🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in Ireland / NCT05445778
Active, not recruiting Phase 3

Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

NCT05445778 · tracked via the Priya Life Science Ireland tracker
Sponsor
AbbVie
Phase
Phase 3
Started
2023-03-15
Last updated
2026-06-02

Condition(s) studied

Ovarian CancerPeritoneal CancerFallopian Tube Cancer

Investigational drug(s) / intervention(s)

Mirvetuximab soravtansine plus BevacizumabBevacizumab

Mirvetuximab soravtansine plus Bevacizumab: Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks

Bevacizumab: Participants will receive Bevacizumab 15mg/kg every 3 weeks

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (264)

FacilityCityRegionStatus
Usa Mitchell Cancer Institute /ID# 269661 Mobile Alabama
Honorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987 Phoenix Arizona
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 269573 Irvine California
Moores Cancer Center at UC San Diego /ID# 269564 La Jolla California
Kaiser Permanente - Los Angeles Medical Center /ID# 269541 Los Angeles California
University Of California Irvine Medical Center /ID# 269572 Orange California
Stanford Women'S Cancer Center /ID# 269552 Palo Alto California
Kaiser Permanente - Riverside Medical Center /ID# 269539 Riverside California
Kaiser Permanente Zion Medical Center /ID# 269537 San Diego California
Kaiser Permanente - San Diego Medical Center /ID# 269540 San Diego California
Kaiser Permanente - San Marcos Medical Offices /ID# 269542 San Marcos California
Olive View-Ucla Medical Center /ID# 269584 Sylmar California
John Muir Health - Walnut Creek Medical Center /ID# 269575 Walnut Creek California
Broward General Medical Center /ID# 269577 Fort Lauderdale Florida
Regional Cancer Center /ID# 269558 Fort Myers Florida
Baptist Md Anderson Cancer Center - Jacksonville - Palm Avenue /ID# 269560 Jacksonville Florida
Mount Sinai Medical Center /ID# 269582 Miami Florida
Sarasota Memorial Hospital /ID# 269526 Sarasota Florida
Northside Hospital /ID# 269660 Atlanta Georgia
Rush University Medical Center /ID# 269583 Chicago Illinois
University of Chicago Medical Center /ID# 269546 Chicago Illinois
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 269110 Indianapolis Indiana
St. Vincent Indianapolis Hospital /ID# 269107 Indianapolis Indiana
University of Iowa /ID# 269566 Iowa City Iowa
The University of Kansas Cancer Center - Westwood /ID# 269106 Westwood Kansas
Baptist Health Lexington /ID# 269568 Lexington Kentucky
University of Kentucky Chandler Medical Center. /ID# 269536 Lexington Kentucky
Louisiana State University Health Sciences Center - New Orleans /ID# 269559 New Orleans Louisiana
Ochsner Medical Center - Jefferson Highway /ID# 269530 New Orleans Louisiana
Maine Medical Center - Scarborough Campus /ID# 269555 Scarborough Maine
Johns Hopkins Hospital /ID# 269579 Baltimore Maryland
Sinai Hospital Of Baltimore /ID# 269567 Manchester Maryland
GBMC Cancer Center /ID# 269561 Towson Maryland
Tufts Medical Center /ID# 269547 Boston Massachusetts
Baystate Medical Center /ID# 269544 Springfield Massachusetts
Corewell Health /ID# 269562 Grand Rapids Michigan
Minnesota Oncology - Coon Rapids Clinic /ID# 269550 Coon Rapids Minnesota
Nebraska Methodist Hospital /ID# 269580 Omaha Nebraska
The Center Of Hope /ID# 269528 Reno Nevada
Dartmouth-Hitchcock Medical Center /ID# 269576 Lebanon New Hampshire

+ 224 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05445778 on ClinicalTrials.gov ↗ ← All trials in Ireland