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    Summary
    EudraCT Number:2021-001065-21
    Sponsor's Protocol Code Number:ET21-023
    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:2021-04-15
    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 number2021-001065-21
    A.3Full title of the trial
    PAXIPEM - Multicenter phase II study of axitinib +/- pembrolizumab in first line treatment for patients with locally advanced or metastatic papillary renal cell carcinoma (PRCC)
    PAXIPEM - Etude de phase II, multicentrique évaluant l’axitinib +/- le pembrolizumab en première ligne de traitement chez des patients ayant un carcinome rénal papillaire localement avancé ou métastatique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study of axitinib +/- pembrolizumab in first line treatment for patients with locally advanced or metastatic papillary renal cell carcinoma (PRCC)
    Etude évaluant l'axitinib avec ou sans le pembrolizumab en première ligne de traitement chez des patients atteints d'un carcinome rénal papillaire avancé ou métastatique
    A.4.1Sponsor's protocol code numberET21-023
    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 LEON BERARD
    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 supportPfizer
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCENTRE LEON BERARD
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address28 rue Laennec
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69373 Cadex 08
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)4 78 78 27 52
    B.5.5Fax number+33(0)478 78 27 15
    B.5.6E-mailellen.blanc@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 Inlyta (axitinib)
    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.3.1Product nameAXITINIB
    D.3.2Product code AG-013736
    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 INNAXITINIB
    D.3.9.1CAS number 319460-85-0
    D.3.9.2Current sponsor codeAG-013736
    D.3.9.4EV Substance CodeSUB25427
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 7
    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 (Pembrolizumab, MK-3475)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    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 namePembrolizumab
    D.3.2Product code MK-3475
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number to 25
    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) 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) 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.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
    Locally advanced or metastatic papillary cell carcinoma (PRCC)
    Carcinomes rénaux papillaires (PRCC) métastatics ou localement avancés
    E.1.1.1Medical condition in easily understood language
    Renal Cancer
    Cancer du rein
    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 10050513
    E.1.2Term Metastatic renal cell carcinoma
    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
    Evaluate the efficacy of axitinib + pembrolizumab versus axitinib in metastatic patients with type 2 papillary renal carcinoma in first-line treatment.
    Evaluer l’efficacité de l’axitinib + pembrolizumab versus axitinib seul chez les patients ayant un carcinome rénal papillaire de type 2 localement avancé ou métastatique en première ligne de traitement
    E.2.2Secondary objectives of the trial
    To evaluate in each arm:
    - The duration of response (DOR),
    - The best overall response (BOR) using RECIST 1.1 ,
    - The progression-free survival (PFS),
    - The overall survival (OS),
    - The safety according to NCI CTC-AE v5.
    Evaluer dans chaque bras :
    - La durée de réponse (DOR)
    - La meilleure réponse globale (BOR) selon les critères RECIST 1.1 (et la meilleure réponse globale immunitaire selon les critères immunologique RECIST 1.1 (iRECIST 1.1))
    - La survie sans progression (PFS), mesurée à partir de la date d’inclusion jusqu’à la date de progression documentée ou de décès quelle qu’en soit la cause,
    - La survie globale (OS), mesurée à partir de la date d’inclusion jusqu’à la date de décès quelle qu’en soit la cause
    - La tolérance (NTI-CTCAE v5.0)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Circulating cytokines which have immunosuppressive properties and known to be correlated with tumor progression will be measured at baseline and at 3 months (notably VEGF, IL6, IL10).
    Parafin embeded tumor will be analysed for the expression of different profiles: i.e. PD-L1 on Immune infiltrating cells, level of CD8 T cell and Treg infiltration as well as T effector gene and interferon signature.
    Les cytokines circulantes, qui ont des propriétés immunosuppressives et sont corrélées à la progression tumorale, seront mesurées à l’inclusion et à 3 mois (notamment VEGF, IL6, IL10).
    Les tissus tumoraux inclus en paraffine seront analysés pour l’expression de différents profils : PD-L1 sur les cellules immunitaires infiltrantes, le taux d’infiltration des lymphocytes T CD8 et des lymphocytes T régulateurs ainsi que la signature du gène T-effecteur et interféron
    E.3Principal inclusion criteria
    I1. Age ≥ 18 years on the day of signing informed consent.
    I2. Metastatic or locally advanced (inoperable) type 2 or mixed PRCC, histologically confirmed by central review: FFPE blocks (or all HES and IHC slides) with the initial histology report must be sent for central reading before confirmation of inclusion in the study.
    I3. No prior systemic treatment for renal cancer (chemotherapy, immunotherapy, anti-angiogenic drugs, or treatment under evaluation) even in adjuvant setting.
    I4. At least one measurable site of disease according to RECIST v1.1.
    I5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1 evaluated within 7 days prior to the date of inclusion.
