type: Registry Identifier

title: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

summary: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

ipd_sharing: No

lead_sponsor: Gilead Sciences

sponsor_collaborators:
Gilead Sciences
Merck Sharp & Dohme LLC

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

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

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

location_facility: Hadassah - Hebrew University Medical Center

location_facility: Florida Cancer Specialists,1100 Goodlette Road

location_facility: Rutgers Cancer Institute of New Jersey,2575 Klockner Road

location_facility: Northwest Cancer Specialists, PC,210 SE 136th Avenue

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: SCRI - Florida Cancer Specialists - North Region R,403 S. Kings Ave.

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: Magee-Womens Hospital of UPMC,200 Oxford Drive

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

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

location_facility: University of Miami - Sylvester Comprehensive Cancer Center,1192 East Newport Center Drive

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: Hôpital Morvan, Institut de cancérologie

location_facility: Virginia Oncology Associates,1051 Loftis Blvd Suite 100

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

location_facility: Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

location_facility: Magee-Womens Hospital of UPMC,200 Village Drive

location_facility: James Lind Centro de Investigacion del Cancer

location_facility: SCRI - Florida Cancer Specialists - North Region R

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

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

location_facility: Sainte Catherine Institut du Cancer Avignon Provence

location_facility: Perlmutter Cancer Center - Manhattan - 34th Street,259 First Street

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

location_facility: Magee-Womens Hospital of UPMC,400 Oxford Drive

location_facility: Comprehensive Cancer Centers of Nevada - Central V,2460 W. Horizon Ridge Parkway

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

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

location_facility: University of Pennsylvania Abramson Cancer Center

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

location_facility: Virginia Cancer Institute,7501 Right Flank Road

location_facility: Hospital de Clinicas de Porto Alegre - HCPA

location_facility: SCRI - Florida Cancer Specialists - North Region R,521 North Lecanto Highway

location_facility: University of Miami - Sylvester Comprehensive Cancer Center

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

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

location_facility: Comprehensive Cancer Centers of Nevada - Central V,10001 S. Eastern Avenue, Suite 108

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia - Hospital Beneficencia Portuguesa (BP) - Unidade Paulista

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

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

location_facility: Universitätsklinikum Schleswig-Holstein Institut fur Klinische Chermie

location_facility: St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare

location_facility: Comprehensive Cancer Centers of Nevada - Central V,9280 W. Sunset Road Suite 100

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

location_facility: Northwest Cancer Specialists, PC,265 N. Broadway

location_facility: SCRI - Florida Cancer Specialists - North Region R,460 N Orlando Ave

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

location_facility: Centro Ricerca Fase I, Fondazione IRCSS San Gerado dei Tintori

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: SCRI - Florida Cancer Specialists - West Palm Beach

location_facility: Tennessee Oncology, PLLC,5653 First Blvd.

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: Centro de Pesquisa Clinica Em Oncologia - ONCOSITE

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

location_facility: The West Clinic, PLLC dba West Cancer Center

location_facility: SCRI - Florida Cancer Specialists - North Region R,1400 US Highway 441 N

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

location_facility: Perlmutter Cancer Center - Manhattan - 34th Street

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

location_facility: University of Miami - Sylvester Comprehensive Cancer Center,3850 Hollywood Blvd

location_facility: New York Cancer & Blood Specialists - Port Jeffers

location_facility: iBiomed - Investigacion Biomedica para el Desarrol

location_facility: Magee-Womens Hospital of UPMC,9100 Babcock Boulevard

location_facility: Florida Cancer Specialists,3630 Manatee Avenue West

location_facility: Hospital Araújo Jorge - Associacao de Combate ao Cancer em Goias - ACCG

location_facility: Genesis Cancer and Blood Institute,1456 Higdon Ferry Road Suite B.

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

location_facility: Montefiore Medical Center - Montefiore Medical Park

location_facility: Nationales Centrum für Tumorerkrankungen

location_facility: Fakultní Nemocnice Královské Vinohrady, Radioterapeuticka a onkologicka klinika

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: University of Miami - Sylvester Comprehensive Cancer Center,5555 Ponce De Leon Blvd

location_facility: Associacao Hosptialar Moinos de Vento - Hospital Moinhos de Vento

location_facility: Tennessee Oncology, PLLC,120 Frank Martin Road

location_facility: Icaro Investigaciones en Medicina S.A. de C.V.

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

location_facility: Magee-Womens Hospital of UPMC,3 St. Francis Way

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

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

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Centro Universitário FMABC

location_facility: Rocky Mountain Cancer Centers,8820 Huron Street

location_facility: Norton Cancer Institute - Saint Matthews

location_facility: Comprehensive Cancer Centers of Nevada - Central V,1501 Wigwam Parkway, Suite 1300

location_facility: Huntsman Cancer Institute, University of Utah,5126 West Daybreak Parkway

location_facility: Virginia Cancer Institute,210 Medical Park Boulevard

location_facility: SCRI - Florida Cancer Specialists - North Region R,9320 State Road 54

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern

location_facility: Florida Cancer Specialists,22395 Edgewater Drive

location_facility: Centre de Lutte contre le Cancer - François Bacles

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

location_facility: Northside Hospital,1505 Northside Blvd, Suite 4600

location_facility: Centro para el Desarrollo de la Medicina

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

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

location_facility: Huntsman Cancer Institute, University of Utah,165 North University Avenue

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: Virginia Oncology Associates,744 N. Battlefield Blvd

location_facility: Advent Health Medical Group,2501 North Orange Ave

location_facility: SCRI - Florida Cancer Specialists - North Region R,7154 Medical Center Drive

location_facility: CAIPO Centro Para La Atención Integral Del Pacient

location_facility: Petz Aladár Egyetemi Oktató Kórház - Gy?r

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

location_facility: Virginia Cancer Institute,1401 Johnston-Willis Drive

location_facility: University of Miami - Sylvester Comprehensive Cancer Center,2801 NE 213th St

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: The Ohio State University Wexner Medical Center Clinical Laboratories

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

location_facility: University of California Irvine Health Chao Family

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

location_facility: Florida Cancer Specialists,1970 Golf Street

location_facility: S.O.C Oncologia Medica, Nuovo Ospedale di Prato Santo Stefano

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

location_facility: Regional Cancer Care Associates - East Brunswick

location_facility: Regional Cancer Care Associates - East Brunswick,34-36 Progress Street

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: Huntsman Cancer Institute, University of Utah,1280 E. Stringham Avenue

location_facility: Universitätsklinikum Erlangen, Frauen klinik

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

location_facility: Regional Cancer Care Associates - East Brunswick,75 Veronica Avenue

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

location_facility: Trakya Universitesi Tip Fakultesi Hastanesi

location_facility: Eastern Connecticut Hematology and Oncology Associates

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

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

location_facility: Northwest Cancer Specialists, PC,5050 NE Hoyt St.

location_facility: SCRI - Florida Cancer Specialists - North Region R,1201 Fifth Avenue North

location_facility: University of California Irvine Health Chao Family,1640 Newport Blvd

location_facility: Kantonsspital Baselland - Standort Liestal

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

location_facility: Comprehensive Cancer Centers of Nevada - Central V,653 North Town Center Drive, Suite 402

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: University of Miami - Sylvester Comprehensive Cancer Center,1400 NW 12th Ave

location_facility: Winship Cancer Institute of Emory University,550 Peachtree St NE

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: Comprehensive Cancer Centers of Nevada - Central V,7445 Peak Drive

location_facility: Klinik Frauenheilkunde, Uniklinik ClO, Studienzentrale

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

location_facility: Praxis für interdisziplinäre Onkologie & Hämatolog

location_facility: SCRI - Florida Cancer Specialists - North Region R,3280 McMullen Booth Road

location_facility: EV. Krankenhaus Bethesda - Johanniter GmbH, Station 1 Brustzentrum Niederrhein

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

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: Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway

location_facility: Nebraska Cancer Specialists,8303 Dodge Street

location_facility: Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho - Hospital Amarval Carvalho

location_facility: Torrance Memorial Physician Network - Cancer Care

location_facility: Kliniken Essen-Mitte - Evangelische Huyssens-Stift

location_facility: Nebraska Cancer Specialists,2730 W. Faidley Ave

location_facility: SCRI - Florida Cancer Specialists - North Region R,70 W. Gore Street

