NCT07222488

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)

Phase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder and has not spread to the bladder muscle or outside of the bladder. In standard treatment for HR NMIBC, doctors first remove the tumor with a procedure called transurethral resection of the bladder tumor (TURBT). Researchers want to learn if using MK-3120, the study medicine, can treat HR NMIBC after TURBT. The goal of this study is to learn about the safety of MK-3120 and if people tolerate it.

Conditions

• Bladder Cancer
• Urinary Bladder Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	MK-3120	Intravesical administration at one of three doses per protocol

Timeline

• Start date: 2025-12-09
• Primary completion: 2029-02-28
• Completion: 2029-02-28
• First posted: 2025-10-30
• Last updated: 2026-04-17

Locations

12 sites across 10 countries: United States, Austria, Belgium, Canada, Greece, Israel, Netherlands, Norway, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study