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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-000834-50
    Sponsor's Protocol Code Number:MGN1703-C06
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-05-12
    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 ConcernedEstonia - SAM
    A.2EudraCT number2014-000834-50
    A.3Full title of the trial
    IMPALA-Trial: Evaluation of an immunomodulatory maintenance treatment in patients with metastatic colorectal cancer with tumor reduction during induction treatment - A phase III trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to assess the effectiveness of treatment with MGN1703 in further delaying the time of first tumour progression in patients with metastatic colorectal cancer that have already experienced tumor reduction after receiving treatment with standard first-line chemotherapy.
    A.3.2Name or abbreviated title of the trial where available
    IMPALA trial
    A.4.1Sponsor's protocol code numberMGN1703-C06
    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 SponsorMOLOGEN AG
    B.1.3.4CountryGermany
    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 supportMOLOGEN AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMOLOGEN AG
    B.5.2Functional name of contact pointDirector Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressFabeckstr. 30
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code14195
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930-84 17 880
    B.5.5Fax number+4930-84 17 88-50
    B.5.6E-mailduemmler@mologen.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 nameMGN1703
    D.3.2Product code MGN1703
    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 INNLefitolimod
    D.3.9.1CAS number 1548439-51-5
    D.3.9.2Current sponsor codeMGN1703
    D.3.9.3Other descriptive nameA synthetic DNA-based double Stem Loop Immunomodulator 30L1
    D.3.9.4EV Substance CodeSUB32567
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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.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
    Metastatic colorectal cancer
    E.1.1.1Medical condition in easily understood language
    Cancer of the colon that has spread to another part of the body.
    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 10010036
    E.1.2Term Colorectal carcinoma
    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
    The primary objective of the IMPALA trial is the evaluation of the efficacy of a novel switch maintenance treatment with lefitolimod (MGN1703) to improve overall survival (OS) in patients with metastatic colorectal cancer with tumor reduction after induction treatment with standard first-line chemotherapy, with or without biological agents.
    E.2.2Secondary objectives of the trial
    The secondary objectives are efficacy parameters such as progression free survival and survival endpoints, toxicity and safety, tolerability, Quality of Life and patient related outcome (in participating study sites), and translational research.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent
    2. Male or female patient 18 years or older
    3. Histologically confirmed diagnosis of colorectal cancer presenting with unresectable stage IV (UICC) disease (primary tumor may be present)
    4. Complete or partial response, as assessed by local investigators according to RECIST 1.1, within 12-30 weeks from start of induction treatment with standard first-line chemotherapy with or without biological agents
    5. ECOG PS 0-1
    6. Haematology and biochemistry laboratory results within the limits expected for a patient population recovering after receiving induction treatment:
    - Platelet count ≥ 80x10 9/L
    - Leukocyte count ≥ 1.50x10 9/L
    - Lymphocytes ≥ 0.50x10 9/L
    - Haemoglobin ≥ 9.0 g/dL or 5.59 mmol/L
    - Total bilirubin ≤ 2.5 times the upper limit of normal (ULN)
    - AST ≤ 3xULN in absence of liver metastases, or ≤ 5.0xULN in presence of liver metastases
    - ALT ≤ 3xULN in absence of liver metastases, or ≤ 5.0xULN in presence of liver metastases
    - Serum creatinine ≤ 2.0xULN
    7. Male and female patients of childbearing potential (i.e. not post-menopausal for at least 24 consecutive months and did not undergo surgical sterilization – hysterectomy, bilateral tubal ligation, or bilateral oophorectomy for women, vasectomy for men) using an effective means of contraception with a failure rate of less than 1% per year, e.g. established use of oral, implanted or injected hormonal contraceptives; placement of intra-uterine device (IUD) or intra-uterine system (IUS); use of barrier methods such as condom or diaphragm together with spermicide product; true abstinence (when it is in line with preferred and usual lifestyle of the patient). Contraception will start after screening and continue throughout study until at least one month after the last dose of lefitolimod (MGN1703) or longer if required according to the SmPCs of the used standard therapy medications. Females of child bearing potential must have a negative serum pregnancy test.
    E.4Principal exclusion criteria
    1. History of other malignant tumors within the last 5 years, except basal cell carcinoma or curatively excised cervical carcinoma in situ

    2. Known brain metastases (present or treated)

    3. Contraindication to receiving lefitolimod (MGN1703) as per current investigator's brochure

    4. Known hypersensitivity to any components of the study product

    5. Prior allogeneic stem cell transplantation or organ transplantation.

    6. Active or uncontrolled infections or undiagnosed febrile condition.

    7. Severe anemia requiring repeated blood cell transfusion

    8. Pre-existing autoimmune or antibody mediated diseases or immune deficiency

    9. Chronic systemic immune therapy or immunosuppressant medication other than steroids within the last 6 weeks; continuous systemic steroid treatment within the last 2 weeks prior to start of study treatment

    10. Use of systemic antibiotic therapy within the last 2 weeks prior to start of study treatment

    11. Inadequate pulmonary function according to the investigator's judgment, history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan

    12. HIV seropositivity or active HBV/HCV infection

    13. Serious concomitant disease or a medical condition that in the judgment of the investigator renders the patient at high risk of treatment complications

    14. Female patient who is pregnant or breast feeding

    15. Contraindication to receiving the planned standard maintenance treatment according to applicable SmPC

    16. Treatment with any anti-cancer investigational drug within 12 months prior to study treatment or participation in another clinical study with other investigational drugs within 28 days prior to study treatment.

    17. Vaccination within 1 month prior to start of study treatment

    18. Any medical, mental, psychological or psychiatric condition that in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is overall survival after randomization (OS), defined as the time between the date of randomization and the date of death from any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary study endpoint is overall survival after randomization (OS), defined as the time between the date of randomization and the date of death from any cause. Measured by imaging (CT/MRI) at screening and throughout study according to local practice.
    E.5.2Secondary end point(s)
    1. Overall survival from start of induction therapy (OSi)
    2. Overall survival rates at 3, 4 and 5 years after Randomization
    3. Progression free survival on study treatment (PFS on study) after randomization until second disease progression (PD) according to RECIST 1.1 (includes PFS1 and PFS2, see below).
    4. Progression free survival after randomization until first PD, necessitating discontinuation of maintenance and re-introduction of all first-line chemotherapy agents (PFS1).
    5. PFS after re-introduction of initial induction therapy until PD (usually followed by the start of a second line treatment) (PFS2)
    6. Progression free survival after first-line treatment, including induction treatment before randomization, maintenance treatment and re-induction until subsequent PD (usually followed by the start of a second line treatment) (PFS3)
    7. PFS rates at 2, 3, 4 and 5 years after randomization
    8. Primary and secondary endpoints will also be analyzed by stratification criteria and by maintenance strategy.
    - Overall response rate (ORR = CR + PR) after randomization according to RECIST v1.1 . PFS will be assessed according to RECIST 1.1.
    9. Responses and PD will be confirmed by independent radiological review for exploratory purposes only (the primary assessment will be that of the local investigators)
    10. Adverse events (toxicity) according to NCI CTC AE v4.03
    11. Quality of Life (QoL) assessment (EORTC QLQ C30 + CR29 and additional tools used locally) in selected study sites
    12. Translational research
    a.) All randomized patients will participate in the immuno-monitoring plan.
    b.) Histopathological and biological markers information available at the centers will be collected.
    c.) The Study Steering Committee may also propose additional research projects for the sponsor's approval. Those selected for separate funding will be detailed in annex protocols submitted to local ethics committees for approval at participating institutions and will be conducted in consenting patients only.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. from start of induction;

    2. 3, 4 and 5 yrs after random.

    3. on treatment after random. to 2nd PD

    4. after random. to 1st PD

    5. after re-intro of induction therapy until PD

    6. after 1st line treat. incl. induction chemo before random, maint treat & reintroduction until PD

    7. PFS rates at 2, 3, 4 yrs after random. All PFS by imaging from Scr to EoT according to local practice

    8. subgroup analyses: performed at various timepoints

    9. imaging from Scr to EoT according to local practice

    10. ongoing through study

    11. Some sites: Scr, Treat phase/maint; Treat phase/ re-induction at various visits to EOT

    12. Bloods: Scr, Treat phase/maintenance;Treat phase/ re-induction at various visits to EOT
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Quality of Life and Translational research
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    The primary analysis of the overall survival will be performed after a total of 365 events have been observed in total from both treatment arms. The study will be closed 36 months after the randomization of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 297
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 243
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 540
    F.4.2.2In the whole clinical trial 540
    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
    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 Decision2014-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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