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 (MIRASOL)

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

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 Overview

• Status: Completed
• Conditions: Fallopian Tube Cancer; Epithelial Ovarian Cancer; Peritoneal Cancer
• Intervention / Treatment: Drug: Paclitaxel; Drug: Pegylated liposomal doxorubicin; Drug: Topotecan; Drug: Mirvetuximab Soravtansine

Detailed Description

Participants will be randomized to either MIRV or IC chemotherapy (paclitaxel, PEGylated liposomal doxorubicin, or topotecan).

• Study Type: Interventional
• Enrollment (Actual): 453
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Saint Leonards, Australia, 2065
    • Royal North Shore Hospital
  • Toorak Gardens, Australia, 5065
    • Burnside War Memorial Hospital - the Brian Fricker Oncology Centre
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, 2305
      • Newcastle Private Hospital
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health
    • Malvern, Victoria, Australia, 3144
      • Oncology Clinics Victoria (OCV) - Cabrini Malvern Hospital Location
• Belgium
  • Aalst, Belgium, 9300
    • OLV Ziekenhuis
  • Brasschaat, Belgium, 2390
    • AZ Klina
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek
  • Ghent, Belgium, 9000
    • AZ St-Lucas
  • Leuven, Belgium, 3000
    • UZ Leuven
• Bulgaria
  • Burgas, Bulgaria, 8000
    • Complex Oncology Center
  • Pleven, Bulgaria, 5800
    • UMHAT Georgi Stranski
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda Hospital
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski", EAD, Sofia
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Ottawa, Ontario, Canada, K1H8L6
      • The Ottawa Hospital General Campus
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Center
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre - University Health Network
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Universite de Montreal
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute & Hospital
  • Anhui
    • Hefei, Anhui, China, 230000
      • Anhui Provincial Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
    • Xiamen, Fujian, China, 361004
      • Zhongshan Hospital Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University, Cancer Center
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430061
      • Zhongnan Hospital of Wuhan University
    • Wuhan, Hubei, China, 430024
      • Wuhan Union Hospital of China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
  • Jilin
    • Changchun, Jilin, China, 130031
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110801
      • Liaoning Cancer Hospital
  • Shanxi
    • Xi’an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
• Czechia
  • Ostrava, Czechia, 708 52
    • Fakultni Nemocnice Ostrava
  • Prague, Czechia, 128 51
    • Vseobecna fakultni nemocnice v Praze
  • Zlín, Czechia, 762 75
    • KNTB a.s. Zlín
• France
  • Besançon, France, 25030
    • CHRU Besançon
  • Bordeaux, France, 33076
    • Institut Bergonie
  • Lyon, France, 69373
    • Centre Léon Bérard
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Paris, France, 75014
    • Cochin Hospital
  • Paris, France, 75960 Cedex 20
    • Groupe Hospitalier Diaconesses Croix Saint-Simon
  • Pierre-Bénite, France, 69310
    • Centre Hospitalier Lyon Sud
  • Plérin, France, 22190
    • Centre Armoricain de radiothérapie, imagerie médicale et oncologie, CARIO
  • Saint-Cloud, France, 92210
    • Institut Curie
  • Saint-Herblain, France, 44805
    • ICO Centre René Gauducheau
  • Vandoeuvre Les Nancy_ Cedex, France, 54519
    • Institut de Cancerologie de Lorraine
  • Villejuif, France, 94805
    • Gustave Roussy
  • Cedex
    • Angers, Cedex, France, 49055
      • Institut de cancérologie de l'ouest, site Angers
  • Cedex 9
    • Toulouse, Cedex 9, France, 31059
      • Institut Claudius Regaud
  • Cedex B.P 307
    • Lille, Cedex B.P 307, France, 59020
      • Centre Oscar Lambret
• Germany
  • Bonn, Germany, 53127
    • Universitatsklinikum Bonn
  • Dessau, Germany, 06847
    • Städtisches Klinikum Dessau, Zentrum für Klinische Studien
  • Dortmund, Germany, 44137
    • Klinikum Dortmund gGmbH / Frauenklinik
  • Freiburg im Breisgau, Germany, 79106
    • University Hospital Freiburg
  • Giessen, Germany
    • UKGM Standort Gießen
  • Hamburg, Germany, 20357
    • Mammazentrum Hamburg am Krankenhaus Jerusalem
  • Baden-Wurttemberg
    • Ulm, Baden-Wurttemberg, Germany, 89075
      • Ulm University Hospital Klinik für Frauenheilkunde und Geburtshilfe
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • UMG Göttingen Frauenklinik
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitatsklinikum Carl Gustav Carus Dresden
• Israel
  • Holon, Israel, 5822012
    • Wolfson Medical Center
  • Jerusalem, Israel, POB 12000
    • Hadassah Ein Kerem Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center
  • Rehovot, Israel, 76100
    • Kaplan Medical Center
  • Safed, Israel, 13100
    • Ziv Medical Center
• Italy
  • Brescia, Italy, 25123
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • Lecco, Italy, 23900
    • ASST Lecco- Ospedale A.Manzoni
  • Milan, Italy, 20141
