Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)
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| ClinicalTrials.gov Identifier: NCT02555657 |
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Recruitment Status :
Completed
First Posted : September 21, 2015
Results First Posted : May 4, 2020
Last Update Posted : December 10, 2021
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Metastatic Triple Negative Breast Cancer |
| Interventions |
Biological: pembrolizumab Drug: capecitabine Drug: eribulin Drug: gemcitabine Drug: vinorelbine |
| Enrollment | 622 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Per protocol, response/progression or adverse events during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures respectively. |
| Arm/Group Title | Pembrolizumab | Chemotherapy |
|---|---|---|
 Arm/Group Description |
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years). Qualified participants who received first course of pembrolizumab but continued to experience disease progression may have, at investigator's discretion, initiated a second course of pembrolizumab at 200 mg IV Q3W for up to 17 administrations (up to ~1 year). | Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines. |
| Period Title: Overall Study | ||
| Started | 312 | 310 |
| Treated | 309 | 292 |
| Completed | 0 | 0 |
| Not Completed | 312 | 310 |
| Reason Not Completed | ||
| Death | 274 | 262 |
| Physician Decision | 0 | 1 |
| Sponsor Decision | 27 | 15 |
| Withdrawal by Subject | 11 | 32 |
Baseline Characteristics
| Arm/Group Title | Pembrolizumab | Chemotherapy | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years). Qualified participants who received first course of pembrolizumab but continued to experience disease progression may have, at investigator's discretion, initiated a second course of pembrolizumab at 200 mg IV Q3W for up to 17 administrations (up to ~1 year). | Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 312 | 310 | 622 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 312 participants | 310 participants | 622 participants | |
| 51.4 (11.4) | 52.6 (11.2) | 52.0 (11.3) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 312 participants | 310 participants | 622 participants | |
| Female |
312 100.0%
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308 99.4%
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620 99.7%
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| Male |
0 0.0%
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2 0.6%
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2 0.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 312 participants | 310 participants | 622 participants | |
| American Indian or Alaska Native |
4 1.3%
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4 1.3%
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8 1.3%
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| Asian |
87 27.9%
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101 32.6%
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188 30.2%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
13 4.2%
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4 1.3%
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17 2.7%
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| White |
183 58.7%
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180 58.1%
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363 58.4%
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| More than one race |
12 3.8%
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12 3.9%
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24 3.9%
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| Unknown or Not Reported |
13 4.2%
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9 2.9%
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22 3.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
| Name/Title: | Senior Vice President, Global Clinical Development |
| Organization: | Merck Sharp & Dohme Corp |
| Phone: | 1-800-672-6372 |
| EMail: | ClinicalTrialsDisclosure@merck.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merck Sharp & Dohme LLC |
| ClinicalTrials.gov Identifier: | NCT02555657 |
| Other Study ID Numbers: |
3475-119 2015-001020-27 ( EudraCT Number ) 153082 ( Registry Identifier: JAPIC-CTI ) MK-3475-119 ( Other Identifier: Merck ) KEYNOTE-119 ( Other Identifier: Merck ) |
| First Submitted: | September 18, 2015 |
| First Posted: | September 21, 2015 |
| Results First Submitted: | March 27, 2020 |
| Results First Posted: | May 4, 2020 |
| Last Update Posted: | December 10, 2021 |