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    The EU Clinical Trials Register currently displays   42147   clinical trials with a EudraCT protocol, of which   6930   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-004397-22
    Sponsor's Protocol Code Number:MS100070_0087
    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:2021-06-11
    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 number2020-004397-22
    A.3Full title of the trial
    Single-arm, multicenter Phase I/Ib study of avelumab + lenvatinib in children with primary CNS tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Avelumab + lenvatinib for children with primary CNS tumors
    A.4.1Sponsor's protocol code numberMS100070_0087
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/504/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Healthcare KGaA
    B.1.3.4CountryGermany
    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 supportMerck Healthcare KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Healthcare KGaA
    B.5.2Functional name of contact pointCommunication Center
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.6E-mailservice@merckgroup.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 Yes
    D.2.1.1.1Trade name BAVENCIO
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe 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 nameBAVENCIO
    D.3.2Product code MSB0010718C
    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 INNAVELUMAB
    D.3.9.3Other descriptive nameAnti PD-L1
    D.3.9.4EV Substance CodeSUB180078
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 LENVIMA
    D.2.1.1.2Name of the Marketing Authorisation holderEisai 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 nameLENVIMA
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLenvatinib
    D.3.9.1CAS number 857890-39-2
    D.3.9.3Other descriptive nameLENVATINIB MESILATE
    D.3.9.4EV Substance CodeSUB72971
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4 and 10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Primary CNS tumors
    E.1.1.1Medical condition in easily understood language
    Primary central nervous system tumors
    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 LLT
    E.1.2Classification code 10065143
    E.1.2Term Malignant solid tumour
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Dose Escalation Part 1
    1. To evaluate the safety and tolerability of avelumab + lenvatinib
    2. To determine the recommended avelumab and lenvatinib dose for expansion

    Dose Expansion Part 2
    1. To assess efficacy by PFS
    E.2.2Secondary objectives of the trial
    Dose Escalation Part 1
    1. To assess PFS based on Investigator assessments and OS

    Dose Expansion Part 2
    1. To assess the OS

    Dose Escalation Part 1 and Dose Expansion Part 2
    1. To further evaluate the safety and tolerability of avelumab + lenvatinib
    2. To assess antitumor activity of avelumab + lenvatinib by ORR and DoR
    3. To characterize the PK profile of avelumab and lenvatinib when administered in combination.
    4. To characterize the immunogenicity of avelumab in combination with lenvatinib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are ≥ 2 and < 18 years of age at the time of signing the informed consent.
    2. A histologically confirmed diagnosis of primary CNS malignancy as follows:
    -Primary CNS tumors
    The tumor should be considered high-grade histologically
    Prior radiotherapy is allowed
    Participants must have progressed after they have been treated based on current treatment guidelines.These treatments are administered until the end of protocol, progressive disease or unacceptable toxicity.
    -Specific for participants with diffuse midline glioma with or without the H3 K27M mutation
    Prior radiotherapy is allowed
    No more than 1 prior systemic therapy is allowed
    Note: Participants with diffuse midline glioma with or without the H3 K27M
    mutation who have not received prior systemic therapy but have prior radiotherapy only are allowed to enroll.
    3. On screening scans, measurable disease by RANO criteria.
    4. Participants must have a Lansky performance status ≥ 50 for age ≤ 16 years or Karnofsky performance status ≥ 50 for age > 16 years at Screening.
    5. Adequate bone marrow function at Screening
    Absolute neutrophil count must be ≥ 1000/μL.
    Platelet count must be ≥ 100,000/mm3.
    Hemoglobin must be ≥ 8 g/dL.
    6. Adequate renal function: Screening serum creatinine must be ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance > 70 mL/minute if serum creatinine > 1.5 × ULN, according to the Cockcroft-Gault formula or by 24-hour urine collection for creatinine clearance or according to local institutional standard method.
    7. Adequate hepatic function
    Screening total bilirubin must be ≤ 1.5 × ULN for age or direct bilirubin ≤ ULN for age if total bilirubin > 1.5 × ULN for age.
    Screening serum aspartate aminotransferase (AST) and ALT must be ≤ 3 × ULN for age.
    8. Screening prothrombin time/international normalized ratio (INR) must be ≤ 1.5 × institutional ULN for age.
    9. Availability of tissue as a formalin-fixed paraffin-embedded (FFPE) block or a minimum of 10 (preferably 25) unstained tumor slides suitable for PD-L1 expression assessment. Tumor tissue from the most recent biopsy should be submitted, and this should be from a nonirradiated area.
    10. A negative serum pregnancy test at Screening for all postmenarchal girls, girls ≥ 10 years of age, or per local or institutional guidelines must be obtained.
    11. For participants of childbearing potential: agreement to remain abstinent or use 2 adequate methods of contraception for the duration of study intervention period and at least for 60 days after stopping the study interventions.
    12. A fractional shortening ≥ 30% or left ventricular ejection fraction ≥ 50% by echocardiogram or multigated acquisition (MUGA) scan within 28 days of study intervention initiation must be demonstrated.
    13. Participants with seizures that are well controlled are eligible and may be on antiepileptic medications, provided the dose of the antiepileptic drug(s) is/are stable.
    14. Participant must demonstrate an ability to comply with study protocol.
    15. Are male and/or female.
    a. Female participants
    Are not pregnant or breastfeeding, and at least one of the following conditions applies:
    Not a woman of childbearing potential
    OR
    If a woman of childbearing potential, use a highly effective contraceptive method (i.e., with a failure rate of < 1% per year), preferably with low user dependency, for the following time periods:
    Before the first dose of the study intervention(s), if using hormonal
    contraception:
    Has completed at least one 4-week cycle of an oral contraception pill and
    either had or has begun her menses
    OR
    Has used a depot contraceptive or extended-cycle oral contraceptive for
    least 28 days and has a documented negative pregnancy test using a highly
    sensitive assay.
    Highly effective contraceptive method has to be used for at least 60 days after
    the last dose of study intervention.
    Additional requirements for pregnancy testing during and after study intervention
    The Investigator reviews the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a female with an early undetected pregnancy.
    b. Male participants
    -Agree to the following during the study intervention period and for at least 60 days after the last dose of study intervention:
    -Refrain from donating sperm PLUS, either Abstain from any activity that allows for exposure to ejaculate
    OR Use a male condom:
    -When having sexual intercourse with a woman of childbearing potential, who
    is not currently pregnant, and advise her to use a highly effective
    contraceptive method with a failure rate of < 1% per year, since a condom may break or leak.
    16. Participant and/or his/her parent(s)/legal representative(s) is capable of giving signed informed consent, as indicated in Appendix 2 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
    E.4Principal exclusion criteria
    1. Participants with low-grade gliomas, for example but not limited to, subependymal giant cell astrocytoma, pilocytic astrocytoma and WHO Grade 1 tumors.
    2. Participants demonstrating evidence of worsening of neurologic deficit within 1 week prior to initiation of study interventions.
    3. Participants with bulky tumor
    4. Participants are not eligible if they experience uncontrolled seizures
    5. Participants who have received major surgery within 28 days prior to the first dose of study interventions.
    6. A history of intracranial hemorrhage/spinal cord hemorrhage within 28 days prior to the first dose of study interventions.
    7. Participants require therapeutic anticoagulation.
    8. Participants with a history of bleeding diathesis or recent major bleeding events considered by the Investigator as high risk for investigational drug treatment.
    9. Participants with urine protein ≥ 1 g protein/24-hour will be ineligible.
    10. Gastrointestinal malabsorption, GI anastomosis, or any other condition that might affect absorption of lenvatinib.
    11. Clinically significant cardiovascular or cerebrovascular disease
    12. Active hemoptysis (bright red blood of at least 2.5 mL) within 3 weeks prior to the first dose of study interventions.
    13. Participants with active hepatitis B or hepatitis C infections.
    14. Participants with known human immunodeficiency virus infection.
    15. Participants with a serious nonhealing wound, ulcer or bone fracture.
    16. The participant has known hypersensitivity to any of the study interventions or any components in their formulations, any history of anaphylaxis, or recent (within 5 months) history of uncontrollable asthma.
    17. Prior solid organ transplantation.
    18. Severe and/or clinically relevant acute or chronic diseases which, might impair the participant’s tolerance for the study or ability to consistently participate in study procedures.
    19. Participants with current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with participation for the full duration of the study.
    20. Pregnancy or breast feeding.
    21. Any other active malignancy within the past 2 years of Screening.
    22. The participant is affected with an autoimmune disease necessitating steroid therapy or other immunomodulatory therapy within the past 2 years of Screening
    23. Known active alcohol or drug abuse.
    Prior/Concomitant Therapy
    24. The participant has received treatment with chemotherapy, differentiation therapy, or other immunotherapy within 3 weeks of study entry.
    25. The participant has received prior therapy with anti-PD-1, anti-PD-L1, anti-CTLA4 or CD137 directed therapy.
    26. The participant has received prior treatment with lenvatinib or any tyrosine kinase inhibitor.
    27. Requirement for daily doses of steroids > 8 mg of methylprednisolone (or equivalent).
    28. The participant is experiencing any nonhematologic toxicity from prior treatment that has not resolved to Grade ≤ 1 per (CTCAE) Version 5.0 at Screening.
    29. The participant has an active infection necessitating systemic treatment with antibiotics, antifungals, antivirals or steroids within 72 hours of the first dose of study intervention.
    30. Prior allogeneic stem cell transplant within the last 5 years.
    31. The participant has received any hematopoietic growth factor within 2 weeks of study entry.
    32. The participant has received transfusion of packed red blood cells or platelets within 2 weeks before Screening to meet eligibility criteria.
    33. The participant has interstitial lung disease OR has a history of drug-induced pneumonitis.
    34. The participant has received treatment with live vaccines or live attenuated vaccines within 4 weeks prior to the first dose of avelumab.
    35. The participant has received treatment with herbal anticancer therapy within 1 week of study entry.
    Prior/Concurrent Clinical Study Experience
    36. The participant has received investigational therapy within 5 half-lives or 28 days of study entry.


