title: A Multicenter, International, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel-group, 2-arm, Phase 3 Study to Compare the Efficacy and Safety of the Oral FXIa Inhibitor Asundexian (BAY 2433334) With Apixaban for the Prevention of Stroke or Systemic Embolism in Male and Female Participants Aged 18 Years and Older With Atrial Fibrillation at Risk for Stroke

acronym: OCEANIC-AF

summary:
Researchers are looking for a better way to treat people with atrial fibrillation and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel).

Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them.

Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding.

The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care with regard to the risk of bleeding.

The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke.

To see how well the study treatment asundexian works researchers compare:

how long asundexian works well and
how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening:
stroke and/or
systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study.

To see how safe asundexian is, the researchers will compare how often major bleedings occur after taking the study treatments asundexian and apixaban, respectively. Major bleedings are bleedings that have a serious or even life-threatening impact on a person's health.

The study participants will be randomly (by chance) assigned to 1 of 2 treatment groups, A and B. Dependent on the treatment group, the participants will either take the study treatment asundexian by mouth once a day or apixaban by mouth twice a day for approximately 9 - 33 months.

Each participant will be in the study for approximately 9 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. Those participants who do not want or are unable to have visits to the study site may join the study remotely in selected locations. The location name contains the abbreviation - DCT in such cases.

During the study, the study team will:

take blood samples
do physical examinations
examine heart health using an electrocardiogram (ECG)
check vital signs such as blood pressure and heart rate
do pregnancy tests
ask the participants questions about their quality of life
ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

status: Active, not recruiting

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Kazakhstan
Turkey
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
India
Romania
Belgium
China
Malaysia
Estonia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Israel

location_facility: CIUSSS de l'Estrie-CHUS, Hopital Fleurimont

location_facility: Buddhist Tzu-Chi General Hospital, Hualien

location_facility: Hyogo Prefectural Harima-Himeji General Medical Center

location_facility: Sydvestjysk Sygehus Esbjerg | Kardiologisk Forskningsenhed

location_facility: Hopital Européen Georges Pompidou - Paris

location_facility: Unicardia Specjalistyczne Centrum Leczenia Ch.Serca i Naczyn

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Cardiology Consultants of Philadelphia-Yardley

location_facility: The First Affiliated Hospital of Jinzhou Medical University

location_facility: Interventional Cardiology Medical Group | West Hills, CA

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: Shanghai Putuo District Central Hospital

location_facility: Ziekenhuis Rivierenland | Cardiology Research Department

location_facility: Akershus University Hospital Cardiology Department

location_facility: Hospital Universitario Virgen de la Victoria | Cardiology Department

location_facility: Eskisehir Osmangazi Universitesi Tip Fakultesi

location_facility: Vestre Viken HF - Bærum Sykehus Cardiology

location_facility: The First Affiliated Hospital of Xinjiang Medical University

location_facility: National hospital Organization Mito Medical Center

location_facility: P. Stradins Clinical University Hospital

location_facility: MedUni Wien | Innere Medizin II, Kardiologie

location_facility: Hospital da Senhora da Oliveira | Clinical Research Department

location_facility: Cardiovascular and Vein Center of Florida

location_facility: University Hospital Louvain Namur | Godinne - Cardiology Department

location_facility: ¿ultidisc. hosp. for act. treatm. Sveti Georgi - Pernik OOD

location_facility: Alta Pharmaceutical Research Center, LLC

location_facility: Multiprofile Hospital for Active Treatment Trakiya Park | Cardiology Department

location_facility: The First Affiliated Hospital of Jinan University

location_facility: Barzilai Ashkelon University Medical Center | Cardiology Department

location_facility: The Sakakibara Heart Institute of Okayama

location_facility: Multiprofile Hospital for Active Treatment Sveta Karidad | Cardiology Department

location_facility: Advanced Research for Health Improvement

location_facility: Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Cardiology, Research Unit

location_facility: Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare

location_facility: Klinikum Wels-Grieskirchen | Innere Medizin II

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

location_facility: Kawaguchi Cardiovascular and Respiratory Hospital

location_facility: Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital

location_facility: University of Colorado Hospital - Cardiology

location_facility: AZ Sint Blasius, Cardiology, Dendermonde

location_facility: Irmandade da Santa Casa de Misericordia - Sao Paulo

location_facility: Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme

location_facility: H. Universitario 12 de Octubre - Cardiologia

location_facility: Aultman | Aultman Hospital Main Campus - Clinical Trials

location_facility: Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

location_facility: The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...

location_facility: University of Pittsburgh Medical Center Hamot

location_facility: Panjin Liaohe Oilfield Gem Flower Hospital

location_facility: Cardiology Associates of Fairfield County, P.C. | Stamford, CT

location_facility: Cardiomobile Egeszsegugyi Szolgaltato Kft.

location_facility: Centro de Investigación y Prevención Cardiovascular

location_facility: Timisoara Institute of Cardiovascular Diseases

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Hospital Garcia de Orta | Research Department

location_facility: Huai'an First People's Hospital, Nanjing Medical University

location_facility: North Alps Medical Center Azumi Hospital

location_facility: China-Japan Union Hospital of Jilin University

location_facility: Capital Region | Frederiksberg Hospital - Department of Cardiology Research

location_facility: Universitetssykehuset Nord-Norge HF Tromsø

location_facility: Mackay Memorial Hospital - Hsinchu Branch

location_facility: Hospital Italiano de La Plata | Clinical Research Department

location_facility: Hospital Pengajar Universiti Putra Malaysia

location_facility: Centre Hospitalier Gustave Dron - Tourcoing

location_facility: Catharina Hospital | Cardiology Department

location_facility: Karolinska Universitetssjukhuset Huddinge Stockholm

location_facility: Public Central Hospital of Matto Ishikawa

location_facility: Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department

location_facility: Union Hospt Tongji Medical Colleg. Huazhong univ. Scien&Tech

location_facility: Hegau-Bodensee-Klinikum Singen|I. Medizinische Klinik

location_facility: AHEPA University General Hospital of Thessaloniki

location_facility: The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)

location_facility: Vall d'Hebron Barcelona Hospital Campus | Vall d'Hebron Hospital Universitario - Cardiology Department

location_facility: All India Institute of Medical Sciences (AIIMS) - New Delhi

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca | Cardiology Department

location_facility: Lundquist Institute Harbor-UCLA | Cardiac CT | Div of Cardio

location_facility: Cardiology Associates of Northwest Indiana, PC

location_facility: General Hospital of Ningxia Medical University

location_facility: CardioAlem Investigaciones Monitoreos San Isidro SRL

location_facility: Niculae Stancioiu Heart Institute Cluj-Napoca

location_facility: Hospital Alta Resolucion de Utrera | Cardiology Service Department

location_facility: Radin Cardiovascular Medical Group, Inc.

location_facility: Advanced Heart Care, LLC | Bridgewater, NJ

location_facility: Landeskrankenhaus Hall | Abteilung fuer Innere Medizin

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Instituto de Investigaciones Clínicas San Nicolás

location_facility: St. Vinzenz-Hospital|Innere Medizin III, Kardiologie

location_facility: Beijing Anzhen Hospital, Capital Medical University

location_facility: Kardiologische Praxis Hr. Dr. A. Al-Zoebi

location_facility: Kardiocentrum Nitra | Cardiology Clinic - Outpatient Department

location_facility: Multiprofile Hospital for Active Treatment Medline Clinic

location_facility: Affiliated Hospital of Jiangsu University

location_facility: Centre Hospitalier Intercommunal de la Côte Basque-Bayonne

location_facility: Afyonkarahisar Saglik Bilimleri Universitesi

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz

location_facility: Internal and Diabetes Clinic - IN-DIA s.r.o. | Lucenec, Slovakia

location_facility: Kardio Egeszseghaz - Dr Amer Sayour Egyeni Vallakozo

location_facility: Valley Clinical Trials, Inc. | Covina, CA

location_facility: Hospital General Universitario de Alicante Doctor Balmis | Cardiology Department

location_facility: Midwest Cardiovascular Research and Education Foundation

location_facility: Eastern Shore Research Institute, LLC | Fairhope, AL

location_facility: Instituto de Investigaciones Clínicas Zárate

location_facility: Teda International Cardiovascular Hospital

location_facility: Japan Community Health Care Organization Osaka Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Nemocnice Ceske Budejovice, a.s. Department of kardiologie

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Imeldaziekenhuis - St-Elisabethkliniek / Cardiology

location_facility: National Yang Ming Chiao Tung University Hospital

location_facility: Japanese RedCross Aichi Medical Center Nagoya Daini Hospital

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Klinikum Klagenfurt | Innere Medizin und Kardiologie

location_facility: Hospital Universitário Evangélico de Curitiba

location_facility: Hospital Universitario La Paz | IdiPAZ - Neurology Department

location_facility: Hospital de Base | Integrated Research Center

location_facility: Spitatul Universitar de Urgenta Bucuresti

location_facility: Hospital Universitario de La Princesa | Internal Medicine Department

location_facility: Unity Health Toronto: St. Michael's Hospital

location_facility: Centrum Medyczne Ogrodowa G. i M. Kania Lekarze i Lekarze Dentysci Spólka Partnerska z siedziba w Skierniewicach

location_facility: Inst. de Cardiología de Corrientes Juana Francisca Cabral

location_facility: Yonsei University Wonju Christian Hospital

location_facility: Region Midtjylland | Aarhus University Hospital - Heart Diseases - Clinical Research

location_facility: NorthBay Clinical Research, LLC | Santa Rosa, CA

location_facility: Emergency Institute for Cardiovascular Diseases

location_facility: The Second Affiliated Hospital of Nanjing Medical university

location_facility: Hwa Mei Hospital, University of Chinese Academy Sciences

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Med

location_facility: Dr. Nagy Laszlo Egyeni Egeszsegugyi Vallalkozo

location_facility: North Dallas Research Associate | McKinney, TX

location_facility: Riga East Clinical University Hospital "Gailezers"

location_facility: Cukurova Universitesi Tip Fakultesi Hastanesi

location_facility: St.Johannes-Hospital|Klinik fuer Innere Medizin I

location_facility: Medical Center Hospital of the President's Affairs Administration of the Republic of Kazakhstan - Cardiology Department No2

location_facility: Centro Hospitalar Universitario Cova de Beira | Clinical Research Department

location_facility: Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial

location_facility: Mazda Hospital of Mazda Motor Corporation

location_facility: Region Nordjylland | Aalborg University Hospital - Cardiology Department

location_facility: Region Nordjylland | Hjoerring - Cardiology Department

location_facility: Texas Health Physicians Group - Fort Worth

location_facility: Uniklinikum Hamburg-Eppendorf|Klinik für Kardiologie

location_facility: Josephs-Hospital|Kardiologie, Rhythmologie und Angiologie

location_facility: Irmed Klimkiewicz, Rudziewicz-Kowalska Sp.j.

location_facility: Centre Hospitalier du Docteur Schnaffer - Lens

location_facility: The First Affiliated Hospital of Baotou Medical College

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Region Midtjylland | Regionshospitalet Godstrup - Clinic for Heart Research

location_facility: University of South Alabama Medical Center

location_facility: Emergency Institute of Cardiovascular Diseases & Transplant

location_facility: Tohoku Medical and Pharmaceutical University Hospital

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Centre de Cardiologie Nord - Saint Denis

location_facility: The Catholic University of Korea Seoul St. Mary's Hospital

location_facility: A.O.R.N. Ospedali dei Colli (Monaldi-Cotugno-CTO)

location_facility: Division of Cardiovascular Research at Peconic Bay Med Ctr

location_facility: Hospital e Maternidade Dr Christóvão da Gama

location_facility: "Nowe Zdrowie-Ck" Kieltucki I Wspolnicy Spolka Jawna

location_facility: Izmir Ekonomi Universitesi Medikal Point Hastanesi

location_facility: University Medical Center (UMC) Utrecht | Heart and Lungs Division

location_facility: Centro de Investigaciones Medicas Temperley

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: The First Affiliated Hospital of Guangzhou University of TCM

location_facility: Ente Ecclesiastico Ospedale Generale Regionale Miulli

location_facility: Kepler UK Linz | Kardiologie & Intensivmedizin Campus III

location_facility: Xiamen Cardiovascular Hospital Xiamen University

location_facility: The 1st Affiliated Hospital of Zhejiang University

location_facility: Hospital Maternidade e Pronto Socorro Santa Lucia

location_facility: Women's College Hospital | WCH Main Site - Women's College Research Institute - Cardiology Department

location_facility: Gita Rancane - cardiology private practice

location_facility: King's College Hospital - NHS Foundation Trust

location_facility: S.C. Centrul Medical de Diagn si Tratam Ambulator Neomed SRL

location_facility: Great Lakes Medical Research, LLC - New York

location_facility: Integrity Clinical Research | Cardiology Associates of South Florida

location_facility: Centre intégré de santé et de services sociaux de Laval, Hôp

location_facility: University General Hospital of Alexandroupolis

location_facility: Okayama City General Medical Center Okayama City Hospital

location_facility: Landesklinikum Mistelbach|Kardiologie u. Internistische Med

location_facility: Klinik Floridsdorf | Herz-, Gefaess- u. Kardio Ambulanz

location_facility: Ev. Krankenhaus Hagen-Haspe|Kardiologie und Rhythmologie

location_facility: Tokyo Medical and Dental University Hospital

location_facility: UPECLIN - Unidade de Pesquisa Clínica de Botucatu

location_facility: Baskent Universitesi Tip Fakultesi Hastanesi

location_facility: LifeBridge Health | Sinai Hospital | Platelet and Thrombosis Research Department

location_facility: Diagnostic-Consultative Center XX | Cardiology Department

location_facility: Akdeniz Universitesi Tip Fakultesi Hastanesi

location_facility: Accellacare | Mt. Pleasant, South Carolina

location_facility: MST|TCT-Foundation Cardiovascular Research and Education

location_facility: Marmara Uni. Tip Fak. Pendik EAH Kardiyoloji

location_facility: Clalit Health Services through HaEmek Medical Center

location_facility: Universitetssykehuset i Nord Norge, Harstad

location_facility: Centro Hospitalar Universitário de Lisboa Norte | Heart and Vessels Department

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho | Unit 1 - Clinical Research Office

location_facility: Sparrow Clinical Research Institute | Sparrow Hospital - Clinical Research Department

location_facility: Centro Hospitalar de Lisboa Ocidental | Clin Res Dept

location_facility: Onga Nakama Medical Association Onga Hospital

location_facility: Algemeen Ziekenhuis Klina | Cardiology Department

location_facility: The 2nd Affiliated Hospital of Guangzhou Medical University

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Nordsjaellands Hospital | Hillerod - Cardiology Department

location_facility: Centre Hospitalier Universitaire - Angers

location_facility: Centre Hospitalier Régional - Saint Brieuc

location_facility: LKH Feldkirch | Innere Medizin I mit Kardiologie

location_facility: Inst. Pesq. Clínica de Campinas - Saraiva & Berlinger

location_facility: Region Midtjylland | Viborg Regional Hospital - Cardiology - Heart Research

location_facility: Core Research Group Pty Ltd | Brisbane, Australia

location_facility: Illawarra Shoalhaven Local Health District

location_facility: Centro Hospitalar De Tras os Montes e Alto Douro, EPE | Hospital Sao Pedro - Centro de investigacao clinica

location_facility: Inspira Medical Centers | Clinical Research Office

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Health Corporation of Galilee Medical Center

location_facility: National Hospital Organization Hamada Medical Center

location_facility: Specializovana nemocnica sv. Svorada Zobor, n.o.

location_facility: Prime Revival Reserach Institute, LLC | Denton, TX

location_facility: Japanese Red Cross Society Suwa Hospital

location_facility: Instituto Médico de la Fundación Estudios Clinicos

location_facility: Kettering Health Network | Research Institute

location_facility: Hospital of LT University of Health Sciences Kaunas Clinics

location_facility: Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.

location_facility: Capital Region | Hvidovre Hospital - Department of Cardiology

location_facility: Jose Manuel Pascual Pascual S.A. | Hospital Virgen del Camino - Internal Medicine Department

location_facility: Kutahya Saglik Bilimleri Uni. Evliya Celebi Egitim ve Arasti

location_facility: Hospital Clinico Universitario de Santiago de Compostela | Cardiology Department

location_facility: Hunter Holmes McGuire Veterans Affairs Medical Center

location_facility: The 4th Affiliated Hospital of Harbin Medical University

location_facility: Algemeen Stedelijk Ziekenhuis Campus Aalst

location_facility: CHUM - Centre hospitalier de l'Université de Montréal

location_facility: Hospital Alta Resolucion de Lebrija | Cardiology Service Department

location_facility: Japan Community Healthcare. Organization Chukyo Hospital

location_facility: 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie

location_facility: EMED Centrum Uslug Medycznych Ewa Smialek

location_facility: La Fe University and Polytechnic Hospital | Cardiology Department

location_facility: Multiprofile Hospital for Active Treatment Sveta Sofia

location_facility: Vestre Viken HF - Drammen Sykehus Cardiology

location_facility: Klaipeda Seamen's Hospital Cardiology Department I

location_facility: Baptist Heart and Vascular/Cardiology Consultants

location_facility: Peace River Cardiovascular Center | Port Charlotte, FL

location_facility: Amphia Breda | Department of Cardiology, BMC Research

location_facility: Centricity Research Mirabel Multispecialty

location_facility: Hainan Third People's Hospital (Province Nongken Sanya Hopt)

location_facility: 1st Affiliated Hospital of Henan Science and Technology Univ

location_facility: Sana-Klinikum Remscheid|Kardio, Angio, Pneumo u. Intensivmed

location_facility: Japan Red Cross Society Azumino Hospital

location_facility: Medikard | Department of Internal Medicine

location_facility: Yangzhou No. 1 People's Hospital (West Hospital)

location_facility: Queen Elizabeth the Queen Mother Hospital

location_facility: Núcleo de Pesquisa Clínica do Hospital Angelina Caron

location_facility: Medical Center Zara-Med EOOD | Cardiology Department

location_facility: AZ St-Lucas Campus St-Lucas - Cardiology

location_facility: The First affiliated Hospital of Hebei North University

location_facility: Centro de Investigaciones Clinicas del Litoral

location_facility: Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.

location_facility: Hospital Al-Sultan Abdullah (UiTM Hospital)

location_facility: Hôpital Guillaume et René Laennec - Nantes

location_facility: Hospital de la Santa Creu i Sant Pau | Cardiology Department

location_facility: London Health Sciences Centre | University Hospital - London Heart Rhythm Program - Cardiology

location_facility: Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention

location_facility: Maria Middelares General Hospital | Cardiology Department

location_facility: Istanbul Universitesi Cerrahpasa - Kardiyoloji Anabilim Dali

location_facility: University of Pittsburgh Medical Center Health System

location_facility: University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Cardiology Clinic

location_facility: Beijing Chaoyang Hospital, Capital Medical University

location_facility: King Edward Memorial (KEM) Hospital - Pune

location_facility: National Hospital Organization Kyoto Medical Center

location_facility: Atyrau Regional Cardiology Center - Department of Cardiology

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Instituto de Investigaciones Clinicas Bahia Blanca

location_facility: Krankenhaus St. Josef Braunau | Innere Medizin I

location_facility: Hôpital La Cavale Blanche - CHU de Brest

location_facility: Cardresearch Cardilogia Assistencial e de Pesquisas LTDA

location_facility: Affinity Health Research Institute | Oak Brook, IL

location_facility: GZA Ziekenhuizen | Saint Augustine Campus - Cardiology Department

location_facility: Hospital Quironsalud Barcelona | Internal Medicine Department

location_facility: Clearwater Cardiovascular Associates | Clearwater, FL

location_facility: Hanusch Krankenhaus | 2. Medizinische Abteilung

location_facility: Capital Region | Gentofte Hospital - Cardiology Research

location_facility: Multiprofile Hospital for Active Treatment Puls | Clinical Trial Center

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Saglik Bilimleri Univ. Samsun EAH Kardiyoloji Departmani

location_facility: Vardhman Mahavir Medical College & Safdarjung Hospital (VMMC-SJH)

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Affiliated Hospital of Jining Medical University

location_facility: Hospital Universitario Central de Asturias | Servicio de Cardiologia

location_facility: Odense University Hospital | Svendborg Hospital - Cardiovascular Research Unit

location_facility: MedUni Innsbruck | Kardiologie und Angiologie

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Medizinische Hochschule Hannover|Kardiologie und Angiologie

