title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)

summary:
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer.

The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Colombia
Portugal
Hungary
United States
Romania
China
Malaysia
Philippines
Italy
Guatemala
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Russian Federation
Israel

location_facility: Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2503)

location_facility: Guangxi Medical University Affiliated Tumor Hospital-Oncology Dept. of Breast and Bone Soft Tissue (

location_facility: Henan Cancer Hospital-Galactophore Department ( Site 2615)

location_facility: Centre Hospitalier de l'Université de Montréal ( Site 0105)

location_facility: Peking University Shenzhen Hospital-Oncology Department ( Site 2601)

location_facility: Podolsk Regional Clinical Hospital ( Site 1907)

location_facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1320)

location_facility: The Royal Cornwall Hospital ( Site 1507)

location_facility: Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)

location_facility: St. Petersburg Clinical Hospital of Russian Academy Of Sciences-Medical Oncology ( Site 1905)

location_facility: Medical Oncology Associates, PS ( Site 0010)

location_facility: Northwest Medical Specialties, PLLC ( Site 0008)

location_facility: Bialostockie Centrum Onkologii-Oddzial Onkologii Klinicznej ( Site 1812)

location_facility: Arkhangelsk Clinical Oncological Dispensary-Chemotherapy department ( Site 1902)

location_facility: Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1354)

location_facility: Hyogo Medical University Hospital ( Site 2201)

location_facility: St. Marianna University School of Medicine Hospital ( Site 2205)

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1333)

location_facility: Saitama Medical University International Medical Center ( Site 2208)

location_facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 2102)

location_facility: Medizinische Universitaet Innsbruck ( Site 1602)

location_facility: Hospital de Câncer de Recife ( Site 0211)

location_facility: MedStar Washington Hospital Center ( Site 0063)

location_facility: Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0603)

location_facility: Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0066)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 1110)

location_facility: Severance Hospital, Yonsei University Health System ( Site 2400)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 1820)

location_facility: Ryazan Regional Clinical Oncology Center-Oncology #1 ( Site 1906)

location_facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1332)

location_facility: Fukushima Medical University ( Site 2200)

location_facility: Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 2009)

location_facility: Zhejiang Cancer Hospital-Breast Oncology ( Site 2622)

location_facility: Cancer Hospital Chinese Academy of Medical Science ( Site 2635)

location_facility: Sarawak General Hospital-Radiotherapy Unit ( Site 2501)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 1700)

location_facility: National Cancer Center-Center for Breast Cancer ( Site 2404)

location_facility: General Hospital of Athens Laiko-First Department of Internal Medicine ( Site 0305)

location_facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0904)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1813)

location_facility: University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0303)

location_facility: Jilin Cancer Hospital-oncology department ( Site 2619)

location_facility: Edward-Elmhurst Healthcare, Edward Hospital - Plainfield-Edward Cancer Center - Plainfield ( Site 00

location_facility: Centro Estatal de Cancerologia-Investigación ( Site 0256)

location_facility: Hygeia Hospital-3rd Oncology Department ( Site 0304)

location_facility: Fudan University Shanghai Cancer Center-Oncology ( Site 2600)

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0208)

location_facility: Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0009)

location_facility: Gynaekologisches Zentrum Bonn ( Site 1201)

location_facility: Instituto de Cancerología-Oncology ( Site 0606)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0412)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center ( Site 2013)

location_facility: Institutul Oncologic-Day Hospital Unit ( Site 2905)

location_facility: Bon Secours St. Francis Medical Center-Oncology Research ( Site 0020)

location_facility: Greater Baltimore Medical Center-Medical Oncology/Hematology ( Site 0062)

location_facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0901)

location_facility: I.E.U. Medical Point Hastanesi-Oncology ( Site 2016)

location_facility: St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1531)

location_facility: ANKARA ŞEHİR HASTANESİ-Medical Oncology ( Site 2014)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1323)

location_facility: Sourasky Medical Center-Oncology ( Site 1701)

location_facility: Anhui Cancer Hospital-medical oncology ( Site 2632)

location_facility: Bnai Zion Medical Center-Oncology ( Site 1704)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii (

location_facility: New England Cancer Specialists ( Site 0007)

location_facility: Soroka Medical Center-Oncology ( Site 1702)

location_facility: Juntendo University Hospital ( Site 2210)

location_facility: Xiangya Hospital Central South University-Breast department ( Site 2621)

location_facility: Landesklinikum Wiener Neustadt-Innere Medizin, Hämatologie und internistische Onkologie ( Site 1604)

location_facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1004)

location_facility: Tianjin Medical University Cancer Institute and Hospital-Department of Breast Cancer ( Site 2612)

location_facility: Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 2012)

location_facility: Georgetown University Medical Center-Department of Medicine and Oncology ( Site 0026)

location_facility: Hematology Oncology Associates of Rockland ( Site 0044)

location_facility: Vivantes Klinikum Am Urban-Haematologie und Onkologie ( Site 1203)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2005)

location_facility: North York General Hospital ( Site 0108)

location_facility: The Third Hospital of Nanchang-Oncology Dept ( Site 2628)

location_facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607)

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1351)

location_facility: Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 1821)

location_facility: Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 0922)

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0028)

location_facility: Leids Universitair Medisch Centrum-Medical Oncology ( Site 1356)

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1818)

location_facility: Central Clinical Hospital of the Presidential Administrative Department ( Site 1904)

location_facility: Beijing Cancer hospital-Department of Breast Cancer ( Site 2605)

location_facility: Hospital Británico de Buenos Aires-Oncology ( Site 0404)

location_facility: The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2604)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1113)

location_facility: West China Hospital Sichuan University-Head and Neck Oncology ( Site 2630)

location_facility: The First People's Hospital of Foshan-Oncology Department of Breast Cancer ( Site 2620)

location_facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinike für Senologie/ Brustzentrum ( Site 1200

location_facility: Radboudumc-Medical Oncology ( Site 1360)

location_facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2629)

location_facility: Maastricht UMC+-Medical Oncology ( Site 1353)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach-Breast Unit ( Site 1811)

location_facility: Parkview Research Center at Parkview Regional Medical Center ( Site 0071)

location_facility: Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 1901)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 2000)

location_facility: Centre de Cancérologie du Grand Montpellier ( Site 0912)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2804)

location_facility: Centro de Investigacion Clinica de Oaxaca ( Site 0252)

location_facility: Xinjiang Medical University Cancer Hospital - Urumqi-galactophore department ( Site 2624)

location_facility: Instituto de Oncologia Saint Gallen ( Site 0206)

location_facility: Lux med onkologia sp. z o.o. ( Site 1808)

location_facility: Westmead Hospital-Department of Medical Oncology ( Site 2101)

location_facility: Blackpool Victoria Hospital ( Site 1503)

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0202)

location_facility: Moscow Clinical Research Center-Chemotherapy department ( Site 1903)

location_facility: Guy's & St Thomas' NHS Foundation Trust ( Site 1501)

location_facility: CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 0800)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0513)

location_facility: Ospedale San Gerardo-ASST Monza-Research Unit Phase 1 ( Site 1115)

location_facility: Baptist MD Anderson Cancer Center ( Site 0013)

location_facility: Assuta Ashdod Medical Center ( Site 1703)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1111)

location_facility: Karolinska Universitetssjukhuset Solna-Tema Cancer - ME Bröst- endokrina tumörer och sarkom ( Site 1

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1116)

location_facility: Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 1112)

location_facility: Institut de Cancérologie de l'Ouest ( Site 0915)

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Breast Oncology Center ( Site 2641)

location_facility: University Malaya Medical Centre ( Site 2505)

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 2805)

location_facility: Elisabeth-TweeSteden Ziekenhuis-Internal Medicine ( Site 1357)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1819)

location_facility: Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0067)

location_facility: Seoul National University Bundang Hospital ( Site 2406)

location_facility: UNIDADE LOCAL DE SAUDE DE MATOSINHOS ( Site 1007)

