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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 18, 2015
Last updated: August 18, 2017
Last verified: August 2017
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 (TPC) in accordance with local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. The primary study hypothesis is that pembrolizumab extends progression free and/or overall survival compared to TPC

Condition Intervention Phase
Metastatic Triple Negative Breast Cancer Biological: pembrolizumab Drug: capecitabine Drug: eribulin Drug: gemcitabine Drug: vinorelbine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Up to 32 months ]

Secondary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: Up to 32 months ]
  • Disease Control Rate (DCR) [ Time Frame: Up to 32 months ]
  • Progression Free Survival (PFS) [ Time Frame: Up to 32 Months ]
  • Duration of Overall Response (DOR) [ Time Frame: Up to 32 months ]

Estimated Enrollment: 600
Actual Study Start Date: October 13, 2015
Estimated Study Completion Date: May 30, 2019
Estimated Primary Completion Date: August 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations.
Biological: pembrolizumab
Other Names:
  • MK-3475
Active Comparator: Chemotherapy
Participants receive capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
Drug: capecitabine Drug: eribulin Drug: gemcitabine Drug: vinorelbine


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02555657

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT02555657     History of Changes
Other Study ID Numbers: 3475-119
2015-001020-27 ( EudraCT Number )
153082 ( Registry Identifier: JAPIC-CTI )
Study First Received: September 18, 2015
Last Updated: August 18, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic processed this record on September 21, 2017