Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Conditions
Keywords
Platinum-sensitive, Folate-receptor alpha expression, Antibody-drug conjugate, Cancer, Ovarian Neoplasma, Recurrent Platinum-Sensitive, High-Grade Ovarian, ADC, Adult
Brief 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.
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
Sponsors
AbbVie
GOG Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess Progression-free survival (PFS) | Up to 4 years | Progression-free survival defined as assessed by BICR per RECIST v1.1, defined as the time from date of randomization until BICR-assessed PD or death due to any cause, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Overall survival (OS) | Up to 10 years | Overall survival (OS), defined as the time from randomization to death |
| Assess Safety and tolerability | Up to 10 years | Adverse events (AEs) will be evaluated according to the NCI CTCAE v5 |
| Assess time to second disease progression (PFS2) | Up to 10 years | Second disease progression (PFS2) defined as the time from date of randomization until second disease progression or death, whichever occurs first |
| Assess Objective Response Rate (ORR) | Up to 10 years | Objective response includes best response of complete response (CR) or partial response (PR). |
| Assess Duration of response (DOR) | Up to 10 years | DOR as assessed by the investigator and by BICR in patients who have measurable disease per RECIST v1.1 at randomization and achieved a confirmed response of CR or PR after maintenance therapy" |
| Assess Disease-free survival (DFS) | Up to 10 years | DOR as assessed by the investigator and by BICR in patients who have no measurable disease per RECIST v1.1 at randomization |
| CA-125 response | Up to 10 years | Serum CA-125 response determined using the GCIG criteria |
| Patient-reported outcome health-related quality of life (HRQoL) of disease-related symptoms using the NCCN-FACT Ovarian Symptom Index (NFOSI-18) DRS-P (disease-related symptom subscale - physical). | Up to 10 years | A questionnaire assessing the health of patients with ovarian cancer. |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Ireland, Israel, Italy, Japan, Philippines, Poland, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed