West Cancer Center

BREAST: Metastatic: TNBC: 2nd or 3rd line: "KEYNOTE 119"

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)

Title

Merck MK-3475-119

Study 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)

Site Link

NCT02555657

Malignancy

Breast, Metastatic triple negative breast cancer, TNBC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd or 3rd line

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

Greg Vidal, MD, PhD

Sponsor

Merck Sharp & Dohme Corp.

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

NCT02555657

Key Eligibility Criteria Details

Confirmed TNBC (must be confirmed through central testing)
Newly obtained tumor biopsy from metastatic site
2nd or 3rd line metastatic
Documented disease progression on most recent therapy
Must have been previously treated with an anthracycline or a taxane in some setting (neoadj, adj, or met)
ECOG PS 0-1
No active autoimmune disease that required systemic tx within last 2 years
No known CNS disease
No other cancer diagnosis within 5 years

Objective

Primary- PFS and OS: Secondary- ORR, DCR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ER negative (ER -), PR negative (PR -), HER2 negative (HER2 -)

Dosing Frequency

Control Agents

MD choice: Vinorelbine, Eribulin, Capecitabine, or Gemcitabine

Study Protocol

Randomized