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

NCT07222488 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: 3120-003U1111-1317-26872025-520467-40-00MK-3120-003
• Study Type: interventional
• Target: 45
• Locations: 12 countries
• Sites: 14

Brief 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.

Conditions

Bladder Cancer; Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to approximately 12 months

Secondary Outcomes (1)

• Complete Response Rate (CRR)

  Up to approximately 3 months

Study Arms (1)

MK-3120

EXPERIMENTAL

Participants will be administered MK-3120 once weekly for the first 6 weeks, followed by once monthly for 9 months.

Biological: MK-3120

Interventions

MK-3120 BIOLOGICAL

Intravesical administration at one of three doses per protocol

Also known as: SKB410

MK-3120

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (14)

Michael G Oefelein Clinical Trials ( Site 0005)

Bakersfield, California, 93301, United States

RECRUITING

Carolina Urologic Research Center ( Site 0006)

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Medizinische Universität Wien ( Site 0021)

Vienna, State of Vienna, 1090, Austria

RECRUITING

UZ Gent ( Site 0031)

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0011)

Québec, Quebec, G1J 1Z4, Canada

RECRUITING

Gustave Roussy ( Site 0041)

Villejuif, Val-de-Marne, 94800, France

RECRUITING

European Interbalkan Medical Center ( Site 0051)

Thessaloniki, 570 01, Greece

RECRUITING

Rabin Medical Center ( Site 0062)

Petah Tikva, 4941492, Israel

RECRUITING

Centro Ricerche Cliniche di Verona ( Site 0072)

Verona, Veneto, 37134, Italy

RECRUITING

Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 0081)

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

Akershus Universitetssykehus ( Site 0091)

Lorenskog, Akershus, 1478, Norway

RECRUITING

Hospital Universitario Virgen de la Victoria ( Site 0111)

Málaga, Andalusia, 29010, Spain

RECRUITING

Hospital Universitario 12 de Octubre ( Site 0112)

Madrid, Madrid, Comunidad de, 28041, Spain

RECRUITING

Ankara University Health Practice and Research Hospitals ( Site 0132)

Ankara, 06620, Turkey (Türkiye)

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: October 30, 2025
• Study Start: December 9, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IL (1); US (2); CA (1); TU (1); GR (1); NO (1); ES (2); BE (1); NL (1); AU (1); IT (1); FR (1)