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    Summary
    EudraCT Number:2018-001757-27
    Sponsor's Protocol Code Number:MK-3475-859
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-18
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-001757-27
    A.3Full title of the trial
    A Phase 3, randomized, double-blind clinical study of pembrolizumab (MK-3475) plus chemotherapy versus placebo plus chemotherapy as first-line treatment in participants with HER2 negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (KEYNOTE-859)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pembrolizumab/placebo plus chemotherapy as first-line therapy in participants with HER2 negative advanced gastric or GEJ adenocarcinoma
    A.4.1Sponsor's protocol code numberMK-3475-859
    A.5.4Other Identifiers
    Name:Other indentificationNumber:123 482
    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 Corp., 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 Corp., 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 organisation
    B.5.2Functional name of contact point
    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 namePEMBROLIZUMAB
    D.3.2Product code MK-3475
    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.3.9.4EV 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.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 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.3.9.4EV 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
    HER2 negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Gastric and gastric esophageal junction (GEJ) adenocarcinoma
    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 10071114
    E.1.2Term Metastatic gastric adenocarcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10058526
    E.1.2Term Oesophageal adenocarcinoma metastatic
    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
    To compare the overall survival (OS) of the participants following administration of pembrolizumab versus placebo when each is combined with chemotherapy
    To compare the progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), as assessed by blinded independent central review (BICR), following administration of pembrolizumab versus placebo when each is combined with chemotherapy
    E.2.2Secondary objectives of the trial
    To compare the objective response rate (ORR) per RECIST 1.1, as assessed by BICR, following administration of pembrolizumab versus placebo when each is combined with chemotherapy
    To compare the duration of response (DOR) per RECIST 1.1, as assessed by BICR, following administration of pembrolizumab versus placebo when each is combined with chemotherapy in all participants and in participants with PD-L1-positive tumors (CPS ≥1)
    To evaluate the safety and tolerability of pembrolizumab plus chemotherapy versus placebo plus chemotherapy
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood and tissue specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    E.3Principal inclusion criteria
    1. Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, with known PD-L1 expression status.
    2. Has HER2 negative cancer. HER2 negative is defined as: IHC (0, or 1+) or fluorescence in situ hybridization (FISH) negative (HER2:CEP17 ratio <2 with an average HER2 copy number <4.0 signals/cell). FISH can be replaced with locally available in situ hybridization (ISH) methods acceptable as per institutional guidelines (eg, DISH).
    3. Is Male or Female.
    4. Is at least 18 years of age at the time of signing the informed consent (or acceptable age according to local regulations, whichever is older).
    5. A male participant must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater, and must refrain from donating sperm during this period.
    6. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 5.
    OR
    b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
    7. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for future
    biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
    8. Has measurable disease per RECIST 1.1 as assessed by investigator assessment. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
    9. Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
    10. Has provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis.
    11. Has provided tumor tissue sample for MSI biomarker analysis.
    12. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 3 days prior to the start of study intervention).
    13. Has adequate organ function, as defined in the protocol. Specimens must be collected within 10 days prior to the start-of-study intervention.
    E.4Principal exclusion criteria
    1. Has squamous cell or undifferentiated gastric cancer.
    2. Has had major surgery, open biopsy, or significant traumatic injury
    within 28 days prior to randomization, or anticipation of the need for
    major surgery during the course of study intervention.
    3. Has pre-existing peripheral neuropathy >Grade 1.
    4. Is a WOCBP who has a positive urine pregnancy test within 72 hours
    prior to randomization or treatment allocation.
    5. Has had previous therapy for locally advanced, unresectable and/or
    metastatic gastric/GEJ cancer. Participants may have received prior
    neoadjuvant or adjuvant therapy as long as it was completed at least 6
    months prior to randomization.
    6. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PDL2
    agent or with an agent directed to another stimulatory or coinhibitory
    T-cell receptor (eg, CTLA-4, OX-40, CD137).
    7. Has received prior systemic anticancer therapy including
    investigational agents within 4 weeks prior to randomization.
    8. Has received prior radiotherapy within 2 weeks prior to start of study
    intervention. Participants must have recovered from all radiation-related
    toxicities, not require corticosteroids, and not have had radiation
    pneumonitis. A 1-week washout is permitted for palliative radiation (≤2
    weeks of radiotherapy) to non-central nervous system (CNS) disease.
    9. Has received a live vaccine within 30 days prior to the first dose of
    study intervention. Examples of live vaccines include, but are not limited
    to, the following: measles, mumps, rubella, varicella/zoster (chicken
    pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid
    vaccine. Seasonal influenza vaccines for injection are generally killed
    virus vaccines and are allowed; however, intranasal influenza vaccines
    (eg, FluMist®) are live attenuated vaccines and are not allowed.
    10. Is currently participating in or has participated in a study of an
    investigational agent or has used an investigational device within 4
    weeks prior to the first dose of study intervention.
    11. 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 to the first dose of study intervention.
    12. Has a known additional malignancy that is progressing or has
    required active treatment within the past 5 years.
    13. Has known active CNS metastases and/or carcinomatous meningitis.
    Participants with previously treated brain metastases may participate
    provided they are radiologically stable (ie, without evidence of
    progression) for at least 4 weeks by repeat imaging (note that the
    repeat imaging should be performed during study screening), clinically
    stable and without requirement of steroid treatment for at least 14 days
    prior to 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 human immunodeficiency virus (HIV)
    infection.
    19. Has a known history of Hepatitis B (defined as Hepatitis B surface
    antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as
    HCV RNA [qualitative] is detected) infection.
    20. Has a known history of active tuberculosis.
    21. Has a history or current evidence of any condition (eg, known
    deficiency of the enzyme dihydropyrimidine dehydrogenase), 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.
    22. Participants with hypokalemia (serum potassium less than the lower
    limit of normal).
    23. Participants with hypomagnesemia (serum magnesium less than the
    lower limit of normal).
    24. Participants with hypocalcemia (serum calcium less than the lower
    limit of normal).
    25. Has a known psychiatric or substance abuse disorder that would
    interfere with the participant's ability to cooperate with the
    requirements of the study.
    26. Is pregnant or breastfeeding or expecting to conceive or father
    children within the projected duration of the study, starting with the
    screening visit through 180 days after the last dose of chemotherapy or
    through 120 days after the last dose of pembrolizumab, whichever is
    greater.
    27. Has had an allogenic tissue/solid organ transplant
    E.5 End points
    E.5.1Primary end point(s)
    - Overall survival (OS), defined as the time from randomization to death due to any cause
    - Progression-free Survival (PFS), defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall survival (OS) = time from randomization to death due to any cause; Progression-free survival (PFS) = time from randomization to the first documented disease progression per RECIST 1.1 by (blinded independent central review (BICR) or death due to any cause, whicherver occurs first
    E.5.2Secondary end point(s)
    - Objective response (OR), defined as Complete response (CR) or partial response (PR)
    - Duration of Response (DOR), defined as the time from first response (CR or PR) to subsequent disease progression, or death from any cause, whichever occurs first
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Objective Response Rate (ORR) = proportion of participants who have an overall response – complete response (CR) or partial response (PR);
    - Duration of Response (DOR) =time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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
    Australia
    Brazil
    Canada
    Chile
    China
    Colombia
    France
    Guatemala
    Hong Kong
    Ireland
    Israel
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Peru
    Poland
    Russian Federation
    South Africa
    Spain
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    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 overall study ends when the last participant completes the last study-related telephone-call or visit, withdraws from the study, or is lost to follow-up (ie, the participant is unable to be contacted by the investigator).
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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: 455
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1087
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 770
    F.4.2.2In the whole clinical trial 1542
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
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