Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-002243-15
    Sponsor's Protocol Code Number:IMCnyeso-101
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-07-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-002243-15
    A.3Full title of the trial
    A Phase I/II Open-Label, Multi-center Study of the Safety and Efficacy of IMCnyeso, an HLA-A* 0201-Restricted, NY-ESO-1 and LAGE-1A-specific soluble T Cell Receptor and Anti-CD3 Bi-specific Molecule, as a Single Agent in HLA-A* 0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE-1A Positive Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label study in patients with advanced cancer.
    A.4.1Sponsor's protocol code numberIMCnyeso-101
    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 SponsorImmunocore Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportImmunocore Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunocore Ltd.
    B.5.2Functional name of contact pointEric Phillips
    B.5.3 Address:
    B.5.3.1Street AddressImmunocore LLC, Six Tower Bridge, 181 Washington Street, Suite 540
    B.5.3.2Town/ cityConshohocken, PA
    B.5.3.3Post code19428
    B.5.3.4CountryUnited States
    B.5.4Telephone number0014842750545
    B.5.6E-maileric.phillips@immunocore.com
    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 nameIMCnyeso
    D.3.2Product code IMCnyeso
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNIMCNYESO
    D.3.9.2Current sponsor codeIMCNYESO
    D.3.9.4EV Substance CodeSUB192776
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) No
    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
    HLA-A*0201 positive patients with advanced antigen-positive cancer with a histologic diagnosis of Non small cell lung carcinoma (NSCLC), melanoma, urothelial carcinoma, or synovial sarcoma with antigen positivity for NY-ESO-1 and/or LAGE-1A
    E.1.1.1Medical condition in easily understood language
    Advanced NSCLC, melanoma, sarcoma and urothelial cancers.
    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 10061873
    E.1.2Term Non-small cell lung 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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025665
    E.1.2Term Malignant melanoma of skin stage unspecified
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10042863
    E.1.2Term Synovial sarcoma
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064467
    E.1.2Term Urothelial carcinoma
    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
    Phase I: To identify the MTD and/or the RP2D of IMCnyeso, as a
    monotherapy, when administered weekly to patients with advanced
    NSCLC, melanoma, urothelial cancer, and synovial sarcoma
    Phase II: To assess the preliminary anti-tumor activity of IMCnyeso as
    monotherapy in advanced NSCLC, urothelial cancer, and synovial
    sarcoma
    E.2.2Secondary objectives of the trial
    Phase II:
    To characterize the safety and tolerability of IMCnyeso
    Phase I and Phase II:
    To assess the preliminary anti-tumor activity of IMCnyeso as
    monotherapy
    To characterize the PK profile of IMCnyeso as monotherapy
    To evaluate the preliminary incidence of anti-IMCnyeso antibody
    formation following multiple infusions of IMCnyeso
    Exploratory:To characterize the relationship between expression levels of NY-ESO-1
    and LAGE-1A in the tumor and anti-tumor activity of IMCnyeso as
    monotherapy
    To assess potential pharmacodynamic changes in systemic and
    intratumoral immune response observed following IMCnyeso treatment
    To assess potential predictors of efficacy of IMCnyeso
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all the following inclusion criteria to be eligible for
    inclusion in the study:
    General
    1.Male or female patients age ≥ 18 years of age at the time of informed
    consent
    2.Ability to understand and provide written informed consent prior to
    undergoing any studyprocedures
    3.Life expectancy of > 3 months as estimated by the Investigator
    4.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
    or 1 at Screening
    5.In the opinion of the Investigator, all other relevant medical conditions
    must bewell-managed and stable for at least 28 days prior to first
    administration of study drug HLA and Tumor Antigen Testing
    6.HLA-A*02:01 positive as confirmed by the central laboratory
    7.NY-ESO-1 and/or LAGE-1A positive tumor confirmed by the central
    laboratory
    Phase I: Disease Under Study and Prior Anti-Cancer Treatment
    8.Histologically confirmed diagnosis of advanced NSCLC, melanoma,
