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

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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

Yes

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

Angeles
Secord

Protocol Number

PRO00112108

NCT ID

NCT05445778

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov