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    Summary
    EudraCT Number:2019-001547-43
    Sponsor's Protocol Code Number:ET19-075
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-09-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-001547-43
    A.3Full title of the trial
    ATEZOGIST – A prospective, randomized, multicenter, comparative study of the efficacy of imatinib resumption combined with atezolizumab versus imatinib resumption alone in patients with unresectable advanced gastrointestinal stromal tumors (GIST) after failure of standard treatments
    ATEZOGIST – Essai randomisé, comparatif, prospectif et multicentrique évaluant l’efficacité de la réintroduction de l’imatinib associé à l’atézolizumab versus la réintroduction de l’imatinib seul chez des patients porteurs de tumeurs stromales gastrointestinales (GIST), non opérables en situation avancée, après échec des traitements standards
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating the efficacy of imatinib resumption with atezolizumab versus imatinib resumption alone in patients with unresectable advanced gastrointestinal stromal tumors (GIST) after failure of standard treatments
    Étude évaluant l'efficacité de la réintroduction de l'imatinib avec l'atezolizumab par rapport à la réintroduction de l'imatinib seul chez les patients atteints de tumeurs stromales gastro-intestinales (GIST), non opérables et en situation avancée, après échec des traitements standards
    A.3.2Name or abbreviated title of the trial where available
    ATEZOGIST
    ATEZOGIST
    A.4.1Sponsor's protocol code numberET19-075
    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 SponsorCentre Léon Bérard
    B.1.3.4CountryFrance
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Léon Bérard
    B.5.2Functional name of contact pointJulien GAUTIER
    B.5.3 Address:
    B.5.3.1Street Address28 rue Laennec
    B.5.3.2Town/ cityLYON cedex 08
    B.5.3.3Post code69373
    B.5.3.4CountryFrance
    B.5.4Telephone number+33426 55 68 29
    B.5.5Fax number+33478 78 27 15
    B.5.6E-mailjulien.gautier@lyon.unicancer.fr
    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
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 injection/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 INNATEZOLIZUMAB
    D.3.9.1CAS number RO5541267
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 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 Glivec
    D.2.1.1.2Name of the Marketing Authorisation holder Novartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMATINIB MESILATE
    D.3.9.1CAS number 220127-57-1
    D.3.9.4EV Substance CodeSUB12517MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    Unresectable locally advanced or metastatic gastrointestinal stromal tumors (GIST) after failure of standard treatments
    Tumeurs gastro-intestinales (GIST) localement avancées et inopérables ou métastatiques après échec des traitements standards
    E.1.1.1Medical condition in easily understood language
    Tumor of the digestive system, which is either advanced and inoperable
    Tumeur de l'appareil digestif, qui est soit à un stade avancé et inopérable
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10051066
    E.1.2Term Gastrointestinal stromal tumour
    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 primary objective is to compare the efficacy (Progression-Free Survival – PFS) of imatinib resumption combined with atezolizumab versus imatinib resumption alone in patients with unresectable locally advanced or metastatic GIST after failure of standard treatments
    L’objectif principal est de comparer l’efficacité anti-tumorale (Survie sans progression, PFS pour Progression-Free Survival) de la réintroduction de l’imatinib associée à l’atézolizumab versus la réintroductionde l’imatinib seul chez des patients présentant des tumeurs gastro-intestinales (GIST) localement avancées et inopérables ou métastatiques après échec des traitements standards.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • Best Response Rate (BRR),
    • Objective Response Rate (ORR)
    • Time to Treatment Failure (TTF)
    • Overall Survival (OS)
    • Quality of Life
    • Tolerability
    Les objectifs secondaires sont:
    • Taux de meilleure réponse au traitement (BRR)
    • Taux de réponse objective (ORR)
    • Temps à échec du traitement (TTF),
    • Survie globale (OS),
    • Qualité de vie,
    • Profil de tolérance
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Exploratory objectives : Overall response will also be assessed using the modified RECIST 1.1 for immune-based therapeutics named iRECIST: iPFS, iBRR and iORR. Any documented disease progression (iUPD (unconfirmed immune PD) according to iRECIST) for patients treated with imatinib combined to atezolizumab will be confirmed 4-6 weeks later (iCPD (confirmed immune PD)).
