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    Summary
    EudraCT Number:2018-003120-36
    Sponsor's Protocol Code Number:IMC-C103C-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:2019-10-01
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-003120-36
    A.3Full title of the trial
    A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as a Single Agent and in Combination with Atezolizumab in HLA-A*0201-positive Patients with Advanced MAGE-A4-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 numberIMC-C103C-101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03973333
    A.5.4Other Identifiers
    Name:INDNumber:137,164
    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 Limited
    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 Limited
    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 pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressSix Tower Bridge, 181, Washington Street, Ste 540
    B.5.3.2Town/ cityConshohocken, PA
    B.5.3.3Post code19428
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12673313302
    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 nameIMC-C103C
    D.3.2Product code IMC-C103C
    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 INNIMC-C103C
    D.3.9.2Current sponsor codeIMC-C103C
    D.3.9.3Other descriptive nameIMC-C103C
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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.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 Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAtezolizumab
    D.3.2Product code 1380723-44
    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 INNATEZOLIZUMAB
    D.3.9.3Other descriptive nameAtezolizumab
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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
    Patients with metastatic/unresectable tumors of interest which include NSCLC, esophageal carcinoma, gastric carcinoma, HNSCC, urothelial carcinoma, ovarian carcinoma and synovial sarcoma
    E.1.1.1Medical condition in easily understood language
    Patients with advanced non-small cell lung cancer, head and neck cancer, esophageal cancer, gastric, bladder cancer (also called urothelial cancer), ovarian cancer and synovial sarcoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10062006
    E.1.2Term HLA marker study
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10030155
    E.1.2Term Oesophageal carcinoma
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10017770
    E.1.2Term Gastric carcinoma
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10033131
    E.1.2Term Ovarian carcinoma
    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.1.3Condition 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 RP2D of IMC-C103C as a single agent administered Q1W (Arm A1) and administered Q1W in combination with Q3W atezolizumab (Arm A2).
    Phase II:
    To assess the preliminary anti-tumor activity of IMC C103C in one or more selected indications, as a single agent administered Q1W (Arm B1) and administered Q1W in combination with Q3W atezolizumab (Arm B2).
    E.2.2Secondary objectives of the trial
    - Phase II: To assess the safety and tolerability of IMC-C103C as a single agent administered Q1W (Arm A1) and administered Q1W in combination with Q3W atezolizumab (Arm A2)
    - To assess the preliminary anti-tumor activity of IMC C103C in one or more selected indications, as a single agent administered Q1W (Arm B1) and administered Q1W in combination with Q3W atezolizumab (Arm B2)
    - To characterize the PK profile of IMC-C103C as monotherapy and in combination with atezolizumab
    - Arms A2 and B2: To characterize the PK profile of atezolizumab in combination with IMC-C103C
    - To evaluate the preliminary incidence of anti IMC C103C antibody formation following multiple infusions of IMC-C103C as a monotherapy and in combination with atezolizumab
    - Arms A2 and B2: To evaluate the preliminary incidence of anti atezolizumab antibody formation following multiple infusions IMC-C103C in combination with atezolizumab
    - To determine pharmacodynamic changes following treatment with IMC-C103C
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years at time of informed consent
    2. Ability to understand and provide written informed consent prior to undergoing any study procedures
    3. Life expectancy of at least 3 months as estimated by the Investigator
    4. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 at start of treatment
    5. HLA-A*02:01 positive (testing by central laboratory)
    6. MAGE-A4-positive tumor , defined as follows:
    a. Documentation of a histologically confirmed diagnosis of a tumor type in which MAGE-A4 expression is detectable in >70% of tumors (eg, serous ovarian carcinoma or synovial sarcoma). Note that the availability of an adequate tumor biopsy (as defined in the study Laboratory Manual) for retrospective MAGE-A4 testing must be confirmed during Screening
    b. For tumor types in which MAGE-A4 expression is detectable in ≤ 70% of tumors (eg, NSCLC, esophageal, gastric, HNSCC, or urothelial carcinoma) and tumor types for which the frequency of MAGE-A4 expression is unknown, tumor MAGE-A4 expression must be documented based on testing by the study central laboratory
    7. Patients enrolling in biomarker backfill cohorts must have disease that is amenable to biopsy and consent to undergo biopsies during Screening and on treatment
    8. Patients who are enrolling in Phase 1 may have either measurable or only non-measurable disease, and patients who are enrolling in Phase 2 must have measurable disease, according to RECIST v1.1
    a. A previously irradiated lesion may be followed as a target lesion only if there was documented progression of the lesion following completion of radiotherapy
    b. A lesion that will be biopsied on study may be followed as a target lesion only if it is > 2 cm in diameter and the biopsy will not significantly impact its diameter
    9. Patients with metastatic/unresectable solid tumors are eligible. Patients must meet the indication-specific histology and biomarker testing requirements specified in the protocol
    10. There is no maximum limit on the number of prior therapies. Patients must be relapsed from, refractory to, or intolerant of all therapies listed in the protocol for their indication and study phase. These therapies must have been given for unresectable / metastatic disease or given in the adjuvant setting if disease progression occurred during or within 6 months of completing adjuvant therapy
    11. Male and female patients who are sexually active with a nonsterilized partner must agree to use highly effective methods of birth control from the trial screening date until 6 months after the final dose of the investigational product; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods of contraception are described in Section 6.4.4.
    • Pregnant or lactating women are prohibited from enrolling
    • Male patients are not allowed to donate sperm from the time of
    enrolment until 6 months post-administration of study drugs
    E.4Principal exclusion criteria
    1. Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression NOTE: patients with treated CNS lesions may enroll provided ALL the following apply:
    • Treated CNS lesions must be radiographically stable for ≥ 2 weeks after intervention (surgery and/or radiation)
    • Patients must be neurologically stable and off systemic corticosteroids for ≥ 2 weeks prior to the planned first dose of study treatment
    2. Bowel obstruction within 3 months prior to the planned first dose of study treatment
    3. Ongoing ascites or pleural effusion requiring recurrent paracentesis (ie, at least twice within 28 days prior to the planned first dose of study treatment)
    4. Presence of NCI CTCAE ≥ Grade 2 toxicity due to prior cancer therapy (excepting Grade 2 alopecia, Grade 2 stable peripheral neuropathy, Grade 2 endocrine disorder [on stable replacement doses], Grade 2 hypophosphatemia [on appropriate replacement therapy], and Grade 2 ototoxicity)
    5. Patients enrolling in Arm A2 or Arm B2 with prior immunotherapy exposure must not have experienced immune-mediated AE (imAE) meeting any of the following criteria:
    • Grade 4 imAE
    • imAE resulting in the discontinuation of any prior single-agent immunotherapy
    •imAE that did not resolve with initial immunosuppressive intervention (eg, corticosteroids, infliximab, mycophenolate mofetil)
    • imAE that recurred upon rechallenge
    • Any neurological or ocular imAE
    • Pneumonitis that required oral or IV steroids
    6. Receipt of anti-cancer therapy for the disease under study within the following times prior to the first planned dose of study drug:
    • Cellular therapies (eg, CAR-T): 90 days. Please refer to the NOTE added in the clinical study protocol for this exclusion criteria.
    • CTLA-4 targeted immunotherapies (eg, ipilimumab):28 days
    • HER2-targeted antibodies (eg, trastuzumab):28 days
    •All other immunotherapies (eg, atezolizumab, pembrolizumab): 21 days
    • All other systemic therapies: 14 days
    • Radiotherapy: 14 days (excepting palliative radiotherapy to a limited field, which is permitted at any time)
    7. Patient with an out-of-range Screening laboratory values defined as shown below
    • Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 40 mL/min
    • Total bilirubin > 1.5 × ULN (patients with Gilbert's syndrome are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 × ULN)
    • ALT > 3 × ULN
    • AST > 3 × ULN
    • Absolute neutrophil count < 1.0 × 109/L
    • Absolute lymphocyte count < 0.5 × 109/L
    • Platelet count < 75 × 109/L
    • Hemoglobin < 8 g/dL
    8. Evidence of active pneumonitis at Screening by chest imaging or the
    ongoing requirement for intermittent or continuous supplemental
    oxygen
    9. Clinically significant cardiac disease or impaired cardiac function,
    including any of the following:
    • Uncontrolled hypertension (consistent findings of systolic blood
    pressure [BP] > 160 mmHg or diastolic BP > 110 mmHg as defined in
    the protocol
    •History of ventricular arrhythmia currently requiring medical treatment
    or uncontrolled atrial fibrillation
    • Ejection fraction < 50% on Screening echocardiogram
    • QTcF > 470 msec on Screening ECGs or known history of congenital
    prolonged QT syndrome
    • Cardiac troponin T > ULN at Screening
    • Acute myocardial infarction or unstable angina pectoris ≤ 6 months
    prior to Screening
    10. Active autoimmune disease requiring treatment, including
    inflammatory bowel disease (ulcerative colitis or Crohn's disease),
    within five years of Screening
    11. Systemic treatment with an immunosuppressive drug within 2 weeks
    of the planned first dose of study drug, with the exceptions listed in the
    protocol
    12. Patients with prior solid organ or bone marrow transplant
    13. Chronic viral infections as indicated below
    • Known history of HIV infection
    • HBV infection, unless on stable anti-viral therapy for > 4 weeks prior to the planned first dose of study drug and viral load confirmed as undetectable during Screening
    • HCV infection. History of HCV is not exclusionary if the patient has received curative treatment and viral load was confirmed as undetectable during Screening
    14. History of malignant disease other than those being treated in this study. See protocol for additional details which malignancies are allowed
    15. Pregnant, likely to become pregnant, or lactating (where pregnancy is defined as the state of a female after conception and until the termination of gestation)
    16. Any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgement, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
    17. Patients requiring systemic antibiotics (IV or oral) for infection within 2 weeks prior to the planned first dose of study treatment
    Please refer to the protocol for full list of the exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Phase I:
    - Incidence of dose-limiting toxicities (DLT)
    - Incidence and severity of AE and SAE
    - Changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF)
    - Dose interruptions, reductions, and discontinuations

    Phase II:
    Best overall response as determined by RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLT:
    The DLT observation period is 21 days for fixed-dose regimens, 28 days for 1-step escalation, and 35 days for 2-step escalation.

    Tumor responses will be determined per local investigators assessment, according to RECIST v1.1. Individual lesion measurements and objective response assessments will be listed by patient and assessment date. Best overall response per RECIST v1.1 will be listed and tabulated. Best overall change in tumor size for individual patients will be shown in waterfall plots.
    E.5.2Secondary end point(s)
    - Phase II: Incidence and severity of AE and SAE,
    - Changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF)
    - Dose interruptions, reductions, and discontinuations
    - Phase I: BOR, PFS, and DOR by RECIST v1.1; OS
    - Phase II: PFS and DOR by RECIST v1.1; OS
    - IMC-C103C serum PK parameters (eg, AUC, Cmax, Tmax, t1/2) after single and multiple doses
    - Arms A2 and B2: Atezolizumab serum PK parameters (eg, AUC, Cmax, Tmax, t1/2) after single and multiple doses
    - Incidence of anti-IMC-C103C antibody formation and its impact on PK
    - Arms A2 and B2: Incidence of anti-atezolizumab antibody formation and its impact on PK
    - Changes in lymphocyte counts over time
    - Changes in serum cytokines over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor responses will be determined per local investigators assessment, according to RECIST v1.1. Individual lesion measurements and objective response assessments will be listed by patient and assessment date. Best overall response per RECIST v1.1 will be listed and tabulated. Best overall change in tumor size for individual patients will be shown in waterfall plots.
    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 Yes
    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 trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Spain
    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 months6
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 174
    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 Decision2019-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-03
    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.

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