Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513870-23-00

Acronym

IMMU-132-13

Enrollment

391

Registered

2024-10-29

Start date

2021-06-28

Completion date

2025-05-21

Last updated

2025-05-13

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

Conditions

Locally Advanced or Metastatic Unresectable Urothelial Cancer

Brief summary

Detailed description

PFS by investigator assessment and BICR using RECIST v1.1, ORR, CBR and DOR by investigator assessment and BICR using RECIST v1.1, Safety and tolerability evaluated by AEs, SAEs, and laboratory changes, Change from baseline in the physical functioning, global health status, pain, and fatigue scales of the EORTC QLQ-C30 score

Interventions

DRUGPaclitaxel 6 mg/mL concentrate for solution for infusion

DRUGJavlor 25 mg/mL concentrate for solution for infusion

DRUGTrodelvy 200 mg powder for concentrate for solution for infusion

DRUGDocetaxel Accord 80 mg/4 ml concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
OS	—

Secondary

Measure	Time frame
PFS by investigator assessment and BICR using RECIST v1.1, ORR, CBR and DOR by investigator assessment and BICR using RECIST v1.1, Safety and tolerability evaluated by AEs, SAEs, and laboratory changes, Change from baseline in the physical functioning, global health status, pain, and fatigue scales of the EORTC QLQ-C30 score	—

Countries

Belgium, France, Germany, Greece, Ireland, Italy, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026