    I6. In case of prior radiation therapy, discontinuation of irradiation for at least 3 weeks before first dose of study treatment, with at least 1 site kept/preserved for evaluation. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks - limited field (<10% of the whole body)) to non-CNS disease.
    I7. Adequate bone-marrow, hepatic, and renal functions within 14 days prior to the inclusion, with:
    - Hemoglobin  9.0 g/dl ou ≥ 5.6 mmol/l, neutrophils  1 000/mm3 (1.0 G/l), Platelets  100 000/mm3 (100 G/l),
    - Serum creatinine  2 x ULN OR creatinine clearance  50 ml/min/1.73m2 (calculated using either MDRD or CKD-EPI formula),
    - AST and ALT  2.5 x ULN (or  5 x ULN in case of liver metastasis),
    - Total serum bilirubin  1.5 x ULN (or direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 × ULN),
    I8. Absence of significant proteinuria (<0.5 g/24h) confirmed by urinary dipstick test. If the dipstick test is ≥ 2+, proteinuria will be quantitated on a complete 24h urine sample (< 1 g/l of protein/24h sample)
    I9. Covered by a medical/health insurance.
    I10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
    I11. Patients of childbearing potential accepting to use effective contraception or abstain from heterosexual activity during study treatment and within 4 months after final dose of study therapy or being surgically sterile. Refer to Appendix 1 for approved methods of contraception.
    I12. Signed and dated approved informed consent form before any study specific procedures or assessments.
    I1. Age ≥18 ans lors de la signature du consentement.
    I2. Carcinome rénal papillaire de type 2 métastatique ou localement avancé (inopérable), confirmé histologiquement par relecture centralisée : bloc FFPE (ou toutes les lames histologiques HES ou ICH) et compte-rendu histologique initial doivent être envoyés pour relecture centralisée avant confirmation de l’inclusion.
    I3. Absence de traitement systémique antérieur du cancer du rein (chimiothérapie, immunothérapie, traitements anti-angiogéniques, ou agents en cours d’investigation), ainsi qu’en traitement adjuvant.
    I4. Au moins une lésion mesurable selon les critères RECIST v1.1.
    I5. Performance status ECOG ≤ 1 évalué dans les 7 jours précédents la date d’inclusion.
    I6. Dans le cas d’une radiothérapie antérieure, arrêt de l’irradiation au moins 3 semaines avant la première dose du traitement expérimental. Ce délai peut être réduit à 1 semaine en cas d’irradiation dans un champ limité (< 10% du corps), sans effets secondaires attendus de grade ≥2, et en conservant au moins 1 lésion pour l’évaluation).
    I7. Paramètres biologiques (fonctions hépatiques, rénales et médullaires) adéquats dans les 14 jours précédant la date d’inclusion, selon les critères suivant :
    - Hémoglobine ≥ 9.0g/dl ou 5.6 mmol/l, polynucléaires neutrophiles (PNN) ≥ 1000/mm3 (1.0 G/l), Plaquettes > 100 000/mm3 (100 G/l)
    - La créatinine sérique ≤ 2 x ULN OU une clairance de la créatinine  50 ml/min (calculé à partir de la formule de MDRD et la formule de CKD-EPI)
    - AST et ALT ≤ 2.5 x ULN (ou ≤ 5 x ULN dans le cas de métastases hépatiques)
    - Bilirubine sérique totale ≤ 1.5 x ULN (ou la bilirubine conjuguée ≤ LSN pour les participants ayant un taux de bilirubine totale > 1.5 x LSN),
    I8. Absence significative de protéinurie (<0.5 g/24h) confirmé par un test urinaire par bandelettes. Si le test par bandelette ≥ 2+, la protéinurie devra être quantifié à partir d’un échantillon urinaire complet 24h (< 1 g/l de protéine/24h)
    I9. Patient affilié ou bénéficiaire d’un régime de sécurité sociale.
    I10. Volonté et capacité de se conformer au calendrier des visites, schéma de traitements, les tests de laboratoires ainsi que toute procédure liées à l’étude.
    I11. Les femmes en âge de procréer doivent accepter d’utiliser une contraception efficace durant le traitement de l’étude et jusqu’à 4 mois après la dernière administration. (l’abstention d’activités hétérosexuelles).
    I12. Consentement éclairé signé avant toutes procédures spécifiques liées à l’étude.
    E.4Principal exclusion criteria
    NI1. Presence of brain metastases on Magnetic Resonance Imaging (MRI) or Computed Tomography-scan (CT-scan) performed within 28 days prior to inclusion. Patients with a history of brain metastases treated by surgery or stereotactic surgery, with normal brain MRI or CT-scan are allowed to participate.
    NI2. Metastases with high risk of nervous compression or bone lesion with high risk of fracture.
    NI3. Prior history of other malignancies other than PRCC (except for curatively treated basal cell or squamous cell carcinoma of the skin or in situ uterine cervix carcinoma) unless the subjects has been free of the disease for at least 5 years.
    NI4. Major surgical procedure, open biopsy, or serious none healing wound within 28 days prior to inclusion.
    NI5. Significant cardiovascular disease, including:
    - Disorder of left ventricular function with a left ventricular ejection fraction (LVEF) < 50%,
    - Uncontrolled arterial hypertension under adapted medication: systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg or both despite appropriate therapy, blood pressure must be monitored and controlled before inclusion, or patients under 3 antihypertensive therapies at screening,
    - Myocardial infarction, severe angina, or unstable angina within 6 months prior to inclusion,
    - History of serious ventricular arrhythmia (ie ventricular tachycardia or ventricular fibrillation),
    - Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication),
    - Coronary or peripheral artery bypass graft or active coronary stent within 6 months prior to inclusion,
    - Veinous thrombosis or pulmonary embolism within 6 months prior to inclusion.
    NI6. Any anti-coagulation therapy except prophylactic low dose.
    NI7. History of auto-immune disease except thyroiditis more than 6 months ago.
    NI8. History of any allograft.
    NI9. HIV, HBV, HCV active infections.
    NI10. Any active acute or chronic or uncontrolled infection/disorder that would impair the ability to evaluate the patient or the ability for the patient to complete the study.
    NI11. Known history of active TB (Bacillus Tuberculosis).
    NI12. Interstitial lung disease, respiratory insuffisancy whatever the cause.
    NI13. Prior (non-infectious) pneumonitis requiring systemic corticosteroid therapy or current pneumonitis.
    NI14. Inability to swallow oral medications, or presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea.
    NI15. History of severe hypersensitivity to another monoclonal antibody.
    NI16. Known hypersensitivity to the active substances or to any of the excipients.
    NI17. Receiving or having received immunosuppressive therapy or corticosteroids within 1 month prior to inclusion (except for hydrocortisone for substitution purposes).
    NI18. Live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. COVID-19 vaccine is allowed if non-living/inactivated.
    NI19. Psychological, familial, sociological, or geographical conditions that would limit compliance with study protocol requirements or known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
    NI20. Inclusion in another clinical trial, except for supportive care trials.
    NI21. Pregnant or breastfeeding woman or patient expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 4 months after the last dose of study treatment (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential).
    NI22. Under or requiring tutorship or curatorship.
    NI1. Présence de métastases cérébrales sur Imagerie par Résonance Magnétique (IRM) ou par CT-Scan effectués dans les 28 jours avant l’inclusion. Les patients ayant déjà eu des métastases cérébrales et qui ont été traités par chirurgie ou par stéréotaxie et sont autorisés à participer si l’IRM/ CT-scan cérébral est normal.
    NI2. Les métastases à haut risque de compression nerveuse ou des lésions osseuses à haut risque de fracture.
    NI3. Antécédents de tumeurs malignes autres que le carcinome rénal papillaire (hormis les carcinomes squameux et basocellulaire de la peau ou des carcinomes in situ du col utérin, traités de manière curative) ou sans résidus tumoral les 5 dernières années.
    NI4. Patient ayant eu une chirurgie majeure, une biopsie ouverte, ou une lésion importante non cicatrisante dans les 28 jours précédant l’inclusion.
    NI5. Maladies cardiovasculaires cliniquement significative telles que
    - Les anomalies de fonction du ventricule gauche avec une fraction d’éjection du ventricule gauche (LVEF) < 50 %,
    - Hypertension artérielle non contrôlée, définir par ression artérielle systolique ≥ 150mmHgdiastolique ≥ 90 mmHg ou les deux malgré un traitement approprié/optimal. La pression artérielle doit être suivis et contrôlé avant l’inclusion, ou le patient doit être sous 3 traitements hypertensifs au screening,
    - Infarctus du myocarde, angor sévère ou instable dans les 6 mois précédents l’inclusion,
    - Antécédent d’arythmie ventriculaire sévère (grade ≥2) (ie tachycardie ventriculaire ou fibrillation ventriculaire)
    - Les arythmies cardiaques nécessitant un traitement anti-arythmique (hormis les fibrillations auriculaires qui sont bien contrôlées sous traitement anti-arythmique) ,
    - Pontage aortocoronarien ou périphérique ou stent coronarien actif dans les 6 mois précédent l’inclusion,
    Thrombose veineuse ou embolie pulmonaire dans les 6 mois précédents l’inclusion
    NI6. Traitement anticoagulant hormis les prophylactique à faible dose
    NI7. Antécédent de maladies auto-immunes hormis la thyroïdite antérieure à 6 mois
    NI8. Antécédent d’allogreffe
    NI9. Infections actives par le virus de l’hépatite B (HBV), le virus à hépatite C (HCV), et virus VIH
    NI10. Toutes anomalies ou infections actives aigues ou chroniques, pouvant altérer la capacité d’évaluation du patient ou la capacité à suivre l’étude.
