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)

Running, not enrolling · Phase 3

Conditions studied: High-risk Non-muscle Invasive Bladder Cancer

In brief

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.

Key facts

Study ID

NCT03711032

Run by

Merck Sharp & Dohme LLC

People needed

1397

Starts

2018-12-24

Expected to finish

2034-11-20

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Has a history of or concurrent locally advanced (i.e., T2, T3, T4) or metastatic UC
• Has concurrent extra-vesical (i.e, urethra, ureter, renal pelvis) non-muscle invasive urothelial carcinoma or a history of extra-vesical non-muscle invasive UC
• Has received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
• Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks of start of study treatment
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks of start of study treatment
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days of start of study treatment
• Has a known additional malignancy that is progressing or requires active treatment within the past 3 years
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has one or more of the following contraindications to BCG: prior BCG sepsis or systemic infection, total bladder incontinence, or an adverse experience to a previous BCG instillation that resulted in treatment discontinuation and precludes retreating with BCG
• Has an active infection or diagnosis requiring systemic antimicrobial therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a known history of Hepatitis B or known active Hepatitis C virus infection
• Has current active tuberculosis
• Has had an allogenic-tissue/solid organ transplant
• Has any contraindication(s) to IV contrast or is otherwise unable to have screening imaging with IV contrast performed
• BCG Post-induction Cohort (Cohort A) Only - Has persistent T1 disease following an induction course of BCG
• BCG Naïve Cohort (Cohort B) Only
• Has received any prior treatment with BCG for their NMIBC within the past 2 years prior to study entry

Where it is running

• Mayo Clinic in Arizona - Phoenix ( Site 1094) — Phoenix, Arizona, United States
• Del Sol Research Management, LLC ( Site 1096) — Tucson, Arizona, United States
• UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 1052) — Los Angeles, California, United States
• University of California Irvine Medical Center ( Site 1061) — Orange, California, United States
• Genesis Research LLC ( Site 1065) — Torrance, California, United States
• Colorado Clinical Research ( Site 1100) — Lakewood, Colorado, United States
• Urological Research Network ( Site 1106) — Hialeah, Florida, United States
• Mayo Clinic in Florida-Urology ( Site 1097) — Jacksonville, Florida, United States
• University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056) — Miami, Florida, United States
• Woodlands Medical Specialists, PA ( Site 8002) — Pensacola, Florida, United States
• Emory School of Medicine ( Site 1076) — Atlanta, Georgia, United States
• Advanced Urology ( Site 1092) — Roswell, Georgia, United States
• Northwestern Memorial Hospital ( Site 1101) — Chicago, Illinois, United States
• Wichita Urology Group ( Site 1086) — Wichita, Kansas, United States
• Ochsner LSU Health Shreveport - Regional Urology ( Site 1099) — Shreveport, Louisiana, United States
• Henry Ford Hospital ( Site 1062) — Detroit, Michigan, United States
• Michigan Institute of Urology ( Site 1077) — Troy, Michigan, United States
• Coastal Urology Associates ( Site 1055) — Brick, New Jersey, United States
• Morristown Medical Center ( Site 1090) — Morristown, New Jersey, United States
• Rutgers Cancer Institute of New Jersey ( Site 1059) — New Brunswick, New Jersey, United States
• St. Peter's Hospital Cancer Care Center ( Site 1087) — Albany, New York, United States
• R.J. Zuckerberg Cancer Center ( Site 1080) — Lake Success, New York, United States
• Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112) — New York, New York, United States
• Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074) — New York, New York, United States
• Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083) — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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