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA

location_facility: Hospital General Universitario de Valencia | Cardiology Department

location_facility: Miyanosawa Clinic of Internal Medicine and Cardiology

location_facility: Uniklinikum Salzburg|Innere Medizin II, Kardiologie

location_facility: Klinikum Lüdenscheid - Märkische Kliniken GmbH

location_facility: Klinikum Worms gGmbH|Kardiologie und Angiologie

location_facility: NYU Langone Medical Associates - Chelsea

location_facility: Poriya Medical Center | Cardiology Department

location_facility: University Hospital of A Coruna | Cardiology department

location_facility: Louisiana Heart Center Research - Slidell

location_facility: Hospital Universitario Virgen del Rocio | Hospital General - Departmaneto de Cardiologia y Cirugia Cardiovascular

location_facility: Reid Physician Associates | Cardiology Department

location_facility: Uni-Klinikum Heidelberg | Kardiologie Angiologie Pneumologie

location_facility: Kobe City Medical Center General Hospital

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz

location_facility: Spitalul Clinic de Recuperare Cluj-Napoca

location_facility: Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Tyler Cardiovascular Consultants | Tyler, TX

location_facility: Nippon Medical School Chiba Hokusoh Hospital

location_facility: Hospital Universitario La Paz | Cardiology Department - AF, Stroke Prevention

location_facility: The Second Hospital of Shandong University

location_facility: Multiprofile Hospital for Active Treatment - Silistra

location_facility: James Cook University Hospital South Tees

location_facility: FutureMeds | Diagnostic Consultative Center Ascendent

location_facility: East Coast Institute for Research, LLC - St Augustine

location_facility: Centro Hospitalar de Tamega e Sousa | Hospital Padre Americo - Cardiology Department

location_facility: South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department

location_facility: AZ Groeninge Campus Kennedylaan - Cardiology

location_facility: Hôpital Arnaud de Villeneuve - Montpellier

location_facility: Hippokration General Hospital of Thessaloniki

location_facility: A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"

location_facility: Christus Trinity Mother Francis Health System

location_facility: St. Luke's Health System | St. Luke's Clinic - Idaho Cardiology Associates

location_facility: Beijing Tongren Hospital, Capital Medical University (West)

location_facility: Peking Union Medical College Hospital CAMS

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Texas Health Research & Education Institute

location_facility: Capital Region | Herlev Hospital - Department of Heart Disease

location_facility: Dr Signe Alliksoo Family Doctors Practice

location_facility: Centro de Investigaciones Medicas Lanus | Research Department

location_facility: Affiliated Hangzhou First People's Hospital, Zhejiang Univ

location_facility: Health Corporation of the Ziv Medical Center (R.A.)

location_facility: Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Cardiology Department

location_facility: Centro Hospitalar de Leiria | Santo Andre Hospital - Research Center

location_facility: Gelre Ziekenhuizen Apeldoorn / Cardiology

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Privado de Comunidad | Clinical Research Department

location_facility: Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz

location_facility: The 1st Affiliated Hospital Fujian Medical University

location_facility: Institut universitaire de cardiologie et de pneumologie de Q

location_facility: Asian Institute of Gastroenterology (AIG Hospital)

location_facility: UniKlinikum Aachen|Kardio, Angio, Intensivmedizin

location_facility: Investigaciones Clinicas Tucuman | San Miguel de Tucuman, Argentina

location_facility: The First Hospital of Hebei Medical Univesity

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: McGill University Health Centre - Glen Site

location_facility: Municipal Clinical Emergency Hospital of Timisoara

location_facility: University General Hospital of Heraklion

location_facility: S.B.U. Adana Sehir Egitim ve Arastirma Hastanesi

location_facility: Pennsylvania State University College of Medicine

location_facility: Cardiology Partners Clinical Research Institute

location_facility: Medical Group Kosice s.r.o. | Kosice, Slovakia

location_facility: Jose Manuel Pascual Pascual S.A. | Hospital Virgen de las Montanas - Internal Medicine Department

location_facility: Capital Region | Amager Hospital - Cardiology Outpatient Clinic

location_facility: VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo

location_facility: Kardiologicka ambulancia Trnava, MUDr. Vladimir Macek

location_facility: Santa Barbara Cottage Hospital | Cardiology

location_facility: AZ Sint-Jan Brugge-Oostende | Sint-Jan - Cardiology

location_facility: The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital

location_facility: Baptist Health Medical Group - Louisville Cardiology

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Elisabethinen Linz | Kardiologie, Angiologie & Intensiv Med

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: MaineHealth Maine Medical Center | Maine Medical Partners Cardiology

location_facility: Medical University of South Carolina - Cardiology

location_facility: Vilnius University Hospital Santaros Klinikos


title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)

summary: The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Hong Kong
Denmark
United States
Iceland
Romania
Belgium
China
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Sweden

location_facility: Instituto de Pesquisa Clínica de Campinas

location_facility: Instituto de Cardiologia do Rio Grande do Sul

location_facility: Unidade Local de Saude de Matosinhos - Hospital Pedro Hispano

location_facility: Hyogo Prefectural Harima-Himeji General Medical Center

location_facility: Fundacion Respirar - Consultorios Médicos Dr. Doreski

location_facility: Winchester Cardiology and Vascular Medicine

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Hospital Universitario Maria Aparecida Pedrossian

location_facility: HonorHealth Research and Innovation Institute

location_facility: Hospital das Clinicas da Universidade Federal de Goias

location_facility: Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

location_facility: Kardiologijos ir reabilitacijos klinika, UAB

location_facility: The Second Affiliated Hospital of Nanjing Medical University

location_facility: Multiprofile Hospital for Active Treatment National Hospital of Cardiology EAD

location_facility: Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Spolka z ograniczona odpowiedzialnos

location_facility: CIPREC - Centro de Investigacion y Prevencion Cardiovascular

location_facility: Highlands Clinical Research Facility, Raigmore Hospital

location_facility: Ziekenhuis Oost-Limburg - Campus Sint-Jan

location_facility: Northern Light Eastern Maine Medical Center

location_facility: Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre

location_facility: NIHR Patient Recruitment Centre Bradford

location_facility: Research Institute of McGill University Health Center - Glen Site

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Dr Nagy Laszlo Kardiologiai maganrendeles es SMO

location_facility: Azienda Ospedaliera Sant Anna e San Sebastiano

location_facility: CMI Cardiologie - Dr. Mercea Corina Delia

location_facility: Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Kardio Vaclavik sro, Interni a kardiologicka ambulance

location_facility: China-Japan Union Hospital of Jilin University

location_facility: IBPClin Instituto Brasil de Pesquisa Clinica

location_facility: AdventHealth Medical Group Cardiology at Orlando

location_facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Procliniq Investigación Clínica Sa de Cv

location_facility: Instituto de Investigaciones Clinicas Zarate

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho EPE

location_facility: Centre de sante et de services sociaux du Nord de Lanaudiere

location_facility: Northwell Health Physician Partners Cardiology at Manhasset

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE

location_facility: Northwell Health Physician Partners at Peconic

location_facility: Novant Health Heart and Vascular Institute

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Krankenhaus der Barmherzigen Brueder Linz

location_facility: Onze Lieve Vrouw Ziekenhuis - campus Aalst

location_facility: The Second Affiliated Hospital to Nanchang University

location_facility: The Peoples Hospital of Guangxi Zhuang Autonomous Region

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Dr Lakatos Ferenc Private Cardiology Practice

location_facility: Northeast Georgia Medical Center Wisteria Building

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Center for Clinical and Basic Research Tallinn

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: FZ Pesquisa e Servicos em Cardiologia LTDA

location_facility: Universitaetsmedizin Goettingen - Georg-August-Universitaet

location_facility: Tokyo Womens Medical University Hospital

location_facility: Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy

location_facility: Oslo Universitetssykehus HF Aker sykehus

location_facility: Instituto de Investigaciones Clínicas Quilmes SRL IICQ

location_facility: Cliniques universitaires de Bruxelles Hopital Erasme

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: National Hospital Organization Shizuoka Medical Center

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: ICBA - Instituto Cardiovascular de Buenos Aires

location_facility: Centre Hospitalier Universitaire de Montpellier - Hopital Lapeyronie

location_facility: Associacao de Amparo a Saude Ensino e Pesquisa

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures

location_facility: Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio

location_facility: Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

location_facility: Wojewodzki Specjalistyczny Szpital im dr Wladyslawa Bieganskiego w Lodzi

location_facility: University of Louisville Health - Jewish Hospital

location_facility: Instituto de Ensino e Pesquisa do Hospital da Bahia

location_facility: Arcturus Healthcare, Public Limited Company, Troy Internal Medicine Research Division

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Kardiologicke centrum MUDr Janky Skrobakove sro

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Icahn School of Medicine at Mount Sinai Queens

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Niigata University Medical and Dental Hospital

location_facility: Centro Medico Dra LAURA MAFFEI e Investigacion clinica aplicada

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Metropolitan Cardiovascular Consultants LLC

location_facility: Centre Hospitalier Universitaire de Quebec, Centre Hotel-Dieu de Quebec

location_facility: Nucleo de Pesquisa Clinica do Rio Grande do Sul

location_facility: Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz

location_facility: Centro Hospitalar de Entre o Douro e Vouga, EPE - Unidade de Sao Sebastiao

location_facility: Universitaets-Herzzentrum Freiburg - Bad Krozingen

location_facility: Fundacion Cardiovascular de Aguascalientes AC

location_facility: Institut de recherches cliniques de Montreal

location_facility: Kardiologische Praxis Doktor Jens Taggeselle

location_facility: Cinme - Centro de Investigaciones Metabolicas

location_facility: Cardiovascular Research of Northwest Indiana LLC

location_facility: Azienda Ospedaliera Universitaria Ospedale San Giovanni di Dio e Ruggi D Aragona

location_facility: Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Multiprofile Hospital for Active Treatment - Haskovo AD

location_facility: Vilnius University Hospital Santaros Clinic Public Institution

location_facility: Otto von Guericke Universitaet Magdeburg

location_facility: Advanced Research for Health Improvement, LLC

location_facility: Hospital Sao Francisco da Santa Casa de Misericordia de Porto Alegre

location_facility: Clinique des Maladies Lipidiques de Quebec Incorporated

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: LMC Clinical Research Incorporated Thornhill

location_facility: University Hospitals Cleveland Medical Center

location_facility: Instituto de Pesquisa em Endocrinologia Clinica IPEC

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna

location_facility: Charite - Universitaetsmedizin Berlin, Campus Virchow

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: North York Diagnostic and Cardiac Centre

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: New York Presbyterian Medical Group Hudson Valley Cardiology

location_facility: Spitalul Clinic Universitar de Urgenta Elias

location_facility: B Braun Ambulantes Herzzentrum Kassel mvz GmbH

location_facility: Instituto de Investigaciones Clinicas de Cordoba

location_facility: Hornicka nemocnice s poliklinikou spol sro

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Universitaetsklinikum der Ruhr-Universitaet Bochum

location_facility: Tidewater Physicians Multispecialty Group Clinical Research

location_facility: Saint Johns Center for Clinical Research

location_facility: Multiprofile Hospital for Active Treatment Puls AD

location_facility: Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec

location_facility: Japan Community Health care Organization Kyushu Hospital

location_facility: Diagnostic-Consultative Center Ascendent OOD

location_facility: Centro Hospitalar do Baixo Vouga, EPE - Hospital Infante Dom Pedro

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur

location_facility: Cardiology Associates of Fairfield County PC

location_facility: American Heart of Poland Spolka Akcyjna Polsko-Amerykanskie Kliniki Serca

location_facility: NZOZ Twoja Przychodnia Spzoo Twoja Przychodnia Spzoo

location_facility: NIHR Patient Recruitment Centre Leicester

location_facility: Clinical Best Solutions Sp zoo Spolka Komandytowa Gabinet Lekarski

location_facility: Narodny ustav srdcovych a cievnych chorob, as

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Grandview Medical Center Affinity Cardiovascular Specialists, LLC

location_facility: Centro de Investigaciones Clinicas del Litoral

location_facility: KO-MED Centra Kliniczne Sp zoo KO-MED Centra Kliniczne Pulawy

location_facility: Centro Hospitalar e Universitario de Coimbra EPE

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Multiprofile Hospital for Active Treatment Heart and Brain EAD

location_facility: Eszak-Pesti Centrum Korhaz - Honvedkorhaz

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Northwell Health Lenox Hill Heart and Vascular

location_facility: NIHR Patient Recruitment Centre Blackpool

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Hospices Civils de Lyon Groupement Hospitalier Est, Hopital Louis Pradel

location_facility: Instituto Latinoamericano de Investigaciones Medicas CIDIM-ILAIM

location_facility: Centro de investigacion Cardiometabolica

location_facility: Jacksonville Center for Clinical Research

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

location_facility: Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

location_facility: Consultorio de Medicina Especializada del Sector Privado

location_facility: Kobe City Medical Center General Hospital

location_facility: Instituto de Investigaciones Clinicas Rosario

location_facility: Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet

location_facility: Hospital de Sant Joan Despi Moises Broggi

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz

location_facility: Konstantopoulio - Agia Olga Hospital of Nea Ionia

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Centro Paulista de Investigacoes Clinicas Cepic

location_facility: WMCHealth Heart and Vascular Institute Kingston Division of Cardiology

location_facility: Szpital Grochowski imienia Doktora medycyny Rafala Masztaka Spzoo

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Baylor Scott and White Heart and Vascular Hospital-Dallas

location_facility: Alaska Cardiovascular Research Foundation

location_facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau

location_facility: Hospital Professor Doutor Fernando Fonseca, EPE

location_facility: Med Partners, Inc dba Premiere Medical Center, Inc

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Futuremeds spolka z ograniczona odpowiedzialnoscia

location_facility: Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika

location_facility: Centre Hospitalier Universitaire de Dijon - Hopital Francois Mitterrand

location_facility: Jellinger and Lerman MD PA dba The Center for Diabetes and Endocrine Care

location_facility: Seoul National University Bundang Hospital

location_facility: Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas

location_facility: Instituto de Investigaciones Clinicas de San Nicolas

location_facility: Jaroslaw Ciosek Rajtar-Medica Centrum Medyczne

location_facility: Ciad - Consultorio Integral de Atencion al Diabetico

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: MUDr Zbynek Kosek, kardiologicka ambulance sro

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Johns Hopkins University School of Medicine

location_facility: Hamilton Health Sciences Hamilton General Hospital

location_facility: Institut Universitaire de cardiologie et de pneumologie de Quebec

location_facility: Azienda Ospedaliera Universitaria Renato Dulbecco

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Yokohama Sakae Kyosai Hospital Federation of National Public Service Personnel Mutual Association

location_facility: Oslo Universitetssykehus HF, Aker sykehus

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

location_facility: Renown Institute for Heart and Vascular Health

location_facility: MUDr Ladislava Harrerova, kardiologicka ordinace

location_facility: Ambulatory for Individual Practice for Specialized Medical Care - Kardio EOOD

location_facility: Loema Instituto de Pesquisa Clinica e Consultores Ltda

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

acronym: EPCORE DLBCL-2

summary:
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.

In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.

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:
Poland
New Zealand
Australia
Brazil
Japan
Croatia
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
China
Puerto Rico
Italy
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Israel

location_facility: CHU UCL Namur - site Godinne /ID# 225742

location_facility: Kagoshima University Hospital /ID# 250163

location_facility: Assuta Tel Aviv Medical Center /ID# 226066

location_facility: Leids Universitair Medisch Centrum /ID# 225606

location_facility: Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 226654

location_facility: The Affiliated Hospital of Xuzhou Medical University /ID# 233174

location_facility: Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 227393

location_facility: CHU Amiens-Picardie Site Sud /ID# 238347

location_facility: Linkoping University Hospital /ID# 233521

location_facility: Hospital Clinico Universitario de Valencia /ID# 225818

location_facility: Klinicki bolnicki centar Split /ID# 250729

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 252192

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 249111

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 225761

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 226838

location_facility: Hospital Universitario 12 de Octubre /ID# 225815

location_facility: Opca bolnica Dr. Josip Bencevic /ID# 251812

location_facility: Theageneio Anticancer Hospital /ID# 225516

location_facility: Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 226846

location_facility: IEO -Istituto Europeo di Oncologia /ID# 225545

location_facility: CHU Grenoble - Hopital Michallon /ID# 226128

location_facility: General University Hospital of Thessaloniki AXEPA /ID# 225398

location_facility: Hospital Santa Creu i Sant Pau /ID# 225813

location_facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 225952

location_facility: 2CA-Braga, Hospital de Braga /ID# 249112

location_facility: The Chaim Sheba Medical Center /ID# 225600

location_facility: University General Hospital Attikon /ID# 225401

location_facility: Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 225751

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 225543

location_facility: Hospital Alemao Oswaldo Cruz /ID# 252833

location_facility: Hospital La Louviere Site Jolimont - Helora /ID# 225738

location_facility: Inje University Busan Paik Hospital /ID# 232262

location_facility: The Cancer Institute Hospital Of JFCR /ID# 230269

location_facility: Fukushima Medical University Hospital /ID# 250869

location_facility: Hospital Universitario Vall d'Hebron /ID# 225811

location_facility: Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065

location_facility: Seoul National University Bundang Hospital /ID# 225763

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245938

location_facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 228063

location_facility: University General Hospital of Ioannina /ID# 225400

location_facility: Hospital Clinic de Barcelona /ID# 226651

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 225542

location_facility: Hospital Universitario Ramon y Cajal /ID# 241750

location_facility: Fakultni nemocnice Hradec Kralove /ID# 225955

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228

location_facility: Ospedale Santa Maria delle Croci /ID# 225571

location_facility: The Fifth Medical Center of PLA General Hospital /ID# 230941

location_facility: Harbin Medical University Cancer Hospital /Id# 241755

location_facility: CHU de Rennes - PONTCHAILLOU /ID# 228207

location_facility: SP ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985

location_facility: China Medical University Hospital /ID# 226188

location_facility: Albert Schweitzer Ziekenhuis /ID# 229560

location_facility: Aichi Cancer Center Hospital /ID# 226090

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 226048

location_facility: The First Affiliated Hospital of Nanchang University /ID# 230399

location_facility: Seoul National University Hospital /ID# 225760

location_facility: Guangdong Provincial People's Hospital /ID# 230945

location_facility: National Cancer Center Hospital East /ID# 250151

location_facility: Goshen Center for Cancer Care /ID# 225534

location_facility: NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 226141

location_facility: Jeonbuk National University Hospital /ID# 232263

location_facility: Universitaetsklinikum St. Poelten /ID# 234016

location_facility: National Cancer Center Hospital /ID# 226089

location_facility: Canisius-Wilhelmina Ziekenhuis /ID# 231291

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234152

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723

location_facility: Kobe City Medical Center General Hospital /ID# 250597

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 226670

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 226125

location_facility: Zealand University Hospital, Roskilde /ID# 226597

location_facility: Kanazawa University Hospital /ID# 251770

location_facility: Keimyung University Dongsan Medical Center /ID# 232264

location_facility: Peking University Third Hospital /ID# 230975

location_facility: Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023

location_facility: National Hospital Organization Kyushu Cancer Center /ID# 251622

location_facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 225541

location_facility: Norton Cancer Institute - St Matthews /ID# 225420

location_facility: The First Hospital of China Medical University /ID# 233201

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230387

location_facility: Millennium Research & Clinical Development /ID# 228284

location_facility: Vista Oncology - East Olympia /ID# 229375

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 225809

location_facility: Elisabeth Tweesteden Ziekenhuis /ID# 229773

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 252832

location_facility: Yamagata University Hospital /ID# 230003

location_facility: Fakultni nemocnice Kralovske Vinohrady /ID# 225956

location_facility: Hospital Universitario Infanta Leonor /ID# 225816

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228360

location_facility: Matsuyama Red Cross Hospital /ID# 251068

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 225396

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 225804

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 228191

location_facility: General Hospital of Athens Laiko /ID# 225399

location_facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616

location_facility: Klinicki bolnicki centar Rijeka /ID# 251811

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773

location_facility: Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809

location_facility: University of Tsukuba Hospital /ID# 251282

location_facility: Universitair Medisch Centrum Groningen /ID# 225602

location_facility: Hokkaido University Hospital /ID# 250149

location_facility: Klinicki bolnicki centar Zagreb /ID# 250709

location_facility: Centre Hospitalier de la Cote Basque /ID# 249143

location_facility: Taichung Veterans General Hospital /ID# 226674

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 226821

location_facility: Tolna Megyei Balassa Janos Korhaz /ID# 250063

location_facility: ASST Spedali civili di Brescia /ID# 225549

location_facility: Hospital Parc de Salut del Mar /ID# 225810

location_facility: National Cheng Kung University Hospital /ID# 226671

location_facility: Hospital Universitario Reina Sofia /ID# 225806

location_facility: CHU de Nice - Hôpital Archet 1 /ID# 226127

location_facility: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 225986

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 226101

location_facility: Medizinische Universitaet Wien /ID# 252095

location_facility: The First Affiliated Hospital of Soochow University /ID# 232569

location_facility: University of Arizona Cancer Center - North Campus /ID# 227463

location_facility: Centrum Medyczne Pratia Poznan /ID# 227236

location_facility: Pan American Center for Oncology Trials, LLC /ID# 230052

location_facility: Vrije Universiteit Medisch Centrum /ID# 225608

location_facility: Tel Aviv Sourasky Medical Center /ID# 225891


type: Other Identifier

title: Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

summary: The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Poland
Netherlands
Belgium
Korea, Republic of
China
Spain
Taiwan
Czechia
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Tianjin Medical University General Hospital

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

location_facility: Hospital Universitari General de Catalunya

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand

location_facility: Beijing Tiantan Hospital Affiliated to Capital Medical University

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University

location_facility: Xiangya Hospital Central South University

location_facility: National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region

location_facility: Beijing Anding Hospital - Affiliated Capital University of Medical Science

location_facility: The Second Affiliated hospital of Zhejiang University school of medicine

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: The First Affiliated Hospital of Soochow University

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Universitätsmedizin Göttingen - Georg-August-Universität

location_facility: The Second Affiliated Hospital of Nanjing Medical University

location_facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

location_facility: ISPG - Institut für Studien zur Psychischen Gesundheit

location_facility: IBISMED Wielospecjalistyczne Centrum Medyczne

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

location_facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

location_facility: Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Centre Hospitalier Universitaire Toulouse - Cité de la Santé

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

location_facility: Hôpital des Charpennes - Hospices Civils de Lyon (HCL)

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Osrodek Badawczo - Naukowo - Dydaktyczny Chorob Otepiennych w Scinawie - Osrodek Alzheimerowski Sp. z o.o.

location_facility: Fujian Medical University Union Hospital-1 Bingfanglou

location_facility: Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière

location_facility: Seoul National University Bundang Hospital

location_facility: Beijing Peking Union Medical College Hospital

location_facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: Tongji Hospital Tongji Medical,Science & Technology

location_facility: Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

location_facility: The Second Xiangya Hospital of Central South University

location_facility: The First Afffiliated Hospital of Chongqing Medical University

location_facility: Charité Universitätsmedizin Berlin - Campus Berlin Buch

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

location_facility: Huashan Hospital Affiliated Fudan University

location_facility: The First Hospital of Hebei Medical University

location_facility: West China Hospital of Sichuan University

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: Centre Hospitalier Universitaire Régional de Nancy


title: A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)

acronym: EPCORE FL-1

summary:
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.

Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).

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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Belgium
China
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Israel

location_facility: Fakultni nemocnice Kralovske Vinohrady /ID# 228564

location_facility: Hospital Universitario Virgen del Rocio /ID# 228118

location_facility: Linkoping University Hospital /ID# 233520

location_facility: Hospital Universitario Ramon y Cajal /ID# 228113

location_facility: Hospital La Louviere Site Jolimont - Helora /ID# 228520

location_facility: ASST Spedali civili di Brescia /ID# 227397

location_facility: Jeonbuk National University Hospital /ID# 228908

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 228706

location_facility: Admiraal de Ruyter Ziekenhuis /ID# 247692

location_facility: Seoul National University Bundang Hospital /ID# 228448

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 227384

location_facility: Groupe Sante CHC - Clinique du MontLegia /ID# 230415

location_facility: Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121

location_facility: Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602

location_facility: Universitaetsklinikum St. Poelten /ID# 234015

location_facility: Universitaetsklinikum Wuerzburg /ID# 229278

location_facility: Royal Prince Alfred Hospital /ID# 239272

location_facility: Albert Schweitzer Ziekenhuis /ID# 247740

location_facility: National Cheng Kung University Hospital /ID# 227381

location_facility: Hospital Santa Creu i Sant Pau /ID# 229859

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633

location_facility: Hospital Parc de Salut del Mar /ID# 228106

location_facility: Universitair Medisch Centrum Groningen /ID# 247741

location_facility: CHU de Rennes - PONTCHAILLOU /ID# 230356

location_facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 228108

location_facility: China Medical University Hospital /ID# 227379

location_facility: Taichung Veterans General Hospital /ID# 227383

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 241595

location_facility: Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 228129

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 228565

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 229287

location_facility: Akdeniz Universitesi Tip Fakul /ID# 227791

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182

location_facility: Ospedale Santa Maria delle Croci /ID# 227394

location_facility: Hospital Universitario Marques de Valdecilla /ID# 228984

location_facility: Hospital Universitario Reina Sofia /ID# 228122

location_facility: The Chaim Sheba Medical Center /ID# 228322

location_facility: Franciscus Gasthuis & Vlietland /ID# 248139

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 229289

location_facility: Fakultni nemocnice Hradec Kralove /ID# 228269

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 227399

location_facility: CHU NIMES - Hopital Caremeau /ID# 230351

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 230347

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 247510

location_facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929

location_facility: Kocaeli University Med Faculty /ID# 227854

location_facility: General Hospital of Athens Laiko /ID# 226626

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 230403

location_facility: CISSSBSL -Hopital regional de Rimouski /ID# 229894

location_facility: Kobe City Medical Center General Hospital /ID# 251945

location_facility: Townsville University Hospital /ID# 231124

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228366

location_facility: CHU Reims - Hôpital Robert Debre /ID# 248710

location_facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 234095

location_facility: Tel Aviv Sourasky Medical Center /ID# 228529

location_facility: Pan American Center for Oncology Trials, LLC /ID# 230055

location_facility: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 229362

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 230471

location_facility: Szpitale Pomorskie Sp. z o.o /ID# 229122

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 228116

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 228447

location_facility: EOC Ospedale Regionale di Bellinzona e Valli /ID# 228922

location_facility: CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 248202

location_facility: General University Hospital of Thessaloniki AXEPA /ID# 226630

location_facility: Leids Universitair Medisch Centrum /ID# 247742

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 230353

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 229157

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 228110

location_facility: Assaf Harofeh Medical Center /ID# 228037

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 227402

location_facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 231537

location_facility: Hospital Universitario 12 de Octubre /ID# 228109

location_facility: Istanbul Florence Nightingale Hastanesi /ID# 229546

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 229754

location_facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 232203

location_facility: Fukushima Medical University Hospital /ID# 251839

location_facility: Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130

location_facility: Universitair Ziekenhuis Leuven /ID# 247780

location_facility: Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286

location_facility: Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 228107

location_facility: Klinikum Mutterhaus der Borromäerinnen /ID# 232354

location_facility: Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 227401

location_facility: Inje University Busan Paik Hospital /ID# 230293

location_facility: Hospital Universitario de Salamanca /ID# 228117

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 245928

location_facility: Centrum Medyczne Pratia Poznan /ID# 229299

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 230402

location_facility: Ege University Medical Faculty /ID# 227792

location_facility: Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 229290

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 227855

location_facility: IEO -Istituto Europeo di Oncologia /ID# 227396

location_facility: Theageneio Anticancer Hospital /ID# 226627

location_facility: University General Hospital Attikon /ID# 226629

location_facility: Pusan National University Hospital /ID# 229798

location_facility: Ankara Universitesi Fakultesi /ID# 227790

location_facility: AZ Turnhout - Campus Sint-Elisabeth /ID# 231628

location_facility: Sun Yat-Sen University Cancer Center /ID# 231463

location_facility: Keimyung University Dongsan Medical Center /ID# 229800

location_facility: University General Hospital of Ioannina /ID# 226628

location_facility: Ondokuz mayis University Facul /ID# 227794

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 228127

location_facility: Universitaetsklinikum Leipzig /ID# 242907

location_facility: Hospital San Pedro de Alcantara /ID# 248845

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246475

location_facility: Instituto D'or de Ensino e Pesquisa - Regional Sao Paulo /ID# 252918

location_facility: Seoul National University Hospital /ID# 228446


title: A Randomized, Double-blind, Placebo-controlled, 2-arm Phase III Study to Assess Efficacy and Safety of Xevinapant and Radiotherapy Compared to Placebo and Radiotherapy for Demonstrating Improvement of Disease-free Survival in Participants With Resected Squamous Cell Carcinoma of the Head and Neck, Who Are at High Risk for Relapse and Are Ineligible for High-dose Cisplatin (XRAY VISION)

summary: The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: EMD Serono Research & Development Institute, Inc.

sponsor_collaborators: EMD Serono Research & Development Institute, Inc.

