Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
18 Years and older, Male and Female
3475-676 (primary)
NCI-2019-00740
2018-001967-22
MK-3475-676
Summary
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.
Eligibility
- Have locally and blinded independent central review (BICR)-confirmed histological diagnosis of high-risk non-muscle invasive (T1, high grade Ta and/or CIS) UC of the bladder
- Has undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove all resectable disease
- Has provided tissue for biomarker analysis
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Has adequate organ function
- During the treatment period and for =7 days after the last dose of BCG, male participants are EITHER abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR, must agree to use contraception unless confirmed to be azoospermic
- Female participants who are not pregnant, not breastfeeding, and either not a woman of child bearing potential (WOCBP); or are a WOCBP who agrees to use a contraception method that is highly effective or remains abstinent from heterosexual intercourse during the treatment period and for =7 days after the last dose of BCG or 120 days after the last dose of pembrolizumab, whichever comes last BCG Post-induction Cohort (Cohort A) Only
- Has been treated with one adequate course of BCG induction therapy for the treatment of HR NMIBC
- Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC
Treatment Sites in Georgia
11660 Alpharetta Highway
Building 700, Suite 700
Roswell, GA 30076
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