    • IRCCS - Istituto Europeo di Oncologia (The European Institute of Oncology) (IEO)
  • Naples, Italy, 80131
    • INT Pascale
  • Perugia, Italy, 6132
    • Centro Operativo Studi Clinici S.C.Oncologia Medica
  • Reggio Emilia, Italy, 42123
    • Oncologia Azienda Osc-IRCCS Reggio Emilia
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Torino, Italy, 10126
    • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Torino, Italy, 10128
    • Ospedale Mauriziano Umberto I
  • Torino, Italy
    • Istituto Oncologico Candiolo
  • PD
    • Padua, PD, Italy, 35128
      • IOV Istituto Oncologico
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam UMC
  • Maastricht, Netherlands, 6229 HX
    • Maastricht UMC
  • Nijmegen, Netherlands, Postbus 9101, 6500 HB
    • Radboud University Medical Center
  • Rotterdam, Netherlands, 3015 AA
    • Erasmus Medical Center
• Poland
  • Gdansk, Poland, 80-214
    • Medical University of Gdansk
  • Lublin, Poland, 20-081
    • Samodzielny Publiczny Szpital Kliniczny nr 1
  • Olsztyn, Poland, 10-561
    • Wojewódzki Szpital Specjalistyczny, Oddzial Kliniczny Ginekologii Onkologiczne
  • Poznan, Poland, 61-866
    • Wielkopolskie Centrum Onkologii
  • Warsaw, Poland, 00-315
    • Szpital Kliniczny im. Ks. Anny Mazowieckiej
• Portugal
  • Lisbon, Portugal, 1400-038
    • Fundacao Champalimaud
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz, S.A
  • Lisbon, Portugal, 1649-028
    • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
  • Loures, Portugal, 2674-514
    • Hospital Beatriz Ângelo
• Russia
  • Moscow, Russia, 10
    • LLC "Vitamed"
  • Saint Petersburg, Russia, 194356
    • Leningrad regional oncology dispensa
  • Ufa, Russia, 450054
    • State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
  • Omsk Oblast
    • Omsk, Omsk Oblast, Russia, 644013
      • BIH of Omsk Region "Clinical Oncology Dispensary"
• Serbia
  • Belgrade, Serbia, 11000
    • Oncology and Radiology Institute Serbia
  • Kamenitz, Serbia, 21204
    • Oncology Institute Vojvodina, Surgical Oncology Clinic
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
• South Korea
  • Gyeonggi-do, South Korea, 10408
    • National Cancer Center - Center for Uterine Cancer
  • Seongnam-si, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital
  • Seoul, South Korea, 05505
    • University of Ulsan College of Medicine - Asan Medical Center
• Spain
  • Badalona, Spain, 8916
    • Institut Catala d'Oncologia
  • Castelló, Spain, 12002
    • Hospital Provincial de Castellon
  • Cáceres, Spain, 10003
    • H. San Pedro de Alcántara
  • Madrid, Spain, 28050
    • Hospital de San Chinarro-Clara Campal
  • Murcia, Spain, 30120
    • Hospital Clinico Universitario Virgen de la Arrixaca
  • Sabadell, Spain, 8208
    • PARC Tauli
  • Seville, Spain, 41013
    • Virgen del Rocio
  • Valencia, Spain, 46026
    • Hospital de la Fe
  • Zaragoza, Spain, 50009
    • HCU Lozano Blesa
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Hospital Clínico de Santiago
  • Andalusia
    • Jaén, Andalusia, Spain, 23007
      • H. U. de Jaén
  • Madrid
    • San Sebastián de los Reyes, Madrid, Spain, 28702
      • Hospital Universitario Infanta Sofía
• Taiwan
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital - Taipei Branch
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Communal non-profit enterprise "Cherkasy Regional Oncology Dispensary of Cherkasy oblast council"
  • Ivano-Frankivsk, Ukraine, 76018
    • Prykarpatskyi Clinical Oncology Center of Ivano-Frankivsk Regional Council
  • Chernihiv Oblast
    • Chernihiv, Chernihiv Oblast, Ukraine, 14029
      • Chernihiv Medical Center of Modern Oncology of Chernihiv Regional Council
  • Kharkivs’ka Oblast’
    • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61024
      • Grigoriev Institute for Medical Radiology NAMS of Ukraine
  • Khmelnytskyi Oblast
    • Khmelnytskyi, Khmelnytskyi Oblast, Ukraine, 29009
      • Communal non-profit enterprise "Khmelnytskyi Regional Antitumor Center" of Khmelnytskoyi Regional Council
• United Kingdom
  • Coventry, United Kingdom, CV2 2DX
    • University Hospitals Coventry and Warwickshire
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West Of Scotland Cancer Centre
  • London, United Kingdom, SM2 5PT
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, NW1 2PG
    • University College London Hospital
  • London, United Kingdom, EC1A 7BE
    • St Bartholomew's Hospital-Barts Health NHS Trust
  • Manchester, United Kingdom, M20 4BX
    • The Christie Nhs Foundation Trust
  • Cambridgeshire
    • Peterborough, Cambridgeshire, United Kingdom, PE3 9GZ
      • Peterborough City Hospital
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon and Exeter Hospital (Wonford)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham (UAB) GYN Oncology
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Women's Cancer Care
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
    • Phoenix, Arizona, United States, 85016
      • Arizona Oncology Associates, PC - HAL - USOR
    • Tucson, Arizona, United States, 85719
      • University of Arizona Cancer Center
    • Tucson, Arizona, United States, 85711
      • USOR: Arizona Oncology Associates, PC - HOPE
