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    Summary
    EudraCT Number:2020-003945-13
    Sponsor's Protocol Code Number:NL7498507820
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-28
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-003945-13
    A.3Full title of the trial
    Safety and efficacy of IMM-101 combined with stereotactic radiotherapy in patients with limited MEtastatic PANcreatic Cancer
    (MEPANC-1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of adding immunotherapy combined with stereotactic radiotherapy in patients with limited metastatic pancreatic cancer
    (MEPANC-1)
    A.3.2Name or abbreviated title of the trial where available
    MEPANC-1
    A.4.1Sponsor's protocol code numberNL7498507820
    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 SponsorErasmus MC
    B.1.3.4CountryNetherlands
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportImmodulon Therapeutics
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointresearch coordinator
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 2040
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3000 CA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031650032401
    B.5.6E-mailj.verhagen-oldenampsen@erasmusmc.nl
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1385
    D.3 Description of the IMP
    D.3.2Product code IMM-101
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMYCOBACTERIUM OBUENSE
    D.3.9.2Current sponsor codeIMM-101
    D.3.9.3Other descriptive nameMYCOBACTERIUM OBUENSE
    D.3.9.4EV Substance CodeSUB121760
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Limited metastatic pancreatic cancer
    E.1.1.1Medical condition in easily understood language
    metastatic pancreatic cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level LLT
    E.1.2Classification code 10033605
    E.1.2Term Pancreatic cancer metastatic
    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
    This is an open-label, non-randomized, multicentre phase II study with an initial safety-run in. During the safety run-in phase, we will investigate the safety of combining IMM-101 administration with SBRT in 20 patients with limited metastatic disease in the liver and/or lung. If deemed safe, we will continue inclusion in the second phase of the study with an additional 80 patients in order to evaluate the efficacy of combining IMM-101 treatment with SBRT based on a 100% improvement of progression free survival.
    The primary objective of the safety run-in is to determine safety of IMM-101 combined with SBRT in patients with limited metastatic pancreatic cancer. When this combination is found to be safe, the second phase of the study will be initiated, the primary objective of the phase II is to investigate the potential efficacy of IMM-101 combined with SBRT.
    E.2.2Secondary objectives of the trial
    • Overall survival calculated from the start of FOLFIRINOX (OS1).
    • Overall survival calculated from start of IMM-101 (OS2).
    • Progression-free survival calculated from the start of IMM-101 (PFS 2) at 12-month to the date of progressive disease of the primary tumour, locoregional recurrence, progression of previously treated lungs and/or liver metastases, the occurrence of new metastases, or death. All included patients will be analysed for this endpoint.
    • Quality of Life.
    • Radiological response rate after IMM-101 and SBRT using iRECIST criteria.
    • Radiological response rate after IMM-101 and SBRT using RECIST criteria (version 1.1).
    • Immunological effects: effect of IMM-101 and SBRT on circulating immune cells.
    • Effect on tumour markers, CA19.9 and CEA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed (metastatic) pancreatic cancer, as indicated by a definite cytology/histology report.
    • ≤5 hepatic and/or pulmonary metastases in total.
    • The combined diameter of all liver metastases AND the primary tumour or local recurrence in the pancreas is <9 cm.
    • The combined diameter of all pulmonary metastases is <9 cm.
    • CA 19-9 < 1000 IU/mL after completion of chemotherapy.
    • Age > 18 years and < 75 years.
    • WHO performance status of 0-2
    • Tumour volume of the primary tumour <7cmx7cmx7cm. Each diameter must not exceed 7 cm.
    • Adequate renal function (eGFR ≥ 30 ml/min).
    • Adequate liver tests (bilirubin < 1.5 times normal; ALAT/ASAT < 5 times normal).
    • Adequate bone marrow function (WBC > 3.0 x 109/L, platelets > 100 x 109/L and hemoglobin > 5.6 mmol/l).
    • Effective contraceptive methods.
    • Written informed consent.
    • Patients who did not complete at least 8 cycles of FOLFIRINOX due to severe toxicity, will be included in the expansion cohort.
    E.4Principal exclusion criteria
    • Metastasis in other organs than the lung and liver.
    • Histopathologically proven extra regional lymph node metastasis.
