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:<ul>
<li>Are diagnosed with high-grade serous epithelial ovarian or fallopian tube cancer</li>
<li>Have relapsed after 1 line of platinum-based chemotherapy</li></ul>
For more information about who can be in this study, please contact the study team at 919-684-3780.
<li>Are diagnosed with high-grade serous epithelial ovarian or fallopian tube cancer</li>
<li>Have relapsed after 1 line of platinum-based chemotherapy</li></ul>
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?
If you agree to be in this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>One group of participants will get a maintenance study drug regimen of MIRV + BEV</li>
<li>The other group of participants will get BEV on its own</li></ul>
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.
<li>One group of participants will get a maintenance study drug regimen of MIRV + BEV</li>
<li>The other group of participants will get BEV on its own</li></ul>
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