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    Summary
    EudraCT Number:2020-002932-64
    Sponsor's Protocol Code Number:APHP200133
    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:2021-03-25
    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 number2020-002932-64
    A.3Full title of the trial
    Prospective randomIzed clinical trial assessing the tolerance and clinical benefit of feCAl tranSplantation in patientS with melanOma treated with CTLA-4 and PD1 inhibitors
    Essai Prospectif randomIsé évaluant la tolérance et le bénéfice clinique de la transplantation féCAle chez les patientS atteintS de mélanOmes traités par inhibiteurs de CTLA-4 et de PD1’’
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research evaluating the safety and efficacy of treatment of melanoma by fecal microbiota transplantation administered in addition to standard antibody therapy
    Recherche évaluant la sécurité et l’efficacité du traitement du mélanome par une transplantation de microbiote fécal administrée en plus du traitement habituel par anticorps
    A.3.2Name or abbreviated title of the trial where available
    PICASSO
    PICASSO
    A.4.1Sponsor's protocol code numberAPHP200133
    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 SponsorAssistance Publique - Hôpitaux de Paris (AP-HP)
    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 supportMaat Pharma
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportFrench Ministry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.5.2Functional name of contact pointDRCI - Hôpital Saint Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33144841751
    B.5.5Fax number33144841701
    B.5.6E-mailfranceguyot@aphp.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 No
    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 nameMaaT013
    D.3.2Product code 7P010
    D.3.4Pharmaceutical form Rectal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMaaT013 - 7P010
    D.3.9.2Current sponsor codeMaaT013 - 7P010
    D.3.9.3Other descriptive nameALLOGENEIC FAECAL MICROBIOTA, POOLED
    D.3.9.4EV Substance CodeSUB193130
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeAllogenic Fecal Microbiota Transfer product for enema administration
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboRectal suspension
    D.8.4Route of administration of the placeboRectal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    melonoma
    mélanome
    E.1.1.1Medical condition in easily understood language
    cutaneus cancer
    cancer cutané
    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 LLT
    E.1.2Classification code 10053571
    E.1.2Term Melanoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether the safety of a 23-week treatment with MaaT013, combined with ipilimumab+nivolumab, is different from that of ipilimumab+nivolumab+placebo in patients with melanoma naïve to Ipilimumab and anti-PD1
    Evaluer la sécurité d’un traitement de 23 semaines avec le MaaT013 associé à ipilimumab+nivolumab, comparé à une association combinant ipilimumab+nivolumab+placebo chez les patients avec un mélanome, naïfs de traitement par ipilimumab et par anti-PD1.
    E.2.2Secondary objectives of the trial
    - To assess whether a 23-week treatment with MaaT013, combined with Ipilimumab and Nivolumab, is more efficient than Ipilimumab and Nivolumab + placebo
    - To assess changes in the tumor microenvironment in patients who have received MaaT013 and placebo ;
    - Changes in plasma levels of proteins or metabolites that play a role in immune activity against cancer and/or are associated with gut microbiome composition, pre and post MaaT013 or placebo
    -To assess peripheral blood T cell subpopulations that have been identified as associated with gut microbiome composition or response to anti CTLA-4 and anti PD1 in previous human studies;
    - To assess the evolution of gut microbial members and metabolites;
    - To assess, on an open basis, the efficacy and safety of MaaT013 combined with Nivolumab in a subset of patients who failed to respond to placebo+Ipilimumab and Nivolumab in the randomized part of the trial.
    - Evaluer l’efficacité d’un traitement de 23 semaines avec le MaaT013 en association avec ipi+nivo, comparée à une association combinant ipi+nivo+placebo
    - Évaluer le changement dans le microenvironnement tumoral chez les patients ayant reçu MaaT013 et un placebo
    - Modifications des taux plasmatiques de protéines ou de métabolites qui jouent un rôle dans l'activité immunitaire contre le cancer et / ou sont associées à la composition du microbiome intestinal, avant et après l’administration du MaaT013 ou placebo
    - Évaluer les sous-populations de cellules T du sang périphérique qui ont été identifiées comme associées à la composition du microbiome intestinal ou à la réponse aux anti CTLA-4 et anti PD1 dans des études antérieures;
    - Evaluer l'évolution de la composition du macrobiote en agents microbiens intestinaux et des métabolites;
    - Évaluer, en ouvert, l'efficacité et la sécurité de MaaT013 associé à Nivo chez les patients n'ayant pas répondu au placebo + Ipi et Nivo .
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged 18 to 80
    - Patients with unresectable or metastatic melanoma
    - Patients with ECOG performance of 0-2
    - Patients able to provide written informed consent and understand the risks associated with MaaT013
    - Have measurable disease as per RECIST version 1.1, on a tumor evaluation (either CT scan, physical evaluation or ultrasonography) performed less than 2 weeks before screening visit
    - Requiring a treatment with Ipilimumab and PD1 inhibitor (Nivolumab) and having no contraindication to these drugs nor to their excipients
    - Patients unexposed to ipilimumab and anti PD1 or anti PDL1 except if they have received it in the adjuvant setting (if the last dose of Ipilimumab® or anti PD1 or anti PDL1 was received at least 6 months before randomization).
    - Negative pregnancy test (serum)
    - Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab, ipilimumab and 6 months after the last dose of study treatment (ie, 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo approximately five half-lives)
    - Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab, ipilimumab and 7 months after the last dose of study treatment {i.e., 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo approximately five half-lives.}
    - Hemoglobin ≥9 g/dL
    - Platelets ≥ 100000mm3
    - Neutrophils ≥ 1500/mm3
    - Creatinine Clearance ≥ 50mL/mn
    - AST ≤ 3N
    - ALT ≤ 3N
    - Total bilirubin ≤ 1.5N (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
    - Alkaline phosphatase ≤ 3N
    - INR < 1.5
    - Prothrombin ≥ 70%
    - TCA < 1.2
    - No Hepatocellular insufficiency
    - Patients âgés de 18 à 80 ans.
    - Patients avec mélanome non résécable ou métastatique.
    - Patients avec un score de 0-2 sur l’échelle de performance ECOG
    - Patients en mesure de donner leur consentement éclairé par écrit et de comprendre les risques associés au MaaT013
    - Patients avec maladie mesurable selon les critères RECIST version 1.1 sur une évaluation de la tumeur (par scanner, évaluation clinique ou échographie) datant de moins de 2 semaines avant la visite de screening
    - Patients avec une indication de traitement par ipilimumab et anti-PD1 (nivolumab), et sans contre-indication à l’un ou l’autre des deux médicaments
    - Patients non exposés au traitement par ipilimumab et anti-PD1 ou anti-PDL1, sauf s’ils l’ont reçu dans le cadre d’un traitement adjuvant (et dans ce cas, si la dernière dose d’ipilimumab et d’anti-PD1 ou d’anti-PDL1 a été reçu au moins 6 mois avant la randomisation).
    - Résultat négatif d’un test sérologique de grossesse.
    - Les femmes en âge de procréer doivent accepter de suivre les instructions pour une(des) méthode(s) de contraception appropriée pendant la durée du traitement de l’étude (nivolumab, ipilimumab) et pendant 6 mois après la dernière dose (c à d, 30 jours (durée du cycle ovulatoire) plus le temps requis pour que le médicament de l’étude subisse environ cinq demi-vies
    - Les hommes qui sont sexuellement actifs avec des femmes en âge de procréer doivent accepter de suivre les instructions pour une méthode de contraception efficace, pendant la durée du traitement de l’étude (nivolumab, ipilimumab) et pendant 7 mois aprés la dernière dose { C.à.d 90 jours de spermatogénèse plus le temps requis pour que le médicament de l’étude subisse environ cinq demi-vies}
    - Hémoglobine ≥ 9 g/dL
    - Plaquettes ≥ 100 000 mm3
    - Neutrophiles ≥ 1500/mm3
    - Clairance de la creatinine ≥ 50mL/min
    - AST ≤ 3N
    - ALT ≤ 3N
    - Bilirubine totale ≤ 1.5N (sauf pour les sujets atteints de syndrome de Gilbert, qui peuvent avoir une bilirubine totale < 3.0 mg/dL)
    - Phosphatases alcalines ≤ 3N
    - INR < 1.5
    - Prothrombine ≥ 70%
    - TCA < 1.2
    - Pas d’insuffisance hépatocélullaire
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding women
    - Antibiotics in the last two weeks prior to the FMT
    - Inability to retain enemas
    - Expected to require any other form of systemic or localized anti-neoplastic therapy while on study
    - Active infection requiring systemic therapy.
    - Active, known or suspected autoimmune disease.
    - No health insurance,
    - Patients already included in a clinical research other than an observational study (e.g: registry, cohort).
    - Patient on AME (state medical aid) (unless exemption from affiliation)
    - Patients guardianship/legal protection/curatorship
    - Contraindication to fecal transplantation
    - Known hypersensitivity to Normacol or Moviprep® or equivalent patent medicines enema or one of their components.
    - Fluid-electrolyte disorders with sodium retention (heart failure, hyperaldosteronism, drug-induced edema)
    - Recent acute coronary syndrome or unstable ischemic heart disease
    - Congestive heart failure ≥ Class III or IV as defined by New York Heart Association
    - Hypersensitivity to the active substances or to any of the excipients: Aspartame (E951), Acesulfame, potassium (E950), lemon flavor (maltodextrin, citral, lemon essential oil, lime essential oil, xanthan gum, vitamin E)
    - Gastrointestinal obstruction or perforation
    - Gastric emptying disorders (gastroparesis),
    - Ileus,
    - Phenylketonuria (due to the presence of aspartame),
    - Deficiency in glucose-6-phosphate dehydrogenase (due to the presence of ascorbate),
    - Toxic megacolon, in severe forms of inflammation of the intestinal tract, including Crohn's disease and ulcerative colitis.
