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

Running, not enrolling · Phase 3

Conditions studied: Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

In brief

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.

Key facts

Study ID

NCT05445778

Run by

AbbVie

People needed

520

Starts

2023-03-15

Expected to finish

2032-05-01

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Kaiser Permanente - Los Angeles Medical Center /ID# 269541 — Los Angeles, 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 - Riverside Medical Center /ID# 269539 — Riverside, 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
• John Muir Health - Walnut Creek Medical Center /ID# 269575 — Walnut Creek, California, United States
• Broward General Medical Center /ID# 269577 — Fort Lauderdale, Florida, United States
• Regional Cancer Center /ID# 269558 — Fort Myers, Florida, United States
• Baptist Md Anderson Cancer Center - Jacksonville - Palm Avenue /ID# 269560 — Jacksonville, Florida, United States
• Mount Sinai Medical Center /ID# 269582 — Miami, Florida, United States
• Sarasota Memorial Hospital /ID# 269526 — Sarasota, Florida, United States
• Northside Hospital /ID# 269660 — Atlanta, Georgia, United States
• Rush University Medical Center /ID# 269583 — Chicago, Illinois, United States
• University of Chicago Medical Center /ID# 269546 — Chicago, Illinois, United States
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 269110 — Indianapolis, Indiana, United States
• St. Vincent Indianapolis Hospital /ID# 269107 — Indianapolis, Indiana, United States
• University of Iowa /ID# 269566 — Iowa City, Iowa, United States
• The University of Kansas Cancer Center - Westwood /ID# 269106 — Westwood, Kansas, United States
• Usa Mitchell Cancer Institute /ID# 269661 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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