Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
a study on Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer
Summary
- Eligibility
- for females ages 18 years and up (full criteria)
- Location
- at La Jolla, California and other locations
- Dates
- study startedcompletion around
Description
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.
Official Title
Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab
Details
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.
Keywords
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Platinum-sensitive, Folate-receptor alpha expression, Antibody-drug conjugate, Cancer, Ovarian Neoplasma, Recurrent Platinum-Sensitive, High-Grade Ovarian, ADC, Adult, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Hypersensitivity, Bevacizumab, Maytansine, Mirvetuximab soravtansine, Mirvetuximab soravtansine plus Bevacizumab
Eligibility
You can join if…
Open to females ages 18 years and up
- 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 CAN'T join 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
Locations
- Moores Cancer Center at UC San Diego /ID# 269564
accepting new patients
La Jolla California 92093 United States - Kaiser Permanente - San Diego Medical Center /ID# 269540
accepting new patients
San Diego California 92123 United States - Kaiser Permanente Zion Medical Center /ID# 269537
accepting new patients
San Diego California 92120 United States - Kaiser Permanente - San Marcos Medical Offices /ID# 269542
accepting new patients
San Marcos California 92069 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- AbbVie
- Links
- Related Info
- ID
- NCT05445778
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 520 study participants
- Last Updated
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