    E.5 End points
    E.5.1Primary end point(s)
    Dose Escalation Part 1
    1. Occurrence and severity of CTCAE Grade ≥ 3 TEAEs according to NCI-CTCAE Version 5.0.
    2. Occurrence of DLTs

    Dose Expansion Part 2
    1. PFS as assessed by Investigators according to RANO criteria
    E.5.2Secondary end point(s)
    Dose Escalation Part 1
    1. PFS per RANO criteria

    Dose Escalation Part 1 and Dose Expansion Part 2
    1. Occurrence and severity of any grade TEAEs, treatment-related AEs, AESIs, deaths, and clinically significant changes in laboratory parameters.
    2. Confirmed objective response as assessed by Investigators according to RANO criteria
    3. DoR according to RANO criteria assessed by Investigator.
    4. Overall Survival
    5. PK parameters including CEOI, AUC, Ctrough of avelumab; Cmax, tmax, and AUC of lenvatinib of at least a single dose as data permit.
    6. Immunogenicity of avelumab as measured by ADA assay
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Evaluation of Avelumab and Lenvatinib in Paediatric Patient
    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) Yes
    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 concerned2
    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
    Canada
    France
    Germany
    Korea, Republic of
    United States
    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
    The end of the study is defined as minimum follow-up of 12 months after the last administration of study intervention or until the objectives of the study are assessed, whichever comes first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minor subjects
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5
    F.4.2.2In the whole clinical trial 18
    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 a participant has completed the study or has withdrawn early, usual treatment will be administered if required,with the study site’s standard of care and generally accepted medical practice and depending on the participant’s individual medical needs. The Sponsor will not provide any additional care to participants after they leave the study because such care should not differ from what is normally expected for participants with solidtumors unless it differs from local laws and regulations.
    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 Decision2021-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-19
    P. End of Trial
    P.End of Trial StatusOngoing
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