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

Study acronym: TroFuse-031

StatusRecruiting

PhasePhase 3

SponsorMerck Sharp & Dohme LLC

Started2026-04-23

View on ClinicalTrials.gov ↗

Amendment history

2026-09-09

Study Status, Contacts/Locations v22

Trial sites expanded: 91 → 94 locations

2026-09-01

Study Status, Contacts/Locations v21

Trial sites expanded: 86 → 90 locations

2026-08-27

Study Status, Contacts/Locations v20

Trial sites expanded: 82 → 86 locations

2026-08-20

Study Status, Contacts/Locations v19

Study sites80→82

2026-08-13

Study Status, Contacts/Locations v18

Study sites79→80

2026-08-05

Study Status, Contacts/Locations v17

Trial sites expanded: 73 → 79 locations

2026-07-30

Study Status, Contacts/Locations v16

Study sites71→73

2026-07-24

Study Status, Contacts/Locations v15

Study sites69→71

2026-07-17

Study Status, Contacts/Locations v14

Study sites67→69

2026-07-09

Study Status, Contacts/Locations, References v13

Study sites65→67

2026-06-30

Study Status, Contacts/Locations v12

Study sites63→65

2026-06-18

Study Status, Eligibility, Contacts/Locations v11

Trial sites expanded: 50 → 63 locations

Eligibility criteria+92 characters

[...] instead of EV before study entry Has received a maximum of 32 prior lines of therapy Has experienced radiographic disease [...] or cerebrovascular disease Has a history of (noninfectious) ~~pneumonitis/~~interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has ~~current~~suspected ILD or pneumonitis~~/interstitial~~ ~~lung~~that ~~disease~~cannot be ruled out by standard diagnostic assessments at Screening HIV-infected participants with a history of Kaposi's sarcom [...]

2026-06-04

Study Status, Contacts/Locations v10

Trial sites expanded: 42 → 50 locations

2026-05-27

Study Status, Contacts/Locations v9

Trial sites expanded: 38 → 42 locations

2026-05-21

Study Status, Contacts/Locations v8

Trial sites expanded: 30 → 38 locations

2026-05-13

Study Status, Contacts/Locations v7

Trial sites expanded: 27 → 30 locations

2026-05-06

Study Status, Contacts/Locations v6

Trial sites expanded: 21 → 27 locations

2026-04-29

Study Status, Contacts/Locations v5

Trial sites expanded: 3 → 21 locations

Start dateestimated 2026-04-30→confirmed 2026-04-23

2026-04-22

Study Identification, Study Status v4

Re-verified, no change to tracked fields

2026-04-17

Study Status v3

Start date2026-04-15→2026-04-30

2026-04-09

Study Status, Contacts/Locations v2

Study sites2→3

2026-03-30

Study Status, Contacts/Locations v1

Recruitment opened

Start date2026-03-17→2026-04-15

Study sites0→2

2026-02-10

Original filing

Merck (MSD)

401 trials monitored

See 24 trials at risk

Bladder Cancer

1,018 trials monitored

See 64 trials at risk

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.

Trial Details

NCT Number	NCT07419295
Lead Sponsor	Merck Sharp & Dohme LLC
Conditions	Bladder Cancer
Enrollment	590 participants
Start Date	2026-04-23
Primary Completion	2029-07-27 (estimated)
Study Completion	2030-04-23 (estimated)
Updated on ClinicalTrials.gov	2026-09-25