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    Summary
    EudraCT Number:2009-017432-40
    Sponsor's Protocol Code Number:MGN1703-C02
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-02-02
    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 ConcernedAustria - BASG
    A.2EudraCT number2009-017432-40
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-Center Clinical Study to Evaluate Efficacy and Safety of a Maintenance Therapy with Immunomodulator MGN1703 in Patients with Advanced Colorectal Carcinoma with Disease Control after Initial First-line Therapy (IMPACT Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a clinical trial to evaluate efficacy and safety of a drug activating the immune system MGN1703 in patients with advanced colorectal cancer, which achieved disease stabilization or improvement after initial chemotherapy. The patients will be assigned occasionally (like by tossing a coin) either to treatment with MGN1703 or with placebo, a preparation matching MGN1703, however, without the active substance.
    A.3.2Name or abbreviated title of the trial where available
    IMPACT Study
    A.4.1Sponsor's protocol code numberMGN1703-C02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01208194
    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 organisationBASG/AGES PharmMed
    B.5.2Functional name of contact pointBundesamt für Sicherheit im Gesundh
    B.5.3 Address:
    B.5.3.1Street AddressSchnirchgasse 9
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1030
    B.5.3.4CountryAustria
    B.5.4Telephone number+4350 555-36111
    B.5.6E-mailpr_pharmmed@ages.at
    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 dSLIM-30L1
    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.3.9.2Current sponsor codeMGN1703
    D.3.9.3Other descriptive namedouble Stem Loop Immunomodulator-30L1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Yes
    D.3.11.13.1Other medicinal product typesynthetic oligonucleotide for immunological treatment
    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
    Patients with advanced colorectal carcinoma (AJCC Stage IV) with disease control after initial first-line therapy
    E.1.1.1Medical condition in easily understood language
    Patients with advanced metastatic colorectal carcinoma which responded to disease control after an initial first line chemotherapy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 this study is to demonstrate that the efficacy variables of MGN1703 in the maintenance treatment of patients with advanced colorectal carcinoma with disease control after initial first-line therapy is superior to placebo. For this purpose median PFS in both treatment groups will be evaluated.
    E.2.2Secondary objectives of the trial
    Median PFS from start of induction therapy
    Assess PFS rate in both groups at landmarks 12, 18 and 24 weeks after treatment start, and afterwards every 12 weeks until treatment stop
    Evaluate median OS and OS from start of induction therapy
    Assess OS proportion in both groups at the same landmarks
    Evaluate ORR
    Evaluate duration of response as time from initial determination of response to progressive disease
    Assess dynamic of clinical and laboratory parameters in terms of
    physical examination, ECOG, CEA in course of treatment
    Evaluate immunologic response to MGN1703 in terms of assessment of cytokine/chemokine, frequency and activation status of cell subpopulations (plasmacytoid dendritic cells, myeloid dendritic cells (mDC), natural killer cells (NK), NKT, B and T cells), cell culture in-vitro test and analysis of blood mRNA in course of treatment
    Assess quality of life (QOL)
    Assess the safety profile of MGN1703
    Assess autoimmunity of subcutaneously administered MGN1703
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects fulfilling the following criteria are eligible for participation in the study:
    1. Male and female subjects older than 18 years of age
    2. Histologically confirmed colorectal carcinoma
    3. Radiological confirmation of unresectable advanced colorectal carcinoma (AJCC Stage IV) prior to start of initial first-line therapy
    4. At least one measurable lesion according to RECIST measured within 2 weeks prior to treatment start in case of partial response or stable disease
    5. Prior initial first-line therapy included oral or intravenous fluoropyrimidines/leucovorin, irinotecan or oxaliplatin with or without a standard dose of bevacizumab lasted between 4.5 and 6 months and finished (last day of last cycle) within 2 weeks prior to treatment start (treatment duration with irinotecan or oxaliplatin should not be less than 3 months)
    6. Patients who achieved disease control measured as objective response or disease stabilization after initial first-line therapy
    7. No curative standard therapy is available for the patient after first-line treatment
    8. ECOG performance status 0-1
    9. Adequate organ function, hemoglobin ≥ 9 g/L, white blood cell count (WBC) ≥ 3.0 x 109/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets > 100 x109/L, aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 x ULN, bilirubin < 1.5 x ULN, blood creatinine ≤ 1.5 X ULN, prothrombin time (PT) and activated thromboplastin time (aPTT) within normal range
    10. Negative pregnancy test in women with childbearing potential
    11. Expected adequacy of follow-up
    12. Signed informed consent form (ICF).
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria will be excluded from the study:
    1. More than one line of systemic chemotherapy for metastatic colorectal carcinoma
    2. Tumor progression after initial first-line therapy
    3. Clinically significant concomitant diseases or conditions unrelated to the underlying malignancy or chemotherapy, which in opinion of the investigator would lead to an unacceptable risk for the subject to participate in the study
    4. Prior or current other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin or other cancer for which the subject has been disease free for more than 3 years
    5. Known central nervous system metastases
    6. Active or uncontrolled infections
    7. Transfusion-dependent anemia
    8. History of autoimmune disease or immune deficiency
    9. Known hypersensitivity to oligonucleotides or excipients of the formulation
    10. Pregnancy and/or nursing
    11. Concurrent chronic systemic immune therapy or immunosuppressant medication, including steroid treatment
    12. Concurrent chemotherapy, hormonal therapy (except hormonal contraception and hormonal replacement therapy for menopausal women), or immunotherapy within the last 2 weeks prior to randomization or during the conduct of the study
    13. Concurrent radiotherapy within the last 6 months prior to randomization or during the conduct of the study
    14. HIV seropositivity or active hepatitis B or C infection
    15. Planned major surgery during the study
    16. Participation in another clinical study with other investigational drugs within 14 days prior to the first treatment day
    17. Vaccination within 3 months prior to the first treatment day
    18. Any medical, mental, psychological or psychiatric condition which in opinion of the investigator would not permit the subject to complete the study or understand the patient information
    19. Presence of drug and/or alcohol abuse.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this clinical study is the median PFS in both treatment groups and their comparison by means of a log rank test. The level of significance will be stipulated to α = 5 %. Moreover, the PFS rates will be analyzed by means of Mantel-Haenszel tests stratified by center. The survival curves will be presented by means of Kaplan-Meier curves.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis was performed on all the data available with a cutoff date of 05 April 2012.
    E.5.2Secondary end point(s)
    Progression-free survival (PFS) from the start of induction therapy, PFS rates at landmark of 12, 18 and 24 weeks after treatment start, and afterwards every 12 weeks until treatment stop, median overall survival (OS), OS from the start of induction therapy, overall survival rates at the same landmark, objective response rate (ORR), and duration of response
    as time from initial determination of response to progressive disease, measured by RECIST, dynamic of clinical and laboratory signs, dynamic of immunologic response, and quality of life.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The evaluation of the efficacy and safety endpoints will be conducted after the treatment with the investigational drugs is finished in all study participants, or when all 74 (65 x 1.125 due to 2:1 randomization) statistically calculated events occurred.
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Austria
    Czech Republic
    France
    Germany
    Russian Federation
    United Kingdom
    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
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 129
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 129
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 129
    F.4.2.2In the whole clinical trial 129
    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)
    After the treatment and the study have been finished in a particular patient, a post-study surveillance phase will be conducted for a total time of 144 weeks (approximately 3 years) after study start. Survival status in each particular patient will be assessed every 12 weeks up to the end of the 2nd year and every 24 weeks up to the end of the 3rd year after the study start.
    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 Decision2010-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-04-01
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