A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)
Condition(s) studied
Investigational drug(s) / intervention(s)
MK-3120: Intravesical administration at one of three doses per protocol
Study 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. 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.
Eligibility
Primary outcome measure(s)
- Number of Participants Who Experience a Dose-limiting Toxicity (DLT) — Up to approximately 5 weeks
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. - Number of Participants Who Experience One or More Adverse Events (AEs) — Up to approximately 24 months
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. - Number of Participants Who Discontinue Study Treatment Due to AEs — Up to approximately 12 months
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.
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Michael G Oefelein Clinical Trials ( Site 0005) | Bakersfield | California | Recruiting |
| Rutgers Cancer Institute of New Jersey ( Site 0007) | New Brunswick | New Jersey | Recruiting |
| Carolina Urologic Research Center ( Site 0006) | Myrtle Beach | South Carolina | Recruiting |
| Urology Austin, PLLC ( Site 0008) | Austin | Texas | Completed |
| Medizinische Universität Wien ( Site 0021) | Vienna | State of Vienna | Recruiting |
| UZ Gent ( Site 0031) | Ghent | Oost-Vlaanderen | Recruiting |
| CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0011) | Québec | Quebec | Active Not Recruiting |
| Gustave Roussy ( Site 0041) | Villejuif | Val-de-Marne | Recruiting |
| European Interbalkan Medical Center ( Site 0051) | Thessaloniki | Greece | Active Not Recruiting |
| Rabin Medical Center ( Site 0062) | Petah Tikva | Israel | Recruiting |
| Centro Ricerche Cliniche di Verona ( Site 0072) | Verona | Veneto | Recruiting |
| Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 0081) | Amsterdam | North Holland | Recruiting |
| Akershus Universitetssykehus ( Site 0091) | Lorenskog | Akershus | Recruiting |
| Hospital Universitario Virgen de la Victoria ( Site 0111) | Málaga | Andalusia | Recruiting |
| Hospital Universitario 12 de Octubre ( Site 0112) | Madrid | Madrid, Comunidad de | Recruiting |
| Ankara University Health Practice and Research Hospitals ( Site 0132) | Ankara | Turkey (Türkiye) | Recruiting |
| Koc Universitesi Hastanesi ( Site 0133) | Istanbul | Turkey (Türkiye) | Recruiting |
More Merck Sharp & Dohme LLC trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07222488 on ClinicalTrials.gov ↗ ← All trials in the USA