OncRef

Clinical Trial: NCT03036488

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2025-10-29

Study Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).

After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.

The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.

Official 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 (TNBC)

Conditions

Triple Negative Breast Neoplasms

Intervention / Treatment

  • Biological: Pembrolizumab
  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Drug: Doxorubicin
  • Drug: Epirubicin
  • Drug: Cyclophosphamide
  • Drug: Placebo
  • Biological: Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim

Other Study ID Numbers

  • 3475-522
  • 173567
  • MK-3475-522
  • KEYNOTE-522
  • 2022-501382-49-00
  • U1111-1280-2361
  • 2016-004740-11
  • 2016

Start Date (Actual)

2017-03-07

Primary Completion Date (Actual)

2025-10-14

Study Completion Date (Actual)

2025-10-14

Enrollment (Actual)

1174

Study Type

Interventional

Phase

Phase 3