AzTrials
AzTrials

Epithelial Ovarian CancerPhase 3MIRASOLNCT04209855

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

A Phase 3 study testing Mirvetuximab Soravtansine, Paclitaxel and Topotecan in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by AbbVie at 214 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Mirvetuximab Soravtansine, Paclitaxel and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
453 participants
Where
214 sitesin 21 countries
Study dates
31 Dec 2019to 29 Oct 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female participants ≥ 18 years of age
  • Participants must have a confirmed diagnosis of high-grade serious epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
  • Participants must have platinum-resistant disease:
  • 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
  • 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
  • Participants must have progressed radiographically on or after their most recent line of therapy
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  • 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
  • Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay
  • 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)
  • 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:
  • Adjuvant ± neoadjuvant considered one line of therapy
  • 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)
  • Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (that is, not counted independently)
  • Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
  • Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Time from prior therapy:
  • Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter)
  • Focal radiation completed at least 2 weeks prior to first dose of study drug
  • Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities
  • 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
  • Participants must have adequate hematologic, liver and kidney functions defined as:
  • 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
  • Platelet count ≥ 100 x 10^9/L (100,000/μL) without platelet transfusion in the prior 10 days
  • Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
  • Serum bilirubin ≤ 1.5 x ULN (participants with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN
  • Serum albumin ≥ 2 grams (g)/deciliter (dL)
  • 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
  • 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
  • WCBP must have a negative pregnancy test within 4 days prior to the first dose of study drug

Who cannot join

  • Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor
  • 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
  • Participants with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
  • Participants with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  • 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
  • Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
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  • Active hepatitis B or C infection (whether or not on active antiviral therapy)
  • Human immunodeficiency virus (HIV) infection
  • Active cytomegalovirus infection
  • 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
  • Participants with history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
  • Participants with clinically significant cardiac disease including, but not limited to, any one of the following:
  • Myocardial infarction ≤ 6 months prior to first dose
  • Unstable angina pectoris
  • Uncontrolled congestive heart failure (New York Heart Association > class II)
  • Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
  • Uncontrolled cardiac arrhythmias
  • 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
  • Participants with a history of hemorrhagic or ischemic stroke within six months prior to randomization
  • Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C)
  • Participants with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis
  • Participants with required use of folate-containing supplements (for example, folate deficiency)
  • Participants with prior hypersensitivity to monoclonal antibodies
  • Women who are pregnant or lactating
  • Participants with prior treatment with MIRV or other FRα-targeting agents
  • Participants with untreated or symptomatic central nervous system (CNS) metastases
  • 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
  • Prior known hypersensitivity reactions to study drugs and/or any of their excipients
  • 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
  • Simultaneous participation in another research study, in countries or localities where this is the health authority guidance

Trial locations and contacts

214 sites in 21 countries.

214 sites in 21 countries

United States78 sites

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • USOR: Texas Oncology-South Austin

    Austin, Texas, 78745

  • University of Alabama at Birmingham (UAB) GYN Oncology

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • University of Chicago

    Chicago, Illinois, 60637

  • 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

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017

  • USOR: Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Oncology_Hematology Care Clinical Trials, LLC

    Fairfield, Ohio, 45014

  • Florida Cancer Specialist South Division

    Fort Myers, Florida, 33901

  • USOR: Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • USOR: Virginia Cancer Specialists, PC

    Gainesville, Virginia, 20155

  • Sletten Cancer Institute

    Great Falls, Montana, 59405

  • The Ohio State University Wexner Medical Center

    Hilliard, Ohio, 43026

  • Dr. Sudarshan K. Sharma, Ltd.

    Hinsdale, Illinois, 60521

  • Hawaii Pacific Health - Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96813

  • University of Texas, Memorial Hermann

    Houston, Texas, 77030

  • Community Health Network

    Indianapolis, Indiana, 46250

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • HCA Midwest Kansas City/ Sarah Cannon

    Kansas City, Missouri, 64132

  • Kadlec Clinic Hematology & Oncology

    Kennewick, Washington, 99336

  • USOR: Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • USOR: Texas Oncology - McAllen South Second

    McAllen, Texas, 78503

  • West Virginia University- MBRCC

    Morgantown, West Virginia, 26506

  • Tennessee Oncology / Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Ochnser Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

  • Hoag Cancer Center

    Newport Beach, California, 92663

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Arizona Oncology Associates, PC - HAL - USOR

    Phoenix, Arizona, 85016

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • FirstHealth of the Carolinas Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • Magee-Women's Hospital-UPMC

    Pittsburgh, Pennsylvania, 15213

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Legacy Gynecologic Oncology

    Portland, Oregon, 97210

  • USOR: Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97227

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Center of Hope

    Reno, Nevada, 89511

  • The Valley Hospital, Inc

    Ridgewood, New Jersey, 07450

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • USOR: Texas Oncology - San Antonio

    San Antonio, Texas, 78240

  • University of California San Francisco

    San Francisco, California, 94143

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Memorial University Medical Center

    Savannah, Georgia, 31404

  • 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

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Women's Care Florida / Women's Cancer Associates

    St. Petersburg, Florida, 33701

  • Florida Cancer Specialist North Division

    St. Petersburg, Florida, 33705

  • USOR: Texas Oncology, P.A.

    Sugar Land, Texas, 77479

  • Olive View - UCLA Medical Center

    Sylmar, California, 91324

  • Florida Cancer Specialists

    Tallahassee, Florida, 32308

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • USOR: Texas Oncology - The Woodlands, Gynecologic Oncology

    The Woodlands, Texas, 77380

  • USOR: Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85711

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74146

  • USOR: Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Kaiser Permanente Oncology Clinical Trials

    Vallejo, California, 94589

  • USOR: Texas Oncology, P.A.

    Webster, Texas, 77598

  • Florida Cancer Specialist East Division

    West Palm Beach, Florida, 33401

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • USOR: Minnesota Oncology Hematology, PA

    Woodbury, Minnesota, 55125

  • University of Massachusetts

    Worcester, Massachusetts, 01605

Other trials in United States

China15 sites

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Cancer Hospital

    Beijing, 100142

  • The First Hospital of Jilin University

    Changchun, Jilin, 130031

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Sun Yat-sen University, Cancer Center

    Guangzhou, Guangdong, 510060

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230000

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110801

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

  • Wuhan Union Hospital of China

    Wuhan, Hubei, 430024

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430061

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

Other trials in China

France15 sites

  • Institut de cancérologie de l'ouest, site Angers

    Angers, Cedex, 49055

  • CHRU Besançon

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Oscar Lambret

    Lille, Cedex B.P 307, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13009

  • Cochin Hospital

    Paris, 75014

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    Paris, 75960 Cedex 20

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Centre Armoricain de radiothérapie, imagerie médicale et oncologie, CARIO

    Plérin, 22190

  • Institut Curie

    Saint-Cloud, 92210

  • ICO Centre René Gauducheau

    Saint-Herblain, 44805

  • Institut Claudius Regaud

    Toulouse, Cedex 9, 31059

  • Institut de cancérologie de Lorraine

    Vandoeuvre Les Nancy_ Cedex, 54519

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Spain12 sites

  • Institut Català d'Oncologia

    Badalona, 8916

  • H. San Pedro de Alcántara

    Cáceres, 10003

  • Hospital Provincial de Castellon

    Castelló, 12002

  • H. U. de Jaén

    Jaén, Andalusia, 23007

  • Hospital de San Chinarro-Clara Campal

    Madrid, 28050

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Parc Taulí

    Sabadell, 8208

  • Hospital Universitario Infanta Sofía

    San Sebastián de los Reyes, Madrid, 28702

  • Hospital Clínico de Santiago

    Santiago de Compostela, A Coruña, 15706

  • Virgen del Rocío

    Seville, 41013

  • Hospital de la Fe

    Valencia, 46026

  • HCU Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Italy11 sites

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia, 25123

  • ASST Lecco- Ospedale A.Manzoni

    Lecco, 23900

  • IRCCS - Istituto Europeo di Oncologia (The European Institute of Oncology) (IEO)

    Milan, 20141

  • INT Pascale

    Naples, 80131

  • IOV Istituto Oncologico

    Padova, PD, 35128

  • Centro Operativo Studi Clinici S.C.Oncologia Medica

    Perugia, 6132

  • Oncologia Azienda Osc-IRCCS Reggio Emilia

    Reggio Emilia, 42123

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168

  • Azienda Ospedaliera Città Della Salute E Della Scienza Di Torino

    Torino, 10126

  • Ospedale Mauriziano Umberto I

    Torino, 10128

  • Istituto Oncologico Candiolo

    Torino

Other trials in Italy

Germany9 sites

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Städtisches Klinikum Dessau, Zentrum für Klinische Studien

    Dessau, 06847

  • Klinikum Dortmund gGmbH / Frauenklinik

    Dortmund, 44137

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, Saxony, 01307

  • University Hospital Freiburg

    Freiburg im Breisgau, 79106

  • UKGM Standort Giessen

    Giessen

  • UMG Göttingen Frauenklinik

    Göttingen, Lower Saxony, 37075

  • Mammazentrum Hamburg am Krankenhaus Jerusalem

    Hamburg, 20357

  • Ulm University Hospital Klinik für Frauenheilkunde und Geburtshilfe

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

Canada8 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Centre Hospitalier de L'Universite de Montreal

    Montreal, Quebec, H2X 0A9

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital General Campus

    Ottawa, Ontario, K1H8L6

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre - University Health Network

    Toronto, Ontario, M5G 2M9

Other trials in Canada

United Kingdom8 sites

  • University Hospitals Coventry and Warwickshire

    Coventry, CV2 2DX

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, Devon, EX2 5DW

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • St Bartholomew's Hospital-Barts Health NHS Trust

    London, EC1A 7BE

  • University College London Hospital

    London, NW1 2PG

  • The Royal Marsden NHS Foundation Trust

    London, SM2 5PT

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Peterborough City Hospital

    Peterborough, Cambridgeshire, PE3 9GZ

Other trials in United Kingdom

Australia6 sites

  • Monash Health

    Clayton, Victoria, 3168

  • Oncology Clinics Victoria (OCV) - Cabrini Malvern Hospital Location

    Malvern, Victoria, 3144

  • Newcastle Private Hospital

    New Lambton Heights, New South Wales, 2305

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Royal North Shore Hospital

    Saint Leonards, 2065

  • Burnside War Memorial Hospital - The Brian Fricker Oncology Centre

    Toorak Gardens, 5065

Other trials in Australia

Israel6 sites

  • Wolfson Medical Center

    Holon, 5822012

  • Hadassah Ein Kerem Medical center

    Jerusalem, POB 12000

  • Meir Medical Center

    Kfar Saba, 4428164

  • Sheba Medical Center

    Ramat Gan, 5265601

  • Kaplan Medical Center

    Rehovot, 76100

  • Ziv Medical Center

    Safed, 13100

Other trials in Israel

South Korea6 sites

  • National Cancer Center - Center for Uterine Cancer

    Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • University of Ulsan College of Medicine - Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Belgium5 sites

  • OLV Ziekenhuis

    Aalst, 9300

  • AZ Klina

    Brasschaat, 2390

  • Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek

    Edegem, 2650

  • AZ St-Lucas

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Poland5 sites

  • Medical University of Gdansk

    Gdansk, 80-214

  • Samodzielny publiczny szpital kliniczny nr 1

    Lublin, 20-081

  • Wojewódzki Szpital Specjalistyczny, Oddzial Kliniczny Ginekologii Onkologiczne

    Olsztyn, 10-561

  • Wielkopolskie Centrum Onkologii

    Poznan, 61-866

  • Szpital Kliniczny im. Ks. Anny Mazowieckiej

    Warsaw, 00-315

Other trials in Poland

Ukraine5 sites

  • Communal non-profit enterprise "Cherkasy Regional Oncology Dispensary of Cherkasy oblast council"

    Cherkasy, 18009

  • Chernihiv Medical Center of Modern Oncology of Chernihiv Regional Council

    Chernihiv, Chernihiv Oblast, 14029

  • Prykarpatskyi Clinical Oncology Center of Ivano-Frankivsk Regional Council

    Ivano-Frankivsk, 76018

  • Grigoriev Institute for Medical Radiology NAMS of Ukraine

    Kharkiv, Kharkiv Oblast, 61024

  • Communal non-profit enterprise "Khmelnytskyi Regional Antitumor Center" of Khmelnytskoyi Regional Council

