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    Summary
    EudraCT Number:2022-003845-36
    Sponsor's Protocol Code Number:EFTISARC-NEO/NIO-0004
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-02-22
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-003845-36
    A.3Full title of the trial
    A Phase II, single-arm clinical trial evaluating efficacy and safety of pembrolizumab in combination with a soluble LAG-3 protein, eftilagimod alpha, and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas (EFTISARC-NEO).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study evaluating the efficacy and safety of preoperative immunotherapy (pembrolizumab with eftilagimod alfa) in combination with radiotherapy in patients with operable soft tissue sarcomas.
    A.3.2Name or abbreviated title of the trial where available
    EFTISARC-NEO/NIO-0004
    A.4.1Sponsor's protocol code numberEFTISARC-NEO/NIO-0004
    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 SponsorNarodowy Instytut Onkologii im. Marii Skłodowskiej-Curie – Państwowy Instytut Badawczy
    B.1.3.4CountryPoland
    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 supportMedical Research Agency
    B.4.2CountryPoland
    B.4.1Name of organisation providing supportImmutep
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNarodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy (NIO-PIB)
    B.5.2Functional name of contact pointKatarzyna Kozak
    B.5.3 Address:
    B.5.3.1Street Addressul. W.K. Roentgena 5
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code02-781
    B.5.3.4CountryPoland
    B.5.4Telephone number22 546 20 51
    B.5.6E-mailkatarzyna.kozak@pib-nio.pl
    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 nameEFTILAGIMOD ALPHA
    D.3.2Product code IMP321
    D.3.4Pharmaceutical form Solution 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 INNEftilagimod alfa
    D.3.9.1CAS number 1800476-36-1
    D.3.9.2Current sponsor codeIMP321
    D.3.9.3Other descriptive nameLAG-3-ig, efti
    D.3.9.4EV Substance CodeSUB193043
    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) Yes
    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.IMP: 2
    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. Waarderweg 39 2031 BN Haarlem Netherlands
    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.3.1Product namePEMBROLIZUMAB
    D.3.4Pharmaceutical form
    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.3.9.4EV 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) 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
    Resectable soft tissue sarcomas
    E.1.1.1Medical condition in easily understood language
    a sarcoma that qualifies for surgical treatment
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    Evaluation of the efficacy of pembrolizumab and eftilagimod
    alfa in combination with preoperative radiotherapy in patients with
    resectable soft tissue sarcomas by analyzing the pathological response in the postoperative material.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    • assessment of the pathological response according to EORTC-STBSG criteria
    • assessment of radiological response according to RECIST 1.1 criteria
    • assessment of disease-free survival (DFS), local relapse-free survival (LRFS) and distant metastasis free survival (DMFS) and overall survival (OS)
    • evaluation of the safety of the combination of pembrolizumab with
    eftilagimod alfa
    • assessment of patients' quality of life (EORTC QLQ-C30 scale and FACT-
    G)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Willing and able to provide written informed consent for the trial.
    -Be ≥ 18 years of age on day of signing informed consent.
    -Performance status of 0 to 1 on the ECOG Performance Scale.
    -Primary or locally recurrent deep-seated extremities, girdles and/or
    superficial trunk (thoracic or abdominal wall) soft tissue
    sarcoma
    -Grade 2 or 3 tumors according FNCLCC.
    -Size of the primary tumor >5 cm at instrumental staging (CT, MRI), or locally recurrent of any
    size;
    - Measurable disease based on RECIST 1.1;
    -Non-metastatic disease.
    -No previous systemic treatment for sarcoma.
    E.4Principal exclusion criteria
    - Ewing sarcoma, Alveolar and embryonal rhabdomyoarcoma.
    -Previous treatment with eftilagimod alpha, anty-PD-1 or ant-PD-L1.
    -Prior radiotherapy to tumor-involved sites.
    -Subjects with active, known or suspected autoimmune disease or inflammatory bowel disease, which, in the opinion of the investigator, might impair the subject’s tolerance of trial treatment. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to
    autoimmune condition only requiring replacement therapy, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
    -A concomitant disease that, in the opinion of the investigator, poses an unacceptable risk to the patient if he or she participates in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the pathological response, defined as percentage of fibrosis and hyalinization found in the surgical
    specimen after completion of preoperative treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Histopathological examination of the excised tumor - resection in the 11th - 12th week of the study.
    E.5.2Secondary end point(s)
    -Treatment safety profile.
    -Number of patients completing neoadjuvant treatment and having a curative surgery according to the protocol.
    -Disease-free survival time (DFS)
    - Local recurrence-free survival (LRFS)
    - Distant metastasis-free survival (DMFS)
    - Overall survival (OS)
    -Overall response rate (ORR) by RECIST 1.1 criteria.
    -Exploratory endpoints include the search for biomarkers and correlations between their occurrence and response to treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse reactions - on every visit.
    Survival based on imaging studies performed every 12 weeks.
    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 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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial 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: 40
    F.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    No further treatment or care is planned after completion of the study.
    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 Decision2023-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-22
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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