Active Cancer NIHR-supported project Digestion, Kidneys & Other Organs

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

Funder NIHR (part of DHSC)
Recipient organisation NIHR Cambridge Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Nov 2027

In plain English

AI plain-English summary

A drug already approved for breast and bladder cancers is now being tested against endometrial cancer in a global trial with 520 participants. This matters because endometrial cancer patients who have already failed both platinum-based chemotherapy and immunotherapy have few effective options left. The current standard of care—physician’s choice of doxorubicin or paclitaxel—offers limited benefit. The trial directly compares sacituzumab govitecan (SG) against these older chemotherapies in a randomised, open-label design. If SG proves superior, it would give clinicians a new, targeted treatment for a patient group that currently faces poor outcomes. The drug works by delivering a chemotherapy payload directly to cancer cells via an antibody that recognises a protein (Trop-2) commonly found on endometrial tumours. Success would mean extending survival and delaying disease progression for women with recurrent or persistent endometrial cancer who have exhausted existing therapies. The study is sponsored by Gilead Sciences and will run at up to 200 sites worldwide.

View original technical description
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.

Researchers

Christine Parkinson (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2?) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH?]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
Ascent 07 - A Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients with Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2-Negative (HER2) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy (GS-US-598-6168)
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

Original classification

Cancer

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.