A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
This study is for women with a type of ovarian cancer called high-grade serous ovarian cancer that has returned after previous treatment. Doctors are looking for better ways to treat this condition. The study is investigating a new treatment called Raludotatug deruxtecan (R-DXd). This drug is designed to find cancer cells and deliver medicine directly to them, helping to destroy them. Researchers want to know if R-DXd is safe when given alone or with other common treatments like chemotherapy. They also want to understand how many people's cancer responds to these treatments, meaning it shrinks or goes away. The study will happen in two stages: first, finding the right dose, and then testing that dose in more people.
At a glance
What is this study about?
This research study is for women who have been diagnosed with a type of ovarian cancer called high-grade serous ovarian cancer. This means the cancer started in the cells covering the ovaries, the lining of the stomach area, or the fallopian tubes. "High-grade" means the cancer cells tend to grow and spread quite quickly. The study is specifically for those whose cancer has returned after previous treatments. When cancer comes back, doctors call this "recurrent" or "relapsed" cancer. Standard treatments for this type of cancer often include chemotherapy (drugs that kill cancer cells) or targeted therapy (drugs that focus on specific ways cancer cells grow).
The main new treatment being studied here is called Raludotatug deruxtecan, or R-DXd for short. You can think of R-DXd as a guided missile with medicine inside. It's designed to find specific proteins on the surface of cancer cells and then deliver medication directly to those cells, hopefully killing them while causing less harm to healthy cells. Researchers want to understand if R-DXd is safe to use, both on its own and when combined with other existing treatments for ovarian cancer.
Another important goal of this study is to see how well R-DXd works. They will be looking to see if the treatment causes the cancer to shrink or even disappear. This study will take place in two parts: initially, they will carefully test different doses of R-DXd to find the safest and most effective amount. Once that dose is found, more people will join the study to further confirm its safety and how well it works.
Key takeaways
- This study is for women with high-grade serous ovarian cancer that has returned.
- It's testing a new targeted drug (R-DXd) to see if it's safe and effective.
- The study aims to find better treatment options for recurrent ovarian cancer.
- It involves regular hospital visits, tests, and closely monitoring your health.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is looking for women with a specific type of ovarian cancer (high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer) that has come back. You would need to have clear signs of the cancer on scans or tests.
Whether you can join also depends on your previous treatments. For example, some parts of the study are for those whose cancer returned more than 6 months after their last platinum-based chemotherapy (meaning your cancer is 'platinum-sensitive'), while other parts are for those whose cancer came back sooner than 6 months (meaning your cancer is 'platinum-resistant'). There are also specific rules about how many previous treatments you've had, especially if you've had bevacizumab or a type of drug called PARPi.
To be considered, you'll need to be generally well enough to take part and have a tissue sample from your cancer available. If you have conditions like HIV or hepatitis, you might still be able to join if these conditions are well controlled with 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.
- I have high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
- My cancer has come back after previous treatment.
- I am generally well enough to take part in a clinical study.
- I'm willing to provide a recent tissue sample from my cancer.
- I understand there are specific rules about my previous treatments and how long ago my cancer returned, which the doctor will check.
What does participation involve?
The detailed participation requirements would be explained by the study team, but generally, this type of study involves regular hospital visits for assessments, including blood tests, scans (like CT scans), and physical examinations. You would be given the study drug, Raludotatug deruxtecan, and potentially other standard treatments, either through an injection or as tablets, according to a set schedule. There would also be follow-up appointments to monitor your health and how you respond to the treatment. The total duration of your involvement would depend on how your cancer responds to the treatment and the specific part of the study you are in.
Potential risks and benefits
Locations (20)
- The University of Louisville, James Graham Brown Cancer Center ( Site 0009)Verified postcodeLouisville, United States· Recruiting
- Dana-Farber Cancer Institute ( Site 0015)Verified postcodeBoston, United States· Recruiting
- Memorial Sloan Kettering Cancer Center ( Site 0003)Verified postcodeNew York, United States· Recruiting
- OU Health University of Oklahoma Medical Center ( Site 7000)Verified postcodeOklahoma City, United States· Recruiting
- Houston Methodist Hospital ( Site 0010)Verified postcodeHouston, United States· Recruiting
- START Mountain Region ( Site 0008)Verified postcodeWest Valley City, United States· Recruiting
- University of Virginia Health System ( Site 0011)Verified postcodeCharlottesville, United States· Recruiting
- Rambam Health Care Campus ( Site 0202)Verified postcodeHaifa, Israel· Recruiting
- Shaare Zedek Medical Center ( Site 0201)Verified postcodeJerusalem, Israel· Recruiting
- Sheba Medical Center ( Site 0200)Verified postcodeRamat Gan, Israel· Recruiting
- Institut Català d'Oncologia - L'Hospitalet ( Site 0302)Verified postcodeL'Hospitalet de Llobregat, Spain· Recruiting
- HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0307)UnverifiedMajadhonda, Spain· Recruiting
Common questions
What is 'high-grade serous ovarian cancer'?
This is a common type of ovarian cancer that tends to grow and spread relatively quickly. It can start in the ovaries, fallopian tubes, or the lining of the abdomen.
What does 'recurrent' or 'relapsed' mean?
It means the cancer has come back after you have already had treatment for it.
What is Raludotatug deruxtecan (R-DXd)?
It's a study drug designed to find cancer cells and deliver medicine directly to them to destroy them, like a targeted guided missile.
Will I definitely get the new drug if I join?
This study tests R-DXd by itself or with other treatments. The study team will explain exactly which treatment group you would be in.
How long will I be in the study?
The length of your participation will depend on your response to treatment and the specific part of the study you join. The study team will provide more details.
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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