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
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
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