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)

Active:	Yes
Cancer Type:	Bladder Cancer	NCT ID:	NCT03711032
Trial Phases:	Phase III	Protocol IDs:	3475-676 (primary) NCI-2019-00740 2018-001967-22 MK-3475-676
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Merck Sharp & Dohme LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT03711032

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.

Treatment Sites in Georgia

Advanced Urology - Alpharetta
11660 Alpharetta Highway
Building 700, Suite 700
Roswell, GA 30076

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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