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NCT07059845RecruitingPhase 2

A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer

A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay. Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 3 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 participants will be enrolled in the study at 100 sites around the world. Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused carboplatin and Bev, or IV infused Bev alone. The total study duration will be approximately 40 months. 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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
400 (estimated)
First submitted
2 Jul 2025
Start date
13 Nov 2025
Primary completion date
31 Jan 2029
Lead sponsor
AbbVie
NCT number
NCT07059845
EU CT number
2025-521606-18-00
EudraCT number
2025-521606-18

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 400
  • From 13 Nov 2025 to the primary completion date, 31 Jan 2029
  • 87 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.
  • Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor (PARPi).
    • Substudy 2
  • More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:
    • Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.
    • Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).
    • If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy
    • Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)
  • Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.
    • Substudy 3
  • More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:
    • Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.
    • Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).
    • If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy
    • Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)
  • Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.

Other illness

  • Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.

Other

  • Substudy 1

Who the study is looking for

  • Substudy 1
  • Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \>= 50% of viable tumor cells with \>= 2+ staining intensity.
  • Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
  • 1L participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
    • 2L participants must have platinum-sensitive high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of most recent platinumbased chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.
  • Participant has a local homologous recombination deficient (HRD) or breast cancer susceptibility gene (BRCA) test result available. Participants with BRCA wild-type will need to have a local HRD test result available.
    • Substudy 2
  • Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \>= 50% of viable tumor cells with \>= 2+ staining intensity.
  • Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
  • Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.
  • Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.
  • Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.
    • Substudy 3
  • Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \>= 50% of viable tumor cells with \>= 2+ staining intensity.
  • Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
  • Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.
  • Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.
  • Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (87)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Burnside War Memorial Hospital /ID# 277602
Coordinator of this site? Confirm its status
AdelaideAustraliaRecruiting
Icon Cancer Centre Wesley /ID# 277199
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AuchenflowerAustraliaRecruiting
Monash Health - Monash Medical Centre - Clayton /ID# 276984
Coordinator of this site? Confirm its status
ClaytonAustraliaRecruiting
Barwon Health /ID# 277297
Coordinator of this site? Confirm its status
GeelongAustraliaRecruiting
Icon Cancer Centre Hobart /ID# 277688
Coordinator of this site? Confirm its status
HobartAustraliaRecruiting
St. George Private Hospital /ID# 276570
Coordinator of this site? Confirm its status
KogarahAustraliaRecruiting
Austin Hospital /ID# 276534
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Epworth HealthCare /ID# 276347
Coordinator of this site? Confirm its status
RichmondAustraliaRecruiting
St. John Of God Subiaco Hospital /ID# 277174
Coordinator of this site? Confirm its status
SubiacoAustraliaRecruiting
Chris O'Brien Lifehouse /ID# 276337
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SydneyAustraliaRecruiting
Az Maria Middelares Gent
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GentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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NamurBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Masarykuv Onkologicky Ustav
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Brno-StredCzechiaRecruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Fakultni Nemocnice Motol a Homolka
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PragueCzechiaRecruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaRecruiting
Aalborg University Hospital
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AalborgDenmarkRecruiting
Region Hovedstaden
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HerlevDenmarkRecruiting
Odense University Hospital
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Odense CDenmarkRecruiting
Complexo Hospitalario Universitario A Coruña (CHUAC)
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A CoruñaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario Donostia
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DonostiaSpainRecruiting
Institut Català d'Oncologia
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GironaSpainRecruiting
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainRecruiting
Clinica Universidad de Navarra
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MadridSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainRecruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainRecruiting
Sainte Catherine Institut Du Cancer Avignon-Provence
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Avignon Cedex 9FranceRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
Centre Francois Baclesse
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Caen Cedex 5FranceRecruiting
Centr Georges Francois Leclerc
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DijonFranceRecruiting
Centre Hospitalier Et Universitaire de Limoges
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LimogesFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceRecruiting
Hôpital Privé des Côtes d'Armor
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PlérinFranceRecruiting
Institut Godinot
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ReimsFranceRecruiting
Institut Curie
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Saint-CloudFranceRecruiting
Groupe Hospitalier Saint Vincent
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StrasbourgFranceRecruiting
Oncopole Claudius Regaud
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ToulouseFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
National Cancer Center /ID# 276283
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Goyang-siSouth KoreaRecruiting
Seoul National University Bundang Hospital /ID# 276280
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Seongnam-siSouth KoreaRecruiting
Yonsei University Health System - Severance Hospital /ID# 276266
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SeoulSouth KoreaRecruiting
Korea University Guro Hospital /ID# 276194
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SeoulSouth KoreaRecruiting
Asan Medical Center /ID# 276955
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SeoulSouth KoreaRecruiting
Seoul National University Hospital /ID# 276182
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SeoulSouth KoreaRecruiting
Samsung Medical Center /ID# 276261
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SeoulSouth KoreaRecruiting
Texas Oncology - Abilene - Antilley Road /ID# 277739
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AbileneUnited StatesRecruiting
Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440
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Baton RougeUnited StatesRecruiting
Intermountain Health - Intermountain Health West End Clinic /ID# 278470
Coordinator of this site? Confirm its status
BillingsUnited StatesRecruiting
Md Anderson Cancer Center At Cooper /ID# 278390
Coordinator of this site? Confirm its status
CamdenUnited StatesRecruiting
University of Texas - Southwestern Medical Center /ID# 278289
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DallasUnited StatesRecruiting
Karmanos Cancer Institute - Detroit /ID# 277085
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DetroitUnited StatesRecruiting
Willamette Valley Cancer Institute and Research Center /ID# 277714
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EugeneUnited StatesRecruiting
Texas Oncology - Fort Worth Cancer Center /ID# 277989
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Fort WorthUnited StatesRecruiting
University of Florida College of Medicine /ID# 278348
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GainesvilleUnited StatesRecruiting
Jamescare Gynecologic Oncology At Mill Run /ID# 277951
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HilliardUnited StatesRecruiting
University Of Tennessee Medical Center /ID# 278225
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KnoxvilleUnited StatesRecruiting
UC San Diego Health - Moores Cancer Center /ID# 277574
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La JollaUnited StatesRecruiting
Baptist Health Lexington /ID# 278267
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LexingtonUnited StatesRecruiting
West Virginia University Hospitals /ID# 278965
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MorgantownUnited StatesRecruiting
Columbia University Medical Center /ID# 277990
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New YorkUnited StatesRecruiting
Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
Penn Medicine University of Pennsylvania Health System /ID# 277963
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
FirstHealth of the Carolinas- Speciality Center /ID# 278636
Coordinator of this site? Confirm its status
PinehurstUnited StatesRecruiting
Western Pennsylvania Gynecologic Oncology /ID# 278632
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PittsburghUnited StatesRecruiting
Virginia Commonwealth University Medical Center /ID# 277932
Coordinator of this site? Confirm its status
RichmondUnited StatesRecruiting
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Maine Medical Center - Scarborough Campus /ID# 277205
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ScarboroughUnited StatesRecruiting
Virginia Mason Hospital and Medical Center /ID# 277259
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SeattleUnited StatesRecruiting
Avera Cancer Institute - Sioux Falls /ID# 278627
Coordinator of this site? Confirm its status
Sioux FallsUnited StatesRecruiting
Sansum Clinic - Solvang /ID# 277712
Coordinator of this site? Confirm its status
SolvangUnited StatesActive, not recruiting
Florida Cancer Specialists - North /ID# 278626
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St. PetersburgUnited StatesRecruiting
SUNY Upstate Medical University - Syracuse /ID# 277245
Coordinator of this site? Confirm its status
SyracuseUnited StatesRecruiting
Texas Oncology - The Woodlands /ID# 277926
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The WoodlandsUnited StatesRecruiting
Texas Oncology - Northeast Texas /ID# 277737
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TylerUnited StatesRecruiting
Florida Cancer Specialists - East /ID# 278605
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West Palm BeachUnited StatesRecruiting
UMass Memorial Medical Center - Belmont Street /ID# 278628
Coordinator of this site? Confirm its status
WorcesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.