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

UVA Tracking #
HSR230039
Principal Investigator
Linda R Duska
Contact
Contact Phone
Official Trial 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,
Study Description

The University of Virginia is participating a clinical research study for adults ages 18 and over, who have folate receptor alphas (FRa)–positive recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers. The purpose of this study is to look at the efficacy and safety of using the investigational study drug, mirvetuximab soravtansine (MIRV) in combination with bevacizumab (BEV) as maintenance therapy, compared to bevacizumab alone. Mirvetuximab Soravtansine (MIRV) is an antibody–drug conjugate targeting FRa and resulting in cancer cell cycle arrest and death.
• To determine if mirvetuximab soravtansine (MIRV) plus bevacizumab (BEV) is effective at managing your type of cancer in a maintenance setting, meaning to assess if it helps to prevent your cancer from returning or delaying your cancer’s return.
• To determine if mirvetuximab soravtansine (MIRV) plus bevacizumab (BEV) is more effective at managing your type of cancer in a maintenance setting than treatment with BEV alone.
• To find out what effects, both good and/or bad, mirvetuximab soravtansine (MIRV) plus bevacizumab (BEV) may have on you and your type of cancer.
• To assess if taking MIRV and BEV affects the quality of life, both good and/or bad.

Participation includes a screening visit, treatment visit per cycle (including CT imaging), end-of-treatment, safety follow-up visit, and a follow-up period to keep track of how you are doing. There are 2 study treatment possibilities:
• Arm 1: Mirvetuximab soravtansine (MIRV) in combination with Bevacizumab (BEV)
• Arm 2: Bevacizumab (BEV) alone

Both MIRV and BEV will be administered as in IV infusion. The length of your participation in this study depends on how your cancer responds to the study drug. It also depends on whether you have side effects from the study drug that makes you want to stop receiving it.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05445778

Compensation

No Compensation