KEYNOTE-522: NCT03036488: Phase 3: Study of Pembrolizumab (MK-3475) Plus Chemo vs Placebo Plus Chemo as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy

First Posted	2017-01-30
Trial status	Completed
Sponsor	Merck Sharp & Dohme LLC
Abstract Presentation	2019 San Antonio Breast Cancer Symposium. Abstract GS3-03. Presented December 12, 2019. Schmid P, Park YH, Ferreira M, et al: KEYNOTE-522: Phase 3 study of neoadjuvant pembrolizumab + chemotherapy versus placebo + chemotherapy, followed by adjuvant pembrolizumab versus placebo for early triple-negative breast cancer: Pathologic complete response in key subgroups and by treatment exposure and residual cancer burden.
Press Release	July 29, 2019 - Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Pathological Complete Response (pCR) in Pivotal Phase 3 KEYNOTE-522 Trial in Patients with Triple-Negative Breast Cancer (TNBC) Click here for details May 13, 2021 - Merck Announces Phase 3 KEYNOTE-522 Trial Met Dual Primary Endpoint of Event-Free Survival (EFS) in Patients With High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC) Click here for details May 28, 2024 - Merck Announces Phase 3 KEYNOTE-522 Trial Met its Overall Survival (OS) Endpoint in Patients With High-Risk Early-Stage Triple Negative Breast Cancer (TNBC) Click here for details
Peer-reviewed journal publication	Pembrolizumab for Early Triple-Negative Breast CancerN Engl J Med 2020 Feb 27 PUBMED NEJM
FDA	July 26, 2021 - FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer Click here for details
NCCN	Templates: BRS187a BRS187b BRS187c

NCT03036488: Phase 3: (MK-3475-522/​KEYNOTE-522) 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)

(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))

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)

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 ( Registry Identifier ) (REGISTRY: JAPIC-CTI)

MK-3475-522 ( Other Identifier ) (OTHER: MSD)

KEYNOTE-522 ( Other Identifier ) (OTHER: MSD)

2022-501382-49-00 ( Registry Identifier ) (REGISTRY: EU CT)

U1111-1280-2361 ( Registry Identifier ) (REGISTRY: UTN)

2016-004740-11 ( EudraCT Number )

ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT03036488