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A 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 (MIRASOL)

Primary Purpose

Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mirvetuximab Soravtansine
Paclitaxel
Topotecan
Pegylated liposomal doxorubicin
Sponsored by
ImmunoGen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Platinum-resistant, Folate-receptor alpha expression, Phase 3, Antibody-drug conjugate, mirvetuximab soravtansine, IMGN853, Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female patients ≥ 18 years of age
  2. Patients must have a confirmed diagnosis of high-grade serious epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
  3. Patients must have platinum-resistant disease:

    1. Patients 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. Patients 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: Patients who are platinum-refractory during front-line treatment are excluded
  4. Patients must have progressed radiographically on or after their most recent line of therapy
  5. Patients 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 IHC confirmation of FRα positivity
  6. Patient's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay
  7. Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
  8. Patients 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 (eg, bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (ie, not counted independently)
    3. Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (ie, not counted independently)
    4. Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
  9. Patient 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. Patients 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. Patients must have adequate hematologic, liver and kidney functions defined as:

    1. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500/μL) without G-CSF in the prior 10 days or long-acting 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 (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN
    7. Serum albumin ≥ 2 g/dL
  14. Patients 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) (as defined in Section 5.9.6 in the protocol) 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. Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor
  2. Patients 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. Patients with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
  4. Patients with > Grade 1 peripheral neuropathy per CTCAE v5.0
  5. Patients 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. Patients 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. 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. Patients with history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
  8. Patients 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. Patients 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. Patients with a history of hemorrhagic or ischemic stroke within six months prior to randomization
  11. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
  12. Patients with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis
  13. Patients with required use of folate-containing supplements (eg, folate deficiency)
  14. Patients with prior hypersensitivity to monoclonal antibodies
  15. Women who are pregnant or lactating
  16. Patients with prior treatment with MIRV or other FRα-targeting agents
  17. Patients with untreated or symptomatic central nervous system (CNS) metastases
  18. Patients 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 (eg, 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