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1005)

location_facility: Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0262)

location_facility: Arizona Oncology Associates-Arizona Oncology ( Site 0049)

location_facility: Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2807)

location_facility: Miami Cancer Institute - Plantation ( Site 0076)

location_facility: Kadlec Clinic Hematology and Oncology ( Site 0055)

location_facility: Providence Portland Medical Center ( Site 0038)

location_facility: University of Illinois at Chicago ( Site 0061)

location_facility: Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)

location_facility: Tokyo Medical University Hospital ( Site 2206)

location_facility: CHRISTUS Highland-Oncology Research ( Site 0073)

location_facility: Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 1609)

location_facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 2002)

location_facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE-oncology breast ( Site 2616)

location_facility: MedStar Good Samaritan Hospital-Oncology Research ( Site 0069)

location_facility: Instituto Nacional del Cancer-CR Investigación ( Site 0511)

location_facility: Haaglanden MC - locatie Antoniushove-Medical oncology ( Site 1355)

location_facility: Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec (

location_facility: Oncomedica S.A.-Oncomedica S.A ( Site 0604)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2209)

location_facility: University of Tennessee Medical Center ( Site 0039)

location_facility: Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 0301)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0154)

location_facility: St. Luke's International Hospital ( Site 2207)

location_facility: Louisiana State University Health Sciences Shreveport ( Site 0072)

location_facility: Jiangsu provincial people's hospital-Oncology Department ( Site 2607)

location_facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1815)

location_facility: Oregon Health and Science University ( Site 0031)

location_facility: Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1202)

location_facility: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2901)

location_facility: Centro de Oncología e Investigación de Buenos Aires ( Site 0400)

location_facility: Instituto de Oncología de Rosario ( Site 0401)

location_facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0403)

location_facility: The First Affiliated Hospital of Wenzhou Medical University-Thyroid and breast surgery ( Site 2625)

location_facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 2401)

location_facility: University Cancer & Blood Center, LLC ( Site 0032)

location_facility: University of Alabama at Birmingham-Medicine ( Site 0065)

location_facility: Alexandra Hospital-ONCOLGOY DEPT. ( Site 0302)

location_facility: Renji Hospital Shanghai Jiao Tong University School of Medicine-Breast surgery ( Site 2626)

location_facility: Medizinische Universität Wien ( Site 1601)

location_facility: Frankston Hospital-Oncology and Haematology ( Site 2103)

location_facility: Sanford Fargo Medical Center ( Site 0040)

location_facility: Wojskowy Instytut Medyczny-Klinika Onkologii ( Site 1803)

location_facility: University of Massachusetts Medical School-Division of Hematology/Oncology ( Site 0052)

location_facility: Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1114)

location_facility: Centro Hospitalar do Porto - Hospital de Santo António-Oncology Service ( Site 1003)

location_facility: Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 2506)

location_facility: Nizhegorodsky Regional Oncology Dispensary-chemotherapy ( Site 1912)

location_facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 0605)

location_facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi-Medical Oncology Department

location_facility: Hospital Italiano de Córdoba ( Site 0409)

location_facility: N.N.Petrov Research Institute of Oncology ( Site 1900)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 1117)

location_facility: Seoul National University Hospital-Internal Medicine ( Site 2403)

location_facility: Princess Margaret Cancer Centre ( Site 0101)

location_facility: Ege University Medicine of Faculty ( Site 2004)

location_facility: Orchard Healthcare Research Inc. ( Site 0037)

location_facility: Miami Cancer Institute at Baptist Health, Inc. ( Site 0070)

location_facility: UCSF Medical Center at Mission Bay ( Site 0043)

location_facility: Kitasato University Hospital ( Site 2204)

location_facility: Taizhou Hospital of Zhejiang Province ( Site 2636)

location_facility: Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 2610)

location_facility: Shandong Cancer Hospital-Breast surgery ( Site 2623)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur

location_facility: The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 2613)

location_facility: Clínica de Oncologia Reichow ( Site 0210)

location_facility: Institut de Cancérologie de l'Ouest ( Site 0907)

location_facility: Waverly Hematology Oncology ( Site 0015)

location_facility: Breast Cancer Research Centre-WA ( Site 2104)


type: EudraCT Number

type: Other Identifier

title: Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

summary: The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
Australia
Canada
France
Hungary
Denmark
United States
Romania
Belgium
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Israel

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Semmelweis Egyetem I. sz. Belgyogyaszati Klinika, Hematologia

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Haematologiai Tanszek

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego

location_facility: Institut Hospital del Mar d'Investigacions Mèdiques

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Barzilai Medical Center, Hematology Institute

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Catholic University of Korea Seoul Saint Mary's Hospital

location_facility: Centre Hospitalier Universitaire de Liège Site Sart Tilman

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: Petz Aladár Egyetemi Oktató Kórház - Győr

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuţă

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii

location_facility: Multiprofile Hospital for Active Treatment Ruse

location_facility: Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata

location_facility: Ospedale Policlinico Giambattista Rossi Borgo Roma

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi

location_facility: University Multiprofile Hospital for Active Treatment St. Ivan Rilski

location_facility: National Specialized Hospital for Active Treatment of Haematologic Diseases

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust

location_facility: Northwest Oncology & Hematology - Rolling Meadows

location_facility: Research Institute of the McGill University Health Centre

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lub

location_facility: Winship Cancer Institute, Emory University

location_facility: Chang Gung Memorial Hospital - Linkou Branch

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Registry Identifier

title: An Open-label, Dose Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-676 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumors

summary: The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in two phases including a dose escalation phase and a dose expansion phase. In the dose escalation phase, escalating doses of dazostinag are being tested alone and in combination with pembrolizumab to treat participants who have advanced or metastatic solid tumors. In the dose expansion phase, dazostinag will be studied with pembrolizumab with or without chemotherapy in participants with untreated metastatic or recurrent, unresectable squamous cell carcinoma of head and neck (SCCHN) and in combination with pembrolizumab in third-line or later recurrent locally advanced or metastatic microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) and third-line recurrent locally advanced or metastatic microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer (CRC).

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Poland
Israel
United Kingdom
Japan
Switzerland
Austria
Belgium
United States
China
Canada
Puerto Rico
France

location_facility: Sixth Affiliated Hospital of Sun Yat-Sen University/Guangdong Gastrointestinal Hospital

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne

location_facility: PRCCI Site: Puerto Rico Medical Research Center Torre Medica Hospital Auxilio Mutuo

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: University of California San Diego Moores Cancer Center

location_facility: Memorial Cancer Institute at Memorial Hospital West - Cancer Institute/Radiology Oncology

location_facility: UCI Health - Chao Family Comprehensive Cancer Center

location_facility: Institut de Cancerologie de lOuest - Saint-Herblain - Site Rene Gauducheau

location_facility: Centre de Lutte contre le Cancer - Centre Oscar Lambret

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: University of California Los Angeles - Jonsson Comprehensive Cancer Center

location_facility: PanOncology Trials: Universidad de Puerto Rico - Centro Comprensivo de Cancer

location_facility: West China School of Medicine - West China Hospital of Sichuan University

location_facility: Centrum Onkologii Im. Prof. F. Lukaszczyka w Bydgoszczy

location_facility: University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

location_facility: University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

location_facility: University of Cincinnati Health Barrett Cancer Center

location_facility: Virginia Cancer Specialists, P.C. - Fairfax

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

location_facility: Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz

location_facility: Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center


lead_sponsor: Astex Pharmaceuticals, Inc.

summary: To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino - IST

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Centre Hospitalier Universitaire Grenoble

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Szpital Wojewódzki w Opolu - Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Hanusch Krankenhaus Wiener Gebietskrankenkasse

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

location_facility: Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: University Hospitals Monarch Medical Center

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Spitalul Clinic Judetean de Urgenta Tirgu-Mures

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

location_facility: Universitätsklinikum Frankfurt Goethe Universität

location_facility: Azienda Ospedaliera Ospedale di Busto Arsizio

location_facility: Hospital Universitario Central de Asturias

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine

location_facility: Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

location_facility: John Theurer Cancer Center at Hackensack

location_facility: Chang Gung Medical Foundation-LinKou Branch

status: Completed

title: A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 Versus Treatment Choice (TC) in Adults With Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy

source: euctr

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Finland
Germany
Poland
Australia
Japan
Czechia
Canada
Serbia
France
Hungary
Denmark
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Sweden

status_simplified: Completed


title: A Multicenter, Randomized, Double-Blind, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Imipenem/Cilastatin/Relebactam in Adults With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia (EudraCT no. 2022-000081-18) (EUCTR no. 2022-501952-27-00) (IND no. 146614)

summary: This study aims to compare treatment with Imipenem/Cilastatin-XNW4107 (IMI-XNW4107) with imipenem/cilastatin/relebactam (IMI/REL) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). The primary hypothesis is that IMI-XNW4107 is non-inferior to IMI/REL in all-cause mortality.

ipd_sharing: No

lead_sponsor: Evopoint Biosciences Inc.

location_country:
United States
Israel
Spain
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: Jackson Memorial Hospital (JMH) - Ryder Trauma Center

location_facility: The University of Tennessee Medical Center

location_facility: Nouvel Hopital CIVIL/ Medecine Intensive Reanimation

location_facility: Hospital Universitario de Tarragona Joan XXIII

location_facility: Galilee Medical Center / Department int med A


title: A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction

acronym: VICTOR

summary: The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.

