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 University College London Hospitals Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Jan 2025 — Oct 2026

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 tried platinum-based chemotherapy and immunotherapy have few effective options left. The current standard is simply the physician’s choice between two older chemotherapies—doxorubicin or paclitaxel—neither of which was designed for this specific situation. The trial directly compares sacituzumab govitecan (SG) against those drugs in a randomised, open-label design. If SG proves superior, it would become a new treatment option for patients whose disease has progressed after the two most common modern therapies. That would fill a clear gap in the treatment pathway for recurrent or persistent endometrial cancer. The study is not fundamental science; it is a late-stage clinical trial aimed at regulatory approval. Success would change clinical practice by giving oncologists a targeted therapy where none currently exists for this patient group.

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

Gemma Eminowicz (Principal Investigator)

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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
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Original classification

Cancer

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