    urothelial carcinoma,or synovial sarcoma
    9.Patients must be relapsed from, refractory to, or intolerant to all
    approved and availableclasses of therapy known to provide clinical
    benefit for their condition
    Phase II: Disease Under Study and Prior Anti-Cancer Treatment
    10.Histologically confirmed diagnosis of advanced NSCLC, urothelial
    carcinoma, or synovialsarcoma
    11.Measurable disease per Response Evaluation Criteria in Solid Tumors
    (RECIST) v.1.1criteria (Section 13.1)
    12.A minimum of 10 patients enrolled in Phase II must have disease that
    is amenable tobiopsy, and consent to provide biopsies during Screening
    and on treatment
    13.Patients will have received the following previous therapies. These
    therapies must havebeen given for unresectable / metastatic disease or
    given in the adjuvant setting if diseaseprogression occurred during or
    within 6 months of completing adjuvant therapy
    •NSCLC — PD-1/PD-L1 inhibitor. Patients with a genomic tumor
    aberration (eg, EGFR,ALK) that is targeted by Health Authority-approved
    agent(s) must be relapsed from,refractory to, or intolerant of relevant
    targeted agent(s)
    •Urothelial cancer — PD-1/PD-L1 inhibitor
    •Synovial sarcoma — at least 1 prior systemic chemotherapy regimen
    Contraception
    14.Female patients should either be of non-childbearing potential or
    must agree to use highly effective methods of contraception from
    Screening until 6 months following administration of the last dose of
    study drug (see Section 6.14)
    15.Male patients must be surgically sterile or use double barrier
    contraception from enrollment through treatment and for 6 months
    E.4Principal exclusion criteria
    Patients with any of the following will not be included in the study:
    Disease Under Study and Prior Anti-Cancer Treatment
    -Presence of symptomatic or untreated CNS metastases, leptomeningeal disease, cord compression, or CNS
    metastases that require doses of corticosteroids within 3 weeks prior to the planned first administration of study drug.
    -Systemic anticancer therapy for disease under study within 2 weeks of the planned first administration of study treatment. For
    cytotoxic or immunotherapy agents that can present with major delayed toxicity, a 4-week washout period is required
    -Radiotherapy within 2 weeks of the planned first administration of
    study drug.
    -Presence of National Cancer Institute Common Terminology Criteria for AEs ≥ Grade 2 toxicity due to prior cancer therapy (except Grade 2 alopecia, stable Grade 2 peripheral neuropathy, Grade 2 endocrine disorder [on stable replacement doses and without
    symptoms]Grade 2 hypophosphatemia [on appropriate replacement therapy] and Grade 2 ototoxicity) Laboratory Parameters
    -Patient with any out-of-range laboratory values defined as shown below. Hematology evaluations must be performed ≥ 7 days after any
    blood or blood product transfusion and≥ 14 days after any dose of
    hematologic growth factor.
    Creatinine clearance (calculated using Cockcroft-Gault formula or
    measured)< 40 mL/min
    Total bilirubin > 1.5 × upper limit of normal (ULN); NOTE: for patients
    with Gilbert's syndrome; exclude if total bilirubin > 3.0 × ULN or direct
    bilirubin > 1.5 × ULN)
    Alanine aminotransferase (ALT) > 3 × ULN
    Aspartate aminotransferase (AST) > 3 × ULN
    Absolute neutrophil count (ANC) < 1.0 × 109/L
    Absolute lymphocyte count < 0.5 × 109/L
    Platelet count < 75 × 109/L
    Hemoglobin < 8 g/dL
    Medical History and Concomitant Medications
    -Any active manifestations of autoimmune disease of the skin, including
    psoriasis and scleroderma, or history of severe skin manifestation of
    graft versus host disease
    -Clinically significant cardiac disease or impaired cardiac function
    including any of the following:
    -Clinically significant and/or uncontrolled heart disease such as
    diagnosed congestive heart failure, uncontrolled hypertension, or clinically significant arrhythmia currently
    requiring medical treatment
    -Confirmed manually over-read QT interval corrected by Fredericia's method (QTcF)>470 msec on Screening ECG or
    known history of congenital long QT syndrome
    -History of acute myocardial infarction or unstable angina pectoris < 6 months prior to planned first administration of study drug
    -Active infection requiring systemic antibiotic therapy. NOTE: Patients requiring systemic antibiotics for infection must have completed treatment with any IV antibiotics at least 14 days before the planned first administration of study drug and any oral antibiotics at least 7 days before the planned first administration of study drug
    -Known history of HIV, Testing for HIV status is not necessary unless clinically indicated
    -Active HBV or HCV infection as defined per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically
    indicated or the patient has a history of HBV or HCV infection
    -Patients receiving systemic treatment with steroid therapy (ie, prednisone > 10mg daily[QD] or the equivalent) or any other immunosuppressive
    medication at any dose level that could interfere with the action of the study drugs, in the opinion of the PI
    -Treatment for well controlled and asymptomatic adrenal insufficiency is permitted provided the patient has no history of adrenal crisis and replacement dosing is limited to prednisone ≤ 10 mg QD or the
    equivalent
    -Local steroid therapies (eg, otic, ophthalmic, intra-articular,
    or inhaled medications) are acceptable
    -Malignant disease other than that being treated in this study, withthe following exceptions:
    •Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment •Completely resected basal cell and
    squamous cell skin cancers•Any malignancy considered to be indolent and that has never required therapy•Completely resected carcinoma in
    situ of any type
    -Any medical condition that would, in the Investigator's judgment prevent the patient's participation in the clinical study due to safety
    concerns, compliance with clinical study procedures, or interpretation ofstudy results
    -Any major surgical procedure(as judged by the PI) within 2 weeks of the planned first administration of study drug NOTE: Minimally invasive procedures such as bronchoscopy, tumor
    biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery and are not exclusionary
    -Pregnant, likely to become pregnant, or lactating women
    E.5 End points
    E.5.1Primary end point(s)
    Phase I
    Incidence of dose-limiting toxicities
    Incidence and severity of AE and SAE
    Changes in laboratory parameters, vital signs, and ECGs
    Dose interruptions, reductions, and discontinuations
    Phase II
    BOR as determined by RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within Each Treatment Cycle Defined As Every 28 Days and In
    Accordance With Section 13.4 and Table 13 -13 (Study Schedule and
    Assessment) of The Study Protocol
    E.5.2Secondary end point(s)
    Phase II - Incidence and severity of AE and SAE
    Changes in laboratory parameters, vital signs, and ECGs
    Dose interruptions, reductions, and discontinuations
    Phase I and II
    Phase I: BOR, PFS, and DoR by RECIST v1.1; OS
    Phase II: PFS, and DoR by RECIST v1.1; OS
    Serum PK parameters (eg, AUC, Cmax, Tmax, t1/2) after single and
    multiple doses
    Incidence of anti- IMCnyeso antibody formation and its impact on PK
    Exploratory
    Tumor expression and localization of NY-ESO-1 and LAGE-1A
    Changes in frequency and phenotype of tumor-infiltrating lymphocytes
    Changes in serum chemokine / cytokine concentrations; changes in
    peripheral blood lymphocyte counts, activation, and phenotype; changes
    in gene expression profile (mRNA)
    Changes in ctDNA
    Tumor expression and localization of biomarkers (which may include,
    but not be limited to PD-1, PD-L1, HLA-DR, CTLA-4, CD3, CD8 and TIL
    counts)
    Soluble blood markers (eg, chemokines / cytokines)
    Cell-based markers (eg, Tregs, MDSCs) Within Each Treatment Cycle Defined As Every 28 Days and In
    Accordance With Section 13.4 and Table 13-13 (Study Schedule and
    Assessment) of The Study Protocol
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within Each Treatment Cycle Defined As Every 28 Days and In Accordance With Section 7 and Table 7-1 (Study Schedule and Assessment) of The Study Protocol
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United Kingdom
    United States
    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 years3
    E.8.9.1In the Member State concerned months0
    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 months0
    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: 53
    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 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 63
    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 Decision2018-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-04
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 15 02:26:06 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA