Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

This study is for women who have been diagnosed with a specific type of high-grade ovarian cancer, or cancer affecting the fallopian tubes or the lining of the abdomen. Your cancer must have continued to grow or come back after previously being treated with platinum-based chemotherapy. If you've had only one round of platinum treatment, you must have completed at least four cycles. If you've had two to four rounds, your cancer must have progressed within six months of your last platinum dose.

You would need to have had at least one, but no more than four, previous rounds of cancer-fighting treatment since your initial diagnosis. Also, you should have received a treatment called bevacizumab, unless there was a medical reason not to, and another called mirvetuximab soravtansine if your tumor had a specific marker called FRɑ, again, unless there was a medical reason not to.

However, you would not be able to join if you have certain other types of ovarian cancer (like endometrioid or clear cell types), or if your cancer is rapidly progressive after your first platinum treatment (within 3 months). You also couldn't join if you have serious heart problems, active cancer that has spread to your brain, another cancer that is currently active or needed treatment in the last three years, or significant stomach or gut issues.

If you decide to take part in this study, you would be randomly assigned to receive either the new medicine, INCB123667, or a chemotherapy chosen by your doctor based on what is generally used. Both treatments would be given according to a specific plan set out by the study.

Throughout the study, you would attend regular visits at the hospital or clinic. These visits will involve various assessments, such as physical exams, blood tests, and scans (like CT or MRI) to see how your body is responding to the treatment and to check the size of your cancer. Your doctor and the study team will monitor you closely for any side effects or changes in your health.

Before you start treatment, a sample of your tumour tissue (either an existing one from over the past 5 years or a new biopsy) would be needed. The duration of your participation would depend on how you respond to the treatment and whether you experience any side effects. After your treatment phase ends, there will typically be a follow-up period where your health continues to be monitored for a certain amount of time.