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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)

Cancer Type
Bladder Cancer
Trial Phase
Phase III
18 Years and older, Male and Female
Study Type
Protocol IDs
3475-676 (primary)
Study Sponsor
Merck Sharp & Dohme LLC


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.


  1. 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
  2. Has undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove all resectable disease
  3. Has provided tissue for biomarker analysis
  4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  5. Has adequate organ function
  6. 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
  7. 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
  8. Has been treated with one adequate course of BCG induction therapy for the treatment of HR NMIBC
  9. Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC

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

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.