ReferenceType: result

ReferenceCitation: Butler J, Usman MS, Anstrom KJ, Blaustein RO, Bonaca MP, Ezekowitz JA, Freitas C, Lam CSP, Lewis EF, Lindenfeld J, McMullan CJ, Mentz RJ, O'Connor C, Rosano GMC, Saldarriaga CI, Senni M, Udelson J, Voors AA, Zannad F. Soluble guanylate cyclase stimulators in patients with heart failure with reduced ejection fraction across the risk spectrum. Eur J Heart Fail. 2022 Nov;24(11):2029-2036. doi: 10.1002/ejhf.2720. Epub 2022 Nov 16. Erratum In: Eur J Heart Fail. 2023 Mar;25(3):444.

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

version: publishedVersion

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

unpaywall_oa_status: green

publisher_dissemination: Wiley

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Colombia
Hungary
Hong Kong
Denmark
United States
Ukraine
China
Malaysia
Peru
Puerto Rico
Italy
Guatemala
United Kingdom
Singapore
Sweden
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

location_facility: Hospital Universiti Sains Malaysia-Medical Department ( Site 2357)

location_facility: Aarhus Universitetshospital, Skejby ( Site 1160)

location_facility: Rambam Health Care Campus-Cardiology ( Site 2053)

location_facility: Antalya Egitim ve Arastırma Hastanesi-Cardiology ( Site 4064)

location_facility: Rostov-on-Don City Emergency Hospital ( Site 3271)

location_facility: Communal Enterprise "Hospital #1" of Zhytomyr City Council-Advisory and Treatment department of Sci

location_facility: Excellentis Clinical Trial Consultants ( Site 3464)

location_facility: Cambridge Cardiac Care Centre ( Site 0658)

location_facility: University General Hospital of Larissa ( Site 1555)

location_facility: Shanghai Xuhui Central Hospital-Cardiovascular Department ( Site 0872)

location_facility: Instituto de Pesquisa clinica de Campinas ( Site 0551)

location_facility: Dunedin Hospital-Cardiology Department ( Site 2653)

location_facility: Unité de Recherche Clinique du CISSS des Laurentides ( Site 0668)

location_facility: Medizinische Hochschule Hannover ( Site 1476)

location_facility: Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 1058)

location_facility: The First Affiliated Hospital, Zhejiang University ( Site 0907)

location_facility: Flor Ferenc Hospital of Pest County-5th Department of Internal Medicine ( Site 1852)

location_facility: Sentara Norfolk General Hospital ( Site 0114)

location_facility: Maryland Cardiovascular Specialists ( Site 0056)

location_facility: Beata Miklaszewicz & Dariusz Dabrowski CARDIAMED s.j. ( Site 3070)

location_facility: OEC Clinical Research - Zalaegerszeg ( Site 1864)

location_facility: Centro de Investigacion Cardiovascular y Metabólica ( Site 2465)

location_facility: Universitetssjukhuset Örebro-Heart-Lung-Physiology Clinic ( Site 3754)

location_facility: Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 2855)

location_facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1556)

location_facility: Communal Non-profit Enterprise "City Hospital #6" Zaporizhzhia City Counci-Therapy department ( Site

location_facility: Omsk Regional Clinical Health Service Number 9 ( Site 3296)

location_facility: Fundación Centro de Investigación Clínica CIC ( Site 0955)

location_facility: Bacs-Kiskun Megyei Korhaz-I. Belgyógyászat - Kardiológia ( Site 1873)

location_facility: Kardiologische Gemeinschaftspraxis ( Site 1460)

location_facility: Zhongshan Hospital,Fudan University-Cardiology ( Site 0851)

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2454)

location_facility: Galilee Medical Center-Cardiology ( Site 2051)

location_facility: Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 0856)

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1874)

location_facility: Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu-Oddz.Klin.Kardiologii i Int.T.Kard. ( Si

location_facility: The First Affiliated Hospital of Xian Jiaotong University ward1 depattment of medical oncology ( Sit

location_facility: Unidad De Diagnostico Cardiologico ( Site 1654)

location_facility: Gachon University Gil Medical Center ( Site 3559)

location_facility: Hospital Universitario La Paz ( Site 3665)

location_facility: The First Affiliated Hospital of Wenzhou Medical University-Vasculocardiology Department ( Site 0874

location_facility: Clínica El Golf-Cardiologia ( Site 2857)

location_facility: CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 3666)

location_facility: Mackay Memorial Hospital-Hsinchu ( Site 3852)

location_facility: Dominion Medical Associates, Inc. ( Site 0089)

location_facility: Institut de Cardiologie de Montreal ( Site 0661)

location_facility: IPS Médicos Internistas de Caldas ( Site 0959)

location_facility: Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer

location_facility: Flinders Medical Centre-Cardiology Research ( Site 0455)

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 2165)

location_facility: Clinical Hospital S.R.Mirotvortseva name SSMU ( Site 3254)

location_facility: Instituto Jalisciense de Metabolismo SC ( Site 2467)

location_facility: Karolinska Universitetssjukhuset Solna-Heart and Vascular theme ( Site 3759)

location_facility: Norton Healthcare-Norton Heart Specialist ( Site 0062)

location_facility: South Florida Research Solutions ( Site 0058)

location_facility: Ryazan State Medical University named after Academician I.P. Pavlova ( Site 3260)

location_facility: Centre Hospitalier intercommunal de Toulon La Seyne sur Mer ( Site 1352)

location_facility: Clinical Research Chile SpA ( Site 0761)

location_facility: IRCCS San Raffaele Pisana-riabilitazione cardiologica ( Site 2156)

location_facility: Staedtisches Klinikum Dresden-2. Medizinische Klinik ( Site 1468)

location_facility: Guangdong Provincial People's Hospital-Cardiology ( Site 0852)

location_facility: Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 1851)

location_facility: SP ZOZ w Puławach- Oddział Kardiologii ( Site 3071)

location_facility: Cardiovascular Institute of the South ( Site 0072)

location_facility: Konstantopoulio General Hospital-Cardiology Clinic ( Site 1553)

location_facility: The University of Hong Kong - Shenzhen Hospital-Cardiovascular department ( Site 0895)

location_facility: Eskisehir Osmangazi University-Cardiology ( Site 4052)

location_facility: Krankenhaus St. Josef Braunau ( Site 0354)

location_facility: Azienda Ospedaliero Universitaria S.Anna ( Site 2152)

location_facility: Centrum Medyczne Dr Sudnik s.c. Wanda i Jerzy Sudnik ( Site 3073)

location_facility: Tianjin Chest Hospital-Cardiology ( Site 0901)

location_facility: First Pavlov State Medical University of Saint Petersburg-Сardiology department ( Site 3257)

location_facility: CAPED Centro Avancado Pesquisa e Diagnostica ( Site 0552)

location_facility: The First People's Hospital of Foshan ( Site 0898)

location_facility: University Hospital Coventry & Warwickshire-Research & Development ( Site 4170)

location_facility: Corcare-Corcare Cardiovascular Research ( Site 0660)

location_facility: Instituto de Investigaciones Clinicas Zarate ( Site 4360)

location_facility: Private Practice - Dr. James Cha ( Site 0655)

location_facility: Kliniken Maria Hilf-Klinik für Kardiologie ( Site 1454)

location_facility: Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 42

location_facility: Chungbuk National University Hospital-Internal medicine ( Site 3551)

location_facility: DRC Gyógyszervizsgáló Központ ( Site 1869)

location_facility: CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 3651)

location_facility: Valley Clinical Trials, Inc. ( Site 0085)

location_facility: St. George's Hospital-Cardiology Clinical Academic Group ( Site 4156)

location_facility: Sheba Medical Center-Leviev Heart Center ( Site 2064)

location_facility: Hospices Civils de Lyon - Hopital Louis Pradel ( Site 1364)

location_facility: Southwest Family Medicine Associates ( Site 0131)

location_facility: Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0754)

location_facility: Medical Park zmir Hastanesi-cardiology ( Site 4059)

location_facility: Netcare Sunninghill Hospital ( Site 3457)

location_facility: Advanced Cardiovascular - Alexander City ( Site 0038)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Cardiology- Day Hospital ( Site 2154)

location_facility: Changhua Christian Hospital ( Site 3857)

location_facility: Hospital Clinico San Carlos-Cardiology ( Site 3661)

location_facility: Anhui Provincil Hospital South District ( Site 0920)

location_facility: Shaanxi provincial people's hospital ( Site 0853)

location_facility: Renown Regional Medical Center-Renown Institute for Heart and Vascular Health ( Site 0168)

location_facility: Hygeia Hospital-6th cardiology clinic ( Site 1560)

location_facility: Centrum Medyczne Zdrowa J. Trebacz, W. Zajdel Sp. J. ( Site 3061)

location_facility: Tolna Megyei Balassa János Kórház ( Site 1868)

location_facility: St. Louis Heart and Vascular, P.C.-Clinical Trials Unit ( Site 0029)

location_facility: Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi ( Site 4063)

location_facility: Yonsei University-Wonju Severance Christian Hospital ( Site 3555)

location_facility: Hospital Sultanah Nur Zahirah-Jabatan Perubatan ( Site 2360)

location_facility: Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente ( Site 2466)

location_facility: Hospital Universitari de Bellvitge-Unitat Multidisciplinar d'Insuficiència Cardíaca Comunitària (UM

location_facility: Fundación Cardiovascular de Colombia ( Site 0961)

location_facility: Hospital General de Acapulco ( Site 2469)

location_facility: Cardiovascular Institute of the South ( Site 0081)

location_facility: Ninewells Hospital and Medical School-Cardiology ( Site 4164)

location_facility: Pitie Salpetriere University Hospital ( Site 1363)

location_facility: Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 3151)

location_facility: Lanzhou university second hospital-Lanzhou university second hospital ( Site 0863)

location_facility: Hospital de Messejana Dr Carlos Alberto Studart Gomes ( Site 0560)

location_facility: Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain

location_facility: Centro de Investigaciones Clinicas SAS ( Site 0957)

location_facility: Fundación Cardiovascular de Aguascalientes A.C. ( Site 2473)

location_facility: European Interbalkan Medical Center-2nd Department of Cardiology ( Site 1557)

location_facility: Hillel Yaffe Medical Center-Heart Institute ( Site 2058)

location_facility: Amici Clinical Research LLC-Research ( Site 0037)

location_facility: Herzzentrum Dresden GmbH Universitätsklinik ( Site 1469)

location_facility: Taichung Veterans General Hospital ( Site 3855)

location_facility: Kaohsiung Medical University Hospital ( Site 3856)

location_facility: Hospital Sultanah Bahiyah-Department of Cardiology ( Site 2355)

location_facility: Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 4352)

location_facility: South Texas Cardiovascular Consultants, PLLC-Research ( Site 0020)

location_facility: ASST Grande Ospedale Metropolitano Niguarda-Unità Ricerche Cliniche della Cardiologia 4 ( Site 2159)

location_facility: National University Heart Centre, Singapore-Department of Cardiology ( Site 3355)

location_facility: Centre Hospitalier Régional Universitaire de Nancy - Hôpitau-Centre Investigation Clinique Plurithé

location_facility: Universidade Federal de Goias-Serviço de Cardiologia ( Site 0553)

location_facility: The Second Hospital of Tianjin Medical University-Endocrinology ( Site 0902)

location_facility: Perm Regional Hospital for War Veterans ( Site 3272)

location_facility: Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 3753)

location_facility: General Hospital of Athens Hippokratio ( Site 1552)

location_facility: Royal Brisbane and Women's Hospital-Cardiology Research ( Site 0453)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 3854)

location_facility: Beijing Tsinghua Changgung Hospital ( Site 0911)

location_facility: Oakville Cardiovascular Research LP ( Site 0657)

location_facility: Ascension Providence Hospital ( Site 0094)

location_facility: Chongqing Three Gorges Central Hospital ( Site 0913)

location_facility: Slagelse Sygehus-Ambulatorium for Hjertesygdomme ( Site 1153)

location_facility: Centro de Investigacion Clinica de Oaxaca ( Site 2457)

location_facility: Hadassah Medical Center-Heart Institute ( Site 2062)

location_facility: Volgograd State Medical University ( Site 3258)

location_facility: Chesterfield Royal Hospital ( Site 4159)

location_facility: ProMedica Toledo Hospital-ProMedica Heart Failure Clinic ( Site 0061)

location_facility: Pécsi Tudományegyetem Klinikai Központ ( Site 1865)

location_facility: National Heart Centre Singapore ( Site 3351)

location_facility: Óbudai Egészségügyi Centrum ( Site 1861)

location_facility: Indago Research and Health Center Inc ( Site 0011)

location_facility: Beijing Friendship Hospital-Cardology ( Site 0865)

location_facility: Afyon Kocatepe Üniversitesi Tıp Fakültesi-Cardiology Department ( Site 4058)

location_facility: Gemeinschaftspraxis Dr. Fabian Krämer, Dr. Ulrich Overhoff ( Site 1459)

location_facility: Emory University School of Medicine ( Site 0123)

location_facility: Almazov National Medical Research Centre ( Site 3320)

location_facility: MultiCare Health System-MultiCare Cardiology - Inland Northwest ( Site 0102)

location_facility: Centre Hospitalier Louis Pasteur ( Site 1360)

location_facility: Universitaetsklinikum Heidelberg-Klinik für Kardiologie, Angiologie und Pneumologie ( Site 1475)

location_facility: Instytut Chorób Serca, Zakład Badań Klinicznych Chorób Układu Krążenia ( Site 3057)

location_facility: IPS Centro Científico Asistencial S.A.S ( Site 0952)

location_facility: Communal non-profit enterprise "Cherkasy Regional Hospital of Сherkasy Regional Council" ( Site 4292

location_facility: Washington University-Department of Medicine ( Site 0044)

location_facility: Hutt Valley District Health board HVDHB-Cardiology Research Unit ( Site 2652)

location_facility: Instituto Del Corazón De Bucaramanga ( Site 0960)

location_facility: Cardiovascular Institute of the South, 3 ( Site 0096)

location_facility: The Second Affiliated Hospital of Nanjing Medical University-Cardiology ( Site 0900)

location_facility: Royal Adelaide Hospital-Cardiology ( Site 0456)

location_facility: Polsko-Amerykańskie Kliniki Serca PAKS Małopolskie Centrum Sercowo-Naczyniowe ( Site 3062)

location_facility: Interregional Clinical Diagnostic Center-Department of Clinical Trials ( Site 3307)

location_facility: Cherkasy Regional Hospital-Cardiorheumatology ( Site 4283)

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital-Cardiology Department ( Site 0855)

location_facility: Alexandra Hospital-HEART FAILURE AND CARDIO-ONCOLOGY UNIT ( Site 1559)

location_facility: Unidad De Diagnostico Cardiologico ( Site 1652)

location_facility: State Institution National Scientific Center M.D. Strazhesko-Resuscitation and Intensive care ( Site

location_facility: Fundacion Valle del Lili- CIC-Internal Medicine ( Site 0962)

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-U.O.C. Cardiologia ( Site 2161)

location_facility: Ankara Bilkent Şehir Hastanesi-cardiology ( Site 4053)

location_facility: The Second Affiliated Hospital Chongqing Medical University-Department of Cardiology ( Site 0908)

location_facility: Centro Médico Viamonte-Clinical Research ( Site 4361)

location_facility: Vojenská Nemocnice Brno-Internal department ( Site 1055)

location_facility: Oaxaca Site Management Organization ( Site 2459)

location_facility: Pokrovskaya Municipal Hospital ( Site 3252)

location_facility: IRCCS - AOU di Bologna-Dept. of Medical and Surgical sciences ( Site 2158)

location_facility: St. Vinzenz-Hospital-Cardiology ( Site 1455)

location_facility: Falu Lasarett-Dep of Cardiology ( Site 3756)

location_facility: CMed Rehabilitacios es Diagnosztikai Kozpont ( Site 1877)

location_facility: Medicus MFC Research Clinic ( Site 0676)

location_facility: Fondazione IRCCS Policlinico San Matteo-Cardiology ( Site 2157)

location_facility: Fundacion Estudios Clinicos ( Site 4356)

location_facility: Hospital Germans Trias i Pujol ( Site 3664)

location_facility: Fakultni Nemocnice u sv. Anny v Brne-I. interni kardioangiologicka klinika ( Site 1066)

location_facility: OSF Healthcare Cardiovascular Institute ( Site 0122)

location_facility: The Affiliated Hospital of Xuzhou Medical College ( Site 0910)

location_facility: Sydvestjysk Sygehus Esbjerg-Hjertemedicinsk Projekt ( Site 1154)

location_facility: Uniklinikum Salzburg-Universitätsklinik für Innere Medizin II, Kardiologie, Internistische Intensiv

location_facility: Lenasia Clinical Trial Centre - Johannesburg ( Site 3470)

location_facility: Central clinical hospital - Ukrzalisnytsia-2nd Cardiology ( Site 4306)

location_facility: University of Alabama at Birmingham - School of Medicine-Cardiology ( Site 0153)

location_facility: Communal non-profit enterprise "City Clinical Hospital # 27" of Kharkiv City Council ( Site 4262)

location_facility: Pulse Heart Institute - Puyallup ( Site 0119)

location_facility: Centro de Estudios de Alta Especialidad de Sinaloa ( Site 2463)

location_facility: NSHA-QEII Health Sciences Centre-Dickson Bldg-Cardiology ( Site 0664)

location_facility: HOSPITAL GENERAL DE MEXICO DR. EDUARDO LICEAGA ( Site 2478)

location_facility: General Hospital of Athens "G. Gennimatas"-General Hospital of Athens "G.Gennimatas" ( Site 1561)

location_facility: Cardiovascular Consultants of South Georgia, LLC ( Site 0137)

location_facility: University Hospital of Ioannina-2nd Department of Cardiology ( Site 1554)

location_facility: People's Hospital of Lishui City-department of cardiovascular ( Site 0862)

location_facility: Hospital Alberto Sabogal Sologuren ( Site 2851)

location_facility: Parc de Salut Mar - Hospital del Mar ( Site 3663)

location_facility: Kawartha Cardiology Clinical Trials ( Site 0654)

location_facility: Cardiovascular Associates of the Delaware Valley ( Site 0097)

location_facility: University of Cincinnati Medical Center-Cardiology ( Site 0071)

location_facility: State Institution National Scientific Center M.D. Strazhesko-Department of clinical arrhythmology a

location_facility: Clinical medical and diagnostic center Limited Liability Company "Simedgroup" ( Site 4284)

location_facility: Hallym University Sacred Heart Hospital-Cardiovascular center ( Site 3556)

location_facility: Peace River Cardiovascular Center ( Site 0088)

location_facility: Ustredni vojenska nemocnice-Oddeleni kardiologie ( Site 1054)

location_facility: Zhejiang Provincial People's Hospital ( Site 0914)

location_facility: Nemocnice Slany-Interna - kardiologicka ambulance ( Site 1063)

location_facility: Hospital Universitario Virgen de Valme ( Site 3654)

location_facility: Polsko-Amerykańskie Kliniki Serca ( Site 3077)

location_facility: Communal nonprofit enterprise "City Hospital #9" of Zaporizhzhia City Council ( Site 4251)

location_facility: Queen Mary Hospital-Medicine - Cardiology ( Site 1752)

location_facility: Excel Medical Clinical Trials ( Site 0008)

location_facility: Centro de Pesquisa Clinica do Coracao ( Site 0561)

location_facility: Private Practice - Dr. Yolanda Figueroa-Torres ( Site 3156)

location_facility: University Hospital of Alexandroupolis-First Department of Internal Medicine ( Site 1551)

location_facility: NZOZ Centrum Medyczne KERmed ( Site 3066)

location_facility: Methodist Medical Center of Illinois ( Site 0098)

location_facility: Centro Cardiologico Monzino-Heart Failure Unit ( Site 2153)

location_facility: New York Presbyterian Medical Group Hudson Valley Cardiology ( Site 0127)

location_facility: East Coast Institute for Research - St. Augustine ( Site 0016)

location_facility: Seoul National University Hospital ( Site 3557)

location_facility: The People's Hospital of Liaoning Province ( Site 0859)

location_facility: Pusan National University Hospital-Internal Medicine ( Site 3553)

location_facility: University of Florida - Jacksonville ( Site 0169)

location_facility: Mercy Gilbert Medical Center-Dignity Health Cardiology ( Site 0075)

location_facility: Cardiocent de Guadalajara S.C. ( Site 2464)

location_facility: The Prince Charles Hospital-Cardiology Research Centre ( Site 0451)

location_facility: Victoria Heart Institute Foundation ( Site 0680)

location_facility: Assuta Ashdod Medical Center-Cardiology ( Site 2063)

location_facility: Consultative - Diagnostic Centre of Pechersky District-Therapeutic department ( Site 4307)

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Cardiology ( Site 0868)

location_facility: VA Caribbean Healthcare System ( Site 3157)

location_facility: Ivanovo Regional Healthcare Institution Cardiology Dispensary ( Site 3265)

location_facility: West Houston Area Clinical Trial Consultants ( Site 0014)

location_facility: William Harvey Heart Centre ( Site 4169)

location_facility: The Heart Center of Lake County Research Institute-Research ( Site 0147)

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-Cardiologia 1 ( Site 2151)

location_facility: Svendborg Hospital Odense Universitets hospital-Kardiologisk Forskningsenhed ( Site 1156)

location_facility: Cardiovascular Center of Sarasota ( Site 0154)

location_facility: Unidad biomedica avanzada monterrey ( Site 2462)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 2474)

location_facility: Diex Recherche Trois-Rivieres ( Site 0677)

location_facility: Private Practice - Dr. Lakatos Ferenc ( Site 1854)

location_facility: Centro de investigacion Clínica Trujillo-Medical specialties ( Site 2860)

location_facility: Wuxi People's Hospital-Cardiovascular Department ( Site 0870)

location_facility: Carient Heart & Vascular - Manassas ( Site 0059)

location_facility: Medivest Centro de Investigación Integral ( Site 2460)

location_facility: Marienhaus Klinikum St. Elisabeth Neuwied ( Site 1452)

location_facility: Worcestershire Royal Hospital-Cardiology Research Department ( Site 4181)

location_facility: Tyler Cardiovascular Consultants ( Site 0039)

location_facility: Centro De Estudios Cardiologicos Y De Medicina Interna ( Site 0752)

location_facility: King's College Hospital-Cardiac Research Department ( Site 4154)

location_facility: Nordsjællands Hospital - Hillerød ( Site 1159)

location_facility: Shanghai Tongji Hospital-Cardiovascular Department ( Site 0905)

location_facility: The Third Xiangya Hospital of Central South University-Cardiology ( Site 0860)

location_facility: Affiliated Hospital of Jiangsu University-Cardiology Department ( Site 0917)

