NCT02819518

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)

A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 882 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in combination with one of three different chemotherapies will be assessed in the treatment of locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has not been previously treated with chemotherapy. In Part 2, the safety and efficacy of pembrolizumab plus background chemotherapy will be assessed compared to the safety and efficacy of placebo plus background chemotherapy in the treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously treated with chemotherapy. The primary hypotheses are that: 1. the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival (PFS) compared to placebo and chemotherapy in: * all participants, * participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 tumors, and * participants with PD-L1 CPS ≥10 tumors, and 2. the combination of pembrolizumab and chemotherapy prolongs Overall Survival (OS) compared to placebo and chemotherapy in: * all participants, * participants with PD-L1 CPS ≥1 tumors, and * participants with PD-L1 CPS ≥10 tumors.

Conditions

• Triple Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	IV infusion
DRUG	Nab-paclitaxel	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Gemcitabine	IV infusion
DRUG	Carboplatin	IV infusion
DRUG	Normale Saline Solution	IV infusion

Timeline

• Start date: 2016-07-27
• Primary completion: 2021-06-15
• Completion: 2023-10-30
• First posted: 2016-06-30
• Last updated: 2024-11-27
• Results posted: 2022-07-05