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    Summary
    EudraCT Number:2020-004536-22
    Sponsor's Protocol Code Number:EPIC2020
    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:2020-10-21
    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 number2020-004536-22
    A.3Full title of the trial
    A phase II Study of Electroporation Potentiated Immunotherapy in Liver Metastatic Pancreatic Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Electrical stimulation and immunotherapy for pancreatic cancer which has spread to the liver
    Elektrisk stimulation og immunterapi til kræft i bugspytkirtlen med spredning til leveren
    A.3.2Name or abbreviated title of the trial where available
    Electroporation Potentiated Immunotherapy in Cancer - 1st study (EPIC-1)
    A.4.1Sponsor's protocol code numberEPIC2020
    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 SponsorOle Thorlacius-Ussing
    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 supportDanish Cancer Society
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMorten Ladekarl
    B.5.2Functional name of contact pointClinical trial information
    B.5.3 Address:
    B.5.3.1Street AddressHobrovej 18-22
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post codeDK-9000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4597660545
    B.5.6E-mailmorten.ladekarl@rn.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 Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Concentrate for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPembrolizumab
    D.3.9.2Current sponsor codeEPIC2020
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 pancreatic cancer
    E.1.1.1Medical condition in easily understood language
    Cancer of the pancreas with metastases
    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 LLT
    E.1.2Classification code 10033605
    E.1.2Term Pancreatic cancer metastatic
    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
    To investigate the efficacy and safety of combined irreversible electroporation and checkpoint inhibition in liver metastatic pancreatic cancer
    E.2.2Secondary objectives of the trial
    - To evaluate the effects of the combined treatment on anti-cancer immunity
    - To evaluate the effects of the combined treatment on perceived quality of life and nutritional status
    - To evaluate the effects of the combined treatment on tumor biological pathways and gene expression
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically verified pancreatic adenocarcinoma, based on either a biopsy of the primary tumor or a metastasis
    2. One liver metastasis treatable by IRE (as determined by MDT at Aalborg University Hospital)
    3. One tumor lesion suited for repeated biopsy by transcutaneous core needle (preferably another lesion than that used for IRE)
    4. At least one measurable lesion (RECIST version 1.1) other than the liver metastasis to be treated by IRE
    5. At least one course of chemotherapy for metastatic or inoperable disease discontinued due to treatment failure or intolerance
    6. Performance status 0-1
    7. ASA ≤ 3
    8. ≥ 18 years of age
    9. Written and orally informed consent
    10. Sufficient available histological tumor material stored in biobank or obtainable by new biopsy
    11. Patient acceptance of collection of blood samples for translational research and two additional biopsies during treatment
    12. Adequate bone marrow function, liver function, and renal function (within 7 days prior to enrollment):
    a. Neutrophils (ANC) ≥ 1.5 x 109/l
    b. Platelet count ≥ 100 x 109/l
    c. Hemoglobin ≥ 6 mmol/l
    d. Plasma bilirubin ≤ 1.5 x ULN
    e. Plasma alanine transaminase (ALAT) < 5 x ULN
    f. Plasma creatinine ≤ 1.5 x ULN
    g. INR ≤ 1.5
    E.4Principal exclusion criteria
    1. Underlying medical disease not adequately treated (e.g. poorly regulated diabetes and symptomatic cardiac disease)
    2. Prior or current autoimmune disorder with risk of serious toxicity during treatment with checkpoint inhibitor
    3. Acute myocardial infarction, cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within 6 months from start of treatment
    4. Previous reception of allogeneic stem cells or solid organ donation
    5. Active infection requiring systemic therapy within 7 days prior to treatment initiation
    6. Positive HIV, HBV, and HCV test results (prior testing or new testing in patients at risk)
    7. Active psychiatric disease or history of drug or alcohol abuse affecting participation
    8. Allergy to active substance or any of the auxiliary agents, including known severe allergy to anesthetic agent, paralytic agent or any of the equipment used during treatment
    9. Expected need for systemic corticosteroid or other systemic immunosuppressive drug during the course of this clinical trial. A low dose of e.g. prednisone ≤ 10 mg/day is permitted for maximally 7 consecutive days
    10. Coexisting malignant disease, except non-melanoma skin cancer
    11. Symptomatic or untreated CNS metastases
    12. Liver cirrhosis Child Pugh >A
    13. Pregnant or breast-feeding patients. For women of childbearing potential, a negative pregnancy test at screening is mandatory
    14. Women of childbearing potential not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment. Male patients with a fertile partner are also required to secure effective methods of contraception
    15. Previous immunotherapy
    16. Patients referred from a hospital outside of Denmark
    17. Major dilation of veins or bowel obstructing the needle path
    18. Persistent atrial fibrillation
    19. Metal objects (e.g. biliary SEMS) within 5 cm of ablation target
    20. Cardiac pacemaker or ICD, that cannot be safely disconnected during IRE treatment
    E.5 End points
    E.5.1Primary end point(s)
    1. Objective response rate (ORR) according to RECIST 1.1 (in patients receiving at least one dose of pembrolizumab, IRE and an evaluable CT-scan)
    2. Serious adverse reaction (SAR) rate according to CTCAEv5 (in patients receiving at least one dose of pembrolizumab)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of trial
    E.5.2Secondary end point(s)
    3. Median overall survival (mOS)
    4. Median progression-free survival (mPFS)
    5. ORR (in patients that have received at least one dose of pembrolizumab and an evaluable CT-scan)
    6. Clinical benefit ratio (defined as objective response or stable disease for at least 8 weeks during treatment in patients receiving at least one dose of pembrolizumab, IRE and an evaluable CT-scan)
    7. Serum CA 19-9 response (response defined as a decrease of at least 20 % observed during treatment in patients with elevated CA 19-9 at baseline)
    8. Survival rate after 6 and 12 months
    9. Progression-free survival rate after 6 and 12 months
    10. Mean difference (multiple timepoints) in perceived quality of life (for subscales of EORTC QLQ C-30 v3 including Global health status / QoL (QL2), Physical functioning (PF2), Fatigue (FA), Nausea and vomiting (NV), Pain (PA), Appetite loss (AP) and Diarrhea (DI)
    11. Mean difference (multiple timepoints) in nutrition status (numerical score of PG-SGA-SF)
    12. Difference in peripheral blood immune cell composition during active treatment and follow-up compared to baseline
    13. Histological tumor regression grade in tumor biopsies after pembrolizumab and after pembrolizumab + IRE compared to baseline
    14. Difference in tumor RNA expression pattern after pembrolizumab and after pembrolizumab + IRE compared to baseline
    15. Mean difference in peripheral blood concentration of cancer immunology associated cytokines during active treatment and follow-up compared to baseline
    16. Difference in (histological) leukocyte infiltration pattern after pembrolizumab and after pembrolizumab + IRE compared to baseline
    17. Difference in detectable peripheral blood cell-free DNA mutations and amount after pembrolizumab and after pembrolizumab + IRE compared to baseline
    18. Adverse event rate (CTCAEv5, all grades)
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of trial
    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 Yes
    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 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 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
    The last visit of the last subject undergoing the trial
    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 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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 Information not present in EudraCT
    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 state16
    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 Decision2020-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-03-07
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