Recruiting

Phase 3

Sacituzumab TirbufecanA Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07419295

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab tirumotecan

Vinflunine

Docetaxel

Paclitaxel

Rescue medications for sacituzumab tirumotecan

Study Details

Brief summary:

Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy.

Researchers want to know if giving sacituzumab tirumotecan (sac-TMT), the trial medicine, can treat locally advanced or metastatic UC that got worse after certain treatments. The goal of this trial is to learn if people who receive sac-TMT live longer than those who receive certain non-platinum chemotherapies.

Conditions

Bladder Cancer

Study ID

NCT07419295

Start date

Apr 23, 2026

Status verified date

Sep, 2026

Completion date

Apr 23, 2030

Anticipated

Primary completion date

Jul 27, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment
Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator
Has received treatment with anti-programmed cell death \[ligand\] 1 (anti-PD-\[L\]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV)
Prior therapy with disitamab vedotin (DV) is allowed but will not meet the requirement for prior treatment with EV, except in China, where participants may have received DV instead of EV before study entry
Has received a maximum of 2 prior lines of therapy
Has experienced radiographic disease progression on or after the immediate prior line of therapy before study entry
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
Is eligible to receive at least one of the control arm nonplatinum chemotherapy options (paclitaxel, docetaxel, or vinflunine)
Is able to provide archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated
If human immunodeficiency virus (HIV) positive, has well-controlled HIV on antiretroviral therapy (ART)
If hepatitis B surface antigen (HBsAg) positive, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load
If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
Has adequate organ function

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from adverse event (AE) associated with anticancer therapy
Has received prior therapy with trophoblast cell-surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC)
Has received prior therapy with a topoisomerase 1 inhibitor-containing ADC
Has completed prior external radiotherapy within 6 weeks or stereotactic radiotherapy within 4 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
Has received prior chemotherapy for urothelial cancer with any of the study therapies in the control arm (paclitaxel, docetaxel, and vinflunine)
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has a current or past history of central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active infection requiring systemic therapy other than those permitted per protocol
Has a history of stem cell/solid organ transplant
Has not adequately recovered from major surgery, or has ongoing surgical complications

Study Design

Enrollment

590 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sacituzumab tirumotecan

Participants receive 4 mg/kg of sacituzumab tirumotecan every 2 weeks (Q2W) via intravenous (IV) infusion until disease progression or unacceptable toxicity.

active comparator: Chemotherapy

Participants receive paclitaxel 175 mg/m\^2, docetaxel 75 mg/m\^2, or vinflunine 320 mg/m\^2 IV every 3 weeks (Q3W), at the investigator's discretion, until disease progression or unacceptable toxicity.

Interventions

Sacituzumab tirumotecan

IV infusion

Vinflunine

IV infusion

Docetaxel

IV infusion

Paclitaxel

IV infusion

Rescue medications for sacituzumab tirumotecan

Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are pegfilgrastim or equivalent, histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).

Rescue medications for chemotherapy

Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are dexamethasone or equivalent, H1 receptor antagonist, H2 receptor antagonist, and laxative.

Primary outcome measure

Overall Survival (OS) [ Time Frame: Up to approximately 40 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

Sibley Memorial Hospital ( Site 0849)

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Study Coordinator

202-537-4000

Johns Hopkins University ( Site 0843)

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Study Coordinator

240-893-4786

Munson Medical Center ( Site 0812)

Recruiting

Traverse City, Michigan, United States, 49684

Contacts

Study Coordinator

231-392-8400

Morristown Memorial Hospital ( Site 0795)

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Study Coordinator

937-917-5000

Memorial Sloan Kettering Cancer Center ( Site 0832)

Recruiting

New York, New York, United States, 10065

Contacts

Study Coordinator

347-798-9213

WakeMed Raleigh Campus ( Site 0811)

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

Study Coordinator

919-350-8585

TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Study Coordinator

513-865-5249

The West Clinic, P.C. ( Site 0791)

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Study Coordinator

901-683-0055

Thompson Cancer Survival Center ( Site 0803)

Recruiting

Knoxville, Tennessee, United States, 37916

Contacts

Study Coordinator

865-331-1720

Virginia Oncology Associates (VOA) ( Site 8002)

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Study Coordinator

757-466-8663

Fred Hutchinson Cancer Research Center ( Site 0787)

Recruiting

Seattle, Washington, United States, 98109

Contacts

Study Coordinator

206-606-1943

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0121)

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Study Coordinator

4185254444

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.