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

Launched by MERCK SHARP & DOHME LLC · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Sacituzumab Tirumotecan (MK-2870) for patients with a type of bladder cancer known as non-muscle invasive bladder cancer (NMIBC). The main goal of the study is to find out how safe this treatment is when given directly into the bladder and to determine the highest dose that patients can tolerate without experiencing serious side effects. Researchers will use the information gathered in this trial to decide on the best dose for future studies that will look at how well the drug works.

To participate in this trial, you must have recurrent low-grade NMIBC and have had a visible tumor in your bladder within the past 12 weeks. You may be eligible if you have certain risk factors, such as having multiple tumors or a solitary tumor larger than 3 cm. Participants will receive the treatment and will be monitored closely for any side effects. This trial is currently recruiting individuals aged 65 and older, regardless of gender. If you think you might qualify or have any questions about being part of this study, it's a good idea to talk to your doctor for more information.

Gender

ALL

Eligibility criteria

• 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.