Sites / Locations

  • University of Alabama at Birmingham (UAB) GYN Oncology
  • Alaska Women's Cancer Care
  • Arizona Oncology Associates, PC - HAL - USOR
  • Mayo Clinic
  • USOR: Arizona Oncology Associates, PC - HOPE
  • University of Arizona Cancer Center
  • UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit
  • Hoag Cancer Center
  • University of California San Francisco
  • Olive View - UCLA Medical Center
  • Kaiser Permanente Oncology Clinical Trials
  • USOR: Rocky Mountain Cancer Centers
  • Yale University School of Medicine
  • Florida Cancer Specialist South Division
  • Mayo Clinic Jacksonville
  • Women's Care Florida / Women's Cancer Associates
  • Florida Cancer Specialist North Division
  • Sarasota Memorial Hospital
  • Florida Cancer Specialists
  • Florida Cancer Specialist East Division
  • Memorial University Medical Center
  • Hawaii Pacific Health - Kapiolani Medical Center for Women and Children
  • Illinois Cancer Specialists
  • University of Chicago
  • Dr. Sudarshan K. Sharma, Ltd.
  • Community Health Network
  • University of Kansas Cancer Center
  • St. Elizabeth Healthcare
  • Norton Cancer Institute
  • Ochnser Medical Center Jefferson
  • WK Physicians Network/Gynecologic Oncology Associates
  • Holy Cross Hospital
  • USOR: Maryland Oncology Hematology, P.A.
  • Tufts Medical Center
  • Baystate Medical Center
  • University of Massachusetts
  • St. Joseph Mercy Hospital
  • Karmanos Cancer Institute
  • Mayo Clinic Rochester
  • USOR: Minnesota Oncology Hematology, PA
  • HCA Midwest Kansas City/ Sarah Cannon
  • Sletten Cancer Institute
  • Center of Hope
  • The Valley Hospital, Inc
  • Holy Name Medical Center
  • Columbia University Medical Center
  • FirstHealth of the Carolinas Outpatient Cancer Center
  • USOR: OHC - Oncology_Hematology Care Clinical Trials, Inc.
  • MetroHealth Medical Center
  • Cleveland Clinic
  • Columbus NCORP
  • Zangmeister Cancer Center
  • The Ohio State University Wexner Medical Center
  • Stephenson Cancer Center
  • Oklahoma Cancer Specialists and Research Institute
  • USOR: Willamette Valley Cancer Institute and Research Center
  • Legacy Gynecologic Oncology
  • USOR: Northwest Cancer Specialists, P.C.
  • University of Pennsylvania
  • Fox Chase Cancer Center
  • Magee-Women's Hospital-UPMC
  • West Penn Hospital
  • Women & Infants Hospital of Rhode Island
  • Tennessee Oncology / Sarah Cannon Research Institute
  • USOR: Texas Oncology-South Austin
  • USOR: Texas Oncology - Fort Worth Cancer Center
  • University of Texas, Memorial Hermann
  • USOR: Texas Oncology - McAllen South Second
  • USOR: Texas Oncology - San Antonio
  • USOR: Texas Oncology, P.A.
  • USOR: Texas Oncology - The Woodlands, Gynecologic Oncology
  • USOR: Texas Oncology - Tyler
  • USOR: Texas Oncology, P.A.
  • University of Virginia Health System
  • USOR: Virginia Cancer Specialists, PC
  • Kadlec Clinic Hematology & Oncology
  • West Virginia University- MBRCC
  • Newcastle Private Hospital
  • Prince of Wales Hospital
  • Monash Health
  • Oncology Clinics Victoria (OCV) - Cabrini Malvern Hospital Location
  • Royal North Shore Hospital
  • Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
  • OLV Ziekenhuis
  • AZ Klina
  • Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek
  • AZ St-Lucas
  • UZ Leuven
  • UMHAT Georgi Stranski
  • Acibadem City Clinic Tokuda Hospital
  • UMHAT "Sv. Ivan Rilski", EAD, Sofia
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • The Ottawa Hospital General Campus
  • Sunnybrook Health Sciences Center
  • Princess Margaret Cancer Centre - University Health Network
  • McGill University Health Centre
  • Centre Hospitalier de L'Universite de Montreal
  • Centre Hospitalier Universitaire de Sherbrooke
  • Anhui Provincial Cancer Hospital
  • Fujian Cancer Hospital
  • Sun Yat-sen University, Cancer Center
  • Wuhan Union Hospital of China
  • Zhongnan Hospital of Wuhan University
  • Hubei Cancer Hospital
  • The First Affiliated Hospital of Soochow University
  • The First Hospital of Jilin University
  • Liaoning Cancer Hospital
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • Peking University First Hospital
  • Beijing Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Tianjin Medical University Cancer Institute & Hospital
  • Fakultní nemocnice Ostrava
  • Všeobecná fakultní nemocnice v Praze
  • KNTB a.s. Zlín
  • Institut Claudius Regaud
  • Centre Oscar Lambret
  • Institut de cancérologie de l'ouest, site Angers
  • CHRU Besançon
  • Institut Bergonie
  • Centre Leon Berard
  • Institut Paoli Calmettes
  • Cochin Hospital
  • Groupe Hospitalier Diaconesses Croix Saint-Simon
  • Centre Hospitalier Lyon Sud
  • Centre Armoricain de radiothérapie, imagerie médicale et oncologie, CARIO
  • Institut Curie
  • ICO Centre René Gauducheau
  • Institut de cancérologie de Lorraine
  • Gustave Roussy
  • Ulm University Hospital Klinik für Frauenheilkunde und Geburtshilfe
  • UMG Göttingen Frauenklinik
  • Universitätsklinikum Carl Gustav Carus Dresden
  • Universitätsklinikum Bonn
  • Städtisches Klinikum Dessau, Zentrum für Klinische Studien
  • Klinikum Dortmund gGmbH / Frauenklinik
  • University Hospital Freiburg
  • Mammazentrum Hamburg am Krankenhaus Jerusalem
  • Wolfson Medical Center
  • Hadassah Ein Kerem Medical center
  • Meir Medical Center
  • Sheba Medical Center
  • Kaplan Medical Center
  • Ziv Medical Center
  • IOV Istituto Oncologico
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • ASST Lecco- Ospedale A.Manzoni
  • IRCCS - Istituto Europeo di Oncologia (The European Institute of Oncology) (IEO)
  • INT Pascale
  • Oncologia Azienda Osc-IRCCS Reggio Emilia
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Azienda Ospedaliera Città Della Salute E Della Scienza Di Torino
  • Ospedale Mauriziano Umberto I
  • National Cancer Center - Center for Uterine Cancer
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital
  • University of Ulsan College of Medicine - Asan Medical Center
  • Samsung Medical Center
  • Amsterdam UMC
  • Maastricht UMC
  • Radboud University Medical Center
  • Erasmus Medical Center
  • Medical University of Gdansk
  • Samodzielny publiczny szpital kliniczny nr 1
  • Wojewódzki Szpital Specjalistyczny, Oddzial Kliniczny Ginekologii Onkologiczne
  • Wielkopolskie Centrum Onkologii
  • Szpital Kliniczny im. Ks. Anny Mazowieckiej
  • Fundação Champalimaud
  • Hospital da Luz, S.A
  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
  • Hospital Beatriz Angelo
  • BIH of Omsk Region "Clinical Oncology Dispensary"
  • LLC "VitaMed"
  • Leningrad regional oncology dispensa
  • State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
  • Oncology and Radiology Institute Serbia
  • Clinical Center Kragujevac
  • Oncology Institute Vojvodina, Surgical Oncology Clinic
  • Hospital Clínico de Santiago
  • H. U. de Jaén
  • Hospital Universitario Infanta Sofía
  • Institut Català d'Oncologia
  • H. San Pedro de Alcántara
  • Hospital Provincial de Castellon
  • Hospital de San Chinarro-Clara Campal
  • Hospital Clínico Universitario Virgen de la Arrixaca
  • Parc Taulí
  • Virgen del Rocío
  • Hospital de la Fe
  • HCU Lozano Blesa
  • Far Eastern Memorial Hospital
  • Mackay Memorial Hospital - Taipei Branch
  • Taipei Veterans General Hospital
  • Chernihiv Medical Center of Modern Oncology of Chernihiv Regional Council
  • Grigoriev Institute for Medical Radiology NAMS of Ukraine
  • Communal non-profit enterprise "Khmelnytskyi Regional Antitumor Center" of Khmelnytskoyi Regional Council
  • Communal non-profit enterprise "Cherkasy Regional Oncology Dispensary of Cherkasy oblast council"
  • Prykarpatskyi Clinical Oncology Center of Ivano-Frankivsk Regional Council
  • Peterborough City Hospital
  • Royal Devon and Exeter Hospital (Wonford)
  • University Hospitals Coventry and Warwickshire
  • Beatson West of Scotland Cancer Centre
  • St Bartholomew's Hospital-Barts Health NHS Trust
  • University College London Hospital
  • The Royal Marsden NHS Foundation Trust
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mirvetuximab soravtansine (MIRV; IMGN853)

Investigator's choice of chemotherapy

Arm Description

MIRV 6 mg/kg adjusted ideal body weight (AIBW) every 3 weeks (Q3W)

Paclitaxel (Pac; 80 mg/m2) administered once per week (QW) within a 4-week cycle Pegylated liposomal doxorubicin (PLD; 40 mg/m2) administered every 4 weeks (Q4W) Topotecan (Topo; 4 mg/m2) administered either on Days 1, 8, and 15 every 4 weeks or for 5 consecutive days (1.25 mg/m2 Days 1-5) every 3 weeks (Q3W)

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
The time from date of randomization until Investigator-assessed progressive disease or death, whichever occurs first.

Secondary Outcome Measures

Safety and tolerability
Adverse events (AEs) will be evaluated according to the NCI CTCAE v5.0. AEs will be coded using the latest Medical Dictionary for Regulatory Activities (MedDRA) version and summarized per system organ class (SOC) and preferred term (PT).
Objective Response Rate (ORR)
Objective response includes best response of complete response (CR) or partial response (PR).
Overall survival
The time from date of randomization until the date of death
Primary patient-reported outcomes
The number of patients achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the European Organization for Research and Treatment of Cancer (EORTC) ovarian cancer specific quality of life questionnaire (QLQ-OV28). A higher score represents a better quality of life.
Duration of response (DOR)
The time from initial response until Investigator-assessed progressive disease for all patients who achieve a confirmed objective response
CA-125 response
Serum CA-125 response determined using the GCIG criteria
Progression-free survival 2 (PFS 2)
The time from date of randomization until second disease progression or death whichever occurs first. Results will be summarized by arm

Full Information

First Posted
December 17, 2019
Last Updated
March 3, 2023
Sponsor
ImmunoGen, Inc.
Collaborators
Gynecologic Oncology Group, European Network of Gynaecological Oncological Trial Groups (ENGOT)
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1. Study Identification

Unique Protocol Identification Number
NCT04209855
Brief Title
A 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
Acronym
MIRASOL
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 31, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmunoGen, Inc.
Collaborators
Gynecologic Oncology Group, European Network of Gynaecological Oncological Trial Groups (ENGOT)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.
Detailed Description
Patients will be randomized to either mirvetuximab soravtansine (MIRV) or Investigator's Choice chemotherapy (paclitaxel, PEGylated liposomal doxorubicin, or topotecan).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Keywords
Platinum-resistant, Folate-receptor alpha expression, Phase 3, Antibody-drug conjugate, mirvetuximab soravtansine, IMGN853, Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
453 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mirvetuximab soravtansine (MIRV; IMGN853)
Arm Type
Experimental
Arm Description
MIRV 6 mg/kg adjusted ideal body weight (AIBW) every 3 weeks (Q3W)
Arm Title
Investigator's choice of chemotherapy
Arm Type
Active Comparator
Arm Description
Paclitaxel (Pac; 80 mg/m2) administered once per week (QW) within a 4-week cycle Pegylated liposomal doxorubicin (PLD; 40 mg/m2) administered every 4 weeks (Q4W) Topotecan (Topo; 4 mg/m2) administered either on Days 1, 8, and 15 every 4 weeks or for 5 consecutive days (1.25 mg/m2 Days 1-5) every 3 weeks (Q3W)
Intervention Type
Drug
Intervention Name(s)
Mirvetuximab Soravtansine
Other Intervention Name(s)
MIRV, IMGN853
Intervention Description
Mirvetuximab soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel is a taxane that can stabilize microtubules to inhibit cell division. It was approved for treatment of recurrent epithelial ovarian cancer.
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
Topotecan induces irreversible DNA damage. It inhibits topoisomerase 1, leading to both single and double strand DNA break that eventually promote apoptosis. Topotecan was approved for treatment of epithelial ovarian cancer after failure of initial or subsequent chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Pegylated liposomal doxorubicin
Intervention Description
Pegylated liposomal doxorubicin is a standard chemotherapy regimen used for treating platinum-resistant ovarian cancer. The active component doxorubicin is an anthracycline that intercalates DNA, leading to inhibition of replication and subsequently, the inhibition of proper cell division.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
The time from date of randomization until Investigator-assessed progressive disease or death, whichever occurs first.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Safety and tolerability
Description
Adverse events (AEs) will be evaluated according to the NCI CTCAE v5.0. AEs will be coded using the latest Medical Dictionary for Regulatory Activities (MedDRA) version and summarized per system organ class (SOC) and preferred term (PT).
Time Frame
Up to 2 years
Title
Objective Response Rate (ORR)
Description
Objective response includes best response of complete response (CR) or partial response (PR).
Time Frame
Up to 2 years
Title
Overall survival
Description
The time from date of randomization until the date of death
Time Frame
Up to 2 years
Title
Primary patient-reported outcomes
Description
The number of patients achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the European Organization for Research and Treatment of Cancer (EORTC) ovarian cancer specific quality of life questionnaire (QLQ-OV28). A higher score represents a better quality of life.
Time Frame
Up to 2 years
Title
Duration of response (DOR)
Description
The time from initial response until Investigator-assessed progressive disease for all patients who achieve a confirmed objective response
Time Frame
Up to 2 years
Title
CA-125 response
Description
Serum CA-125 response determined using the GCIG criteria
Time Frame
Up to 2 years
Title
Progression-free survival 2 (PFS 2)
Description
The time from date of randomization until second disease progression or death whichever occurs first. Results will be summarized by arm
Time Frame
Up to 2 years
Other Pre-specified Outcome Measures:
Title
Patient-reported outcomes using EORTC QLQ-C30 questionnaires
Description
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.
Time Frame
Up to 2 years
Title
Patient-reported outcomes using EQ-5D-5L questionnaires
Description
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.
Time Frame
Up to 2 years
Title
Pharmacokinetic parameters
Description
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.
Time Frame
Up to 2 years
Title
Immunogenicity
Description
The presence of anti-drug antibodies to mirvetuximab soravtansine
Time Frame
Up to 2 years
Title
Identification of soluble FRα levels and other biomarkers
Time Frame
Up to 2 years
Title
Patient-reported outcomes using PGIS questionnaires
Description
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.
Time Frame
Up to 2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients ≥ 18 years of age Patients must have a confirmed diagnosis of high-grade serious epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer Patients must have platinum-resistant disease: Patients 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 Patients 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: Patients who are platinum-refractory during front-line treatment are excluded Patients must have progressed radiographically on or after their most recent line of therapy Patients 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 IHC confirmation of FRα positivity Patient's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator) Patients 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 (eg, bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (ie, not counted independently) Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (ie, not counted independently) Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance Patient 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 Patients 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 Patients must have adequate hematologic, liver and kidney functions defined as: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500/μL) without G-CSF in the prior 10 days or long-acting 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 (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN Serum albumin ≥ 2 g/dL Patients 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) (as defined in Section 5.9.6 in the protocol) 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 Exclusion Criteria: Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor Patients 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 Patients with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow Patients with > Grade 1 peripheral neuropathy per CTCAE v5.0 Patients 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 Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following: Active hepatitis B or C infection (whether or not on active antiviral therapy) 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 Patients with history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome) Patients 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 Patients 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 Patients with a history of hemorrhagic or ischemic stroke within six months prior to randomization Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C) Patients with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis Patients with required use of folate-containing supplements (eg, folate deficiency) Patients with prior hypersensitivity to monoclonal antibodies Women who are pregnant or lactating Patients with prior treatment with MIRV or other FRα-targeting agents Patients with untreated or symptomatic central nervous system (CNS) metastases Patients 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 (eg, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Method, MPH, MBA
Organizational Affiliation
ImmunoGen, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB) GYN Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Alaska Women's Cancer Care
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Arizona Oncology Associates, PC - HAL - USOR
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
USOR: Arizona Oncology Associates, PC - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Hoag Cancer Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Olive View - UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Kaiser Permanente Oncology Clinical Trials
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
USOR: Rocky Mountain Cancer Centers
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Florida Cancer Specialist South Division
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Women's Care Florida / Women's Cancer Associates
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Florida Cancer Specialist North Division
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Florida Cancer Specialists
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Florida Cancer Specialist East Division
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Memorial University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Hawaii Pacific Health - Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Illinois Cancer Specialists
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dr. Sudarshan K. Sharma, Ltd.
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Community Health Network
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
St. Elizabeth Healthcare
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Ochnser Medical Center Jefferson
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
WK Physicians Network/Gynecologic Oncology Associates
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
771103
Country
United States
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
USOR: Maryland Oncology Hematology, P.A.
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
USOR: Minnesota Oncology Hematology, PA
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
HCA Midwest Kansas City/ Sarah Cannon
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Center of Hope
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
The Valley Hospital, Inc
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
FirstHealth of the Carolinas Outpatient Cancer Center
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
USOR: OHC - Oncology_Hematology Care Clinical Trials, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Columbus NCORP
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Zangmeister Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Hilliard
State/Province
Ohio
ZIP/Postal Code
43026
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
USOR: Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Legacy Gynecologic Oncology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
USOR: Northwest Cancer Specialists, P.C.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Magee-Women's Hospital-UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Tennessee Oncology / Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
USOR: Texas Oncology-South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
USOR: Texas Oncology - Fort Worth Cancer Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas, Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
USOR: Texas Oncology - McAllen South Second
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
USOR: Texas Oncology - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
USOR: Texas Oncology, P.A.
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
USOR: Texas Oncology - The Woodlands, Gynecologic Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
USOR: Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
USOR: Texas Oncology, P.A.
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
USOR: Virginia Cancer Specialists, PC
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
Country
United States
Facility Name
Kadlec Clinic Hematology & Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
West Virginia University- MBRCC
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Newcastle Private Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Oncology Clinics Victoria (OCV) - Cabrini Malvern Hospital Location
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Royal North Shore Hospital
City
Saint Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
City
Toorak Gardens
ZIP/Postal Code
5065
Country
Australia
Facility Name
OLV Ziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
AZ Klina
City
Brasschaat
ZIP/Postal Code
2390
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
AZ St-Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
UMHAT Georgi Stranski
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Acibadem City Clinic Tokuda Hospital
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski", EAD, Sofia
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
The Ottawa Hospital General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre - University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Centre Hospitalier de L'Universite de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Sun Yat-sen University, Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Wuhan Union Hospital of China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430024
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430061
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130031
Country
China
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110801
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Fakultní nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Všeobecná fakultní nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 51
Country
Czechia
Facility Name
KNTB a.s. Zlín
City
Zlín
ZIP/Postal Code
762 75
Country
Czechia
Facility Name
Institut Claudius Regaud
City
Toulouse
State/Province
Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
State/Province
Cedex B.P 307
ZIP/Postal Code
59020
Country
France
Facility Name
Institut de cancérologie de l'ouest, site Angers
City
Angers
State/Province
Cedex
ZIP/Postal Code
49055
Country
France
Facility Name
CHRU Besançon
City
Besançon Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Leon Berard
City
Lyon Cedex
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Groupe Hospitalier Diaconesses Croix Saint-Simon
City
Paris
ZIP/Postal Code
75960 Cedex 20
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Centre Armoricain de radiothérapie, imagerie médicale et oncologie, CARIO
City
Plerin
ZIP/Postal Code
22190
Country
France
Facility Name
Institut Curie
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
ICO Centre René Gauducheau
City
St. Herblain CEDEX
ZIP/Postal Code
44805
Country
France
Facility Name
Institut de cancérologie de Lorraine
City
Vandoeuvre les Nancy_ Cedex
ZIP/Postal Code
54519
Country
France
Facility Name
Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Ulm University Hospital Klinik für Frauenheilkunde und Geburtshilfe
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89075
Country
Germany
Facility Name
UMG Göttingen Frauenklinik
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Städtisches Klinikum Dessau, Zentrum für Klinische Studien
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Klinikum Dortmund gGmbH / Frauenklinik
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
University Hospital Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Mammazentrum Hamburg am Krankenhaus Jerusalem
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Hadassah Ein Kerem Medical center
City
Jerusalem
ZIP/Postal Code
POB 12000
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Ziv Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
IOV Istituto Oncologico
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
ASST Lecco- Ospedale A.Manzoni
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
IRCCS - Istituto Europeo di Oncologia (The European Institute of Oncology) (IEO)
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
INT Pascale
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Oncologia Azienda Osc-IRCCS Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Città Della Salute E Della Scienza Di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale Mauriziano Umberto I
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
National Cancer Center - Center for Uterine Cancer
City
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
University of Ulsan College of Medicine - Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Amsterdam UMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Maastricht UMC
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
Postbus 9101, 6500 HB
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015 AA
Country
Netherlands
Facility Name
Medical University of Gdansk
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Samodzielny publiczny szpital kliniczny nr 1
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny, Oddzial Kliniczny Ginekologii Onkologiczne
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Wielkopolskie Centrum Onkologii
City
Poznań
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Szpital Kliniczny im. Ks. Anny Mazowieckiej
City
Warszawa
ZIP/Postal Code
00-315
Country
Poland
Facility Name
Fundação Champalimaud
City
Lisbon
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Hospital da Luz, S.A
City
Lisbon
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
City
Lisbon
ZIP/Postal Code
1649-028
Country
Portugal
Facility Name
Hospital Beatriz Angelo
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
BIH of Omsk Region "Clinical Oncology Dispensary"
City
Omsk
State/Province
Omsk Oblast
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
LLC "VitaMed"
City
Moscow
ZIP/Postal Code
10
Country
Russian Federation
Facility Name
Leningrad regional oncology dispensa
City
St-Petersburg
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Oncology and Radiology Institute Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Oncology Institute Vojvodina, Surgical Oncology Clinic
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Hospital Clínico de Santiago
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
H. U. de Jaén
City
Jaén
State/Province
Andalucia
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital Universitario Infanta Sofía
City
San Sebastián de los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
Institut Català d'Oncologia
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
H. San Pedro de Alcántara
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Provincial de Castellon
City
Castelló
ZIP/Postal Code
12002
Country
Spain
Facility Name
Hospital de San Chinarro-Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Parc Taulí
City
Sabadell
ZIP/Postal Code
8208
Country
Spain
Facility Name
Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital de la Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
HCU Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Facility Name
Mackay Memorial Hospital - Taipei Branch
City
Taipei City
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chernihiv Medical Center of Modern Oncology of Chernihiv Regional Council
City
Chernihiv
State/Province
Chernihiv Region
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
Grigoriev Institute for Medical Radiology NAMS of Ukraine
City
Kharkiv
State/Province
Kharkiv Region
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Communal non-profit enterprise "Khmelnytskyi Regional Antitumor Center" of Khmelnytskoyi Regional Council
City
Khmelnytskyi
State/Province
Khmelnytskyi Region
ZIP/Postal Code
29009
Country
Ukraine
Facility Name
Communal non-profit enterprise "Cherkasy Regional Oncology Dispensary of Cherkasy oblast council"
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Prykarpatskyi Clinical Oncology Center of Ivano-Frankivsk Regional Council
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Peterborough City Hospital
City
Peterborough
State/Province
Cambridgeshire
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
University Hospitals Coventry and Warwickshire
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
St Bartholomew's Hospital-Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A 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

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