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    Summary
    EudraCT Number:2015-002541-63
    Sponsor's Protocol Code Number:IMP321-P011
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-07-06
    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 ConcernedGermany - PEI
    A.2EudraCT number2015-002541-63
    A.3Full title of the trial
    AIPAC (Active Immunotherapy PAClitaxel): A multicentre, Phase IIb, randomised, double blind, placebo-controlled study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 (LAG-3Ig fusion protein) or placebo as adjunctive to a standard chemotherapy treatment regimen of paclitaxel.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 or placebo as adjunctive to a standard chemotherapy treatment regimen of paclitaxel.
    A.3.2Name or abbreviated title of the trial where available
    AIPAC
    A.4.1Sponsor's protocol code numberIMP321-P011
    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 SponsorImmutep S.A.S.
    B.1.3.4CountryFrance
    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 supportImmutep S.A.S.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSMS-oncology
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressWalaardt Sacréstraat 401-403
    B.5.3.2Town/ citySchiphol
    B.5.3.3Post code1117 BM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31204350580
    B.5.5Fax number+31204350589
    B.5.6E-mailregulatory@sms-oncology.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 nameIMP321
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNeftilagimod alfa
    D.3.9.1CAS number 1800476-36-1
    D.3.9.3Other descriptive nameIMP321
    D.3.9.4EV Substance CodeSUB178475
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 +/- 3mg/ml
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Female metastasized oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Female hormone receptor-positive metastatic breast cancer
    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 PT
    E.1.2Classification code 10006202
    E.1.2Term Breast cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objectives:
     Safety run-in stage: determine the recommended phase two dose for the randomised phase
     Randomised stage: to determine efficacy of IMP321 combined with weekly paclitaxel compared to weekly paclitaxel plus placebo in hormone receptor-positive metastatic breast cancer patients
    E.2.2Secondary objectives of the trial
    Secondary objectives:
     to further characterise the anti-tumour activity of IMP321 in combination with weekly paclitaxel in
    terms of clinical responses and clinical outcomes and compare it to placebo
     to examine the safety and tolerability of IMP321 in combination with weekly paclitaxel and compare it to placebo
     to characterise the pharmacokinetic (safety run-in only) and immunogenic properties of IMP321
     to assess the quality of life related to IMP321 compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to give written informed consent and to comply with the protocol
    2.1 Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or a metastasis
    3. Female of age 18 years or above
    4. Patients who are indicated to received first line chemotherapy with weekly paclitaxel
    5.1 All patients of childbearing potential must have a negative highly sensitive pregnancy test at screening and agree to use highly effective method for contraception according to the EU Clinical Trial Facilitation Group guidance from time of study entry until at least 6 months after the last administration of study drug. The partners of patients with childbearing potential must also apply
    contraceptive methods. Patients who are either ,
    o postmenopausal (≥ 60 years of age, or < 60 years of age and amenorrhoeic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression with folliclestimulating hormone (FSH) above 40 U/L and oestradiol below 30 ng/L; or if taking tamoxifen or toremifene, and age < 60 years, then FSH and oestradiol in the postmenopausal range), permanently sterilized (e.g., bilateral tubal occlusion, hysterectomy),
    o or otherwise be incapable of pregnancy are not considered to be of childbearing potential
    6. ECOG performance status 0-1
    7. Expected survival longer than three months
    8. Resolution of toxicity of prior therapy to grade < 2 (except for alopecia and transaminases in case of liver metastases)
    9. Evidence of measurable disease as defined by RECIST version 1.1
    10.1 Laboratory criteria:
     Total white cell count ≥ 3 x 10^9/L
     Platelet count ≥ 100 x 10^9/L
     Haemoglobin ≥ 9 g/dL or 5.58 mmol/L
     Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L
     Serum creatinine ≤ 1.5 × ULN
     Total bilirubin ≤ 20 μmol/L, except for familial cholaemia (Gilbert’s disease)
     Serum ASAT and ALAT ≤ 3 times ULN or ≤ 5 times ULN if liver metastases are present
    E.4Principal exclusion criteria
    1. Prior chemotherapy for metastatic breast adenocarcinoma
    2. Disease-free interval of less than twelve months from the last dose of
    adjuvant chemotherapy
    3. Prior high-dose chemotherapy requiring hematopoietic stem cell
    rescue
    4.1 Inflammatory carcinoma at time of screening
    5.1 Candidate for treatment with trastuzumab (or other Her2/neu
    targeted agents) or endocrine based therapy according to the applicable
    treatment guidelines
    6.2 Systemic chemotherapy, radiation therapy or any other
    investigational agent within 4 weeks, endocrine therapy within 1 week
    or CDK4/6 inhibitors within 5 times half-life (acc. to SPC) prior to first
    dose of study treatment
    7.1 Symptomatic known cerebral and/or leptomeningeal metastases
    8. Women who are pregnant or lactating
    9. Serious intercurrent infection within 4 weeks prior to first dose of
    study treatment
    10. QTcF >480 ms, family or personal history of long or short QT
    syndrome, Brugada syndrome or known history of QTc prolongation, or
    Torsade de Pointes (TdP)
    11. Uncontrolled electrolyte disorders that can worsen the effects of a
    QTc-prolonging drug (e.g., hypocalcaemia, hypokalaemia,
    hypomagnesemia)
    12.1 Evidence of severe or uncontrolled cardiac disease (NYHA III-IV)
    within 6 months prior to first dose of study treatment including:
    myocardial infarction, severe/unstable angina, ongoing cardiac
    dysrhythmias of NCI CTCAE version 4.03 Grade ≥2, atrial fibrillation ,
    coronary/peripheral artery bypass graft, symptomatic congestive heart
    failure, cerebrovascular accident including transient ischemic attack,
    ventricular arrhythmias requiring medication or symptomatic pulmonary
    embolism
    13. Active acute or chronic infection
    14. Active autoimmune disease requiring immunosuppressive therapy
    15.1 Positive test for HIV
    16.1 Positive test for Hepatitis B (anti–HBc) or C (Patients who are anti-
    HBc+ and HBsAg negative are eligible and are not excluded from
    participation in this study)
    17. Life threatening illness unrelated to cancer
    18. Previous malignancies within the last three years other than breast
    carcinoma, except successfully treated squamous cell carcinoma of the
    skin, superficial bladder cancer, and in situ carcinoma of the cervix
    19. Any current disorder that would impede the patient's ability to
    provide informed consent or to comply with the protocol
    20. Any condition requiring continuous systemic treatment with either
    corticosteroids (>10 mg daily prednisone equivalents) or other
    immunosuppressive medications within 4 weeks prior to first dose of
    study treatment. Inhaled or topical steroids and physiological
    replacement doses of up to 10 mg daily prednisone equivalent are
    permitted in the absence of active autoimmune disease
    21. Past history of severe allergic episodes and/ or Quincke's oedema
    22. Alcohol or substance abuse disorder
    23. Known hypersensitivity to any of the components of the study agents
    24.1 Participation in an interventional clinical study within 4 weeks prior
    to first dose of study treatment, with intervention not covered by
    exclusion criterion 6.2
    25. Unwilling or unable to follow protocol requirements
    26. In the clinical judgment of the Investigator, the patient is unsuitable
    for participation in this study
    27. Persons with any kind of dependency on the Investigator or
    employed by the sponsor or Investigator
    28. Persons held in an institution by legal or official order
    29. Patients with prior organ or stem cell transplantation
    30. Patients having received a live, attenuated vaccine within 4 weeks
    prior to the first administration of study treatment
    31. Patients treated with systemic immune stimulatory agents within 6
    weeks or five half lives
    of the drug prior to first administration of study treatment
    E.5 End points
    E.5.1Primary end point(s)
    Stage 1: to determine DLTs and the recommended phase II dose
    Stage 2: To determine progression free survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Radiology assessments in the treatment phase will be every 8 weeks until week 73. It may be performed +/- 3 days prior to that specific radiological assessment during the chemo-immunotherapy phase and +/- 7 days during the maintenance and follow-up phase
    PFS at Follow-Up visits every 12 weeks (± 1 week) until PD, start of next line of therapy, withdrawal of consent, loss to follow-up, death from any cause, or the end of the study (whichever occurs first).
    For patients who prematurely discontinue treatment for any reason except PD, PFS Follow-Up Visits will occur every 8 weeks until weeks 73 and every 12 weeks thereafter dependent on the most recent radiological assessment prior to discontinuation.
    E.5.2Secondary end point(s)
    Secondary endpoints
    • To assess overall survival (OS)
    • To assess adverse events according to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) and other safety parameters
    • To assess the time to next treatment (TTNT), objective response rate (ORR) according to RECIST 1.1, time to and duration of response and duration of stable disease
    • To assess the plasma concentration time profile of IMP321 and derived PK parameters
    • To assess the quality of life (QOL)
    • To assess development of anti-drug (IMP321) antibodies (ADA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS: After documented PD, every 12 weeks after enrolment into the trial for the first 2 years and every 24 weeks thereafter (± 4 weeks).
    Other efficacy parameters (TTNT, ORR, time to and duration of response, duration of stable disease) at same timepoints as PFS and OS.

    (S)AEs will be collected from the time of ICF signature until 30 days after last study drug administration, and after this period only when considered (in the opinion of the Investigator) related to study treatment.

    PK parameters: run-in stage only at cycle 1 day 2, 3 and 4 and cycle 6 day 16, 17 and 18.

    QoL: chemo-immunotherapy stage visit 1 and visit 16; Maintenance phase visit 31 and visit 37; At end of treatment, visit 43.

    ADA: at screening, visit 6, 11, 21, 31, 34, 37, 40 and at end of
    treatment
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    Immuno-monitoring ( on blood cells and soluble Th 1 biomarkers)
    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 Yes
    E.8.1.7.1Other trial design description
    Run-in stage: open-label. Randomization stage: placebo-controlled double-blind.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Run-in stage: not placebo-controlled. Randomization stage: placebo-controlled double-blind.
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    36 months after last patient first visit (stage 2). Approximately 65 months after first patient first visit in the randomised stage 2. During this follow up period data on progression-free survival and overall survival will be collected. Additionally, any next line of anti-cancer therapy will be recorded.
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 121
    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 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 241
    F.4.2.2In the whole clinical trial 241
    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 who progress while on study treatment may receive endocrine or any other therapy as clinically indicated and as part of the next line of therapy, after performing the EOT visit.
    Patient who do not progress and complete the study treatment period (i.e. reach the end of maintenance phase without progression) may receive endocrine or any other therapy as clinically indicated and as part of the next line of therapy, after performing the EOT visit.
    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 Decision2017-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-03
    P. End of Trial
    P.End of Trial StatusOngoing
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