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    Summary
    EudraCT Number:2020-002821-28
    Sponsor's Protocol Code Number:ET20-128
    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 number2020-002821-28
    A.3Full title of the trial
    RAR-Immune: A randomised, comparative, prospective, multicentre study of the efficacy of nivolumab + ipilimumab versus pazopanib alone in patients with metastatic or unresectable advanced sarcoma of rare subtype
    RAR-Immune: Etude randomisée, comparative, prospective et multicentrique de l’efficacité du nivolumab + ipilimumab versus pazopanib seul chez des patients atteints d’un sous-type rare de sarcome avancé non résécable ou métastatique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the efficacy of nivolumab + ipilimumab versus pazopanib alone in patients with metastatic or unresectable advanced sarcoma of rare subtype
    Etude d'efficacité du nivolumab + ipilimumab versus pazopanib seul chez des patients atteints d’un sous-type rare de sarcome avancé non résécable ou métastatique
    A.4.1Sponsor's protocol code numberET20-128
    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 supportBMS
    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+33478 78 27 86
    B.5.5Fax number+33478 78 27 15
    B.5.6E-mailseverine.metzger@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 Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameNivolumab
    D.3.4Pharmaceutical form Solution for injection
    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 INNNIVOLUMAB
    D.3.9.1CAS number NIVOLUMAB
    D.3.9.2Current sponsor codeET20-128
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.IMP: 2
    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 Yervoy
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameIpilimumab
    D.3.4Pharmaceutical form Solution for injection
    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 INNIPILIMUMAB
    D.3.9.1CAS number 477202-00-9
    D.3.9.4EV Substance CodeSUB29397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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.IMP: 3
    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 Votrient
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namePazopanib
    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 INNPAZOPANIB
    D.3.9.1CAS number 444731-52-6
    D.3.9.4EV Substance CodeSUB29175
    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
    Metastatic or unresectable advanced rare sarcomas
    Sarcomes rares avancés non résécables ou métastatiques
    E.1.1.1Medical condition in easily understood language
    Metastatic advanced rare sarcomas
    Sarcomes rares avancés métastatiques
    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 is to compare the efficacy (Progression-Free Survival) of nivolumab + ipilimumab versus pazopanib in the treatment of patients with metastatic or unresectable advanced rare sarcomas.
    L’objectif principal est de comparer l’efficacité (survie sans progression) de l’association nivolumab + ipilimumab versus pazopanib dans le traitement des patients atteints d’un sous-type rare de sarcome avancé non résécable ou métastatique.
    E.2.2Secondary objectives of the trial
    Secondary objectives will include the following clinical and translational objectives:
    • To determine in both study arms:
    • The Best Overall Response (BOR), the Objective Response Rate (ORR) and the duration of response (DOR);
    • The Time to Treatment Failure (TTF);
    • The Overall Survival (OS);
    • The Quality of Life (QoL);
    • The profile of tolerance.
    • To determine in the experimental arm
    The Progression-Free Survival using the iRECIST (immune Response Evaluation Criteria for Solid Tumours).
    • Translational objectives will be to:
    i) Quantify tumour PD-L1 expression and Combined Positive Score (CPS) in patients in both arms
    ii) Identify the predictive biomarkers of treatment response
    Les objectifs secondaires comprendront les objectifs cliniques et translationnels suivants :
    • Déterminer dans les 2 bras :
    o Le meilleur taux de réponse (BOR), le Taux de réponse objective (ORR) et la durée de réponse(DOR);
    o Délai d’échec du traitement (TTF);
    o La survie globale (OS);
    o La qualité de vie (QoL);
    o Le profil de tolérance
    • Déterminer dans le bras expérimental :
    o La survie sans progression selon iRECIST (critères d'évaluation de la réponse immunitaire pour les tumeurs solides)
    • Les objectifs translationnels seront de :
    i) Quantifier l’expression tumorale de PD-L1 et le score positif combiné (CPS) dans les 2 bras de traitement
    ii) Identifier les biomarqueurs prédictifs de la réponse au traitement
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational research will be conducted by a team from the “Centre de Recherche en Cancérologie of Lyon” (Centre Léon Bérard, Lyon). The objectives are to identify:
    - biomarkers predicting the therapeutic response for immunotherapy in rare sarcomas
    - resistance pathways and new targets for immunotherapy in rare sarcomas
    La recherche translationnelle sera menée par une équipe du Centre de Recherche en Cancérologie de Lyon (Centre Léon Bérard, Lyon). Les objectifs sont d’étudier :
    • Les biomarqueurs prédictifs de la réponse thérapeutique de l'immunothérapie dans les sarcomes rares,
    • Les mécanismes de résistance et les nouvelles cibles pour l'immunothérapie dans les sarcomes rares.
    E.3Principal inclusion criteria
    I1. Age ≥ 18 years at the day of consenting to the study ;
    I2. Only histologically confirmed sarcoma of rare subtype, defined as one of the following subtypes :
    - AS (Angiosarcoma)
    - ASPS (Alveolar Soft Part Sarcoma)
    - CCSA (Clear Cell Sarcoma)
    - DSRCT (Desmoplastic Small Round Cell Tumour)
    - SEF (Sclerosing Epithelioïd Fibrosarcoma)
    - PEComa (Perivascular Epithelioid Cell Tumour)
    - IS (Intimal sarcoma)
    - EMC (Extraskeletal Myxoid Chondrosarcoma)
    - SFT (Solitary Fibrous Tumour)
    - EHE (Epithelioid HemangioEndothelioma)
    - IMT (Inflammatory Myofibroblastic Tumour)
    - ES (Epithelioïd sarcoma)
    - FS (FibroSarcoma)
    - SMARCA-4 deficient sarcoma
    - MPNST (Malign Peripheral Nerve Sheath Tumours)
    - Chordoma ;
    I3. Metastatic disease or unresectable locally advanced malignancy that is resistant or refractory to standard therapy or for which standard therapy does not exist or is not considered appropriate by the Investigator ;
    I4. Measurable disease as per the RECIST version 1.1 ;
    I5. Previously treated with anthracycline-based regimen except for whom standard therapy does not exist or is not considered appropriate by the Investigator: inclusion in first line is allowed (randomisation will be stratified according to the number of previous treatment lines) ;
    ...See the protocol
    I1. Age ≥ 18 ans le jour du consentement
    I2. Patient(e) présentant uniquement un sarcome rare histologiquement confirmé, défini comme l’un des sous-types rares suivants :
    - AS (Angiosarcome)
    - ASPS (Sarcome alvéolaire des parties molles)
    - CCSA (sarcome à cellules claires)
    - DSRCT (Tumeur desmoplastique à petites cellules rondes)
    - SEF (Fibrosarcome épithélioïde sclérosant)
    - PEComa (Tumeur des cellules épithélioïdes périvasculaires)
    - IS (sarcome intimal)
    - EMC (Chondrosarcome myxoïde extrasquelettique)
    - SFT (tumeur fibreuse solitaire)
    - EHE (Hémangio-endothéliome épithélioïde)
    - IMT (Tumeur myofibroblastique inflammatoire)
    - ES (Sarcome épithélioïde)
    - FS (FibroSarcome)
    - Sarcome déficient en SMARCA-4
    - MPNST (tumeurs malignes de la gaine nerveuse périphérique))
    - Chordome
    I3. Maladie métastatique ou tumeur maligne localement avancée non résécable résistante ou réfractaire au traitement standard ou pour laquelle le traitement standard n'existe pas ou n'est pas considéré comme approprié par l'investigateur
    I4. Tumeur mesurable selon RECIST version 1.1;
    I5. Patient(e) précédemment traité(e) avec un traitement à base d'anthracycline, sauf si le traitement standard n'existe pas ou s’il n'est pas jugé approprié par l'investigateur : l'inclusion en première ligne est autorisée (la randomisation sera stratifiée en fonction du nombre de lignes de traitement précédentes)
    ...Voir le protocole
    E.4Principal exclusion criteria
    E1. Concurrent use of any other approved or investigational antineoplastic agent ;
    E2. Prior or concurrent treatment with any antibody targeting PD1, PDL1, PDL2 or CTLA4 ;
    E3. Prior treatment with pazopanib ;
    E4. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases ;
    Note: Asymptomatic patients with treated CNS lesions are eligible,
    E5. Patients using, or requirement to use while on the study, or not respecting the minimal wash-out period of médications ;
    ...See the protocol
    E1. Utilisation concomitante de tout autre traitement antinéoplasique autorisé ou expérimental
    E2. Antécédent ou traitement concomitant de tout anticorps ciblant PD1, PDL1, PDL2 ou CTLA4
    E3. Antécédent de traitement par pazopanib
    E4. Métastases du système nerveux central (SNC) symptomatiques, non traitées ou en progression active
    Note: Les patients asymptomatiques atteints d’un SNC sous traitement sont éligibles
    E5. Patient(e) utilisant, ou ayant besoin d'utiliser pendant la durée de l'étude, ou ne respectant pas la période minimale de « wash out » des médicaments
    ...Voir le protocole
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be Progression-Free Survival.
    Le critère de jugement principal sera la survie sans progression.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression-Free Survival : defined as the time from the date of randomisation to the date of first documented progression or death due to any cause. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment
    Survie sans progression : définie comme le temps écoulé entre la date de randomisation et la date de la première progression documentée ou du décès quelle qu'en soit la cause. Les patients qui n'auront pas progressé ou qui seront décédés au moment de l'analyse seront censurés au moment de la dernière date d'évaluation
    E.5.2Secondary end point(s)
    Secondary endpoints :
    Best Overall Response
    Objective Response Rate
    Duration of response
    Time to Treatment Failure
    Overall Survival
    Quality of Life
    Tolerance profile
    Progression-Free Survival
    Critères de jugement secondaires :
    Meilleur taux de réponse
    Taux de réponse objective
    Durée de la réponse
    Délai d’échec du traitement
    Survie globale
    Qualité de vie
    Profil de tolérance
    Survie sans progression
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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) No
    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 concerned14
    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
    LPLV
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months48
    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 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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state96
    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 physician discretion
    A la discrétion du médecin
    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 Decision2020-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-27
    P. End of Trial
    P.End of Trial StatusOngoing
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