A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)
This research is investigating new ways to treat advanced or recurrent endometrial cancer, which is a type of cancer that starts in the lining of the womb. The study is specifically for those whose cancer cells show a 'proficient mismatch repair' (pMMR) characteristic, meaning they have certain normal proteins. We're testing if a combination of two medicines, sacituzumab tirumotecan (sac-TMT) and pembrolizumab, works better than pembrolizumab by itself. Sac-TMT is a clever drug designed to find and destroy cancer cells. The main goal is to find out if patients receiving the combination treatment live longer and if their cancer is kept under control for a longer time compared to those receiving only pembrolizumab.
At a glance
What is this study about?
This study is about finding better treatments for a type of cancer that affects the womb, called endometrial cancer. This cancer can sometimes be quite serious, either because it has spread to other parts of the body (advanced) or because it has come back after previous treatment (recurrent). We're particularly interested in patients whose cancer cells have a normal repair system, which doctors call 'proficient mismatch repair' or pMMR. This is important because it helps us understand which treatments might work best.
The main idea behind this study is to test two different medicines. One is called sacituzumab tirumotecan, or sac-TMT for short. This drug is like a guided missile: it's designed to attach to specific parts of cancer cells and then deliver a dose of medicine directly to them, helping to destroy the cancer. The other medicine is pembrolizumab, which helps your own body's immune system fight the cancer. We want to see if using these two medicines together is more effective than using pembrolizumab on its own.
The main goal is to find out if people who receive the combination of sac-TMT and pembrolizumab live longer and have their cancer kept under control for a longer period, compared to those who just receive pembrolizumab. This research is a really important step in trying to improve the lives of people living with advanced or recurrent endometrial cancer.
Key takeaways
- This study is testing new treatments for advanced or recurrent womb cancer.
- It focuses on cancers with 'proficient mismatch repair' (pMMR).
- It compares a new drug combination with an existing treatment.
- The goal is to see if the new combination can help people live longer and keep cancer under control.
- Participation involves different stages of treatment and regular check-ups.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you must be an adult woman diagnosed with advanced or recurrent endometrial cancer. Your cancer must have been checked and confirmed to have 'proficient mismatch repair' (pMMR). This means your cancer cells have a normal way of fixing DNA errors. Your cancer also needs to be visible on scans and cannot have been treated much before, though some previous treatments like certain types of chemotherapy or hormone therapy might be allowed if you stopped them a while ago.
There are also some reasons why you might not be able to join. For example, if your cancer is a very specific rare type of womb cancer, or if your cancer cells show something called 'mismatch repair deficient' (dMMR), which is the opposite of what the study is looking for. You also can't join if you're able to have surgery that would completely remove all your cancer, or if you have certain other serious health issues like severe dry eyes, inflammatory bowel disease that needs strong medicines, or serious heart problems.
- I have advanced or recurrent endometrial (womb) cancer.
- My cancer has been confirmed to have 'proficient mismatch repair' (pMMR).
- I have not had much previous treatment for my endometrial cancer (some specific treatments are allowed if stopped previously).
- I do not have very rare types of womb cancer or certain other serious health conditions like severe dry eyes or inflammatory bowel disease.
- I am not a candidate for surgery that would remove all the cancer.
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you'll first go through an 'Induction Phase' for about 18 weeks (six cycles, each lasting three weeks). During this time, you'll receive the drug pembrolizumab along with standard chemotherapy drugs like carboplatin and paclitaxel or docetaxel. After this initial phase, if your cancer hasn't gotten worse, you'll then be randomly assigned to one of two groups: either you'll continue with pembrolizumab and start receiving sac-TMT, or you'll continue with pembrolizumab alone. If your cancer does get worse during the initial phase, you might still have the option to join another part of the study where you'd be randomly assigned to receive pembrolizumab with sac-TMT, or sac-TMT by itself. You'll have regular hospital visits, including physical exams, blood tests, and scans, to check how you're responding to the treatment and for any side effects. The total length of your participation will depend on how you respond to the treatment and your health, but you'll have regular follow-up for a long time.
Potential risks and benefits
Locations (253)
- University of South Alabama, Mitchell Cancer Institute ( Site 6033)Mobile, United States· Recruiting
- Alaska Women's Cancer Care ( Site 6036)Anchorage, United States· Recruiting
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020)Orange, United States· Recruiting
- John Muir Health Cancer Center ( Site 6028)Walnut Creek, United States· Recruiting
- Yale University School of Medicine ( Site 6009)New Haven, United States· Recruiting
- MedStar Washington Hospital Center ( Site 5005)Washington D.C., United States· Recruiting
- Florida Cancer Specialists - South ( Site 7003)Fort Myers, United States· Recruiting
- UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026)Gainesville, United States· Recruiting
- Mount Sinai Braman Comprehensive Cancer Center ( Site 6031)Miami Beach, United States· Recruiting
- AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 6002)Orlando, United States· Recruiting
- Florida Cancer Specialists ( Site 7002)St. Petersburg, United States· Recruiting
- Florida Cancer Specialists East ( Site 7001)West Palm Beach, United States· Recruiting
+241 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 womb (uterus). This study focuses on cases where the cancer has spread or come back after previous treatment.
What does 'proficient mismatch repair' (pMMR) mean?
pMMR means that your cancer cells have a normal way of fixing small mistakes in their DNA. This helps doctors decide which treatments might be most effective for your specific cancer.
What are sacituzumab tirumotecan (sac-TMT) and pembrolizumab?
Sac-TMT is a 'smart' drug designed to find and destroy cancer cells directly. Pembrolizumab is a drug that helps your body's immune system fight the cancer.
Will I definitely receive the new drug combination?
Initially, everyone gets a standard treatment combination. If your cancer doesn't get worse, you'll then be randomly assigned to either receive the new combination or pembrolizumab alone.
What happens if I want to stop participating?
You are free to leave the study at any time, for any reason, without it affecting your current or future medical care. Your doctors will support your decision.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
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