Actively Recruiting
A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-23
45
Participants Needed
14
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 and has not spread to the bladder muscle or outside of the bladder. In standard treatment for HR NMIBC, doctors first remove the tumor with a procedure called transurethral resection of the bladder tumor (TURBT). Researchers want to learn if using MK-3120, the study medicine, can treat HR NMIBC after TURBT. The goal of this study is to learn about the safety of MK-3120 and if people tolerate it.
CONDITIONS
Official Title
A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has histologically confirmed carcinoma in situ (CIS) with or without papillary high-risk non-muscle invasive bladder cancer (NMIBC)
- Most recent transurethral resection of bladder tumor (TURBT) was within 12 weeks before enrollment and showed high-risk NMIBC
- Complete TURBT performed for papillary tumors (Ta and T1) with visually complete tumor removal
- Is either BCG-nafve (never received BCG or last BCG more than 2 years ago with complete response) or BCG-exposed with adequate prior therapy and recurrence 12 to 24 months after last BCG dose
- HIV-infected participants must have well-controlled HIV on antiretroviral therapy
- Hepatitis B surface antigen positive participants must have received at least 4 weeks of antiviral therapy and have undetectable viral load
- Participants with history of hepatitis C virus infection must have undetectable viral load at screening
You will not qualify if you...
- History of or current locally advanced (T2, T3, T4) or metastatic urothelial cancer
- Concurrent or recent extravesical non-muscle invasive urothelial cancer within last 2 years
- Active total bladder incontinence, urinary tract infection, neurogenic bladder, or urethral stricture
- Conditions preventing normal voiding or holding urine for 1 to 2 hours
- Uncontrolled significant cardiovascular or cerebrovascular disease including severe heart failure, unstable angina, recent myocardial infarction, symptomatic arrhythmia, or prolonged QTcF interval
- History of severe dry eye syndrome, Meibomian gland disease, blepharitis, or severe corneal disease
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Known additional malignancy progressing or requiring treatment within past 3 years
- Known active central nervous system metastases or carcinomatous meningitis
- Active infection requiring systemic therapy
- History or current pneumonitis or interstitial lung disease requiring steroids
- Not recovered from major surgery or has ongoing surgical complications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 14 locations
1
Michael G Oefelein Clinical Trials ( Site 0005)
Bakersfield, California, United States, 93301
Actively Recruiting
2
Carolina Urologic Research Center ( Site 0006)
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
3
Medizinische Universität Wien ( Site 0021)
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
4
UZ Gent ( Site 0031)
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
5
CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0011)
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
6
Gustave Roussy ( Site 0041)
Villejuif, Val-de-Marne, France, 94800
Actively Recruiting
7
European Interbalkan Medical Center ( Site 0051)
Thessaloniki, Greece, 570 01
Actively Recruiting
8
Rabin Medical Center ( Site 0062)
Petah Tikva, Israel, 4941492
Actively Recruiting
9
Centro Ricerche Cliniche di Verona ( Site 0072)
Verona, Veneto, Italy, 37134
Actively Recruiting
10
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 0081)
Amsterdam, North Holland, Netherlands, 1066 CX
Actively Recruiting
11
Akershus Universitetssykehus ( Site 0091)
Lorenskog, Akershus, Norway, 1478
Actively Recruiting
12
Hospital Universitario Virgen de la Victoria ( Site 0111)
Málaga, Andalusia, Spain, 29010
Actively Recruiting
13
Hospital Universitario 12 de Octubre ( Site 0112)
Madrid, Madrid, Comunidad de, Spain, 28041
Actively Recruiting
14
Ankara University Health Practice and Research Hospitals ( Site 0132)
Ankara, Turkey (Türkiye), 06620
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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