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

location_facility: Hospital General Universitario Gregorio Marañón

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

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: Texas Oncology-Austin,901 West 38th Street

location_facility: Department of Medicine, Queen Mary Hospital

location_facility: Huntsman Cancer Institute, University of Utah

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Florida Cancer Specialists,8260 Gladiolus Dr

location_facility: Centre Hospitalier Universitaire Université Cathol

location_facility: Rocky Mountain Cancer Centers,1700 South Potomac Street

location_facility: Princess Margaret Cancer Centre - University Health Network

location_facility: Narodowy Instytut Onkologii im.Marii Marii Sklodowskiejs

location_facility: SCRI - Florida Cancer Specialists - North Region R,750 Orienta Ave

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Fondazione IRCCS - Istituto Nazionale dei Tumori

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

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

location_facility: Tennessee Oncology, PLLC,103 Natchez Park Drive

location_facility: Regional Cancer Care Associates - East Brunswick,9 Centre Drive

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

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

location_facility: University of Miami - Sylvester Comprehensive Cancer Center,8100 SW 10 Street

location_facility: Winship Cancer Institute of Emory University,5665 Peachtree Dunwoody Road

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

location_facility: Tennessee Oncology, PLLC,4220 Harding Rd

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Texas Oncology-Austin,4101 James Casey, Suite 100

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

location_facility: Ascension Providence Hospital Southfield Cancer Center

location_facility: Sheba Medical Center Hospital - Tel Hashomer

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Panamerican Clinical Research Mexico - Guadalajara

location_facility: SCRI - Florida Cancer Specialists - North Region R,4100 Waterman Way

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: Grand River Regional Cancer Centre at Grand River Hospital

location_facility: Fundacion CORI para la Investigacioy y Prevención del Cancer

location_facility: University of California San Diego Moores Cancer

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: Clinical Trials Unit Lvl 0 Cancer Research UK Beatson Institute

location_facility: University of Texas MD Anderson Cancer Center,1155 Pressler St

location_facility: SCRI - Florida Cancer Specialists - North Region R,2824 Enterprise Rd

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

location_facility: Rhode Island Hospital,164 Summit Ave, Fain 275A

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Winship Cancer Institute of Emory University

location_facility: SCRI - Florida Cancer Specialists - North Region R,6420 W. Newberry Road

location_facility: University of Miami - Sylvester Comprehensive Cancer Center,8932 S.W. 97 Ave

location_facility: Florida Cancer Specialists,836 Sunset Lake Blvd

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

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Magee-Womens Hospital of UPMC,100 Fairfield Dr

location_facility: Piedmont Cancer Institute - Atlanta,775 Poplar Road

location_facility: The Center for Cancer and Blood Disorders - Magnolia

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

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

location_facility: Comprehensive Cancer Centers of Nevada - Central V

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: Tennessee Oncology, PLLC,1840 Medical Center Parkway

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

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: Regulatory Management Only: TRIO-US Central Administration

location_facility: SCRI - Florida Cancer Specialists - North Region R,4945 SW 49th Place

location_facility: Taipei Medical University-Shuang Ho Hospital

location_facility: Summit Medical Group,1 Diamond Hill Road

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

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: Magee-Womens Hospital of UPMC,470 Johnson Road

location_facility: Osaka Prefectural Hospital Organization Osaka International Cancer Institute

location_facility: Masarykuv Onkologicky Ustav, Klinika Komplexni Onkologicke Pece

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Vseobecna Fakultni Nemocnice v Praze, Onkologicka klinika

location_facility: Tennessee Oncology, PLLC,397 Wallace Road

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

location_facility: : Gynakologisches Zentrum Bonn, Schwerpunkt Gyn. Onkologie,

location_facility: IRCCS Istituto Tumori "Giovanni Paolo 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: Universitatsklinikum Mannheim GmBH, Frauenklinik

location_facility: Hospices Civils de Lyon, Hôpital Lyon Sud

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: Centro de Cancer Pontificia Universidad Catolica

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: UO Oncologia, ASST degli Spedali Civili di Brescia

location_facility: SCRI - Florida Cancer Specialists - North Region R,100 Highland Avenue

location_facility: Mater Misericordiae Limited and Mater Research Limited

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


title: A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease

summary:
The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold:

Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD
Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Basic Science

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: Amgen

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

location_facility: Tianjin Medical University General Hospital

location_facility: Instituto de Cardiologia do Rio Grande do Sul

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

location_facility: Hyogo Prefectural Harima-Himeji General Medical Center

location_facility: Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Hospital Universitario Maria Aparecida Pedrossian

location_facility: The First Affiliated Hospital of Xinjiang Medical University

location_facility: Hospital das Clinicas da Universidade Federal de Goias

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

location_facility: Kardiologijos ir reabilitacijos klinika, UAB

location_facility: Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi

location_facility: The Second Affiliated Hospital of Nanjing Medical University

location_facility: The Sakakibara Heart Institute of Okayama

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

location_facility: Samodzielny Publiczny Szpital Wojewodzki im Papieza Jana Pawla II w Zamosciu

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

location_facility: CIPREC - Centro de Investigacion y Prevencion Cardiovascular

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Highlands Clinical Research Facility, Raigmore Hospital

location_facility: Ziekenhuis Oost-Limburg - Campus Sint-Jan

location_facility: Kawaguchi Cardiovascular and Respiratory Hospital

location_facility: Northern Light Eastern Maine Medical Center

location_facility: Afyonkarahisar Saglik Bilimleri Universitesi Hastanesi

location_facility: Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre

location_facility: NIHR Patient Recruitment Centre Bradford

location_facility: American heart of poland spolka skcyjna polsko amerykanskie kliniki serca

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

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Dr Nagy Laszlo Kardiologiai maganrendeles es SMO

location_facility: Azienda Ospedaliera Sant Anna e San Sebastiano

location_facility: CMI Cardiologie - Dr. Mercea Corina Delia

location_facility: The First Affiliated Hospital of Xiamen University

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

location_facility: Adnan Menderes Universitesi Medical Faculty

location_facility: Kardio Vaclavik sro, Interni a kardiologicka ambulance

location_facility: China-Japan Union Hospital of Jilin University

location_facility: IBPClin Instituto Brasil de Pesquisa Clinica

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

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: Del-budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz

location_facility: Procliniq Investigación Clínica Sa de Cv

location_facility: Instituto de Investigaciones Clinicas Zarate

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

location_facility: Centro de Especialidades Medicas - Cemedic

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Novant Health Heart and Vascular Institute

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Krankenhaus der Barmherzigen Brueder Linz

location_facility: Onze Lieve Vrouw Ziekenhuis - campus Aalst

location_facility: The Second Affiliated Hospital to Nanchang University

location_facility: General Hospital of Ningxia Medical University

location_facility: The Peoples Hospital of Guangxi Zhuang Autonomous Region

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Dr Lakatos Ferenc Private Cardiology Practice

location_facility: Northeast Georgia Medical Center Wisteria Building

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Center for Clinical and Basic Research Tallinn

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: FZ Pesquisa e Servicos em Cardiologia LTDA

location_facility: Universitaetsmedizin Goettingen - Georg-August-Universitaet

location_facility: Dr Siyami Ersek Gogus Kalp ve Damar Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Oslo Universitetssykehus HF Aker sykehus

location_facility: South Texas Cardiovascular Consultants PLLC

location_facility: Cliniques universitaires de Bruxelles Hopital Erasme

location_facility: London Health Sciences Centre, University Hospital

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: National Hospital Organization Shizuoka Medical Center

location_facility: East Coast Institute for Research LLC at Northeast Florida Endocrine and Diabetes Research Associate

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: ICBA - Instituto Cardiovascular de Buenos Aires

location_facility: Centre Hospitalier Universitaire de Montpellier - Hopital Lapeyronie

location_facility: Associacao de Amparo a Saude Ensino e Pesquisa

location_facility: The First Affiliated Hospital of Wenzhou Medical University

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

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures

location_facility: Kocaeli Universitesi Tip Fakultesi Hastanesi

location_facility: Wojewodzki Specjalistyczny Szpital im dr Wladyslawa Bieganskiego w Lodzi

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi

location_facility: Instituto de Ensino e Pesquisa do Hospital da Bahia

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

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Kardiologicke centrum MUDr Janky Skrobakove sro

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: The Cardiac and Vascular Institute Research

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Hospital Clinico Universitario de Valencia

location_facility: NIHR Patient Recruitment Centre Newcastle

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Kartal Kosuyolu Yuksek Ihtisas Egitim ve Arastirma Hastanesi

location_facility: Niigata University Medical and Dental Hospital

location_facility: Centro Medico Dra LAURA MAFFEI e Investigacion clinica aplicada

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Metropolitan Cardiovascular Consultants LLC

location_facility: Nucleo de Pesquisa Clinica do Rio Grande do Sul

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

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

location_facility: Universitaets-Herzzentrum Freiburg - Bad Krozingen

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

location_facility: Millennium Physician Group, LLC dba Charlotte Heart Group Research Center

location_facility: Fundacion Cardiovascular de Aguascalientes AC

location_facility: Tennova Healthcare-Turkey Creek Medical Center

location_facility: Institut de recherches cliniques de Montreal

location_facility: Kardiologische Praxis Doktor Jens Taggeselle

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi

location_facility: Cinme - Centro de Investigaciones Metabolicas

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

location_facility: Cardiovascular Research of Northwest Indiana LLC

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

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

location_facility: Multiprofile Hospital for Active Treatment - Haskovo AD

location_facility: Vilnius University Hospital Santaros Clinic Public Institution

location_facility: Otto von Guericke Universitaet Magdeburg

location_facility: Advanced Research for Health Improvement, LLC

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

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Clinique des Maladies Lipidiques de Quebec Incorporated

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: LMC Clinical Research Incorporated Thornhill

location_facility: University Hospitals Cleveland Medical Center

location_facility: Instituto de Pesquisa em Endocrinologia Clinica IPEC

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna

location_facility: Charite - Universitaetsmedizin Berlin, Campus Virchow

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: New York Presbyterian Medical Group Hudson Valley Cardiology

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Spitalul Clinic Universitar de Urgenta Elias

location_facility: B Braun Ambulantes Herzzentrum Kassel mvz GmbH

location_facility: Instituto de Investigaciones Clinicas de Cordoba

location_facility: Hornicka nemocnice s poliklinikou spol sro

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Universitaetsklinikum der Ruhr-Universitaet Bochum

location_facility: Tidewater Physicians Multispecialty Group Clinical Research

location_facility: Saint Johns Center for Clinical Research

location_facility: Multiprofile Hospital for Active Treatment Puls AD

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

location_facility: Japan Community Health care Organization Kyushu Hospital

location_facility: Diagnostic-Consultative Center Ascendent OOD

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

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Diabetologische Gemeinschaftspraxis Dr Schaper und Dr Faulmann

location_facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur

location_facility: Cardiology Associates of Fairfield County PC

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

location_facility: Azienda Ospedaliera Universitaria Maggiore della Carita

location_facility: NIHR Patient Recruitment Centre Leicester

location_facility: Clinical Best Solutions Sp zoo Spolka Komandytowa Gabinet Lekarski

location_facility: Narodny ustav srdcovych a cievnych chorob, as

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Grandview Medical Center Affinity Cardiovascular Specialists, LLC

location_facility: Centro de Investigaciones Clinicas del Litoral

location_facility: Centro Hospitalar e Universitario de Coimbra EPE

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

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Shanghai Yangpu District Central Hospital（ Yangpu Hospital Affiliated to Tongji University）

location_facility: Multiprofile Hospital for Active Treatment Heart and Brain EAD

location_facility: Eszak-Pesti Centrum Korhaz - Honvedkorhaz

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: NIHR Patient Recruitment Centre Blackpool

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

location_facility: Siauliai Republican Hospital, Public Institution

location_facility: Instituto Latinoamericano de Investigaciones Medicas CIDIM-ILAIM

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: Jacksonville Center for Clinical Research

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

location_facility: Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

location_facility: Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon

location_facility: Kobe City Medical Center General Hospital

location_facility: Instituto de Investigaciones Clinicas Rosario

location_facility: Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet

location_facility: Hospital de Sant Joan Despi Moises Broggi

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

location_facility: Universitaetsklinikum Dresden, Medizinische Klinik und Poliklinik III

location_facility: Konstantopoulio - Agia Olga Hospital of Nea Ionia

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Centro Paulista de Investigacoes Clinicas Cepic

location_facility: WMCHealth Heart and Vascular Institute Kingston Division of Cardiology

location_facility: Szpital Grochowski imienia Doktora medycyny Rafala Masztaka Spzoo

location_facility: Instituto de Pesquisa Clinica de Campinas

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

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

location_facility: Alaska Cardiovascular Research Foundation

location_facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau

location_facility: Hospital Professor Doutor Fernando Fonseca, EPE

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

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Futuremeds spolka z ograniczona odpowiedzialnoscia

location_facility: Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika

location_facility: Centre Hospitalier Universitaire de Dijon - Hopital Francois Mitterrand

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

location_facility: Seoul National University Bundang Hospital

location_facility: Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas

location_facility: Instituto de Investigaciones Clinicas de San Nicolas

location_facility: Jaroslaw Ciosek Rajtar-Medica Centrum Medyczne

location_facility: Ciad - Consultorio Integral de Atencion al Diabetico

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: MUDr Zbynek Kosek, kardiologicka ambulance sro

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi

location_facility: Johns Hopkins University School of Medicine

location_facility: Hamilton Health Sciences Hamilton General Hospital

location_facility: Azienda Ospedaliera Universitaria Renato Dulbecco

location_facility: The Second Xiangya Hospital of Central South University

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

location_facility: Oslo Universitetssykehus HF, Aker sykehus

location_facility: Yonsei University Wonju Severance Christian Hospital

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

location_facility: Renown Institute for Heart and Vascular Health

location_facility: MUDr Ladislava Harrerova, kardiologicka ordinace

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

location_facility: Loema Instituto de Pesquisa Clinica e Consultores Ltda

location_facility: The Peoples Hospital of Liaoning Province

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


intervention_type: Drug

lead_sponsor: Regeneron Pharmaceuticals

summary:
The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS)

The secondary objectives of the study are:

To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS)
To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab
To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component
To assess immunogenicity of fianlimab and cemiplimab
To assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults
To characterize safety and tolerability of treatment in patients 12 to <18 years of age
To characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age
To assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab
To characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years

location_facility: Hopital de la Miletrie Centre Hospitalier Universitaire de Poitiers

location_facility: INCA - Brazilian National Cancer Institute

location_facility: CH Le Mans - Plateforme de recherche clinique

location_facility: Fakultni nemocnice Kralovske Vinohrady, Dermatovenerologicka klinika

location_facility: JSC K. Eristavi National Center of Experimental and Clinical Surgery

location_facility: Centre Hospitalier Universitaire De Grenoble Alpes Service Dermatologie

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak

location_facility: U.O. Oncologia Medica Universitaria - Istituto Toscano Tumori Polo Oncologico

location_facility: Clinique Sainte Anne/Strasbourg Oncologie Liberale

location_facility: Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB) St Josef Hospital

location_facility: Barwon Health Andrew Love Cancer Centre, University Hospital Geelong

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

location_facility: Centro Avancado de Tratamento Oncologico (CENANTRON)

location_facility: University Health Network, Princess Margaret Cancer Centre

location_facility: Helios Klinikum Erfurt Klinik fur Hautkrankheiten und Allergologie

location_facility: Istituto Dermopatico Dell'Immacolata Irccs

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

location_facility: Hopital Avicenne Service de Dermatologie du Pr Caux

location_facility: Animi Unidade de Tratamento Oncologico Ltda

location_facility: Universidad Mayor - Centro Oncologia de Precision

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

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

location_facility: Israeli Georgian medical research clinic Helsicore

location_facility: Fundacao PIO XII - Hospital de Amor Amazonia

location_facility: Centro Estatal de Cancerologia de Chihuahua

location_facility: Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii

location_facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

location_facility: Clinica de Neoplasias Litoral/atarina Pesquisa Clínica

location_facility: Centro Oncologico Antofagasta Bradford Hill Norte

location_facility: The Townsville Hospital and Health Service

location_facility: Instituto Joinvilense De Hematologia E Oncologia

location_facility: Instituto Peruano de Oncologia and Radioterapia

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Ospedale Policlinico San Martino - IRCCS

