Recruiting

Phase 1

Phase 2

Sacituzumab TirumotecanA Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06637423

Conditions

Non-Muscle Invasive Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab tirumotecan

Rescue medication

Supportive care measures

Study Details

Brief summary:

The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.

Conditions

Non-Muscle Invasive Bladder Cancer

Study ID

NCT06637423

Start date

Dec 20, 2024

Status verified date

Aug, 2026

Completion date

Mar 14, 2029

Anticipated

Primary completion date

Mar 14, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in the bladder
Must have visible tumor by cystoscopy within 12 weeks prior to first dose
Has intermediate-risk NMIBC defined as 1 or more of the following risk factors:

Multiple tumors
>1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening
Early recurrence (<1 year) of the initial diagnosis of low-grade disease
Solitary tumor >3 cm
Failure of prior intravesical treatment
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 14 days prior to first dose

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in the bladder
Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)
Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours)
Has history of documented severe dry eye syndrome, severe Meibomian gland disease, and/or blepharitis, or severe corneal disease that prevents and/or delays corneal healing
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron's disease, ulcerative colitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Known additional malignancy that is progressing or has required active treatment within the past 3 years
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sacituzumab tirumotecan

Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks

Interventions

Sacituzumab tirumotecan

Intravesical administration

Rescue medication

Participants are allowed to take rescue medication for stomatitis or oral mucositis. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion or steroid mouthwash (dexamethasone or equivalent), antiemetic medications, oral nystatin suspension or antifungal medications, antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.

Supportive care measures

Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Artificial tear drops or gel may be given as a supportive care for Ocular Surface Toxicity.

Primary outcome measure

Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Up to approximately 7 weeks ]
Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to approximately 10 weeks ]
Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE) [ Time Frame: Up to approximately 6 weeks ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Michael G Oefelein Clinical Trials ( Site 0053)

Recruiting

Bakersfield, California, United States, 93301

Contacts

Study Coordinator

661-310-1063

Moffitt Cancer Center ( Site 0057)

Recruiting

Tampa, Florida, United States, 33612

Contacts

Study Coordinator

888-663-6488

Northwestern University ( Site 0051)

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Study Coordinator

312-695-1102

Johns Hopkins University ( Site 0055)

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Study Coordinator

410-614-0009

Princess Margaret Cancer Centre ( Site 0003)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

4169462246

CIUSSS de l'Estrie-CHUS ( Site 0002)

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Study Coordinator

8193461110 x13446

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

Non-Muscle Invasive Bladder Cancer
Low Grade
Intermediate Risk
Recurrent Low-Grade

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.