Actively Recruiting
A Phase 1/2 Study Evaluating Safety and Efficacy of Intravesical Sacituzumab Tirumotecan in Intermediate-risk Non-Muscle Invasive Bladder Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-01
32
Participants Needed
13
Research Sites
108 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying Sacituzumab Tirumotecan to understand its safety and tolerability when given directly into the bladder for people with intermediate-risk non-muscle invasive bladder cancer (NMIBC). The study aims to find the highest dose participants can take without serious problems and will use this information to guide future studies on how well the drug works. This is a phase 1/2 open-label clinical trial sponsored by Merck Sharp & Dohme LLC. Participants receive Sacituzumab Tirumotecan through intravesical administration once a week for 6 weeks. Supportive care and rescue medications are allowed to manage side effects such as stomatitis, oral mucositis, ocular surface toxicity, and other adverse events. The study involves only one treatment group receiving the experimental drug. During the study, researchers monitor participants for dose-limiting toxicities and adverse events up to about 7 to 10 weeks. They also collect blood samples to measure drug levels and assess the complete response rate and duration of response for up to 24 months. Participants are closely followed to evaluate safety, treatment tolerance, and the drug’s effects over time.
CONDITIONS
Brief Title
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Have recurrent low-grade (Ta) non-muscle invasive bladder cancer (NMIBC) in the bladder
- Visible tumor confirmed by cystoscopy within 12 weeks before first dose
- Intermediate-risk NMIBC with one or more risk factors: multiple tumors, more than one low-grade occurrence within 1 year, early recurrence under 1 year, solitary tumor larger than 3 cm, or failure of prior intravesical treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 14 days before first dose
You will not qualify if you...
- Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC)
- Past or current high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC), or metastatic urothelial carcinoma
- Conditions preventing normal bladder voiding for 1 to 2 hours
- History of severe dry eye syndrome, Meibomian gland disease, blepharitis, or severe corneal disease delaying healing
- Active or past inflammatory bowel disease requiring immunosuppressive medications
- Uncontrolled significant cardiovascular or cerebrovascular disease
- Additional malignancy progressing or treated in past 3 years
- History or current pneumonitis/interstitial lung disease requiring steroids or ongoing
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.
screening and enrollment visit
Duration - 6 weeks
Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks.
Weekly visits for 6 weeks
Trial Site Locations
Total: 13 locations
1
Michael G Oefelein Clinical Trials ( Site 0053)
Bakersfield, California, United States, 93301
Actively Recruiting
2
Moffitt Cancer Center ( Site 0057)
Tampa, Florida, United States, 33612
Actively Recruiting
3
Northwestern University ( Site 0051)
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Johns Hopkins University ( Site 0055)
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
Princess Margaret Cancer Centre ( Site 0003)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
6
CIUSSS de l'Estrie-CHUS ( Site 0002)
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
7
Hôpital Claude Huriez ( Site 0012)
Lille, Nord, France, 59037
Actively Recruiting
8
HENRI MONDOR HOSPITAL ( Site 0011)
Créteil, Val-de-Marne, France, 94010
Actively Recruiting
9
Gustave Roussy ( Site 0013)
Villejuif, Val-de-Marne, France, 94805
Actively Recruiting
10
Erasmus Medisch Centrum ( Site 0032)
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
11
Hospital Universitario Virgen de la Victoria ( Site 0043)
Málaga, Andalusia, Spain, 29010
Actively Recruiting
12
Hospital Universitario 12 de Octubre ( Site 0042)
Madrid, Spain, 28041
Actively Recruiting
13
St Bartholomew s Hospital ( Site 0061)
London, London, City of, United Kingdom, EC1A 7BE
Actively Recruiting
Research Team
T
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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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