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

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

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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 FRa-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