RECRUITING

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

Conditions

Non-Muscle Invasive Bladder Cancer Low Grade Intermediate Risk Recurrent Low-Grade

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2024-12-20

Study Completion:2026-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06637423

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Toll Free Number

CONTACT

1-888-577-8839

Trialsites@msd.com

Principal Investigator

Medical Director

STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Locations (Sites)

Michael G Oefelein Clinical Trials ( Site 0053)

Bakersfield, California, 93301

United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-20

Study Completion Date2026-11-30

Study Record Updates

Study Start Date2024-12-20

Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

Non-Muscle Invasive Bladder Cancer
Low Grade
Intermediate Risk
Recurrent Low-Grade

Additional Relevant MeSH Terms

Non-Muscle Invasive Bladder Cancer