    • Malignant ascites.
    • Liver function insufficient to tolerate the prescribed dose of radiotherapy.*
    • Child-Pugh Classification grade B/C.
    • Lung function insufficient to tolerate the prescribed dose of radiotherapy.*
    • Diffuse liver metastasis pattern on CT scan.
    • Current or previous treatment with immunotherapeutic drugs.
    • Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 5 years previously to diagnosis of pancreatic cancer and without evidence of recurrence.
    • Pregnancy, breast feeding.
    • An active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or other immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the planned first dose of the study. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
    • History of Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies).
    • Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
    • Positive PCR test for presence of SARS-CoV-2 during screening stage.
    • Live virus vaccine within 30 days of planned start of trial treatment.
    • Use of herbal remedies, including traditional Chinese herbal products (e.g., mistletoe).
    • Allergic reaction to M. obuense or had previously received IMM-101.
    • Otherwise deemed unsuitable by the Investigator.
    *To be determined by the treating radiologist.
    E.5 End points
    E.5.1Primary end point(s)
    Safety run-in
    The main goal of this study is to determine safety of IMM-101 and SBRT in patients with limited metastatic disease in the lung and/or liver from PDAC. The toxicity of IMM-101 and SBRT is defined according to Common Terminology Criteria for Adverse Events (CTCAE version 5). Safety will be assessed in terms of grade 3, 4 and 5 events related to the IMM-101 vaccination or SBRT before, during and after IMM-101 and SBRT in patients included in the standard and expansion cohort. With a sample size of 20 (10 per cohort), we will be able to estimate a toxicity rate of 10 % to within a 95% confidence interval of [1.2%, 31.7%] using the binomial exact method. This means at 95% confidence level max. up to 6 patients out of 20 patients can be allowed to have grade 3/4/5 toxicity. If up to a maximum of 6 patients out of 20 develop AEs related to IMM-101 administration, then we feel that including the remaining patients in the phase II study testing efficacy is warranted. All grade 3, 4 and 5 events related to the administration of the IMM-101 product will be considered events for this endpoint.

    Phase II
    The main endpoint of the second inclusion phase is to asses efficacy of IMM-101 therapy and SBRT in patients with limited metastatic disease in the lungs and/or liver from PDAC. Efficacy will be determined using 1-year progression free survival. Progression free survival will be calculated from the start FOLFIRINOX to the date of death. With a power of 0,80 and α of 0.05 a total of 56 (standard cohort) and 44 (expansion cohort) (including patients of the safety run-in patients will be included in the phase II study to determine an increase of the 1-year progression-free survival from 12% to 24% (standard cohort) and 5% to 15% (expansion cohort) (Fleming’s procedure). All included patients (i.e. 100 patients) will be analysed for this endpoint.
    E.5.1.1Timepoint(s) of evaluation of this end point
    LPLV
    E.5.2Secondary end point(s)
    • Overall survival calculated from the start of FOLFIRINOX (OS1).
    • Overall survival calculated from start of IMM-101 (OS2).
    • Progression-free survival calculated from the start of IMM-101 (PFS 2) at 12-month to the date of progressive disease of the primary tumour, locoregional recurrence, progression of previously treated lungs and/or liver metastases, the occurrence of new metastases, or death. All included patients will be analysed for this endpoint.
    • Quality of Life.
    • Radiological response rate after IMM-101 and SBRT using iRECIST criteria.
    • Radiological response rate after IMM-101 and SBRT using RECIST criteria (version 1.1). Details about the RECIST criteria are shown in Appendix A.
    • Determining immune responses as described in section 8.3.6.
    • Effect on tumour markers: pre- and 2x post-treatment CA19.9 and CEA levels will be assessed on blood samples.
    E.5.2.1Timepoint(s) of evaluation of this end point
    LPLV
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months7
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state100
    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)
    Following standard of care procedures patients will undergo a CT scan 12 weeks after SBRT completion. If the CT-scan shows progression of metastatic burden, patients will be discussed with medical oncologists for further palliative treatment. If the patient does not show (clinical) progression, IMM-101 will be administered at a 4-week interval for a maximum of 12 months.
    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 Decision2020-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
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