Informations générales (source: ClinicalTrials.gov)
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 (GLORIOSA)
Interventional
Phase 3
AbbVie (Voir sur ClinicalTrials)
décembre 2022
avril 2029
24 juin 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:07 | Contacter | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard /ID# 269418 - 69373 - Lyon CEDEX 08 - Rhone - France | Contact (sur clinicalTrials) | ||||
| CHU Brest /ID# 269422 - 29200 - Brest - Finistere - France | Contact (sur clinicalTrials) | ||||
| Chu Dijon /Id# 269417 - 21000 - Dijon - Bourgogne-Franche-Comte - France | Contact (sur clinicalTrials) | ||||
| Hôpital La Timone /ID# 269421 - 13885 - Marseille - Bouches-du-Rhone - France | Contact (sur clinicalTrials) | ||||
| Institut de cancérologie Strasbourg Europe (ICANS) /ID# 269419 - 67200 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
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
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
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