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2468)

location_facility: South Texas Cardiovascular Consultants, PLLC-Research ( Site 0024)

location_facility: Waikato Hospital-Cardiology Clinical Trials Unit ( Site 2654)

location_facility: Cardiovascular Research of Northwest Indiana ( Site 0036)

location_facility: Vanderbilt University Medical Center-Vanderbilt Heart and Vascular Institue ( Site 0060)

location_facility: Unidad Médica para la Salud Integral ( Site 2472)

location_facility: Capitol Cardiology Associates - Lanham Office-Maryland Research Centers ( Site 0167)

location_facility: Centro de Investigaciones Clinicas del Litoral ( Site 4354)

location_facility: China-Japan Union Hospital-department of cardiology ( Site 0916)

location_facility: Professor Ntsekhe Cardiology Clinic ( Site 3454)

location_facility: INOVA Fairfax Medical Campus ( Site 0136)

location_facility: Yitzhak Shamir Medical Center-Cardiology ( Site 2060)

location_facility: Başkent Üniversitesi Istanbul Hastanesi ( Site 4057)

location_facility: University Malaya Medical Centre ( Site 2351)

location_facility: University of Pretoria - Faculty of Health Sciences-CRU ( Site 3462)

location_facility: The First Hospital of Harbin Medical University-Cardiology ( Site 0903)

location_facility: Pokrovskaya Municipal Hospital-1-st cardiology department ( Site 3251)

location_facility: St. Boniface General Hospital ( Site 0667)

location_facility: Louisiana Heart Center - Hammond ( Site 0004)

location_facility: Aultman Hospital-Cardiology Clinical Trials ( Site 0064)

location_facility: Ukrayins'kyy Derzhavnyy Naukovo-Doslidnyy Instytut Rebilitatsiyi Invalidiv ( Site 4274)

location_facility: Taipei Veterans General Hospital-General Clinical Research Center ( Site 3851)

location_facility: Hospital Queen Elizabeth II ( Site 2359)

location_facility: Semmelweis University-Városmajori Szív- és Érgyógyászati Klinika ( Site 1855)

location_facility: Consultorio de Medicina Especilizada del Sector Privado ( Site 2455)

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Cardiolggy

location_facility: Hospital Universitario Ramón y Cajal ( Site 3662)

location_facility: Chonnam National University Hospital ( Site 3558)

location_facility: Ege University Medicine of Faculty-Cardilogy Department ( Site 4054)

location_facility: Clemenstorgets Hjartmottagning ( Site 3755)

location_facility: Aleris Specialistvård Sabbatsberg ( Site 3762)

location_facility: Private Practice - Dr. Robert Witek-Ośrodek Badań Klinicznych "METABOLICA" Lek. Robert Witek ( Site

location_facility: Kocaeli Üniversitesi-Cardiology ( Site 4060)

location_facility: Chungnam national university hospital ( Site 3554)

location_facility: Municipal Non-commercial Enterprise "Ivano-Frankivsk Regional Clinical Cardiology Center of Ivano-Fr

location_facility: First Pavlov State Medical University of Saint Petersburg ( Site 3288)

location_facility: Institute for Medical Research ( Site 3316)

location_facility: Centro de Imagen y Tecnología en Intervención Cardiovascular ( Site 2477)

location_facility: Cardiovascular Research Center of South Florida ( Site 0074)

location_facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur-Service cardiologie ( Site 1353)

location_facility: Hospital Cayetano Heredia-Servicio de cardiologia ( Site 2852)

location_facility: Praktyka Lekarska Lidia Pawlowicz ( Site 3053)

location_facility: Universal Axon Clinical Research, LLC ( Site 0022)

location_facility: Rostov State Medical University ( Site 3259)

location_facility: Medizinische Universität Graz-Department of Cardiology ( Site 0351)

location_facility: North York Diagnostic and Cardiac Centre ( Site 0682)

location_facility: Heritage Medical Research Clinic ( Site 0679)

location_facility: Herlev and Gentofte Hospital-Department of Cardiology ( Site 1158)

location_facility: Medical Care and Research SA de CV ( Site 2461)

location_facility: Medifarma 98 Kft-Outpatient Clinic ( Site 1859)

location_facility: Vseobecna fakultni nemocnice v Praze-Centrum srdečního selhání ( Site 1059)

location_facility: Doylestown Hospital-Cardiology ( Site 0030)

location_facility: East Coast Institute for Research, LLC ( Site 0047)

location_facility: Klinik Floridsdorf-Karl Landsteiner Institute for Cardiovascular and Critical Care Research c/o Dep

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 1356)

location_facility: State Institution National Scientific Center M.D. Strazhesko-Essential Hypertension ( Site 4259)

location_facility: Lutsk City Clinical Hospital-Center for Cardiovascular Disease ( Site 4255)

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii Lek. med. Krzysztof Cymerman

location_facility: Hospital Tengku Ampuan Afzan ( Site 2353)

location_facility: Dokuz Eylül Üniversitesi-CARDIOLOGY ( Site 4055)

location_facility: University of Missouri Hospital ( Site 0163)

location_facility: AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 1558)

location_facility: St. John of God Subiaco Hospital ( Site 0457)

location_facility: The University of Mississippi Medical Center-Cardiovascular ( Site 0073)

location_facility: State budgetary Healthcare Institution of the city of Moscow "V. V. Vinogradov City Clinical Hospita

location_facility: Kaplan Medical Center-Heart Institution ( Site 2054)

location_facility: Georgia Arrhythmia Consultants and Research Institute ( Site 0042)

location_facility: Cattinara Hospital-Cardiovascular Department ( Site 2162)

location_facility: The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0909)

location_facility: Hospital de Clínicas de Ribeirão Preto ( Site 0559)

location_facility: Katholisches Krankenhaus St. Johann Nepomuk ( Site 1462)

location_facility: Chris Hani Baragwanath Academic Hospital ( Site 3455)

location_facility: Franciscan Physician Network - Indiana Heart Physicians ( Site 0087)

location_facility: Istanbul University Cerrahpasa Medical School Internal Diseases Institute-CARDIOLOGY INSTITUTE ( Sit

location_facility: MNE " Kyiv City Clinical Emergency Hospital" of Kyiv Regional Council (KCSA) ( Site 4256)

location_facility: Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 4257)

location_facility: University Of Alberta Hospital ( Site 0669)

location_facility: Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien ( Site 1477)

location_facility: Shanghai Yangpu District Central Hospital-Cardiology ( Site 0876)

location_facility: Universitaetsklinikum Wuerzburg ( Site 1458)

location_facility: Xiangya Hospital Central South University-Cardiological Department ( Site 0899)

location_facility: PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR ( Site 0555)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0161)

location_facility: St. James's Hospital-Cardiology ( Site 1951)

location_facility: L.T. Mala National Institute of Therapy of NAMS of Ukraine-Clinical Pharmacology and Pharmacogeneti

location_facility: Khmelnytskyi Regional Cardiovascular Center-department of invasive cardiology and interventional ra

location_facility: Skellefteå Lasarett-Research unit, floor 5 ( Site 3760)

location_facility: Southeastern Cardiology and Cardiovascular-Duke HC CRU - Lumberton ( Site 0134)

location_facility: Zakarpattya Regional Clinical Cardiology Dispensary-Dept. of Hospital Therapy, Uzhhorod National Un

location_facility: Rabin Medical Center-Cardiology - CHF ( Site 2052)

location_facility: Universitätsmedizin Greifswald ( Site 1470)

location_facility: Severance Hospital, Yonsei University Health System ( Site 3552)

location_facility: Wuxi No.2 People's Hospital-Cardiology Department ( Site 0877)

location_facility: North Shore Hospital-Cardiology Research ( Site 2656)

location_facility: Northern Jiangsu People's Hospital ( Site 0861)

location_facility: West China Hospital Sichuan University ( Site 0904)

location_facility: Shaare Zedek Medical Center-Cardiology ( Site 2055)

location_facility: Blackpool Victoria Hospital ( Site 4161)

location_facility: Västmanlands Sjukhus Västerås ( Site 3757)

location_facility: Christchurch Heart Institute ( Site 2651)

location_facility: Alliance for Multispecialty Research, LLC ( Site 0143)

location_facility: Siping Central People's Hospital-Cardiovascular Department ( Site 0915)

location_facility: Research and Cardiovascular Corp. ( Site 3152)

location_facility: Universitas Private Hospital-Cardiology Research ( Site 3453)

location_facility: Centro de Atención e Investigación Cardiovascular del Potosí ( Site 2453)

location_facility: The Second Affiliated Hospital of Nanchang University-Cardiology ( Site 0912)

location_facility: MUDr. Libor Nechvatal s.r.o. , Kardiologie ( Site 1057)

location_facility: Hospital Universitari Vall d'Hebron ( Site 3659)

location_facility: University Hospital of North Tees ( Site 4172)

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Cardiology ( Site 1878)

location_facility: Hunan Provincial People's Hospital ( Site 0857)

location_facility: Institut Klinicke a Experimentalni Mediciny-Klinika kardiologie ( Site 1052)

location_facility: Municipal Non-Profit Enterprise -City clinical hospital No8 of Kharkiv city council ( Site 4278)

location_facility: VA West Los Angeles Medical Center-Cardiology ( Site 0149)

location_facility: Sygehus Vendsyssel Hjoerring ( Site 1164)

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0010)

location_facility: HOSPITAL CLINICO DE VALENCIA ( Site 3656)

location_facility: Incor - Instituto do Coracao ( Site 0557)

location_facility: Centro Cardiovascular Colombiano Clínica Santa María ( Site 0951)

location_facility: The First Affiliated Hospital of Jinan University ( Site 0897)

location_facility: Hôpital de la Cité-de-la-Santé ( Site 0673)

location_facility: Krasnodar Regional Clinical Hospital Number 1 S.V. Ochapovskogo ( Site 3281)


acronym: ROSEWOOD

lead_sponsor: BeiGene

summary: The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.

