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    Summary
    EudraCT Number:2016-001432-35
    Sponsor's Protocol Code Number:MK-3475-355
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-21
    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 ConcernedIreland - HPRA
    A.2EudraCT number2016-001432-35
    A.3Full title of the trial
    A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) plus Chemotherapy vs Placebo plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer – (KEYNOTE-355)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III Study to Evaluate Chemotherapy With or Without Pembrolizumab as First Line Treatment for Triple Negative Breast Cancer
    A.3.2Name or abbreviated title of the trial where available
    A Phase III Study of Pembrolizumab + Chemotherapy in 1L Triple Negative Breast Cancer
    A.4.1Sponsor's protocol code numberMK-3475-355
    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
    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
    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 (UK) Limited
    B.5.2Functional name of contact pointGlobal Clinical Trial Operations
    B.5.3 Address:
    B.5.3.1Street Address120 Moorgate
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC2M 6UR
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailGeoff.Tansley@msd.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 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.3.9.2Current sponsor codeMK-3475
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    D.3.9.4EV Substance CodeAS1
    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
    Triple-Negative Breast Cancer
    E.1.1.1Medical condition in easily understood language
    Triple-Negative Breast Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative breast 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
    Part 1 (Safety Run-In):
    - To evaluate the safety and tolerability of 3 pembrolizumab + chemotherapy combinations, namely, pembrolizumab + paclitaxel, pembrolizumab + nab paclitaxel, and pembrolizumab + gemcitabine/carboplatin.

