What is Sacituzumab Tirumotecan studying for bladder cancer?

This clinical trial is studying Sacituzumab Tirumotecan given directly into the bladder to learn about its safety and how well people tolerate it. Researchers want to find the highest dose that patients can take without serious problems and choose a dose for future studies to evaluate its effects. The study is sponsored by Merck Sharp & Dohme LLC.

Who may be eligible for this bladder cancer clinical trial?

Adults 18 years and older with recurrent low-grade non-muscle invasive bladder cancer and visible tumors by cystoscopy may be eligible. Participants should have intermediate-risk disease based on specific factors and a good performance status. People with high-grade bladder cancer or muscle invasive disease are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this bladder cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal expenses such as travel to and from the study site may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06637423

A Phase 12 Study to Evaluate the Safety and Effectiveness of Sacituzumab Tirumotecan Given in the Bladder for Intermediate-risk Non-Muscle Invasive Bladder Cancer

Led by Merck Sharp & Dohme LLC · Updated on 2026-07-10

Participants Needed

Research Sites

N/A

Total Duration

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 that participants can take without serious problems and to select a dose for future research to evaluate how well the drug works. Participants receive Sacituzumab Tirumotecan administered intravesically once a week for 6 weeks. In addition to the study drug, they may use rescue medications and supportive care measures to manage side effects as needed. Rescue medications include antihistamines, steroids, antiemetics, antifungals, and pain relief agents. Supportive care may include treatments like artificial tear drops for eye-related side effects. During the study, participants will be closely monitored for any dose-limiting toxicities, adverse events, and treatment discontinuations over approximately 6 to 10 weeks. Blood samples will be taken to measure drug levels in the body. The research team will also assess treatment response up to 6 months and how long any complete response lasts over 24 months. Overall participation lasts until the primary study completion date in March 2029.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older
Have recurrent low-grade (Ta) non-muscle invasive bladder cancer in the bladder
Have visible tumor by cystoscopy within 12 weeks prior to first dose
Have intermediate-risk NMIBC defined by one or more of the following: multiple tumors; more than one occurrence of low-grade NMIBC within 1 year of current diagnosis; early recurrence within 1 year of initial diagnosis; solitary tumor larger than 3 cm; failure of prior intravesical treatment
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 14 days prior to first dose

You will not qualify if you...

Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC)
Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer, or metastatic urothelial carcinoma
Condition that prevents normal voiding or holding bladder voiding for 1 to 2 hours
History of severe dry eye syndrome, severe Meibomian gland disease, blepharitis, or severe corneal disease delaying corneal healing
Active inflammatory bowel disease requiring immunosuppressive medication or previous inflammatory bowel disease such as Crohn's disease or ulcerative colitis
Uncontrolled significant cardiovascular or cerebrovascular disease
Known progressing malignancy or malignancy requiring active treatment within past 3 years
History of pneumonitis or interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease

Research Team

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A Phase 12 Study to Evaluate the Safety and Effectiveness of Sacituzumab Tirumotecan Given in the Bladder for Intermediate-risk Non-Muscle Invasive Bladder Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria