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

Part of paid clinical trials in Traverse City, Michigan.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07419295
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab tirumotecan — BIOLOGICAL
    IV infusion
  • Vinflunine — DRUG
    IV infusion
  • Docetaxel — DRUG
    IV infusion
  • Paclitaxel — DRUG
    IV infusion
  • Rescue medications for sacituzumab tirumotecan — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

First listed
Feb 19, 2026
Start date
Apr 23, 2026
Status verified
Aug 2026
Primary completion
Jul 27, 2029
Completion
Apr 23, 2030

Study Design

Enrollment
590 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Munson Medical Center ( Site 0812)Traverse CityMichigan49684
Study Coordinator
231-392-8400
Morristown Memorial Hospital ( Site 0795)MorristownNew Jersey07960
Study Coordinator
937-917-5000
Memorial Sloan Kettering Cancer Center ( Site 0832)New YorkNew York10065
Study Coordinator
347-798-9213
WakeMed Raleigh Campus ( Site 0811)RaleighNorth Carolina27610
Study Coordinator
919-350-8585
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)CincinnatiOhio45220
Study Coordinator
513-865-5249
The West Clinic, P.C. ( Site 0791)GermantownTennessee38138
Study Coordinator
901-683-0055
Thompson Cancer Survival Center ( Site 0803)KnoxvilleTennessee37916
Study Coordinator
865-331-1720
Virginia Oncology Associates (VOA) ( Site 8002)NorfolkVirginia23502
Study Coordinator
757-466-8663

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Munson Medical Center· Traverse City, MIMorristown Memorial Hospital· Morristown, NJMemorial Sloan Kettering Cancer Center· New York, NYWakeMed Raleigh Campus· Raleigh, NCTriHealth Cancer Institute-Good Samaritan Hospital· Cincinnati, OHThe West Clinic, P.C.· Germantown, TN

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