Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AbbVie
Study ID
NCT05445778
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jul 6, 2022
Start date
Mar 15, 2023
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2032

Study Design

Enrollment
520 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Mirvetuximab Soravtansine (MIRV) plus Bevacizumab
  • Active Comparator: Arm 2
    Bevacizumab monotherapy

Primary Outcome Measure

Assess Progression-free survival (PFS) [ Time Frame: Up to 4 years ]

Locations (74)

FacilityCityStateZIPSite coordinators
Usa Mitchell Cancer Institute /ID# 269661MobileAlabama36604-
Honorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987PhoenixArizona85016-
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 269573IrvineCalifornia92618-
Moores Cancer Center at UC San Diego /ID# 269564La JollaCalifornia92093-
Kaiser Permanente - Los Angeles Medical Center /ID# 269541Los AngelesCalifornia90027-
University Of California Irvine Medical Center /ID# 269572OrangeCalifornia92868-
Stanford Women'S Cancer Center /ID# 269552Palo AltoCalifornia94304-
Kaiser Permanente - Riverside Medical Center /ID# 269539RiversideCalifornia92505-
Kaiser Permanente - San Diego Medical Center /ID# 269540San DiegoCalifornia92123-
Kaiser Permanente Zion Medical Center /ID# 269537San DiegoCalifornia92120-
Kaiser Permanente - San Marcos Medical Offices /ID# 269542San MarcosCalifornia92069-
Olive View-Ucla Medical Center /ID# 269584SylmarCalifornia91342-
John Muir Health - Walnut Creek Medical Center /ID# 269575Walnut CreekCalifornia94598-
Broward General Medical Center /ID# 269577Fort LauderdaleFlorida33316-
Regional Cancer Center /ID# 269558Fort MyersFlorida33905-
Baptist Md Anderson Cancer Center - Jacksonville - Palm Avenue /ID# 269560JacksonvilleFlorida32207-
Mount Sinai Medical Center /ID# 269582MiamiFlorida33140-
Sarasota Memorial Hospital /ID# 269526SarasotaFlorida34239-
Northside Hospital /ID# 269660AtlantaGeorgia30342-
Rush University Medical Center /ID# 269583ChicagoIllinois60612-
University of Chicago Medical Center /ID# 269546ChicagoIllinois60637-
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 269110IndianapolisIndiana46202-5116-
St. Vincent Indianapolis Hospital /ID# 269107IndianapolisIndiana46260-
University of Iowa /ID# 269566Iowa CityIowa52242-
The University of Kansas Cancer Center - Westwood /ID# 269106WestwoodKansas66205-
Baptist Health Lexington /ID# 269568LexingtonKentucky40503-
University of Kentucky Chandler Medical Center. /ID# 269536LexingtonKentucky40536-
Louisiana State University Health Sciences Center - New Orleans /ID# 269559New OrleansLouisiana70112-
Ochsner Medical Center - Jefferson Highway /ID# 269530New OrleansLouisiana70121-
Maine Medical Center - Scarborough Campus /ID# 269555ScarboroughMaine04074-
Johns Hopkins Hospital /ID# 269579BaltimoreMaryland21287-
Sinai Hospital Of Baltimore /ID# 269567ManchesterMaryland21215-
GBMC Cancer Center /ID# 269561TowsonMaryland21204-6831-
Tufts Medical Center /ID# 269547BostonMassachusetts02111-1552-
Baystate Medical Center /ID# 269544SpringfieldMassachusetts01199-
Corewell Health /ID# 269562Grand RapidsMichigan49503-
Minnesota Oncology - Coon Rapids Clinic /ID# 269550Coon RapidsMinnesota55433-
Nebraska Methodist Hospital /ID# 269580OmahaNebraska68114-
The Center Of Hope /ID# 269528RenoNevada89511-
Dartmouth-Hitchcock Medical Center /ID# 269576LebanonNew Hampshire03756-
John Theurer Cancer Center /ID# 269109HackensackNew Jersey07601-
The Valley Hospital /ID# 269548ParamusNew Jersey07652-
Holy Name Medical Center /ID# 269543TeaneckNew Jersey07666-
New York Oncology Hematology - Albany Cancer Center /ID# 269565AlbanyNew York12206-5013-
Women'S Cancer Care Associates /ID# 269553AlbanyNew York12208-
Northwell Health Center for Advanced Medicine. /ID# 269108Lake SuccessNew York11042-
Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates - Mineola /ID# 269534MineolaNew York11501-
Icahn School of Medicine at Mount Sinai /ID# 269529New YorkNew York10029-
NYU Laura and Isaac Perlmutter Cancer Center /ID# 269556New YorkNew York10016-
University of North Carolina at Chapel Hill /ID# 269563Chapel HillNorth Carolina27514-
Duke Cancer Institute /ID# 269557DurhamNorth Carolina27710-
University of Cincinnati /ID# 269578CincinnatiOhio45267-2827-
Jamescare Gynecologic Oncology At Mill Run /ID# 269105HilliardOhio43026-
Kettering Medical Center /ID# 269585KetteringOhio45429-
OU Health - Stephenson Cancer Center /ID# 269525Oklahoma CityOklahoma73104-
Oklahoma Cancer Specialists and Research Institute /ID# 269527TulsaOklahoma74146-
Willamette Valley Cancer Institute and Research Center /ID# 269988EugeneOregon97401-
Compass Oncology - Rose Quarter /ID# 270131PortlandOregon97227-
Oregon Health and Science University /ID# 269581PortlandOregon97239-
Allegheny Health Network West Penn Hospital /ID# 269551PittsburghPennsylvania15244-
University Of Pittsburgh Medical Center Magee - Womens Hospital /ID# 269659PittsburghPennsylvania15213-
Asplundh Cancer Pavilion /ID# 269574Willow GrovePennsylvania19090-
Sanford Cancer Center /ID# 269535Sioux FallsSouth Dakota57104-
West Cancer Center and Research Institute - Germantown /ID# 269569GermantownTennessee38138-
Texas Oncology - Austin Central /ID# 269531AustinTexas78731-
Texas Oncology - Bedford /ID# 269571BedfordTexas76022-
Texas Oncology - Methodist Dallas Cancer Center /ID# 269554DallasTexas75203-
Texas Oncology - Fort Worth Cancer Center /ID# 269532Fort WorthTexas76104-
US Oncology Research Investigational Products Center /ID# 278746IrvingTexas75063-
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 269549San AntonioTexas78240-
University of Virginia Health System /ID# 269545CharlottesvilleVirginia22908-0816-
Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 269533NorfolkVirginia23502-
VCU Health Adult Outpatient Pavillion /ID# 269570RichmondVirginia23219-
Swedish Cancer Institute /ID# 269538SeattleWashington98104-3588-

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