Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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 Non-muscle Invasive Bladder Cancer (NMIBC)

A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027) (NCT06637423) is a Phase 1 / Phase 2 interventional studying Non-Muscle Invasive Bladder Cancer, sponsored by Merck Sharp & Dohme LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Non-Muscle Invasive Bladder Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 32 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: The key inclusion criteria include but are not limited to the following: - Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in the bladder - 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 Who Should NOT Join This Trial: The key exclusion criteria include but are not limited to the following: - Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in the bladder - 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 severe 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in the bladder * 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 Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in the bladder * 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 severe 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.

Treatments Being Tested

DRUG

Sacituzumab tirumotecan

Intravesical administration

DRUG

Rescue medication

Participants are allowed to take rescue medication for stomatitis or oral mucositis. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion or steroid mouthwash (dexamethasone or equivalent), antiemetic medications, oral nystatin suspension or antifungal medications, antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.

DRUG

Supportive care measures

Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Artificial tear drops or gel may be given as a supportive care for Ocular Surface Toxicity.

Locations (13)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Michael G Oefelein Clinical Trials ( Site 0053)

Bakersfield, California, United States

Moffitt Cancer Center ( Site 0057)

Tampa, Florida, United States

Northwestern University ( Site 0051)

Chicago, Illinois, United States

Johns Hopkins University ( Site 0055)

Baltimore, Maryland, United States

Princess Margaret Cancer Centre ( Site 0003)

Toronto, Ontario, Canada

CIUSSS de l'Estrie-CHUS ( Site 0002)

Sherbrooke, Quebec, Canada

Hôpital Claude Huriez ( Site 0012)

Lille, Nord, France

HENRI MONDOR HOSPITAL ( Site 0011)

Créteil, Val-de-Marne, France

Gustave Roussy ( Site 0013)

Villejuif, Val-de-Marne, France

Erasmus Medisch Centrum ( Site 0032)

Rotterdam, South Holland, Netherlands

Hospital Universitario Virgen de la Victoria ( Site 0043)

Málaga, Andalusia, Spain

Hospital Universitario 12 de Octubre ( Site 0042)

Madrid, Spain

St Bartholomew s Hospital ( Site 0061)

London, London, City of, United Kingdom

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06637423), the sponsor (Merck Sharp & Dohme LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06637423 clinical trial studying?

Who can participate in NCT06637423?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06637423?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06637423. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06637423. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.