Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)
NCT ID: NCT02555657
Last Updated: 2021-12-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
622 participants
INTERVENTIONAL
2015-10-13
2020-11-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab
Participants receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years). Qualified participants who receive first course of pembrolizumab but continue to experience disease progression may, at investigator's discretion, initiate a second course of pembrolizumab at 200 mg IV Q3W for up to 17 administrations (up to \~1 year).
pembrolizumab
Chemotherapy
Participants receive capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
capecitabine
eribulin
gemcitabine
vinorelbine
Interventions
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pembrolizumab
capecitabine
eribulin
gemcitabine
vinorelbine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly obtained tumor biopsy from metastatic site
* Central determination of programmed cell death ligand 1 (PD-L1) tumor status
* Received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy
* Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start
* Adequate organ function
Exclusion Criteria
* Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks
* Chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks
* Active autoimmune disease that required systemic treatment in the past 2 years
* Diagnosed with immunodeficiency or receiving systemic steroid therapy or another form of immunosuppressive therapy within 7 days
* Known additional malignancy that required treatment or progressed in last 5 years
* Known active brain metastases and/or carcinomatous meningitis
* Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand-1 (anti-PD-L1), anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte associated protein 4 \[CTLA-4\], OX-40, CD137) or previously participated in any pembrolizumab (MK-3475) clinical studies
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Countries
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References
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Essalihi A, Bouchra O, Khadiri K, Khadrouf Z, Karkouri M. Immunotherapy for triple-negative breast cancer: current trends and future prospects. J Egypt Natl Canc Inst. 2025 Jun 17;37(1):51. doi: 10.1186/s43046-025-00295-x.
Schmid P, Lipatov O, Im SA, Goncalves A, Munoz-Couselo E, Lee KS, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Mejia JA, Zhou X, Haiderali A, Nguyen AM, Cortes J, Winer EP. Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study. Eur J Cancer. 2023 Dec;195:113393. doi: 10.1016/j.ejca.2023.113393. Epub 2023 Oct 21.
Cortes J, Lipatov O, Im SA, Goncalves A, Lee KS, Schmid P, Tamura K, Testa L, Ohtani S, Harbeck N, Loi S, Salgado R, Karantza V, Mejia J, Cristescu R, Loboda A, Nebozhyn M, Jelinic P, Huang L, Winer EP. Association of potential biomarkers with clinical outcomes in metastatic triple-negative breast cancer treated with pembrolizumab or chemotherapy. NPJ Breast Cancer. 2025 Oct 2;11(1):109. doi: 10.1038/s41523-025-00814-y.
Winer EP, Lipatov O, Im SA, Goncalves A, Munoz-Couselo E, Lee KS, Schmid P, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Zhou X, Karantza V, Mejia J, Cortes J; KEYNOTE-119 investigators. Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):499-511. doi: 10.1016/S1470-2045(20)30754-3. Epub 2021 Mar 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Merck Oncology Clinical Trial Information
Other Identifiers
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2015-001020-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
153082
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-3475-119
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-119
Identifier Type: OTHER
Identifier Source: secondary_id
3475-119
Identifier Type: -
Identifier Source: org_study_id