A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT06890338
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Carboplatin — DRUG
    Intravenous (IV) infusion
  • Mirvetuximab Soravtansine — DRUG
    Intravenous (IV) infusion
  • Bevacizumab — DRUG
    Intravenous (IV) infusion (per investigator's discretion)

Study Details

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). 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 cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States. Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years . There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Key Dates

Start date
Nov 21, 2025
Status verified
May 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Carboplatin + Mirvetuximab Soravtansine
    Participants will receive carboplatin in combination with mirvetuximab soravtansine on Day 1 of a 21-day cycle per dose +/- Bevacizumab per investigator's discretion.

Primary Outcome Measure

Objective Response (OR) by Independent Central Review (ICR) [ Time Frame: Up to Approximately 3 years ]

Central Contacts

Locations (64)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham (UAB) Hospital /ID# 274793BirminghamAlabama35294-
Usa Mitchell Cancer Institute /ID# 276022MobileAlabama36604-
University of California Los Angeles Medical Center /ID# 274566Los AngelesCalifornia90095-
Scripps Md Anderson - Prebys Cancer Center /ID# 276891San DiegoCalifornia92103-
California Pacific Medical Center /ID# 275329San FranciscoCalifornia94109-
Ridley Tree Cancer Center /ID# 275219Santa BarbaraCalifornia93105-
Danbury Hospital, Western Connecticut Health Network /ID# 274783DanburyConnecticut06810-
Yale University School of Medicine /ID# 275794New HavenConnecticut06510-
Norwalk Hospital /ID# 274561NorwalkConnecticut06856-
Jupiter Medical Center /ID# 276616JupiterFlorida33458-
Mount Sinai Medical Center /ID# 274868Miami BeachFlorida33140
Site Coordinator
0
Rush Md Anderson Cancer Center /ID# 274926ChicagoIllinois60607-
OSF St. Francis Medical Center /ID# 274752PeoriaIllinois61637-0001-
Parkview Research Center /ID# 274338Fort WayneIndiana46845-
Indiana University Melvin and Bren Simon Cancer Center /ID# 275492IndianapolisIndiana46202-
Baptist Health Lexington /ID# 275218LexingtonKentucky40503-
Norton Cancer Institute - St. Matthews /ID# 276173LouisvilleKentucky40207-
Women'S Cancer Care /ID# 276469CovingtonLouisiana70433-
University Medical Center New Orleans /ID# 274755New OrleansLouisiana70112-
Trials 365 /ID# 274310ShreveportLouisiana71103-
University of Maryland, Baltimore /ID# 275308BaltimoreMaryland21201-
Holy Cross Hospital /ID# 275872Silver SpringMaryland20910-
University of Minnesota - Minneapolis /ID# 275718MinneapolisMinnesota55455-0341-
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780Saint Louis ParkMinnesota55416-
University Of Mississippi Medical Center /ID# 276342JacksonMississippi39216-
Cox Medical Center South /ID# 274826SpringfieldMissouri65807-
Mercy Hospital St. Louis /ID# 275655St LouisMissouri63141-
The Center Of Hope /ID# 274313RenoNevada89511-
Dartmouth-Hitchcock Medical Center /ID# 274676LebanonNew Hampshire03756-
Rutgers Cancer Institute of New Jersey /ID# 274358New BrunswickNew Jersey08901-
Holy Name Medical Center /ID# 276240TeaneckNew Jersey07666-
Optimum Clinical Research Group /ID# 274583AlbuquerqueNew Mexico87109-
Imbert Cancer Center /ID# 275634Bay ShoreNew York11706-
Northwell Health Cancer Institute At Huntington /ID# 276814GreenlawnNew York11740-
Northwell Health Center for Advanced Medicine. /ID# 275641Lake SuccessNew York11042-
Northwell Health Queens Cancer Center /ID# 274850Rego ParkNew York11374-
University of North Carolina Medical Center /ID# 275307Chapel HillNorth Carolina27514-
East Carolina University - Brody School of Medicine /ID# 275770GreenvilleNorth Carolina27834-
Atrium Health Wake Forest Baptist Medical Center /ID# 276952Winston-SalemNorth Carolina27157-
Sanford Fargo Medical Center - Fargo /ID# 275489FargoNorth Dakota58102-
Cleveland Clinic - Cleveland /ID# 276133ClevelandOhio44195-
Cleveland Clinic - Cleveland /ID# 278273ClevelandOhio44195-
Cleveland Clinic - Cleveland /ID# 278274ClevelandOhio44195-
The Mark H Zangmeister Center /ID# 275106ColumbusOhio43219-
Kettering Medical Center /ID# 274365KetteringOhio45429-
Oncology Associates of Oregon, P.C. /ID# 275006EugeneOregon97401-
Compass Oncology - West - Tigard /ID# 275101TigardOregon97223
Site Coordinator
(971) 708-7600
St. Lukes University Hospital /ID# 274362BethlehemPennsylvania18015-
University of Pennsylvania /ID# 275612PhiladelphiaPennsylvania19104-
Women & Infants Hospital /ID# 274716ProvidenceRhode Island02905-
Avera Cancer Institute - Sioux Falls /ID# 276226Sioux FallsSouth Dakota57105-
Sanford Cancer Center /ID# 274901Sioux FallsSouth Dakota57104-
Texas Oncology - Austin Central /ID# 275046AustinTexas78731-
Texas Oncology - Fort Worth Cancer Center /ID# 275043Fort WorthTexas76104-
Houston Methodist Hospital /ID# 274568HoustonTexas77030
Site Coordinator
713.441.3250
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090San AntonioTexas78240-
Texas Oncology - The Woodlands /ID# 275015The WoodlandsTexas77380-
Texas Oncology - Northeast Texas /ID# 275057TylerTexas75702-
UVA Health University Hospital /ID# 275309CharlottesvilleVirginia22903-
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 276456FairfaxVirginia22031-
Virginia Oncology Associates- Norfolk (Brock) /ID# 275227NorfolkVirginia23502-2800-
Carilion Roanoke Memorial Hospital /ID# 274684RoanokeVirginia24014-
Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585SpokaneWashington99204-
West Virginia University School of Medicine /ID# 274556MorgantownWest Virginia26506-

Find similar trials in Birmingham, AL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Alabama at Birmingham (UAB) Hospital· Birmingham, ALUsa Mitchell Cancer Institute· Mobile, ALUniversity of California Los Angeles Medical Center· Los Angeles, CAScripps Md Anderson - Prebys Cancer Center· San Diego, CACalifornia Pacific Medical Center· San Francisco, CARidley Tree Cancer Center· Santa Barbara, CA

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