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    Summary
    EudraCT Number:2021-003447-25
    Sponsor's Protocol Code Number:CHUBX2021/08
    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:2021-10-05
    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 number2021-003447-25
    A.3Full title of the trial
    Strategic treatment Pause of first-line Immune Check point Inhibitor + VEGFR-Tyrosine Kinase Inhibitor in good or intermediate risk with only one adverse prognostic factor in metastatic renal cell carcinoma (mRCC) patients with an objective response: a randomised, non-inferiority phase III study
    Pause thérapeutique après un traitement associant un modulateur de la réponse immunitaire et un anti angiogénique en première ligne chez les patients présentant un cancer du rein métastatique de groupe pronostic favorable ou de groupe pronostic intermédiaire avec un seul critère de mauvais pronostic présentant une réponse objective: une étude randomisée de non-infériorité de phase III
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment pause versus treatment continuation in good or intermediate risk with only one adverse prognostic factor in mRCC patients that has achieved an objective response at 12 months of treatment with PD-1/ PD-L1 ICIs + VEGFR-Tyrosine Kinase Inhibitors (TKI)
    Pause du traitement versus poursuite du traitement chez les patients atteints d’un CRccm de pronostic favorable ou de pronostic intermédiaire ne présentant qu'un seul facteur de pronostic défavorable ayant obtenu une réponse objective à 12 mois de traitement par un ICI PD-1/ PD-L1 + un inhibiteurs de la tyrosine kinase-VEGFR
    A.3.2Name or abbreviated title of the trial where available
    SPICI
    SPICI
    A.4.1Sponsor's protocol code numberCHUBX2021/08
    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 SponsorCHU DE BORDEAUX
    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 supportsophie.tabuteau@chu-bordeaux.fr
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU DE BORDEAUX
    B.5.2Functional name of contact pointSophie TABUTEAU
    B.5.3 Address:
    B.5.3.1Street Address12 RUE DUBERNAT
    B.5.3.2Town/ cityTALENCE
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number33557821066
    B.5.5Fax number33556794926
    B.5.6E-mailsophie.tabuteau@chu-bordeaux.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 INLYTA
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameAXITINIB
    D.3.4Pharmaceutical form 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.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 KEYTRUDA
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namePENBROLIZUMAB
    D.3.4Pharmaceutical form Solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic renal cell carcinoma (mRCC) with a good or only one adverse prognostic factor intermediate risk per IMDC score
    Cancer du rein métastatique de risque favorable ou intermédiaire, ne présentant qu’un seul facteur de pronostic défavorable selon l'IMDC
    E.1.1.1Medical condition in easily understood language
    Metastatic renal cell carcinoma (mRCC) with a good or only one adverse prognostic factor intermediate risk per IMDC score
    Cancer du rein métastatique de risque favorable ou intermédiaire, ne présentant qu’un seul facteur de pronostic défavorable selon l'IMDC
    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
    To demonstrate the non-inferiority of treatment pause compared to treatment continuation with PD-1/ PD-L1 ICI +VEGFR-TKI in an IMDC good or intermediate risk with only one adverse prognostic factor in mRCC population that has achieved an objective response at 12 months of treatment with the combination regimens
    Démontrer la non-infériorité de l'interruption du traitement par rapport à la poursuite du traitement par ICI PD-1/ PD-L1 + inhibiteur de la tyrosine kinase -VEGFR dans une population de patient atteint d’un CRccm de risque favorable ou intermédiaire, avec un seul facteur pronostique défavorable selon l’IMDC et ayant obtenu une réponse objective à 12 mois de traitement avec ce schéma d'association
    E.2.2Secondary objectives of the trial
    To compare between treatment pause (experimental arm) and treatment continuation (control arm):
    • The overall safety and tolerability
    • The health-related quality of life
    • The anxiety and depression
    • The quality-adjusted survival,
    • 2-year overall survival and progression-free survival.

    To describe the following for patients in the experimental arm:
    • the modalities of progression (site, known lesions, or new lesions or both)
    • the therapeutic modalities at progression
    • the oncological outcomes when restarting PD-1/ PD-L1 ICI + VEGFR-TKI in the event of progression

    (In France only) To compare healthcare resource utilization and costs at 12 months between treatment pause (experimental arm) and treatment continuation (control arm). Costs will be estimated in the perspective of the French Healthcare System.
    Comparer entre la pause du traitement et la poursuite du traitement :
    • La tolérance du traitement,
    • La qualité de vie,
    • La survie sans progression,
    • La survie globale à 2 ans.

    Décrire les éléments suivants pour les patients du bras expérimental :
    • Les modalités de progression (site, lésions connues ou nouvelle(s) lésion(s) ou les deux),
    • Les modalités thérapeutiques à la progression,
    • Les résultats oncologiques lors de la reprise de l'ICI PD-1/ PD-L1 + VEGFR-TKI en cas de progression.
    (En France uniquement) Comparer l'utilisation des ressources de santé et leurs coûts à 12 mois entre la pause du traitement (bras expérimental) et la poursuite du traitement (bras témoin). Les coûts seront estimés dans la perspective du système de santé français.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 years at time of signing informed consent form
    • Signed informed consent form
    • Histological confirmation of RCC with a Clear-cell component, including subject who also have a sarcomatoïd feature
    • Advanced (not amenable to curative surgery or radiation therapy) or Metastatic RCC (American Joint Committee on Cancer [AJCC] Stage IV)
    • Participants with good or intermediate risk with only one adverse prognostic factor will be eligible as per International Metastatic RCC Database Consortium (IMDC) criteria
    • Prior first line therapy for mRCC with the combination of PD-1/ PD-L1 ICI plus VEGFR-TKI
    • First line treatment with the combination of PD-1/PD-L1 ICI and VEGFR-TKI must be ongoing whatever the dose with no period of discontinuation > 6 consecutive weeks in the last 12 months for the PD-1/PD-L1 ICI, and 2 consecutive weeks in the last 3 months before randomisation for the VEGFR-TKI
    • Patients with an objective response (complete response or partial response) after 12 months of the combination treatment with PD-1/PD-L1 ICI and VEGFR-TKI.
    CT scan at the initiation of this treatment must be available.
    • Karnofsky Performance Status (KPS) grade ≥ 70%
    • Measurable disease as per RECIST v1.1 per investigator
    • Adequate organ function
    • Females of childbearing potential must use a highly effective contraception (combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral ; intravaginal ;transdermal) ; progestogen-only hormonal contraception associated with inhibition of ovulation (oral ; injectable ; implantable ; intrauterine device (IUD) ; intrauterine hormone-releasing system ( IUS)) ; bilateral tubal occlusion ; vasectomised partner ; sexual abstinence) and continue its use for 5 months after the last PD1/PD L1 ICI administration.
    • Sexually active male patients must agree to use condoms and continue its use for 5 months after the last PD1/PD L1 ICI administration.
    • Willingness and ability to comply with study procedures.
    • Patient affiliated to a social security system or benefit from the same system
    • Âge ≥ 18 ans au moment de la signature du formulaire de consentement éclairé.
    •Formulaire de consentement éclairé signé
    • Confirmation histologique d'un CRccm avec une composante à cellules claires, y compris les sujets qui présentent également une caractéristique sarcomatoïde.
    • Cancer du rein avancé (ne pouvant pas faire l'objet d'une chirurgie curative ou d'une radiothérapie) ou métastatique (stade IV de l'American Joint Committee on Cancer [AJCC])
    • Patients de risque favorable ou intermédiaire avec un seul facteur de pronostic défavorable selon les critères de l'International Metastatic RCC Database Consortium (IMDC)
    • Traitement antérieur de première ligne du cancer du rein métastatique par l'association d'un ICI PD-1/ PD-L1 et d'un VEGFR-TKI.
    • Le traitement de première ligne par l'association d'un ICI PD-1/PD-L1 et d'un VEGFR-TKI doit être continu, quelle que soit la dose, sans période d'arrêt > 6 semaines consécutives au cours des 12 derniers mois pour l'ICI PD-1/PD-L1, et 2 semaines consécutives au cours des 3 derniers mois avant la randomisation pour le VEGFR-TKI.
    • Patients présentant une réponse objective (réponse complète ou réponse partielle) après 12 mois de traitement combiné avec un ICI PD-1/PD-L1 et un VEGFR-TKI.
    Le scanner de l’initiation de ce traitement doit être disponible.
    • Niveau de performance de Karnofsky (KPS) ≥ 70%.
    • Maladie mesurable selon RECIST v1.1 par l'investigateur
    • Patients capables de répondre aux exigences spécifiées par le protocole.
    • Fonctionnement adéquate des organes
    • Pour les patientes en capacité de procréer: utilisation d’une méthode de contraception hautement efficace (contraception hormonale oestroprogestative, contraception progestative entrainant l’inhibition de l’ovulation, dispositif intra-utérin, salpyngectomie bilatérale, partenaire vasectomisé, abstinence sexuelle) à poursuivre 5 mois après la dernière administration d’ICI.
    • Pour les hommes sexuellement actifs: utilisation de préservatif à poursuivre 5 mois après la dernière administration d’ICI
    E.4Principal exclusion criteria
    • Any active central nervous system (CNS) metastases.
    • Prior therapy with PD-1/PD-L1 ICI or VEGFR-TKI monotherapy.
    • Poorly controlled hypertension despite antihypertensive therapy
    • More than one adverse prognostic factor (IMDC criteria)
    • Women who are pregnant or lactating;
    • Current participation in an investigational program
    • Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
    • Toute métastase active du système nerveux central (SNC).
    • Traitement antérieur par un ICI PD-1/PD-L1 ou par VEGFR-TKI en monothérapie.
    • Hypertension mal contrôlée malgré un traitement antihypertenseur
    • Plus d'un facteur de mauvais pronostic (critères IMDC)
    • Les femmes enceintes ou allaitantes ;
    • Participation actuelle à une étude clinique
    • Patient présentant un état médical ou psychiatrique ou une maladie compromettant la compréhension de l’information ou la réalisation de l’étude
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants without progression at up to 12 months after randomisation, based on a blinded independent central review (BICR) according to RECIST v1.1 criteria
    Proportion de participants sans progression jusqu'à 12 mois après la randomisation, sur la base d'une relecture indépendante et centralisée en insu selon les critères RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    At up to 12 months after randomisation
    Jusqu'à 12 mois après la randomisation
    E.5.2Secondary end point(s)
    • Proportion of participants who experience an adverse event or serious adverse event, and mean number of adverse events or serious adverse events up to 12 months after randomisation.
    • Mean change in quality of life up to 12 months after randomisation, measured by the NCCN functional assessment of cancer therapy-kidney symptom index (FKSI-19)
    • Mean scores in the Hospital Anxiety and Depression Scale at up to 12 months after randomisation
    • Quality-adjusted time without symptoms of disease or toxicity (Q-TWiST)

    For patients in the experimental arm:
    • Site and distribution of the sites of progression: known lesions, new lesion(s) or both
    • Distribution of treatment modality after progression: surveillance, focal treatment or general treatment
    • If general treatment when restarting PD-1/PD-L1 ICI + VEGFR-TKI, percentage of patients with status SD or in objective response at 6 months

    In France only :
    • Healthcare resource utilisation up to 12 months after randomisation, measured by medication use and hospitalisations.
    • Costs of care will be estimated in the perspective of the French Healthcare System over a 12-month times horizon. Conventional tariffs of medication and hospitalizations will be used to calculate costs.
    • La proportion de participants ayant subi un événement indésirable ou un événement indésirable grave, et le nombre moyen d'événements indésirables ou d'événements indésirables graves durant les 12 mois après la randomisation.

    • Evolution moyenne de la qualité de vie jusqu'à 12 mois après la randomisation, mesurée par l'indice FKSI-19 (functional assessment of cancer therapy-kidney symptom index) du NCCN.

    • Les scores moyens sur l'échelle d'anxiété et de la dépression (Hospital Anxiety and Depression Scale) durant les 12 mois après la randomisation.

    • Le temps sans symptômes de la maladie ou toxicité pondéré par la qualité (quality-adjusted time without symptoms or toxicity, Q-TWiST)

    Pour les patients du bras expérimental :
    • Les sites et répartition des sites de progression : lésions connues, nouvelle(s) lésion(s) ou les deux.
    • La répartition des modalités de traitement après progression : surveillance, traitement focal ou traitement général.
    • Si le traitement général lors de la reprise est l'ICI PD-1/PD-L1 + VEGFR-TKI, le pourcentage de patients avec un statut SD ou en réponse objective à 6 mois.

    En France uniquement :
    • L’utilisation des ressources de santé jusqu'à 12 mois après la randomisation, mesurée par l’analyse des médicaments prescrits et des hospitalisations.
    • Les coûts des soins associés seront estimés dans la perspective du système de santé français sur un horizon de 12 mois.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 12 months after randomisation
    Durant les 12 mois après la randomisation
    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) 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 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 concerned27
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    End of the participation of the last person participating in the study
    also called last visit of the last participant included in the study
    Terme de la participation de la dernière personne qui se prête à la
    recherche aussi appelé dernière visite du dernier participant inclus
    dans la recherche (DVDP)
    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
    E.8.9.2In all countries concerned by the trial months48
    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: 111
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state186
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 372
    F.4.2.2In the whole clinical trial 372
    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)
    None
    Aucun
    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 Decision2021-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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