A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)

Description

The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.

Conditions

Non-Muscle Invasive Bladder Cancer

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Study Overview

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Study Details

Study overview

The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.

A Phase 1/2 Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravesical Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Participants With Intermediate-risk Nonmuscle Invasive Bladder Cancer (NMIBC)

A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)

Condition
Non-Muscle Invasive Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Bakersfield

Michael G Oefelein Clinical Trials ( Site 0053), Bakersfield, California, United States, 93301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC)
  • * Must have visible tumor by cystoscopy within 12 weeks prior to first dose
  • * Has intermediate-risk NMIBC defined as 1 or more of the following risk factors:
  • * Multiple tumors
  • * \>1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening
  • * Early recurrence (\<1 year) of the initial diagnosis of low-grade disease
  • * Solitary tumor \>3 cm
  • * Failure of prior intravesical treatment
  • * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 14 days prior to first dose
  • * Newly diagnosed low-grade nonmuscle invasive bladder cancer (Ta NMIBC)
  • * Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)
  • * Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours)
  • * Has history of documented severe dry eye syndrome, severe Meibomian gland disease, and/or blepharitis, or corneal disease that prevents and/or delays corneal healing
  • * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron's disease, ulcerative colitis, or chronic diarrhea)
  • * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • * Known additional malignancy that is progressing or has required active treatment within the past 3 years
  • * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2026-11-30