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    Summary
    EudraCT Number:2019-003003-35
    Sponsor's Protocol Code Number:2019_41
    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:2020-03-03
    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 number2019-003003-35
    A.3Full title of the trial
    THE IMMUNOTHERAPY PLEURAL 5-ALA PDT “IMPALA” trial: Intrapleural Photodynamic Therapy by Video-Assisted Thoracoscopy followed by Anti-PD-1 NIVOLUMAB in Patients with Malignant Pleural Mesothelioma- a pilot study
    Arial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IMPALA
    IMPALA
    A.4.1Sponsor's protocol code number2019_41
    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 LILLE
    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 supportBristol-Myers Squibb
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Lille
    B.5.2Functional name of contact pointLANGLOIS Audrey
    B.5.3 Address:
    B.5.3.1Street Address6 rue du Professeur Laguesse
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number+330320444145
    B.5.5Fax number+330320445711
    B.5.6E-mailaudrey.langlois@chru-lille.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 Nivolumab solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    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 nameNivolumab
    D.3.2Product code BMS936558
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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.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
    Pilot study of the feasibility of an innovative multimodal treatment combining intrapleural photodynamic therapy with videothoracoscopy followed by adjuvant immunotherapy with anti-PD-1 Nivolumab antibodies in patients with malignant pleural mesothelioma
    Etude pilote de faisabilité d’un traitement innovant combinat la thérapie photodynamique intrapleurale et une immunothérapie adjuvante par Nivolumab chez des patients porteurs d’un mésothéliome pleural malin
    E.1.1.1Medical condition in easily understood language
    Malignant Pleural Mesothelioma
    Mésothéliome Pleural Malin
    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 main objective of this study is to demonstrate the feasibility of the innovative therapeutic strategy combining intrapleural PDT by VATS then immunotherapy by Nivolumab in MPM patients without inacceptable and unexpected toxicity.
    Démontrer la faisabilité de cette stratégie thérapeutique innovante combinant la PDT et l’immunothérapie par Nivolumab chez les patients porteurs d’un MPM sans survenue d’une toxicité inacceptable ou inattendue.
    E.2.2Secondary objectives of the trial
    (a) to describe patients outcome
    (b) to assess the impact of experimental treatment on quality of life and chest pain
    (a) décrire l’état clinique des patients au cours de l’étude
    (b) mesurer l’impact du traitement multimodal sur la qualité de vie et la douleur des patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients (male or female) ≥18 years old (n=20)
    ECOG Performance status (PS) 0-1 (WHO)
    Unresectable Malignant Pleural Mesothelioma
    Suffering from unresectable MPM (n=20), relapsing after one or 2 lines of treatment with platinum-based doublet of chemotherapy (including pemetrexed) [Note: MPM patients having contra-indications for, or refusing chemotherapy may also be recruited], and candidate for palliative pleural procedure (i.e. thoracoscopy for pleurodesis by talc or by insertion of indwelled pleural catheter, IPC)
    Documented progression after previous 1 or 2 lines of chemotherapy including Platinum/Pemetrexed chemotherapy*
    Measurable disease according to modified RECIST 1.1. for MPM (Nowak and Armato, J Thorac Oncol 2018)
    Malignant pleural lesion assessed to be accessible by local PDT treatment during thoracoscopy, as validated by expert MTB (“MESOCLIN”, Lille, France)
    Histological diagnosis confirmed by national expert pathology panel (“MESOPATH” - Institut Léon Bérard, Lyon, France)
    Weight loss <10%
    Available tumor tissue (archival or fresh)
    No contraindications to 5-ALA, PDT or Nivolumab
    Obtention of an informed written consent before any specific procedure of the study
    Decision to treat the patient within this clinical trial taken during MPM dedicated multidisciplinary board (RCP MESOCLIN in France )
    Women of child-bearing potential must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 5 months after the final dose of investigational product
    Women of child-bearing potential must have a negative pregnancy test within 24h before administration of investigational product
    *First line patients may also be recruited if they declined or if they have contra-indications for chemotherapy.
    Homme ou Femme ≥18 ans
    ECOG 0-1
    MPM non-résécable
    Souffrant d’un MPM non-résécable rechutant après une ou 2 lignes de traitements par chimiothérapie (y compris chimiothérapie par cisplatine +/- pemetrexed)
    Rechute documentée après 1 ou 2 lignes de traitement y compris la chimiothérapie
    Lésion MPM accessible pour la PDT pendant la thoracoscopie
    Diagnostic histologique confirmé par MESOCLIN (panel d’expert national)
    Perte de poids < 10%
    Pas de contre-indications connues au 5-ALA, Nivolumab et PDT
    Femme en âge de procréer doivent utiliser une méthode de contraception effective 28 jours avant toute administration prévue par l’essai et doivent accepter de continuer à prendre cette contraception 5 mois après le traitement
    Test de grossesse négatif pour les femmes en âge de procréer
    E.4Principal exclusion criteria
    Pregnant, breastfeeding patients, and female patients of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for the duration of the study and for at least 5 months after the last dose of nivolumab
    Male patients who are unwilling or unable to use contraception methods for the duration of the study and for at least 7 months after the last dose of nivolumab
    A previous treatment by anti-PD-1 or anti-PD-L1 antibodies for their cancer or any other cancer in the last 5 years
    Usual contra-indications for anti-PD-1 antibodies (Nivolumab) or PDT
    Contra-indications for thoracoscopy (VATS)
    Any other comorbidity precluding the feasibility of the therapeutic protocol: uncontrolled cardiac failure, pulmonary hypertension, liver or kidney severe dysfunction (creatinin clairance <60 ml/min), uncontroled infection, or other disease according to the investigator
    Other cancer treated within 5 years before inclusion except baso-cellular skin carcinoma or cervical / bladder in situ carcinoma
    Inability to receive study information and to give informed consent
    Patient unable to have a clinical follow-up due to psychological, familial, social or geographical reasons
    Legal incapacity (people in jail), or under supervision (i.e. guardianship or curatorship)
    Treatment with experimental drug within 30 days before the start of the study
    Femme enceinte, allaitante ou femme en âge de procréer refusant ou incapable de prendre une contraception effective ; durant l’étude et ce 5 mois après la dernière dose de Nivolumab
    Homme refusant ou incapable de prendre une contraception effective durant le traitement de l’étude et ce 7 mois après la dernière dose de Nivolumab
    Patient ayant déjà reçu un traitement par un anti-PD-1 ou anticorps anti-PD-1 pour leur MPM ou autre cancer dans les 5 dernières années avant l’inclusion
    Contre-indications usuelles au Nivolumab ou à la PDT
    Autre cancer traité dans les 5 ans avant l’inclusion à l’exception des carcinomes baso-cellulaire de la peau et carcinomes in situ cervicaux et de la vessie
    Traitement expérimental dans les 30 jours avant le début de l’étude.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients having the full multimodal treatment (target: 70% minimum of total patients, i.e. 14 out of 20 patients) without inacceptable and unexpected toxicity (grade≥3) according National Cancer Institute (NCI) criteria, reviewed by an Independent Survey Committee.
    Proportion de patients ayant reçus le traitement multimodal en entier (cible : 70% des patients inclus c’est-à-dire 14 sur les 20 prévus) sans survenue de toxicité inacceptable ou inattendue (grade ≥3) selon les critères définis par l’Institut National du cancer et revu par le CSI
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the treatment for each patient
    A lin fin du traitement de chaque patient
    E.5.2Secondary end point(s)
    (a)objective response rate (ORR), progression free survival (PFS), and overall survival (OS);
    (b)score Meso LCSS-30, and EVA scale
    (a)réponse au traitement ; survie globale et survie sans rechute
    (b)Score Meso LCSS-30 et échelle EVA
    E.5.2.1Timepoint(s) of evaluation of this end point
    (a) at the end of the study (LVLS)
    (b) throughout the study (screening, treatment, end of treatment)
    (a) en fin d'étude
    (b) au cours de l'étude (screening, en cours et en fin de traitement)
    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 No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    etude pilote de faisabilité, un bras de traitement et monocentrique
    pilot, feasibility, one-arm, monocentric study
    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 trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months47
    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: 20
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state20
    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
    Les patients continueront d'être suivi selon la procédure standard
    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 Decision2020-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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