GOG-3078 Immunogen IMGN853-0421 (Ovarian and Fallopian Tube Cancers)

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug combination of mirvetuximab (MIRV) plus bevacizumab (BEV) is more effective at managing platinum-sensitive ovarian and fallopian tube cancers in a maintenance setting than bevacizumab on its own.

What is the Condition Being Studied?

Recurrent, Platinum-Sensitive Ovarian and Fallopian Tube Cancers

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with high-grade serous epithelial ovarian or fallopian tube cancer
  • Have relapsed after 1 line of platinum-based chemotherapy

For more information about who can be in this study, please contact the study team at 919-684-3780.

Age Group
Adults

What is Involved?

If you agree to be in this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:

  • One group of participants will get a maintenance study drug regimen of MIRV + BEV
  • The other group of participants will get BEV on its own

If you are assigned to the MIRV + BEV group, you will receive an infusion of MIRV followed by an infusion of BEV once every 3 weeks. If you are assigned to the BEV alone group, you will receive an infusion of BEV every 3 weeks.

You can remain enrolled in the study for as long as you and your doctor feel that you are getting a positive benefit from your study regimen.

Study Details

Full Title
Randomized, multicenter, open-label, phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FR?-positive recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second line platinum-based chemotherapy plus bevacizumab
Principal Investigator
Professor of Obstetrics and Gynecology
Protocol Number
IRB: PRO00112108
NCT: NCT05445778
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL
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