Keynote 522

For patients with triple negative breast cancer

Study of Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer

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 when combined with chemotherapy is superior to placebo with chemotherapy in the treatment of participants with locally advanced TNBC.

Status:

Active, not recruiting

Phase 3 Icon

Trial Phase

The investigational immunotherapy is being studied in a large group of patients to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the investigational immunotherapy to be used safely.

Eligibility

About the Trial

All patients who enroll in the trial will receive medication while on the study.

  • 67% will receive pembrolizumab along with chemotherapy before surgery, and pembrolizumab alone after surgery
  • 33% will receive placebo along with chemotherapy before surgery, and placebo alone after surgery

You will be assigned by chance (a process called randomization) to receive one of the above treatments.

Trial Purpose
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US Trial Locations

Clinical trial sites are places such as hospitals or clinics where the trial is being conducted.

See Locations

National Trial Reference Number

NCT03036488 Read More at clinicaltrials.gov

What Can You Do Next?

If you would like to learn about this clinical trial or see if you can participate, you can:

Contact Our Trial Info Center

To learn more, call 1-888-577-8839

Discuss With Your Doctor

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Stay Informed

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Tip: To help with understanding of some clinical terms used on the page, select an underlined term to see what they mean.

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Condition

The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Triple Negative Breast Neoplasms

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

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 when combined with chemotherapy is superior to placebo with chemotherapy in the treatment of participants with locally advanced TNBC.

Important information

Participating in a clinical trial is an important decision. Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.

Trial Locations

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    Location
    Status
  • Tucson, Arizona, United States, 85711
    Not Recruiting
  • Skokie, Illinois, United States, 60077
    Not Recruiting
  • Minneapolis, Minnesota, United States, 55404
    Not Recruiting
  • Johnson City, New York, United States, 13790
    Not Recruiting
  • Nyack, New York, United States, 10960
    Not Recruiting
  • Cincinnati, Ohio, United States, 45242
    Not Recruiting
  • Portland, Oregon, United States, 97227
    Not Recruiting
  • Austin, Texas, United States, 78731
    Not Recruiting
  • Houston, Texas, United States, 77024
    Not Recruiting
  • Plano, Texas, United States, 75075
    Not Recruiting
  • San Antonio, Texas, United States, 78217
    Not Recruiting
  • Tyler, Texas, United States, 75702
    Not Recruiting
  • Norfolk, Virginia, United States, 23502
    Not Recruiting
  • Goshen, Indiana, United States, 46526
    Not Recruiting
  • Fairfax, Virginia, United States, 22031
    Not Recruiting
  • Kennewick, Washington, United States, 99336
    Not Recruiting
  • Monterey, California, United States, 93940
    Not Recruiting
  • Dallas, Texas, United States, 75246
    Not Recruiting
  • Detroit, Michigan, United States, 48202
    Not Recruiting
  • Newport News, Virginia, United States, 23601
    Not Recruiting
  • Scarborough, Maine, United States, 04074
    Not Recruiting
  • Midlothian, Virginia, United States, 23114
    Not Recruiting
  • Aurora, Colorado, United States, 80045
    Not Recruiting
  • Miami, Florida, United States, 33176
    Not Recruiting
  • Iowa City, Iowa, United States, 52242
    Not Recruiting
  • Germantown, Tennessee, United States, 38138
    Not Recruiting
  • Houston, Texas, United States, 77030
    Not Recruiting
  • Pittsburgh, Pennsylvania, United States, 15213
    Not Recruiting
  • Dallas, Texas, United States, 75235
    Not Recruiting
  • Fort Worth, Texas, United States, 76104
    Not Recruiting
  • Chicago, Illinois, United States, 60637-1447
    Not Recruiting
  • Dallas, Texas, United States, 75390-9015
    Not Recruiting
  • Newark, Delaware, United States, 19713
    Not Recruiting
  • Cincinnati, Ohio, United States, 45220
    Not Recruiting
  • Portland, Oregon, United States, 97213
    Not Recruiting
  • Los Angeles, California, United States, 90048
    Not Recruiting
  • Evanston, Illinois, United States, 60201
    Not Recruiting
  • Providence, Rhode Island, United States, 02903
    Not Recruiting
  • New Haven, Connecticut, United States, 06510
    Not Recruiting
  • Dallas, Texas, United States, 75390-9179
    Not Recruiting
  • Spokane, Washington, United States, 99208
    Not Recruiting
  • Charlottesville, Virginia, United States, 22903
    Not Recruiting
  • Whittier, California, United States, 90603
    Not Recruiting
  • New Brunswick, New Jersey, United States, 08903
    Not Recruiting
  • Scottsdale, Arizona, United States, 85268
    Not Recruiting
  • Seattle, Washington, United States, 98109
    Not Recruiting
  • Yakima, Washington, United States, 98902
    Not Recruiting

How to Learn More

When speaking to your doctor, please have the trial reference number available. You can also call 1-888-577-8839 for more information.

Print or email this page.

Trial reference number

A unique identification code given to each clinical trial registered on clinicaltrials.gov.

Keynote number

A unique identification code used by the sponsor to identify a specific trial.
Keynote-522

Official title

A description of the clinical trial that the trial sponsor and clinicians use to identify a specific trial and its purpose.
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)
keynote 522 trial logo

Call 1-888-577-8839 to contact our trial information center

Clinical Trials: Important Information to Consider

There is a lot to consider when deciding whether to participate in a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before participating.