    - Femmes enceintes ou allaitantes
    - Traitement par antibiotiques dans les 2 semaines précédant la FMT
    - Incapacité à retenir un lavement intestinal
    - Patients chez qui toute autre forme de traitement antinéoplasique, systémique ou local, est anticipée pendant la durée de l’étude
    - Infection active nécessitant un traitement systémique
    - Patients non bénéficiaires d’un régime de sécurité sociale
    - Patients déjà inclus dans une étude clinique autre qu’une étude observationnelle (registre ou cohorte).
    - Patients bénéficiaires de l’aide médicale d’état (AME) (sauf exemption d’affiliation)
    - Patients sous tutelle ou curatelle
    - Contre-indication à la transplantation de microbiote fécal
    - Hypersensibilité connue au Normacol ou au Moviprep ® ou à tout médicament équivalent ou à l’une de ses composantes
    - Désordres électrolytiques avec rétention hydro sodée (insuffisance cardiaque, hyperaldostéronisme, œdème d’origine médicamenteuse)
    - Syndrome coronarien aigu récent ou cardiopathie ischémique instable
    - Insuffisance cardiaque congestive ≥ Classe III ou IV telle que définie par la New York Heart Association
    - Hypersensibilité au principe actif ou à l’un des excipients : Aspartame (E951), Acesulfame potassium (E950), arôme citron (maltodextrine, citral, huile essentielle de citron, huile essentielle de citron vert, gomme xanthane, vitamine E)
    - Obstruction ou perforation gastro-intestinale
    - Troubles de la vidange gastrique (gastroparésie),
    - Iléus
    - Phénylcétonurie (en raison de la présence d’aspartame),
    - Déficit en Glucose-6-Phosphate Déshydrogénase (en raison de la présence d’ascorbate),
    - Mégacôlon toxique, dans les formes sévères d’inflammation intestinale, y compris la maladie de Crohn et la rectocolite hémorragique.
    E.5 End points
    E.5.1Primary end point(s)
    Safety will be measured by the occurrence of Grade 3 and grade 4 adverse events (AE), as graded by the CTCAE v 5.0 during the 27 weeks of the trial.
    La sécurité sera évaluée par la survenue d’événements indésirables de grade 3 ou 4 selon la classification CTCAE v 5.0, durant les 27 semaines de l’étude
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 27
    Semaine 27
    E.5.2Secondary end point(s)
    - Efficacy will be assessed by the best overall response rate, rated by immunological Response Evaluation Criteria in Solid Tumors (iRECIST; 19) in the experimental and control arms and among them, within the subgroup of patients who carried the unfavourable baseline microbiota.
    - Changes in the tumor micro environment (TME) pre and post MaaT013 or placebo
    - Changes in plasma levels of proteins or metabolites that play a role in immune activity against cancer and/or are associated with gut microbiome composition, pre and post MaaT013 or placebo
    - Changes in peripheral blood immune cell subpopulations pre and post MaaT013 or placebo
    - Changes in gut microbiome and metabolites pre and post MaaT013 or placebo
    - Overall response rate, either complete or partial, rated by RECIST in patients with a stable disease or disease progression who received placebo and subsequently, MaaT013, in an open-label basis.
    - Progression-free survival at week 15, 27, 51
    - Overall survival at week 15, 27, 51
    - Best overall response rate, either complete or partial, rated by RECIST v1.1. and PET scan
    - Disease control rate (complete or partial response or stable disease)
    - Pseudo progression rate
    - L’efficacité sera évaluée par le meilleur taux de réponse obtenu, selon les critères iRECIST (immunological Response Evaluation Criteria in Solid Tumors; Lancet Oncol. 2017;18:e143-e152) dans le bras expérimental et dans le bras placebo, et parmi tous les patients, dans le sous-groupe de patients avec un microbiote défavorable à la baseline.
    - Modification du microenvironnement tumoral avant et après Maat013 ou placebo.
    - Modifications du niveau plasmatique des différentes protéines qui jouent un rôle dans l’activité immunitaire anti-cancer, avant et après Maat013 ou placebo.
    - Modifications des sous-populations de cellules immunitaires dans le sang périphérique Maat013 ou placebo.
    - Modifications du microbiome intestinal et des métabolites pré- et post Maat013 ou Placebo
    - Taux de réponse globale (complète ou partielle), selon les critères RECIST, chez les patients avec stabilité tumorale ou progression de la maladie sous placebo et qui reçoivent ensuite le MaaT013 en ouvert.
    - Survie sans progression à 15, 27, et 51 semaines
    - Survie globale à 15, 27, et 51 semaines
    - Meilleure réponse objective (complète ou partielle), évaluée selon les critères RECIST v1.1 et TEP scan.
    - Taux de contrôle de la maladie (réponse complète ou partielle ou maladie stable)
    - Taux de pseudo progression.
    E.5.2.1Timepoint(s) of evaluation of this end point
    until Week 51
    jusqu'à la semaine 51
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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 months37
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations 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 state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    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 Decision2021-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-06
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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