A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
Researchers are exploring new treatments for advanced ovarian cancer. After initial surgery and chemotherapy, many women receive maintenance treatment to prevent the cancer from returning or growing. This study is testing if a new targeted therapy, called sacituzumab tirumotecan (sac-TMT), either alone or with another standard drug called bevacizumab, can extend the time before the cancer worsens. This is compared to current standard care options, which include bevacizumab maintenance or close observation. The aim is to find out if sac-TMT can help women live longer without their cancer progressing, for those whose cancer has responded well to their first round of treatment.
At a glance
What is this study about?
When someone is diagnosed with ovarian cancer, doctors often try to remove as much of the cancer as possible with surgery. After surgery, chemotherapy is typically given to kill any remaining cancer cells. The next step is often to keep the cancer from coming back or growing, and this is where this study comes in.
Currently, after chemotherapy, some people receive maintenance treatment, which is like a protective shield designed to keep the cancer at bay. Bevacizumab is a common maintenance drug. Other times, doctors might just keep a close eye on the cancer with regular check-ups. This study is trying to understand if a new medicine, called sacituzumab tirumotecan (sac-TMT), can be a better maintenance treatment.
Sac-TMT is a type of targeted therapy, which means it's designed to specifically attack cancer cells while trying to leave healthy cells alone. The main goal of this research is to see if giving sac-TMT, either by itself or along with bevacizumab, helps women with ovarian cancer live longer without their cancer getting worse, compared to the usual treatments. This is especially for women whose cancer has responded well to their first set of treatments.
Key takeaways
- This study is testing a new drug for advanced ovarian cancer after initial treatment.
- It aims to see if sac-TMT (a targeted therapy) can keep cancer from worsening longer.
- Participation involves receiving either the new drug or standard care, assigned by chance.
- This is a Phase 3 trial, meaning it's a large study comparing the new treatment to existing ones.
- It's for women whose cancer responded well to their first round of chemotherapy.
- You have the right to leave the study at any time.
Who may be eligible?
This study is looking for women who have advanced ovarian cancer, or similar cancers of the fallopian tube or peritoneum, that has been confirmed by a doctor. You would need to have already had surgery and completed your first course of chemotherapy, and your cancer should have responded well to that treatment – meaning it’s stable, partly gone, completely gone, or not detectable.
There are also some important health checks. For example, if you have HIV, it needs to be well-controlled. Similar rules apply if you have hepatitis B or C – these conditions need to be managed and not active. You would also need to provide a sample of your tumor tissue that hasn't been treated with radiation before.
However, there are reasons why you might not be able to join. For instance, if your cancer is a very specific type (like certain low-grade or borderline tumors), or if you have cancer that has spread to your brain or spinal cord. Other health conditions like severe eye disease, active inflammatory bowel disease needing strong medication, or serious, uncontrolled heart or blood vessel problems would also prevent you from taking part. You also can’t have had systemic cancer treatment (other than your initial chemotherapy) or certain vaccinations recently, or another type of active cancer or serious infection.
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 advanced ovarian, fallopian tube, or peritoneal cancer?
- Have I completed surgery and my first course of platinum-based chemotherapy?
- Has my cancer responded well to my first chemotherapy (stable, getting better, or undetectable)?
- Do I have any other serious uncontrolled health conditions like heart problems or active inflammatory bowel disease?
- Do I have any cancer spread to my brain or spinal cord?
- Am I over 18 years old and female?
What does participation involve?
If you decide to take part in this study, you would first go through a screening process to make sure the study is right for you. This might involve additional hospital visits, more tests, and discussions with the study team. Once enrolled, you would receive either the study medicine (sac-TMT, with or without bevacizumab) or standard care, which could be bevacizumab or observation, depending on which group you are assigned to. This is done by chance, like flipping a coin. You'll need regular appointments, usually at the clinic, for check-ups, blood tests, and to receive your treatment. Doctors will closely monitor your health and how your cancer is responding. The duration of your participation will vary depending on your treatment plan and how your body responds. The study team will explain the full schedule of visits and assessments to you in detail.
Potential risks and benefits
Locations (99)
- Mount Sinai Cancer Center ( Site 0029)Verified postcodeMiami Beach, United States· Recruiting
- Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)Verified postcodeOrlando, United States· Recruiting
- Winship Cancer Institute of Emory University ( Site 0037)Verified postcodeAtlanta, United States· Recruiting
- Parkview Research Center at Parkview Regional Medical Center ( Site 0055)Verified postcodeFort Wayne, United States· Recruiting
- Women's Cancer Care ( Site 0018)Verified postcodeCovington, United States· Recruiting
- Nebraska Methodist Hospital ( Site 0004)Verified postcodeOmaha, United States· Recruiting
- University Of Nebraska Medical Center ( Site 0035)Verified postcodeOmaha, United States· Recruiting
- Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)Verified postcodeTulsa, United States· Recruiting
- West Cancer Center and Research Institute ( Site 0013)Verified postcodeGermantown, United States· Recruiting
- Instituto Alexander Fleming ( Site 2902)City onlyCiudad Autónoma de Buenos Aires, Argentina· Recruiting
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)Verified postcodeMar del Plata, Argentina· Recruiting
- Fundación Respirar ( Site 2912)Verified postcodeBuenos Aires, Argentina· Recruiting
Common questions
What is 'advanced ovarian cancer'?
Advanced ovarian cancer means the cancer has spread beyond the ovaries and may have reached other parts of the body.
What is a 'targeted therapy'?
A targeted therapy is a type of medicine that specifically attacks certain parts of cancer cells, aiming to cause less harm to healthy cells.
What is 'maintenance treatment'?
After initial treatment like surgery and chemotherapy, maintenance treatment is given to help keep the cancer from growing, spreading, or coming back.
Will I definitely receive the new medicine?
No, participants are randomly assigned to either receive the new study medicine (with or without bevacizumab) or standard care, such as bevacizumab or observation.
How long would I be in the study?
The length of time you'd be involved in the study can vary depending on your treatment plan and how your cancer responds. The doctors will explain this to you.
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?
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