Active not recruitingPHASE3INTERVENTIONAL

Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)

This research study is looking at a new medicine called sacituzumab tirumotecan for people with endometrial cancer. It's for patients whose cancer has come back or worsened after they've already had two specific types of treatment: platinum-based chemotherapy and immunotherapy. Immunotherapy is a treatment that helps your body’s own immune system fight cancer. The study aims to compare sacituzumab tirumotecan with typical chemotherapy treatments. The main goal is to find out if sacituzumab tirumotecan helps people live longer overall and if it can stop the cancer from getting worse for a longer period of time, compared to standard chemotherapy. This study is in its Phase 3 stage, which means it’s being tested on a larger group of people to confirm its effectiveness and safety.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

710

Start

06 Dec 2023

Estimated completion

10 Jan 2028

Endometrial Cancer

What is this study about?

This clinical trial is designed to investigate a new treatment for endometrial cancer, which is a type of cancer that starts in the lining of the womb. The study is particularly for people who have already undergone specific treatments for their cancer, including a type of chemotherapy called platinum-based therapy and also immunotherapy. Immunotherapy is a modern treatment that helps your body's immune system recognise and fight cancer cells more effectively.

The new medicine being tested is called sacituzumab tirumotecan. The researchers want to compare how well this new medicine works against the usual chemotherapy treatments that are given in these situations. The main things they want to learn are whether sacituzumab tirumotecan helps people live longer and if it can prevent the cancer from growing or spreading for a longer time, compared to chemotherapy.

This is a Phase 3 study, which means it's a crucial step in the development of new medicines. In this phase, a new treatment is usually compared to existing standard treatments to confirm its effectiveness, monitor side effects, and gather information that will allow it to be used safely. By taking part, you could help doctors understand more about how to treat advanced endometrial cancer.

Key takeaways

This study is for endometrial cancer that has returned or progressed after previous treatments.
It compares a new medicine (sacituzumab tirumotecan) with standard chemotherapy.
The main goal is to see if the new medicine helps people live longer and stops cancer growth for longer.
It's a Phase 3 study, meaning its findings could lead to a new standard treatment.
Participation involves regular hospital visits, close monitoring, and careful management of any side effects.

Who may be eligible?

This study is for women who have received a diagnosis of endometrial cancer, or a related type called carcinosarcoma. You must have cancer that doctors can see and measure with scans. You also need to have already been treated with platinum-based chemotherapy and a type of immunotherapy for your cancer, either together or separately.

There are also reasons why you might not be able to join. For example, if you have certain other types of cancer like neuroendocrine tumours or particular sarcomas of the womb. You also can't join if you have severe dry eyes, certain bowel conditions needing strong medication, or a history of lung inflammation (pneumonitis) that needed steroid treatment.

Finally, if your cancer has come back more than a year after finishing a platinum-based treatment that was meant to cure it, you might not be eligible. Also, if you’ve had more than three previous courses of treatment for your endometrial cancer (not counting the very first one), you would not be able to join this particular study.

Quick self-check

Do I have a diagnosis of endometrial cancer or carcinosarcoma?
Has my cancer already been treated with platinum-based chemotherapy?
Have I also received immunotherapy for my cancer?
Is my cancer visible on scans and able to be measured?
Have I had three or fewer previous courses of treatment for my endometrial cancer (excluding first-line treatment if it’s a recurrence)?

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

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic for assessments and to receive your treatment. You would be given either the new medicine, sacituzumab tirumotecan, or one of the standard chemotherapy drugs (doxorubicin, paclitaxel, or nab-paclitaxel). Doctors and nurses will monitor your health closely, including physical exams, blood tests, and scans, to see how you are responding to the treatment and to check for any side effects.

You might also receive what are called 'rescue medications' if needed, which are medicines to help manage any side effects or complications that might arise. The total duration of your participation would depend on how your cancer responds to the treatment and how you are feeling. You would have regular follow-up appointments even after you stop receiving the main study treatment, to keep an eye on your long-term health and wellbeing.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and close monitoring by a specialist medical team. While sacituzumab tirumotecan is being studied for its potential benefits, there are also potential risks, including side effects that can be mild or more serious, as with any cancer treatment. These will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care. This decision would always be respected and supported by your healthcare team.

Locations (241)

USA Mitchell Cancer Institute ( Site 4142)
Mobile, United States
Alaska Womens Cancer Care ( Site 4122)
Anchorage, United States
HonorHealth (HH) ( Site 8000)
Phoenix, United States
Arizona Oncology Associates - HOPE ( Site 8002)
Tucson, United States
UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4131)
Los Angeles, United States
California Pacific Medical Center - Van Ness Campus ( Site 4129)
San Francisco, United States
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 4114)
New Haven, United States
MedStar Washington Hospital Center ( Site 4108)
Washington D.C., United States
Mount Sinai Cancer Center ( Site 4117)
Miami Beach, United States
AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 4113)
Orlando, United States
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, United States
Northside Hospital ( Site 4112)
Atlanta, United States

+229 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 lining of the uterus (womb).

What is immunotherapy?

Immunotherapy is a treatment that uses your body's own immune system to fight cancer cells.

What does 'platinum-based chemotherapy' mean?

This is a common type of chemotherapy that uses drugs containing platinum to kill cancer cells.

Why is this study important?

This study aims to find better treatments for endometrial cancer, especially for people whose cancer has returned after previous treatments.

Will I definitely get the new medicine?

You will either receive the new medicine or standard chemotherapy. Which one you receive is usually decided by chance, like flipping a coin, so both groups can be fairly compared.