Keynote 057

For patients with high risk non-muscle invasive bladder cancer (NMIBC) not responsive to bacillus calmette-guerin (BCG) therapy

Study of Pembrolizumab in Participants With High Risk Non-muscle Invasive Bladder Cancer

In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy, will receive pembrolizumab therapy. The primary study hypothesis is that treatment with pembrolizumab will result in a clinically meaningful response.

Status:

Recruiting

Phase 2 Icon

Trial Phase

The investigational immunotherapy is being studied in a group of patients to see if it is safe and effective.

Eligibility

About the Trial

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

  • 100% will receive pembrolizumab only

Trial Purpose
25

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

NCT02625961 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.
Bladder Cancer

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy, will receive pembrolizumab therapy. The primary study hypothesis is that treatment with pembrolizumab will result in a clinically meaningful response.

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
  • Orange, California, United States, 92868
    Recruiting
  • Houston, Texas, United States, 77024
    Recruiting
  • Santa Monica, California, United States, 90404
    Recruiting
  • Las Vegas, Nevada, United States, 89148
    Recruiting
  • New York, New York, United States, 10016
    Recruiting
  • Salt Lake City, Utah, United States, 84112
    Recruiting
  • Detroit, Michigan, United States, 48202
    Recruiting
  • Pittsburgh, Pennsylvania, United States, 15232
    Recruiting
  • Duarte, California, United States, 91010
    Recruiting
  • Hackensack, New Jersey, United States, 07601
    Recruiting
  • Los Angeles, California, United States, 90048
    Recruiting
  • Minneapolis, Minnesota, United States, 55455
    Recruiting
  • Cleveland, Ohio, United States, 44106
    Recruiting
  • Lake Success, New York, United States, 11042-1133
    Recruiting
  • New York, New York, United States, 10065
    Recruiting
  • Seattle, Washington, United States, 98109
    Recruiting
  • Boston, Massachusetts, United States, 02115
    Recruiting
  • Voorhees, New Jersey, United States, 08043
    Recruiting
  • Myrtle Beach, South Carolina, United States, 29572
    Recruiting
  • Virginia Beach, Virginia, United States, 23462
    Recruiting
  • Bala-Cynwyd, Pennsylvania, United States, 19004
    Recruiting
  • Syracuse, New York, United States, 13210
    Recruiting
  • Hanover, Maryland, United States, 21076
    Recruiting
  • New Brunswick, New Jersey, United States, 08903
    Recruiting
  • Cincinnati, Ohio, United States, 45212
    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-057

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 II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects With High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy
keynote 057 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.