What is MK-3120 studying for bladder cancer?

MK-3120 is being studied to understand its safety and how well people tolerate it in treating high-risk non-muscle invasive bladder cancer after tumor removal. Researchers want to find new ways to help people with this bladder cancer type. The study is sponsored by Merck Sharp & Dohme LLC.

Who may be eligible for this bladder cancer clinical trial?

Adults aged 18 and older with high-risk non-muscle invasive bladder cancer who recently had tumor removal may be eligible. Both people new to BCG treatment and those previously treated with BCG under specific conditions can join. People with certain infections or advanced cancer are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this bladder cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses to and from the study site may vary and are not guaranteed to be covered. Participants should plan accordingly for their travel needs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID07222488

Phase 12 Study of MK-3120 Given Inside the Bladder for High-Risk Non-Muscle Invasive Bladder Cancer

Led by Merck Sharp & Dohme LLC · Updated on 2026-07-17

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating MK-3120, a study medicine, for its safety and tolerability in people with high-risk non-muscle invasive bladder cancer HR NMIBC. This type of cancer affects the tissue lining the inside of the bladder without spreading to the muscle or beyond. Standard treatment involves removing the tumor through a procedure called transurethral resection of the bladder tumor TURBT, and this study aims to see how MK-3120 works after TURBT. Participants in this study will receive MK-3120 through intravesical administration. The treatment is given once weekly for the first 6 weeks, followed by once monthly for 9 months. The study includes people who are either new to Bacillus Calmette-Gurin BCG therapy or have been exposed to BCG under specific conditions. The dosing and schedule are designed to assess safety and participant tolerance over an extended period. During the study, participants will be closely monitored for dose-limiting toxicities, adverse events, and treatment discontinuations due to side effects. Researchers will also evaluate the complete response rate within approximately 3 months. The overall safety assessment will continue for up to 24 months, while treatment discontinuations due to adverse events will be tracked for about 12 months. This extended monitoring helps ensure thorough evaluation of MK-3120s effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Has histologically confirmed carcinoma in situ (CIS) with or without papillary high-risk non-muscle invasive bladder cancer (NMIBC), confirmed locally.
Had transurethral resection of bladder tumor (TURBT) within 12 weeks before allocation showing high-risk NMIBC histology.
For papillary tumors (Ta and T1), complete TURBT with visually complete resection of all papillary tumors.
Is either BCG-naïve (never received BCG or received BCG more than 2 years prior with complete response) or BCG-exposed with adequate therapy and recurrence between 12 and 24 months after last BCG dose.
HIV-infected participants must have well-controlled HIV on antiretroviral therapy.
Hepatitis B surface antigen positive participants must have received at least 4 weeks of antiviral therapy with undetectable viral load.
Participants with history of hepatitis C virus (HCV) infection must have undetectable viral load at screening.

You will not qualify if you...

History or current locally advanced (T2, T3, T4) or metastatic urothelial cancer.
Concurrent extravesical non-muscle invasive urothelial cancer or history of recurrence within last 2 years.
Active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture.
Condition preventing normal voiding or holding bladder voiding for 1 to 2 hours.
Uncontrolled, significant cardiovascular or cerebrovascular disease including severe heart failure, unstable angina, recent myocardial infarction, arrhythmia, prolonged QTcF interval, or other serious conditions within 6 months before study.
History of severe dry eye syndrome, severe Meibomian gland disease, blepharitis, or severe corneal disease affecting healing.
HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease.
Known progressing malignancy requiring active treatment within past 3 years.
Known active central nervous system metastases or carcinomatous meningitis.
Active infection requiring systemic therapy.
History or current pneumonitis or interstitial lung disease requiring steroids.
Not recovered from major surgery or ongoing surgical complications.

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Phase 12 Study of MK-3120 Given Inside the Bladder for High-Risk Non-Muscle Invasive Bladder Cancer

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AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria