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
NCT ID: NCT04209855
Last Updated: 2025-08-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
453 participants
INTERVENTIONAL
2019-12-31
2024-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Mirvetuximab Soravtansine
Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.
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.
Paclitaxel
Paclitaxel will be administered per dose and schedule specified in the arm.
Topotecan
Topotecan will be administered per dose and schedule specified in the arm.
Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.
Interventions
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Mirvetuximab Soravtansine
Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.
Paclitaxel
Paclitaxel will be administered per dose and schedule specified in the arm.
Topotecan
Topotecan will be administered per dose and schedule specified in the arm.
Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Gynecologic Oncology Group
NETWORK
European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Alabama at Birmingham (UAB) GYN Oncology
Birmingham, Alabama, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Arizona Oncology Associates, PC - HAL - USOR
Phoenix, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
USOR: Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit
Los Angeles, California, United States
Hoag Cancer Center
Newport Beach, California, United States
University of California San Francisco
San Francisco, California, United States
Olive View - UCLA Medical Center
Sylmar, California, United States
Kaiser Permanente Oncology Clinical Trials
Vallejo, California, United States
USOR: Rocky Mountain Cancer Centers
Lakewood, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Florida Cancer Specialist South Division
Fort Myers, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Women's Care Florida / Women's Cancer Associates
St. Petersburg, Florida, United States
Florida Cancer Specialist North Division
St. Petersburg, Florida, United States
Florida Cancer Specialists
Tallahassee, Florida, United States
Florida Cancer Specialist East Division
West Palm Beach, Florida, United States
Memorial University Medical Center
Savannah, Georgia, United States
Hawaii Pacific Health - Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Dr. Sudarshan K. Sharma, Ltd.
Hinsdale, Illinois, United States
Community Health Network
Indianapolis, Indiana, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Ochnser Medical Center Jefferson
New Orleans, Louisiana, United States
WK Physicians Network/Gynecologic Oncology Associates
Shreveport, Louisiana, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
USOR: Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
USOR: Minnesota Oncology Hematology, PA
Woodbury, Minnesota, United States
HCA Midwest Kansas City/ Sarah Cannon
Kansas City, Missouri, United States
Sletten Cancer Institute
Great Falls, Montana, United States
Center of Hope
Reno, Nevada, United States
The Valley Hospital, Inc
Ridgewood, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
FirstHealth of the Carolinas Outpatient Cancer Center
Pinehurst, North Carolina, United States
USOR: OHC - Oncology_Hematology Care Clinical Trials, Inc.
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Columbus NCORP
Columbus, Ohio, United States
Zangmeister Cancer Center
Columbus, Ohio, United States
Oncology_Hematology Care Clinical Trials, LLC
Fairfield, Ohio, United States
The Ohio State University Wexner Medical Center
Hilliard, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States
USOR: Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Legacy Gynecologic Oncology
Portland, Oregon, United States
USOR: Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Magee-Women's Hospital-UPMC
Pittsburgh, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Tennessee Oncology / Sarah Cannon Research Institute
Nashville, Tennessee, United States
USOR: Texas Oncology-South Austin
Austin, Texas, United States
USOR: Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, United States
University of Texas, Memorial Hermann
Houston, Texas, United States
USOR: Texas Oncology - McAllen South Second
McAllen, Texas, United States
USOR: Texas Oncology - San Antonio
San Antonio, Texas, United States
USOR: Texas Oncology, P.A.
Sugar Land, Texas, United States
USOR: Texas Oncology - The Woodlands, Gynecologic Oncology
The Woodlands, Texas, United States
USOR: Texas Oncology - Tyler
Tyler, Texas, United States
USOR: Texas Oncology, P.A.
