Study of Pembrolizumab (MK-3475) Monotherapy for Metastatic Triple-Negative Breast Cancer (MK-3475-086/KEYNOTE-086)
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ClinicalTrials.gov Identifier: NCT02447003 |
Recruitment Status :
Completed
First Posted : May 18, 2015
Results First Posted : December 16, 2020
Last Update Posted : December 16, 2020
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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 |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Breast Cancer |
Intervention |
Biological: Pembrolizumab |
Enrollment | 254 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Per protocol, response or progression during the second pembrolizumab course was not counted towards efficacy outcome measures, and adverse events during the second pembrolizumab course were not counted towards safety outcome measures. Based on protocol-specified inclusion criteria and outcome analyses requirements, Part 2 was not conducted. |
Arm/Group Title | Cohort A: Pembrolizumab | Cohort B: Pembrolizumab |
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Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants were administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years). Qualified participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year). | Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants were administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years). Qualified participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year). |
Period Title: Overall Study | ||
Started | 170 | 84 |
Completed | 0 | 0 |
Not Completed | 170 | 84 |
Reason Not Completed | ||
Other | 0 | 4 |
Site discontinued | 0 | 2 |
Physician Decision | 0 | 1 |
Withdrawal by Subject | 4 | 3 |
Sponsor Decision | 6 | 11 |
Progressive Disease | 1 | 0 |
Lost to Follow-up | 5 | 0 |
Death | 154 | 63 |
Baseline Characteristics
Arm/Group Title | Cohort A: Pembrolizumab | Cohort B: Pembrolizumab | Total | |
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Participants in Cohort A previously received at least one prior systemic treatment for metastatic breast cancer. Participants were administered pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years). Qualified participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year). | Participants in Cohort B previously received no prior systemic treatment for metastatic breast cancer AND had a programmed cell death-ligand 1 (PD-L1) positive tumor expression. Participants were administered pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to ~2 years). Qualified participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year). | Total of all reporting groups | |
Overall Number of Baseline Participants | 170 | 84 | 254 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 170 participants | 84 participants | 254 participants | |
54.6 (12.8) | 54.2 (14.1) | 54.5 (13.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 170 participants | 84 participants | 254 participants | |
Female |
170 100.0%
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84 100.0%
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254 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 170 participants | 84 participants | 254 participants | |
Hispanic or Latino |
10 5.9%
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6 7.1%
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16 6.3%
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Not Hispanic or Latino |
146 85.9%
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74 88.1%
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220 86.6%
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Unknown or Not Reported |
14 8.2%
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4 4.8%
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18 7.1%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 170 participants | 84 participants | 254 participants | |
American Indian or Alaska Native |
1 0.6%
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0 0.0%
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1 0.4%
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Asian |
24 14.1%
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15 17.9%
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39 15.4%
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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 |
12 7.1%
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14 16.7%
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26 10.2%
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White |
129 75.9%
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53 63.1%
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182 71.7%
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More than one race |
3 1.8%
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0 0.0%
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3 1.2%
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Unknown or Not Reported |
1 0.6%
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2 2.4%
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3 1.2%
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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 study 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: | NCT02447003 |
Other Study ID Numbers: |
3475-086 2015-000294-13 ( EudraCT Number ) 152987 ( Registry Identifier: JAPIC ) |
First Submitted: | May 14, 2015 |
First Posted: | May 18, 2015 |
Results First Submitted: | November 18, 2020 |
Results First Posted: | December 16, 2020 |
Last Update Posted: | December 16, 2020 |