Clinical trial NCT05445778: Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer
Official title: Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab (GLORIOSA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Keywords: Platinum-sensitive
Folate-receptor alpha expression
Antibody-drug conjugate
Cancer
Ovarian Neoplasma
Recurrent Platinum-Sensitive
High-Grade Ovarian
ADC
Adult
AYA
Adolescent Young Adult
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: GOG Foundation
First posted: 2022-07-06
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.

Detailed description: Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRα positivity by the Ventana FOLR1 Assay.

Eligibility criteria: Inclusion Criteria:

1. Patients must be ≥ 18 years of age
2. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
4. Patients must be willing to provide an archival tumor tissue block or slides, or must undergo a procedure to obtain a new biopsy using a low-risk, medically routine procedure for IHC confirmation of high FRα expression (reported as "positive") as defined by the Ventana FOLR1 Assay. Patients must be confirmed FRα-high as defined by FRα positivity of ≥ 75% of tumor membrane staining at ≥ 2+ intensity (PS2+) for entry into the study.
5. Prior BRCA testing on the tumor or prior germline testing is required for eligibility. If not done prior, tumor or germline testing will need to be done before study entry. Somatic and germline BRCA-positive patients must have received prior treatment with a PARPi in maintenance following first-line treatment.

   Note: Local tumor or germline BRCA testing will be acceptable for stratification. If the patient has not been tested, recommend archival tumor samples to be assessed for tissue BRCA. All patients who have received prior first line PARPi maintenance and/or bevacizumab are eligible.
6. Patients' disease must have relapsed after 1 line (first line) of platinum based chemotherapy and must be platinum-sensitive defined as progression greater than 6 months from last dose of primary platinum therapy.
7. Patients must be appropriate for, currently be on, or have completed platinum-based triplet therapy in the second line (recurrent PSOC).
8. After completion of triplet therapy and before randomization, patients must have received no less than 4 and no greater than 8 cycles of platinum-based triplet therapy in the second line, to include no less than 3 cycles of bevacizumab in combination with platinum-based chemotherapy. If the number of cycles received is less than 6 due to toxicity, this must be documented and toxicity assessed as unlikely related to bevacizumab.

   Note: A minimum of 4 cycles of combination chemotherapy is required. If carboplatin, paclitaxel, gemcitabine, or pegylated liposomal doxorubicin (PLD) is stopped due to toxicity, up to 4 additional cycles of single agent in combination with bevacizumab is acceptable if appropriately documented.
9. After completion of triplet therapy and before randomization: In the case of interval secondary cytoreductive surgery, patients are permitted to have received only 2 cycles of bevacizumab if given in combination with the last 3 cycles of platinum-based triplet therapy in the second line. In the case of primary cytoreductive surgery before secondline platinum-based triplet therapy, patients must have received no fewer than 3 cycles of bevacizumab in combination with platinum-based chemotherapy after their surgery and before randomization.
10. Patients either will receive (per investigator's choice), must be receiving, or have received paclitaxel, gemcitabine, or pegylated liposomal doxorubicin as the partner drug to platinum-based triplet therapy in the second line.
11. After completion of triplet therapy and before randomization, patients must have achieved a CR, PR, or SD, per the investigator, in the second line to be eligible for randomization into the study population. All patients will have CT or MRI scans and CA-125 measurements at least 3 weeks but no more than 8 weeks after their last planned dose of triplet therapy and before randomization.
12. Patients must be randomized no later than 8 weeks from the last dose of platinum-based triplet therapy in the second line.
13. After completion of triplet therapy and before randomization, patients must meet one of the following criteria:

    1. Have at least 1 lesion that meets the definition of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (radiologically measured by the investigator), and determined by the investigator to either have SD or a PR to their treatment; or
    2. Have persistently elevated CA-125 without measurable disease and determined by the investigator to have either SD or a PR to their treatment; or
    3. Have clinically no evidence of disease by both radiographic interpretation by the investigator and normalization of their CA-125, determined to be a CR.
14. Patients must have stabilized or recovered (to Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia).
15. Patients must have completed any major surgery at least 4 weeks before the first dose of study treatment (either Run-In or maintenance therapy) and have recovered or stabilized from the side effects of prior surgery before the first dose of treatment on study.
16. Patients must have adequate hematologic, liver, and kidney functions defined as follows:

    1. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/μL) without granulocyte colony-stimulating factor in the prior 10 days or longacting white blood cell (WBC) growth factors in the prior 10 days of C1D1 of maintenance treatment.
    2. Platelet count ≥ 100 × 109/L (100,000/μL) without platelet transfusion in the prior 10 days of C1D1 of maintenance treatment
    3. Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 10 days of C1D1 of maintenance treatment
    4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
    5. Aspartate aminotransferase and alanine aminotransferase ≤ 3.0 × ULN
    6. Serum bilirubin ≤ 1.5 × ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 × ULN)
    7. Serum albumin ≥ 2 g/dL
17. Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.
18. Females of childbearing potential (FCBP) must agree to use highly effective contraceptive method(s) (as defined in Section 5.10.7) while on study medication and for at least 3 months after the last dose.
19. FCBP must have a negative pregnancy test within 4 days before the first dose of therapy.

Exclusion Criteria:

1. Patients with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or lowgrade/borderline ovarian tumor
2. More than one line of prior chemotherapy before current/planned triplet therapy. Lines of prior anticancer therapy are counted with the following considerations:

   1. Neoadjuvant ± adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.
   2. Maintenance therapy (eg, bevacizumab, PARPi) will be considered part of the preceding line of therapy (ie, not counted independently).
   3. Change due to toxicity will be considered part of the proceeding line of therapy.
3. Patients with PD while on or following platinum-based triplet therapy
4. After completion of triplet therapy and prior to randomization: Patients who receive an intervening dose of bevacizumab after the last dose of triplet therapy before randomization
5. Patients with prior wide-field radiotherapy affecting at least 20% of the bone marrow
6. Patients with \> Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
7. 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
8. 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 intravenous (IV) antibiotics within 2 weeks before the first dose of maintenance therapy Note: Testing at screening is not required for the above infections unless clinically indicated.
9. Patients with a history of multiple sclerosis or other demyelinating diseases and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
10. Patients with clinically significant cardiac disease including, but not limited to, any of the following:

    1. Myocardial infarction ≤ 6 months prior to C1D1 of maintenance treatment
    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
11. Patients with a history of hemorrhagic or ischemic stroke within 6 months before enrollment
12. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
13. Patients with a previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis (exception: Grade 1 noninfectious pneumonitis diagnosed on or within 6 weeks after treatment with an immunotherapeutic agent used in the treatment of their malignancy that has resolved per investigator or resolution of the radiologic findings)
14. History of bowel obstruction (including sub-occlusive disease) related to underlying disease within 6 months before the start of maintenance study treatment (triplet therapy for Run-In patients).
15. History of abdominal fistula or gastrointestinal perforation
16. Intra-abdominal abscess, evidence of rectosigmoid involvement by pelvic examination, bowel involvement on CT scan, or clinical symptoms of bowel obstruction within 4 weeks prior to randomization (or within 4 weeks prior to starting triplet therapy for Run- In patients)
17. Clinically significant proteinuria: urine-protein to creatinine (UPC) ratio ≥ 1.0 or urine dipstick result ≥ 2+; patients with UPC ratio ≥ 1.0 or ≥ 2+ proteinuria should undergo 24-hour urine collection and must show result ≤ 1 g of protein in a 24-hour period.
18. History of Grade 4 thromboembolic events
19. Patients not appropriate for bevacizumab 15 mg/kg dosing at the start of maintenance therapy as per the treating physician
20. Patients requiring use of folate-containing supplements (eg, folate deficiency)
21. Patients with prior hypersensitivity to monoclonal antibodies (mAbs)
22. Women who are pregnant or breastfeeding
23. Patients who received prior treatment with MIRV or other FRα-targeting agents
24. Patients with untreated or symptomatic central nervous system metastases
25. Patients with a history of other malignancy within 3 years prior to signing study consent Note: Patients with tumors with a negligible risk for metastasis or death (eg, controlled basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.
26. Prior known hypersensitivity reactions to study drugs or any of their excipients

