Keynote 564

For patients with renal cell carcinoma who have undergone nephrectomy

Safety and Efficacy Study of Pembrolizumab as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.

Status:

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

Patients who enroll in the trial will be assigned to one of the following study groups.

  • 50% will receive pembrolizumab
  • 50% will receive placebo

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

Trial Purpose
54

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

NCT03142334 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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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.
Renal Cell Carcinoma

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.

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
  • Phoenix, Arizona, United States, 85016
    Completed
  • Santa Barbara, California, United States, 93105
    Recruiting
  • Niles, Illinois, United States, 60714
    Completed
  • Minneapolis, Minnesota, United States, 55404
    Recruiting
  • Las Vegas, Nevada, United States, 89148
    Completed
  • Charleston, South Carolina, United States, 29414
    Recruiting
  • Austin, Texas, United States, 78731
    Recruiting
  • Denton, Texas, United States, 76210
    Completed
  • Houston, Texas, United States, 77024
    Recruiting
  • Paris, Texas, United States, 75460-5004
    Completed
  • Tyler, Texas, United States, 75702
    Recruiting
  • Norfolk, Virginia, United States, 23502
    Recruiting
  • Washington, District of Columbia, United States, 20007
    Recruiting
  • Detroit, Michigan, United States, 48202
    Recruiting
  • Royal Oak, Michigan, United States, 48073
    Completed
  • Tualatin, Oregon, United States, 97062
    Recruiting
  • Aurora, Colorado, United States, 80012
    Recruiting
  • Yakima, Washington, United States, 98902
    Completed
  • Marietta, Georgia, United States, 30060
    Recruiting
  • Sioux Falls, South Dakota, United States, 57105
    Completed
  • Tacoma, Washington, United States, 98405
    Recruiting
  • Omaha, Nebraska, United States, 68130
    Recruiting
  • Waco, Texas, United States, 76712
    Completed
  • Easton, Pennsylvania, United States, 18045
    Recruiting
  • Philadelphia, Pennsylvania, United States, 19104
    Recruiting
  • Bronx, New York, United States, 10461
    Recruiting
  • Edina, Minnesota, United States, 55435
    Recruiting
  • Everett, Washington, United States, 98201
    Recruiting
  • Billings, Montana, United States, 59102
    Recruiting
  • Dallas, Texas, United States, 75246
    Recruiting
  • Saint Louis Park, Minnesota, United States, 55426
    Recruiting
  • Madison, Wisconsin, United States, 53792
    Recruiting
  • Boston, Massachusetts, United States, 02215
    Recruiting
  • Boston, Massachusetts, United States, 02215
    Recruiting
  • Cincinnati, Ohio, United States, 45242
    Recruiting
  • Spokane, Washington, United States, 99202
    Recruiting
  • Iowa City, Iowa, United States, 52242
    Recruiting
  • Albuquerque, New Mexico, United States, 87106
    Recruiting
  • Seattle, Washington, United States, 98109
    Recruiting
  • Boca Raton, Florida, United States, 33486
    Recruiting
  • Los Angeles, California, United States, 90033
    Recruiting
  • Charleston, South Carolina, United States, 29425
    Recruiting
  • Palo Alto, California, United States, 94305
    Recruiting
  • Detroit, Michigan, United States, 48201
    Recruiting
  • Houston, Texas, United States, 77030
    Recruiting
  • San Antonio, Texas, United States, 78229
    Recruiting
  • Spokane, Washington, United States, 99208
    Recruiting
  • Baltimore, Maryland, United States, 21237
    Recruiting
  • Ann Arbor, Michigan, United States, 48109
    Recruiting
  • Durham, North Carolina, United States, 27710
    Recruiting
  • Dallas, Texas, United States, 75390
    Recruiting
  • Ames, Iowa, United States, 50010-3014
    Recruiting
  • Rockville, Maryland, United States, 20850
    Recruiting
  • Pensacola, Florida, United States, 32503
    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-564

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, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)
keynote 564 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.