A Randomized, Open-label, Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
Categories (click each to see list of all clinical trials associated with that category): Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: McAlarnen, Lindsey
Contact Information:
Pamela Nielsen
pnielsen@nebraskamed.com
Eligibility: https://clinicaltrials.gov/study/NCT06486441?term=GOG-3104%2FGS-US-682-6769&rank=1#participation-criteria
Summary
Primary Objectives
-To compare the effect of SG relative to TPC on PFS as assessed by BICR
-To compare the effect of SG relative to TPC on OS
Key Secondary Objectives
-To compare the effect of SG relative to TPC on ORR as assessed by BICR
-To compare the effect of SG relative to TPC on physical function
Secondary Objectives
-To compare the effect of SG relative to TPC on the following:
PFS as assessed by investigator
ORR as assessed by investigator
DOR as assessed by BICR and investigator
CBR as assessed by BICR and investigator
-To evaluate safety and tolerability of SG relative to TPC
-To compare the effect of SG relative to TPC on GHS/Qol
Exploratory Objectives
-To assess the tumor expression of Trop-2 as a potential predictive biomarker of response to SG
-To assess tumor MMR/MSI status and clinical response or resistance to treatment
-To explore blood and tumor biomarkers that may predict clinical response or resistance to treatment
-To characterize the pharmacokinetics (PK) and immunogenicity of SG
-To further characterize health-related QoL