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BREAST: NEOADJUVANT: TRIPLE NEGATIVE: \\\\\\\"KEYNOTE 522\\\\\\\"

A phase III, randomized, double-blind study to evaluate pembrolizumab plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy for triple negative breast cancer

Title
Merck MK-3475-522- KEYNOTE 522
Study Title

A phase III, randomized, double-blind study to evaluate pembrolizumab plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy for triple negative breast cancer

Site Link
Malignancy
Triple Negative Breast Cancer
Stage
Disease Setting
Locally advanced
Line Of Therapy
Neoadjuvant
Investigational Agent
Pembrolizumab
Drug Class
PD-1 inhibitor
PI
Greg Vidal, MD, PhD
Sponsor
Merck Sharp & Dohme Corp.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Previously untreated locally advanced non-metastatic TNBC definedn as one of the following TNM classifications:
    • T1c, N1-N2
    • T2, N0-N2
    • T3, N0-N2
    • T4a-d, N0-N2
  • ECOG Performance Status 0-1
  • No history of other malignancy within 5 years except cervical CIS, or non-melanoma skin cancer
  • No prior therapy with anti-PD-1
  • No active autoimmune disease that required systemic treatment in past 2 years
Objective

Primary- pathologic CR, Event Free Survival. Secondary- OS

Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
ER negative, PR negative, HER2 negative
Dosing Frequency
Control Agents
Placebo
Study Protocol
Randomized
Yes
X