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    Summary
    EudraCT Number:2015-005382-23
    Sponsor's Protocol Code Number:IMDZ-G142
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-10-10
    Trial results View 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 number2015-005382-23
    A.3Full title of the trial
    Phase 1/2 Study Of Intratumoral G100 With Or Without Pembrolizumab In Patients With Follicular Non-Hodgkin’s Lymphoma
    Étude de Phase I/II sur le G100 en injection intratumorale avec ou sans le pembrolizumab chez des patients porteurs de lymphome non hodgkinien folliculaire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2 Study of G100 Therapy injected directly into the tumor or in combination with Pembrolizumab of patients with Follicular non-Hodgkin's Lymphoma.
    Une étude de Phase I/II sur la thérapie G100 injectée direcement dans la tumeur ou en combinaison avec Pembrolizumab des patients porteurs de lymphome non hodgkinien folliculaire.
    A.4.1Sponsor's protocol code numberIMDZ-G142
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02501473
    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 SponsorImmune Design Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportImmune Design Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmaceutical Research Associates, Inc.
    B.5.2Functional name of contact pointJoe Potworka
    B.5.3 Address:
    B.5.3.1Street AddressSuite 300, 655 Tyee Road
    B.5.3.2Town/ cityVictoria, BC
    B.5.3.3Post codeV9A 6X5
    B.5.3.4CountryCanada
    B.5.4Telephone number +1 250 483-4488
    B.5.6E-mailPotworkajoe@prahs.com
    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 nameglucopyranosyl lipid A stable emulsion (GLA-SE)
    D.3.2Product code G100
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codeIMDZ-G142
    D.3.9.3Other descriptive nameGLA-SE (GLUCOPYRANOSYL LIPID ADJUVANT-STABLE EMULSION)
    D.3.9.4EV Substance CodeSUB131024
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Limited
    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.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.3Other descriptive nameKeytruda
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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
    follicular non-Hodgkin's lymphoma
    lymphome non hodgkinien folliculaire
    E.1.1.1Medical condition in easily understood language
    A specific form of non-Hodgkin's lymphoma
    Une forme spécifique de lymphome non hodgkinien folliculaire
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10067070
    E.1.2Term Follicular B-cell non-Hodgkin's lymphoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In Part 1: Evaluate the safety and tolerability of ascending doses of intratumoral G100 in patients with low-grade non-Hodgkin’s lymphoma (NHL) receiving local radiation

    In Part 2: Assess the safety and tolerability of intratumoral G100 or sequential intratumoral G100 and anti-PD-1 therapy in patients with follicular NHL receiving local radiation
    E.2.2Secondary objectives of the trial
    To assess clinical responses by Immune-related Response Criteria (irRC) using bi-dimensional measurements and time to progression (TTP) as a preliminary indication of efficacy.

    For comparison, clinical responses will also be assessed by the International Working Group response criteria for lymphomas.

    To assess abscopal tumor responses in non-treated, distal tumor sites

    Evaluate pre- and post-regimen tumor tissue and blood for exploratory biomarkers of immunologic and tumor response
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Follicular low grade NHL: either treatment naïve or relapsed or refractory following at least one prior treatment. In Part 1 Dose
    Escalation only, in addition to follicular NHL, marginal zone B cell lymphomas: either treatment
    naïve or relapsed or refractory following at
    least one prior treatment.

