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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
520
Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks
Participants will receive Bevacizumab 15mg/kg every 3 weeks
Usa Mitchell Cancer Institute /ID# 269661
Mobile, Alabama, United States
RECRUITINGHonorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987
Phoenix, Arizona, United States
RECRUITINGCity of Hope - Orange County Lennar Foundation Cancer Center /ID# 269573
Irvine, California, United States
COMPLETEDMoores Cancer Center at UC San Diego /ID# 269564
La Jolla, California, United States
Assess Progression-free survival (PFS)
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
Time frame: Up to 4 years
Assess Overall survival (OS)
Overall survival (OS), defined as the time from randomization to death
Time frame: Up to 10 years
Assess Safety and tolerability
Adverse events (AEs) will be evaluated according to the NCI CTCAE v5
Time frame: Up to 10 years
Assess time to second disease progression (PFS2)
Second disease progression (PFS2) defined as the time from date of randomization until second disease progression or death, whichever occurs first
Time frame: Up to 10 years
Assess Objective Response Rate (ORR)
Objective response includes best response of complete response (CR) or partial response (PR).
Time frame: Up to 10 years
Assess Duration of response (DOR)
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"
Time frame: Up to 10 years
Assess Disease-free survival (DFS)
DOR as assessed by the investigator and by BICR in patients who have no measurable disease per RECIST v1.1 at randomization
Time frame: Up to 10 years
CA-125 response
Serum CA-125 response determined using the GCIG criteria
Time frame: Up to 10 years
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).
A questionnaire assessing the health of patients with ovarian cancer.
Time frame: Up to 10 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University Of California Irvine Medical Center /ID# 269572
Orange, California, United States
RECRUITINGStanford Women'S Cancer Center /ID# 269552
Palo Alto, California, United States
COMPLETEDKaiser Permanente Zion Medical Center /ID# 269537
San Diego, California, United States
RECRUITINGKaiser Permanente - San Diego Medical Center /ID# 269540
San Diego, California, United States
RECRUITINGKaiser Permanente - San Marcos Medical Offices /ID# 269542
San Marcos, California, United States
RECRUITINGOlive View-Ucla Medical Center /ID# 269584
Sylmar, California, United States
COMPLETED...and 250 more locations