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    Summary
    EudraCT Number:2019-002629-31
    Sponsor's Protocol Code Number:ET19-144
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-23
    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 number2019-002629-31
    A.3Full title of the trial
    REGOMAIN – A randomized, placebo-controlled, double-blinded, multicentre, comparative phase II study of the efficacy of regorafenib as maintenance treatment in patients with high grade bone sarcomas (HGBS) at diagnosis or relapse and without complete remission after standard treatment
    REGOMAIN – Essai de phase II randomisé, contrôlé contre placebo, en double insu, multicentrique et comparatif évaluant l’efficacité du traitement de maintenance par regorafenib chez des patients présentant des sarcomes osseux de haut grade lors du diagnostic ou en rechute sans rémission complète après le traitement standard
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study evaluating the efficacy of regorafenib as maintenance treatment in patients with high grade bone sarcomas (HGBS) at diagnosis or relapse and without complete remission after standard treatment
    Etude évaluant l’efficacité du traitement de maintenance par regorafenib chez des patients présentant des sarcomes osseux de haut grade lors du diagnostic ou en rechute sans rémission complète après le traitement standard
    A.3.2Name or abbreviated title of the trial where available
    REGOMAIN
    REGOMAIN
    A.4.1Sponsor's protocol code numberET19-144
    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 supportBayer AG
    B.4.2CountryFrance
    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 pointDRCI
    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 Stivarga
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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 nameRegorafenib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with high grade bone sarcomas (HGBS) at diagnosis or first relapse and without complete remission after standard treatment
    Patients présentant un sarcome osseux de haut grade au diagnostic ou après récidive et sans rémission complète après le traitement standard
    E.1.1.1Medical condition in easily understood language
    Patients with high grade bone sarcomas
    Patients présentant un sarcome osseux de haut grade
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 of the trial is to compare the efficacy of regorafenib versus placebo as maintenance treatment in patients who did not achieve a complete response after their standard treatment sequence (either at diagnosis or at first relapse)
    L’objectif principal de cet essai est de comparer l’efficacité d’un traitement de maintenance par regorafenib versus placebo chez les patients qui n’ont pas obtenu de réponse complète après leur traitement standard (au diagnostic ou lors de la première rechute).
    E.2.2Secondary objectives of the trial
    To determine in both arms:
    • The Objective Response Rate (ORR),
    • The Disease Control Rate (DCR),
    • The Time to Treatment Failure (TTF),
    • The Overall Survival
    • The Quality of Life (EORTC QLQ-C30),
    • The tolerance profile (NCI-CTC AE version 5)
    In patients from the placebo arm who switched into the active treatment group, the following additional objectives will be studied from regorafenib initiation:
    • The Progression-Free Survival (PFS)
    • The Objective Response Rate (ORR)
    • The Disease Control Rate (DCR)
    • The Overall Survival
    • The tolerance profile
    Déterminer dans les deux bras :
    • Le taux de réponse objective (ORR),
    • Le taux de contrôle de la maladie (DCR),
    • Le temps à échec du traitement (TTF),
    • La survie globale,
    • La qualité de vie (questionnaire EORTC QLQ-C30),
    • Le profil de tolérance (NCI-CTC AE version 5).

    Pour les patients du bras « placebo » qui passeront dans le bras « traitement expérimental », les objectifs supplémentaires suivants seront évalués depuis l’initiation du Regorafenib :
    • La survie sans progression (PFS),
    • Le taux de réponse objective (ORR),
    • Le taux de contrôle de la maladie (DCR),
    • La survie globale,
    • Le 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
    In tumor environment (FFPE block pre-treatment [biopsy or surgery]): Multi-IF analysis to define CD3, CD20 and CD8 expression, T cell activation including KI67 / PD1, Tumor-Associated Macrophages, Dendritic cells, Expression of Immune checkpoints and ligands including PDL1 / L2.
    Other research on blood samples (Plasma): Flow cytometry for phenotypic analysis, distribution of immune populations (T, B, NK, Monocytes and dendritic cells (cDC1, cDC2, pDC)) and adaptive (CD4 and CD8 T populations, Treg, B populations and plasma cells), quantification of CD146+ CECs (and plasma level of VEGF).
    E.3Principal inclusion criteria
    I1. Age ≥ 16 years at the day of consenting to the study ;
    I2. Patients must have histologically confirmed high-grade bone sarcomas of one of the following histotypes:
    • Osteosarcomas (conventional-intramedullary/central high grade, small cell, telangiectatic or high-grade surface osteosarcomas) ;
    • Bone sarcomas other than Ewing sarcoma, chondrosarcoma and chordoma ;
    I3. Measurable residual disease after multimodal treatment principles either at diagnosis (after surgery and pre and/or post-surgery chemotherapy) or at first relapse (chemotherapy).
    I4. Non progressive disease (defined by the investigator according to the RECIST version 1.1 Appendix 1) at study entry ;
    I5. Interval between the date of last anticancer treatment (chemotherapy or surgery) and the date of randomization : at least 4 weeks but no longer than 2 months ;
    ...See the protocol
    I1. Age ≥ 16 ans le jour d’obtention du consentement éclairé du patient ;
    I2. Les patients doivent avoir un diagnostic histologique confirmé de sarcome osseux de haut grade de l’un des histotypes suivants :
    • Ostéosarcomes (conventionnel, intramédullaire/central de haut grade, à petite cellule, télangiectasique, ou ostéosarcome de surface de haut grade),
    • Sarcomes osseux autres que sarcome d’Ewing, chondrosarcome et chordome ;
    I3. Maladie résiduelle mesurable après traitements multimodaux soit au diagnostic (après chirurgie et chimiothérapie néoadjuvante et/ou adjuvante) ou à la première progression (chimiothérapie) ;
    I4. Maladie non progressive (définie par l’investigateur selon RECIST 1.1) lors de l’inclusion ;
    I5. Délai entre la date du dernier traitement anticancéreux (chimiothérapie or chirurgie) et la date de randomisation : au moins 4 semaines mais inférieur à 2 mois ;
    ...See the protocole
    E.4Principal exclusion criteria
    E1. Prior treatment with any VEGFR inhibitor (thus, any prior exposure to regorafenib, sunitinib, sorafenib, pazopanib, bevacizumab, or other VEGFR inhibitor) ;
    E2. All soft tissue sarcomas (including but not limited to soft tissue osteosarcoma), and Ewing sarcoma, chondrosarcoma and chordoma ;
    E3. Prior history of malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within 3 years prior to randomization ;
    E4. Cardiovascular dysfunction defined by:
    • Left ventricular ejection fraction (LVEF) < 50%,
    • Congestive heart failure ≥ New York Heart Association (NYHA) class 2,
    • Myocardial infarction < 6 months prior to first study drug administration,
    • Cardiac arrhythmias requiring therapy (beta blockers or digoxin are permitted),
    • Unstable (angina symptoms at rest) or new-onset angina within the last 3 months prior to first study drug administration ;
    • Uncontrolled hypertension (systolic blood pressure > 150mmHg or diastolic pressure > 90 mmHg despite optimal treatment) ;
    • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the last 6 months before the first study drug administration ;
    E5. Major surgical procedure, open biopsy or significant traumatic injury within 28 days before the first study drug administration ;
    ...See the protocol
    E1. Traitement antérieur par un inhibiteur du VEGFR (donc aucune exposition antérieure au regorafenib, sunitinib, sorafenib, pazopanib, bevacizumab ou tout autre inhibiteur du VEGFR) ;
    E2. Tous les sarcomes des tissus mous (incluant mais non limités aux ostéosarcomes des tissus mous), sarcome d’Ewing, chondrosarcome et chordome ;
    E3. Antécédents de tumeurs malignes autres que celle de l’étude (à l’exception des carcinomes basocellulaires ou épidermoïdes ou carcinome in situ du col utérin) durant les 3 ans précédant la randomisation ;
    E4. Trouble cardiovasculaire défini par :
    • Fraction d’éjection ventriculaire gauche (FEVG) < 50%,
    • Insuffisance cardiaque ≥ classe 2 de la classification « New York Heart Association (NYHA) »,
    • Infarctus du myocarde dans les 6 mois précédant la première administration du traitement,
    • Arythmie cardiaque nécessitant un traitement (les bêtabloquants ou la digoxine sont autorisés),
    • Angine de poitrine instable (symptomatique au repos) ou nouvellement diagnostiquée dans les 3 mois précédant l’administration du traitement,
    • Hypertension non contrôlée (pression systolique > 150mmHg ou pression diastolique > 90 mmHg malgré un traitement optimal),
    • Evénements thromboemboliques, veineux ou artériels tels qu’un AVC (incluant les AVC ischémiques transitoires), thrombose veineuse profonde ou embolie pulmonaire durant les 6 derniers mois précédant la première administration du traitement à l’étude,
    E5. Chirurgie majeure, biopsie ouverte ou blessure traumatique dans les 28 jours précédant l’administration de la première dose de traitement ;
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the Progression-Free Survival (PFS), defined as the time from the date of randomization to the date of first documented disease progression (according to the RECIST V1.1) or the date of death due to any cause.
    Le critère de jugement principal sera la survie sans progression (PFS), définie par le temps depuis la date de randomisation jusqu’à la date de la première progression documentée de la maladie (selon RECIST V1.1) ou date de décès toute cause confondue.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessment according to the RECISTv1.1
    Evaluation selon les RECIST v1.1
    E.5.2Secondary end point(s)
    The Objective Response Rate (ORR)
    The Disease Control Rate (DCR)
    The Time to Treatment Failure (TTF)
    The Overall Survival (OS)/OS from switch
    The patient’s Quality of Life (EORTC QLQ-C30),
    The safety (NCI-CTC AE version 5)
    Le taux de réponse objective (ORR),
    Le taux de contrôle de la maladie (DCR),
    Le temps à échec du traitement (TTF),
    La survie globale (OS)/OS from switch,
    La qualité de vie (questionnaire EORTC QLQ-C30),
    Le profil de tolérance (NCI-CTC AE version 5).
    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 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 concerned15
    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
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    16-17 years
    16-17 ans
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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 investigator discretion
    A la discrétion du médecin
    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 Decision2020-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-07
    P. End of Trial
    P.End of Trial StatusOngoing
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