Active not recruitingPHASE3INTERVENTIONAL

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)

This research study is for women with endometrial cancer that has returned or not responded well to previous treatments, including platinum-based chemotherapy and immunotherapy. The main aim is to compare a new drug, sacituzumab govitecan, with standard treatments chosen by doctors. Scientists want to see if sacituzumab govitecan can help stop the cancer from growing for longer (called progression-free survival) and if it helps women live longer overall (called overall survival). By carefully comparing these treatments, the study hopes to find a better way to treat this type of cancer. It's a Phase 3 study, meaning it's in the later stages of testing new treatments, often involving a larger group of participants.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Gilead Sciences

Enrolment target

640

Start

28 Aug 2024

Estimated completion

01 Jun 2029

Endometrial Cancer

What is this study about?

This study is designed for women who have endometrial cancer, which is a type of cancer that starts in the lining of the womb. Specifically, it's for those whose cancer has returned after previous treatments or has continued to grow despite earlier chemotherapy and immunotherapy.

The main goal is to find out if a new study drug, called sacituzumab govitecan, is more effective than the usual treatments doctors might choose. Doctors will monitor how long it takes for the cancer to grow or spread (they call this progression-free survival) and how long people live overall (overall survival). They do this by regularly checking scans and health updates from the participants.

By comparing sacituzumab govitecan with other standard treatments like doxorubicin or paclitaxel, researchers hope to see if this new drug can offer a better option for women with endometrial cancer who have already had several treatments. This could potentially lead to new and more effective ways to manage this disease in the future.

Key takeaways

This study evaluates a new drug, sacituzumab govitecan, for advanced endometrial cancer.
It's for women who have already tried chemotherapy and immunotherapy.
The study compares the new drug to standard treatments like doxorubicin or paclitaxel.
Researchers want to see if the new drug helps control cancer growth and improves survival.
It's a Phase 3 study, aiming to find better treatment options.
Participation involves regular clinic visits, checks, and scans.

Who may be eligible?

This study is for adult women, aged 18 and older, who have endometrial cancer that has either come back or hasn't responded to previous treatments. You must have already had certain types of chemotherapy (platinum-based) and immunotherapy. Your doctor will also need to confirm that you are generally well enough to take part and that your body's organs are working properly.

However, some people may not be able to join. For example, if you have a different kind of womb cancer (like leiomyosarcoma), or if your doctor thinks other standard cancer treatments could cure you. You also can't have had a similar type of drug called a Trop-2 antibody-drug conjugate before, nor can you be pregnant or breastfeeding. Other health conditions, like serious infections or inflammatory bowel disease, might also prevent you from joining.

Quick self-check

I am an adult woman (18 or older) with endometrial cancer.
My cancer has come back or grown after previous treatments including platinum-based chemotherapy and immunotherapy.
My doctors think I could receive doxorubicin or paclitaxel.
I am generally well and active with good organ function.
I am not pregnant or breastfeeding, and I don't have certain other serious health conditions.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive either the new study drug (sacituzumab govitecan) or one of two standard chemotherapy drugs (doxorubicin or paclitaxel). You would have regular visits to the clinic for treatments, check-ups, blood tests, and scans (like CT or MRI). These visits help doctors monitor your health, how you're responding to treatment, and any side effects you might experience. The exact schedule of visits and duration of treatment would be explained in detail by the study team, but typically, you would continue treatment as long as it's helping and not causing too many problems. After treatment ends, there would likely be follow-up calls or visits to keep an eye on your long-term health.

Potential risks and benefits

Taking part in a study like this could offer benefits, such as access to a new treatment that isn't widely available yet, which might help your cancer more than existing options. You'd also receive very close medical attention and monitoring. However, there are also risks; the new drug, or even the standard treatments, could cause side effects, and it's not guaranteed to work for everyone. Before joining, the study team will explain all known potential side effects. Please remember that you always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (189)

University of Arkansas for Medical Sciences
Little Rock, United States
City of Hope
Duarte, United States
UC San Diego Medical Center
La Jolla, United States
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, United States
Stanford Women's Cancer Center
Palo Alto, United States
Kaiser Permanente Medical Center
Vallejo, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, United States
Hartford HealthCare Cancer Institute at Hartford Hospital
Hartford, United States
Yale University School of Medicine
New Haven, United States
Florida Cancer Specialists
Fort Myers, United States
University of Florida
Gainesville, United States
Baptist MD Anderson Cancer Center
Jacksonville, United States

+177 more sites — see the official record for the full list.

Common questions

What is endometrial cancer?

Endometrial cancer is a type of cancer that starts in the cells that form the lining of your womb (uterus).

What does 'platinum-based chemotherapy' mean?

This refers to cancer treatments that use drugs containing platinum, which are effective in killing cancer cells.

What is immunotherapy?

Immunotherapy is a treatment that helps your body's own immune system fight cancer.

What is a Phase 3 study?

A Phase 3 study is a later stage of research where a new treatment is compared to existing standard treatments in a larger group of people to confirm its effectiveness and safety.

Will I know which treatment I'm getting?

In some studies, participants are randomly assigned to a treatment and may not know which one they are receiving, or it might be an open study where you do know. The study team will explain this to you.