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    Summary
    EudraCT Number:2018-004040-28
    Sponsor's Protocol Code Number:MS200647_0024
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-004040-28
    A.3Full title of the trial
    A Phase Ib/II, Open-Label Study of M7824 in Combination with Chemotherapy in Participants with Stage IV Non-small Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase Ib/II Study of M7824 in Combination with Chemotherapy in Stage IV Non-small Cell Lung Cancer
    A.4.1Sponsor's protocol code numberMS200647_0024
    A.5.4Other Identifiers
    Name:IND numberNumber:124757
    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 SponsorMerck 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 KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    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.5.4Telephone number+49 6151 72 5200
    B.5.5Fax number+49 6151 72 2000
    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 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 nameM7824
    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 INNbintrafusp alfa (proposed INN)
    D.3.9.2Current sponsor codeM7824
    D.3.9.3Other descriptive nameMSB0011359C
    D.3.9.4EV Substance CodeSUB179957
    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.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
    Stage IV Non-small Cell Lung Cancer (NSCLC)
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate safety and tolerability of M7824 in combination with chemotherapy
    E.2.2Secondary objectives of the trial
    •To evaluate objective response rate (ORR) for M7824 in combination with chemotherapy
    •To evaluate Progression-Free Survival (PFS) for M7824 in combination with chemotherapy
    • To evaluate overall survival (OS) for M7824 in combination with chemotherapy
    • To evaluate Duration of Response (DoR) for M7824 in combination with chemotherapy
    •To characterize pharmacokinetic (PK) profile of M7824 (Sample collection has been stopped as communicated in the Investigator letter dated as 2 November 2021)
    • To evaluate the immunogenicity of M7824 (Sample collection has been stopped as communicated in the Investigator letter dated as 2 November 2021)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants ≥ 18 years of age inclusive at the time of signing the informed consent.
    2. Are participants who have histologically confirmed diagnosis of Stage IV NSCLC.
    a. Participants in Cohort A, B, and C must not have received prior systemic therapy treatment for their Stage IV NSCLC.
    b. Resolution of toxic effects of previous chemotherapy to Grade ≤ 1 must be confirmed prior to enrollment
    c. Participants who had disease progression on previous 1L treatment with PD (L)1 inhibitors in combination with platinum-based chemotherapy are enrolled in Cohort D.
    d. Have measurable disease based on RECIST 1.1
    e. Have a life expectancy of at least 3 months
    f. Availability of archived tumor material (< 6 months old) adequate for biomarker analysis is mandatory at Screening, central laboratory confirmation is required. Fresh biopsies should be collected if archived tumor material is not available.
    3. ECOG PS of 0 to 1 at study entry and date of first dose.
    4. Other criteria may apply.
    E.4Principal exclusion criteria
    1. The participant’s tumor harbors an EGFR sensitizing (activating) mutation, ROS1 rearrangement, BRAF V600E Mutation or is ALK positive, if targeted therapy is locally approved.
    2. Mixed small cell with NSCLC cancer histology.
    3. Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy (RT) of > 30 Gy within 6 months prior to the first dose of study intervention.
    4. Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years.
    5. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks after the end of the RT and have no evidence of new or enlarging brain metastases evaluated by Image, preferably brain MRI.
    6. Active autoimmune disease that has required systemic treatment in the past 1 year (e.g. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), OR is receiving systemic steroid therapy < 3 days prior to the first dose of study intervention (M7824, cisplatin, carboplatin, pemetrexed, paclitaxel, nab-paclitaxel, gemcitabine, or docetaxel) or receiving any other form of immunosuppressive medication.
    7. Known severe hypersensitivity to study intervention or any components in their formulations.
    8. For participants in Cohort A, B and C: Has received prior systemic therapy for Stage IV NSCLC, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
    9. Other criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    1. Occurrence of DLTs during the 3-week DLT observation period.
    2. Occurrence of TEAEs and treatment-related AEs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From first dose of study drug administration up to 3 weeks.
    2. From first dose of study drug administration to final assessment, up to 3 years.
    E.5.2Secondary end point(s)
    1. Confirmed objective response according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
    2. Progression-Free Survival (PFS) according to RECIST 1.1
    3. Overall survival (OS)
    4. Duration of Response (DoR) assessed from complete response (CR) or partial response (PR) until progression of disease (PD), death or last tumor assessment.
    5. PK (Pharmacokinetic) parameters for M7824 for all participants (Sample collection has been stopped as communicated in the Investigator letter dated as 02 November 2021).
    6. Immunogenicity of M7824 (Sample collection has been stopped as communicated in the Investigator letter dated as 02 November 2021).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From first assessment to final assessment, up to 3 years.
    2. From first administration of study intervention to final assessment, up to 3 years.
    3. From first administration of study intervention to final assessment, up to 3 years.
    4. From first administration of study intervention to final assessment, up to 3 years.
    5. From first assessment up to 3 years
    6. From first assessment up to 3 years
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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
    Ib/II
    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 Information not present in EudraCT
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 trial4
    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 EEA10
    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 States
    European Union
    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 3 years after treatment start of the last participant or until all participants in the study experienced PD to the subsequent treatment, whichever occurs 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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 64
    F.1.3Elderly (>=65 years) Yes
    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 state37
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 64
    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)
    On withdrawal from the study, participants may receive whatever care they and their physicians agree upon.
    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 Decision2019-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-13
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