Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab
AbbVie
Summary
GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine + Bevacizumab as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.
Description
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRα positivity by the Ventana FOLR1 A…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult women \>/=18 years old 2. Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer 3. Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1) 4. Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive 5. Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements 6. Negative pregnancy test and willing to use highly effective contraceptive method(s) while on study medication and for at least 7 months after…
Interventions
- DrugMirvetuximab soravtansine plus Bevacizumab
Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks
- DrugBevacizumab
Participants will receive Bevacizumab 15mg/kg every 3 weeks
Locations (264)
- Usa Mitchell Cancer Institute /ID# 269661Mobile, Alabama
- Honorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987Phoenix, Arizona
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 269573Irvine, California
- Moores Cancer Center at UC San Diego /ID# 269564La Jolla, California
- Kaiser Permanente - Los Angeles Medical Center /ID# 269541Los Angeles, California
- University Of California Irvine Medical Center /ID# 269572Orange, California