Recruiting

Intravesical MK-3120 for High-Risk Non-Muscle Invasive Bladder Cancer

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What is being tested

MK-3120

Biological
Who is being recruted

Urogenital Diseases+8

+ Urinary Bladder Diseases

+ Urinary Bladder Neoplasms

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2025

Actual date on which the first participant was enrolled.

Researchers are conducting a study to find new treatment options for high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that affects the inner lining of the bladder but hasn't spread to the muscle or outside the bladder. The current standard treatment involves surgically removing the tumor using a method called transurethral resection of the bladder tumor (TURBT). This study aims to evaluate a new medicine called MK-3120, to see if it can effectively treat HR NMIBC after this surgical procedure. The focus is on understanding how safe MK-3120 is and whether patients can tolerate it well. In this study, participants who have either not been treated with or have been previously exposed to a therapy called BCG will receive MK-3120 directly into the bladder, which is referred to as "intravesical administration." The study will carefully monitor participants to assess any side effects and determine how well the drug is tolerated. The researchers will gather data on the safety of MK-3120, as well as its potential effectiveness in treating HR NMIBC, to provide insights that could lead to better treatment options for this condition.

Official TitlePhase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer 
NCT07222488
Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesUrinary Bladder DiseasesUrinary Bladder NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsNeoplasmsNeoplasms by SiteUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

6 inclusion criteria required to participate
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.
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12 exclusion criteria prevent from participating
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).
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Michael G Oefelein Clinical Trials ( Site 0005)

Bakersfield, United StatesSee the location
Recruiting

Carolina Urologic Research Center ( Site 0006)

Myrtle Beach, United States
Recruiting
2 Study Centers