A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)
This important study is for women who have ovarian, fallopian tube, or primary peritoneal cancer that has come back after platinum-based chemotherapy and is considered 'platinum-sensitive'. Researchers are investigating a new treatment named sacituzumab tirumotecan, which may be given alongside another medicine called bevacizumab. The main goals are to find out if this new treatment combination is safe for patients and how well their bodies can handle it. Crucially, the study also aims to discover if women receiving sacituzumab tirumotecan (with or without bevacizumab) live longer without their cancer growing or spreading when compared to those receiving the usual care. This is a Phase 3 study, meaning it's a large trial following earlier successful research.
At a glance
What is this study about?
This study is designed for women who have ovarian, fallopian tube, or primary peritoneal cancer. These are cancers that start in the ovaries, fallopian tubes, or the lining of the abdomen. Specifically, it's for those whose cancer has returned after initial treatment with platinum-based chemotherapy and is still thought to respond to platinum treatments – this is often called 'platinum-sensitive' cancer.
The main idea behind this research is to test a new treatment called sacituzumab tirumotecan. In some cases, this new medicine might be given together with another drug called bevacizumab. The research team wants to understand two key things: first, how safe these treatments are and whether people can take them without too many problems. Second, they want to see if people who receive sacituzumab tirumotecan (with or without bevacizumab) live longer without their cancer growing or spreading, compared to those who receive the standard, usual care for their condition.
By comparing these different approaches, the researchers hope to find out if sacituzumab tirumotecan could be a better way to manage this type of cancer and potentially offer a new treatment option for patients in the future. This is a 'Phase 3' study, which means it’s a detailed, large-scale investigation that comes after promising results in earlier, smaller studies.
Key takeaways
- This study is for recurrent ovarian, fallopian tube, or primary peritoneal cancer.
- It is for cancer types described as 'platinum-sensitive'.
- It tests a new drug, sacituzumab tirumotecan, possibly with bevacizumab, against standard care.
- The main goals are to check safety and if the new drug helps people live longer without their cancer worsening.
- Eligibility depends on specific cancer type, previous treatments, and general health.
- You can discuss this study with your cancer doctor to see if it's right for you.
Who may be eligible?
This study is for women aged 18 and over. To join, you must have certain types of ovarian, fallopian tube, or primary peritoneal cancer that has been confirmed by a lab test. Your cancer should have responded to previous platinum-based chemotherapy and be considered 'platinum-sensitive' – meaning it's likely to respond to platinum-based treatments again. You should also generally be well enough to take part in a study like this, as assessed by your doctor, and able to provide a tissue sample from your cancer.
There are also reasons why you might not be able to join. For example, if you have certain rare types of ovarian cancer, if your cancer is 'platinum-resistant' (meaning it doesn't respond well to platinum treatments), or if you have certain other serious health problems like very bad dry eyes, active inflammatory bowel disease, or severe heart or brain conditions that are not well controlled.
- Are you 18 years old or older?
- Do you have ovarian, fallopian tube, or primary peritoneal cancer that has returned?
- Was your cancer previously treated with platinum-based chemotherapy and described as 'platinum-sensitive'?
- Are you generally well and active enough for a clinical study?
- Do you not have certain other serious health conditions like severe inflammatory bowel disease or uncontrolled heart/brain problems?
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 will be assigned to receive either the new study treatment (sacituzumab tirumotecan, possibly with bevacizumab) or the standard, usual treatment for your cancer. You'll have regular hospital visits, where you'll receive your medication, have physical exams, and provide blood and urine samples. You might also have scans or other tests to monitor your health and how the treatment is working. Some medicines, like anti-allergy drugs and steroids, might be given to help prevent or manage side effects. The total length of your participation, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (168)
- University of Alabama at Birmingham ( Site 0006)Birmingham, United States· Recruiting
- Alaska Women's Cancer Care ( Site 0096)Anchorage, United States· Recruiting
- Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)New Haven, United States· Recruiting
- Mount Sinai Cancer Center ( Site 0078)Miami Beach, United States· Recruiting
- Sarasota Memorial Hospital ( Site 0075)Sarasota, United States· Recruiting
- Florida Cancer Specialists East ( Site 7000)West Palm Beach, United States· Recruiting
- Winship Cancer Institute of Emory University ( Site 0086)Atlanta, United States· Recruiting
- Augusta University - Georgia Cancer Center ( Site 0066)Augusta, United States· Recruiting
- Parkview Research Center at Parkview Regional Medical Center ( Site 0003)Fort Wayne, United States· Recruiting
- Women's Cancer Care ( Site 0067)Covington, United States· Recruiting
- Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008)Scarborough, United States· Recruiting
- St. Dominic's Hospital ( Site 0064)Jackson, United States· Active not recruiting
+156 more sites — see the official record for the full list.
Common questions
What does 'platinum-sensitive' mean?
It means your cancer responded well to previous chemotherapy that included platinum-based drugs, and it's likely to respond to them again.
What is the new treatment called?
The new treatment being studied is called sacituzumab tirumotecan, which might be given with bevacizumab.
Will I definitely get the new treatment?
Not necessarily. Participants will be assigned to either receive the new study treatment or the standard, usual care.
How long will I be in the study?
The duration of your participation, including treatment and follow-up, will be fully explained by the study team.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and it will not affect your future medical care.
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
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.