This clinical trial is focused on studying a type of cancer known as platinum-resistant ovarian cancer. This condition occurs when ovarian cancer does not respond to treatments that contain platinum, a common component in chemotherapy. The study will compare the effects of a new treatment called rinatabart sesutecan (Rina-S) with other treatments chosen by the doctors involved in the study. The goal is to see which treatment helps patients live longer without the cancer getting worse.
Participants in the study will receive either Rina-S or one of several other treatments, which may include topotecan, glatiramer acetate, paclitaxel, doxorubicin hydrochloride, or gemcitabine hydrochloride. These treatments are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The study will last for up to 36 months, during which time the participants’ health and response to the treatment will be closely monitored.
The purpose of the study is to determine how well Rina-S works compared to the other treatments in terms of delaying the progression of the cancer. The study will also look at other important factors, such as overall survival, the response of the cancer to the treatment, and the quality of life of the participants. This information will help doctors understand the best ways to treat platinum-resistant ovarian cancer in the future.
1joining the study
Upon joining the study, you will be randomly assigned to receive either the experimental treatment, rinatabart sesutecan (Rina-S), or a treatment chosen by the study doctor. This is to compare the effectiveness of the new treatment against standard options.
2treatment administration
If you are assigned to the Rina-S group, you will receive the medication through an intravenous infusion. This means the medicine will be given directly into your vein using a needle.
If you are assigned to the treatment of the investigator’s choice, the specific medication and method of administration will be explained to you by the study doctor. This could include medications like topotecan, paclitaxel, doxorubicin hydrochloride, or gemcitabine hydrochloride, which are also given through intravenous infusion.
3monitoring and follow-up
Throughout the study, your health will be closely monitored. This includes regular check-ups and tests to assess how the treatment is affecting your condition and overall health.
You will be asked to complete questionnaires about your quality of life and any symptoms you experience. This helps the study team understand the impact of the treatment on your daily life.
4end of treatment
The treatment phase will continue until the study doctor determines it is time to stop, based on your health and the study’s guidelines.
After the treatment ends, there will be a follow-up period where your health will continue to be monitored to gather additional information about the long-term effects of the treatment.
Who Can Join the Study?
Participants must have a confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This means the cancer has been identified through specific medical tests.
Participants can join the study regardless of their level of FRα expression. FRα is a protein that may be present in cancer cells.
Participants must have received between 1 to 4 previous treatments for their cancer.
Participants must have previously been treated with platinum chemotherapy, a common cancer treatment using drugs containing the metal platinum.
Participants must have received bevacizumab treatment if it is standard care at their treatment center, unless they have a medical reason not to use it.
Participants with certain BRCA gene mutations who responded to platinum-based chemotherapy must have been treated with a PARP inhibitor, a type of drug used to treat cancers with these mutations, unless they are not eligible for it.
If available in their region, participants must have been treated with mirvetuximab soravtansine if they have a positive FRα expression and no medical reasons preventing its use, such as certain eye conditions.
Participants must have platinum-resistant disease, meaning their cancer did not respond to platinum-based treatments as expected. Specific criteria apply based on the number of platinum-based treatments received.
Participants must be female.
Who Cannot Join the Study?
Patients who are not diagnosed with platinum-resistant ovarian cancer cannot participate. This means the cancer does not respond to treatments containing platinum.
Only female patients can participate. Male patients are not eligible.
Patients who are part of a vulnerable population are not eligible. This generally refers to groups who may have limited ability to give informed consent or are at higher risk of being exploited.
Rinatabart Sesutecan (Rina-S) is a medication being studied for its potential to help patients with ovarian cancer that has not responded to platinum-based treatments. This medication is designed to target and attack cancer cells, potentially slowing down the progression of the disease. In this clinical trial, researchers are comparing the effects of Rina-S to other treatments chosen by the doctors involved in the study. The goal is to see if Rina-S can help patients live longer without their cancer getting worse.
Platinum-resistant Ovarian Cancer – Platinum-resistant ovarian cancer is a type of ovarian cancer that does not respond to platinum-based chemotherapy treatments. This form of cancer typically occurs when the disease returns or progresses within six months after completing platinum-based therapy. The cancer cells in this condition have developed resistance to the effects of platinum drugs, making them less effective. As the disease progresses, patients may experience symptoms such as abdominal pain, bloating, and changes in bowel habits. The cancer can spread to other parts of the body, including the pelvis and abdomen. Managing this condition often involves exploring alternative treatment options to control the disease’s progression.
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