Clinical trial NCT04209855: 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
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Gynecologic Oncology Group
name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
First posted: 2019-12-24
Enrollment: 453
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRα positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

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

Eligibility criteria: Inclusion Criteria:

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

   1. Participants who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between \>3 months and ≤ 6 months after the date of the last dose of platinum
   2. Participants who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression. Note: Participants who are platinum-refractory during front-line treatment are excluded
4. Participants must have progressed radiographically on or after their most recent line of therapy
5. Participants must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity
6. Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay
7. Participants must have at least one lesion that meets the definition of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (radiologically measured by the Investigator)
8. Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment:

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

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

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

Exclusion Criteria:

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

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

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

Primary outcomes:
measure: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
timeFrame: From randomization until PD or death, whichever occurred first (up to 28 months)
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 28 months
measure: Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1
timeFrame: Up to 28 months
measure: Overall Survival Assessed by the Investigator Using RECIST v1.1
timeFrame: Up to 30 months
measure: Number of Participants Achieving at Least 15 Point Absolute Improvement at Week 8 or 9 in the Abdominal/GI Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)
timeFrame: Baseline and Week 8 or 9
measure: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
timeFrame: Up to 28 months
measure: Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
timeFrame: Up to 28 months
measure: Time to Second Progression-Free Survival (PFS 2)
timeFrame: Up to 28 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB) GYN Oncology
state: Alabama
city: Anchorage
country: United States
facility: Alaska Women's Cancer Care
state: Alaska
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC - HAL - USOR
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Tucson
country: United States
facility: USOR: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit
state: California
city: Newport Beach
country: United States
facility: Hoag Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Sylmar
country: United States
facility: Olive View - UCLA Medical Center
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Oncology Clinical Trials
state: California
city: Lakewood
country: United States
facility: USOR: Rocky Mountain Cancer Centers
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialist South Division
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Saint Petersburg
country: United States
facility: Women's Care Florida / Women's Cancer Associates
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialist North Division
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialist East Division
state: Florida
city: Savannah
country: United States
facility: Memorial University Medical Center
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Health - Kapiolani Medical Center for Women and Children
state: Hawaii
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Hinsdale
country: United States
facility: Dr. Sudarshan K. Sharma, Ltd.
state: Illinois
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: New Orleans
country: United States
facility: Ochnser Medical Center Jefferson
state: Louisiana
city: Shreveport
country: United States
facility: WK Physicians Network/Gynecologic Oncology Associates
state: Louisiana
city: Silver Spring
country: United States
facility: Holy Cross Hospital
state: Maryland
city: Silver Spring
country: United States
facility: USOR: Maryland Oncology Hematology, P.A.
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Woodbury
country: United States
facility: USOR: Minnesota Oncology Hematology, PA
state: Minnesota
city: Kansas City
country: United States
facility: HCA Midwest Kansas City/ Sarah Cannon
state: Missouri
city: Great Falls
country: United States
facility: Sletten Cancer Institute
state: Montana
city: Reno
country: United States
facility: Center of Hope
state: Nevada
city: Ridgewood
country: United States
facility: The Valley Hospital, Inc
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas Outpatient Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: USOR: OHC - Oncology_Hematology Care Clinical Trials, Inc.
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Columbus NCORP
state: Ohio
city: Columbus
country: United States
facility: Zangmeister Cancer Center
state: Ohio
city: Fairfield
country: United States
facility: Oncology_Hematology Care Clinical Trials, LLC
state: Ohio
city: Hilliard
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute
state: Oklahoma
city: Eugene
country: United States
facility: USOR: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Portland
country: United States
facility: Legacy Gynecologic Oncology
state: Oregon
city: Portland
country: United States
facility: USOR: Northwest Cancer Specialists, P.C.
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital-UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Nashville
country: United States
facility: Tennessee Oncology / Sarah Cannon Research Institute
state: Tennessee
city: Austin
country: United States
facility: USOR: Texas Oncology-South Austin
state: Texas
city: Fort Worth
country: United States
facility: USOR: Texas Oncology - Fort Worth Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas, Memorial Hermann
state: Texas
city: McAllen
country: United States
facility: USOR: Texas Oncology - McAllen South Second
state: Texas
city: San Antonio
country: United States
facility: USOR: Texas Oncology - San Antonio
state: Texas
city: Sugar Land
country: United States
facility: USOR: Texas Oncology, P.A.
state: Texas
city: The Woodlands
country: United States
facility: USOR: Texas Oncology - The Woodlands, Gynecologic Oncology
state: Texas
city: Tyler
country: United States
facility: USOR: Texas Oncology - Tyler
state: Texas
city: Webster
country: United States
facility: USOR: Texas Oncology, P.A.
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Gainesville
country: United States
facility: USOR: Virginia Cancer Specialists, PC
state: Virginia
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology & Oncology
state: Washington
city: Morgantown
country: United States
facility: West Virginia University- MBRCC
state: West Virginia
city: New Lambton Heights
country: Australia
facility: Newcastle Private Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Malvern
country: Australia
facility: Oncology Clinics Victoria (OCV) - Cabrini Malvern Hospital Location
state: Victoria
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
city: Toorak Gardens
country: Australia
facility: Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek
city: Gent
country: Belgium
facility: AZ St-Lucas
city: Leuven
country: Belgium
facility: UZ Leuven
city: Burgas
country: Bulgaria
facility: Complex Oncology Center
city: Pleven
country: Bulgaria
facility: UMHAT Georgi Stranski
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD, Sofia
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital General Campus
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre - University Health Network
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de L'Universite de Montreal
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University, Cancer Center
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Union Hospital of China
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Ostrava
country: Czechia
facility: Fakultní nemocnice Ostrava
city: Praha 2
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Zlín
country: Czechia
facility: KNTB a.s. Zlín
city: Toulouse
country: France
facility: Institut Claudius Regaud
state: Cedex 9
city: Lille
country: France
facility: Centre Oscar Lambret
state: Cedex B.P 307
city: Angers
country: France
facility: Institut de cancérologie de l'ouest, site Angers
state: Cedex
city: Besançon Cedex
country: France
facility: CHRU Besançon
city: Bordeaux Cedex
country: France
facility: Institut Bergonie
city: Lyon Cedex
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Paris
country: France
facility: Cochin Hospital
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint-Simon
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Plerin
country: France
facility: Centre Armoricain de radiothérapie, imagerie médicale et oncologie, CARIO
city: Saint Cloud
country: France
facility: Institut Curie
city: St. Herblain CEDEX
country: France
facility: ICO Centre René Gauducheau
city: Vandoeuvre les Nancy_ Cedex
country: France
facility: Institut de cancérologie de Lorraine
city: Villejuif Cedex
country: France
facility: Gustave Roussy
city: Ulm
country: Germany
facility: Ulm University Hospital Klinik für Frauenheilkunde und Geburtshilfe
state: Baden-Württemberg
city: Göttingen
country: Germany
facility: UMG Göttingen Frauenklinik
state: Niedersachsen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
state: Saxony
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Dessau
country: Germany
facility: Städtisches Klinikum Dessau, Zentrum für Klinische Studien
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH / Frauenklinik
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Giessen
country: Germany
facility: UKGM Standort Giessen
city: Hamburg
country: Germany
facility: Mammazentrum Hamburg am Krankenhaus Jerusalem
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem Medical center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Safed
country: Israel
facility: Ziv Medical Center
city: Padova
country: Italy
facility: IOV Istituto Oncologico
state: PD
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
city: Lecco
country: Italy
facility: ASST Lecco- Ospedale A.Manzoni
city: Milan
country: Italy
facility: IRCCS - Istituto Europeo di Oncologia (The European Institute of Oncology) (IEO)
city: Naples
country: Italy
facility: INT Pascale
city: Perugia
country: Italy
facility: Centro Operativo Studi Clinici S.C.Oncologia Medica
city: Reggio Emilia
country: Italy
facility: Oncologia Azienda Osc-IRCCS Reggio Emilia
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Torino
country: Italy
facility: Azienda Ospedaliera Città Della Salute E Della Scienza Di Torino
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I
city: Torino
country: Italy
facility: Istituto Oncologico Candiolo
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center - Center for Uterine Cancer
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: University of Ulsan College of Medicine - Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Gdańsk
country: Poland
facility: Medical University of Gdansk
city: Lublin
country: Poland
facility: Samodzielny publiczny szpital kliniczny nr 1
city: Olsztyn
country: Poland
facility: Wojewódzki Szpital Specjalistyczny, Oddzial Kliniczny Ginekologii Onkologiczne
city: Poznań
country: Poland
facility: Wielkopolskie Centrum Onkologii
city: Warszawa
country: Poland
facility: Szpital Kliniczny im. Ks. Anny Mazowieckiej
city: Lisbon
country: Portugal
facility: Fundação Champalimaud
city: Lisbon
country: Portugal
facility: Hospital da Luz, S.A
city: Lisbon
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo
city: Omsk
country: Russian Federation
facility: BIH of Omsk Region "Clinical Oncology Dispensary"
state: Omsk Oblast
city: Moscow
country: Russian Federation
facility: LLC "VitaMed"
city: St-Petersburg
country: Russian Federation
facility: Leningrad regional oncology dispensa
city: Ufa
country: Russian Federation
facility: State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
city: Belgrade
country: Serbia
facility: Oncology and Radiology Institute Serbia
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Sremska Kamenica
country: Serbia
facility: Oncology Institute Vojvodina, Surgical Oncology Clinic
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico de Santiago
state: A Coruña
city: Jaén
country: Spain
facility: H. U. de Jaén
state: Andalucia
city: San Sebastián de los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofía
state: Madrid
city: Badalona
country: Spain
facility: Institut Català d'Oncologia
city: Caceres
country: Spain
facility: H. San Pedro de Alcántara
city: Castelló
country: Spain
facility: Hospital Provincial de Castellon
city: Madrid
country: Spain
facility: Hospital de San Chinarro-Clara Campal
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Sabadell
country: Spain
facility: Parc Taulí
city: Sevilla
country: Spain
facility: Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital de la Fe
city: Zaragoza
country: Spain
facility: HCU Lozano Blesa
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital - Taipei Branch
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Chernihiv
country: Ukraine
facility: Chernihiv Medical Center of Modern Oncology of Chernihiv Regional Council
state: Chernihiv Region
city: Kharkiv
country: Ukraine
facility: Grigoriev Institute for Medical Radiology NAMS of Ukraine
state: Kharkiv Region
city: Khmelnytskyi
country: Ukraine
facility: Communal non-profit enterprise "Khmelnytskyi Regional Antitumor Center" of Khmelnytskoyi Regional Council
state: Khmelnytskyi Region
city: Cherkasy
country: Ukraine
facility: Communal non-profit enterprise "Cherkasy Regional Oncology Dispensary of Cherkasy oblast council"
city: Ivano-Frankivsk
country: Ukraine
facility: Prykarpatskyi Clinical Oncology Center of Ivano-Frankivsk Regional Council
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital
state: Cambridgeshire
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
state: Devon
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: St Bartholomew's Hospital-Barts Health NHS Trust
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: