Trials / Recruiting
RecruitingNCT05445778
Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 520 (estimated)
- Sponsor
- AbbVie · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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 Assay.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mirvetuximab soravtansine plus Bevacizumab | Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks |
| DRUG | Bevacizumab | Participants will receive Bevacizumab 15mg/kg every 3 weeks |
Timeline
- Start date
- 2023-03-15
- Primary completion
- 2027-04-01
- Completion
- 2032-05-01
- First posted
- 2022-07-06
- Last updated
- 2026-02-23
Locations
264 sites across 22 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Ireland, Israel, Italy, Japan, Philippines, Poland, South Korea, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05445778. Inclusion in this directory is not an endorsement.