NCT02622074

Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-173/KEYNOTE-173)

A Phase 1b Study to Evaluate Safety and Clinical Activity of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Triple Negative Breast Cancer (TNBC) - (KEYNOTE 173)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and clinical activity of pembrolizumab (MK-3475) in combination with six chemotherapy regimens as neoadjuvant treatment for participants with triple negative breast cancer (TNBC).

Conditions

• Triple Negative Breast Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	200 mg administered Q3W as an IV infusion.
DRUG	Nab-paclitaxel	125 mg/m\^2 or 100 mg/m\^2 administered weekly as an IV infusion, according to allocation.
DRUG	Anthracycline (doxorubicin)	60 mg/m\^2 administered Q3W as an IV injection.
DRUG	Cyclophosphamide	600 mg/m\^2 administered Q3W as an IV infusion.
DRUG	Carboplatin	AUC 6 or AUC5 administered Q3W as an IV infusion, or AUC2 administered weekly as an IV infusion, according to allocation.
DRUG	Paclitaxel	80 mg/m\^2 or 70 mg/m\^2 administered weekly as an IV infusion, according to allocation.

Timeline

• Start date: 2016-01-27
• Primary completion: 2018-05-31
• Completion: 2019-11-18
• First posted: 2015-12-04
• Last updated: 2020-09-10
• Results posted: 2019-10-24

Regulatory

• FDA-regulated drug study