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    Summary
    EudraCT Number:2015-005382-23
    Sponsor's Protocol Code Number:IMDZ-G142
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-02-18
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-005382-23
    A.3Full title of the trial
    Phase 1/2 Study Of Intratumoral G100 With Or Without Pembrolizumab or Rituximab In Patients With Follicular Non-Hodgkin’s Lymphoma
    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 or Rituximab in patients with Follicular non-Hodgkin's Lymphoma.
    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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/103/17
    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 typerange
    D.3.10.3Concentration number5 to 80
    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.3.1Product namePEMBROLIZUMAB
    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.IMP: 3
    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 Mab Thera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.1Product nameRituximab
    D.3.2Product code L01XC02
    D.3.4Pharmaceutical form Concentrate for 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 200
    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: 4
    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.3.1Product namePEMBROLIZUMAB
    D.3.2Product code L01XC18
    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.3.9.3Other descriptive nameKeytruda
    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 number25
    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
    E.1.1.1Medical condition in easily understood language
    A specific form of non-Hodgkin's lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    Part 1: Evaluate the safety and tolerability of ascending doses of intratumoral G100 in patients with low-grade NHL receiving local radiation
    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
    Part 3: Evaluate the safety and tolerability of 20 μg/dose of intratumoral G100 in patients with low-grade NHL receiving local radiation
    Part 4: Evaluate safety and preliminary clinical efficacy of intratumoral G100 at 20 μg/lesion in single or multiple tumour lesions and pembrolizumab (anti-PD-1) therapy in patients with relapses or refractory follicular NHL who have received at least 3 prior systemic treatments, one of which was or included an anti-CD20 antibody.
    Part 5: Evaluate safety and preliminary clinical efficacy of standard induction therapy with rituximab (anti-CD20) in combination with escalating doses of intratumoral G100 in single tumour lesion (etc)
    E.2.2Secondary objectives of the trial
    - The nature, frequency and severity of AEs and laboratory abnormalities until 21 days after G100 regimen is completed or discontinued
    - Clinical responses by irRC using bi-dimensional measurements and expressed as partial response (PR), complete response (CR), stable disease (SD), or progressive disease (PD), time-to-progression (TTP) and/or progression-free survival (PFS) 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). Sponsor will assess for clinical responses by the Lugano criteria for lymphomas (Cheson 2014).
    - Abscopal tumor responses in non-treated, distal tumour sites
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Follicular low grade NHL, (grades 1, 2, 3A) either treatment naïve or relapsed or refractory following at least one prior treatment. For france, patients with either relapsed or refractory only. 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. In Part 4, enrollment is limited to relapsed or refractory follicular NHL patients who hasve received at least 3 treatments, one of which was or included an anti-CD20 antibody. In Part 5, enrollment will include relapsed or refractory CD20+ follicular NHL following at least one but not more than 2 prior treatments.
    2. Tumour 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 (Imaging assisted injections are allowed following approval by Medical Monitor). For Parts 4 and 5, radiation therapy is omitted. Measurable tumour mass(es) accessible for intratumoral injections must be present for treatment and assessment of 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 2 methods of birth control or is considered highly unlikely to conceive 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 effective contraception such as latex condom or is sterile (e.g. following surgical procedure) during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four months after last treatment
    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 G100 or 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. In Parts 4 and 5, any involvement with lymphoma in a closed or confined space such as the retroorbital area will need to be pre-approved by the Medical Monitor.
    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. (Replacement therapy for hypothyroidism or diabetes is allowed.)
    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 and if enrolled in Part 2, anti-PD-1 antibodies pembrolizumab and/or any of its excipients, and if enrolled in Part 5, anti-CD20 antibodies including rituximab as excipients
    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 or Part 4 with the potential to receive pembrolizumab:
    15. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis or interstitial lung disease
    16. Has received a live virus vaccine within 30 days prior to the first dose of study drug (Applies to patients who may receive either pembrolizumab or rituximab). Examples of live vaccines include, but are not limited to the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
    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 had an allogeneic tissue/solid organ transplant
    19. Has received prior therapy with an anti-PD-1, anti-programmed death ligand (PD-L)1, or anti-PD-L2 agent or if the patient has previously participated in Merck MK-3475 clinical trials or was previously treated
    with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) please refer to the protocol
    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

    Part 3: The nature, frequency, and severity of AEs and laboratory abnormalities occurring in patients with follicular NHL receiving local
    radiation and G100 at 20 μg/dose

    Part 4: The nature, frequency and severity of AEs and laboratory abnormalities and the frequency of clinical responses occurring in patients with follicular NHL receiving intratumoral G100 at 20 μg/lesion in single or multiple tumour masses and pembrolizumab therapy

    Part 5: The nature, frequency and severity of AEs and laboratory abnormalities and the frequency of clinical responses occurring in patients with follicular NHL receiving rituximab therapy in combination with escalating doses of intratumoral G100 in single tumour lesions
    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

    Part 3: 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
    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.) Sponsor will assess for clinical responses by the Lugano criteria for lymphomas (Cheson 2014).

    Assess abscopal tumour responses in non-treated, distal tumour sites
    E.5.2.1Timepoint(s) of evaluation of this end point
    See Section 3.2, 3.3 and 3.4 in Protocol IMDZ-G142 for the schedule of events for the secondary endpoints.
    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 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 Yes
    E.8.2.3.1Comparator description
    G100 with Pembrolizumab
    E.8.2.4Number of treatment arms in the trial5
    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 EEA15
    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
    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 months10
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years4
    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: 143
    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 effective contraception
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 143
    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.
    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 Decision2016-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-08-01
    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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