Status:
RECRUITING
Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Lead Sponsor:
AbbVie
Collaborating Sponsors:
GOG Foundation
Conditions:
Ovarian Cancer
Peritoneal Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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-sensiti...
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-killin...
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Key Trial Info
Start Date :
March 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2032
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT05445778
Start Date
March 15 2023
End Date
May 1 2032
Last Update
February 23 2026
Active Locations (264)
Enter a location and click search to find clinical trials sorted by distance.
1
Usa Mitchell Cancer Institute /ID# 269661
Mobile, Alabama, United States, 36604
2
Honorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987
Phoenix, Arizona, United States, 85016
3
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 269573
Irvine, California, United States, 92618
4
Moores Cancer Center at UC San Diego /ID# 269564
La Jolla, California, United States, 92093