Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Mirvetuximab soravtansine plus Bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Mirvetuximab Soravtansine (MIRV) plus Bevacizumab
- interventionNames
- Drug: Mirvetuximab soravtansine plus Bevacizumab
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- Bevacizumab monotherapy
- interventionNames
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Assess Progression-free survival (PFS)
- timeFrame
- Up to 4 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 the last dose of MIRV and 6 months after the last dose of bevacizumab Exclusion Criteria: 1. Endometrioid, clear cell, mucinous, or sarconmatous histology; mixed tumors containing any of the above or low grade/borderline ovarian tumor 2. More than one line of prior chemotherapy before current/planned triplet therapy 3. PD (progressive disease) while on or following platinum-based therapy 4. Prior or whole-pelvis or wide-field radiotherapy 5. \> Grade 1 peripheral neuropathy 6. History of or concurrent ocular disorders 7. Grade 4 thromboembolic events 8. Not appropriate for bevacizumab treatment 9. Requiring use of folate-containing supplements 10. Prior hypersensitivity to monoclonal antibodies 11. Pregnant or breatfeeding women 12. Received prior MIRV or other FRα-targeting agents 13. Untreated or symptomatic central nervous system metastases 14. History of other malignancy within 3 years prior to signing study consent
References
Publications (1)
- DERIVEDO'Malley DM, Myers T, Wimberger P, Van Gorp T, Redondo A, Cibula D, Nicum S, Rodrigues M, Backes FJ, Barlin JN, Lewin SN, Lim P, Pothuri B, Diver E, Banerjee S, Lorusso D. Maintenance with mirvetuximab soravtansine plus bevacizumab vs bevacizumab in FRalpha-high platinum-sensitive ovarian cancer. Future Oncol. 2024;20(32):2423-2436. doi: 10.1080/14796694.2024.2372241. Epub 2024 Jul 31. PMID 39082675