Trial Purpose

Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment.

The goals of this study are to learn: 1. If more people who receive pembrolizumab with Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer without the cancer growing, spreading, or coming back compared to people who receive BCG alone. 2. About the safety and how well people tolerate BCG alone or in combination with pembrolizumab.

View full trial information on Clinicaltrials.gov

NATIONAL TRIAL REFERENCE NUMBER

NCT03711032

When speaking to your doctor or clinical trial representative, please have the trial reference number available.

Resources

Eligibility

Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.

Conditions

High-risk Non-muscle Invasive Bladder Cancer

Age Range

18+

Sex

All

About The Study

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

50% of participants will receive BCG+Pembrolizumab

50% of participants will receive BCG only

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

33% of participants will receive Pembrolizumab and BCG (reduced BCG course)

33% of participants will receive Pembrolizumab and BCG (full BCG course)

33% of participants will receive BCG alone (full BCG course)

Trial Phase

Trial Phase 3

In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participants who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.

Trial start and end dates
  • Actual study start date December 24, 2018
  • Estimated primary completion date December 31, 2025
  • Estimated study completion date October 12, 2028

Trial Locations

Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.

What can you do next?

If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.

Discuss with your doctor or care team

Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.

Get help talking with your doctor or care team

Contact our Trial Information Center

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

NATIONAL TRIAL REFERENCE NUMBER

NCT03711032

When speaking to your doctor or clinical trial representative, please have the trial reference number available.

Taking part in a clinical trial is an important decision

If you are considering joining a clinical trial, first learn as much as you can about:

  • The investigational treatment that is being studied
  • What the risks and possible benefits are for participants

Talk to your doctor about the clinical trial before you decide to join.

Read our “What to Consider” page for more questions to ask and think about