Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
- Conditions
- Ovarian CancerPeritoneal CancerFallopian Tube Cancer
- Interventions
- Registration Number
- NCT05445778
- Lead Sponsor
- AbbVie
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 520
- Adult women >/=18 years old
- Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1)
- Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive
- Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements
- 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
- Endometrioid, clear cell, mucinous, or sarconmatous histology; mixed tumors containing any of the above or low grade/borderline ovarian tumor
- More than one line of prior chemotherapy before current/planned triplet therapy
- PD (progressive disease) while on or following platinum-based therapy
- Prior or whole-pelvis or wide-field radiotherapy
- > Grade 1 peripheral neuropathy
- History of or concurrent ocular disorders
- Grade 4 thromboembolic events
- Not appropriate for bevacizumab treatment
- Requiring use of folate-containing supplements
- Prior hypersensitivity to monoclonal antibodies
- Pregnant or breatfeeding women
- Received prior MIRV or other FRα-targeting agents
- Untreated or symptomatic central nervous system metastases
- History of other malignancy within 3 years prior to signing study consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Mirvetuximab soravtansine plus Bevacizumab Mirvetuximab Soravtansine (MIRV) plus Bevacizumab Arm 2 Bevacizumab Bevacizumab monotherapy
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Assess Overall survival (OS) Up to 10 years Overall survival (OS), defined as the time from randomization to death
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.
Trial Locations
- Locations (240)
Usa Mitchell Cancer Institute /ID# 269661
🇺🇸Mobile, Alabama, United States
Honorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987
🇺🇸Phoenix, Arizona, United States
City of Hope Orange County Lennar Foundation Cancer Center /ID# 269573
🇺🇸Irvine, California, United States
Moores Cancer Center at UC San Diego /ID# 269564
🇺🇸La Jolla, California, United States
University Of California Irvine Medical Center /ID# 269572
🇺🇸Orange, California, United States
Stanford Women'S Cancer Center /ID# 269552
🇺🇸Palo Alto, California, United States
Kaiser Permanente Zion Medical Center /ID# 269537
🇺🇸San Diego, California, United States
Kaiser Permanente - San Diego Medical Center /ID# 269540
🇺🇸San Diego, California, United States
Kaiser Permanente - San Marcos Medical Offices /ID# 269542
🇺🇸San Marcos, California, United States
Olive View-Ucla Medical Center /ID# 269584
🇺🇸Sylmar, California, United States
Scroll for more (230 remaining)Usa Mitchell Cancer Institute /ID# 269661🇺🇸Mobile, Alabama, United States