RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07222488

Registry updated: 2026-09-11

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

MK-3120 (Biological)
Intravesical administration at one of three doses per protocol

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.

Conditions

Bladder Cancer Urinary Bladder Neoplasms

Locations

Michael G Oefelein Clinical Trials ( Site 0005) — Bakersfield, California, United States
Rutgers Cancer Institute of New Jersey ( Site 0007) — New Brunswick, New Jersey, United States
Carolina Urologic Research Center ( Site 0006) — Myrtle Beach, South Carolina, United States
Urology Austin, PLLC ( Site 0008) — Austin, Texas, United States
Medizinische Universität Wien ( Site 0021) — Vienna, State of Vienna, Austria
UZ Gent ( Site 0031) — Ghent, Oost-Vlaanderen, Belgium
CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0011) — Québec, Quebec, Canada
Gustave Roussy ( Site 0041) — Villejuif, Val-de-Marne, France
European Interbalkan Medical Center ( Site 0051) — Thessaloniki, Greece
Rabin Medical Center ( Site 0062) — Petah Tikva, Israel
Centro Ricerche Cliniche di Verona ( Site 0072) — Verona, Veneto, Italy
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 0081) — Amsterdam, North Holland, Netherlands
Akershus Universitetssykehus ( Site 0091) — Lorenskog, Akershus, Norway
Hospital Universitario Virgen de la Victoria ( Site 0111) — Málaga, Andalusia, Spain
Hospital Universitario 12 de Octubre ( Site 0112) — Madrid, Madrid, Comunidad de, Spain
Ankara University Health Practice and Research Hospitals ( Site 0132) — Ankara, Turkey (Türkiye)
Koc Universitesi Hastanesi ( Site 0133) — Istanbul, Turkey (Türkiye)

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment