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    Summary
    EudraCT Number:2020-000693-18
    Sponsor's Protocol Code Number:BreakB5/CA209-7WF
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-25
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-000693-18
    A.3Full title of the trial
    Breaking the big Five Barriers of Brain Metastasis (Break B5-BM NSCLC Trial):
    A prospective phase II, open-label, multi-center trial of combined nivolumab, ipilimumab and bevacizumab together with 2 cycles of induction chemotherapy in patients with non-squamous non-small-cell lung cancer (NSCLC) metastatic to the brain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective phase II, open-label, multi-center trial of combined nivolumab, ipilimumab and bevacizumab together with 2 cycles of induction chemotherapy in patients with non-squamous non-small-cell lung cancer (NSCLC) metastatic to the brain
    A.4.1Sponsor's protocol code numberBreakB5/CA209-7WF
    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 SponsorUniversity Hospital Regensburg
    B.1.3.4CountryGermany
    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 supportBristol-Myers Sqibb (BMS)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation University Hospital Regensburg
    B.5.2Functional name of contact pointDr. Daniel Heudobler
    B.5.3 Address:
    B.5.3.1Street AddressFranz-Josef-Strauß-Allee 11
    B.5.3.2Town/ cityRegensburg
    B.5.3.3Post code93053
    B.5.3.4CountryGermany
    B.5.4Telephone number00499419444800
    B.5.5Fax number00499419445537
    B.5.6E-maildaniel.heudobler@ukr.de
    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 Yes
    D.2.1.1.1Trade name Yervoy (TM)
    D.2.1.1.2Name of the Marketing Authorisation holder Bristol-Myers Squibb Pharma EEIG
    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.3.2Product code BMS-734016
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNIpilimumab
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeBMS-734016
    D.3.9.3Other descriptive nameBMS734016
    D.3.9.4EV Substance CodeSUB22577
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Opdivo (100 mg/10 ml
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 name Nivolumab-10 ml vial-COMMERCIAL
    D.3.2Product code BMS-936558
    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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor code BMS-936558
    D.3.9.3Other descriptive nameBMS936558
    D.3.9.4EV Substance CodeSUB32944
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) 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 Zirabev
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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 nameBevacizumab
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    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
    non-squamous non-small-cell lung cancer (NSCLC) metastatic to the brain
    E.1.1.1Medical condition in easily understood language
    non-squamous non-small-cell lung cancer (NSCLC) metastatic to the brain
    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 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess safety of the new combined treatment regime. In the safety run in phase, the occurrence and frequency of dosis limiting toxicities (DLTs) is of primary interest. Further throughout the whole study, an evaluation of incidence and intensity of adverse events (AEs) and serious adverse events (SAE) according to Common Terminology Criteria for Adverse Events (CTCAE) version v5.0 of the combination is a primary objective.
    - To evaluate the central nervous system (CNS) clinical benefit rate (CBR) of the new combined treatment regime.
    E.2.2Secondary objectives of the trial
    • To assess intracranial progression-free-survival (iPFS)
    • To assess extracranial progression-free-survival (ePFS)
    • To assess overall survival (OS)
    • To assess OS-rate at 12 and 24 months
    • To assess the duration of response (DOR) per RANO-BM and Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
    • To evaluate the CNS-specific safety and tolerability of the combination regimen in patients with or without stereotactic radiotherapy (SRT) received prior to study entry.
    • To assess patient reported outcomes (PROs) of lung cancer symptoms, patient functioning, and health-related quality of life (HRQoL), using the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30), Quality-of-Life Questionnaire brain module (EORTC QLQ-BN20) and Lung Cancer Module (LC29)
    • To assess exploratory biomarkers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed Written Informed Consent
    1. Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care
    2. Subjects must be willing and able to comply with protocol.
    Target Population
    3. Males and Females, ages ≥ 18 years of age
    4. ECOG performance status of 0, 1 and 2 (patients with a decline in performance status due to neurologic symptoms of brain metastasis are eligible for the study up to ECOG 3)
    5. Life expectancy ≥ 12 weeks
    6. Histologically or cytologically documented metastatic non-squamous NSCLC stage IVB (IASLC) 90
    7. Measurable disease, as defined by RANO-BM (intracranial) and RECIST v1.1 (extracranial)
    8. at least one measurable brain metastasis (tumor diameter: 0.5 to 3 cm) which has not been previously irradiated and is not judged to require immediate local intervention (radiation/surgery)
    9. Known PD-L1 tumor status

    10. no prior cytotoxic/systemic (chemo)therapy regimens for metastatic disease (in this context neo-/adjuvant therapy including immunotherapy is not counted as line of therapy)
    11. The last dose of prior (neo-/adjuvant) systemic anti-cancer therapy or immunotherapy must have been administered ≥ 21 days prior to first dose of study treatment.
    12. The last dose of treatment with any investigational agent or participation in a clinical trial with therapeutic intent must have ended ≥ 28 days prior to first dose of study treatment.
    13. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to first study treatment:
    a. ANC ≥ 1500 cells/μL (without granulocyte colony-stimulating factor support within 2 weeks of test)
    b. WBC counts > 2000/μL
    c. Lymphocyte count ≥ 500/μL
    d. Platelet count ≥ 100.000/μL
    e. Hemoglobin ≥ 9.0 g/dL. Patients may be transfused or receive erythropoietic treatment to meet this criterion.
    14. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 mL/min (using the Cockcroft Gault formula)
    15. Adequate liver function: AST or ALT ≤ 3 × ULN; Serum bilirubin ≤ 1.5 × ULN. With the following exceptions:
    a. Subjects with Gilbert Syndrome who must have a total bilirubin level < 3.0 mg/dL
    b. Subjects with documented liver metastases: AST and/or ALT ≤ 5 × ULN
    c. Subjects with documented liver or bone metastases: alkaline phosphatase ≤ 5 × ULN.
    Reproductive Status
    16. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test [minimum sensitivity 25 units per litre (IU/L) or equivalent units of human chorionic gonadotropin (HCG)] within 3 days prior to the start of study drug.
    17. Women must not be breastfeeding and not start breastfeeding for at least six months following the last dose of bevacizumab.
    18. WOCBP must agree to follow instructions for method(s) of contraception from the time of enrollment for the duration of treatment plus 5 half-lives of nivolumab (half-life up to 25 days) plus 30 days (duration of ovulatory cycle) for a total of 23 weeks post treatment completion.
    19. Male patients should seek advice on conservation of sperm prior to treatment. Carboplatin and nab-Paclitaxel could cause irreversible infertility.
    20.Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with nivolumab plus 5 half-lives of nivolumab plus 90 days (duration of sperm turnover) for a total of 31 weeks post treatment completion.
    E.4Principal exclusion criteria
    1. History of known leptomeningeal involvement (lumbar puncture not required).
    2. History of whole brain irradiation
    3. History of previous intracranial hemorrhage (patients brain metastasis showing signs
    of bleeding without mass effect/signs of increased intracranial pressure may be
    eligible upon investigator’s decision)
    4. 'Untreated (surgery and/or radiation) and/or clinically unstable spinal cord
    compression'
    5. Subjects with oligometastatic disease according to IASLC eligible for a definitive local
    therapy in curative intent
    6. Subjects with oncogenic driver mutations which are sensitive to available targeted
    inhibitor therapy (i.e. EGFR mutation, ALK or ROS1 translocation, BRAF V600
    mutation, NTRK fusion). In subjects with high therapeutic pressure and low pretest
    probability for the presence of druggable oncogenic driver mutations (i.e. smoking
    status) study treatment may be initiated at investigators’s discretion while molecular
    pathology results are pending. Patients with druggable alterations are excluded.
    7. Uncontrolled pleural effusion, pericardial effusion, or ascites (patients with pleural
    drainage system like PleurX catheter and controlled situation are eligible)
    8. Uncontrolled tumor-related pain: Patients requiring pain medication must be on a
    stable regimen at study entry. Symptomatic lesions amenable to palliative
    radiotherapy (e.g., bone metastases or metastases causing nerve impingement) may
    be treated by radiotherapy
    Autoimmune disease: subjects with a documented history of inflammatory bowel
    disease, including ulcerative colitis and Crohn’s disease are excluded from study
    treatment as are subjects with a history of symptomatic disease (eg, rheumatoid
    arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus
    Erythematosus, autoimmune vasculitis [eg, Granulomatosis with polyangiitis,
    (Wegener's)], and sarcoidosis including interferon-induced sarcoidosis. Subjects with
    motor neuropathy considered of autoimmune origin (eg, Guillain-Barre Syndrome
    and Myasthenia Gravis) are excluded from study treatment.
    a. Patients with a history of autoimmune-related hypothyroidism on a stable dose
    of thyroid replacement hormone may be eligible for this study.
    b. Patients with controlled Type I diabetes mellitus on a stable dose of insulin
    regimen are eligible for this study.
    10. Subjects with major medical, neurologic or psychiatric condition who are judged as
    unable to fully comply with study therapy or assessments should not be enrolled.
    11. Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in
    situ of the cervix. For any prior invasive malignancy, at least 3 years must have
    elapsed since curative therapy and patients must have no residual sequelae of prior
    therapy.
    12. Significant cardiovascular disease, such as New York Heart Association cardiac
    disease (Class II or greater), myocardial infarction within 3 months prior to start of
    study treatment, unstable arrhythmias, or unstable angina.
    a. Patients with known coronary artery disease, congestive heart failure not
    meeting the above criteria, or left ventricular ejection fraction < 50% must be
    on a stable medical regimen that is optimized in the opinion of the treating
    physician, in consultation with a cardiologist if appropriate.
    13. Major surgical procedure other than for diagnosis or treatment of symptomatic brain
    metastasis within 28 days prior to randomization or anticipation of need for a major
    surgical procedure during the course of the study
    14. Prior allogeneic bone marrow transplantation or solid organ transplant
    15. Active or latent tuberculosis
    16. Symptomatic interstitial lung disease
    17. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus
    ribonucleic acid (HCV antibody) indicating acute or chronic infection.
    18. Known history of testing positive for human immunodeficiency virus (HIV) or known
    acquired immunodeficiency syndrome (AIDS) even if fully immunocompetent on
    ART—due to the unknown effects of HIV on the immune response to combined
    nivolumab plus ipilimumab or the unique toxicity spectrum of these drugs in patients
    with HIV.
    Active viral infection (e.g., COVID-19, influenza, SARS, MERS). (Two weeks after full
    recovery or a negative virus test patients are eligible.)
    Exclusion Criteria related to Medications
    20. Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy
    within 3 weeks prior to initiation of study treatment; the following exceptions are
    allowed: Hormone-replacement therapy or oral contraceptives
    21. Treatment with any other investigational agent or participation in another clinical trial
    with therapeutic intent within 28 days prior to start of study treatment
    22. Simultaneous treatment with another investigational agent or simultaneous
    anticancer treatment outside this trial


    E.5 End points
    E.5.1Primary end point(s)
    Safety
    Safety will be monitored throughout the whole study, with a specific focus on the safety-lead-in phase.
    • Predefined dose limiting toxicities (DLTs) will be counted and dosing will be adjusted according to the recommendations of the DSMB.
    • Incidence and intensity of adverse events (AEs) and serious adverse events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version v5.0
    Primary Efficacy Endpoint
    Central nervous system (CNS) clinical benefit rate (CBR) 6 months after patient inclusion (pCBR), defined as either
    • complete response [CR],
    • partial response [PR] or
    stable disease [SD] ≥ 6 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety will be monitored throughout the whole study, with a specific focus on the safety-lead-in phase. For CNS-clinical benefit rate (CNS-CBR) is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) 6 months after study inclusion (pCBR).
    E.5.2Secondary end point(s)
    • Intracranial progression free survival (iPFS)
    • Extracranial progression free survival (ePFS)
    • Overall survival (OS)
    • OS rate at 12 and 24 months
    • Duration of response (DOR) per RANO BM and Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
    • CNS specific safety and tolerability of the combination regimen in patients with or without stereotactic radiotherapy (SRT) received prior to study entry.
    • Patient reported outcomes (PROs) of lung cancer symptoms, patient functioning, and health related quality of life (HRQoL), using the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30), Quality-of-Life Questionnaire brain module (EORTC QLQ-BN20) and Lung Cancer Module (LC29)
    • Exploratory biomarkers
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety will be monitored throughout the whole study, with a specific focus on the safety-lead-in phase. Subjects will be followed for drug-related toxicities until these toxicities resolve, return to baseline or are deemed irreversible. All adverse events will be documented for a minimum of 100 days after the last dose of study medication. After completion of the safety follow-up visit, subjects will be followed every 3 months for survival. Survival Follow-up visits may be performed by phone contact or office visit. All AEs (including SAEs) that occur during the time period beginning with the subject’s written informed consent and ending 100 days after the last dose of IMP must be reported, whether related or unrelated to the study treatments.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned 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 concerned10
    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 Yes
    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
    FPFV: Jan-2021
    LPFV: Jul-2023
    LPLV: Jul-2026
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 state39
    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)
    After finishing all study relevant procedures, therapy and follow-up period, the patient will be followed in terms of routine aftercare and treated if necessary by the primary responsible oncology center.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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