    2. Tumor mass(es) accessible for intratumoral injection and are being considered for local radiation therapy and at least one additional site of disease outside the radiation field for assessment of distal (abscopal) response
    3. ≥ 18 years of age
    4. Life expectancy of ≥ 6 months per the investigator
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    6. ECG without evidence of clinically significant arrhythmia or ischemia
    7. If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use at least one highly effective or two effective contraceptive methods during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four
    months after last treatment.
    8. If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom during the dosing period and for three months after last study treatment, or if receiving
    pembrolizumab, four months after last treatment
    1. LNH folliculaire de bas grade : naïf de traitement, récidivant ou réfractaire à la suite d’un traitement antérieur au moins. Dans la partie 1, escalade de doses uniquement, en plus des LNH folliculaires, lymphomes B de la zone marginale : naïf de traitement, récidivant ou réfractaire à la suite d’un traitement antérieur au moins.
    2. Masse(s) tumorale(s) accessibles en vue d’une injection intratumorale et envisageables pour une radiothérapie locale et au moins un site de maladie supplémentaire hors du champ de rayonnement pour évaluation de la réponse distale (abscopale)
    3. Être âgé(e) de 18 ans et plus
    4. Espérance de vie de 6 mois et plus selon l’investigateur
    5. Indice de performance ECOG (Eastern Cooperative Oncology Group) de 0 ou 1
    6. ECG ne présentant pas de signes d’arythmie ou d’ischémie cliniquement importante(s)
    7. Les femmes susceptibles d’être enceintes doivent être disposées à se soumettre à un test de grossesse et accepter d’utiliser au moins une méthode de contraception hautement efficace ou deux méthodes efficaces durant toute la période d’administration et pendant une durée de trois mois après la dernière dose du traitement de l’étude, ou en cas d’administration du pembrolizumab, quatre mois après la dernière dose du traitement
    8. Les hommes sexuellement actifs et susceptibles de pouvoir engendrer des enfants doivent accepter d’utiliser une contraception hautement efficace telle que le préservatif en latex durant toute la période d’administration et pendant une durée de trois mois après la dernière dose du traitement de l’étude, ou en cas d’administration du pembrolizumab, quatre mois après la dernière dose du traitement
    E.4Principal exclusion criteria
    1. Cancer therapies, including chemotherapy, radiation (non-study
    regimen related), biologics or kinase inhibitors, G-CSF or GM-CSF within
    4 weeks prior to the first scheduled G100 dose
    2. Investigational therapy within 4 weeks prior to G100 dosing
    3. Prior administration of other intratumoral immunotherapeutics
    4. Inadequate organ function including:
    a. Marrow: Peripheral blood leukocyte count (WBC) < 3000/mm3, absolute neutrophil count ≤ 1500/mm3,
    platelets < 75000/mm3, or haemoglobin < 10 gm/dL
    b. Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x ULN, total
    serum bilirubin > 1.5 x ULN (patients with Gilbert's Disease may be included if their total
    bilirubin is
    ≤3.0 mg/dL)
    c. Renal: Creatinine > 1.5x ULN
    d. Other: INR (prothrombin time ratio) or partial thromboplastin time
    (PTT) >1.5 x ULN
    5. Significant immunosuppression from:
    a. Concurrent, recent (≤ 4 weeks ago) or anticipated treatment with systemic corticosteroids at any
    dose, or
    b. Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine or
    conditions such as common variable hypogammaglobulinemia
    6. Pregnant or nursing
    7. Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York
    Heart Association (NYHA) Grade III or IV heart failure
    8. History of other cancer within 2 years (except non-melanoma cutaneous malignancies and cervical
    carcinoma in situ)
    9. Recent (< 1 week ago) clinically significant infection, active tuberculosis or evidence of
    active hepatitis B, hepatitis C or HIV infection
    10. Central nervous system involvement with lymphoma, including parenchymal and leptomeningeal
    disease
    11. Significant autoimmune disease, including active non-infectious pneumonitis, with the exception
    of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or
    were transient and have completely resolved and require no ongoing therapy
    12. Psychiatric, other medical illness or other condition that in the opinion of the PI prevents
    compliance with study procedures or ability to provide valid informed consent
    13. History of significant adverse or allergic reaction to any component of G100 including egg
    lecithin, and if enrolled in Part 2, anti-PD-1 antibodies
    14. Use of anti-coagulant agents or history a significant bleeding
    diathesis. (If a superficial lymph node or subcutaneous mass is to be
    injected, patients on agents such as non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or