    Objectifs exploratoires : L’ensemble des réponses sera également évalué à l’aide de la version modifiée de RECIST 1.1, pour les immunothérapies, nommée iRECIST: iPFS, iBRR and iORR. Toute progression documentée (iUPD (pour pseudo-progression : unconfirmed immune PD) selon iRECIST) chez les patients traités par l’association de l’imatinib et de l’atézolizumab devra être confirmée dans les 4 à 6 semaines qui suivent (iCPD (progression confirmée : confirmed immune PD)).
    E.3Principal inclusion criteria
    I1. Male or female ≥ 18 years at the day of consenting to the study;
    I2. Patients must have histologically confirmed diagnosis of GIST (within the French Reference Network in Pathology of Sarcomas - RRePS network); archival tumor sample must be made available for translational research program (in case there is no sufficient archival tumor material available, a biopsy must be performed prior to treatment start);
    Nota Bene: mutational status and level of expression of PD1/PD-L1 will not be considered as selection criteria but will be studied as endpoints for translational objectives.
    I3. Locally advanced or metastatic disease confirmed as measurable according to the RECIST V1.1;
    I4. Patients who previously failed to at least imatinib then sunitinib. Failure is defined for Imatinib as progressive disease and for sunitinib as progressive disease and/or intolerance;
    Nota Bene: Patients may have received a 3rd line with regorafenib or subsequent anticancer treatments
    I5. Performance Status of the ECOG of 0 or 1;
    … See the protocol
    I1. Homme ou femme ≥ 18 ans à la date de signature du consentement éclairé de participation;
    I2. Patient avec un diagnostic de GIST confirmé histologiquement (revu par le Réseau de Référence en Pathologie des Sarcomes des tissus mous et des viscères - RRePS); un échantillon de tumeur archivé doit être mis à disposition pour le programme de recherche translationnelle (en cas d'absence de matériel tumoral archivé disponible, une biopsie doit être réalisée avant le début du traitement) ;
    Nota Bene: le statut mutationnel et le niveau d’expression de PD1/PD-L1 ne seront pas utilisés comme critères de sélections mais ils seront étudiés au cours de l’étude translationnelle.
    I3. GIST localement avancé ou métastatique, confirmé par la présence de lésions mesurable selon RECIST V1.1;
    I4. Patient en échec de traitement pour au moins l’imatinib et le sunitinib. L’échec est défini par une progression de la maladie lors du traitement par imatinib et par une progression de la maladie et/ou une intolérance lors du traitement par sunitinib
    Nota Bene: Les patients peuvent avoir reçu du regorafenib comme 3ème ligne de traitement
    I5. Indice de performance de l’ECOG de 0 ou 1;
    … Voir le protocole
    E.4Principal exclusion criteria
    E1. Prior malignancy within the last 3 years except for locally curable disease with no sign of relapse;
    E2. Patients in whom imatinib had been already reintroduced after sunitinib as second line;
    E3. Known D842V mutation in Exon 18 of PDGFRA;
    E4. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4 , anti-TIGIT, anti PD-1,and anti PD-L1 therapeutic antibodies;
    E5. Any approved anticancer therapy (chemotherapy, hormonal therapy or radiotherapy) or treatment with any investigational product within 2 weeks or within 5 elimination half-lives (whichever is longer) prior to study treatments start;
    … See the protocol
    E1. Antécédents de tumeurs malignes autres que celles de l’étude durant les 3 ans précédant la randomisation, à l’exception des maladies locales curables avec aucun signe de récidive ;
    E2. Patients pour lesquels l’imatinib a déjà été réintroduit après le sunitinib comme seconde ligne;
    E3. Patient présentant une mutation documentée de l’exon 18 de PDGFRA (substitution D842V) ;
    E4. Traitement antérieur avec des agonistes CD137 ou des inhibiteurs de points de contrôle immunitaire, y compris les anticorps anti-CTLA-4, anti-TIGIT, anti-PD-1 et anti-PD-L1
    E5. Toute thérapie anticancéreuse approuvée (chimiothérapie, thérapie hormonal ou radiothérapie) ou traitement expérimental dans les 2 semaines ou dans les 5 demi-vies d'élimination (selon la période la plus longue) précédant le début des traitements de l’étude ;
    … Voir le protocole
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the Progression-Free Survival, assessed using the RECIST version 1.1.
