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

Fallopian Tube Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04209855
• Other study ID #: IMGN853-0416
• Secondary ID: 2019-003509-80
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 31, 2019
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: ImmunoGen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients will be randomized to either mirvetuximab soravtansine (MIRV) or Investigator's Choice chemotherapy (paclitaxel, PEGylated liposomal doxorubicin, or topotecan).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 453
• Est. completion date: April 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 FRa positivity

6. Patient's tumor must be positive for FRa 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 FRa-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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Peritoneal Cancer

Intervention

Drug:
• Mirvetuximab Soravtansine
Mirvetuximab soravtansine is an antibody drug conjugate designed to target folate receptor a (FRa). It consists of the humanized anti-FRa mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.
• Paclitaxel
Paclitaxel is a taxane that can stabilize microtubules to inhibit cell division. It was approved for treatment of recurrent epithelial ovarian cancer.
• Topotecan
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.
• Pegylated liposomal doxorubicin
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.

Locations

Country	Name	City	State
Australia	Monash Health	Clayton	Victoria
Australia	Oncology Clinics Victoria (OCV) - Cabrini Malvern Hospital Location	Malvern	Victoria
Australia	Newcastle Private Hospital	New Lambton Heights	New South Wales
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Royal North Shore Hospital	Saint Leonards
Australia	Burnside War Memorial Hospital - The Brian Fricker Oncology Centre	Toorak Gardens
Belgium	OLV Ziekenhuis	Aalst
Belgium	AZ Klina	Brasschaat
Belgium	Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek	Edegem
Belgium	AZ St-Lucas	Gent
Belgium	UZ Leuven	Leuven
Bulgaria	UMHAT Georgi Stranski	Pleven
Bulgaria	Acibadem City Clinic Tokuda Hospital	Sofia
Bulgaria	UMHAT "Sv. Ivan Rilski", EAD, Sofia	Sofia
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Centre Hospitalier de L'Universite de Montreal	Montréal	Quebec
Canada	The Ottawa Hospital General Campus	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Princess Margaret Cancer Centre - University Health Network	Toronto	Ontario
Canada	Sunnybrook Health Sciences Center	Toronto	Ontario
China	Beijing Cancer Hospital	Beijing
China	Peking University First Hospital	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Sun Yat-sen University, Cancer Center	Guangzhou	Guangdong
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	Fudan University Shanghai Cancer Center	Shanghai
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Wuhan Union Hospital of China	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
Czechia	Fakultní nemocnice Ostrava	Ostrava
Czechia	Všeobecná fakultní nemocnice v Praze	Praha 2
Czechia	KNTB a.s. Zlín	Zlín
France	Institut de cancérologie de l'ouest, site Angers	Angers	Cedex
France	CHRU Besançon	Besançon Cedex
France	Institut Bergonie	Bordeaux Cedex
France	Centre Oscar Lambret	Lille	Cedex B.P 307
France	Centre Leon Berard	Lyon Cedex
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	Plerin
France	Institut Curie	Saint Cloud
France	ICO Centre René Gauducheau	St. Herblain CEDEX
France	Institut Claudius Regaud	Toulouse	Cedex 9
France	Institut de cancérologie de Lorraine	Vandoeuvre les Nancy_ Cedex
France	Gustave Roussy	Villejuif Cedex
Germany	Universitätsklinikum Bonn	Bonn
Germany	Städtisches Klinikum Dessau, Zentrum für Klinische Studien	Dessau
Germany	Klinikum Dortmund gGmbH / Frauenklinik	Dortmund
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden	Saxony
Germany	University Hospital Freiburg	Freiburg
Germany	UMG Göttingen Frauenklinik	Göttingen	Niedersachsen
Germany	Mammazentrum Hamburg am Krankenhaus Jerusalem	Hamburg
Germany	Ulm University Hospital Klinik für Frauenheilkunde und Geburtshilfe	Ulm	Baden-Württemberg
Israel	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
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	IOV Istituto Oncologico	Padova	PD
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
Korea, Republic of	National Cancer Center - Center for Uterine Cancer	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	University of Ulsan College of Medicine - Asan Medical Center	Seoul
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Maastricht UMC	Maastricht
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	Erasmus Medical Center	Rotterdam
Poland	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	Warszawa
Portugal	Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria	Lisbon
Portugal	Fundação Champalimaud	Lisbon
Portugal	Hospital da Luz, S.A	Lisbon
Portugal	Hospital Beatriz Angelo	Loures
Russian Federation	LLC "VitaMed"	Moscow
Russian Federation	BIH of Omsk Region "Clinical Oncology Dispensary"	Omsk	Omsk Oblast
Russian Federation	Leningrad regional oncology dispensa	St-Petersburg
Russian Federation	State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan	Ufa
Serbia	Oncology and Radiology Institute Serbia	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Oncology Institute Vojvodina, Surgical Oncology Clinic	Sremska Kamenica
Spain	Institut Català d'Oncologia	Badalona
Spain	H. San Pedro de Alcántara	Caceres
Spain	Hospital Provincial de Castellon	Castelló
Spain	H. U. de Jaén	Jaén	Andalucia
Spain	Hospital de San Chinarro-Clara Campal	Madrid
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
Spain	Parc Taulí	Sabadell
Spain	Hospital Universitario Infanta Sofía	San Sebastián de los Reyes	Madrid
Spain	Hospital Clínico de Santiago	Santiago de Compostela	A Coruña
Spain	Virgen del Rocío	Sevilla
Spain	Hospital de la Fe	Valencia
Spain	HCU Lozano Blesa	Zaragoza
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Mackay Memorial Hospital - Taipei Branch	Taipei City
Taiwan	Taipei Veterans General Hospital	Taipei City
Ukraine	Communal non-profit enterprise "Cherkasy Regional Oncology Dispensary of Cherkasy oblast council"	Cherkasy
Ukraine	Chernihiv Medical Center of Modern Oncology of Chernihiv Regional Council	Chernihiv	Chernihiv Region
Ukraine	Prykarpatskyi Clinical Oncology Center of Ivano-Frankivsk Regional Council	Ivano-Frankivsk
Ukraine	Grigoriev Institute for Medical Radiology NAMS of Ukraine	Kharkiv	Kharkiv Region
Ukraine	Communal non-profit enterprise "Khmelnytskyi Regional Antitumor Center" of Khmelnytskoyi Regional Council	Khmelnytskyi	Khmelnytskyi Region
United Kingdom	University Hospitals Coventry and Warwickshire	Coventry
United Kingdom	Royal Devon and Exeter Hospital (Wonford)	Exeter	Devon
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	St Bartholomew's Hospital-Barts Health NHS Trust	London
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	University College London Hospital	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Peterborough City Hospital	Peterborough	Cambridgeshire
United States	Alaska Women's Cancer Care	Anchorage	Alaska
United States	St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Illinois Cancer Specialists	Arlington Heights	Illinois
United States	USOR: Texas Oncology-South Austin	Austin	Texas
United States	University of Alabama at Birmingham (UAB) GYN Oncology	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
United States	USOR: OHC - Oncology_Hematology Care Clinical Trials, Inc.	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Columbus NCORP	Columbus	Ohio
United States	Zangmeister Cancer Center	Columbus	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	St. Elizabeth Healthcare	Edgewood	Kentucky
United States	USOR: Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Florida Cancer Specialist South Division	Fort Myers	Florida
United States	USOR: Texas Oncology - Fort Worth Cancer Center	Fort Worth	Texas
United States	USOR: Virginia Cancer Specialists, PC	Gainesville	Virginia
United States	Sletten Cancer Institute	Great Falls	Montana
United States	The Ohio State University Wexner Medical Center	Hilliard	Ohio
United States	Dr. Sudarshan K. Sharma, Ltd.	Hinsdale	Illinois
United States	Hawaii Pacific Health - Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	University of Texas, Memorial Hermann	Houston	Texas
United States	Community Health Network	Indianapolis	Indiana
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	HCA Midwest Kansas City/ Sarah Cannon	Kansas City	Missouri
United States	Kadlec Clinic Hematology & Oncology	Kennewick	Washington
United States	USOR: Rocky Mountain Cancer Centers	Lakewood	Colorado
United States	UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	USOR: Texas Oncology - McAllen South Second	McAllen	Texas
United States	West Virginia University- MBRCC	Morgantown	West Virginia
United States	Tennessee Oncology / Sarah Cannon Research Institute	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Ochnser Medical Center Jefferson	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Hoag Cancer Center	Newport Beach	California
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Oncology Associates, PC - HAL - USOR	Phoenix	Arizona
United States	Mayo Clinic	Phoenix	Arizona
United States	FirstHealth of the Carolinas Outpatient Cancer Center	Pinehurst	North Carolina
United States	Magee-Women's Hospital-UPMC	Pittsburgh	Pennsylvania
United States	West Penn Hospital	Pittsburgh	Pennsylvania
United States	Legacy Gynecologic Oncology	Portland	Oregon
United States	USOR: Northwest Cancer Specialists, P.C.	Portland	Oregon
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island
United States	Center of Hope	Reno	Nevada
United States	The Valley Hospital, Inc	Ridgewood	New Jersey
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Florida Cancer Specialist North Division	Saint Petersburg	Florida
United States	Women's Care Florida / Women's Cancer Associates	Saint Petersburg	Florida
United States	USOR: Texas Oncology - San Antonio	San Antonio	Texas
United States	University of California San Francisco	San Francisco	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Memorial University Medical Center	Savannah	Georgia
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	Baystate Medical Center	Springfield	Massachusetts
United States	USOR: Texas Oncology, P.A.	Sugar Land	Texas
United States	Olive View - UCLA Medical Center	Sylmar	California
United States	Florida Cancer Specialists	Tallahassee	Florida
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	USOR: Texas Oncology - The Woodlands, Gynecologic Oncology	The Woodlands	Texas
United States	University of Arizona Cancer Center	Tucson	Arizona
United States	USOR: Arizona Oncology Associates, PC - HOPE	Tucson	Arizona
United States	Oklahoma Cancer Specialists and Research Institute	Tulsa	Oklahoma
United States	USOR: Texas Oncology - Tyler	Tyler	Texas
United States	Kaiser Permanente Oncology Clinical Trials	Vallejo	California
United States	USOR: Texas Oncology, P.A.	Webster	Texas
United States	Florida Cancer Specialist East Division	West Palm Beach	Florida
United States	University of Kansas Cancer Center	Westwood	Kansas
United States	USOR: Minnesota Oncology Hematology, PA	Woodbury	Minnesota
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
ImmunoGen, Inc.	European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Oncology Group

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  China,  Czechia,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Russian Federation,  Serbia,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-reported outcomes using EORTC QLQ-C30 questionnaires	The EORTC QLQ-C30 questionnaires will be used to collect data on the patient's functioning, health-related QOL, disease symptoms and health status. A higher score represents a higher response level.	Up to 2 years
Other	Patient-reported outcomes using EQ-5D-5L questionnaires	The EuroQol-5 Dimension 5-level (EQ-5D-5L) questionnaires will be used to collect data on the patient's functioning, health-related QOL, disease symptoms and health status. A higher score represents a higher response level.	Up to 2 years
Other	Pharmacokinetic parameters	Plasma samples will be collected to determine the concentration of MIRV (antibody-drug conjugate, total antibody, free DM4, S-methyl DM4 and possibly other metabolites). Summary statistics of the concentration at each time point (nominal time) will be presented. Graphical presentation of the data may also be completed using nominal time.	Up to 2 years
Other	Immunogenicity	The presence of anti-drug antibodies to mirvetuximab soravtansine	Up to 2 years
Other	Identification of soluble FRa levels and other biomarkers		Up to 2 years
Other	Patient-reported outcomes using PGIS questionnaires	The Patient Global Impression of Severity (PGIS) questionnaires will be used to collect data on the patient's perception of overall cancer symptom severity. This is a single question survey.	Up to 2 years
Primary	Progression-free survival (PFS)	The time from date of randomization until Investigator-assessed progressive disease or death, whichever occurs first.	Up to 2 years
Secondary	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).	Up to 2 years
Secondary	Objective Response Rate (ORR)	Objective response includes best response of complete response (CR) or partial response (PR).	Up to 2 years
Secondary	Overall survival	The time from date of randomization until the date of death	Up to 2 years
Secondary	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.	Up to 2 years
Secondary	Duration of response (DOR)	The time from initial response until Investigator-assessed progressive disease for all patients who achieve a confirmed objective response	Up to 2 years
Secondary	CA-125 response	Serum CA-125 response determined using the GCIG criteria	Up to 2 years
Secondary	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	Up to 2 years