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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)

Status
Active
Cancer Type
Bladder Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03711032
Protocol IDs
3475-676 (primary)
NCI-2019-00740
2018-001967-22
MK-3475-676
Study Sponsor
Merck Sharp & Dohme LLC

Summary

Researchers are looking for new ways to treat high-risk non muscle invasive bladder
cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but
has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may
have a high chance of getting worse or coming back after treatment.

The goals of this study are to learn: 1. If more people who receive pembrolizumab with
Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer
without the cancer growing, spreading, or coming back compared to people who receive BCG
alone. 2. About the safety and how well people tolerate BCG alone or in combination with
pembrolizumab.

Eligibility

  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
www.emoryhealthcare.org

**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.