Loading clinical trials...

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003) | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT07222488•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

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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.
+2 more criteria

Locations (5)

Michael G Oefelein Clinical Trials ( Site 0005)

Bakersfield, California, United States

Carolina Urologic Research Center ( Site 0006)

Myrtle Beach, South Carolina, United States

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

Québec, Quebec, Canada

Rabin Medical Center ( Site 0062)

Petah Tikva, Israel

Ankara University Health Practice and Research Hospitals ( Site 0132)

Ankara, Turkey (Türkiye)

Key Dates

Start Date

December 9, 2025

Primary Completion Date

February 28, 2029

Completion Date

February 28, 2029

Last Updated

February 20, 2026

Enrollment

ESTIMATED participants

Conditions

Bladder CancerUrinary Bladder Neoplasms

Interventions

MK-3120

BIOLOGICAL

Contacts

Toll Free Number

CONTACT

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

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

NCT03375307

Advanced Bladder CarcinomaAdvanced Genitourinary System Carcinoma+4 more

View study

RECRUITING

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

NCT04235764

Bladder Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery