EudraCT Number:2020-003762-39
    Sponsor's Protocol Code Number:GOIRC–03-2019
    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:2021-05-24
    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 number2020-003762-39
    A.3Full title of the trial
    PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION
    Studio di fase III con atezolizumab verso placebo in pazienti con mesotelioma pleurico maligno dopo pleurectomia/decorticazione
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION
    Studio di fase III con atezolizumab verso placebo in pazienti con mesotelioma pleurico maligno dopo pleurectomia/decorticazione
    A.3.2Name or abbreviated title of the trial where available
    AtezoMeso
    AtezoMeso
    A.4.1Sponsor's protocol code numberGOIRC–03-2019
    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 SponsorGRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
    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 supportRoche S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAUSL/IRCCS di Reggio Emilia
    B.5.2Functional name of contact pointDipartimento ONCOLOGICO e TECNOLOGI
    B.5.3 Address:
    B.5.3.1Street AddressVia Risorgimento, 80
    B.5.3.2Town/ cityReggio Emilia
    B.5.3.3Post code42123
    B.5.3.4CountryItaly
    B.5.4Telephone number0522296546
    B.5.6E-mailpinto.carmine@ausl.re.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 Yes
    D.2.1.1.1Trade name TECENTRIQ - 1200 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 20 ML (60 MG/ML) - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION GMBH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameTecentriq
    D.3.2Product code [R00554-1267/F03-01]
    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.3.9.2Current sponsor codeTecentriq
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB 178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    MALIGNANT PLEURAL MESOTHELIOMA PATIENTS
    Pazienti con mesotelioma pleurico maligno
    E.1.1.1Medical condition in easily understood language
    MALIGNANT PLEURAL MESOTHELIOMA PATIENTS
    Pazienti con mesotelioma pleurico maligno
    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 10059518
    E.1.2Term Pleural mesothelioma malignant
    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 Disease Free Survival (DFS) defined as the time between the date of start of study drug and the first date of documented recurrence, based on investigator assessment as per RECIST 1.1 criteria, or death due to any cause, whichever occurs first.
    Valutare il Disease Free Survival (DFS) definito come il tempo tra la data di inizio del farmaco in studio e la prima data di recidiva documentata, sulla base della valutazione dello sperimentatore secondo i criteri RECIST 1.1, o morte per qualsiasi causa, a seconda di quale si verifica per prima.
    E.2.2Secondary objectives of the trial
    Secondary End points
    To evaluate the safety of atezolizumab in terms of incidence, nature, frequency, duration, timing and severity of Adverse Events (AEs) and laboratory abnormalities graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.
    To evaluate the efficacy in terms of overall survival (OS) defined as the time from start of study drug to the date of death from any cause.
    To evaluate the quality of life of patients determinated with the EQ-5D questionnaire.

    Exploratory end points
    • To assess the role of biomarkers in the progression and fundamental biology of MPM
    • To evaluate biomarkers (e.g., cancer-related genes) as prognostic biomarkers
    End point secondari
    Valutare la sicurezza di atezolizumab in termini di incidenza, natura, frequenza, durata, tempo di insorgenza e gravità degli eventi avversi (EA) e delle anomalie di laboratorio classificate secondo i Common Terminology Criteria for Adverse Events (CTCAE) v. 5 del National Cancer Institute (NCI).
    Valutare l'efficacia in termini di sopravvivenza globale (OS) definita come il tempo dall'inizio del farmaco in studio alla data di morte per qualsiasi causa.
    Valutare la qualità della vita dei pazienti determinata con il questionario EQ-5D.

    End point esploratori
    Valutare il ruolo dei biomarcatori nella progressione e nella biologia del mesotelioma pleurico maligno.
    Valutare i biomarcatori (ad es. geni correlati al cancro) come biomarcatori prognostici
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age = 18 years on day of signing informed consent
    • Histologically confirmed malignant pleural mesothelioma
    • Surgical resection (P/D), without macroscopic residual. In stage I patients without visceral involvement a total pleurectomy is allowed
    • Patients must have received at least 4 cycles of perioperative platinum/pemetrexed chemotherapy as per local practice. Less than 4 cycles of chemotherapy are allowed for clinical decisions
    - In patients previously treated with neoadjuvant chemotherapy, randomization should occur within 50 days from surgical resection.
    - In patients treated with adjuvant chemotherapy, randomization should occur within 30 ± 7 days from last dose of adjuvant treatment.
    • Performance status of 0-1 on the ECOG Performance Scale
    • Adequate organ function, all screening labs should be performed within 14 days of treatment initiation.
    • Availability of 1 tumor block at baseline.
    Età = 18 anni alla firma del consenso informato.

    I pazienti devono avere conferma istologica di mesotelioma pleurico maligno.

    Resezione chirurgica (P / D), senza residuo macroscopico. Nei pazienti in stadio I senza coinvolgimento viscerale è consentita una pleurectomia totale.

    I pazienti devono aver ricevuto almeno 4 cicli di chemioterapia perioperatoria con platino / pemetrexed secondo la pratica locale. Sono consentiti meno di 4 cicli di chemioterapia per le decisioni cliniche.

    • Nei pazienti precedentemente trattati con chemioterapia neoadiuvante, la randomizzazione deve avvenire entro 50 giorni dalla resezione chirurgica.

    • Nei pazienti trattati con chemioterapia adiuvante, la randomizzazione deve avvenire entro 30 ±7 giorni dall'ultima dose di trattamento adiuvante.

    Stato delle prestazioni di 0-1 sulla scala delle prestazioni ECOG.

    Adeguata funzionalità degli organi, tutti i laboratori di screening devono essere eseguiti entro 14 giorni dall'inizio del trattamento.

    Disponibilità di 1 blocco tumorale al basale.
    E.4Principal exclusion criteria
    • Patient with macroscopic residual disease after surgery
    • Subjects with active, known or suspected autoimmune disease. Subjects 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 enroll
    • Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
    • Active infection requiring systemic therapy
    • History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
    • Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
    • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
    • Women with a positive pregnancy test at enrollment or prior to administration of study medication
    Pazienti con malattia residua macroscopica dopo l'intervento chirurgico.

    Soggetti con malattia autoimmune attiva, nota o sospetta. Possono essere arruolati soggetti con vitiligine, diabete mellito di tipo I, ipotiroidismo residuo dovuto a condizioni autoimmuni che richiedono solo la terapia sostitutiva ormonale, psoriasi che non richieda trattamento sistemico o condizioni che non si prevede si ripresenteranno in assenza di un fattore scatenante esterno.

    Storia di carcinomi maligni negli ultimi 5 anni. Le eccezioni includono carcinoma a cellule basali della pelle, carcinoma a cellule squamose della pelle o cancro cervicale in situ che è stato sottoposto a terapia potenzialmente curativa.

    Infezione attiva che richiede terapia sistemica.

    Storia del virus dell'immunodeficienza umana (HIV) (anticorpi HIV 1/2).

    Epatite B attiva (ad es. HBsAg reattivo) o epatite C (ad es. HCV RNA rilevato [qualitativo]).

    Trattamento con un vaccino vivo attenuato entro 4 settimane prima dell'inizio del trattamento in studio, o anticipazione della necessità di un tale vaccino durante il trattamento con atezolizumab o entro 5 mesi dalla dose finale di atezolizumab.

    Donne con un test di gravidanza positivo all'arruolamento o prima della somministrazione del farmaco in studio.
    E.5 End points
    E.5.1Primary end point(s)
    DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first. DFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
    DFS, definito come il tempo che intercorre tra l'inizio del trattamento in studio e la prima recidiva della malattia o la morte per qualsiasi causa, a seconda di quale si verifica per prima. La DFS sarà calcolata in base allo stato della malattia valutato dallo sperimentatore secondo i criteri di valutazione della risposta nei tumori solidi, versione 1.1 (RECIST v1.1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first.
    dall'inizio del trattamento e la prima recidiva della malattia o la morte per qualsiasi causa, a seconda di quale si verifica per prima
    E.5.2Secondary end point(s)
    Incidence, nature, frequency, duration, timing and severity of serious adverse events (SAEs) and non-serious adverse events (AEs) related to atezolizumab treatment graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.; OS, defined as the time from start of study drug to the date of death from any cause.; EQ-5D-3L questionnaire; Sicurezza ed efficacia di atezolizumab in sottogruppi della popolazione in studio differenziati in base a:
    Espressione della proteina PD-L1 nel tessuto tumorale
    Presenza / assenza di altri biomarcatori nel tessuto tumorale
    Correlazioni tra l'espressione di PD-L1 e altri biomarcatori
    Incidenza, natura, frequenza, durata, tempo di insorgenza e gravità degli eventi avversi (EA) e delle anomalie di laboratorio classificate secondo i Common Terminology Criteria for Adverse Events (CTCAE) v. 5 del National Cancer Institute (NCI).; OS definita come il tempo dall'inizio del farmaco in studio alla data di morte per qualsiasi causa.; Questionario EQ-5D-3L; Safety and efficacy of atezolizumab in subgroups of the study population differentiated according to:
    Expression of PD-L1 protein in tumor tissue
    Presence/absence of other biomarkers in tumor tissue
    Correlations between PD-L1 expression and other biomarkers
    E.5.2.1Timepoint(s) of evaluation of this end point
    each visit; death; screening, ogni ciclo (eccetto il ciclo 1), fine del trattamento; screening
    ad ogni visita; morte; screening, every cycle (except cycle 1), end of treatment; screening
    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 No
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned20
    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
    The end of study will occur when all enrolled patients have either died, withdrawn consent, are lost to follow up, or have been followed for 24 months since the treatment start, whichever occurs first.
    La fine dello studio si verificherà quando tutti i pazienti arruolati saranno deceduti, ritirato il consenso, persi al follow-up o saranno stati seguiti per 24 mesi dall'inizio del trattamento, a seconda di quale condizione si verifichi per prima.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state162
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 162
    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)
    normal patient care
    normale percorso assistenziale
    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 Decision2021-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
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