ReferenceType: background

ReferenceCitation: Trotman J, Folwer N, Auer R, Flowers C, Reed W, Stern JC, Huang J, Zinzani PL. Phase 2 Obinutuzumab Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL). American Society of Clinical Oncology, 2018.

ReferenceCitation: Fowler N, Trotman J, Auer R, Flowers C, Reed W, Marimpietri C, Huang J, Zinzani PL.Randomized phase 2 zanubrutinib (BGB-3111) + obinutuzumab (obi) vs obi monotherapy in patients (pts) with relapsed/refractory follicular lymphoma (R/R FL). American Society of Clinical Oncology. 2019

ReferenceCitation: Fowler NH, Trotman J, Auer R, Flowers CR, Reed WF, Ivanova E, Huang J, Zinzani PL.Randomized Phase 2 Zanubrutinib (BGB-3111) + Obinutuzumab vs Obinutuzumab Monotherapy in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL). American Society of Hematology. 2019

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: N.N. Alexandrov National Cancer Centre of Belarus

location_facility: IRCCS Ospedale di Circolo e Fondazione Macchi

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: State Budgetary Healthcare Institution. Volgograd

location_facility: Gomel Regional Clinical Oncology Dispensary

location_facility: Minsk City Clinical Oncological Dispensary

location_facility: Soon Chun Hyang University Hospital Seoul

location_facility: Nanfang Hospital,Southern Medical University

location_facility: University of Illinois Hospital & Health Sciences System

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

location_facility: Institut Català d'Oncologia de l'Hospitalet de Llobregat

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois

location_facility: Keimyung University Dongsan Medical Center

location_facility: Azienda Unita Sanitaria Locale di Ravenna Ospedale Santa Maria delle Croci

location_facility: Nizhniy Novgorod Regional Clinical Hospital N.A.

location_facility: Tongji Hospital of Tongji Medical College Huazhong University of Science Technology

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska

location_facility: University Multiprofile Hospital for Active Treatment Saint Ivan Rilski

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie - Oddział w Gliwicach

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Second Affiliated Hospital of Army Medical University, PLA (Xinqiao Hospital)

location_facility: Centre de Lutte Contre le Cancer - Institut Bergonie

location_facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology

location_facility: Centre Hospitalier Universitaire d'Amiens - Hopital Sud

location_facility: Centre Hospitalier Universitaire de Poitier- Hopital de la Miletrie - Hopital Jean Bernard

location_facility: State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: N. N. Blokhin Russian Cancer Research Center

location_facility: Tianjin Medical University Cancer Institute & Hospital

title: An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

location_country:
Germany
Belarus
Italy
Poland
New Zealand
United Kingdom
Australia
United States
China
Korea, Republic of
Spain
Taiwan
Czechia
Bulgaria
Canada
Russian Federation
France


title: Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma

summary:
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 394 adult participants with NHL will be enrolled in 100 sites globally.

In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28-day or 21 day cycles dependent on the arm in combination with the anti-neoplastic agents described below:

1: Oral lenalidomide in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in participants with newly diagnosed treatment-naïve DLBCL; 4: Oral CC-99282 in participants with R/R DLBCL; 5: Oral CC-99282 in participants with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in participants with R/R mantle cell lymphoma (MCL); 6B: Oral ibrutinib, and oral venetoclax in participants with R/R MCL; 7: Oral ibrutinib, and oral venetoclax in participants with newly diagnosed treatment-naïve MCL.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

sponsor_collaborators: AbbVie Genmab

location_country:
Germany
Hungary
Israel
Denmark
Japan
Netherlands
United States
Korea, Republic of
Spain
Taiwan
Czechia
France

location_facility: Thompson Cancer Survival Ctr /ID# 242150

location_facility: Maastricht Universitair Medisch Centrum /ID# 243317

location_facility: East Carolina University Brody School of Medicine /ID# 242506

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 242342

location_facility: Multicare Institute for Research and Innovation /ID# 242127

location_facility: National Cheng Kung University Hospital /ID# 242894

location_facility: Christiana Care Health Service /ID# 242301

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 242345

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 242335

location_facility: The Chaim Sheba Medical Center /ID# 243010

location_facility: Joe Arrington Cancer Research /ID# 242226

location_facility: Icahn School of Medicine at Mount Sinai /ID# 242123

location_facility: CHU de Rennes - PONTCHAILLOU /ID# 242339

location_facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265

location_facility: Taipei Veterans General Hosp /ID# 242892

location_facility: Tel Aviv Sourasky Medical Center /ID# 243012

location_facility: Hospital Universitario de Salamanca /ID# 243368

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 242450

location_facility: Vrije Universiteit Medisch Centrum /ID# 243319

location_facility: Hospital Clinico Universitario de Valencia /ID# 243269

location_facility: Hospital Universitario Vall d'Hebron /ID# 243260

location_facility: China Medical University Hospital /ID# 242893

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 245031

location_facility: Swedish Cancer Institute- First Hill /ID# 242269

location_facility: Institut de Recherche Saint Louis - Hopital St Louis /ID# 242336

location_facility: Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144

location_facility: Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 243261

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268

location_facility: Northwell Health - Monter Cancer Center /ID# 245435

location_facility: Hokkaido University Hospital /ID# 248999

location_facility: Universitair Medisch Centrum Groningen /ID# 243318

location_facility: National Cancer Center Hospital /ID# 248995

location_facility: University of Arizona Cancer Center - North Campus /ID# 242219

location_facility: University of Maryland School of Medicine /ID# 242218

location_facility: Hadassah Medical Center-Hebrew University /ID# 243013

location_facility: Hospital Universitario 12 de Octubre /ID# 243262

location_facility: Seoul National University Hospital /ID# 242402

location_facility: Seoul National University Bundang Hospital /ID# 242404

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 242403

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 243264

location_facility: Novant Health Presbyterian Medical Center /ID# 242148

location_facility: Leids Universitair Medisch Centrum /ID# 243316

location_facility: Novant Health Forsyth Medical Center /ID# 242198

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 242685

location_facility: Hospital Universitario Virgen del Rocio /ID# 243267

location_facility: Fakultni nemocnice Hradec Kralove /ID# 241722


title: A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

summary: The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

collaborators:
Seagen Inc.
Astellas Pharma Inc

sponsor_collaborators:
Merck Sharp & Dohme LLC
Seagen Inc.
Astellas Pharma Inc

location_country:
Germany
Poland
Argentina
Australia
Japan
Croatia
Czechia
Canada
France
Colombia
Portugal
Hungary
United States
Ukraine
Romania
China
Malaysia
Philippines
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1057)

location_facility: Ottawa Hospital Research Institute ( Site 0109)

location_facility: UT Southwestern Medical Center ( Site 0003)

location_facility: Oregon Health and Science University ( Site 0028)

location_facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0662)

location_facility: Hadassah Medical Center-Oncology ( Site 0757)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1107)

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval ( Site 0952)

location_facility: National Medical Research Centre of Oncology named after N.N. Blokhin ( Site 0865)

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S

location_facility: Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600)

location_facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)

location_facility: Mayo Clinic in Arizona - Phoenix ( Site 0043)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 0461)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1103)

location_facility: CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0401)

location_facility: Fakultni nemocnice u sv. Anny v Brne ( Site 0253)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)

location_facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 0050)

location_facility: Klinički bolnički centar Zagreb-Klinika za onkologiju ( Site 1701)

location_facility: Nagasaki University Hospital ( Site 1517)

location_facility: Nantong Tumor Hospital-Urology ( Site 1405)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1102)

location_facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 1653)

location_facility: Krankenhaus Martha Maria Halle-Doelau ( Site 0507)

location_facility: China Medical University Hospital ( Site 1202)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 0035)

location_facility: Sourasky Medical Center-Oncology ( Site 0755)

location_facility: Taipei Veterans General Hospital ( Site 1201)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)

location_facility: BC Cancer - Vancouver Center ( Site 0110)

