Brief Title: Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Participants with Dose Limiting Toxicity (DLT)

Primary Outcome 1 - Timeframe: Up to approximately 7 weeks

Primary Outcome 2 - Measure: Number of Participants Experiencing an Adverse Event (AE)

Primary Outcome 2 - Timeframe: Up to approximately 10 weeks

Primary Outcome 3 - Measure: Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)

Primary Outcome 3 - Timeframe: Up to approximately 6 weeks

CONDITION

• Non-Muscle Invasive Bladder Cancer

ELIGIBILITY

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)

- * 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 nonmuscle invasive bladder cancer (Ta NMIBC)

- * 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 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme LLC

Overall Contact

Name: Toll Free Number

Phone: 1-888-577-8839

Email: [email protected]

LOCATION