Trial Purpose

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER

NCT03711032

EudraCT Number

2018-001967-22

When you talk with your doctor or clinical trial team member, please have the trial identifier 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 Icon

Conditions

High-risk Non-muscle Invasive Bladder Cancer

Age Range Icon

Age Range

18+

Sex Icon

Sex

All

About the trial

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 Icon Current 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 Icon Trial start and end dates
  • Trial start date December 24, 2018
  • Estimated primary completion date December 31, 2025
  • Estimated trial 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.

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CLINICALTRIALS.GOV IDENTIFIER

NCT03711032

EudraCT Number

2018-001967-22

When you talk with your doctor or clinical trial team member, please have the trial identifier 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