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0852)

location_facility: University of Louisville, James Graham Brown Cancer Center ( Site 0022)

location_facility: Kitasato University Hospital ( Site 1506)

location_facility: University Malaya Medical Centre ( Site 0352)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0011)

location_facility: Centro Hospitalar e Universitario de Coimbra ( Site 0406)

location_facility: Duke University Medical Center ( Site 0017)

location_facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1558)

location_facility: Chonnam National University Hwasun Hospital ( Site 1353)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)

location_facility: Kyungpook National University Chilgok Hospital ( Site 1354)

location_facility: Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)

location_facility: Fundacion Valle del Lili- CIC ( Site 1656)

location_facility: MI Clinical oncology dispensary of Dnipropetrovsk regional council ( Site 0954)

location_facility: THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo

location_facility: Saint Francis Cancer Center ( Site 0008)

location_facility: MHAT Central Onco Hospital OOD ( Site 1158)

location_facility: Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0254)

location_facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)

location_facility: SC Radiotherapy Center Cluj SRL ( Site 1108)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0463)

location_facility: University of Iowa Hospital and Clinics ( Site 0029)

location_facility: Fundacion Estudios Clinicos-Oncology ( Site 1557)

location_facility: Fudan University Shanghai Cancer Center-Urology department ( Site 1401)

location_facility: Azienda Ospedaliero Universitaria delle Marche-Clinica Oncologica ( Site 0593)

location_facility: Klinički bolnički centar Osijek ( Site 1705)

location_facility: Caritas Krankenhaus St. Josef ( Site 0502)

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)

location_facility: Houston Methodist Urology Associates ( Site 0033)

location_facility: National Medical Research Radiology Centre ( Site 0869)

location_facility: Hopital Diaconesses Croix Saint Simon ( Site 0465)

location_facility: Hospital Británico de Buenos Aires-Oncology ( Site 1551)

location_facility: Kanazawa University Hospital ( Site 1509)

location_facility: The University of Tennessee Medical Center ( Site 0034)

location_facility: Universitaetsklinikum Wuerzburg ( Site 0520)

location_facility: Korea University Anam Hospital ( Site 1357)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0657)

location_facility: Yokohama City University Medical Center ( Site 1508)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0871)

location_facility: Osaka Metropolitan University Hospital ( Site 1515)

location_facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1002)

location_facility: Fakultni Thomayerova nemocnice ( Site 0252)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)

location_facility: Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965)

location_facility: Meir Medical Center-oncology ( Site 0754)

location_facility: Fundación Cardiovascular de Colombia-Santander ( Site 1657)

location_facility: University General Hospital of Larissa ( Site 0302)

location_facility: Rabin Medical Center-Oncology ( Site 0752)

location_facility: Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1402)

location_facility: Steve Biko Academic Hospital ( Site 0601)

location_facility: I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital ( Site 0959)

location_facility: Seoul National University Hospital ( Site 1351)

location_facility: Seoul National University Bundang Hospital ( Site 1355)

location_facility: Universitaetsklinikum Muenster ( Site 0516)

location_facility: Volgograd Regional Uronephrological Center ( Site 0870)

location_facility: Hospital Italiano de Buenos Aires ( Site 1554)

location_facility: IRCCS Ospedale San Raffaele ( Site 0596)

location_facility: Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1058)

location_facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 1203)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro

location_facility: University of Wisconsin Hospital and Clinics ( Site 0037)

location_facility: Osaka International Cancer Institute ( Site 1514)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0588)

location_facility: Frankston Hospital-Oncology and Haematology ( Site 1258)

location_facility: Klinički Bolnički Centar Split-Oncology and Radiotherapy ( Site 1702)

location_facility: MNPE Regional Center of Oncology ( Site 0955)

location_facility: Volga District Medical Center ( Site 0876)

location_facility: Universitaetsklinik fuer Urologie ( Site 0501)

location_facility: University of California San Francisco ( Site 0010)

location_facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 1259)

location_facility: General Hospital of Athens "Alexandra" ( Site 0303)

location_facility: St.Petersburg Clinical Hospital RAS ( Site 0864)

location_facility: CHU Limoges Hopital Dupuytren ( Site 0459)

location_facility: AOU San Luigi Gonzaga di Orbassano ( Site 0595)

location_facility: Hospital Universitario Central de Asturias ( Site 0654)

location_facility: University of Tsukuba Hospital ( Site 1502)

location_facility: Xarxa Assistencial Universitaria Manresa ( Site 0655)

location_facility: Complex Oncology Center Plovdiv ( Site 1151)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 0753)

location_facility: Universitaetsklinikum Freiburg ( Site 0512)

location_facility: Altay Regional Oncology Dispensary ( Site 0851)

location_facility: Tokyo Medical and Dental University Hospital ( Site 1505)

location_facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0409)

location_facility: Zhytomyr Regional Oncology Center ( Site 0961)

location_facility: Hirosaki University Hospital ( Site 1501)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 0867)

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1413)

location_facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1654)

location_facility: Klinički bolnički centar Sestre milosrdnice ( Site 1703)

location_facility: Okayama University Hospital ( Site 1516)

location_facility: Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital ( Site 1802)

location_facility: St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0856)

location_facility: Institut Català d'Oncologia (ICO) - Girona ( Site 0653)

location_facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1406)

location_facility: UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0305)

location_facility: Yitzhak Shamir Medical Center-Oncology ( Site 0756)

location_facility: Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553)

location_facility: Hamamatsu University Hospital ( Site 1511)

location_facility: Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960)

location_facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1801)

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1010)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)

location_facility: Narodowy Instytut Onkologii ( Site 1051)

location_facility: Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)

location_facility: Clinical Research Center Medic-R ( Site 1061)

location_facility: Hospital Geral de Santo Antonio ( Site 0408)

location_facility: Rambam Health Care Campus-Oncology ( Site 0751)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0509)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 0009)

location_facility: Institutul Oncologic Cluj-Oncologie Medicala ( Site 1109)

location_facility: Sverdlovsky Regional Clinical hospital #1 ( Site 0868)

location_facility: Gachon University Gil Medical Center ( Site 1356)

intervention_type: Procedure


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects With Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

summary: The objective of this study is to evaluate the effect of cabozantinib compared with placebo on progression free survival (PFS) and objective response rate (ORR) in subjects with Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) who have progressed after prior vascular endothelial growth factor receptor (VEGFR)-Targeted therapy.

ReferenceType: derived

ReferenceCitation: Brose MS, Robinson B, Sherman SI, Krajewska J, Lin CC, Vaisman F, Hoff AO, Hitre E, Bowles DW, Hernando J, Faoro L, Banerjee K, Oliver JW, Keam B, Capdevila J. Cabozantinib for radioiodine-refractory differentiated thyroid cancer (COSMIC-311): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1126-1138. doi: 10.1016/S1470-2045(21)00332-6. Epub 2021 Jul 5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Exelixis

sponsor_collaborators: Exelixis Ipsen

location_country:
Germany
Poland
Argentina
Australia
Brazil
Thailand
Croatia
Czechia
Canada
France
Hungary
Hong Kong
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility:
Exelixis Clinical Site #148
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acronym: EXTEND

lead_sponsor: Biogen

summary:
The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).

Secondary objectives of this study in this study population are as follows:

To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401).

ReferenceCitation: Gold R, Stefoski D, Selmaj K, Havrdova E, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Neurol Ther. 2016 Dec;5(2):169-182. doi: 10.1007/s40120-016-0048-2. Epub 2016 Jul 13.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

sponsor_collaborators: Biogen AbbVie

status: Terminated

title: A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Czechia
Canada
Serbia
France
Hungary
Denmark
Switzerland
United States
Ukraine
India
Romania
Moldova, Republic of
Italy
United Kingdom
Sweden
Mexico
Spain
Greece
Georgia
Russian Federation
Israel

status_simplified: Unknown