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    Summary
    EudraCT Number:2020-003166-39
    Sponsor's Protocol Code Number:ChImDLP-2
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-25
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2020-003166-39
    A.3Full title of the trial
    A study of the safety of chemoimmunotherapy with autologous Dendritic Cell Preparations in patients with stage III ovarian cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the safety of chemotherapy and immunotherapy in patients with ovarian cancer
    A.4.1Sponsor's protocol code numberChImDLP-2
    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 SponsorUAB Froceth
    B.1.3.4CountryLithuania
    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 supportUAB Froceth
    B.4.2CountryLithuania
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUAB Froceth
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressMokslininkų str. 6A
    B.5.3.2Town/ cityVilnius
    B.5.3.3Post codeLT-08214
    B.5.3.4CountryLithuania
    B.5.4Telephone number+37064837 591
    B.5.6E-mailinfo@froceth.lt
    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 nameDendritic Cells Preparation
    D.3.4Pharmaceutical form Suspension 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 INNDendritic Cells Vaccine for ovarian cancer
    D.3.9.3Other descriptive nameCELL SUSPENSION CONTAINING DENDRITIC CELLS
    D.3.9.4EV Substance CodeSUB120526
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    Stage III of high malignancy Ovarian serous adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10070907
    E.1.2Term Ovarian 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
    To determine the safety and tolerability of autologous dendritic cell preparations (DCPs) in combination with carboplatin and paclitaxel in patients with stage III high malignancy G2-G3 ovarian serous adenocarcinoma.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of immunotherapy with DCP in combination with carboplatin and paclitaxel on the survival of patients with stage III high malignancy ovarian serous adenocarcinoma until the first progression of the disease.
    2. To evaluate the effect of immunotherapy with DCP in combination with carboplatin and paclitaxel on the overall survival of patients with stage III high malignancy ovarian serous adenocarcinoma.
    3. To evaluate the changes in quality of life according to EORTC (QLQ C30 (3rd edition) and QLQ OV28) criteria using DCP.
    4. To identify immunological markers whose values or dynamics would be associated with a positive response to DCP treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Has a major, stage III, high malignancy (G2-G3) ovarian adenocarcinoma confirmed by histological examination and no BRCA1/2 gene mutation has been identified;
    • Optimal citoreduction was performed (R0);
    • Post-operative chemotherapy with combination of carboplatin and paclitaxel is indicated;
    • Signed Informed consent form;
    • Age 18-70
    • Karnovsky Index> 70%, ECOG 0-1;
    • Hemoglobin concentration ≥ 110 g / l;
    • Leukocyte count ≥ 3 × 109 / l, neutrophil count ≥ 1.5 × 109 / l, lymphocyte count ≥ 0.5 × 109 / l, platelet count ≥ 100 × 109 / l, monocyte count ≥ 0.2 × 109 / l;
    • Albumin concentration> 25 g / l;
    • CRP - not more than 20 mg / L (and without signs of infection), creatinine - up to 140 mkmol / L,
    • Normal or no more than 5 times the upper limit of normal for the following biochemical tests: AST, ALT, bilirubin (total, direct), pancreatic α-amylase;
    • Prothrombin time (TNS / INR = 0.7-2.5);
    • Negative blood test results for HIV-1/2, HBV (anti-HBcor + anti-HBs + HBsAg), HCV and syphilis (RPR and TPHA) infections;
    • Do not suffer from autoimmune diseases, active tuberculosis, acute or chronic boreal (Lyme disease);
    • Do not suffer from severe cardiovascular disease (acute or chronic arrhythmia, unstable angina pectoris, uncontrolled heart failure (NYHA class IV), cerebral ischemic stroke or myocardial infarction in the last 12 months)
    E.4Principal exclusion criteria
    • BRCA1 / 2 gene mutation has been identified;
    • Suffer from unstable or / and complicated respiratory, digestive, urogenital, endocrine, metabolic and haematological diseases that may affect the patient's survival (eg unstable angina, severe chronic obstructive pulmonary disease, etc.) ;
    • Have autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, type I diabetes, heavy myasthenia, dermatomyositis, etc.);
    • Have had other localized malignancies in the last ten years, except for epithelial skin tumors (basal cell carcinoma and non-widespread flat cell carcinoma);
    • Severe post-operative complications (sepsis, peritonitis due to bowel anostomosis, intra-abdominal abscesses, etc.) which, according to the investigator, is significant related to the immune system response
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events in treatment group; safety difference between the study groups
    E.5.1.1Timepoint(s) of evaluation of this end point
    THE SAFETY OF TREATMENT WILL BE ASSESSED:
    • according to the CTCAE v5.0 (Common Terminology Criteria for Adverse Events) description;
    • according to the ECG: before the first course of chemotherapy; 5-10 days after the third course of chemotherapy; 28 d. after VI chemotherapy injection; 84 days after completion of chemotherapy
    • according to general blood and biochemical tests (general blood and biochemical tests are performed in a local laboratory according to the methodologies used in clinical practice):
    - before each course of chemotherapy;
    - after 4, 8, and 12 weeks. after chemotherapy (study group) and 4, 12 weeks. after chemotherapy (control group);
    -in follow up until disease progression as clinically indicated.
    E.5.2Secondary end point(s)
    1. Differences in overall survival between the study groups
    2. The time of onset of disease progression in patients in the treatment group
    3. Changes of immunological markers in the treatment group compared to baseline.
    4. Changes of quality of life compared to between the study groups
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. The computer tomography and marker Ca-125 will be tested:
    • before postoperative treatment
    • every 2 months until 12 months after the chemotherapy end, then every 3 months until the first progression of the disease;
    2. The immunoprofile:
    • before the start of post-operative treatment;
    • 5-10 days after the 3rd chemotherapy course;
    • 4 weeks after chemotherapy (control group) or chemoimmunotherapy (study group)
    3. Changes in quality of life will be recorded:
    - during randomization;
    - before each course of chemotherapy;
    - after 4 and 8 weeks after chemotherapy, later every 3 months until the first progression of the disease (study group);
    - every 3 months after completion of chemotherapy until the first progression of the disease (control group)
    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) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    The patients in the control group will not receive the treatment with Dendritic Cells preparation
    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 years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 state44
    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 complete the trial or will be withdrawn will receive a standard treatment for ovarian cancer
    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 Decision2022-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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