RecruitingPhase 1Phase 2NCT07222488

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

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


Sponsor

Merck Sharp & Dohme LLC

Enrollment

45 participants

Start Date

Dec 9, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (MK-3120-003) is testing a new treatment called MK-3120 for high-risk, non-muscle invasive bladder cancer (NMIBC) — specifically cancer that stays in the bladder lining and hasn't grown into the muscle wall. This type of bladder cancer is difficult to treat and has a high recurrence rate. **You may be eligible if...** - You have confirmed high-risk non-muscle invasive bladder cancer, including carcinoma in situ (CIS) - Your most recent surgical removal of bladder tumors (TURBT) was within the last 12 weeks and was complete - You are either BCG-naive (never received BCG treatment or relapsed more than 2 years after BCG) or have been adequately treated with BCG before **You may NOT be eligible if...** - Your TURBT was incomplete (tumors not fully removed) - You have muscle-invasive or metastatic bladder cancer - You received inadequate or recent BCG treatment without a full response Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMK-3120

Intravesical administration at one of three doses per protocol


Locations(14)

Michael G Oefelein Clinical Trials ( Site 0005)

Bakersfield, California, United States

Carolina Urologic Research Center ( Site 0006)

Myrtle Beach, South Carolina, 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)

View Full Details on ClinicalTrials.gov

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NCT07222488


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