Clinical trial · Interventional

Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)

A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119)

NCT02555657CI-TRIAL-00055472completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

In this study, participants with metastatic triple negative breast cancer (mTNBC) will be randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. The primary study hypothesis is that pembrolizumab extends overall survival compared to TPC.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Metastatic Triple Negative Breast Cancer	Triple-Negative Breast Carcinoma	CURATED_BROADER	0.78

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
capecitabine	Drug	Capecitabine	ALIAS
eribulin	Drug	Eribulin	ALIAS
gemcitabine	Drug	Gemcitabine	ALIAS
pembrolizumab	Biological	Pembrolizumab	ALIAS
vinorelbine	Drug	Vinorelbine	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Pembrolizumab
description
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).
interventionNames
1. Biological: pembrolizumab
type
ACTIVE_COMPARATOR
label
Chemotherapy
description
Participants receive capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
interventionNames
1. Drug: capecitabine
2. Drug: eribulin
3. Drug: gemcitabine
4. Drug: vinorelbine

Primary outcomes (3)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Centrally confirmed Stage IV/M1 mTNBC
* 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:

* Participation in another clinical trial within 4 weeks
* 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

References

Publications (4)

DERIVEDCortes 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. PMID 41038856
DERIVEDEssalihi 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. PMID 40526219
DERIVEDSchmid 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. PMID 37976633
DERIVEDWiner 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. PMID 33676601