Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician's Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer

Official Title

A 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

Summary:

The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).

Trial Description

Primary Outcome:

• Overall Survival (OS)

• Progression-Free Survival (PFS) by Investigator Assessment
• Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR)
• Objective Response Rate (ORR) by Investigator Assessment
• Objective Response Rate (ORR) by BICR
• Clinical Benefit Rate (CBR) by Investigator Assessment
• Clinical Benefit Rate (CBR) by BICR
• Duration of Objective Tumour Response (DOR) by Investigator Assessment
• Duration of Objective Tumour Response (DOR) by BICR
• Percentage of Participants Experiencing any Treatment Emergent Adverse Events
• Percentage of Participants Experiencing any Serious Treatment Emergent Adverse Events
• Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities
• European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score
• European Quality of Life 5-Dimensions 5 Levels Instrument (EuroQOL EQ-5D-5L) Score

View this trial on ClinicalTrials.gov