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

NCT ID: NCT07222488

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-09
• Study Completion Date: 2029-02-28

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK-3120

Participants will be administered MK-3120 once weekly for the first 6 weeks, followed by once monthly for 9 months.

Group Type: EXPERIMENTAL

MK-3120

Intervention Type: BIOLOGICAL

Intravesical administration at one of three doses per protocol

Interventions

MK-3120

Intravesical administration at one of three doses per protocol

Intervention Type: BIOLOGICAL

Other Intervention Names

SKB410

Eligibility Criteria

Inclusion Criteria

• Has histologically confirmed carcinoma in situ (CIS) +/- papillary high-risk non-muscle invasive bladder cancer (NMIBC), confirmed locally.
• Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before allocation and showed high-risk NMIBC histology. For individuals with papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by attainment of a visually complete resection of all papillary tumors (Ta and T1).
• Is either: a) Bacillus Calmette-Guérin (BCG)-naïve, defined as either having never received BCG or having received BCG more than 2 years before CIS +/- papillary high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post-BCG OR; b) BCG-exposed and received adequate BCG therapy and had recurrence of CIS +/- papillary high-risk NMIBC >12 months but ≤24 months after the last BCG dose.
• Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy.
• Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation.
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.

Exclusion Criteria

• Has history of or current locally advanced (ie, T2, T3, T4) or metastatic urothelial cancer (UC).
• Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or history of extravesical non-muscle invasive UC that recurred within the last 2 years.
• Has active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture.
• Has a condition that would prohibit normal voiding (or holding bladder voiding for 1 to 2 hours).
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
• Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has known active central nervous system metastases and/or carcinomatous meningitis.
• Has active infection requiring systemic therapy.
• Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, or has current pneumonitis/ILD.
• Has not adequately recovered from major surgery or has ongoing surgical complications.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Michael G Oefelein Clinical Trials ( Site 0005)

Bakersfield, California, United States

Site Status: RECRUITING

Carolina Urologic Research Center ( Site 0006)

Myrtle Beach, South Carolina, United States

Site Status: RECRUITING

CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0011)

Québec, Quebec, Canada

Site Status: RECRUITING

Rabin Medical Center ( Site 0062)

Petah Tikva, , Israel

Site Status: RECRUITING

Ankara University Health Practice and Research Hospitals ( Site 0132)

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

United States; Canada; Israel; Turkey (Türkiye)

Central Contacts

Toll Free Number

Role: CONTACT

Trialsites@msd.com

1-888-577-8839

Facility Contacts

Study Coordinator

Role: primary

661-310-1063

Study Coordinator

Role: primary

843-449-1010

Study Coordinator

Role: primary

418-525-4444

Study Coordinator

Role: primary

+97239377377

Study Coordinator

Role: primary

+90 312 595 71 12

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

U1111-1317-2687

Identifier Type: REGISTRY

Identifier Source: secondary_id

2025-520467-40-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-3120-003

Identifier Type: OTHER

Identifier Source: secondary_id

3120-003

Identifier Type: -

Identifier Source: org_study_id