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    Summary
    EudraCT Number:2019-004046-16
    Sponsor's Protocol Code Number:IMC-F106C-101
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-16
    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 number2019-004046-16
    A.3Full title of the trial
    A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2 Study of IMC-F106C in Advanced PRAME-Positive Cancers
    A.3.2Name or abbreviated title of the trial where available
    Phase 1/2 Study of IMC-F106C in Advanced PRAME-Positive Cancers
    A.4.1Sponsor's protocol code numberIMC-F106C-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 200
    B.5.3.2Town/ cityConshohocken, PA
    B.5.3.3Post code19428
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 267 3313302
    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.2.1.1.1Trade name IMC-F106C
    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-F106C
    D.3.2Product code IMC-F106C
    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-F106C
    D.3.9.2Current sponsor codeIMC-F106C
    D.3.9.3Other descriptive nameIMC-F106C
    D.3.9.4EV Substance CodeAS1
    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 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 nameTecentriq
    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.3.9.1CAS number 1380723-44-3
    D.3.9.4EV Substance CodeAS2
    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.IMP: 3
    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.3.1Product nameKEYTRUDA
    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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.4EV Substance CodeAS3
    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
    HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers. Study IMC-F106C-101 will enroll participants with advanced cancers, including unresectable or metastatic melanoma, ovarian carcinoma, uterine carcinoma, non-small cell lung cancer (NSCLC), small-cell lung cancer (SCLC), triple negative breast cancer (TNBC), and urothelial carcinoma, that are relapsed from, refractory to, or intolerant of standard treatment regimens
    E.1.1.1Medical condition in easily understood language
    Patients with advanced cancer, unresectable or metastatic melanoma, ovarian & uterine carcinoma, non-small cell lung and small-cell lung cancer, triple negative breast cancer & urothelial carcinoma
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative breast 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046769
    E.1.2Term Uterine 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary (Phase 1): To assess the safety and tolerability of IMC-F106C and identify the MTD and/or RP2D for the D1D, D8D, and CDD of IMC-F106C as:
    o A monotherapy in advanced solid tumors
    o In combination with a checkpoint inhibitor in advanced solid tumors
    Primary (Phase 2): To characterize the initial efficacy of IMC-F106C as a monotherapy in selected advanced solid tumors
    E.2.2Secondary objectives of the trial
    To assess the antitumor efficacy of IMC-F106C as a monotherapy and in combination with a checkpoint inhibitor
    To characterize the PK profile of IMC-F106C as a monotherapy and in combination with a checkpoint inhibitor
    To evaluate the frequency of antibody formation against IMC-F106C following treatment with IMC-F106C as a monotherapy and in combination with a checkpoint inhibitor
    To determine pharmacodynamic changes in peripheral cytokines and lymphocyte counts following treatment with IMC-F106C
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all the following criteria apply:
    1. Participant must be ≥ 18 years of age, inclusive, at the time of signing the ICF
    2. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 at start of treatment
    3. HLA-A*02:01-positive (testing by central laboratory)
    4. PRAME-positive tumor, defined as one of the following:
    a.Documentation of histologically confirmed diagnosis of a tumor type in which PRAME is expressed in >70% of tumors (eg, cutaneous melanoma, serous ovarian carcinoma, or endometrial carcinoma). Note: availability of an adequate tumor biopsy (as defined in the study Laboratory Manual) for retrospective PRAME testing must be confirmed during Screening
    b.For tumor types where the frequency of PRAME expression is ≤70% (eg, NSCLC, SCLC, urothelial carcinoma, TNBC), and tumor types where the frequency of PRAME expression is unknown, tumor PRAME expression must be documented based on testing by the study central laboratory
    5. Participants who are enrolling in biomarker cohorts must have disease that is amenable to biopsy and consent to undergo tumor biopsies during Screening and treatment
    6. Participants who are enrolling in Phase 1 must have evaluable disease, and participants who are enrolling in Phase 2 must have measurable disease according to RECIST v1.1
    7. Participants with metastatic or unresectable solid tumors are eligible for Arm A and Arm B. Participants must meet the indication-specific histology/tumor site requirements specified below:
    - R/M melanoma: All primary sites allowed, including cutaneous, mucosal, and uveal
    - R/M ovarian carcinoma: All histologies allowed; Includes fallopian tube and primary peritoneal cancers
    - R/M uterine carcinoma: All histologies allowed
    - R/M NSCLC: All histologies allowed
    - R/M SCLC: All histologies allowed, including high-grade neuroendocrine large cell lung cancer
    - R/M breast cancer: Triple-negative breast cancer
    - R/M urothelial carcinoma: Tumors are allowed from renal pelvis, ureters, urinary bladder, and urethra
    - Other R/M solid tumors: All histologies allowed (pending availability of a validated assay to assess tumor PRAME expression)
    8. Participants must have relapsed from, are 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. There is no maximum limit on the number of prior therapies received. Biomarker testing requirements are shown in Table 13 in the protocol; additional biomarker test results may be requested if available but are not required for eligibility
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    1. Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. NOTE: Participants with treated CNS lesions may enroll provided all the following apply: a. Treated CNS lesions must be radiographically stable for ≥ 2 weeks after intervention (surgery and/or radiation); b. Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to enrollment.
    2. Bowel obstruction within 3 months prior to the planned first dose of study treatment
    3. Ongoing ascites 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 (except Grade 2 alopecia, Grade 2 stable peripheral neuropathy, Grade 2 endocrine disorder [on stable replacement doses and asymptomatic], Grade 2 hypophosphatemia [on appropriate replacement therapy], and Grade 2 ototoxicity)
    5. Participants enrolling in Arm B with prior immunotherapy exposure must not have experienced immune-mediated AE (imAE) meeting any of the following criteria: a. Grade 4 imAE; b. imAE resulting in the discontinuation of any prior immunotherapy; c. imAE that failed initial immunosuppressive intervention (eg, corticosteroids, infliximab, mycophenolate mofetil); d. imAE that recurred upon rechallenge; e. Pneumonitis that required oral or IV steroids; f. Any neurological, ocular, or renal imAE
    6. Receipt of anticancer therapy for the disease under study within the following times prior to the first planned dose of study intervention: a. Cellular therapies (eg, T-cell therapies): 90 days; b. Cytotoxic T-lymphocyte associated protein-4 (CTLA4)-targeted immunotherapies (eg, ipilimumab): 28 days; c. All other immunotherapies, including PD-(L)1-targeted immunotherapies (eg, atezolizumab, pembrolizumab): 21 days; d. All other systemic therapies: 14 days; e. Radiotherapy: 14 days (excepting palliative radiotherapy to a limited field, which may be administered within 14 days, eg, for a focally painful tumor mass)
    7. Participant with an out-of-range Screening laboratory values defined as shown below. NOTE: Hematology evaluations must be performed ≥ 7 days from any blood or blood product transfusion and ≥ 14 days from any dose of hematologic growth factor: a. Glomerular filtration rate (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula, see Section 10.3) < 50 mL/min; b. Urine protein ≥ 2+, unless reflex testing confirms urine protein < 1 g/24h; c. Total bilirubin > 1.5 × upper limit of normal (ULN); participants with Gilbert’s syndrome are excluded if total bilirubin > 3.0 × ULN or direct bilirubin > 1.5 × ULN); d. Alanine aminotransferase > 3 × ULN; e. Aspartate aminotransferase > 3 × ULN; f. Absolute neutrophil count < 1.0 × 109/L; g. Absolute lymphocyte count < 0.5 × 109/L; h. Platelet count < 75 × 109/L; i. Hemoglobin < 8 g/dL; j. Morning cortisol < lower limit of normal (unless the participant has asymptomatic adrenal insufficiency and is receiving stable replacement doses)
    8. History of pneumonitis requiring oral or intravenous (IV) steroids, evidence of active pneumonitis on Screening chest imaging, or ongoing requirement for intermittent or continuous supplemental oxygen
    9. Clinically significant cardiac disease or impaired cardiac function, including any of the following: a. Congestive heart failure (New York Heart Association Class ≥ 3); b. Uncontrolled hypertension (consistent findings [as defined in Section 8.2.3] of systolic blood pressure [BP] > 160 mmHg or diastolic BP > 110 mmHg); c. History of ventricular arrhythmia currently requiring medical treatment; d. Uncontrolled atrial fibrillation; e. Electrocardiogram QT interval corrected for heart rate by Fridericia’s method (QTcF) > 470 msec during Screening obtained on triplicate ECGs or known history of congenital prolonged QT syndrome; f. Acute myocardial infarction or unstable angina pectoris ≤ 6 months prior to Screening
    10. Active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease (ulcerative colitis or Crohn’s disease), within 5 years of Screening
    11. Systemic treatment with steroids or any other immunosuppressive drug use within 4 weeks of the planned first dose of study intervention, with the following exceptions: a. Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 10 mg daily or the equivalent; b. Local steroid therapies (eg, optic, ophthalmic, intra-articular, or inhaled medications) are acceptable; c. Premedication for allergy to contrast reagent; d. Steroids for management of CNS metastases > 2 weeks prior to the planned first dose of study intervention
    PLEASE SEE THE PROTOCOL FOR REMAINDER OF EXCLUSION CRITERIA
    E.5 End points
    E.5.1Primary end point(s)
    Primary (Phase 1):
    • Incidence of DLTs
    • Incidence and severity of AEs and SAEs
    • Changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF)
    • Incidence of dose interruptions, reductions, and discontinuations
    Primary (Phase 2):
    • 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 21 Days and In Accordance With Section 1.3.2 and Table 2 (Schedule of Assessments, Treatment Stage) of The Study Protocol
    E.5.2Secondary end point(s)
    Secondary
    • BOR by RECIST v1.1 (Phase 1 only)
    • PFS and DOR by RECIST v1.1
    • OS
    • IMC-F106C serum PK parameters (eg, AUC, Cmax, Tmax, t1/2) after single and multiple doses
    • Incidence of anti-IMC-F106C antibody formation
    • Change in peripheral blood lymphocyte counts and serum cytokine concentrations over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within Each Treatment Cycle Defined As Every 21 Days and In Accordance With Section 1.3.2 and Table 2 (Schedule of Assessments, Treatment Stage) 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 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.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    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 years4
    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 years4
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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