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A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator’s Choice of Non-platinum Chemotherapy in Participants with Pretreated Locally Advanced/Metastatic Urothelial Carcinoma

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520014-22-00
Enrollment
182
Registered
2026-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced/metastatic urothelial carcinoma

Brief summary

Overall Survival (OS)

Detailed description

Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DOR), Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score, Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Change From Baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Change From Baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score, Change From Baseline in EORTC QLQ-C30 Nausea/Vomiting (Items 14 and 15) Combined Score, Change From Baseline in EORTC QLQ-C30 Diarrhea (Item 17) Score

Interventions

DRUGDOCETAXEL
DRUGMK-2870
DRUGVINFLUNINE
DRUGPACLITAXEL
DRUG-

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS)—

Secondary

MeasureTime frame
Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DOR), Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score, Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Change From Baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Change From Baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score, Change From Baseline in EORTC QLQ-C30 Nausea/Vomiting (Items 14 and 15) Combined Score, Change From Baseline in EORTC QLQ-C30 Diarrhea (Item 17) Score—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 22, 2026