    Part 2 (Phase III study):
    1. To compare progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by a blinded central imaging vendor (CIV) in all subjects.
    2. To compare PFS based on RECIST 1.1 as assessed by a blinded CIV in subjects with PD-L1 positive tumors (combined positive score [CPS] ≥1).
    3. To compare PFS based on RECIST 1.1 as assessed by a blinded CIV in subjects with PD-L1 positive tumors (CPS ≥10).
    4. To compare overall survival (OS) in all subjects.
    5. To compare OS in subjects with PD-L1 positive tumors (CPS ≥1).
    6. To compare OS in subjects with PD-L1 positive tumors (CPS ≥10).
    E.2.2Secondary objectives of the trial
    Part 2 (Phase III study):
    1. To compare objective response rate (ORR) based on RECIST 1.1 as assessed by a blinded CIV in all subjects, in subjects with PD-L1 positive tumors (CPS ≥1 and CPS ≥10).
    2. To evaluate duration of response (DOR) based on RECIST 1.1 as assessed by a blinded CIV in all subjects and in subjects with PD-L1 positive tumors (CPS ≥1 and CPS ≥10).
    3. To compare DCR based on RECIST 1.1 as assessed by a blinded CIV in all subjects and in subjects with PD-L1 positive tumors (CPS ≥1 and CPS ≥10).
    4. To evaluate the safety and tolerability of 3 pembrolizumab + chemotherapy combinations.
    5. To evaluate changes in health-related quality-of-life (QoL) assessments from baseline in all subjects and in subjects with PD-L1 positive tumors (CPS ≥1 and CPS ≥10) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer– Specific Quality of Life Questionnaire (EORTC QLQ-BR23).
    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 tumor 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.Have locally recurrent inoperable breast cancer not previously treated with chemotherapy and which cannot be treated with curative intent.
    OR
    Have metastatic breast cancer not previously treated with chemotherapy.
    Note: Subjects with a history of locally recurrent breast cancer, which was previously treated with curative intent, may be eligible.
    2.Have centrally confirmed TNBC, as defined by the most recent ASCO/CAP guidelines.
    Note: Subjects initially diagnosed with hormone receptor–positive and/or HER2 positive breast cancer must have central confirmation of TNBC in a tumor biopsy obtained from a local recurrence or distant metastasis site.
    3.Have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence.
    Note: Adjuvant radiation therapy is not considered treatment with curative intent for the purpose of calculating the ≥6 month interval requirement described above.
    Note: First documentation of local or distant disease recurrence must be in the form of a dated biopsy, pathology, or imaging study report. A laboratory report indicating tumor marker elevation cannot be used as documentation of local or distant disease recurrence, unless accompanied by dated biopsy, pathology, or imaging study report.
    Note: Subjects who received taxane, gemcitabine, or platinum agents in the (neo)adjuvant setting can be treated with same class of chemotherapy (taxane or gemcitabine/carboplatin), if ≥12 months have elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence.
    4.Have been treated with (neo)adjuvant anthracycline, if they received systemic treatment in the (neo)adjuvant setting, unless anthracycline was contraindicated or not considered the best treatment option for the subject in the opinion of the treating physician.
    Note: Subjects presenting with de novo metastatic TNBC are eligible for the study, if anthracycline is contraindicated or not considered the best treatment option for the subject in the opinion of the treating physician.
    5.Have measurable disease based on RECIST 1.1 as determined by local radiology review.
    Note: Target lesions situated in a previously irradiated area are considered measurable, only if they have shown unequivocal progression based on RECIST 1.1 after radiation therapy.
    Note: Chest wall recurrence can be used as a target lesion, only if measurable by diagnostic quality imaging modality (digital photography alone is not adequate).
    6.Have provided recently or newly obtained core or excisional biopsy from a locally recurrent inoperable or metastatic tumor lesion for central determination of TNBC status and PD-L1 expression, unless contraindicated due to site inaccessibility and/or subject safety concerns.
    Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory. Submission of another tumor specimen may be required, if adequate tumor tissue was not provided the first time.
    Note: An archival tumor specimen obtained before the diagnosis of locally recurrent inoperable or metastatic breast cancer may be submitted after consultation with the Sponsor, if neither a recently nor a newly obtained biopsy from a locally recurrent inoperable or a metastatic site is available.
    7.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to the start of study treatment.
    8.Have life expectancy ≥12 weeks from randomization.
    9.Demonstrate adequate organ function, within 10 days prior to the start of study treatment, as defined in the following table.
    Refer to protocol for complete list.
    10. A Female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following :
    Is not a WOCBP
    OR
    Is a WOCBP and :
    -Uses a contraceptive method that is highly effective.
    -Has a negative highly-sensitive pregnancy test.
    -Has had her medical history, menstrual history, and recent sexual activity reviewed by the investigator to decrease the risk for inclusion of a woman with an undetected pregnancy.
    11. Male participants are eligible to participate is they agree :
    Refrain from donating sperm
    PLUS either:
    Be abstinent from heterosexual intercourse as their preferred and usual lifestyle
    OR
    Must agree to use contraception unless confirmed to be azoospermic.
    E.4Principal exclusion criteria
    1.Is currently participating in a clinical study and receiving an investigational agent and/or using an investigational device, or has participated in a clinical study and received an investigational agent and/or used an investigational device within 4 weeks prior to randomization.
    Note: Subjects who have entered the follow-up phase of a clinical study may participate as long as 4 weeks have elapsed since the last dose of the investigational agent and/or removal of the device.
    Note: Subjects who were treated with radiation therapy may participate as long as at least 2 weeks have elapsed since the last dose of radiation therapy was administered.
    2.Has not recovered (e.g., to ≤Grade 1 or to baseline) from AEs due to a previously administered therapy.
    Note: Alopecia of any grade is an exception to this criterion.
    Note: Prior to randomization, the subject must have recovered adequately from any toxicity and/or complications associated with any recent procedure.
    3.Has neuropathy ≥Grade 2.
    4.Has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
    5.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization.
    6.Has a known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.
    7.Has known active CNS metastases and/or carcinomatous meningitis. Subjects with known brain metastases may participate provided that the brain metastases have been previously treated (except with chemotherapy) and are radiographically stable. To demonstrate radiographic stability of previously treated brain metastases, a minimum of 2 post-treatment brain imaging assessments are required: 1) The first brain imaging must be acquired after treatment of brain metastases has been completed 2) The second brain imaging must be obtained during screening (i.e. within 28 days of randomisation) and ≥ 4 weeks after the previous post-treatment brain imaging.
    Note: Known brain metastases are considered active, if any of the following criteria are applicable:
    a. Brain imaging during screening demonstrates progression of existing metastases and/or appearance of new lesions compared to brain imaging performed at least 4 weeks earlier.
    Radiographic stability of previously treated brain metastases is based on local radiology/investigator review, but dated reports of 2 imaging studies (the most recent performed during screening) documenting stability of brain metastasis(es) over ≥4 weeks must be submitted to the Sponsor. Such brain imaging studies should be available at the site for submission to CIV, if later needed.
    b.Neurological symptoms attributed to brain metastases have not returned to baseline
    c.Steroids were used for management of symptoms related to brain metastases within 28 days of randomization
    8.Has history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
    9.Has received prior therapy with an anti–PD-1, anti–PD-L1, or anti–PD-L2 agent or with an agent directed to another co-inhibitory T cell receptor (such as CTLA-4, OX 40, CD137) or has previously participated in Merck pembrolizumab (MK-3475) clinical studies.
    Refer to protocol for compete list.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1:
    Safety and tolerability.

    Part 2:
    1. Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by a blinded central imaging vendor (CIV) in all subjects.
    2. PFS based on RECIST 1.1 as assessed by a blinded CIV in subjectswith PD-L1 positive tumors (CPS ≥1).
    3. PFS based on RECIST 1.1 as assessed by a blinded CIV in subjects with PD-L1 positive tumors (CPS ≥10).
    4. Overall survival (OS) in all subjects.
    5. OS in subjects with PD-L1 positive tumors (CPS ≥1).
    6. OS in subjects with PD-L1 positive tumors (CPS ≥10).
    E.5.1.1Timepoint(s) of evaluation of this end point
    One safety interim analysis for Part 1 and 3 efficacy interim analyses for Part 2 will be performed.

    Part 1 -
    Safety IA: ~ 3 mo after first subject randomized. After all Part 1 subjects have completed the first 21 or 28 days (depending on chemotherapy treatment) of treatment.

    Part 2
    IA1- interim PFS and interim OS analysis: ~ 9 months after first 640 Part 2 subjects are randomized. IA2 - interim OS analysis and final PFS analysis. After ~ 185 OS events among subjects with CPS ≥10 have been observed.
    IA3 - interim OS analysis: after ~ 210 OS events among subjects with CPS ≥10 have been observed.
    FA - final OS analysis: after ~ 664 OS events among all subjects, ~ 482 OS events among subjects with CPS ≥1, and ~ 240 OS events among subjects with CPS ≥10 have been observed.
    E.5.2Secondary end point(s)
    Part 2
    Objective response rate (ORR) based on RECIST 1.1 as assessed by a blinded CIV in all subjects and in subjects with PD-L1 positive tumors (CPS ≥1).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Interim analysis 1 (IA1): ~ 9 months after first 640 Part 2 subjects are randomized.
    Primary purpose: final ORR analysis.
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Part 1: open-label study. Part 2: double-blind, part under in-house blinding procedures.
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Australia
    Brazil
    Canada
    Chile
    Colombia
    Hong Kong
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    New Zealand
    Taiwan
    United States
    Austria
    Finland
    France
    Poland
    Netherlands
    Spain
    Czechia
    Germany
    Italy
    Belgium
    Denmark
    Russian Federation
    Turkey
    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 years5
    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 years5
    E.8.9.2In all countries concerned by the trial months5
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 773
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 283
    F.4.2.2In the whole clinical trial 858
    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 discontinuation of all study treatments, each subject will be followed for 30 days for adverse events monitoring; serious adverse events will be collected for 90 days after the end of study treatment or starts of a new anti-cancer treatment, but for at least 30 days after the last dose of study treatment, whichever is first.

    All subjects will be followed by phone every 12 weeks, or more often as needed, for overall survival (OS) until death, withdrawal of consent, or end of the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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