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Completed Phase 3 Interventional Results available

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression

ClinicalTrials.gov ID: NCT04209855

Public ClinicalTrials.gov record NCT04209855. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 6:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRα positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

Study identification

NCT ID
NCT04209855
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AbbVie
Industry
Enrollment
453 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2019 (Actual)
Primary completion
Mar 6, 2023 (Actual)
Completion
Oct 29, 2024 (Actual)
Last update posted
Aug 27, 2025

2019 – 2024

United States locations

U.S. sites
78
U.S. states
34
U.S. cities
69
Facility City State ZIP Site status
University of Alabama at Birmingham (UAB) GYN Oncology Birmingham Alabama 35233 —
Alaska Women's Cancer Care Anchorage Alaska 99508 —
Arizona Oncology Associates, PC - HAL - USOR Phoenix Arizona 85016 —
Mayo Clinic Phoenix Arizona 85054 —
USOR: Arizona Oncology Associates, PC - HOPE Tucson Arizona 85711 —
University of Arizona Cancer Center Tucson Arizona 85719 —
UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit Los Angeles California 90095 —
Hoag Cancer Center Newport Beach California 92663 —
University of California San Francisco San Francisco California 94143 —
Olive View - UCLA Medical Center Sylmar California 91324 —
Kaiser Permanente Oncology Clinical Trials Vallejo California 94589 —
USOR: Rocky Mountain Cancer Centers Lakewood Colorado 80228 —
Yale University School of Medicine New Haven Connecticut 06520 —
Florida Cancer Specialist South Division Fort Myers Florida 33901 —
Mayo Clinic Jacksonville Jacksonville Florida 32224 —
Sarasota Memorial Hospital Sarasota Florida 34239 —
Women's Care Florida / Women's Cancer Associates St. Petersburg Florida 33701 —
Florida Cancer Specialist North Division St. Petersburg Florida 33705 —
Florida Cancer Specialists Tallahassee Florida 32308 —
Florida Cancer Specialist East Division West Palm Beach Florida 33401 —
Memorial University Medical Center Savannah Georgia 31404 —
Hawaii Pacific Health - Kapiolani Medical Center for Women and Children Honolulu Hawaii 96813 —
Illinois Cancer Specialists Arlington Heights Illinois 60005 —
University of Chicago Chicago Illinois 60637 —
Dr. Sudarshan K. Sharma, Ltd. Hinsdale Illinois 60521 —
Community Health Network Indianapolis Indiana 46250 —
University of Kansas Cancer Center Westwood Kansas 66205 —
St. Elizabeth Healthcare Edgewood Kentucky 41017 —
Norton Cancer Institute Louisville Kentucky 40207 —
Ochnser Medical Center Jefferson New Orleans Louisiana 70121 —
WK Physicians Network/Gynecologic Oncology Associates Shreveport Louisiana 771103 —
Holy Cross Hospital Silver Spring Maryland 20902 —
USOR: Maryland Oncology Hematology, P.A. Silver Spring Maryland 20902 —
Tufts Medical Center Boston Massachusetts 02111 —
Baystate Medical Center Springfield Massachusetts 01199 —
University of Massachusetts Worcester Massachusetts 01605 —
St. Joseph Mercy Hospital Ann Arbor Michigan 48106 —
Karmanos Cancer Institute Detroit Michigan 48201 —
Mayo Clinic Rochester Rochester Minnesota 55905 —
USOR: Minnesota Oncology Hematology, PA Woodbury Minnesota 55125 —
HCA Midwest Kansas City/ Sarah Cannon Kansas City Missouri 64132 —
Sletten Cancer Institute Great Falls Montana 59405 —
Center of Hope Reno Nevada 89511 —
The Valley Hospital, Inc Ridgewood New Jersey 07450 —
Holy Name Medical Center Teaneck New Jersey 07666 —
Columbia University Medical Center New York New York 10032 —
FirstHealth of the Carolinas Outpatient Cancer Center Pinehurst North Carolina 28374 —
USOR: OHC - Oncology_Hematology Care Clinical Trials, Inc. Cincinnati Ohio 45242 —
MetroHealth Medical Center Cleveland Ohio 44109 —
Cleveland Clinic Cleveland Ohio 44195 —
Columbus NCORP Columbus Ohio 43215 —
Zangmeister Cancer Center Columbus Ohio 43219 —
Oncology_Hematology Care Clinical Trials, LLC Fairfield Ohio 45014 —
The Ohio State University Wexner Medical Center Hilliard Ohio 43026 —
Stephenson Cancer Center Oklahoma City Oklahoma 73104 —
Oklahoma Cancer Specialists and Research Institute Tulsa Oklahoma 74146 —
USOR: Willamette Valley Cancer Institute and Research Center Eugene Oregon 97401 —
Legacy Gynecologic Oncology Portland Oregon 97210 —
USOR: Northwest Cancer Specialists, P.C. Portland Oregon 97227 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 —
Magee-Women's Hospital-UPMC Pittsburgh Pennsylvania 15213 —
West Penn Hospital Pittsburgh Pennsylvania 15224 —
Women & Infants Hospital of Rhode Island Providence Rhode Island 02905 —
Tennessee Oncology / Sarah Cannon Research Institute Nashville Tennessee 37203 —
USOR: Texas Oncology-South Austin Austin Texas 78745 —
USOR: Texas Oncology - Fort Worth Cancer Center Fort Worth Texas 76104 —
University of Texas, Memorial Hermann Houston Texas 77030 —
USOR: Texas Oncology - McAllen South Second McAllen Texas 78503 —
USOR: Texas Oncology - San Antonio San Antonio Texas 78240 —
USOR: Texas Oncology, P.A. Sugar Land Texas 77479 —
USOR: Texas Oncology - The Woodlands, Gynecologic Oncology The Woodlands Texas 77380 —
USOR: Texas Oncology - Tyler Tyler Texas 75702 —
USOR: Texas Oncology, P.A. Webster Texas 77598 —
University of Virginia Health System Charlottesville Virginia 22908 —
USOR: Virginia Cancer Specialists, PC Gainesville Virginia 20155 —
Kadlec Clinic Hematology & Oncology Kennewick Washington 99336 —
West Virginia University- MBRCC Morgantown West Virginia 26506 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 136 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04209855, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2025 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04209855 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →