West Cancer Center

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

Site Link

NCT03036488

Malignancy

Triple Negative Breast Cancer

Stage

Stage 2

Disease Setting

Locally advanced

Line Of Therapy

Neoadjuvant

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

Greg Vidal, MD, PhD

Sponsor

Merck Sharp & Dohme Corp.

Phase

Phase 3

Status

Closed to Accrual

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