Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Ovarian Cancer,Peritoneal Cancer,Fallopian Tube Cancer
Age
18+
Phase
PHASE3
Participants Needed
520
Est. Completion Date
Apr 30, 2029
Treatment Type
INTERVENTIONAL
Sponsor
AbbVie
ClinicalTrials.gov NCT Identifier
NCT05445778
Study Number
IMGN853-0421
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