NCT02555657 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2021-12-10

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 (Treatment of Physician's Choice, 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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10

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outcome · POSTED

Overall Survival in Participants With PD-L1 CPS ≥1

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outcome · POSTED

Overall Survival in All Participants

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outcome · POSTED

Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10

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outcome · POSTED

Overall Response Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1

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outcome · POSTED

Overall Response Rate Per RECIST 1.1 in All Participants

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outcome · POSTED

Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥10

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outcome · POSTED

Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥1

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outcome · POSTED

Progression-Free Survival Per RECIST 1.1 in All Participants

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outcome · POSTED

Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 Who Had a Confirmed Response

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outcome · POSTED

Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 Who Had a Confirmed Response

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outcome · POSTED

Duration of Response Per RECIST 1.1 in All Participants Who Had a Confirmed Response

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outcome · POSTED

Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥10

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outcome · POSTED

Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1

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outcome · POSTED

Disease Control Rate Per RECIST 1.1 in All Participants

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outcome · POSTED

Number of Participants Who Experienced One or More Adverse Events

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outcome · POSTED

Number of Participants Who Discontinued Study Treatment Due to an Adverse Event

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years). Qualified participants who receive first course of pembrolizumab but continue to experience disease progression may, at investigator's discretion, initiate a second course of pembrolizumab at 200 mg IV Q3W for up to 17 administrations (up to \~1 year).
intervention Names
Biological: pembrolizumab
label
Pembrolizumab
type
EXPERIMENTAL
description
Participants receive capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
intervention Names
Drug: capecitabine
Drug: eribulin
Drug: gemcitabine
Drug: vinorelbine
label
Chemotherapy
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Pembrolizumab
name
pembrolizumab
other Names
MK-3475
KEYTRUDA®
type
BIOLOGICAL
arm Group Labels
Chemotherapy
name
capecitabine
other Names
XELODA®
type
DRUG
arm Group Labels
Chemotherapy
name
eribulin
other Names
HALAVEN®
type
DRUG
arm Group Labels
Chemotherapy
name
gemcitabine
other Names
GEMZAR®
type
DRUG
arm Group Labels
Chemotherapy
name
vinorelbine
other Names
NAVELBINE®
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 622
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Overall survival (OS) was defined as the time from randomization to death due to any cause.
measure
Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
description
Overall survival (OS) was defined as the time from randomization to death due to any cause.
measure
Overall Survival in Participants With PD-L1 CPS ≥1
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
description
Overall survival (OS) was defined as the time from randomization to death due to any cause.
measure
Overall Survival in All Participants
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

secondary Outcomes

description
Overall Response Rate (ORR), based on a Blinded Independent Central Review (BICR) assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions).
measure
Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
description
Overall Response Rate (ORR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions).
measure
Overall Response Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
description
Overall Response Rate (ORR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions).
measure
Overall Response Rate Per RECIST 1.1 in All Participants
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
description
Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
measure
Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥10
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
description
Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
measure
Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
description
Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
measure
Progression-Free Survival Per RECIST 1.1 in All Participants
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
description
For participants with PD-L1 CPS ≥10 who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR.
measure
Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 Who Had a Confirmed Response
time Frame
Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)
description
For participants with PD-L1 CPS ≥1 who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR.
measure
Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 Who Had a Confirmed Response
time Frame
Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)
description
For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR.
measure
Duration of Response Per RECIST 1.1 in All Participants Who Had a Confirmed Response
time Frame
Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)
description
Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.\])
measure
Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥10
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
description
Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.\])
measure
Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
description
Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.\])
measure
Disease Control Rate Per RECIST 1.1 in All Participants
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

Full study description

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 (Treatment of Physician's Choice, 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.

Source references

references

citation
Cortes J, Lipatov O, Im SA, Goncalves A, Lee KS, Schmid P, Tamura K, Testa L, Ohtani S, Harbeck N, Loi S, Salgado R, Karantza V, Mejia J, Cristescu R, Loboda A, Nebozhyn M, Jelinic P, Huang L, Winer EP. Association of potential biomarkers with clinical outcomes in metastatic triple-negative breast cancer treated with pembrolizumab or chemotherapy. NPJ Breast Cancer. 2025 Oct 2;11(1):109. doi: 10.1038/s41523-025-00814-y.
pmid
41038856
type
DERIVED
citation
Essalihi A, Bouchra O, Khadiri K, Khadrouf Z, Karkouri M. Immunotherapy for triple-negative breast cancer: current trends and future prospects. J Egypt Natl Canc Inst. 2025 Jun 17;37(1):51. doi: 10.1186/s43046-025-00295-x.
pmid
40526219
type
DERIVED
citation
Schmid P, Lipatov O, Im SA, Goncalves A, Munoz-Couselo E, Lee KS, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Mejia JA, Zhou X, Haiderali A, Nguyen AM, Cortes J, Winer EP. Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study. Eur J Cancer. 2023 Dec;195:113393. doi: 10.1016/j.ejca.2023.113393. Epub 2023 Oct 21.
pmid
37976633
type
DERIVED
citation
Winer EP, Lipatov O, Im SA, Goncalves A, Munoz-Couselo E, Lee KS, Schmid P, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Zhou X, Karantza V, Mejia J, Cortes J; KEYNOTE-119 investigators. Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):499-511. doi: 10.1016/S1470-2045(20)30754-3. Epub 2021 Mar 4.
pmid
33676601
type
DERIVED