    Khmelnytskyi, Khmelnytskyi Oblast, 29009

Other trials in Ukraine

Bulgaria4 sites

  • Complex Oncology Center

    Burgas, 8000

  • UMHAT Georgi Stranski

    Pleven, 5800

  • Acibadem City Clinic Tokuda Hospital

    Sofia, 1407

  • UMHAT "Sv. Ivan Rilski", EAD, Sofia

    Sofia, 1431

Other trials in Bulgaria

Netherlands4 sites

  • Amsterdam UMC

    Amsterdam, 1105 AZ

  • Maastricht UMC

    Maastricht, 6229 HX

  • Radboud University Medical Center

    Nijmegen, Postbus 9101, 6500 HB

  • Erasmus Medical Center

    Rotterdam, 3015 AA

Other trials in Netherlands

Portugal4 sites

  • Fundação Champalimaud

    Lisbon, 1400-038

  • Hospital da Luz, S.A

    Lisbon, 1500-650

  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-028

  • Hospital Beatriz Angelo

    Loures, 2674-514

Other trials in Portugal

Russia4 sites

  • LLC "VitaMed"

    Moscow, 10

  • BIH of Omsk Region "Clinical Oncology Dispensary"

    Omsk, Omsk Oblast, 644013

  • Leningrad regional oncology dispensa

    Saint Petersburg, 194356

  • State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

    Ufa, 450054

Other trials in Russia

Czechia3 sites

  • Fakultní nemocnice Ostrava

    Ostrava, 708 52

  • Všeobecná fakultní nemocnice v Praze

    Prague, 128 51

  • KNTB a.s. Zlín

    Zlín, 762 75

Other trials in Czechia

Serbia3 sites

  • Oncology and Radiology Institute Serbia

    Belgrade, 11000

  • Oncology Institute Vojvodina, Surgical Oncology Clinic

    Kamenitz, 21204

  • Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Taiwan3 sites

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • Mackay Memorial Hospital - Taipei Branch

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

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

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.

Read the detailed description

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

Being tested
Mirvetuximab Soravtansine, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin
Keywords
Platinum-resistant, Folate-receptor alpha expression, Phase 3, Antibody-drug conjugate, mirvetuximab soravtansine, IMGN853, Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mirvetuximab SoravtansineDrug

    Also called MIRV, IMGN853

    Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.

  • PaclitaxelDrug

    Paclitaxel will be administered per dose and schedule specified in the arm.

  • TopotecanDrug

    Topotecan will be administered per dose and schedule specified in the arm.

  • Pegylated liposomal doxorubicinDrug

    Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.

Study groups in NCT04209855
Study groupRoleWhat they receive
Mirvetuximab SoravtansineExperimentalParticipants 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).
Receives: Drug: Mirvetuximab Soravtansine
Investigator's Choice (IC) ChemotherapyActive comparatorParticipants 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.
Receives: Drug: Paclitaxel; Drug: Topotecan; Drug: Pegylated liposomal doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization until PD or death, whichever occurred first (up to approximately 36 months)

Secondary outcomes (7)

  1. 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.

    Measured: Up to approximately 36 months

  2. 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.

    Measured: Up to approximately 45 months

  3. 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.

    Measured: Baseline and Week 8 or 9

  4. 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.

    Measured: Up to approximately 37 months

  5. 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.

    Measured: Up to approximately 34 months

  6. 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.

    Measured: Baseline up to approximately 36 months

  7. 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.

    Measured: Up to approximately 44 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2019
  2. Study start31 Dec 2019
  3. Primary completion6 Mar 2023
  4. Study completion29 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04209855
Sponsor's protocol ID
IMGN853-0416
Other IDs
2019-003509-80, 2019
Acronym
MIRASOL
Status last verified
Aug 2025
First submitted
17 Dec 2019
Last updated
27 Aug 2025
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 40179908

  • 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.

    PubMed 38055253

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirvetuximab Soravtansine, Paclitaxel and Topotecan in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by AbbVie at 214 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 214 sites in United States, China, France, Spain, Italy and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: From randomization until PD or death, whichever occurred first (up to approximately 36 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04209855, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.

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