A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
This research is looking for better ways to treat cervical cancer that has spread to other parts of the body (this is called metastatic cervical cancer). The study is testing a new medicine called sacituzumab tirumotecan (sac-TMT) in combination with existing treatments, pembrolizumab and possibly bevacizumab. Sac-TMT is a smart medicine designed to target and destroy cancer cells. Researchers want to find out if these combinations are safe and if they can help women live longer or prevent their cancer from growing. Women will first receive standard treatment, and if their cancer doesn't get worse, they may be offered one of the study's maintenance treatments.
At a glance
What is this study about?
Cervical cancer happens in the cervix, which is the lower part of the womb. When cervical cancer spreads to other parts of the body, it's called metastatic. This study is for women with metastatic cervical cancer that cannot be cured by surgery or radiation. Doctors are always looking for new and better ways to treat cancer, and this trial is exploring a new approach.
The main aim of this study is to see if a newer medicine, sacituzumab tirumotecan (sac-TMT), combined with other common treatments like pembrolizumab and sometimes bevacizumab, can be effective. Sac-TMT is a special type of medicine called an antibody-drug conjugate. Think of it like a smart bomb: it’s designed to find and attach to specific parts of cancer cells, then deliver a powerful drug directly to destroy them, while hopefully causing less harm to healthy cells. We want to know if these combinations are safe to use together and if they can help people live longer, or stop their cancer from getting worse compared to standard treatments.
This study is split into two parts. In the first part, a small group of participants will receive sac-TMT, pembrolizumab, and bevacizumab to make sure the combination is safe. In the second part, all participants will first receive standard initial cancer treatment. If their cancer is stable after this, they will then be randomly assigned to receive either pembrolizumab alone or the combination of sac-TMT and pembrolizumab as a longer-term (maintenance) treatment. Some women in the second part might also receive bevacizumab, depending on what their doctor thinks is best for them. By comparing these groups, doctors hope to understand which treatment approach is most beneficial.
Key takeaways
- This study is for women with advanced cervical cancer that has already spread.
- It tests new combinations of a 'smart' drug (sac-TMT) with existing treatments.
- The goal is to find safer and more effective ways to control the cancer.
- Participation involves initial standard treatment, then potentially new maintenance treatments.
- You'll have regular medical checks throughout the study.
- You can stop participating at any time.
Who may be eligible?
To join this study, you would generally need to be a woman aged 18 or older with cervical cancer that has been confirmed by a doctor. This cancer must be either still present after treatment, have come back, or be newly diagnosed as metastatic (meaning it has spread) to other parts of your body. Importantly, your cancer should not be treatable with surgery or radiation.
There are also some health checks. For example, if you have HIV, hepatitis B, or hepatitis C, these conditions would need to be well controlled with treatment. Your general health and how well you can do daily activities (known as your performance status) also play a part. Doctors will also check specific features of your cancer cells to see if they match the study criteria.
However, some things would prevent you from joining. This includes certain types of severe eye problems, active inflammatory bowel disease, or serious heart or brain conditions that are not well controlled. You also couldn't join if you’ve recently had other cancer treatments (apart from what’s allowed in the study) or if you have certain other serious medical conditions or certain types of additional cancers that are actively growing or needing treatment.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Have I been diagnosed with cervical cancer that has spread?
- Is my cervical cancer not treatable with surgery or radiation?
- Do I have any severe, active medical conditions like certain eye, bowel, heart, or brain diseases?
- Have I recently received other cancer treatments that might exclude me?
- Am I aged 18 or older?
What does participation involve?
If you decide to take part, the study involves two main parts. In the first part, a small group will receive sac-TMT, pembrolizumab, and bevacizumab. In the second part, everyone starts with standard initial cancer treatment. If your cancer doesn't get worse after this, you'll then be randomly assigned to get either pembrolizumab alone or sac-TMT plus pembrolizumab as a maintenance treatment. Depending on your doctor's decision, you might also receive bevacizumab.
Taking part means you'll have regular hospital visits for treatments, check-ups (including blood tests and scans) to monitor your health and how the treatment is working. The exact number of visits and the total length of your participation would be explained in detail by the study team, as it depends on whether you're in the first or second part of the study and how your body responds to the treatment. There will also be a follow-up period after your treatment finishes to monitor your long-term health.
Potential risks and benefits
Locations (138)
- Mount Sinai Comprehensive Cancer Center ( Site 6000)Verified postcodeMiami Beach, United States· Recruiting
- Florida Cancer Specialists - East ( Site 7000)Verified postcodeWest Palm Beach, United States· Recruiting
- Winship Cancer Institute of Emory University ( Site 5005)Verified postcodeAtlanta, United States· Recruiting
- Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005)Verified postcodeSavannah, United States· Recruiting
- TRIALS 365 ( Site 6008)Verified postcodeShreveport, United States· Recruiting
- Minnesota Oncology Hematology, PA ( Site 8003)Verified postcodeEdina, United States· Recruiting
- Women's Cancer Center of Nevada ( Site 6011)Verified postcodeLas Vegas, United States· Recruiting
- Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)Verified postcodeNew York, United States· Recruiting
- Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001)Verified postcodeTulsa, United States· Recruiting
- Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)Verified postcodeEugene, United States· Recruiting
- Women & Infants Hospital ( Site 6003)Verified postcodeProvidence, United States· Recruiting
- University of Tennessee Medical Center ( Site 6012)Verified postcodeKnoxville, United States· Recruiting
Common questions
What is metastatic cervical cancer?
It's cervical cancer that has spread from the cervix to other parts of your body.
What is sac-TMT?
It's a newer 'smart' medicine (antibody-drug conjugate) designed to target and destroy cancer cells more precisely.
Will I definitely get the new maintenance treatment?
In Part 2, after initial standard treatment, you'll be randomly assigned to either pembrolizumab alone or sac-TMT plus pembrolizumab. It's like flipping a coin for which group you're in.
Who is funding this research?
The trial is sponsored by Merck, Sharp & Dohme LLC, known as MSD outside the US and Canada.
What does 'maintenance treatment' mean?
It's treatment given for a longer period after initial therapy, to prevent the cancer from growing or coming back.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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