Bladder CancerPhase 1/2NCT07222488
A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)
A Phase 1/2 study testing MK-3120 in people with Bladder Cancer and Urinary Bladder Neoplasms, run by Merck Sharp & Dohme LLC at 17 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urinary Bladder Neoplasms
- What is being tested?
- MK-3120
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 17 sitesin 12 countries
- Study dates
- 9 Dec 2025to 28 Feb 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 and contacts
17 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 12 countries
United States4 sites, 4 recruiting
- Recruiting
Urology Austin, PLLC ( Site 0008)
Austin, Texas, 78759
Study Coordinator, 512-410-3773
- Recruiting
Michael G Oefelein Clinical Trials ( Site 0005)
Bakersfield, California, 93301
Study Coordinator, 661-310-1063
- Recruiting
Carolina Urologic Research Center ( Site 0006)
Myrtle Beach, South Carolina, 29572
Study Coordinator, 843-449-1010
- Recruiting
Rutgers Cancer Institute of New Jersey ( Site 0007)
New Brunswick, New Jersey, 08901
Study Coordinator, 732-235-7530
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario 12 de Octubre ( Site 0112)
Madrid, Madrid, Comunidad de, 28041
Study Coordinator, +34913908121
- Recruiting
Hospital Universitario Virgen de la Victoria ( Site 0111)
Málaga, Andalusia, 29010
Study Coordinator, +34 951 032 095
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara University Health Practice and Research Hospitals ( Site 0132)
Ankara, 06620
Study Coordinator, +90 312 595 71 12
- Recruiting
Koc Universitesi Hastanesi ( Site 0133)
Istanbul, 34010
Study Coordinator, +905326761078
Austria1 site, 1 recruiting
- Recruiting
Medizinische Universität Wien ( Site 0021)
Vienna, State of Vienna, 1090
Study Coordinator, +4367761942300
Belgium1 site, 1 recruiting
- Recruiting
UZ Gent ( Site 0031)
Ghent, Oost-Vlaanderen, 9000
Study Coordinator, +32 9 332 21 11
Canada1 site, 1 recruiting
- Recruiting
CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0011)
Québec, Quebec, G1J 1Z4
Study Coordinator, 418-525-4444
France1 site, 1 recruiting
- Recruiting
Gustave Roussy ( Site 0041)
Villejuif, Val-de-Marne, 94805
Study Coordinator, +33142114571
Greece1 site
- Active, not recruiting
European Interbalkan Medical Center ( Site 0051)
Thessaloniki, 570 01
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center ( Site 0062)
Petah Tikva, 4941492
Study Coordinator, +97239377377
Italy1 site, 1 recruiting
- Recruiting
Centro Ricerche Cliniche di Verona ( Site 0072)
Verona, Veneto, 37134
Study Coordinator, +390458126564
Netherlands1 site, 1 recruiting
- Recruiting
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 0081)
Amsterdam, North Holland, 1066 CX
Study Coordinator, +31205129111
Norway1 site, 1 recruiting
- Recruiting
Akershus Universitetssykehus ( Site 0091)
Lorenskog, Akershus, 1478
Study Coordinator, +4767960000
About this study
Official title: Phase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer
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.
- Conditions
- Bladder Cancer, Urinary Bladder Neoplasms
- Being tested
- MK-3120
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-3120Biological
Also called SKB410
Intravesical administration at one of three doses per protocol
| Study group | Role | What they receive |
|---|---|---|
| MK-3120 | Experimental | Participants will be administered MK-3120 once weekly for the first 6 weeks, followed by once monthly for 9 months. Receives: Biological: MK-3120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Any of the following toxicities will be considered a DLT:
Hematuria leading to clot or obstruction; Grade (Gr) 4 thrombocytopenia; Gr 3 thrombocytopenia associated with clinically significant bleeding; Febrile neutropenia for more than 1 hour; Other Gr ≥3 hematologic toxicity lasting >7 days; Nonhematologic AE ≥Gr 3 (with exceptions); ≥Gr 2 pneumonitis/ interstitial lung disease; Any ≥Gr 3 nonhematologic laboratory value if clinically significant medical intervention is required, leads to hospitalization, persists for >7 days, results in a drug induced liver injury, or elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value >8 ×upper limit of normal (ULN) regardless of duration and AST or ALT elevation 5 × to 8 × ULN that persists for greater than 2 weeks; Recurrent Gr 2 AE resulting in >2 weeks delay in receiving the next treatment dose; Any intervention-related toxicity that results in study intervention discontinuation; Gr 5 toxicity or AE.
Measured: Up to approximately 5 weeks
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Measured: Up to approximately 24 months
Number of Participants Who Discontinue Study Treatment Due to AEs
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Measured: Up to approximately 12 months
Secondary outcomes (1)
Complete Response Rate (CRR)
CR is defined as the absence of all of the following as determined by local assessment using urine cytology, cystoscopy, biopsy and radiology assessments as applicable:
- High-risk non-muscle invasive urothelial cancer (UC) (defined as high-grade [HG] noninvasive papillary [Ta], carcinoma in situ [CIS], or any submucosal invasive [T1] disease of the bladder, urethra, or upper tract [ureters, renal pelvis])
- Any muscle invasive tumor (T2) or greater in the bladder, including transurethral prostate stromal invasion of UC, or in the upper tract (ureters, renal pelvis)
- Metastatic UC, defined as:
- Regional lymph node metastasis of UC (N1 or greater)
- Distant lymph node or visceral metastasis of UC (M1)
Measured: Up to approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start9 Dec 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222488
- Sponsor's protocol ID
- 3120-003
- Other IDs
- U1111-1317-2687, 2025-520467-40-00, MK-3120-003, 2025
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf