Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca
Status:
Recruiting
Trial end date:
2023-02-28
Target enrollment:
Participant gender:
Summary
This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of
immunotherapy consisting of sequential decitabine followed by pembrolizumab administered
prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced
HER2-negative breast cancer. The primary efficacy objective is to determine if the
immunotherapy increases the presence and percentage of tumor and/or stromal area of
infiltrating lymphocytes prior to initiation of standard neoadjuvant chemotherapy. Efficacy
will be evaluated in 2 cohorts based on hormone receptor status.
Phase:
Phase 2
Details
Lead Sponsor:
Virginia Commonwealth University
Collaborators:
Merck Sharp & Dohme Corp. National Cancer Institute (NCI)