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

When speaking to your doctor, please have the trial identifier number available.

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

Phase 3

Tests the medicine or vaccine in approximately 1,000 to 5,000 volunteers. For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or physician offices.

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Dates

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

Eligibility

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Conditions

High-risk Non-muscle Invasive Bladder Cancer

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Age Range

18 - No Age Maximum

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Sex

All

Trial locations

What Can You Do Next?

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

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Discuss With Your Doctor

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CLINICALTRIALS.GOV IDENTIFIER:

NCT03711032

When speaking to your doctor, please have the trial identifier number available.

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.