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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02555657
First Posted: September 21, 2015
Last Update Posted: September 25, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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 37 months ]

Secondary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: Up to 37 months ]
  • Disease Control Rate (DCR) [ Time Frame: Up to 37 months ]
  • Progression Free Survival (PFS) [ Time Frame: Up to 37 Months ]
  • Duration of Overall Response (DOR) [ Time Frame: Up to 37 months ]

Estimated Enrollment: 600
Actual Study Start Date: October 13, 2015
Estimated Study Completion Date: May 30, 2019
Estimated Primary Completion Date: December 11, 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
  • KEYTRUDA®
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

  Eligibility

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.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT02555657


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

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02555657     History of Changes
Other Study ID Numbers: 3475-119
2015-001020-27 ( EudraCT Number )
153082 ( Registry Identifier: JAPIC-CTI )
First Submitted: September 18, 2015
First Posted: September 21, 2015
Last Update Posted: September 25, 2017
Last Verified: September 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.:
PD1
PD-1
PDL1
PD-LI

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Capecitabine
Pembrolizumab
Vinorelbine
Antimetabolites, Antineoplastic
Antimetabolites
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