Primary outcomes:
measure: Assess Progression-free survival (PFS)
timeFrame: Up to 4 years
Secondary outcomes:
measure: Assess Overall survival (OS)
timeFrame: Up to 7 years
measure: Assess Safety and tolerability
timeFrame: Up to 7 years
measure: Assess second disease progression (PFS2)
timeFrame: Up to 7 years
measure: Assess Objective Response Rate (ORR)
timeFrame: Up to 7 years
measure: Assess Duration of response (DOR)
timeFrame: Up to 7 years
measure: Assess Disease-free survival (DFS)
timeFrame: Up to 7 years
measure: CA-125 response
timeFrame: Up to 7 years
measure: Patient-reported outcome health-related quality of life (HRQoL) of disease-related symptoms using the NCCN-FACT Ovarian Symptom Index (NFOSI-18) DRS-P (disease-related symptom subscale - physical).
timeFrame: Up to 7 years
Other outcomes:
Locations:
city: Mobile
country: United States
facility: USA Mitchell Cancer Institute
state: Alabama
city: Phoenix
country: United States
facility: Honor Health Cancer Care, Biltmore, 2222 E. Highland Ave, #400
state: Arizona
city: Concord
country: United States
facility: John Muir Health
state: California
city: Irvine
country: United States
facility: City of Hope
state: California
city: Irvine
country: United States
facility: Kaiser Permanente Irvine Medical Center, 6650 Alton Pkwy
state: California
city: La Jolla
country: United States
facility: UC San Diego Health - Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center, 4950 Sunset Blvd., 6th Floor
state: California
city: Orange
country: United States
facility: UCI Health- Chao Family Comprehensive Cancer Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Riverside Medical Center, 10800 Magnolia Ave
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Zion Medical Center, 4647 Zion Ave
state: California
city: San Marcos
country: United States
facility: Kaiser Permanente San Marcos Medical Offices, 400 Craven Road
state: California
city: Sylmar
country: United States
facility: Olive View UCLA Medical Center Inpatient Pharmacy, 14445 Olive View Dr, Rm 1C101
state: California
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Fort Myers
country: United States
facility: Regional Cancer Center/ Florida Gynecologic Oncology
state: Florida
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Miami
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center, 1725 West Harrison Street
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medicine, 5841 S Maryland Ave, MC 2115
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: St Vincent Gynecologic Oncology
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: LSUHSC
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Scarborough
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore, Inc.
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institute
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Gynecologic Oncology - Tolosky Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology, P.A. (USOR)
state: Minnesota
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Reno
country: United States
facility: Center of Hope at Renown Medical Center
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical, One Medical Center Drive
state: New Hampshire
city: Hackensack
country: United States
facility: John Theurer Cancer Center, University Medical Center, 92 Second Street
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital -Luckow Pavilion
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, P.C. (USOR)
state: New York
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Health-Long Island
state: New York
city: New York
country: United States
facility: Perlmutter Cancer Center at NYU Langone Health
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Northwell Health Cancer Institute
state: New York
city: New York
country: United States
facility: Womens Cancer Care Associates
state: New York
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Kettering
country: United States
facility: Kettering Health
state: Ohio
city: Oklahoma City
country: United States
facility: OU Health 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: Willamette Valley Cancer Institute and Research Center (USOR)
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C. (USOR)
state: Oregon
city: Portland
country: United States
facility: OHSU Center for Health & Healing, Building 2 (CHH2), 3485 S Bond Ave
state: Oregon
city: Pittsburgh
country: United States
facility: Magee Women's Hospital - UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Willow Grove
country: United States
facility: Sidney Kimmel Cancer Center Asplundh Cancer Pavilion
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Gynecologic Oncology, 1309 W. 17th street
state: South Dakota
city: Germantown
country: United States
facility: The West Clinic, PLLC dba West Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology, P.A. (USOR)
state: Texas
city: Bedford
country: United States
facility: Texas Oncology - DFWW (USOR)
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Dallas Presbyterian Hospital (USOR)
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology (USOR)
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio (USOR)
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates (USOR)
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University (VCU)- Massey Comprehensive Cancer Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Caba
country: Argentina
facility: Instituto Alexander Fleming
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Caba
country: Argentina
facility: Instituto de Oncologia Angel Roffo
city: Córdoba
country: Argentina
facility: Hospital Italiano de Cordoba
city: Rosario
country: Argentina
facility: Sanatorio de la Mujer
city: Santa Fe
country: Argentina
facility: Isis Centro Especializado
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Ballarat
country: Australia
facility: Grampians Health Service
state: Victoria
city: Brighton
country: Australia
facility: Cabrini Health
state: Victoria
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Centre
state: Victoria
city: Richmond
country: Australia
facility: Epworth Health
state: Victoria
city: Subiaco
country: Australia
facility: Bendat Family Comprehensive Cancer Centre St John of God - Subiaco Hospital
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis, Apotheek Klinische Studies, Imeldalaan 9 Centraal Magazjin
city: Brussel
country: Belgium
facility: Cliniques Universitaires St-Luc Woluwe-Saint-Lambert
city: Charleroi
country: Belgium
facility: GHDC Grand Hôpital de Charleroi, Site Notre-Dame, Grand Rue 3
city: Gent
country: Belgium
facility: AZ Sint Lucas Gent, Groenebriel 1
city: Leuven
country: Belgium
facility: UZ Leuven, Apotheek Klinische studies, Herestraat, 49
city: Namur
country: Belgium
facility: CHU UCL Namur - Site Sainte-Elisabeth, Route (Road) 471 Place Louise Godin 15, Oncology Day Hospital, 3rd Floor
city: Roeselare
country: Belgium
facility: AZ Delta apotheek, Tav Klinische studies, Kwadestraat 78
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Amor de Barretos
city: Belo Horizonte
country: Brazil
facility: Oncocentro
city: Cuiabá
country: Brazil
facility: Clinica Oncolog
city: Fortaleza
country: Brazil
facility: Instituo de Ensino e Pesquisa (IEP) Oncocentro
city: Itajaí
country: Brazil
facility: Catarina Pesquisa Clinica
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Santa Casa Misericordia Porto Alegre
city: Recife
country: Brazil
facility: IMIP
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Cancer
city: Rio De Janeiro
country: Brazil
facility: Instituto COI
city: Salvador
country: Brazil
facility: Hospital Santa Izabel
city: Salvador
country: Brazil
facility: Ensino e Terapia de Inovacao Clinica AMO-ETICA
city: São Paulo
country: Brazil
facility: BP A Beneficencia Portuguesa de Sao Paulo
city: São Paulo
country: Brazil
facility: Dasa
city: São Paulo
country: Brazil
facility: Ac camargo Cancer center
city: Shumen
country: Bulgaria
facility: Complex Oncology Center - Shumen Ltd
city: Vratsa
country: Bulgaria
facility: Comprehensive Cancer Center - Vratsa
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre, Alberta Health Services
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta - Cross Cancer Institute (CCI)
state: Alberta
city: Surrey
country: Canada
facility: BC Cancer Surrey
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver
state: British Columbia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kinston Health Sciences Center - KGH Site
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de L'Universite de Montreal - Centre de Recherche
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hôpital Fleurimont
state: Quebec
city: Beijing
country: China
facility: Bejing Obstetrics and Gynecology Hospital, Capital Medical University
city: Beijing
country: China
facility: Bejing Cancer Hospital
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical University
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: The First Affliliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital,Sun Yat-sen University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Hangzhou
country: China
facility: Woman's Hospial School of Medicine ZheJiang University
city: Harbin
country: China
facility: Harbin medical university Cancer Hospital
city: Jinan
country: China
facility: Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Kunming
country: China
facility: Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University )
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: Naning
country: China
facility: Guangxi Cancer Hospital (Guangxi Medical University Cancer Hospital)
city: Shanghai
country: China
facility: Fudan University shanghai Cancer Center
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute&Hospital
city: Urumqi
country: China
facility: Cancer Hospital Affiliated to Xinjiang Medical University
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Xian
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Brno
country: Czechia
facility: University Hospital Brno
city: Nový Jicín
country: Czechia
facility: Nemocnice AGEL Nový Jicín a.s.
city: Ostrava Poruba
country: Czechia
facility: University Hospital Ostrava
city: Prague
country: Czechia
facility: General University Hospital in Prague
city: Aalborg
country: Denmark
facility: Onkologisk Afd, Aalborg Universitets hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet (Copenhagen University Hospital)
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Brest
country: France
facility: Institut de cancérologie et d'imagerie (ICI) CHU BREST
city: Dijon
country: France
facility: CHU Dijon
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Hôpital Timone
city: Paris
country: France
facility: Institut Curie
city: Strasbourg
country: France
facility: ICANS
city: Bielefeld
country: Germany
facility: Studiengesellschaft Onkologie Bielefeld
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Erlangen
country: Germany
facility: Universitaetsklinik Erlangen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Essen
country: Germany
facility: KEM Evang. Kliniken Essen-Mitte
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH
city: Giesen
country: Germany
facility: UKGM Giessen
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Mammazentrum Hamburg am Krankenhaus Jerusalem
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz Frauenklinik
city: Munich
country: Germany
facility: LMU Klinikum Großhadern
city: Athens
country: Greece
facility: Alexandra Hospital
city: Athens
country: Greece
facility: Aretaieio Hospital
city: Athens
country: Greece
facility: IASO Hospital
city: Maroúsi
country: Greece
facility: Hygeia Hospital
city: Thessaloníki
country: Greece
facility: St. Luke's Hospital S.A.
city: Cork
country: Ireland
facility: Cork University Hospital
city: Cork
country: Ireland
facility: Bon Secours
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: St. James's Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Sligo
country: Ireland
facility: Sligo University Hospital
city: Waterford
country: Ireland
facility: University Hospital Waterford
city: Haifa
country: Israel
facility: Carmel Medical Centre
city: Holon
country: Israel
facility: Wolfson Medical Centre
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Centre
city: Jerusalem
country: Israel
facility: Hadassah Medical Ctr. Ein Kerem. Sharett Institute of oncology
city: Kefar Sava
country: Israel
facility: Meir Medical Centre
city: Petah Tikva
country: Israel
facility: Rabin Medical Centre
city: Ramat Gan
country: Israel
facility: Sheba Medical Centre
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
city: Safed
country: Israel
facility: Ziv Medical Centre
city: Tel Aviv Yaffo
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi
city: Catania
country: Italy
facility: Ospedale Cannizzaro
city: Firenze
country: Italy
facility: AOU Careggi
city: Genova
country: Italy
facility: Ente Ospedaliero Ospedali Galliera
city: Genova
country: Italy
facility: IRCCS AOU San Martino
city: Lecco
country: Italy
facility: ASST Ospedale Alessandro Manzoni
city: Lucca
country: Italy
facility: Azienda USL Toscana Nord Ovest Ospedale San Luca
city: Meldola
country: Italy
facility: IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milano
country: Italy
facility: IRCCS San Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milan
country: Italy
facility: Humanitas San Pio X
city: Mirano
country: Italy
facility: Ospedale di Mirano
city: Napoli
country: Italy
facility: Naples, Ist. Naz. Tumori-Fondazione Pascale
city: Parma
country: Italy
facility: AOU di Parma
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Piacenza
country: Italy
facility: AUSL Piacenza Ospedale Guglielmo da Saliceto
city: Prato
country: Italy
facility: Nuovo Ospedale di Prato - Santo Stefano
city: Reggio Emilia
country: Italy
facility: AUSL RE Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Akashi-shi
country: Japan
facility: Hyogo Cancer Center
city: Chiba-shi
country: Japan
facility: Chiba University Hospital
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
city: Isehara
country: Japan
facility: Tokai University Hospital
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center
city: Niigata-shi
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Yahaba
country: Japan
facility: Iwate Medical University Hospital - Yahabacho
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: CHA University - Bundang CHA General Hospital
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Keimyung Dongsan University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Oslo
country: Norway
facility: Oslo University Hospital, Radiumhospitalet
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Pasig
country: Philippines
facility: The Medical City -Ortigas
state: Metro Manila
city: San Juan
country: Philippines
facility: Cardinal Santos Medical Center
state: Metro Manila
city: Quezon City
country: Philippines
facility: East Avenue Medical Centre
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o.
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii
city: Kraków
country: Poland
facility: Centrum Badan Klinicznych JCI Jagiellonskie Centrum Innowacji Sp. z o.o.
city: Lublin
country: Poland
facility: Samodzielny publiczny szpital kliniczny nr 1
city: Poznań
country: Poland
facility: Szpital Kliniczny im. Heliodora Swiecickiego
city: Poznań
country: Poland
facility: Wielkopolskie Centrum Onkologii
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki im. sw. Jana Pawla II w Siedlcach Sp. z o.o.
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron, CT Pharm General Building-Floor B, Passeig Vall d'Hebron
city: Barcelona
country: Spain
facility: Instituto Catalán de Oncologia, 199-203 Av Gra Via CT Pharmacy, Hospital Duran i Reynals
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
city: Coruña
country: Spain
facility: Hospital Universitario de A Coruña (CHUAC)
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Girona
country: Spain
facility: ICO-Hospital Universitario de Girona
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital La Paz CT Pharmacy, 261 Paseo Castellana, North Building Ground Floor
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Pamplona
country: Spain
facility: Clinica Universitaria Navarra Pamplona
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Akademiske Sjukhuset
city: Adana
country: Turkey
facility: Baskent University Hospital
city: Adana
country: Turkey
facility: Cukurova University Balcali Hospital Application and Research Center
city: Ankara
country: Turkey
facility: Hacettepe University Hospital, Hacettepe Mahallesi
city: Ankara
country: Turkey
facility: Ankara Baskent University
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa Medical Faculty Gynecologic Oncology Department
city: İzmir
country: Turkey
facility: Ege University Hospital
city: Fulham
country: United Kingdom
facility: The Royal Marsden Hospital - Chelsea
state: London
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital - Sutton
state: Surrey
city: Swansea
country: United Kingdom
facility: Singleton Hospital
state: Wales
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie / The Christie NHS Foundation Trust
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre East and North Hertfordshire NHS Trust Site
city: Southampton
country: United Kingdom
facility: Southampton University NHS Trust
Study officials:
affiliation: AbbVie
name: Abbvie INC.
role: STUDY_DIRECTOR
References: