title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].

lead_sponsor: Abivax S.A.

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Japan
Brazil
Bosnia and Herzegovina
Croatia
Czechia
Canada
Serbia
France
Lithuania
Slovakia
Hungary
United States
India
Romania
Belgium
Italy
United Kingdom
Mexico
Spain
Bulgaria
Israel

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC

location_facility: SUBARU Health Insurance Society Ota Memorial Hospital

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: West Central Gastroenterology d/b/a Gastro Florida

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Clinical Hospital Center "Bezanijska kosa

location_facility: Kindred Medical Institute for Clinical Trials, LLC

location_facility: Institute of Post Graduate Medical Education And Research

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz

location_facility: Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal

location_facility: Lakeshore Hospital and Research Centre Ltd.

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)

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

location_facility: Shinseikai Sai Gastroenterology, Proctology Clinic

location_facility: Centro de Investigaciones Medicas Tucuman

location_facility: Clinical Research Institute of Michigan, LLC

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

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: Nowe zdrowie-CK, Kieltucki i wspolnicy sp. j.

location_facility: CECIP - Centro de Estudos Clínicos do Interior Paulista

location_facility: University Hospitals Cleveland Medical Center

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Irmandade da Santa Casa da Misericórdia de Santos

location_facility: Datta Meghe Institute of Medical Sciences (Deemed University)

location_facility: L2IP - Instituto de Pesquisas Clínicas Ltda.

location_facility: Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Lokmanya Tilak Municipal General Hospital & Medical College

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Gordon and Leslie Diamond Health Care Centre - Vancouver General Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

location_facility: HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

location_facility: Hospital das Clínicas da Faculdade de Medicina da UNICAMP

location_facility: Kaplan Medical Center KMC Institute of Gastroenterology and Liver Diseases

location_facility: Postgraduate Institute of Medical Education and Research

location_facility: Ishida Clinic of IBD and Gastroenterology

location_facility: London Health Sciences Centre (LHSC) - Victoria Hospital

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Our Lady of the Snow St. Mary's Hospital

location_facility: General Hospital "Dr.Tomislav Bardek" Koprivnica

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

location_facility: NHO Kure Medical Center and Chugoku Cancer Center

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

location_facility: Fortis Escorts Heart Institute and Research Centre

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Gastroenterology Consultants and Endoscopy Center of Southwest Virginia

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

location_facility: Klaipeda University Hospital branch "Seamen's Hospital"

location_facility: Lithuanian University of Health Sciences Kaunas Hospital

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie

location_facility: Board of Regents of the University of Oklahoma Health Sciences Center

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: Showa University Northern Yokohama Hospital

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals

location_facility: 1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Lublinie


type: EudraCT Number

type: Registry Identifier

title: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

summary: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

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: No

lead_sponsor: Gilead Sciences

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Slovakia
Hungary
Hong Kong
Switzerland
United States
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Israel

location_facility: Virginia Cancer Specialists, PC,7501 Right Flank Road

location_facility: Oncologia Medica Senologica Sperimentale - Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: Florida Cancer Specialists - North Region Research Office,3402 West Dr. Martin Luther King Jr. Boulevard

location_facility: Hadassah - Hebrew University Medical Center

location_facility: Florida Cancer Specialists,1100 Goodlette Road

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: The University of Kansas Cancer Center,4881 N.E. Goodview Circle

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: The University of Kansas Cancer Center,12200 W. 110th Street

location_facility: Rutgers Cancer Institute of New Jersey,600 River Avenue

location_facility: Sinacor - Centro para el Desarrollo de la Medicina

location_facility: Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd.

location_facility: Novant Health Cancer Institute - Forsyth,2131 S. 17th Street

location_facility: Nebraska Cancer Specialists,611 Fenwick Dr

location_facility: Magee-Womens Hospital of UPMC,1703 Innovation Drive

location_facility: The University of Kansas Cancer Center,2750 Clay Edwards Drive

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: CEPHO - Centro de Estudos e PesquisaS de Hematologia e Oncologia

location_facility: Hôpital Morvan, Institut de cancérologie

location_facility: Hospices Civils de Lyon Hôpital Lyon Sud

location_facility: Virginia Oncology Associates,1051 Loftis Blvd Suite 100

location_facility: Magee-Womens Hospital of UPMC,2500 West 12th Street

location_facility: James Lind Centro de Investigacion del Cancer

location_facility: The University of Kansas Cancer Center,2000 Olathe Blvd

location_facility: Istanbul Il Saglik Mudurlugu Goztepe Prof. Dr. Sul

location_facility: Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,100 Market Place Blvd

location_facility: Sainte Catherine Institut du Cancer Avignon Provence

location_facility: Tennessee Oncology, PLLC,353 New Shackle Island Road

location_facility: Florida Cancer Specialists - North Region Research Office

location_facility: Rocky Mountain Cancer Centers,4700 E. Hale Parkway

location_facility: Magee-Womens Hospital of UPMC,5115 Centre Avenue

location_facility: Novant Health Cancer Institute - Forsyth,125 Queens Road, Suite 650

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: AdventHealth Medical Group,2501 North Orange Ave

location_facility: New York Cancer & Blood Specialists - Port Jeffers,750 Old County Rd. Suite 4

location_facility: Hospital de Clinicas de Porto Alegre - HCPA

location_facility: Virginia Cancer Specialists, PC,210 Medical Park Boulevard

location_facility: New York Cancer & Blood Specialists - Port Jeffers,72 East Main St.

location_facility: Summit Medical Group Eastside Clinic,1 Diamond Hill Road

location_facility: Evangelisches Krankenhaus Bethesda Mönchengladbach

location_facility: Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210

location_facility: Swedish Cancer Institute-First Hill,751 NE Blakely Drive

location_facility: Novant Health Cancer Institute - Forsyth

location_facility: Universitätsklinikum Schleswig-Holstein Institut fur Klinische Chermie

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4455 Weaver Parkway

location_facility: University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200

location_facility: The Center for Cancer & Blood Disorders - Magnolia,515 W. Mayfield Rd.

location_facility: Magee-Womens Hospital of UPMC,4300 Londonberry Road

location_facility: University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600

location_facility: Piedmont Cancer Institute - Atlanta,1267 Hwy 54W

location_facility: New York Cancer & Blood Specialists - Port Jeffers,12 East 86th St, Suite 4

location_facility: Rocky Mountain Cancer Centers,22 West Dry Creek Circle

location_facility: Masarykuv onkologicky ustav, klinika komplexni onkologickie pece

location_facility: Tennessee Oncology, PLLC,5653 First Blvd.

location_facility: Capital Health Medical Center - Hopewell

location_facility: Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie

location_facility: Florida Cancer Specialists,5985 Silver Falls Run

location_facility: Fondazione Policlinico Universitario Agostino Geme

location_facility: Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd

location_facility: University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240

location_facility: Fakultni nemocnice Olomouc, Onkologicka klinika

location_facility: Narodowy Instytut Onkologii im.Marii Marii Sklodowskiej

location_facility: The Center for Cancer & Blood Disorders - Magnolia,11805 South Freeway

location_facility: SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego

location_facility: The West Clinic, PLLC dba West Cancer Center

location_facility: New York Cancer & Blood Specialists - Port Jeffers,49 Rte. 347, Newconset Hwy

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University,10 Health Services Drive

location_facility: Fort Wayne Medical Oncology and Hematology - Fort

location_facility: Sacred Heart Heatlh System, Inc., d/b/a Ascension Sacred Heart

location_facility: Florida Cancer Specialists - North Region Research Office,460 N Orlando Ave

location_facility: New York Cancer & Blood Specialists - Port Jeffers

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kliniken Essen-Mitte - Evangelische Huyssens-Stift Breast Unit

location_facility: iBiomed - Investigacion Biomedica para el Desarrol

location_facility: Florida Cancer Specialists - North Region Research Office,6420 W. Newberry Road

location_facility: Florida Cancer Specialists - West Palm Beach,1037 S. State Road 7, Bldg B, Suite 303

location_facility: Florida Cancer Specialists,3630 Manatee Avenue West

location_facility: S.O.C Patologia Clinica (Laboratorio Analisi), Nuovo Ospedale di Prato - Santo Stefano

location_facility: Rocky Mountain Cancer Centers,6031 E. Woodman Rd.

location_facility: Montefiore Medical Center - Montefiore Medical Park

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1 Kish Hospital Drive

location_facility: Rocky Mountain Cancer Centers,3676 Parker Blvd

location_facility: Massachusetts General Hospital,102 Endicott Street

location_facility: CISSS du Bas-Saint-Laurent - Hôpital régional de Rimouski

location_facility: Northwest Cancer Specialists, P.C,265 N. Broadway

location_facility: Tennessee Oncology, PLLC,120 Frank Martin Road

location_facility: Florida Cancer Specialists - North Region Research Office,403 S. Kings Ave.

location_facility: University College London Hospitals NHS Foundation

location_facility: SSD Oncologia Medica Addarii-Zamagni, IRCSS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Rutgers Cancer Institute of New Jersey,300 Second Ave

location_facility: Rocky Mountain Cancer Centers,2312 N. Nevada Avenue

location_facility: Rocky Mountain Cancer Centers,8820 Huron Street

location_facility: Norton Cancer Institute - Saint Matthews

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern

location_facility: Florida Cancer Specialists,22395 Edgewater Drive

location_facility: Florida Cancer Specialists - North Region Research Office,750 Orienta Ave

location_facility: The Center for Cancer & Blood Disorders - Magnolia,920 Santa Fe Drive

location_facility: Petz Aladar Egyetemi Oktaté Kérhaz - Osztaly

location_facility: Rutgers Cancer Institute of New Jersey,414 Grand Street

location_facility: Northside Hospital,1505 Northside Blvd, Suite 4600

location_facility: Rutgers Cancer Institute of New Jersey,99 Highway 37 West

location_facility: Nationales Centrum für Tumorerkrankungen - Heidelb

location_facility: Florida Cancer Specialists - North Region Research Office,3280 McMullen Booth Road

location_facility: Tennessee Oncology, PLLC,3443 Dickerson Road

location_facility: University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200

location_facility: Florida Cancer Specialists,681 4th Avenue North

location_facility: Virginia Oncology Associates,744 N. Battlefield Blvd

location_facility: University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4405 Weaver Parkway

location_facility: Hematology Oncology Clinic - Baton Rouge,1673 E Mount Please Drive

location_facility: Tennessee Oncology, PLLC,2004 Hayes Street

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University,25 N Winfield Road

location_facility: Rocky Mountain Cancer Centers,11750 West 2nd Place

location_facility: Rutgers Cancer Institute of New Jersey,94 Old Short Hills Road

location_facility: Florida Cancer Specialists,1970 Golf Street

location_facility: Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,157 Clinic Avenue

location_facility: Rutgers Cancer Institute of New Jersey,201 Lyons Avenue

location_facility: Florida Cancer Specialists - West Palm Beach,301 SE Ocean Blvd, Suite 102

location_facility: Norton Cancer Institute - Saint Matthews,676 S. Floyd Street

location_facility: University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304

location_facility: Universitätsklinikum Erlangen, Frauen klinik

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

location_facility: The Center for Cancer & Blood Disorders - Magnolia

location_facility: Vychodoslovensky onkologicky ustav, a.s., Oddelenie klinickej onkologie

location_facility: Trakya Universitesi Tip Fakultesi Hastanesi

location_facility: Eastern Connecticut Hematology and Oncology Associates

location_facility: Genesis Cancer and Blood Institute,1455 Higdon Ferry Road Suite B.

location_facility: New York Cancer & Blood Specialists - Port Jeffers,365 East Main St.

location_facility: Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Rutgers Cancer Institute of New Jersey,150 Bergen St.

location_facility: Hematology Oncology Associates of Central New York

location_facility: Centro para la Atencion Integral del Paciente Oncologico Centro Médico C.A.I.P.O

location_facility: Kantonsspital Baselland - Standort Liestal

location_facility: Orchard Healthcare Research Inc,2845 North Sheridan Road, 1st Floor

location_facility: Magee-Womens Hospital of UPMC,2035 Technology Parkway

location_facility: Northwest Cancer Specialists, P.C,210 SE 136th Avenue

location_facility: Florida Cancer Specialists - North Region Research Office,100 Highland Avenue

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Real e Portuguesa de Beneficéncia - Hospital Beneficéncia Portuguesa (BP) - Unidade Paulista

location_facility: NYP/Columbia Univeresity Medical Center/Herbert Irving Comprehensive Cancer Center

location_facility: Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road

location_facility: Osaka Prefectural Hospital Organization - Osaka In

location_facility: Klinik Frauenheilkunde, Uniklinik ClO, Studienzentrale

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Virginia Oncology Associates,1950 Glenn Mitchell Drive

location_facility: Tennessee Oncology, PLLC,4488 Carothers Parkway

location_facility: Nucleo de Pesquisa Clinica da Rede Sao Camilo

location_facility: Klinik und Poliklinik für Frauenheilkunde

location_facility: Praxis für interdisziplinäre Onkologie & Hämatolog

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University,304 Randall Road

location_facility: Orchard Healthcare Research Inc,800 Austin Street, Suite 360, East Tower

location_facility: Norton Cancer Institute - Saint Matthews,4955 Norton Healthcare Blvd

location_facility: Hospital Araújo Jorge - Associação de Combate ao Câncer em Goiás - ACCG

location_facility: Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

location_facility: Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway

location_facility: Nebraska Cancer Specialists,8303 Dodge Street

location_facility: Torrance Memorial Physician Network - Cancer Care

location_facility: Nebraska Cancer Specialists,2730 W. Faidley Ave

location_facility: Florida Cancer Specialists,600 North Cattlemen Road

location_facility: The University of Kansas Cancer Center,10730 Nall Avenue

location_facility: Rutgers Cancer Institute of New Jersey,110 Rehill Ave

location_facility: Northwest Cancer Specialists, P.C,5050 NE Hoyt St.

location_facility: Northside Hospital,308 Deep South Farm Rd, Suite 200

location_facility: The University of Kansas Cancer Center,10710 Nall Avenue

location_facility: Massachusetts General Hospital,2014 Washington St

location_facility: New York Cancer & Blood Specialists - Port Jeffers,2330 Eastchester Road, Suite 360

location_facility: Florida Cancer Specialists - North Region Research Office,4100 Waterman Way

location_facility: Swedish Cancer Institute-First Hill,21632 Highway 99

location_facility: Florida Cancer Specialists,8260 Gladiolus Dr

location_facility: Centre Hospitalier Universitaire Université Cathol

location_facility: St. Josefs-Hospital Wiesbaden GmbH , Gynäkologie und Geburtshilfe

location_facility: Rocky Mountain Cancer Centers,1700 South Potomac Street

location_facility: Fondazione IRCCS - Istituto Nazionale dei Tumori

location_facility: Sacred Heart Heatlh System, Inc., d/b/a Ascension Sacred Heart,27 Mack Bayou Loop

location_facility: Guy's and Saint Thomas' NHS Foundation Trust

location_facility: Florida Cancer Specialists,8981 Colonial Center Drive

location_facility: Hematology Oncology Clinic - Baton Rouge

location_facility: Florida Cancer Specialists,901 South Tamiami Trail

location_facility: Magee-Womens Hospital of UPMC,201 State Street, 6 Main

location_facility: University of Iowa Hospitals and Clinics

location_facility: Tennessee Oncology, PLLC,103 Natchez Park Drive

location_facility: Tennessee Oncology, PLLC,225 Big Station Camp Blvd

location_facility: Universitätsklinikum Münster, Bereich Senologie an der klinik fur Frauenheilkunde und Gerburtschilfe

location_facility: Tennessee Oncology, PLLC,4220 Harding Rd

location_facility: Fakultni nemocnice Karlovske Vinohrady, Radioterapeuticka a onkologicka klinika

location_facility: Florida Cancer Specialists - North Region Research Office,521 North Lecanto Highway

location_facility: Instituto Nacional de Câncer - INCA - HCIII

location_facility: New York Cancer & Blood Specialists - Port Jeffers,1 Delaware Dr.

location_facility: Sheba Medical Center Hospital - Tel Hashomer

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Florida Cancer Specialists - North Region Research Office,7154 Medical Center Drive

location_facility: Panamerican Clinical Research Mexico - Guadalajara

location_facility: Florida Cancer Specialists - West Palm Beach,3730 7th Terrace, Suite 101

location_facility: Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve A

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Rutgers Cancer Institute of New Jersey,100 State Route 36

location_facility: Oncology Consultants,1631 North Loop West

location_facility: Florida Cancer Specialists - West Palm Beach,224 Memorial Medical Parkway, Suite 300

location_facility: Grand River Regional Cancer Centre at Grand River Hospital

location_facility: University of California San Diego Moores Cancer

location_facility: Virginia Cancer Specialists, PC,1401 Johnston-Willis Drive

location_facility: Azienda Ospedaliera Universitaria Senese - Losped

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej

location_facility: Ospedale Generale Provinciale - Macerata

location_facility: Saint Bernards Medical Center,4000 Linwood Drive

location_facility: Northside Hospital,3855 Pleasant Hill Rd., Suite 480

location_facility: Fundação Pio XII - Hospital de Amor de Barretos

location_facility: Gynakologisches Zentrum Bonn, Schwerpunkt Gyn. Onkologie,

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

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Florida Cancer Specialists,836 Sunset Lake Blvd

location_facility: Florida Cancer Specialists - North Region Research Office,4945 SW 49th Place

location_facility: Rocky Mountain Cancer Centers,525 W. 15th Street

location_facility: Florida Cancer Specialists - North Region Research Office,70 W. Gore Street

location_facility: Florida Cancer Specialists - North Region Research Office,1400 US Highway 441 N

location_facility: Fundacion CORI para la Investigacion y Prevencion del Cancer

location_facility: Piedmont Cancer Institute - Atlanta,775 Poplar Road

location_facility: The West Clinic, PLLC dba West Cancer Center,7668 Airways Blvd

location_facility: Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 A

location_facility: Norton Cancer Institute - Saint Matthews,234 E. Gray Strret

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1000 N. Westmoreland Road

location_facility: Centre Hospitalier Régional et Universitaire de Be

location_facility: Florida Cancer Specialists - North Region Research Office,9320 State Road 54

location_facility: Tennessee Oncology, PLLC,1840 Medical Center Parkway

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University,300 Randall Road

location_facility: Florida Cancer Specialists - North Region Research Office,2824 Enterprise Rd

location_facility: Institutal Oncologic, Prof. Dr Ion Chiricuta

location_facility: Seoul National University Bundang Hospital

location_facility: Breast Cancer Research Center - Western Australia

location_facility: University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100

location_facility: Uzsoki Utcai Kornaz, Onkoradiologiai Osztaly

location_facility: New York Cancer & Blood Specialists - Port Jeffers,1500 Rte, 112, Building 4

location_facility: Azienda Ospedaliero-Universitaria Maggiore della C

location_facility: Centre Armoricain de Radiothérapie, dImagerie Méd

location_facility: Tennessee Oncology, PLLC,103 Physicians Way

location_facility: Hospital Teresa Herrera - Materno Infantil

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Tennessee Oncology, PLLC,397 Wallace Road

location_facility: Florida Cancer Specialists - West Palm Beach

location_facility: Piedmont Cancer Institute - Atlanta,1240 Eagles Landing Pkwy

location_facility: Mazowiecki Szpital Wojewódzki im. w. Jana Pawa II

location_facility: Tennessee Oncology, PLLC,300 Stonecrest Blvd

location_facility: Clinica de Pesquisas e Centro de Estudos em Oncolo

location_facility: Northside Hospital,5670 Peachtree Dunwoody Rd.

location_facility: Fakultni nemocnice Hradec Kravlove, Klinika onkologie a radioterapie

location_facility: Universitatsklinikum Mannheim GmBH, Frauenklinik

location_facility: Swedish Cancer Institute-First Hill,747 Broadway

location_facility: Hospital Clínico Universitario de Valencia

location_facility: The University of Kansas Cancer Center,8700 North Green Hills Road

location_facility: Kure Medical Center And Chugoku Cancer Center

location_facility: Florida Cancer Specialists,1030 Commerce Creek Blvd

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Texas Oncology PA,4101 James Casey, Suite 100

location_facility: UO Oncologia, ASST degli Spedali Civili di Brescia

location_facility: Mater Misericordiae Limited and Mater Research Limited

location_facility: Baskent Uni. Dr Turgut Noyan Uyg. ve Aras. Merkezi

location_facility: Florida Cancer Specialists - North Region Research Office,1201 Fifth Avenue North

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: A Study Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® as Well as Evaluating Long-term Safety of Somapacitan in a Basket Study Design in Children With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome, or Idiopathic Short Stature

acronym: REAL 8

summary: The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.

ipd_sharing: Yes

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Germany
Ireland
Poland
Japan
Brazil
Thailand
Croatia
Canada
Serbia
France
Slovenia
Lithuania
Portugal
Switzerland
United States
Latvia
India
Belgium
China
Malaysia
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
South Africa
Bulgaria
Israel


title: A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease

acronym: ENVISION

summary: The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

lead_sponsor: Biogen

location_country:
Finland
Germany
Italy
Poland
Portugal
United Kingdom
Australia
Brazil
Japan
Mexico
Belgium
Sweden
United States
Korea, Republic of
Spain
Canada
France

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Zentrum für klinische Forschung Dr.med. Irma Schöll

location_facility: Michigan Institute for Neurological Disorders

location_facility: Brigham and Women's Hospital Department of Neurology

location_facility: Australian Alzheimer's Research Foundation

location_facility: Health Pharma Professional Research S.A. de C.V.

location_facility: Irvine Center for Clinical Research, Inc.

location_facility: Azienda Ospedaliera e Universitaria di Perugia

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Tokushukai Kishiwada Tokushukai Hospital

location_facility: Rhode Island Mood & Memory Research Institute

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

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Glennan Center for Geriatrics and Gerontology

location_facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

location_facility: Instituto de Neurologia de Curitiba - Hospital Ecoville

location_facility: Research Center for Clinical Studies, Inc.

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

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Centro de Estudios Clinicos y Especialidades Medicas, S.C.

location_facility: Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

location_facility: National Clinical Research Inc. - Richmond

location_facility: NZOZ Wroclawskie Centrum Alzheimerowskie

location_facility: Tokushukai Shonan Kamakura General Hospital

location_facility: Institute for Neurodegenerative Disorders (IND)

location_facility: Deutsches Zentrum fuer Neurodegenerative Erkrankungen (DZNE)

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: CenExel Advanced Memory Research Institute of NJ

location_facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit

location_facility: National Center For Geriatrics And Gerontology

location_facility: Institute of Psychiatry, Psychology and Neuroscience

location_facility: University of California San Francisco (PARENT)

location_facility: Seoul National University Bundang Hospital

location_facility: Ascension Via Christi Research, a division of Ascension Via Christi Hospitals Wichita, Inc.

location_facility: Instituto do Cerebro do Rio Grande do Sul

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: The Methodist Hospital Research Institute

location_facility: New York University Medical Center PRIME

location_facility: University of Calgary - Heritage Medical Research Clinic

location_facility: National Center of Neurology and Psychiatry

location_facility: Trial Tech Tecnologia em Pesquisas com Medicamentos Ltda

location_facility: Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic

location_facility: Mary S. Easton Center for Alzheimer's Disease Research, UCLA

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Alexian Brothers Medical Center - Neuroscience Research Institute

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Institut fuer Schlaganfall- und Demenzforschung (ISD)


title: A Randomised, Double-blind, Parallel Group Phase III Study to Assess the Efficacy and Safety of 100 mg SC Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)

summary: This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with CRSwNP.

status: Active, not recruiting

enrollment_type: Actual

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency

lead_sponsor: GlaxoSmithKline

location_country:
Germany
United Kingdom
Argentina
Japan
Netherlands
Belgium
United States
China
Spain
Canada
France


lead_sponsor: AstraZeneca

summary: This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

sponsor_collaborators:
AstraZeneca
Arcus Biosciences, Inc.

title: A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

source: euctr

location_country:
Germany
Poland
Japan
Brazil
Turkey
Chile
Canada
France
Hungary
Hong Kong
Switzerland
United States
India
Romania
Belgium
China
Malaysia
Philippines
Italy
Norway
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan


title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (TITANIA)

acronym: TITANIA

summary: The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.

location_country:
Germany
Poland
Australia
Brazil
Thailand
Chile
France
Colombia
United States
Romania
China
Peru
Puerto Rico
Philippines
Italy
United Kingdom
Greece
Taiwan
Russian Federation
Israel


title: A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)

summary:
This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy.

The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).

ReferenceType: derived

ReferenceCitation: Tabernero J, Shen L, Elimova E, Ku G, Liu T, Shitara K, Lin X, Boyken L, Li H, Grim J, Ajani J. HERIZON-GEA-01: Zanidatamab + chemo +/- tislelizumab for 1L treatment of HER2-positive gastroesophageal adenocarcinoma. Future Oncol. 2022 Sep;18(29):3255-3266. doi: 10.2217/fon-2022-0595. Epub 2022 Aug 24.

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

lead_sponsor: Jazz Pharmaceuticals

sponsor_collaborators:
Jazz Pharmaceuticals
BeiGene, Ltd.

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Chile
Czechia
Canada
Serbia
France
Portugal
Ukraine
India
Romania
Belgium
China
Malaysia
Estonia
Italy
Guatemala
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Georgia

location_facility: Bioclinic Thessaloniki Oncology Department

location_facility: Interbalkan Medical Center of Thessaloniki Oncology Department

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: Tianjin Medical University General Hospital

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

location_facility: Ruijin hospital Shanghai Jiao Tong University School of Medicine

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Cancer Hospital affiliated to Xinjiang Medical University

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Medical Center of Limited Liability Company "Medical center "VERUM EXPERT"

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: The Fourth Hospital of Hebei Medical University

location_facility: All India Institute of Medical Sciences, Bhubaneswar

location_facility: Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies

location_facility: Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto

location_facility: Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Union Hospital Tongji Medical College HuaZhong University of Science and Technology

location_facility: Instituto de Investigaciones Metabólicas - IDIM

location_facility: The Second Affiliated Hospital of Anhui Medical University

location_facility: The First Hospital of China Medical University

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council

location_facility: MNJ Institute of Oncology and Regional Cancer Centre

location_facility: Centro de Investigaciones Médicas Tucumán

location_facility: The First People's Hospital of Changzhou

location_facility: Affiliated Hospital of Jiangnan University

location_facility: Gangnam Severance Hospital, Yonsei University Health System

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

location_facility: Fudan University Affiliated Zhongshan Hospital

location_facility: Cryptex Investigación Clínica, S.A. de C.V.

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

location_facility: Western General Hospital Edinburgh - PPDS

location_facility: Instituto do Cancer do Estado de São Paulo ICESP

location_facility: Hospital de Gastroenterología Dr Bonorino Udaondo

location_facility: The First Hospital of Lanzhou University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Sociedad de Investigaciones Medicas Limitada

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Fundación Centro de Medicina Nuclear y Molecular ER

location_facility: Municipal Non-profit Enterprise "Odessa Regional Oncology Dispensary" of Odesa RC

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

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

location_facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Centro Medico Integral de Cancerologia CEMIC

location_facility: Affiliated Hospital of Inner Mongolia Medical University

location_facility: Fundação Pio XII Hospital de Câncer de Barretos

location_facility: Centro de Investigación Clínica - Clínica Viedma

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: Azienda ULSS 8 "Berica" - Ospedale San Bortolo

location_facility: Southern Cross Research South Africa (PTY) LTD

location_facility: INCA - Instituto Nacional de Câncer José Alencar G

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Cenantron - Centro Avancado de Tratamento Oncologico Ltda

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

location_facility: Beijing Luhe Hospital, Capital Medical University

location_facility: Treatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima

location_facility: Prof Dr I Chiricuta Institute of Oncology - PPDS

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Regional Cancer Centre Indira Gandhi Institute of Medical Sciences

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

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Institute for Oncology and Radiology of Serbia - PPDS

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Instituto Brasileiro de Controle Do Câncer IBCC

location_facility: Beijing Chao-Yang Hospital, Capital Medical University

location_facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University

location_facility: The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council

location_facility: Bangkok Metropolitan Administration Medical College and Vajira Hospital

location_facility: First Affiliated Hospital of Xi 'an Jiaotong University

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: EDOG Institut de Cancerologie de l'Ouest - PPDS

location_facility: University Clinical Center of Serbia - PPDS

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Hospital Universitario Dr. Jose Eleuterio González

location_facility: CHA Bundang Medical Center, CHA University

location_facility: SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center

location_facility: Universite de Bourgogne - Faculte de Medecine - IN

location_facility: National Cancer Institute ( Institut Kanser Negara)


title: A Phase 2, Double-Masked, Placebo-Controlled, Dose Range Finding Study of Danicopan (ALXN2040) in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

summary: This is a dose finding study designed to evaluate the efficacy, safety, and pharmacokinetics of danicopan in participants with GA secondary to AMD. The study consists of a Screening Period of up to 6 weeks, a 104-week masked Treatment Period, followed by a 30-day Follow-up after the last dose. This study will have 4 treatments arms: 100 milligrams (mg) twice daily (bid), 200 mg bid, 400 mg once daily (qd), and matching placebo.

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Germany
Italy
Slovakia
Hungary
United Kingdom
Australia
Japan
United States
Korea, Republic of
Latvia
Spain
Czechia
Canada
France


acronym: EXCALIBER-RRMM

lead_sponsor: Celgene

summary: This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

location_facility: Genesis cancer and Blood Institute (GCBI) - Sarah Cannon

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: Compassionate Cancer Care Medical Group Inc.

location_facility: Norton Cancer Institute - St. Matthews Campus

location_facility: Oklahoma Cancer Specialists and Research Institute

location_facility: The First Affiliated Hospital Of Soochow University

location_facility: MetroHealth Medical Center - Main Campus

location_facility: Tennessee Oncology Nashville Drug Development Unit

location_facility: New York - Presbyterian/Weill Cornell Medical Center

title: A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Portugal
Denmark
Switzerland
United States
India
Belgium
China
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

summary:
The purpose of this extension trial is to evaluate the long-term safety of delgocitinib.

Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.

status: Completed

study_completion_date_type: Actual

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

lead_sponsor: LEO Pharma

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Netherlands
Belgium
Spain
Canada
France

location_facility:
LEO Pharma Investigational Site
LEO Investigational Site
Leo Investigational Site
LEO Investigitional Site
LEO investigational site
LEO Investigational Sites

status_simplified: Completed


title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept Versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

acronym: CADENCE

summary:
This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF.

The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

lead_sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Sweden
Belgium
United States
Spain
Canada
France

location_facility: South Denver Cardiology Associates ( Site 1091)

location_facility: Hopital de Rangueil du Toulouse ( Site 1322)

location_facility: Pulmonary Health Physicians ( Site 1080)

location_facility: Cleveland Clinic Foundation ( Site 1065)

location_facility: University of Nebraska Medical Center ( Site 1053)

location_facility: Inova Heart and Vascular Institute ( Site 1078)

location_facility: CHRU de Nancy Hopitaux de Brabois ( Site 1308)

location_facility: University Hospitals Cleveland Medical Center ( Site 1005)

location_facility: Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2801)

location_facility: AOU di Bologna Policlinico S Orsola Malpighi ( Site 2409)

location_facility: Oregon Health Science University ( Site 1054)

location_facility: University of Kansas Medical Center ( Site 1020)

location_facility: The George Washington University Medical Faculty Associates ( Site 1025)

location_facility: University of Minnesota Hospitals ( Site 1062)

location_facility: Hospital Clinic de Barcelona ( Site 1602)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 3201)

location_facility: Brigham and Women's Hospital [Boston, MA] ( Site 1014)

location_facility: Washington University School of Medicine [Saint Louis, MO] ( Site 1022)

location_facility: University of Rochester Medical Center - PPDS ( Site 1039)

location_facility: Universitaetsmedizin Johannes Gutenberg Universitaet Mainz ( Site 1515)

location_facility: Intermountain Medical Center ( Site 1079)

location_facility: IU Health Advanced Heart and Lung Care ( Site 1092)

location_facility: Shamir Medical Center Assaf Harofeh ( Site 1713)

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)

location_facility: The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)

location_facility: Centre Hospitalier Universitaire du Besancon ( Site 1324)

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)

location_facility: Statcare Pulmonary Consultants - Knoxville ( Site 1031)

location_facility: Hospital Universitario 12 de Octubre ( Site 1603)

location_facility: CHU de Nantes - Hoptal Nord Laennec ( Site 1309)

location_facility: University of Iowa Hospital and Clinics ( Site 1050)

location_facility: Hamilton General Hospital-Special Immunology Services Clinic ( Site 2110)

location_facility: University of Toledo Medical Center ( Site 1070)

location_facility: University Hospital Regensburg ( Site 1503)

location_facility: Medical University of South Carolina - PPDS ( Site 1003)

location_facility: Institut Universitaire de Cardiologie et de Pneumologie ( Site 2107)

location_facility: Lady Davis Carmel Medical Center ( Site 1705)

location_facility: Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)

location_facility: Hospital Universitario de Toledo ( Site 1607)

location_facility: Centre Hospitalier Universitaire de Grenoble ( Site 1303)

location_facility: Aurora St Luke's Medical Center ( Site 1083)

location_facility: Weill Cornell Medical College ( Site 1046)

location_facility: Mayo Clinic Jacksonville - PPDS ( Site 1045)

location_facility: UZ Leuven - Campus Gasthuisberg ( Site 1401)

location_facility: Kerckhoff-Klinik-Forschungs-GmbH ( Site 1514)

location_facility: Norton Pulmonary Specialists ( Site 1066)

location_facility: Azienda Policlinico Umberto I ( Site 2402)

location_facility: Imperial College Healthcare NHS Trust ( Site 1203)

location_facility: Bon Secours St. Mary's Hospital ( Site 1069)

location_facility: Assuta Ashdod Medical Center ( Site 1710)

location_facility: CHU Montpellier Hôpital Arnaud de VIlleneuve ( Site 1301)

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden. ( Site 1501)

location_facility: University of California Irvine ( Site 1086)

location_facility: Ascension Medical Group St. Vincent ( Site 1076)

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)

location_facility: Fondazione IRCCS-Policlinico San Matteo ( Site 2401)

location_facility: Jeffrey S.Sager MD Medical Corporation ( Site 1060)

location_facility: Lankenau Institute for Medical Research ( Site 1089)

location_facility: Tufts Medical Center - PPDS ( Site 1012)

location_facility: Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)

location_facility: Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)

location_facility: Centre Hospitalier Universitaire de Bicetre ( Site 1304)

location_facility: Hospital Universitario Virgen Macarena ( Site 1612)

location_facility: Thoraxklinik-Heidelberg gGmbH ( Site 1509)

location_facility: Cedars Sinai Medical Center ( Site 1082)


title: Tamibarotene in Combination With Venetoclax and Azacitidine in Previously Untreated Adult Patients Selected for RARA-positive AML Who Are Ineligible for Standard Induction Therapy

summary:
Tamibarotene is being studied as a treatment for participants with a type of leukemia called acute myeloid leukemia, or AML for short. Tamibarotene is being studied as a treatment for participants with AML whose cancer has a specific genetic abnormality characterized by the overexpression of the retinoic acid receptor alpha (RARA) gene. This genetic profile is found in about 3 of every 10 people with AML.

During the trial, tamibarotene will be given with 2 other drugs that are already used together to treat people who have AML and who cannot start treatment with standard chemotherapy.

lead_sponsor: Syros Pharmaceuticals

location_country:
United States
France

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: The Ohio State University James Cancer Hospital

location_facility: Sarah Cannon Research Institute at Colorado Blood Cancer Institute

location_facility: UCLA Medical Center Division of Hematology/Oncology


acronym: Astefania

lead_sponsor: Hoffmann-La Roche

summary: This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.

ReferenceCitation: Hurvitz SA, Bachelot T, Bianchini G, Harbeck N, Loi S, Park YH, Prat A, Gilham L, Boulet T, Gochitashvili N, Monturus E, Lambertini C, Nyawira B, Knott A, Restuccia E, Schmid P. ASTEFANIA: adjuvant ado-trastuzumab emtansine and atezolizumab for high-risk, HER2-positive breast cancer. Future Oncol. 2022 Oct;18(32):3563-3572. doi: 10.2217/fon-2022-0485. Epub 2022 Nov 16.

location_facility: Budapesti Szent Margit Korhaz; Onkologia Osztaly

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie Dr. Reichert/Dr.Janssen

location_facility: Gazi University Medical Faculty, Oncology Hospital

location_facility: Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii

location_facility: Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde

location_facility: Mays Cancer Center at UT Health San Antonio MD Anderson Cancer

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Hospital CUF Tejo; Oncologia Médica e Hematologia

location_facility: Centrum Onkologii Instytut im.M. Sklodowskiej-Curie; Klin. Nowot. Piersii i Chirurgii Rekonstruk

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Hospital Juan Ramon Jimenez;Servicio de Oncologia

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: Fakultni Thomayerova nemocnice; Onkologicka klinika 1. LF UK a FTN

location_facility: Inonu University Medical Faculty of Medicine; Medical Oncology Department

location_facility: Hospital Universitario Dr. Peset; Servicio de Oncologia

location_facility: Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Städtisches Klinikum Karlsruhe gGmbH; Frauenklinik

location_facility: Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Podmaniczky utcai telephely

location_facility: West China Hospital - Sichuan University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Gynonco Düsseldorf, MVZ Medical Center GmbH

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Virginia Oncology Associates - New Port News

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: National Cancer Centre; Medical Oncology

location_facility: National Taiwan University Hospital ; Dept of Surgery & Hepatitis Research Center

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie

location_facility: Henry Ford Health System; Clinical Trials Office; Clinical Trials Office

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: SBI of Healthcare Leningrad Regional Oncology Dispensary

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: LLC Medical and Sanitary Unit "Clinician"

location_facility: Severance Hospital, Yonsei University Health System

location_facility: SBIH Kaluga Region Clinical Oncology Dispensary

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Oncology Dispensary#1; Out-Patient Oncology Dept

location_facility: Sahyadri Super Specialty Hospital Hadapsar

location_facility: Joe Arrington Cancer Research & Treatment Center

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Klinikum Ernst von Bergmann; Frauenklinik

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp

location_facility: Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie

location_facility: Princess Alexandra Hospital; Cancer Trials Unit

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF

location_facility: The Affiliated Hospital of Medical College Qingdao University

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Medical Park Seyhan Hospital; Oncology Department

location_facility: Filantropia Clinical Hospital; Medical oncology

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center

location_facility: Max Super Speciality Hospital; Medical Oncology

location_facility: Hospital de Jerez de la Frontera; Servicio de Oncologia

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

location_facility: Municipal Institution Kirovograd Regional Oncology Dispensary

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Medical Center "Nadezhda Clinical" EOOD; Medical Oncology Department

location_facility: Katip Celebi University Ataturk Training and Research Hospital; Oncology

location_facility: Rajiv Gandhi Cancer Institute & Research Center

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Metropolitan Hospital; 2Nd Oncology Clinic

location_facility: Nizhny Novgorod Regional Clinical Oncology Center

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

location_facility: Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Mackay Memorial Hospital; Dept of Surgery

location_facility: Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie

location_facility: Manipal Hospital; Department of Oncology

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona

location_facility: UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

location_facility: Hospital Universitario Clínico San Cecilio; Servicio de oncologia

location_facility: Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen

location_facility: Hematology Oncology Associates of Fredericksburg, Inc.

location_facility: Hospital Alvaro Cunqueiro; Servicio de Oncologia

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Songklanagarind Hospital; Department of Surgery

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology

location_facility: MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department

location_facility: Virginia Oncology Associates - Virginia Beach

location_facility: Antalya Training and Research Hospital ; Oncology Department

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

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

location_facility: Velindre Cancer Centre; Clinical Trials Unit

location_facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

location_facility: Hemato Oncology Clinic Ahmedabad Pvt Ltd

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

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

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

location_facility: Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: Guangdong Provincial People's Hospital; Breast

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

location_facility: Greater Baltimore Med Ctr; Dept Berman Cancer Institute

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

location_facility: Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy

location_facility: Städtische Klinik Lüneburg; Frauenklinik

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

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: COC Plovdiv; First Medical Oncology Department

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: China Medical University Hospital; Surgery

location_facility: Bradford Royal Infirmary; Oncology Department

location_facility: Kyungpook National University Medical Center

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: University of Eastern Piedmont - Maggiore della Carità University Hospital

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

location_facility: Srinagarind Hospital; Department of Surgery

location_facility: Prof.dr. Alexandru Trestioreanu, The Oncology Institute; Medical oncology I

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: Hospital Clinic Barcelona; Servicio de oncologia

location_facility: Medeniyet University Goztepe Training and Research Hospital.

location_facility: California Cancer Associate for Research & Excellence

location_facility: Seoul National University Bundang Hospital

location_facility: Hochtaunus-Kliniken gGmbH; Krankenhaus Bad Homburg; Frauenklinik

location_facility: AKH - Medizinische Universität Wien; Department of Oncology

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: HOPITAL RENE HUGUENIN, Institut Curie; Service d'Oncologie Médicale.

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: University General Hospital of Heraklion

location_facility: ASU FC S. M. DELLA MISERICORDIA; Oncologia

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR

location_facility: Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol

location_facility: Republican Clinical Oncological Dispensary of the Ministry of Healthcare; Chemotherapy department

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Taipei Veterans General Hospital; Department of Clinical Trial Pharmacy

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Thailand
Turkey
Czechia
France
Portugal
Hungary
Hong Kong
Denmark
United States
Kenya
Ukraine
Uganda
India
Romania
Belgium
China
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation


title: A Pivotal Phase II Randomised, Multi-centre, Open-label Study to Evaluate the Efficacy and Safety of MB-CART2019.1 Compared to SoC Therapy in Participants With r/r DLBCL, Who Are Not Eligible for HDC and ASCT

acronym: DALY 2-EU

summary: This is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.

lead_sponsor: Miltenyi Biomedicine GmbH

sponsor_collaborators:
Miltenyi Biomedicine GmbH
ICON plc

location_country: Germany Italy Lithuania Poland Hungary Sweden Netherlands Austria Belgium Spain Turkey Czechia France

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

location_facility: Klinikum der Universitat München, Studienzentrale fur Hematologie der Medizinischen Klinik II

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Centre Hospitalier Universitaire de Montpellier - Hopital Saint-Eloi

location_facility: IRCCS - Azienda Ospedaliera Universitaria - IST San Martino

location_facility: Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu

location_facility: Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)

location_facility: Amsterdam Universitaire Medische Centra (UMC) - locatie Amsterdam Medisch Centrum (AMC)

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Institut Universitaire du Cancer Service d´hématologie

location_facility: Centre Hospitalier Lyon Sud, Hospices Civils de Lyon Groupement Hospitalier Sud

location_facility: Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

location_facility: Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu. Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

location_facility: Hospital Universitario Virgen De La Arrixaca (Huva)

location_facility: Catalan Institute of Oncology (ICO) Hospitalet

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Universite Catholique de Louvain Namur, Centre Hospitalier Universitaire Dinant Godinne Site Godinne

location_facility: Dolnoslakie Centrum Onkologii,pulmonologii i hematologii

location_facility: Klinikum Erlangen der Friedrich-Alexander-Universitaet Erlangen-Nuernberg

location_facility: Azienda Ospedaliera San Giovanni Battista Di Torino

location_facility: Universitatsklinikum Innsbruck Universitatsklinik fur Innere Medizin V

location_facility: Universitaetsklinikum Knappschaftskrankenhaus Bochum der Ruhr-Universitat Bochum

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque

location_facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: LKH - Universitaetsklinikum der PMU Salzburg

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego w Poznaniu

location_facility: Del-Pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Ist Dept Medicine, 1st Fac Medicine, Charles University, General Hospital


title: A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia

summary: The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).

location_country:
Germany
Italy
United Kingdom
Hong Kong
Denmark
Australia
Japan
Sweden
Austria
Belgium
Switzerland
United States
Spain
Canada
France

location_facility: Universitatsklinikum Carl Gustav Carus Dresden an der Technische Universitat Dresden, Medizinische Klinik und Poliklinik 1, Bereich Hamatologie

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: SC Ematologia, Azienda Ospedaliera di Perugia - Santa Maria della Misericordia

location_facility: Universitätsklinikum Düsseldorf -Klinik für Hämatologie, Onkologie und Klinische Immunologie

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

location_facility: SCDU Ematologia e Terrapie cellulari AO O Ordine Mauriziano Torino

location_facility: Mayo Clinic Cancer Center Outpatient Pharmacy

location_facility: University of Oklahoma Health Sciences Center - OU Health Stephenson Cancer Center

location_facility: Universitatsspital Basel - Klinik fur Hamatrologie, Bereich Innere Medizin

location_facility: Azienda Ospedaliero Universitaria delle Marche

location_facility: Westmead Hospital / Department of Haematology and Bone Marrow Transplantation

location_facility: Kobe City Medical Center General Hospital

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Inselspital, Universitatsspital Bern - Universitatsklinik fur Medizinisch Onkologie

location_facility: Oxford University Hospital NHS Foundation Trust

location_facility: Complejo Hospitalario San Pedro de Alcantara

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen, Klinik und Poliklinik fur Innere Medizin III

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: CIUSSS de L'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont

location_facility: The Ohio State University Wexner Medical Center/ James Cancer Hospital

location_facility: Hospital of the University of Occupational and Environmental Health, Japan

location_facility: Hospital Universitari I Politècnic La Fe

location_facility: The University of Chicago Medical Centre

location_facility: Dept. of Hematology, Oncology and Tumor Immunology, Charite- University Medicine Berlin, Campus Virchow Klinikum

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: United Lincolnshire Hospitals NHS Trust, Pilgrim Hospital, Sibsey Road

location_facility: Univ. -Klinik für Hämatologie und Internistische Onkologie, Kepler Universitätskilkun GmbHMed

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Uniklinikum Salzburg, Universitatsklinik f. Innere Medizin III der PMU

location_facility: Clinica Universidad de Navarra - Pamplona (Main Site)

location_facility: Uniklinik RWTH Aachen, Medizinische Klunuk IV - Klinik fur Hamatologie, Onkologie, Hamastaseologie und Srammzelltransplantation

location_facility: Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Innere Medizin III

location_facility: Hospital Regional Universitario de Malaga

location_facility: Cambridge University Hospital NHS Foundation Trust

location_facility: Huntsman Cancer Institute ,The University of Utah

location_facility: Complejo Asistencial Universitario de Burgos/H.U. de Burgos

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

location_facility: Department of Hematology and Oncology, Braunschweig Community Hospital

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization

location_facility: Hospital General Universitario de Alicante

location_facility: Dept. of Medicine II, University Hospital Hamburg-Eppendorf

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli U.O.S.C. di Ematologia con Trapianto di Midollo Osseo

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende AV

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola-Malphigi U.O Ematologia

location_facility: ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

location_facility: LMU - Klinikum der Universitat Munchen, Medizinische Klinik und Poliklinik III, Campus Grosshadern

location_facility: AORM - AO Riuniti Marche Norde - Pesaro Presidio "San Salvatore" - Muraglia

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRS - Oncologia Medica

location_facility: Cardiff and Vale University Health Board

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Clinico Universitario de Valencia

location_facility: SSM Health Saint Louis University Hospital

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: UNC Hospitals, The University of North Carolina at Chapel Hill

location_facility: Froedtert Hospital / Medical College of Wisconsin

location_facility: Complejo Asistencial Universitario de Salamanca - Hsopital Clinico

location_facility: Universitatsklinikum Heidelberg, Innere Medizin V, Hamatologie, Onkologie und Rheumatologie

location_facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

location_facility: Klinikum Ludwigshafen Medizinische Klinik A

location_facility: Baylor College of Medicine Medical Center

location_facility: Andrew Love Cancer Centre, University Hospital Geelong

location_facility: MidAmerica Division, Inc., c/o Research Medical Center

location_facility: Prince of Wales Hospital, The Chinese University of Hong Kong


title: A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE Plus)

summary:
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease.

Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance.

The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken.

Participants must have a study partner, who is willing to take part in the study.

Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.

A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Croatia
Czechia
Canada
Serbia
France
Slovenia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
China
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Phase III, Open-Label, Randomized Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

summary: This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Finland
Germany
Japan
Brazil
Costa Rica
Thailand
Turkey
Croatia
Chile
Canada
France
Slovenia
Switzerland
Belgium
China
Malaysia
Estonia
Philippines
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Adana Ac?badem Hospital Oncology Department

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

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

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Pontificia Universidad Catolica de Chile; Clinica San Carlos de Apoquindo

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Churchill Hospital; Department of Oncology

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: CHU Grenoble Sud; Service hépato-gastroentérologie

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hepatologia

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Fondazione Pascale; U.O. Sperimentazioni Cliniche

location_facility: Freeman Hospital; Gastroenterology & Liver Unit

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Centre Eugene Marquis; Service d'oncologie; Direction de la Recherche Clinique

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: North Estonia Medical Centre, Oncology and hematology Clinic; Department of Chemotherapy

location_facility: Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I

location_facility: A.O. S. Orsola Malpighi; Ambulatorio Epatocarcinoma (Bolondi)

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology

location_facility: I.M.Sechenov First Moscow State Medical University (1st MSMU)

location_facility: Beacon International Specialist Centre; Clinical Research Department, Level 2

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Medipol Mega Üniversite Hastanesi Göztepe

location_facility: Shengjing Hospital of China Medical University

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin?

location_facility: SHATOD Dr. Marko Antonov Markov-Varna, EOOD; Department of Medicinall Onchotherapy and Palliative

location_facility: Klinikum Esslingen; Allg. Innere Med., Onkologie, Hämatologie, Gastroenterologie und Infektiologie

location_facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

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

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Hepatologia

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Inselspital Bern Medizin Gastroenterologie

location_facility: TAYS Radius rakennus; onkologinen lääketutkimusyksikkö

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Hospital Clinico de La Universidad de Chile J.J.A.; Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Aparato Digestivo

location_facility: A.O.U. Policlinico Paolo Giaccone; Gastroenterologia ed Epatologia

location_facility: Anticancer Hospital of Thessaloniki " Theagenio"

location_facility: Laiko General Hospital Athen; Uni Clinic of Gastrenterology

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Clinica Universitaria de Navarra; Servicio de Hepatologia

location_facility: Cebu Doctors' University Hospital; Research Office

location_facility: CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie

location_facility: Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

location_facility: National Taiwan University Hospital; Oncology

location_facility: Complex Oncological Center - Plovdiv, EOOD; Second Internal Department

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: The Fifth Medical Center of People's Liberation Army General Hospital

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

location_facility: West China Hospital - Sichuan University

location_facility: Sourasky Medical Center; Oncology Department

location_facility: Queen Elizabeth Hospital; Hepatobiliary Unit

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Medizinische Universität Innsbruck; Universitätsklinik für Innere Medizin I

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

location_facility: Agioi Anargiroi Hospital of Kifissia; University Internal Medicine Clinic

location_facility: Sociedade beneficente de senhoras Hospital Sirio Libanes

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: Uni Malaya Medical Center; Clinical Oncology Unit, Menara Timur

location_facility: Hospital Universitario Reina Sofia; Servicio de Hepatologia

location_facility: King College Hospital NHS Foundation Trust

location_facility: Med. Hochschule Hannover; Gastroenterologie

location_facility: University Medical Center Ljubljana; Clinical Dept. of Gastroenterology

location_facility: Klinik Favoriten; Abteilung für Chirurgie

location_facility: Universitätsklinikum St. Pölten; Innere Medizin 2

location_facility: MHAT Sveta Sofia; Department of medical oncology

location_facility: Hippokratio Hospital; 4Th Internal Medicine Dpt

location_facility: Hopital Paul Brousse; Centre Hepatologie Biliaire

location_facility: Hopitaux de Brabois - Gastro-Entereologie

location_facility: Universität Tübingen; Med. Klinik; Innere Medizin I

location_facility: Moscow City Oncology Hospital #62; Outpatient Care Center

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Universitätsspital Zürich Medizin Gastroenterologie; Klinik für Gastroenterologie und Hepatologie

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: Hammersmith Hospital; Clinical trials unit