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A Study of MK-3120 for High-Risk Non-Muscle Invasive Bladder Cancer

This study is looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). HR NMIBC is cancer in the lining of the bladder that hasn't spread to the muscle. Standard treatment involves removing the tumor with a procedure called TURBT. Researchers want to see if a medicine called MK-3120, given directly into the bladder, can help after TURBT. The main goals are to understand the safety of MK-3120 and how well people tolerate it. You might be able to join if you are 18 or older and have HR NMIBC that was recently confirmed and removed by TURBT. The study plans to enroll about 45 people, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment (MK-3120). It aims to enroll 45 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for up to approximately 24 months, and discontinuations due to side effects will be tracked for up to approximately 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07222488

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~45 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:MK-3120

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Measured over Up to approximately 5 weeks
+2 more outcomes measured

Conditions

Bladder Cancer
Urinary Bladder Neoplasms

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Bladder CarcinomaHepatitis C Infection

Where it's being run

16 sites across 15 states
Turkey (Türkiye)2
California1
New Jersey1
South Carolina1
State of Vienna1
Oost-Vlaanderen1
Quebec1
Val-de-Marne1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants Who Experience a Dose-limiting Toxicity (DLT)Up to approximately 5 weeks

    Any of the following toxicities will be considered a DLT: Hematuria leading to clot or obstruction; Grade (Gr) 4 thrombocytopenia; Gr 3 thrombocytopenia associated with clinically significant bleeding; Febrile neutropenia for more than 1 hour; Other Gr ≥3 hematologic toxicity lasting \>7 days; Nonhematologic AE ≥Gr 3 (with exceptions); ≥Gr 2 pneumonitis/ interstitial lung disease; Any ≥Gr 3 nonhematologic laboratory value if clinically significant medical intervention is required, leads to hospitalization, persists for \>7 days, results in a drug induced liver injury, or elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value \>8 ×upper limit of normal (ULN) regardless of duration and AST or ALT elevation 5 × to 8 × ULN that persists for greater than 2 weeks; Recurrent Gr 2 AE resulting in \>2 weeks delay in receiving the next treatment dose; Any intervention-related toxicity that results in study intervention discontinuation; Gr 5 toxicity or AE.

  • Number of Participants Who Experience One or More Adverse Events (AEs)Up to approximately 24 months

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

  • Number of Participants Who Discontinue Study Treatment Due to AEsUp to approximately 12 months

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.