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 Neoplasms
Summary
- Eligibility
- for females ages 18 years and up (full criteria)
- Location
- at UC Irvine UCLA UCSD
- Dates
- study startedstudy ends 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, Ovarian Neoplasms, Fallopian Tube Neoplasms, Neoplasms, mirvetuximab soravtansine, Bevacizumab, 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 5363943 California 5332921 92093 United States - University Of California Irvine Medical Center /ID# 269572
accepting new patients
Orange 5379513 California 5332921 92868 United States - Olive View-Ucla Medical Center /ID# 269584
accepting new patients
Sylmar 5400784 California 5332921 91342 United States - Kaiser Permanente - San Diego Medical Center /ID# 269540
accepting new patients
San Diego 5391811 California 5332921 92123 United States - City of Hope Orange County Lennar Foundation Cancer Center /ID# 269573
accepting new patients
Irvine 5359777 California 5332921 92618 United States - Kaiser Permanente Zion Medical Center /ID# 269537
accepting new patients
San Diego 5391811 California 5332921 92120 United States - Kaiser Permanente - San Marcos Medical Offices /ID# 269542
accepting new patients
San Marcos 5392368 California 5332921 92069 United States - John Muir Health - Walnut Creek Medical Center /ID# 269575
accepting new patients
Walnut Creek 5406990 California 5332921 94598 United States - Stanford Women'S Cancer Center /ID# 269552
accepting new patients
Palo Alto 5380748 California 5332921 94304 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