Webster, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
USOR: Virginia Cancer Specialists, PC
Gainesville, Virginia, United States
Kadlec Clinic Hematology & Oncology
Kennewick, Washington, United States
West Virginia University- MBRCC
Morgantown, West Virginia, United States
Newcastle Private Hospital
New Lambton Heights, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Oncology Clinics Victoria (OCV) - Cabrini Malvern Hospital Location
Malvern, Victoria, Australia
Royal North Shore Hospital
Saint Leonards, , Australia
Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
Toorak Gardens, , Australia
OLV Ziekenhuis
Aalst, , Belgium
AZ Klina
Brasschaat, , Belgium
Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek
Edegem, , Belgium
AZ St-Lucas
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Complex Oncology Center
Burgas, , Bulgaria
UMHAT Georgi Stranski
Pleven, , Bulgaria
Acibadem City Clinic Tokuda Hospital
Sofia, , Bulgaria
UMHAT "Sv. Ivan Rilski", EAD, Sofia
Sofia, , Bulgaria
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
The Ottawa Hospital General Campus
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, Canada
Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China
Wuhan Union Hospital of China
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Peking University First Hospital
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Fakultní nemocnice Ostrava
Ostrava, , Czechia
Všeobecná fakultní nemocnice v Praze
Prague, , Czechia
KNTB a.s. Zlín
Zlín, , Czechia
Institut Claudius Regaud
Toulouse, Cedex 9, France
Centre Oscar Lambret
Lille, Cedex B.P 307, France
Institut de cancérologie de l'ouest, site Angers
Angers, Cedex, France
CHRU Besançon
Besançon, , France
Institut Bergonie
Bordeaux, , France
Centre Leon Berard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Cochin Hospital
Paris, , France
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Armoricain de radiothérapie, imagerie médicale et oncologie, CARIO
Plérin, , France
Institut Curie
Saint-Cloud, , France
ICO Centre René Gauducheau
Saint-Herblain, , France
Institut de cancérologie de Lorraine
Vandoeuvre Les Nancy_ Cedex, , France
Gustave Roussy
Villejuif, , France
Ulm University Hospital Klinik für Frauenheilkunde und Geburtshilfe
Ulm, Baden-Wurttemberg, Germany
UMG Göttingen Frauenklinik
Göttingen, Lower Saxony, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany
Universitätsklinikum Bonn
Bonn, , Germany
Städtisches Klinikum Dessau, Zentrum für Klinische Studien
Dessau, , Germany
Klinikum Dortmund gGmbH / Frauenklinik
Dortmund, , Germany
University Hospital Freiburg
Freiburg im Breisgau, , Germany
UKGM Standort Giessen
Giessen, , Germany
Mammazentrum Hamburg am Krankenhaus Jerusalem
Hamburg, , Germany
Wolfson Medical Center
Holon, , Israel
Hadassah Ein Kerem Medical center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
Ziv Medical Center
Safed, , Israel
IOV Istituto Oncologico
Padua, PD, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, , Italy
ASST Lecco- Ospedale A.Manzoni
Lecco, , Italy
IRCCS - Istituto Europeo di Oncologia (The European Institute of Oncology) (IEO)
Milan, , Italy
INT Pascale
Naples, , Italy
Centro Operativo Studi Clinici S.C.Oncologia Medica
Perugia, , Italy
Oncologia Azienda Osc-IRCCS Reggio Emilia
Reggio Emilia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, , Italy
Azienda Ospedaliera Città Della Salute E Della Scienza Di Torino
Torino, , Italy
Ospedale Mauriziano Umberto I
Torino, , Italy
Istituto Oncologico Candiolo
Torino, , Italy
Amsterdam UMC
Amsterdam, , Netherlands
Maastricht UMC
Maastricht, , Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Medical University of Gdansk
Gdansk, , Poland
Samodzielny publiczny szpital kliniczny nr 1
Lublin, , Poland
Wojewódzki Szpital Specjalistyczny, Oddzial Kliniczny Ginekologii Onkologiczne
Olsztyn, , Poland
Wielkopolskie Centrum Onkologii
Poznan, , Poland
Szpital Kliniczny im. Ks. Anny Mazowieckiej
Warsaw, , Poland
Fundação Champalimaud
Lisbon, , Portugal
Hospital da Luz, S.A
Lisbon, , Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, , Portugal
Hospital Beatriz Angelo
Loures, , Portugal
BIH of Omsk Region "Clinical Oncology Dispensary"
Omsk, Omsk Oblast, Russia
LLC "VitaMed"
Moscow, , Russia
Leningrad regional oncology dispensa
Saint Petersburg, , Russia
State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
Ufa, , Russia
Oncology and Radiology Institute Serbia
Belgrade, , Serbia
Oncology Institute Vojvodina, Surgical Oncology Clinic
Kamenitz, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
National Cancer Center - Center for Uterine Cancer
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
University of Ulsan College of Medicine - Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Clínico de Santiago
Santiago de Compostela, A Coruña, Spain
H. U. de Jaén
Jaén, Andalusia, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain
Institut Català d'Oncologia
Badalona, , Spain
Hospital Provincial de Castellon
Castelló, , Spain
H. San Pedro de Alcántara
Cáceres, , Spain
Hospital de San Chinarro-Clara Campal
Madrid, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Parc Taulí
Sabadell, , Spain
Virgen del Rocío
Seville, , Spain
Hospital de la Fe
Valencia, , Spain
HCU Lozano Blesa
Zaragoza, , Spain
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Mackay Memorial Hospital - Taipei Branch
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chernihiv Medical Center of Modern Oncology of Chernihiv Regional Council
Chernihiv, Chernihiv Oblast, Ukraine
Grigoriev Institute for Medical Radiology NAMS of Ukraine
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Communal non-profit enterprise "Khmelnytskyi Regional Antitumor Center" of Khmelnytskoyi Regional Council
Khmelnytskyi, Khmelnytskyi Oblast, Ukraine
Communal non-profit enterprise "Cherkasy Regional Oncology Dispensary of Cherkasy oblast council"
Cherkasy, , Ukraine
Prykarpatskyi Clinical Oncology Center of Ivano-Frankivsk Regional Council
Ivano-Frankivsk, , Ukraine
Peterborough City Hospital
Peterborough, Cambridgeshire, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, Devon, United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
St Bartholomew's Hospital-Barts Health NHS Trust
London, , United Kingdom
University College London Hospital
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-003509-80
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IMGN853-0416
Identifier Type: -
Identifier Source: org_study_id
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