Working… Menu
Trial record 1 of 1 for:    NCT02555657
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02555657
Recruitment Status : Active, not recruiting
First Posted : September 21, 2015
Last Update Posted : August 26, 2019
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 overall survival compared to TPC.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 622 participants
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)
Actual Study Start Date : October 13, 2015
Actual Primary Completion Date : April 11, 2019
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 42 months ]

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 42 months ]
  2. Disease Control Rate (DCR) [ Time Frame: Up to 42 months ]
  3. Progression Free Survival (PFS) [ Time Frame: Up to 42 months ]
  4. Duration of Overall Response (DOR) [ Time Frame: Up to 42 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02555657

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Additional Information:
Layout table for additonal 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 )
MK-3475-119 ( Other Identifier: Merck Protocol Number )
KEYNOTE-119 ( Other Identifier: Merck )
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Layout table for additional information
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:
Layout table for 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, Immunological
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators