ASCENT-GYN-01
Research type
Research Study
Full title
A Randomized, Open-label, Phase 3 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.
IRAS ID
1010399
Contact name
Kimberly Komatsubara
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of this research study is to learn if sacituzumab govitecan (also called SG or Trodelvy®) can improve lifespan and delay the growth or spread of the disease in participants with endometrial cancer when compared to chemotherapy (doxorubicin or paclitaxel).
Study Drug - Sacituzumab Govitecan (TRODELVY® ; GS-0132 ; IMMU-132)
Comparator drugs -compared with treatment of physician's choice ("TPC") (doxorubicin or paclitaxel).
SG is approved for the treatment of adult patients with certain types of breast cancer in the United States (US), European Union (EU), and several other regions. It is also approved in the US for the treatment of adult patients with certain types of bladder cancer. It is not approved to treat endometrial cancer and is only being used for research purposes during this study.
The proposed new pivotal study will be conducted to evaluate the treatment effect of SG versus TPC in participants with recurrent/persistent endometrial cancer who have disease progression on or following prior platinum-based chemotherapy and prior immunotherapy (anti-PD-1/PD-L1).
About 520 participants are planned to take part in the study. The study will take place at up to 200 locations globally. This is a randomized, open-label study.
The study will consist of the following periods:
- A pretreatment 28-day screening period;
-treatment period of 21-day cycles for participants assigned to receive SG or doxorubicin and 28-day cycles for participants assigned to receive paclitaxel;
- An end-of-treatment (EOT) visit;
- A long-term follow-up period to collect survival data.
Sponsor of this study is Gilead Sciences Inc.REC name
East of England - Essex Research Ethics Committee
REC reference
24/EE/0185
Date of REC Opinion
22 Oct 2024
REC opinion
Further Information Favourable Opinion