    NI11. Tuberculose active connue (Bacillus tuberculosis)
    NI12. Maladies pulmonaires interstitiels ou insuffisance respiratoire quel que soit la cause.
    NI13. Antécédent (non-infectieux) de pneumonie nécessitant un traitement systémique de corticoïde ou une pneumonie en cours
    NI14. Incapacité à avaler des traitements oraux, ou présence d’une maladie inflammatoire de l’intestin avec une obstruction intestinale complète ou partiel ou une diarrhée chronique.
    NI15. Antécédent d’hypersensibilité sévère à d’autres anticorps monoclonaux.
    NI16. Hypersensibilité connues envers les substances actives ou excipients.
    NI17. Recevant ou ayant reçu un traitement immunosuppressive ou des corticoïdes dans les 1 moins précédent l’inclusion (hormis l’hydrocortisone pour une substitution).
    NI18. Vaccins vivants atténués dans les 30 jours précédant la première dose du traitement expérimental.
    NI19. Conditions psychologiques, familiales, sociologiques ou géographiques pouvant limiter l’observance aux procédures de l'étude.
    NI20. Participation à d’autre essai clinique, hormis les essais cliniques portant sur le soutient de soins.
    NI21. Femme enceinte, allaitante ou patiente souhaitant concevoir un enfant durant sa participation à cette étude, à partir de la visite de screening jusqu’à 4 mois après la dernière dose reçu des traitements de l’étude (obligation d’avoir test de grossesse sérique ou urinaire négatif à l’entrée de l’étude pour chez toutes les femmes en âge de procréer).
    NI22. Patient sous tutelle ou curatelle.
    E.5 End points
    E.5.1Primary end point(s)
    objective response rate (ORR )
    Taux de réponse objective
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.5.2Secondary end point(s)
    To evaluate in each arm:
    - The duration of response (DOR)
    - The best overall response (BOR),
    - The progression-free survival (PFS),
    - The overall survival (OS),
    - The safety according to NCI CTC-AE v5.
    Evaluer dans chaque bras :
    - La durée de réponse (DOR)
    - La meilleure réponse globale (BOR) selon les critères RECIST 1.1
    - La survie sans progression (PFS)
    - La survie globale (OS)
    - La tolérance (NTI-CTCAE v5.0)


    E.5.2.1Timepoint(s) of evaluation of this end point
    • DOR, calculated from the date of first documented response (CR or PR) to the date of first documented progression or death. It applies only to patients whose BOR is either SR or PR.
    • BOR, defined as the best response according to RECIST v1.1 recorded from the baseline until the end of the study (treatment).
    • PFS, defined as the time from the date of first treatment administration to the date of documented progression or death from any cause.
    • OS, defined as the time from the date of first treatment administration to the date of death from any cause.
    • Safety profile, determined using the National Cancer Institute – Common Terminology Criteria for Adverse Event (NCI-CTC AE) grading scale version 5.0. Adverse events will be described by their intensity and severity.
    - La durée de réponse (DOR) est calculée à partir de la date de la première réponse documentée à l'inclusion jusqu'à la date de progression documentée ou de décès
    - La meilleure réponse globale est calculée à partir de l'inclusion jusqu'à la fin de l'étude (fin de traitement)
    - La survie sans progression (PFS) est calculée à partir de la date de première administration de traitement (à l'inclusion) jusqu'à la date de progression documentée ou de décès quelle qu'en soit la cause.
    - La survie globale (OS) est mesurée à partir de la date d'inclusion jusqu'à la date de décès quelle qu'en soit la cause
    - La tolérance aux traitements à partir de leur première administration jusqu'à la fin de l'étude
    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 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 Yes
    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.8.3 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 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
    LVLP
    Dernière visite du dernier patient (LVLP)
    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 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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state72
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 72
    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)
    Treatment will be maintained until confirmed or unequivocal progression or unacceptable adverse event(s)
    or intercurrent illness
    that prevents further administration of treatment or patient’s willingness to stop the treatment
    or decision to withdraw from the study (withdrawal of consent) or pregnancy or general or
    specific changes in the patient's condition that render the patient unacceptable for further treatment
    in the judgment of the investigator
    Le(s) traitement(s) sera(ont) poursuivi(s) en l’absence de progression documentée
    ou d’événement indésirable inacceptable ou de maladie intercurrente empêchant la poursuite du traitement ou
    de volonté du patient d'arrêter le traitement ou de décision de se retirer de l'étude (retrait du consentement)
    ou de grossesse ou de changements généraux ou spécifiques de l'état du patient le rendant inapte à la poursuite
    du traitement selon le jugement de l’investigateur
    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 Decision2021-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-06
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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