Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-090
Prinicipal Investigator
Joshi, Monika
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
IMMU-132-13
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
Objective
Primary Objective:
To assess overall survival (OS) with sacituzumab govitecan in comparison with treatment of physician s choice (TPC) in subjects with metastatic or locally advanced unresectable urothelial cancer (UC)

Secondary Objectives:
To assess progression-free survival (PFS) with sacituzumab govitecan in comparison with TPC by investigator assessment and blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

To assess objective response rate (ORR), clinical benefit rate (CBR), and duration of objective tumor response (DOR) with sacituzumab govitecan in comparison with TPC by investigator assessment and BICR using RECIST v1.1
To assess safety and tolerability of sacituzumab govitecan in comparison with TPC
To assess Quality of Life (QOL) with sacituzumab govitecan in comparison with TPC

Exploratory Objectives:
To assess and compare efficacy in a subset defined by tumor expression of Trop-2 and ascertain the role of expression of Trop-2 as a biomarker for response
To investigate candidate blood and tumor biomarkers as a biomarker for response
To investigate potential correlation between serum sacituzumab govitecan pharmacokinetics (PK) and the development of immunogenicity (ADA)
To characterize the PK of sacituzumab govitecan in metastatic UC subjects



Applicable Disease Sites
Urinary Bladder
Status
Open
Participating Institutions
Hershey Medical Center