GOG-3078/GLORIOSA/IMGN853-0421

This research study is recruiting patients who have ovarian, peritoneal, or fallopian tube cancer that has come back after the first round of treatment, patients who are currently on or have recently completed a second round of treatment with “triplet therapy” (meaning, a combination treatment with a platinum agent and bevacizumab (BEV) plus one of the following: paclitaxel or gemcitabine or pegylated lysosomal doxorubicin (PLD)), patients whose tumor has tested positive for high levels of folate receptor-alpha (FRα), and whose cancer has not worsened following recent triplet therapy.

A new drug called mirvetuximab soravtansine (MIRV) is being studied as a possible maintenance treatment for this type of cancer. The study aims to determine if MIRV is effective at managing cancer in a maintenance setting, meaning to assess if it helps to prevent your cancer from returning or delaying your cancer’s return when administered after a triplet therapy regimen in combination with BEV.

If you participate in this study, you will be assigned randomly (by chance, like the flipping of a coin, a 50/50 chance) to receive either MIRV plus BEV or BEV alone as maintenance treatment.

You can stay on the study as long as you are doing well, and your cancer has not gotten worse. If you are not doing well and/or your cancer is getting worse, you will stop receiving study treatments. After you stop receiving study treatment, you will return to the clinic 30 days later to see how well you are doing. Thereafter, you will be contacted, by phone, by the study staff every 4 months (for the first 2 years) and then every 6 months (after 2 years) to see how you are and to find out what anti-cancer therapy you may be getting until the study closes. There may be additional times during the study when you will be contacted for this information.

During these visits, you will be asked to have physical and eye exams, receive the study drug, complete questionnaires, and have lab and imaging tests done.

In order to participate you must meet the following criteria:

• Have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
• Have relapsed after 1 line (first line) of platinum-based chemotherapy and are platinum-sensitive defined as progression greater than 6 months from last dose of primary platinum therapy.
• Are appropriate for, currently are on, or have completed platinum-based triplet therapy in the second line (recurrent PSOC).
• Are randomized no later than 8 weeks from the last dose of platinum-based triplet therapy in the second line.

You will be excluded from the study if any of the following criteria apply to you:

• Have endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor.
• Have had more than one line of prior chemotherapy before current/planned triplet therapy.
• Have active or chronic eye disease. (Specific diseases of the eye will be evaluated by the study nurse.)

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.