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

NCT02555657 | Completed Phase 3 Results DMC FDA Drug

• 5 other identifiers: 3475-1192015-001020-27153082MK-3475-119KEYNOTE-119
• Study Type: interventional
• Target: 622
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Triple Negative Breast Cancer

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)

Outcome Measures

Primary Outcomes (3)

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

  Overall survival (OS) was defined as the time from randomization to death due to any cause.

  Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

• Overall Survival in Participants With PD-L1 CPS ≥1

  Overall survival (OS) was defined as the time from randomization to death due to any cause.

  Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

• Overall Survival in All Participants

  Overall survival (OS) was defined as the time from randomization to death due to any cause.

  Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

Secondary Outcomes (14)

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

  Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

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

  Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

• Overall Response Rate Per RECIST 1.1 in All Participants

  Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

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

  Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

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

  Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

Study Arms (2)

Pembrolizumab

EXPERIMENTAL

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).

Biological: pembrolizumab

Chemotherapy

ACTIVE COMPARATOR

Participants receive capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.

Drug: capecitabine; Drug: eribulin; Drug: gemcitabine; Drug: vinorelbine

Interventions

pembrolizumab BIOLOGICAL

Also known as: MK-3475, KEYTRUDA®

Pembrolizumab

capecitabine DRUG

Also known as: XELODA®

Chemotherapy

eribulin DRUG

Also known as: HALAVEN®

Chemotherapy

gemcitabine DRUG

Also known as: GEMZAR®

Chemotherapy

vinorelbine DRUG

Also known as: NAVELBINE®

Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (4)

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

Related Links

• Merck Oncology Clinical Trial Information

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Capecitabine; eribulin; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 21, 2015
• Study Start: October 13, 2015
• Primary Completion: April 11, 2019
• Study Completion: November 10, 2020
• Last Updated: December 10, 2021
• Results First Posted: May 4, 2020

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share