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    Summary
    EudraCT Number:2020-000725-27
    Sponsor's Protocol Code Number:2020-000725-27
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-24
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-000725-27
    A.3Full title of the trial
    Intratumoral Influenza Vaccine for Early Colorectal Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intratumoral Influenza Vaccine for Early Colorectal Cancer
    A.4.1Sponsor's protocol code number2020-000725-27
    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 SponsorCenter for Surgical Science, Department of Surgery, Zealand 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 supportNot applied yet
    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 pointResearch fellow
    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.5.4Telephone number004531429929
    B.5.6E-mailmgog@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 Influvactetra
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Denmark
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntestinal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfluenza vaccine
    D.3.9.1CAS number 8500000-45-5
    D.3.9.2Current sponsor codeInfluvactetra
    D.3.9.3Other descriptive nameINFLUENZA VIRUS VACCINE POLYVALENT
    D.3.9.4EV Substance CodeSUB14213MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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
    Patients with colorectal cancer
    E.1.1.1Medical condition in easily understood language
    Patients with colorectal cancer
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10010032
    E.1.2Term Colorectal cancer stage I
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10010033
    E.1.2Term Colorectal cancer stage II
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10010034
    E.1.2Term Colorectal cancer stage III
    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:
    To investigate if intratumoral influenza vaccine is a safe treatment modality for tumor down staging prior to intended curative surgery in patients undergoing treatment for colorectal cancer.
    E.2.2Secondary objectives of the trial
    Secondary:
    To investigate if intratumoral influenza vaccine will induce immunologic invassion of the primary tumor.
    Tertiary:
    To investigate if the treatment will induce a systemic immunologic response
    Quality of recovery:
    To assess quality of recovery for patients recruited into this trial. A quality of recovery questionnaire will be given to patients pre- and post-treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients must be mentally capable of understanding the information given.
    • Patients must give written informed consent.
    • Clinically suspected or histologically verified malignant tumor of the rectum or sigmoid colon.
    • Tumor described as passable at index endoscopy.
    • Men or women aged at least 18 years.
    • Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection.
    E.4Principal exclusion criteria
    • Highly inflamed gastrointestinal tissue which is ulcerated and bleeding
    • Ongoing immunosuppressive treatment.
    • Concurrent treatment with an investigational medicinal product.
    • Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
    • Advanced tumor stages, clinical UICC stage IV.
    • Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
    • Acute surgical resection.
    • Pregnancy
    • Any previous allergic reaction to influenza vaccine or constituents, egg and chicken proteins, neomycin, formaldehyde or octoxinol-9
    • Acute febrile illness
    • Acute infectious disease
    • Influenza vaccine administered within 30 days before study inclusion
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints
    Safety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. We will conduct the pilot study in order to measure potential safety issues in a small cohort of patients before including patients in the phase 2 study.
    The investigation will be put on hold if unacceptable safety issues are detected.
    Primary safety endpoints:
    1. Evaluation of serious adverse events
    2. Evaluation of any adverse events reported.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before treatment with influenza vaccine and before surgery.
    E.5.2Secondary end point(s)
    The efficacy of the treatment will be evaluated according to the pathological examination of the surgical specimen. As such, final tumor staging, tumor regression grade (Mandard classification) T-cell subtype infiltration of the primary tumor and PD1/PDL-1 status before respective to after treatment are considered endpoints parameters. Furthermore, systemic immune responses will be evaluated through a multiplex gene assay, flow cytometry and NK cell activity analysis. A detailed evaluation of patient reported quality of recovery will be performed through repetitive administration of standardized questionnaires before the treatment with influenza vaccine (baseline), before surgery, postoperative day 2-3, and at follow-up (postoperative day 12-16).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before treatment with influenza vaccine, before surgery, postoperative day 2-3 and postoperative day 12-16
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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)
    The patients will follow standard treatment and monitoring guidelines
    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 Decision2020-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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