    The PFS will be defined as the time from the date of randomization to the date of first disease progression, or death from any cause, whichever occurs first. Confirmation of PD (iCPD according to iRECIST) will not be considered in the assessment of the primary endpoint.
    Le critère d'évaluation principal sera la survie sans progression, évaluée selon la version 1.1 de RECIST.
    La PFS sera définie comme le temps écoulé entre la date de la randomisation et la date de la première progression de la maladie ou le décès, quelle qu'en soit la cause, la première étant retenue.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    Each tumor assessment
    Tout au long de l'étude
    A chaque évaluation tumorale
    E.5.2Secondary end point(s)
    BOR and ORR: will be summarized by a proportion together with its 95% confidence interval.
    TTF and OS: Number and percentage of patients with event, number and percentage of censored patients and number of patients at risk at each time point of interest will be reported.
    OS and TTF will be estimated using the Kaplan-Meier method, and will be described in terms of median (resp. median OS and TTF) along with the associated 2-sided 95% CIs for the estimates.
    QoL will be analyzed descriptively. Descriptive statistics and listings will be reported using appropriate methodology described by the EORTC.
    The assessment of safety will be based mainly on the frequency of AE. Descriptive statistics will be provided for characterizing and assessing patient tolerability to treatments.
    BOR et ORR : seront résumés par une proportion ainsi que son intervalle de confiance à 95%.
    TTF et OS : Le nombre et le pourcentage de patients présentant un événement, le nombre et le pourcentage de patients censurés et le nombre de patients à risque à chaque point temporel d'intérêt seront rapportés.
    La OS et la TTF seront estimées par la méthode de Kaplan-Meier, et seront décrites en termes de médiane (respectivement OS et TTF médians) ainsi que les IC à 95 % bilatéraux associés aux estimations.
    La qualité de vie sera analysée de manière descriptive. Les statistiques descriptives et les listes seront rapportées en utilisant la méthodologie appropriée décrite par l'EORTC.
    L'évaluation de la tolérance sera basée principalement sur la fréquence des EI. Des statistiques descriptives seront fournies pour caractériser et évaluer la tolérance des patients aux traitements.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    Each tumor assessment
    Tout au long de l'étude
    A chaque évaluation tumorale
    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 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 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 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) 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 concerned19
    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 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
    LVLS
    Dernière visite du dernier patient inclus
    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
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state110
    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 who still benefit from the study treatments at the end of the 12-month treatment period may continue to receive imatinib until disease progression, unacceptable toxicity or willingness to stop, whichever occurs first.

    A short term follow-up visit will be conducted 30 days after the last dose administered of atezolizumab or imatinib discontinuation to ensure that any AE has resolved or returned to baseline.
    Les patients qui bénéficient encore des traitements de l'étude à la fin de la période de traitement de 12 mois peuvent continuer à recevoir de l'imatinib jusqu'à la progression de la maladie, une toxicité inacceptable ou la volonté d'arrêter, la première éventualité étant retenue.

    Une visite de suivi à court terme sera effectuée 30 jours après l'administration de la dernière dose d'atezolizumab ou l'arrêt de l'imatinib pour s'assurer que tout EI a disparu ou est revenu au niveau de base.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Groupe Sarcome Français (GSF)
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-19
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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