keynote 676
This study is designed to assess the antitumour 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.
CLINICALTRIALS.GOV IDENTIFIER:
NCT03711032
When speaking to your doctor, please have the trial identifier number available.
All patients who enrol in the trial will receive medication while on 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
Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). 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.
Dates
Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.
Conditions
High-risk Non-muscle Invasive Bladder Cancer
Age Range
18 - No Age Maximum
Sex
All
Locations provided may not reflect the most current site information. Please call the number provided in the location results to confirm.
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