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New treatment option for Bladder Cancer
Official title A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)
ClinicalTrials.gov ID: NCT07222488
What this study is testing
What is MK-3120?
MK-3120 is an investigational medicine, being studied as a potential treatment for bladder cancer.
Also referred to as SKB410.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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...
- 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...
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays...
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bakersfield, California, United States
- Myrtle Beach, South Carolina, United States
- Vienna, State of Vienna, Austria
- Ghent, Oost-Vlaanderen, Belgium
- Québec, Quebec, Canada
- Villejuif, Val-de-Marne, France
- Thessaloniki, Greece
- Petah Tikva, Israel
- Verona, Veneto, Italy
- Amsterdam, North Holland, Netherlands
- Lorenskog, Akershus, Norway
- Málaga, Andalusia, Spain
- Madrid, Madrid, Comunidad de, Spain
- Ankara, Turkey (Türkiye)
- Istanbul, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bakersfield, California, United States; Myrtle Beach, South Carolina, United States; Vienna, State of Vienna, Austria; Ghent, Oost-Vlaanderen, Belgium; Québec, Quebec, Canada; Villejuif, Val-de-Marne, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.