At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Nab-paclitaxel, and 4 other interventions for Triple Negative Breast Cancer (TNBC). Completed, enrolled 882 participants.
Detailed 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.
Study Details
Timeline
Interventions
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion