Phase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer
Merck Sharp & Dohme LLC
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 eithe…
Interventions
- BiologicalMK-3120
Intravesical administration at one of three doses per protocol
Locations (14)
- Michael G Oefelein Clinical Trials ( Site 0005)Bakersfield, California
- Carolina Urologic Research Center ( Site 0006)Myrtle Beach, South Carolina
- Medizinische Universität Wien ( Site 0021)Vienna, State of Vienna
- UZ Gent ( Site 0031)Ghent, Oost-Vlaanderen
- CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0011)Québec, Quebec
- Gustave Roussy ( Site 0041)Villejuif, Val-de-Marne