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    Summary
    EudraCT Number:2020-004567-11
    Sponsor's Protocol Code Number:75911
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-29
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-004567-11
    A.3Full title of the trial
    Effect of Low-dose Interferon-alfa2a on peri operative immune suppression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Low-dose Interferon-alfa2a on immune suppression after surgery
    A.4.1Sponsor's protocol code number75911
    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 SponsorZealand University Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCenter for Surgical Science, Department of Surgery, Zealand University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenter for Surgical Science, Department of Surgery, Zealand University Hospital
    B.5.2Functional name of contact pointCenter for Surgical Science
    B.5.3 Address:
    B.5.3.1Street AddressLykkebækvej 1
    B.5.3.2Town/ cityKøge
    B.5.3.3Post code4600
    B.5.3.4CountryDenmark
    B.5.6E-mailheyi@regionsjaelland.dk
    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 Yes
    D.2.1.1.1Trade name Pegylated Interfeon alfa 2a
    D.2.1.1.2Name of the Marketing Authorisation holderRoche A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 namePegylated Interferon alfa 2a
    D.3.4Pharmaceutical form 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 INNPEGINTERFERON ALFA-2A
    D.3.9.1CAS number 198153-51-4
    D.3.9.3Other descriptive namePeginterferon Alfa-2a
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    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
    pMMR Colon cancer
    E.1.1.1Medical condition in easily understood language
    Colon cancer with proficient mismatch repair system
    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 10009944
    E.1.2Term Colon 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
    The aim of this study is to examine the effect of pre-operative Interferon-α2a administration on post-operative immune suppression and changes in the tumour microenvironment. We hypothesize, that interferon enhances pre-operative immune function, lowers post-operative immune paralysis and increases infiltration of lymphocytes in the local tumor microenvironment.
    E.2.2Secondary objectives of the trial
    Patient reported outcome measures
    NanoString analysis
    cfDNA analysis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients above 18 years of age.
    2. Patients diagnosed with pMMR colonic adenocarcinoma and scheduled for laparoscopic hemicolectomy.
    3. ASA class I-III (Classification of the American Society of Anesthesiology)
    E.4Principal exclusion criteria
    • Patients with childbearing potential without a negative pregnancy test before initiating
    study drug and / or non-acceptance to the use of contraceptive methods *
    • ECOG score function> / = 3
    • Current liver or renal disease.
    • Previous depression diagnosed by a psychiatrist or in treatment with antidepressant
    • Autoimmune disease.
    • Uncontrolled thyroid disease.
    • Patients who are or have recently (within 6 months) received
    treatment with immunosuppressive agents other than corticosteroid treatment.
    • Epilepsy and / or other serious CNS disorders.
    • Patients that have undergone major surgery within one month before planned colon resection.
    • Known hypersensitivity to recombinant interferon or auxiliary products of Pegasys®.
    * Spiral, pill, implant, transdermal patch, vaginal ring or depot injection. Sterile / infertile
    subjects are exempt from the use of contraception. To be considered sterile or infertile must
    generally be surgical sterilization (vasectomy, bilateral tubectomy, hysterectomy or
    ovariectomy) or be postmenopausal, defined as absent menstruation for at least 12 months
    prior to study enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint consists of two primary outcomes:
    • Differences in measures of lymphocytic subpopulations (FLOW) between intervention and placebo group, seen as a higher number of CD3, 4, 8 and HLA-positive cells in the intervention group, on the day before and the day after surgery.
    • Differences in tumor-infiltrating lymphocytes in the resected specimen at the tumor center and invasive margin between the intervention and placebo group. This will be analysed via immunohistochemistry with staining for CD3+, CD4+ and CD8+ T-cells.
    E.5.1.1Timepoint(s) of evaluation of this end point
    FLOW analysis: On blood samples the day before surgery versus blood samples the day after surgery
    Tumor-infiltrating lymphocyte analysis: On the resected specimen on the day of surgery.
    E.5.2Secondary end point(s)
    • Differences in measures of Quality of recovery (QoR-15) between intervention and placebo group, seen as a higher mean QoR in intervention group on the third and 12-16 post-operative day.
    • Differences in key systemic immune responses in blood, between the intervention and placebo group on samples taken before first treatment and before surgery, analysed via a multiplex gene assay. The multiplex gene assays include pathways related to antigen presentation (MHC-I, MHC-II, CD3, CD4 and CD8 related pathways) and related to innate cytotoxic and inflammatory activity (NK cells, macrophages and neutrophils).
    • Differences in tumor microenvironment in the resected specimen, analysed via a multiplex gene assay, between the placebo and intervention group. The multiplex gene assays include pathways related to antigen presentation (MHC-I, MHC-II, CD3, CD4 and CD8 related pathways) and related to innate cytotoxic and inflammatory activity (NK cells, macrophages and neutrophils).
    • Differences in cfDNA on approximately day 7 and day 1 before surgery and day 2, 12-16 and 28-32 after surgery between the placebo and intervention group.
    • Intragroup differences in tumor microenvironment in the biopsy before surgery vs the resected specimen.
    • Differences in measures of standard blood samples between the two groups, seen as a lower inflammation-grade in the intervention group, on the day prior to surgery (lower CRP and neutrophil/leukocyte ratio).
    • Differences in cytokines and interleukins related to post-operative inflammation between placebo and intervention group, with lower measures of inflammatory cytokines on the day before and the day after surgery in the intervention group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Differences in QoR-15: Third and 12-16 postoperative day
    Multiplex gene assay of systemic immune response: Blood samples taken before first treatment and before surgery.
    Multiplex gene assay of tumor microenvironment: On the resected specimen on the day of the surgery.
    cfDNA analysis: On blood samples taken before first treatment, before surgery, and day 2, 12-16 and 28-32 after surgery
    Intragroup differences in tumor microenvironment: Biopsies from index colonoscopy (3 weeks before surgery) and from the resected specimen..
    Difference in standard blood samples: On blood samples taken before first treatment, before surgery, and day 2, 12-16 and 28-32 after surgery.
    Cytokines related to postoperative inflammation: On blood samples taken before and after surgery.
    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 No
    E.6.5Efficacy No
    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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 48
    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 state68
    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 continue to receive standard post-operative care and treatment for colon cancer after completion of this trial
    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 Decision2020-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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