    clopidogrel are eligible and these agents do not have to be withheld. For procedures with moderate
    or significant risk of bleeding, long-acting agents such as aspirin or clopidogrel should be
    discussed with the Medical Monitor and may need to be discontinued before G100 therapy.
    For patients enrolled in Part 2 with the potential to receive pembrolizumab:
    15. History of interstitial lung disease
    16. Received a live virus vaccine within 30 days of planned study start
    17. Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
    (Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no
    symptoms of GVHD.)
    18. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD- L2 agent or if the
    patient has previously participated in Merck MK-3475
    clinical trials.
    1. Traitements anticancéreux, y compris chimiothérapie, radiothérapie (non liée à un traitement de l’étude), inhibiteurs biologiques ou de kinase, G-CSF ou GM-CSF 4 semaines avant l’administration de la première dose prévue du G100
    2. Traitement expérimental 4 semaines avant l’administration du G100
    3. Administration antérieure d’autres immunothérapies intratumorales
    4. Fonction organique inadéquate, notamment :
    a. Fonction médullaire : numération leucocytaire du sang périphérique (GB) < 3000/mm3, numération de neutrophiles absolus ≤ 1500/mm3, plaquettes < 75000/mm3, ou hémoglobine < 10 g/dl
    b. Fonction hépatique : alanine aminotransférase (ALAT) et aspartate aminotransférase (ASAT) > 2,5 X LSN, bilirubine sérique totale > 1,5 x LSN (les patients atteints de la maladie de Gilbert pourront être inclus si leur bilirubine totale est de ≤ 3,0 mg/dl)
    c. Fonction rénale : créatinine > 1,5x LSN
    d. Autre : TP (taux de prothrombine) ou temps de céphaline activée (TCA) > 1,5x LSN
    5. Immunosuppression importante découlant de :
    a. Traitement concomitant, récent (commencé il y a 4 semaines au plus) ou anticipé par des corticostéroïdes systémiques à n’importe quelle dose, ou
    b. Autres médicaments immunosuppresseurs tels que le méthotrexate, la ciclosporine, l’azathioprine ou des affections telles qu’une hypogammaglobulinémie commune d’expression variable
    6. Grossesse ou allaitement
    7. Infarctus du myocarde dans les 6 mois précédant le début de l’étude, une ischémie cardiaque active ou une insuffisance cardiaque de grade III ou IV selon la New York Heart Association (NYHA)
    8. Antécédent de cancer autre survenu dans les 2 dernières années (sauf tumeurs malignes cutanées autres que le mélanome et carcinome cervical in situ)
    9. Infection récente (moins d’une semaine), significative sur le plan clinique, tuberculose active ou signes d’hépatite B, d’hépatite C ou d’infection par le VIH active
    10. Atteinte du système nerveux central avec lymphome, y compris atteinte parenchymateuse et leptoméningée
    11. Maladie auto-immune importante, y compris pneumopathie non infectieuse active, à l’exception de l’alopécie, du vitiligo, de l’hypothyroïdie ou d’autres affections qui n’ont jamais été actives cliniquement ou étaient transitoires, se sont complètement résolues et ne nécessitent aucun traitement continu
    12. Maladie psychiatrique, autre maladie médicale ou autre état pathologique qui de l’avis de l’IP limite l’observance des procédures de l’étude ou l’aptitude à fournir un consentement éclairé valable
    13. Antécédent de réaction indésirable ou allergique importante à un composant du G100, dont la lécithine d’oeuf, et si recruté dans la partie 2, aux anticorps anti-PD-1
    14. Utilisation d’agents anticoagulants ou antécédent de diathèse hémorragique importante. (Si un ganglion superficiel ou une masse sous-cutanée doit être injectée, les patients sous agents tels que les anti-inflammatoires non stéroïdiens (AINS), l’aspirine ou le clopidogrel sont éligibles et ces agents ne nécessitent pas d’être suspendus. Pour les procédures comportant un risque modéré ou important d’hémorragie, les agents à action prolongée tels que l’aspirine ou le clopidogrel devront être abordés avec le moniteur médical et leur arrêt pourra s’avérer nécessaire avant le traitement par le G100.)
    Pour les patients inclus dans la partie 2 pouvant potentiellement recevoir le pembrolizumab :
    15. Antécédent de maladie interstitielle pulmonaire
    16. A reçu un vaccin à virus vivant dans les 30 jours précédant le début prévu de l’étude
    17. A subi une greffe de cellules souches hématopoïétiques allogéniques dans les 5 dernières années. (Les patients qui ont subi une greffe dans un délai supérieur aux 5 dernières années sont éligibles pourvu qu’ils n’aient aucun symptôme de RGCH.)
    18. A reçu un traitement antérieur par un agent anti-PD-1, anti-PD-L1 ou anti-PD-L2 ou si le patient a participé antérieurement à des essais cliniques MK-3475 de Merck.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: The nature, frequency and severity of adverse events (AEs) and laboratory abnormalities up through Study Day 28 in patients with low-grade NHL receiving intratumoral G100 and local radiation

    Part 2: Assess the nature, frequency and severity of adverse events (AEs) and laboratory abnormalities occurring in patients with follicular NHL receiving local radiation and either intratumoral G100 alone or sequential intratumoral G100 and anti-PD-1 therapy
    Partie 1 : évaluer la nature, la fréquence et la gravité des événements indésirables (EI) et des anomalies aux analyses biologiques jusqu’au jour 28 de l’étude chez des patients porteurs de LNH de bas grade recevant le G100 en injection intratumorale et une radiothérapie locale

    Partie 2 : évaluer la nature, la fréquence et la gravité des événements indésirables (EI) et des anomalies aux analyses biologiques chez les patients porteurs de LNH folliculaire recevant une radiothérapie locale et, soit le G100 en injection intratumorale seul, soit le traitement séquentiel par le G100 en injection intratumorale et un anti-PD-1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: All AEs and SAEs will be evaluated and reported during visits 2, 5, 6, 7, 8, 9, 10, 10A, 10B, 11, 12; and possibly-related SAEs will be evaluated and reported at follow-up (Day 112) then every 8 weeks

    Part 2: All AEs and SAEs will be evaluated and reported during visits 2, 5, 6, 7, 8, 9, 10, 10A, 10B, 11, 12; and possibly-related SAEs will be evaluated and reported during long term follow-up after PD
    Partie 1: Tous les EI et les EIG seront évalués et reportés durant les visites 2, 5, 6, 7, 8, 9, 10, 10A, 10B, 11, 12; les EIGs potentiellement liés seront évalués et reportés lors de la visite de follow-up (Jour 112) puis toutes les 8 semaines.
    Partie 2: Tous les EI et EIGs seront évalués et reportés lors des visites 2, 5, 6, 7, 8, 9, 10, 10A, 10B, 11, 12; et les EIGs potentiellement liés seront évalués et reportés lors de la visite de suivi à long terme après la progression de la maladie
    E.5.2Secondary end point(s)
    The nature, frequency and severity of AEs and laboratory abnormalities until 21 days after G100 regimen is completed or discontinued

    Assess clinical responses by irRC using bi-dimensional measurements and expressed as partial response (PR), complete response (CR), stable disease (SD), or progressive disease (PD), and time to progression (TTP) as a preliminary indication of efficacy
    As an exploratory comparison, assess clinical responses by the International Working Group response criteria for lymphomas. (For determining PD, the irRC criteria will be used.)

    Assess abscopal tumor responses in non-treated, distal tumor sites

    Assess blood and tumor samples for exploratory biomarkers of immunologic and tumor response
    Evaluer la nature, la fréquence et la gravité des EI et des anomalies aux analyses biologiques jusqu’à 21 jours après que le traitement par le G100 arrive à son terme ou soit arrêté

    Évaluer les réponses cliniques selon les critères irRC sur la base de mesures bidimensionnelles exprimées sous la forme de réponse partielle (RP), réponse complète (RC), stabilisation de la maladie (SM) ou progression de la maladie (PM), et du délai avant progression (TTP) comme indication préliminaire d’efficacité
    À des fins de comparaison exploratoire, évaluer les réponses cliniques selon les critères de réponse du « International Working Group » pour les lymphomes. (Pour déterminer la PM, les critères irRC seront utilisés.)

    Évaluer les réponses tumorales abscopales dans des sites de tumeurs non traités, distaux

    Évaluer les échantillons sanguins et tumoraux à la recherche des biomarqueurs exploratoires de réponse immunitaire et tumorale
    E.5.2.1Timepoint(s) of evaluation of this end point
    See Section 3.2 and 3.3 in Protocol IMDZ-G142 for the schedule of events for the secondary endpoints.
    Veuillez vous réferer aux sections 3.2 et 3.3 du protocole IMDZ-G142 pour le calendrier des procédures et des critère d'évaluations secondaires.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1/2 Study
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    G100 with Pembrolizumab
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Spain
    United Kingdom
    United States
    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
    Derniere visite du dernier patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days16
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    If male and sexually active with a FCBP, must agree to use highly effective contraception
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 40
    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)
    Patients will receive telephone follow-up every 8-12 weeks after disease progression until 1 year after first study injection. Follow-up will include vital status and cancer status including time to next treatment. In addition, any SAE and that comes to the attention of the site staff that may be causally related to study drug must be reported to Immune Design, regardless of time elapsed.
    Les patient recevront un appel téléphone de suivi toutes les 8-12 semaines après la progression de la maladie jusqu'à 1 an après la première injection de l'étude. Le suivi incluera le status vital and le status du cancer incluant le delai avant le traitement suivant. De plus, tout EIG qui serait porté à l'attention du centre et qui serait potentiellement lié au traitement doit etre reporté à Immune Design, quelque soit le temps écoulé.
    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 Decision2016-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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