location_country:
Germany
Poland
Argentina
Japan
Brazil
Czechia
France
Portugal
United States
India
Romania
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Georgia
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor

location_facility: CHU Tours - Hôpital Bretonneau - Service d'Oncologie Médicale

location_facility: Centre Georges François Leclerc - Oncologie Médicale

location_facility: CHU Brest - Hôpital Morvan - Service d'Oncologie Médicale

location_facility: High Technology Medical Center, University Clinic

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Hôpital de la Timone - Oncologie Médicale Hématologie & Soins Palliatifs

location_facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L - parent

location_facility: Centre Francois Baclesse - Service d'Oncologie Medicale

location_facility: Liga Norte-Rio-Grandense Contra o Câncer

location_facility: Fakultni nemocnice Kralovske Vinohrady - Dept of Radioterapeuticka a onkologicka klinika

location_facility: NHO Kyushu Cancer Center - Dept of Head and Neck Surgery

location_facility: Hospital Clinic de Barcelona - Medical Oncology

location_facility: IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica

location_facility: Amsterdam UMC, Locatie VUMC - Dept of Medical Oncology

location_facility: Xiangya Hospital, Central South University

location_facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia

location_facility: Krankenhaus der barmherzigen Schwestern Linz - Abteilung für HNO

location_facility: Fakultni nemocnice Olomouc - Dept of Onkologicka klinika

location_facility: Kagawa University Hospital - Dept of Oncology

location_facility: Centro de Atención e Investigación Clínica en Oncología

location_facility: Universitaetsmedizin Goettingen - Georg-August-Universität

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Radioterapia 1

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC

location_facility: NHO Hokkaido Cancer Center - Dept of Oral Oncology Surgery

location_facility: Hyogo Cancer Center - Dept of Head and Neck Surgery

location_facility: Oncosite - Centro de Pesquisa Clinica e Oncologia

location_facility: Centre Hospitalier Privé Saint-Gregoire (Rennes) - Cancerologie

location_facility: Antwerp University Hospital (UZA Parent)

location_facility: General Hospital of Athens of Chest Diseases "SOTIRIA" - Sotiria Thoracic Diseases Hospital of Athens

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische Radiologie

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Tumori della Testa e del Collo

location_facility: Prisma Health Cancer Institute, ITOR, CRU

location_facility: Kindai University Hospital - Dept of Oncology

location_facility: A.O.U. Policlinico di Modena - U.O. Oncologia

location_facility: Hiroshima University Hospital - Dept of Otorhinolaryngology/ Head and Neck Surgery

location_facility: Okayama University Hospital - Dept of Otorhinolaryngology

location_facility: Fakultni nemocnice Bulovka - Dept of Radiodiagnosticka klinika

location_facility: Centre Azureen Cancerologie - Service De Radiotherapie

location_facility: Shengjing Hospital of China Medical University

location_facility: Hospital del Mar - Servicio de Oncologia

location_facility: Hospital Universitario Virgen del Rocio - Oncology Service

location_facility: Osaka International Cancer Institute - Dept of Head and Neck Surgery

location_facility: Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica

location_facility: BP A Beneficencia Portuguesa da Sao Paulo

location_facility: Kobe University Hospital - Dept of Oncology/Hematology

location_facility: Institut Jules Bordet - Medical Oncology

location_facility: Saitama Medical University International Medical Center - Dept of Otorhinolaryngology/ Head and Neck Surgery

location_facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology

location_facility: Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia

location_facility: Cancer Institute Hospital of JFCR - Dept of Medical Oncology

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - U.O.C. di Oncologia B

location_facility: Perlmutter Cancer Center at NYU Langone Hospital ae Long Island

location_facility: Tohoku University Hospital - Dept of Otorhinolaryngology/Head and Neck Surgery

location_facility: Institut Curie - site de Paris - Service d'Oncologie Médicale

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: National Cancer Center Hospital - Dept of Gastroenterology

location_facility: Centre Henri Becquerel - Service de radiothérapie

location_facility: University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology

location_facility: Institut Claudius Regaud - service de Radiothérapie

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: Nagoya University Hospital - Dept of Otorhinolaryngology

location_facility: Centre Antoine Lacassagne - Service d'Hématologie Oncologie

location_facility: S.C Radiotherapy Center Cluj S.R.L - Parent

location_facility: Pusan National University Yangsan Hospital

location_facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center

location_facility: ICO - Site Paul Papin - service d'oncologie medicale

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Hopital Tenon - service radiologie et imagerie medicale

location_facility: Seoul National University Bundang Hospital

location_facility: Sir Run Shaw Hospital, Zhejiang University, School of Medicine

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Regional Universitario de Malaga - Oncology Dept

location_facility: Institut Régional du Cancer de Montpellier - Service de Professeur Senesse

location_facility: CHI Toulon La Seyne - Hôpital Sainte Musse - Service d'Onco-Hematologie

location_facility: Hospital Universitario Lucus Augusti - Oncology

location_facility: LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie

location_facility: Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale

location_facility: Yokohama City University Hospital - Dept of Otorhinolaryngology

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)

location_facility: Clinica Universidad de Navarra (MAD) - Oncology Service

location_facility: Universitaetsklinikum Leipzig - Klinik fuer Strahlentherapie und Radioonkologie

location_facility: CRIO - Centro Regional Integrado de Oncologia

location_facility: Hospital Universitario Fundacion Jimenez Diaz - Oncology

location_facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - U. Operativa di Immunoterapia e Terapia Cellulare

location_facility: Centre Hospitalier de la Croix Rousse - Service ORL et chirurgie cervico-faciale

location_facility: Hospital Universitari Vall d'Hebron - Oncology Dept.

location_facility: Complejo Hospitalario Universitario Insular Materno-Infantil - Servicio de Oncologia

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Państwowy Instytut Badawczy - Zakład Medycyny Nuklearnej i Endokrynologii Onkolo

location_facility: S.C Oncocenter Oncologie Clinica S.R.L - parent

location_facility: Complejo Hospitalario Universitario A Coruña - CHUAC-Hospital Teresa Herrera

location_facility: NHO Shikoku Cancer Center - Dept of Head and Neck Surgery

location_facility: Hospital Universitario La Paz - Oncology Department

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) - Oncologia Medica

location_facility: IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2

location_facility: Saitama Cancer Center - Dept of Head and Neck Surgery

location_facility: Universitair Medisch Centrum Groningen - Cancer Center

location_facility: CHU Bordeaux - Service d'Oncologie Médicale

location_facility: Universitaetsmedizin Rostock - Klinik und Poliklinik für Strahlentherapie

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo - Div. di Oncologia Medica ed Ematologia

location_facility: Hokkaido University Hospital - Dept of Otorhinolaryngology

location_facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Pesquisa Clínica

location_facility: Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale

location_facility: Hospital de Braga - Serviço de Oncologia Medica

location_facility: Centre Oscar Lambret - service de cancerologie gynecologique

location_facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen - Hals-, Nasen- und Ohrenklinik

location_facility: Hopital Prive Drome Ardeche - Service D Oncologie

location_facility: Aichi Cancer Center Hospital - Dept of Head and Neck Surgery

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: National Cancer Center Hospital East - Dept of Head and Neck Medical Oncology

location_facility: Cliniques Universitaires Saint-Luc - STL

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: Institut Gustave Roussy - Oncologie Médicale

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: ICO - Site René Gauducheau - Service d'Oncologie medicale

location_facility: Complejo Hospitalario Universitario A Coruña - Servicio de Oncologia

location_facility: CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale