NCT02555657

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 622 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	pembrolizumab
DRUG	capecitabine
DRUG	eribulin
DRUG	gemcitabine
DRUG	vinorelbine

Timeline

• Start date: 2015-10-13
• Primary completion: 2019-04-11
• Completion: 2020-11-10
• First posted: 2015-09-21
• Last updated: 2021-12-10
• Results posted: 2020-05-04

Regulatory

• FDA-regulated drug study