  • California
    • Los Angeles, California, United States, 90095
      • UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit
    • Newport Beach, California, United States, 92663
      • Hoag Cancer Center
    • San Francisco, California, United States, 94143
      • University of California San Francisco
    • Sylmar, California, United States, 91324
      • Olive View - UCLA Medical Center
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Oncology Clinical Trials
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • USOR: Rocky Mountain Cancer Centers
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School Of Medicine
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialist South Division
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
    • St. Petersburg, Florida, United States, 33701
      • Women's Care Florida / Women's Cancer Associates
    • St. Petersburg, Florida, United States, 33705
      • Florida Cancer Specialist North Division
    • Tallahassee, Florida, United States, 32308
      • Florida Cancer Specialists
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialist East Division
  • Georgia
    • Savannah, Georgia, United States, 31404
      • Memorial University Medical Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawaii Pacific Health - Kapiolani Medical Center for Women and Children
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Illinois Cancer Specialists
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Hinsdale, Illinois, United States, 60521
      • Dr. Sudarshan K. Sharma, Ltd.
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Community Health Network
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Healthcare
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochnser Medical Center Jefferson
    • Shreveport, Louisiana, United States, 771103
      • WK Physicians Network/Gynecologic Oncology Associates
  • Maryland
    • Silver Spring, Maryland, United States, 20902
      • Holy Cross Hospital
    • Silver Spring, Maryland, United States, 20902
      • USOR: Maryland Oncology Hematology, P.A.
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • St. Joseph Mercy Hospital
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
    • Woodbury, Minnesota, United States, 55125
      • USOR: Minnesota Oncology Hematology, PA
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • HCA Midwest Kansas City/ Sarah Cannon
  • Montana
    • Great Falls, Montana, United States, 59405
      • Sletten Cancer Institute
  • Nevada
    • Reno, Nevada, United States, 89511
      • Center of Hope
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital, Inc
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth of the Carolinas Outpatient Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • USOR: OHC - Oncology_Hematology Care Clinical Trials, Inc.
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Columbus, Ohio, United States, 43215
      • Columbus NCORP
    • Columbus, Ohio, United States, 43219
      • Zangmeister Cancer Center
    • Fairfield, Ohio, United States, 45014
      • Oncology_Hematology Care Clinical Trials, LLC
    • Hilliard, Ohio, United States, 43026
      • The Ohio State University Wexner Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute
  • Oregon
    • Eugene, Oregon, United States, 97401
      • USOR: Willamette Valley Cancer Institute and Research Center
    • Portland, Oregon, United States, 97210
      • Legacy Gynecologic Oncology
    • Portland, Oregon, United States, 97227
      • USOR: Northwest Cancer Specialists, P.C.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Women's Hospital-UPMC
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women & Infants Hospital of Rhode Island
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology / Sarah Cannon Research Institute
  • Texas
    • Austin, Texas, United States, 78745
      • USOR: Texas Oncology-South Austin
    • Fort Worth, Texas, United States, 76104
      • USOR: Texas Oncology - Fort Worth Cancer Center
    • Houston, Texas, United States, 77030
      • University of Texas, Memorial Hermann
    • McAllen, Texas, United States, 78503
      • USOR: Texas Oncology - McAllen South Second
    • San Antonio, Texas, United States, 78240
      • USOR: Texas Oncology - San Antonio
    • Sugar Land, Texas, United States, 77479
      • USOR: Texas Oncology, P.A.
    • The Woodlands, Texas, United States, 77380
      • USOR: Texas Oncology - The Woodlands, Gynecologic Oncology
    • Tyler, Texas, United States, 75702
      • USOR: Texas Oncology - Tyler
    • Webster, Texas, United States, 77598
      • USOR: Texas Oncology, P.A.
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Gainesville, Virginia, United States, 20155
      • USOR: Virginia Cancer Specialists, PC
  • Washington
    • Kennewick, Washington, United States, 99336
      • Kadlec Clinic Hematology & Oncology
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University- MBRCC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female participants ≥ 18 years of age
2. Participants must have a confirmed diagnosis of high-grade serious epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer

3. Participants must have platinum-resistant disease:

   1. Participants who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between >3 months and ≤ 6 months after the date of the last dose of platinum
   2. Participants who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum 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. Note: Participants who are platinum-refractory during front-line treatment are excluded
4. Participants must have progressed radiographically on or after their most recent line of therapy
5. Participants must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity
6. Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay
7. Participants must have at least one lesion that meets the definition of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (radiologically measured by the Investigator)

8. Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment:

   1. Adjuvant ± neoadjuvant considered one line of therapy
   2. Maintenance therapy (for example, bevacizumab, poly (ADP-ribose) polymerase [PARP] inhibitors) will be considered as part of the preceding line of therapy (that is, not counted independently)
   3. Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (that is, not counted independently)
   4. Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
9. Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

10. Time from prior therapy:

    1. Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter)
    2. Focal radiation completed at least 2 weeks prior to first dose of study drug
11. Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities
12. Major surgery must be completed at least 4 weeks prior to first dose and have recovered or stabilized from the side effects of prior surgery

13. Participants must have adequate hematologic, liver and kidney functions defined as:

    1. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/liter (L) (1,500/microliter [μL]) without granulocyte colony-stimulating factor (G-CSF) in the prior 10 days or long-acting white blood cell (WBC) growth factors in the prior 20 days
    2. Platelet count ≥ 100 x 10^9/L (100,000/μL) without platelet transfusion in the prior 10 days
    3. Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days
    4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
    5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
    6. Serum bilirubin ≤ 1.5 x ULN (participants with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN
    7. Serum albumin ≥ 2 grams (g)/deciliter (dL)
14. Participants or their legally authorized representative must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements
15. Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) while on study drug and for at least 3 months after the last dose of MIRV or at least 6 months after the last dose of paclitaxel, pegylated liposomal doxorubicin, or topotecan
16. WCBP must have a negative pregnancy test within 4 days prior to the first dose of study drug

Exclusion Criteria:

1. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor
2. Participants with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy
3. Participants with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
4. Participants with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
5. Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision

6. Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:

   1. Active hepatitis B or C infection (whether or not on active antiviral therapy)
   2. Human immunodeficiency virus (HIV) infection
   3. Active cytomegalovirus infection
   4. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks before starting study drug Note: Testing at screening is not required for the above infections unless clinically indicated
7. Participants with history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)

8. Participants with clinically significant cardiac disease including, but not limited to, any one of the following:

   1. Myocardial infarction ≤ 6 months prior to first dose
   2. Unstable angina pectoris
   3. Uncontrolled congestive heart failure (New York Heart Association > class II)
   4. Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
   5. Uncontrolled cardiac arrhythmias
9. Participants assigned to PLD stratum only: Left ventricular ejection fraction (LVEF) below the institutional limit of normal as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan
10. Participants with a history of hemorrhagic or ischemic stroke within six months prior to randomization
11. Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C)
12. Participants with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis
13. Participants with required use of folate-containing supplements (for example, folate deficiency)
14. Participants with prior hypersensitivity to monoclonal antibodies
15. Women who are pregnant or lactating
16. Participants with prior treatment with MIRV or other FRα-targeting agents
17. Participants with untreated or symptomatic central nervous system (CNS) metastases
18. Participants with a history of other malignancy within 3 years prior to randomization. Note: does not include tumors with a negligible risk for metastasis or death (for example, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast
19. Prior known hypersensitivity reactions to study drugs and/or any of their excipients
20. People who are detained through a court or administrative decision, receiving psychiatric care against their will, adults who are the subject of a legal protection order (under tutorship/curatorship), people who are unable to express their consent, and people who are subject to a legal guardianship order
21. Simultaneous participation in another research study, in countries or localities where this is the health authority guidance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirvetuximab Soravtansine; Participants will receive single-agent mirvetuximab soravtansine (MIRV) at 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of every 3-week cycle (Q3W).	Drug: Mirvetuximab Soravtansine; Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.; Other Names: IMGN853; MIRV
Active Comparator: Investigator's Choice (IC) Chemotherapy; Participants will receive a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel administered at 80 milligrams/square meter (mg/m^2) as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could be administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could be administered as a 1-hour infusion.	Drug: Paclitaxel; Paclitaxel will be administered per dose and schedule specified in the arm.; Drug: Pegylated liposomal doxorubicin; Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.; Drug: Topotecan; Topotecan will be administered per dose and schedule specified in the arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	PFS was defined as the time from randomization until progressive disease (PD) or death whichever occurred first. PD: At least a 20% increase in the sum of the longest diameters (SoD) of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.	From randomization until PD or death, whichever occurred first (up to approximately 36 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1	ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.	Up to approximately 36 months
Overall Survival Assessed by the Investigator Using RECIST v1.1	Overall survival was defined as the time from the date of first dose until the date of death from any cause, estimated using the Kaplan-Meier method.	Up to approximately 45 months
Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)	The EORTC QLQ-OV28 is specific for ovarian cancer and consists of 28 items assessing abdominal/gastrointestinal symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items) and 4 other single items. Each scale was scored from 0 to 100 with higher scores on the symptom scales indicating greater symptom burden. Higher scores represent a higher ("better") level of functioning. Presented here are the number of participants achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the EORTC QLQ-OV28.	Baseline and Week 8 or 9
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAEs were defined as AEs with an onset date on or after the first dose of study drug, and within 30 days of the last dose of study drug or prior to the start of a new anticancer treatment, whichever occurred first. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.	Up to approximately 37 months
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1	DOR was defined as the time from the date of the first response (CR or PR), until the date of PD or death from any cause, whichever occurred first. DOR for participants who have not progressed or died at the time of analysis are censored at the date of their last tumor assessment. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also have demonstrated an absolute increase of at least 5 mm. DOR was estimated using the Kaplan-Meier method.	Up to approximately 34 months
Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria	The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days.	Baseline up to approximately 36 months
Time to Second Progression-Free Survival (PFS 2)	PFS 2 was defined as the time from date of randomization until second disease progression or death whichever occurred first.	Up to approximately 44 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported outcomes using EORTC QLQ-C30 questionnaires	The EORTC QLQ-C30 questionnaires will be used to collect data on the patient's functioning, health-related QOL, disease symptoms and health status. A higher score represents a higher response level.	Up to 2 years
Patient-reported outcomes using EQ-5D-5L questionnaires	The EuroQol-5 Dimension 5-level (EQ-5D-5L) questionnaires will be used to collect data on the patient's functioning, health-related QOL, disease symptoms and health status. A higher score represents a higher response level.	Up to 2 years
Pharmacokinetic parameters	Plasma samples will be collected to determine the concentration of MIRV (antibody-drug conjugate, total antibody, free DM4, S-methyl DM4 and possibly other metabolites). Summary statistics of the concentration at each time point (nominal time) will be presented. Graphical presentation of the data may also be completed using nominal time.	Up to 2 years
Immunogenicity	The presence of anti-drug antibodies to mirvetuximab soravtansine	Up to 2 years
Identification of soluble FRα levels and other biomarkers		Up to 2 years
Patient-reported outcomes using PGIS questionnaires	The Patient Global Impression of Severity (PGIS) questionnaires will be used to collect data on the patient's perception of overall cancer symptom severity. This is a single question survey.	Up to 2 years

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: Gynecologic Oncology Group; European Network of Gynaecological Oncological Trial Groups (ENGOT)
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• Van Gorp T, Moore KN, Konecny GE, Leary A, Garcia-Garcia Y, Banerjee S, Lorusso D, Lee JY, Moroney JW, Caruso G, Klasa-Mazurkiewicz D, Tromp J, Martin LP, Breuer S, Leath CA 3rd, Cibula D, Weroha SJ, Estevez-Garcia P, O'Malley DM, Miller RE, Coffman L, Scandurra G, Berton D, Li L, Zagadailov E, Diver EJ, Tredan O, Hilpert F. Patient-reported outcomes from the MIRASOL trial evaluating mirvetuximab soravtansine versus chemotherapy in patients with folate receptor alpha-positive, platinum-resistant ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Apr;26(4):503-515. doi: 10.1016/S1470-2045(25)00021-X.
• Moore KN, Angelergues A, Konecny GE, Garcia Y, Banerjee S, Lorusso D, Lee JY, Moroney JW, Colombo N, Roszak A, Tromp J, Myers T, Lee JW, Beiner M, Cosgrove CM, Cibula D, Martin LP, Sabatier R, Buscema J, Estevez-Garcia P, Coffman L, Nicum S, Duska LR, Pignata S, Galvez F, Wang Y, Method M, Berkenblit A, Bello Roufai D, Van Gorp T; Gynecologic Oncology Group Partners and the European Network of Gynaecological Oncological Trial Groups. Mirvetuximab Soravtansine in FRalpha-Positive, Platinum-Resistant Ovarian Cancer. N Engl J Med. 2023 Dec 7;389(23):2162-2174. doi: 10.1056/NEJMoa2309169.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2019
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): October 29, 2024

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Epithelial Ovarian Cancer; Platinum-resistant; Phase 3; Peritoneal Cancer; Fallopian Tube Cancer; IMGN853; Folate-receptor alpha expression; Antibody-drug conjugate; mirvetuximab soravtansine
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Fallopian Tube Diseases; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Organic Chemicals; Heterocyclic Compounds; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Camptothecin; Alkaloids; Taxoids; Cyclodecanes; Diterpenes; Paclitaxel; Topotecan; mirvetuximab soravtansine; liposomal doxorubicin
• Other Study ID Numbers: IMGN853-0416; 2019-003509-80 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No