A Phase 3 Randomized Open-Label Study of Sacituzumab Govitecan Versus Physician’s Choice in Recurrent or Persistent Endometrial Cancer Post-Chemotherapy and Immunotherapy

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What is this study about?

This clinical trial is focused on studying a treatment for endometrial cancer, which is a type of cancer that begins in the lining of the uterus. The study will compare the effects of a medication called sacituzumab govitecan with other treatments chosen by doctors. Sacituzumab govitecan is a type of medicine known as an antibody-drug conjugate, which is designed to target and kill cancer cells. The other treatments that may be used in the study include doxorubicin, a chemotherapy drug, and paclitaxel, another type of chemotherapy that works by stopping cancer cells from dividing.

The purpose of the study is to see how well sacituzumab govitecan works compared to the other treatments in terms of slowing down the progression of the cancer and improving overall survival. Participants in the study will be randomly assigned to receive either sacituzumab govitecan or one of the other treatments. The study will involve regular visits to the clinic for treatment and monitoring, which will include tests like computed tomography (CT) or magnetic resonance imaging (MRI) to check the status of the cancer.

The study will continue for several years, with participants being closely monitored for any changes in their condition and any side effects from the treatments. The goal is to gather information that could help improve treatment options for people with endometrial cancer in the future.

Who Can Join the Study?

You must be willing and able to follow all the rules and requirements of the study.
You must be assigned female at birth and be of childbearing potential, which means you are still able to have children; if you have sex with a male partner, you must agree to use specific birth control methods.
You must have an expected life expectancy, or the amount of time you are expected to live, of at least 3 months.
You must be 18 years of age or older, or the minimum age required in your country.
You must be able to understand the study and provide written informed consent, which is a signed document showing you agree to participate after being fully informed.
You must have medical proof of recurrent or persistent endometrial cancer, which means the cancer has returned or has not gone away.
You must have received up to 3 previous lines of systemic therapy, which refers to different types of medical treatments, such as drugs, used to treat cancer throughout the entire body.
You must be able to safely receive certain medications called doxorubicin or paclitaxel, as determined by your doctor.
Your cancer must be visible on imaging tests like a computed tomography (CT) scan or magnetic resonance imaging (MRI), which are special pictures taken of the inside of your body.
There must be proof that your cancer has progressed, meaning the cancer has grown or spread, based on your imaging tests.
You must have available tumor tissue from a previous sample or a new biopsy, which is a procedure to remove a small piece of tissue for testing, to check for specific markers called Trop-2 and other biomarkers.
You must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which is a scale used by doctors to measure how well you can perform daily activities and your overall level of physical functioning.

Who Cannot Join the Study?

You are currently receiving other systemic anticancer therapies, which are medicines used throughout the entire body to treat cancer, other than the medicine being studied.
You have an active infection of Hepatitis B or Hepatitis C, which are viruses that affect the liver. This includes having a detectable amount of the virus in your blood.
You have uterine leiomyosarcoma or endometrial stromal sarcomas, which are specific, rare types of cancer that start in the uterus.
You have a scheduled surgery planned during the study, unless it is a minor procedure that will not delay your treatment.
You have had active chronic inflammatory bowel disease, such as ulcerative colitis or Crohn’s disease (long-term swelling and irritation in the digestive tract), or a gastrointestinal perforation (a hole in the stomach or intestines) within the last 6 months.
You are pregnant, plan to become pregnant, or plan to breastfeed during the study and for one month after your last dose of the study medicine.
You have used a live vaccine (a vaccine that uses a weakened form of a germ) within the last 30 days.
You have other medical or psychiatric conditions (mental health conditions) that the doctor believes might make it difficult to understand the study results or complete the study requirements.
You have any medical condition that the doctor or the study sponsor believes makes participating in the study too risky for you.
You are currently a candidate for curative-intent therapy, which means a treatment specifically intended to completely get rid of your cancer.
You are eligible to try platinum-based chemotherapy again, which is a type of cancer treatment that uses platinum to kill cancer cells.
You have a known or severe hypersensitivity (an extreme allergic reaction) to the study medicine, the other medicines used in the study, or any of the ingredients used to make them.
You have previously received treatment with a Trop-2-directed ADC, which is a specific type of targeted drug that delivers medicine directly to cancer cells.
You have previously taken any medicine that targets an enzyme called topoisomerase I.
You have used anticancer biologic agents (medicines made from living organisms) within 4 weeks, or other treatments like chemotherapy, hormonal therapy, or radiation therapy within 2 weeks of starting the study.
You are using other investigational drugs (medicines that are still being tested and are not yet available to the public) within 28 days of starting the study.
You have not yet recovered from adverse events (side effects or medical problems) caused by a previous treatment. Note that mild nerve tingling or hair loss are exceptions.
You are required to take any prohibited medications that are specifically listed as not allowed for this study.
You have active central nervous system metastases (cancer that has spread to the brain or spinal cord) or carcinomatous meningitis (cancer that has spread to the protective layers covering the brain and spinal cord).
You have a second, active malignancy (another type of cancer), unless it was completely treated at least 3 years ago or was a low-risk type like certain skin cancers.
Your left ventricular ejection fraction is less than 50%, which is a measurement of how much blood your heart pumps out with each beat.
You have a history of significant cardiovascular disease (heart problems), such as a myocardial infarction (heart attack), unstable chest pain, serious irregular heartbeats, or congestive heart failure.
You have an active, serious infection that requires systemic antimicrobial therapy (medicine like antibiotics used to fight an infection throughout the body).
You have a known history of HIV-1 or 2 with a detectable amount of the virus in your blood.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
General Hospital Of Messinia	Kalamata	Greece
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Hospital Clinico San Carlos	Madrid	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centre Antoine Lacassagne	Nice	France
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Fakultni Nemocnice Bulovka	Prague	Czechia
Hospital Universitario De Jaen	Jaen	Spain
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.	Siedlce	Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Hochtaunus-Kliniken gGmbH	Bad Homburg	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Universita’ Di Pisa	Pisa	Italy
Alessandro Manzoni Hospital	Lecco	Italy
Nemocnice AGEL Novy Jicin a.s.	Novy Jicin	Czechia
St. Luke’s Hospital S.A.	Thessaloniki	Greece
Mitera S.A.	Athens	Greece
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Servei De Salut De Les Illes Balears	Palma	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
University Hospital Ostrava	Ostrava	Czechia
Centre Francois Baclesse	Caen	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Uyvxghbasb Mzijdxb Cmozdc Heujaafsoudmknvjx	Hamburg	Germany
Udgzinpajbpbunzfxmjtu Ehwno Apj	Essen	Germany
Ivbscm Ixbrdnjt Facxebueakvtv Oribfitnpmn	Rome	Italy
Dzjyqfajxnhf Cywhoei Ouwkowixc Pzbmbsgipptb I Heemxzuoeei	Wroclaw	Poland
Shhngqgx Pnzzhowfd Sqi z ozak	Gdynia	Poland
Gwirfeq Hppaptka Ok Pwflot Asvuk Abfqoku	Patras	Greece
Pvkr Tkdwg Hgqlynvk Uobroppfoqcm	Sabadell	Spain
Ilbcysgu Ryjiyoolj Plb Ld Sbzkox Dzf Txcbyv Dese Aivbqez Iutv Sfeexd	Meldola	Italy
Uzgahfvjtntohixrzwghp Dygwanvkyvz Aiw	Duesseldorf	Germany
Abtbgce Oqdpcsfprhq Utfxfbbrfiggq Cowgjcbirtnx Deemt Svfdbl E Djbzc Sjrwbsy Dh Tpjeay	Turin	Italy
Hekvtqyx Uciqxxngfkpdi Dmerjyxe	Donostia / San Sebastian	Spain
Avuwgwl Hosqyuey	Athens	Greece
Ijyzexfy Plhpaeqvcipiwnm Clpqmu Cjhfxa	Marseille	France
Hekcbvhx Ucrnfhtwylazi da A Cxdmlu	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	02.12.2024
France	Not recruiting	02.12.2024
Germany	Not recruiting	02.12.2024
Greece	Not recruiting	02.12.2024
Italy	Not recruiting	02.12.2024
Poland	Not recruiting	02.12.2024
Spain	Not recruiting	02.12.2024

Trial locations

Investigated drugs:

Sacituzumab govitecan is the experimental drug being tested in this study. It is a type of therapy designed to target and kill cancer cells in people with endometrial cancer.

Paclitaxel is a chemotherapy medication used as a comparison treatment to see how effective it is compared to the experimental drug.

Doxorubicin is a chemotherapy medication used as a comparison treatment to see how effective it is compared to the experimental drug.

Investigated diseases:

Endometrial cancer recurrent

Recurrent or Persistent Endometrial Cancer – This condition occurs when cancer cells in the lining of the uterus return after a period of being undetectable. It can also happen if the cancer cells do not fully disappear following initial treatment. The disease involves the uncontrolled growth of abnormal cells within the uterine lining. These cells may continue to multiply and spread within the pelvic region or to other parts of the body. The progression is marked by the regrowth or continued presence of these malignant cells.

Trial ID:

2024-511957-23-00

Protocol code:

GS-US-682-6769

NCT ID:

NCT06486441

Trial Phase:

Therapeutic confirmatory (Phase III)

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A Phase 3 Randomized Open-Label Study of Sacituzumab Govitecan Versus Physician’s Choice in Recurrent or Persistent Endometrial Cancer Post-Chemotherapy and Immunotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?