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Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT05445778.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Kansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Active
Name Not Available
New Hampshire
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Status: Active
Name Not Available
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not Available
Durham
Duke University Medical Center
Status: Active
Name Not Available
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available
Oregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
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.
