MK-3120 treatment for high-risk non‑muscle invasive bladder cancer (CIS ± papillary)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 interventional trial gives MK-3120 to adults with histologically confirmed carcinoma in situ (CIS) with or without papillary high‑risk non‑muscle invasive bladder cancer after a complete TURBT performed within 12 weeks. The primary focus is on safety and tolerability, with enrollment of both BCG‑naïve patients and those with prior adequate BCG who meet the recurrence timing criteria. Participants receive MK-3120 per protocol and are monitored with cystoscopy and routine assessments for adverse events and early signs of activity. The study is sponsored by Merck and is being conducted at sites in the United States and Vienna.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rutgers Cancer Institute of New Jersey ( Site 0007)
  New Brunswick, New Jersey, United States Recruiting
• Carolina Urologic Research Center ( Site 0006)
  Myrtle Beach, South Carolina, United States Recruiting
• Medizinische Universität Wien ( Site 0021)
  Vienna, State of Vienna, Austria Recruiting
• UZ Gent ( Site 0031)
  Ghent, Oost-Vlaanderen, Belgium Recruiting
• Gustave Roussy ( Site 0041)
  Villejuif, Val-de-Marne, France Recruiting
• Rabin Medical Center ( Site 0062)
  Petah Tikva, Israel Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.