Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery

This study is open to adult women, aged 18 or older, who have recently been diagnosed with advanced ovarian cancer. This includes cancer starting in the ovaries, fallopian tubes, or the lining of the abdomen. Importantly, you must have already had surgery to remove as much of the cancer as possible, and this surgery must have been considered successful in removing most or all visible cancer tissue.

Your medical team will need to confirm the specific type of ovarian cancer you have (e.g., high-grade serous, endometrioid, or clear cell carcinoma). You also need to be well enough to receive treatment, with healthy blood counts, and your doctors will check specific blood markers, like CA-125 levels, to ensure you meet the criteria.

There are two main groups for starting treatment: if you are having surgery first, you'll start chemotherapy (with either oregovomab or placebo) within six weeks of your operation. If you had some chemotherapy before surgery, you'll start the remaining cycles (with either oregovomab or placebo) within six weeks of your surgery.

If you join this study, you will receive either the study drug oregovomab or a placebo, in addition to your standard chemotherapy (paclitaxel and carboplatin). You will receive four doses of oregovomab or placebo given into a vein over the course of your treatment. The chemotherapy typically involves six cycles, given every three weeks.

You will have regular hospital visits for your treatments and check-ups. These visits will include blood tests, physical examinations, and possibly scans to monitor your health and how the treatment is working. The total length of your participation will depend on how you respond to treatment and the study’s follow-up schedule, but typically involves continued monitoring even after your main treatments are finished.