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    Summary
    EudraCT Number:2020-003424-17
    Sponsor's Protocol Code Number:MK3475-B21/ENGOT-en11/GOG-3053
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-10-21
    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 number2020-003424-17
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study with chemotherapy plus pembrolizumab or placebo after curative surgery for endometrial cancer in women 18 years or older
    A.4.1Sponsor's protocol code numberMK3475-B21/ENGOT-en11/GOG-3053
    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 Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    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 Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trial Operations
    B.5.3 Address:
    B.5.3.1Street Address126 East Lincoln Avenue P.O. Box 2000
    B.5.3.2Town/ cityRahway, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.6E-mailmsd42bamg@msd.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 KEYTRUDA (pembrolizumab, MK-3475)
    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.3.4Pharmaceutical form 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.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    Newly diagnosed high risk endometrial cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10014733
    E.1.2Term Endometrial cancer
    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
    1. To compare pembrolizumab with placebo, both in combination with adjuvant chemotherapy +/- XRT, with respect to disease-free survival (DFS) assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence.
    2. To compare pembrolizumab with placebo, both in combination with adjuvant chemotherapy +/- XRT, with respect to overall survival (OS).
    E.2.2Secondary objectives of the trial
    1. To compare pembrolizumab with placebo, both in combination with adjuvant chemotherapy +/- XRT, with respect to DFS assessed radiographically by blinded independent central review or by histopathologic confirmation of disease recurrence.
    2. To compare pembrolizumab with placebo, both in combination with adjuvant chemotherapy +/- XRT, with respect to OS and DFS assessed radiographically by the investigator or by histopathologic confirmation of disease recurrence by PD-L1 status, and by tumor mutation burden (TMB) status.
    3. To evaluate the safety and tolerability of pembrolizumab in combination with adjuvant chemotherapy +/- XRT.
    4. To compare pembrolizumab with placebo, both in combination with adjuvant chemotherapy +/- XRT, with respect to change from baseline score in the EORTC Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (QoL) scale and Physical Function subscale, and the EORTC endometrial cancer-specific QoL module (EORTC QLQ-EN24).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:
    a) Has undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy. Pelvic lymph node sampling, para-aortic lymph node sampling, including sentinel lymph node, and lymph node dissection are optional but strongly encouraged.
    b) Is at high risk for recurrence following treatment with curative intent surgery, ie, one of the following:
    - FIGO (2009) Surgical Stage I/II with myometrial invasion of nonendometrioid histology including serous adenocarcinoma, clear cell carcinoma, mixed epithelial carcinoma, dedifferentiated/undifferentiated carcinoma or carcinosarcoma.
    - FIGO (2009) Surgical Stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation
    - FIGO (2009) Surgical Stage III or IVA of any histology
    2. Is disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.
    3. Has not received any radiation or systemic therapy, including immunotherapy or hormonal therapy or HIPEC, in any setting including the neoadjuvant setting for EC.
    4. Is female and at least 18 years of age at the time of providing documented informed consent.
    5. Has ECOG performance status of 0 or 1 within 7 days before randomization.
    6. The participant (or legally acceptable representative) has provided documented informed consent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
    7. Submission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and MMR status by central vendor is required for all participants.
    8. Have adequate organ function. Specimens must be collected within 7 days before randomization.
    E.4Principal exclusion criteria
    1. Has recurrent endometrial carcinoma or carcinosarcoma.
    2. Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are also not allowed.
    3. Has FIGO (2009) Surgical Stage I/II EC of endometrioid histology without a known aberrant p53 expression or p53 mutation.
    4. Is known to have a POLE mutation.
    5. Has FIGO Stage IVB disease of any histology even if there is no evidence of disease after surgery.
    6. Has residual tumor whether measurable or nonmeasurable after surgery.
    7. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
    8. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
    9. Has received a live vaccine within 30 days before the first dose of study intervention.
    10. Has a known intolerance to study intervention (or any of the excipients).
    11. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
    12. Has any contraindication to the use of carboplatin or paclitaxel.
    13. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
    14. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
    15. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement
    therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
    16. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
    17. Has an active infection requiring systemic therapy.
    18. Has a known history of HIV infection.
    19. Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
    20. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
    21. Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study.
    22. Has had an allogenic tissue/solid organ transplant.
    23. Has not recovered adequately from surgery and/or any complications from the surgery.
    24. Is breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    1. Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence
    2. Overall Survival (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 42 months
    2. Up to approximately 54 months
    E.5.2Secondary end point(s)
    1. Disease-Free Survival (DFS) as Assessed Radiographically by Blinded Independent Central Review (BICR) or by Histopathologic Confirmation of Suspected Disease Recurrence
    2. Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Combined Positivity Score (CPS)-Determined Programmed Cell Death 1 Ligand 1 (PD-L1) Status
    3. Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Combined Positivity Score (CPS)-Determined Programmed Cell Death 1 Ligand 1 (PD-L1) Status
    4.Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status
    5.Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status
    6. Number of Participants Who Experience One or More Adverse Events (AEs)
    7. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
    8. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (QoL) Score
    9. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function Score
    10. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Endometrial Cancer (EORTC QLQ-EN24) Score
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 42 months
    2. Up to approximately 42 months
    3. Up to approximately 54 months
    4. Up to approximately 42 months
    5. Up to approximately 54 months
    6. Up to approximately 54 months
    7. Up to approximately 52 weeks
    8. Up to approximately 54 months
    9. Up to approximately 54 months
    10. Up to approximately 54 months
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Argentina
    Canada
    Chile
    China
    Colombia
    Israel
    Japan
    Korea, Democratic People's Republic of
    Mexico
    Taiwan
    United States
    Russian Federation
    Turkey
    Ukraine
    Austria
    Belgium
    Czechia
    Denmark
    Finland
    France
    Germany
    Greece
    Italy
    Norway
    Poland
    Spain
    Sweden
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    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 months6
    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: 495
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 495
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 990
    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
    G.4.1Name of Organisation European Network of Gynaecological Oncological Trial groups (ENGOT)
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation The GOG Foundation, Inc
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation AGO Research GmbH
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-31
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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