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

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

Phase1; Phase2 Interventional Merck Sharp & Dohme LLC · NCT07222488

We will test whether MK-3120 can be given safely and is tolerated by people with high‑risk non‑muscle invasive bladder cancer after tumor removal (TURBT).

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment45 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations14 sites (Bakersfield, California and 13 other locations)
Trial IDNCT07222488 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed CIS with or without papillary high‑risk NMIBC who had a complete TURBT within the past 12 weeks and are either BCG‑naïve or meet the trial's BCG exposure/timing criteria.

Not a fit: People with muscle‑invasive or metastatic bladder cancer, those whose TURBT was more than 12 weeks ago, or who do not meet the BCG exposure or timing requirements are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, MK-3120 could become a new treatment option to lower recurrence risk and help people avoid more invasive surgery for high‑risk NMIBC.

How similar studies have performed: Some immune‑based and other therapies have shown benefit in BCG‑unresponsive NMIBC, but MK-3120 itself is a novel agent with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Bakersfield, California and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bladder CancerUrinary Bladder Neoplasms
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.