Study on MK-3120 for Treating Bladder Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT07222488

This clinical trial is exploring a new treatment, MK-3120, for high-risk non-muscle invasive bladder cancer (HR NMIBC) to see if it is safe and well-tolerated after standard tumor removal surgery.

Patient Parameters

Program Overview

Researchers are testing a new medicine called MK-3120 to see if it can help treat high-risk non-muscle invasive bladder cancer (HR NMIBC) after the standard procedure to remove the tumor, known as transurethral resection of the bladder tumor (TURBT). This type of cancer is found in the lining of the bladder and has not spread to the muscle or outside the bladder. The study aims to learn about the safety of MK-3120 and how well patients can tolerate it.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-risk non-muscle invasive bladder cancer (NMIBC), confirmed by a recent medical test.
  • Had a tumor removal surgery (TURBT) within the last 12 weeks, showing high-risk NMIBC.
  • Either never received BCG treatment or had it more than 2 years ago with no cancer return during that time, or had BCG treatment and cancer returned between 12 to 24 months after the last dose.
  • If HIV-positive, must have well-controlled HIV with medication.
  • If hepatitis B positive, must have been on antiviral treatment for at least 4 weeks with no detectable virus.
  • If previously infected with hepatitis C, must have no detectable virus at screening.

Exclusion Criteria

  • Have or had advanced or spreading bladder cancer.
  • Have bladder cancer outside the bladder that returned in the last 2 years.
  • Have active bladder issues like incontinence or infection.
  • Have a condition that prevents normal urination.
  • Have serious heart or blood vessel problems in the last 6 months.
  • Have severe eye conditions affecting the cornea.
  • If HIV-positive, have a history of certain cancers.
  • Have another progressing cancer needing treatment in the last 3 years.
  • Have cancer spread to the brain or spinal fluid.
  • Have an active infection needing treatment.
  • Have a history of lung disease needing steroids or current lung issues.
  • Have not fully recovered from major surgery or have ongoing complications.

Locations

FACILITYZIPCITYSTATE
Michael G Oefelein Clinical Trials ( Site 0005)93301BakersfieldCalifornia
Carolina Urologic Research Center ( Site 0006)29572Myrtle BeachSouth Carolina

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