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

New bladder cancer treatment tested in early-stage trial

NCT: NCT07222488 · Status: RECRUITING · Phase: Phase 2 · Sponsor: Merck Sharp & Dohme LLC · Started: 2025-12-09 · Est. Completion: 2029-02-28

Plain English Summary

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003) is a Phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC studying Bladder Cancer, Urinary Bladder Neoplasms. This trial tests a new drug called MK-3120 for high-risk bladder cancer that hasn't spread to the muscle. It's for adults with a specific type of bladder cancer who have either not received prior treatment with BCG or have had their cancer return after BCG treatment. Participants will receive MK-3120 directly into their bladder after surgery to remove the tumor. Standard treatment options for this condition include surgery and other medications placed into the bladder. The trial aims to enroll 45 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have high-risk non-muscle invasive bladder cancer (like CIS or papillary tumors) that was confirmed by a recent surgery. You may be eligible if you haven't had BCG treatment before, or if your cancer returned more than 12 months after your last BCG dose. You cannot join if you have cancer that has spread to the bladder muscle or other parts of the body, or if you have certain other medical conditions like severe heart disease or active infections. This trial is studying Bladder Cancer, Urinary Bladder Neoplasms, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes will show how safe MK-3120 is and how well patients tolerate it, meaning researchers will carefully monitor for any side effects and see if patients can complete the treatment. The specific primary outcome measures are: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) (Up to approximately 5 weeks); Number of Participants Who Experience One or More Adverse Events (AEs) (Up to approximately 24 months); Number of Participants Who Discontinue Study Treatment Due to AEs (Up to approximately 12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial is important because it explores a new treatment option for high-risk bladder cancer that has not responded well to standard therapies, addressing a significant unmet need. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Bladder Cancer, Urinary Bladder Neoplasms, where improved treatment options are needed.

Investor Insight

This trial targets a significant market for bladder cancer treatments, with a new drug potentially offering an alternative for patients who don't respond to existing therapies, suggesting a moderate t Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of MK-3120, and how it compares to other available treatments. Participation involves receiving the study drug directly into your bladder after surgery, with regular check-ups to monitor for side effects and cancer recurrence. Day-to-day life may involve some discomfort or frequent urination after treatment, and you'll need to attend scheduled appointments for monitoring. This trial is currently recruiting participants. The trial is being conducted at 11 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full 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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07222488?

NCT07222488 is a Phase 2 INTERVENTIONAL study titled "A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 45 participants.

What conditions does NCT07222488 study?

This trial investigates treatments for Bladder Cancer, Urinary Bladder Neoplasms. The primary condition under study is Bladder Cancer.

What treatments are being tested in NCT07222488?

The interventions being studied include: MK-3120 (BIOLOGICAL). Intravesical administration at one of three doses per protocol

What does Phase 2 mean for NCT07222488?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT07222488?

This trial is currently "Recruiting." It started on 2025-12-09. The estimated completion date is 2029-02-28.

Who is sponsoring NCT07222488?

NCT07222488 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07222488?

The trial aims to enroll 45 participants. The trial is currently recruiting and accepting new participants.

How is NCT07222488 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT07222488?

The primary outcome measures are: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) (Up to approximately 5 weeks); Number of Participants Who Experience One or More Adverse Events (AEs) (Up to approximately 24 months); Number of Participants Who Discontinue Study Treatment Due to AEs (Up to approximately 12 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07222488 being conducted?

This trial is being conducted at 11 sites, including Bakersfield, California; Myrtle Beach, South Carolina; Ghent, Oost-Vlaanderen; Québec, Quebec and 7 more sites (United States, Belgium, Canada).

Where can I find official information about NCT07222488?

The official record for NCT07222488 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07222488. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07222488 testing in simple terms?

This trial tests a new drug called MK-3120 for high-risk bladder cancer that hasn't spread to the muscle. It's for adults with a specific type of bladder cancer who have either not received prior treatment with BCG or have had their cancer return after BCG treatment.

Why is this trial significant?

This trial is important because it explores a new treatment option for high-risk bladder cancer that has not responded well to standard therapies, addressing a significant unmet need.

What are the potential risks of participating in NCT07222488?

Common side effects may include irritation or discomfort in the bladder, and frequent urination. More serious risks could involve allergic reactions, infection, or kidney problems. Some participants may experience fatigue or flu-like symptoms. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07222488?

Ask your doctor about the potential benefits and risks of MK-3120, and how it compares to other available treatments. Participation involves receiving the study drug directly into your bladder after surgery, with regular check-ups to monitor for side effects and cancer recurrence. Day-to-day life may involve some discomfort or frequent urination after treatment, and you'll need to attend scheduled appointments for monitoring. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07222488 signal from an investment perspective?

This trial targets a significant market for bladder cancer treatments, with a new drug potentially offering an alternative for patients who don't respond to existing therapies, suggesting a moderate t This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants will receive MK-3120 directly into their bladder after surgery to remove the tumor. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.