Actively Recruiting
Phase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-23
45
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment called MK-3120 for people with high-risk non-muscle invasive bladder cancer (HR NMIBC). This type of bladder cancer affects the tissue lining the bladder and has not spread to the muscle or beyond. The study aims to learn about the safety and tolerance of MK-3120 in patients who have had their tumor removed by a procedure called transurethral resection of the bladder tumor (TURBT). This is a Phase 1/2 clinical study sponsored by Merck Sharp & Dohme LLC. Participants in the study will receive MK-3120 through intravesical administration, which means the medicine is delivered directly into the bladder. Treatment starts with weekly doses for six weeks, followed by monthly doses for nine months. The study includes patients who are either new to Bacillus Calmette-Guérin (BCG) therapy or have been previously exposed to BCG. The goal is to assess the safety and effects of MK-3120 during this treatment period. During the study, researchers will monitor participants closely for any dose-limiting toxicities and adverse events up to 24 months. They will also track how many participants stop treatment due to side effects within 12 months. In addition, the study will evaluate the complete response rate at around three months. Participants will have regular visits for treatment and assessments, including laboratory tests and evaluations of their bladder cancer status. The total duration of involvement may extend up to two years to ensure safety and treatment effects are well understood.
CONDITIONS
Brief 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) performed within 12 weeks before allocation showing high-risk NMIBC histology
- For papillary tumors (Ta and T1), complete TURBT with visually complete resection of all papillary tumors
- Is either BCG-naïve (never received BCG or received BCG more than 2 years ago with complete response) or BCG-exposed with adequate therapy and recurrence between more than 12 months but 24 months or less after last BCG dose
- Well-controlled HIV infection on antiretroviral therapy
- Hepatitis B surface antigen positive with at least 4 weeks of antiviral therapy and undetectable viral load
- History of hepatitis C virus infection with undetectable viral load at screening
You will not qualify if you...
- History or current locally advanced (T2, T3, T4) or metastatic urothelial cancer
- Concurrent or history of extravesical non-muscle invasive urothelial cancer with recurrence within last 2 years
- Active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture
- Condition prohibiting normal voiding or holding bladder voiding 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, severe Meibomian gland disease, blepharitis, or severe corneal disease delaying corneal healing
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Known additional malignancy progressing or treated 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 ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 10 months
Participants receive intravesical MK-3120 once weekly for the first 6 weeks, followed by once monthly for 9 months.
Weekly visits for 6 weeks, then monthly visits for 9 months
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
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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