location_facility: Università della Campania Luigi Vanvitella

location_facility: Hospital Sao Vicente de Paulo (HSVP) Instituto do Cancer

location_facility: Fundacao Pio XII - Hospital de Amor de Barretos

location_facility: Centro integral Oncologico HM Clara Campal

location_facility: Royal Devon and Exeter Hospital NHS Trust

location_facility: Universitatsmedizin Gottingen Klinik fur Dermatologie

location_facility: Clinique et Maternite Sainte-Elisabeth (CMSE)

location_facility: Fundacion CENIT Centro Medico de Neurociencias

location_facility: Prof. Dr. Suleyman Yalcin Sehir Hospital

location_facility: Centro De Atencion E Investigacion Clinica En Oncologia Scp

location_facility: Hospital Regional Universitario de Malaga

location_facility: Fondazione IRCCS San Gerardo dei Tintori

location_facility: IRCCS Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale

location_facility: Atlantic Health System - Morristown Medical Center

location_facility: DIABAID - Instituto de Asistencia Integral en Diabetes

location_facility: Institut Gustave Roussy Cancer Center DITEP

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu

location_facility: IOV - Istituto Oncologico Veneto - IRCCS

location_facility: Centro De Estudios Y Prevencion Del Cancer A. C.

location_facility: INCLIVA-Instituto de Investigacion Sanitaria

location_facility: Hospital Universitario Central de Asturias

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck

location_facility: The Netherlands Cancer Institute (NKI) - Antoni van Leeuwenhoek Hospital

location_facility: The Angeles Clinic and Research Institute

location_facility: Universitatsklinikum Augsburg Klinik fur Dermatologie und Allergologie Campus Sud

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

location_facility: University Hospitals Seidmand Cancer Center

location_facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Ospedale Udine

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet

location_facility: Narodowego Instytutu Onkologii im Maria Sklodowska Curie

location_facility: Fondazione IRCSS Casa Sollievo Della Sofferenza

location_facility: Catalan Institute of Oncology (ICO) Hospitalet

location_facility: SCDU di Oncologia AOU Maggiore Della Carita

location_facility: Centro De Investigacion Clinica Bradford Hill

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Hospital de Clinicas de Porto Alegre (HCPA)

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Harzklinikum, Klinik fur Dermatologie und Allergologie

location_facility: Azienda Sanitaria Ospedaliera Santa Croce E Carle - Cuneo

location_facility: Oncosite Centro De Pesquisa Clinica Em Oncologia

title: A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

primary_purpose: Treatment

type: EudraCT Number

source: euctr

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

design_allocation: Randomized

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Hungary
United States
Romania
Belgium
Peru
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
South Africa
Georgia


title: A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

summary: This study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival of study participants, when overall survival is defined as the time from randomization until the date of death due to any cause.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Poland
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Hungary
United States
India
Belgium
China
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Israel


title: A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes

summary: This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.

status: Active, not recruiting

enrollment_type: Actual

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country: Germany Italy Poland Portugal Hungary Norway Sweden Netherlands Austria Belgium Switzerland Spain Czechia Canada France

location_facility: Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

location_facility: Universitair Ziekenhuis Antwerpen (UZA) - Antwerp University Hospital

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Centre Hospitalier Universitaire De Nantes - G. R. Laennec

location_facility: Klinik fur Kinder- und Jugendmedizin, Universitatsklinikum Munster

location_facility: National Koranyi Institute for TBC and Pulmonology

location_facility: University of Alberta Hospital, Edmonton Clinic

location_facility: Charite Paediatric Pulmonology Department

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie

location_facility: Azienda Ospedaliera Universitaria Federico II (Adults)

location_facility: Academisch Medisch Centrum (Academic Medical Centre)

location_facility: Instytut Matki i Dziecka, Klinika Mukowiscydozy IMiD, Oddział Chorób Płuc SZPZOZ im.Dzieci Warszawy w Dziekanowie Leśnym

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Azienda Ospedaliera di Verona - Ospedale Civile Maggiore

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Centre Hospitalier Universitaire De Reims, Hopital Sebastopol

location_facility: Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Oslo University Hospital, Department of Paediatric Medicine

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: UMCU, Locatie Wilhelmina Kinderziekenhuis

location_facility: Pediatric Hospital Polanki named of Maciej Płażyński

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen


title: A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

summary:
This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study.

The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.

Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

ipd_sharing_description:
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Slovenia
Portugal
Hungary
Denmark
Switzerland
United States
India
Belgium
China
Malaysia
Estonia
Puerto Rico
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
South Africa
Taiwan
Georgia
Israel

location_facility: Markusovszky University Teaching Hospital

location_facility: Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

location_facility: Tianjin Medical University General Hospital

location_facility: Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

location_facility: University Clinical Center of the Medical University of Warsaw

location_facility: Hospital of the University of Occupational and Environmental Health

location_facility: The Second Affiliated Hospital Zhejiang University School of Medicine

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Serviços Medicos Respirar Sul Fluminense

location_facility: Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.

location_facility: Instituto D´Or de Pesquisa e Ensino - Bahia

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

location_facility: University of Florida Health Shands Hospital

location_facility: Dr. Syed Anees Medicine Professional Corporation

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: University Hospital Bern/Inselspital Bern

location_facility: Hospital Golnik - Univ. Clinic of Pulmonary and Allergic Diseases

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Centro de Prevención y Rehabilitación de Enfermedades Pulmon

location_facility: General Hospital of Ningxia Medical University

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: National Center for Tuberculosis and Lung Diseases, Tbilisi

location_facility: University of Utah Health Sciences Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: The Second Xiangya Hospital Of Central South University

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: CEMER-Centro Medico De Enfermedades Respiratorias

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Second Affiliated Hospital of Xi'an JiaoTong University

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Affiliated Hospital, Xuzhou Medical college

location_facility: Medical University of Graz State Hospital - University Hospital Graz

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: Washington University School of Medicine

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Kobe City Hospital Organization Kobe City Medical Center West Hospital

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: The First Affiliated Hospital of Wenzhou Med College

location_facility: The Affiliated Hospital of Inner Mongolia Medical University

location_facility: University Clinical Center of Kragujevac

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: First Affiliated Hospital of Xi'an JiaoTong University

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: King Fahad Specialist Hospital - Research Center

location_facility: Koranyi National Institute For Pulmonolgy

location_facility: Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol

location_facility: Instituto Médico de la Fundación Estudios Clínicos

location_facility: The Chaim Sheba Medical Center Tel HaShomer

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: The First Affiliated Hospital of Ningbo University

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: Asociación Mexicana para la Investigacion Clínica, A.C(AMIC)

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Clinical Trials Center of Middle Tennessee, LLC

location_facility: Premier Pulmonary Critical Care and Sleep Medicine

location_facility: NewYork-Presbyterian/Weill Cornell Medical Center

location_facility: Hospital das Clinicas da Universidade Federal HC-UFMG

location_facility: Centro de Investigacion Integral MEDIVEST S.C

location_facility: King Faisal Specialist Hospital and Research Center

location_facility: Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks

location_facility: Kobe City Medical Center General Hospital

location_facility: The First Affiliated Hospital of Soochow University

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

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

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: General Hospital of Thessaloniki "Hippokrateio"

location_facility: Hospital General Universitario de Valencia

location_facility: Hospital de Braga - Centro Clínico Académico (2CA)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: First Affiliated Hospital of Guangzhou Medical University

location_facility: Hospital General Universitario de Alicante

location_facility: Seoul National University Bundang Hospital

location_facility: University of Alberta Hospital (University of Alberta)

location_facility: North Estonia Medical Centre Foundation, Tallinn

location_facility: King Abdullah International Medical Research Center

location_facility: Centro de Investigacion Farmacologica del Bajío, S.C.

location_facility: Oaxaca Site Management Organization, S.C.

location_facility: Dr. Georges-L.-Dumont University Hospital Centre


title: A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary:
This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF.

Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.

Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Croatia
Chile
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
China
Malaysia
Estonia
Puerto Rico
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Sweden

location_facility: Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

location_facility: Tianjin Medical University General Hospital

location_facility: The Second Affiliated Hospital Zhejiang University School of Medicine

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Serviços Medicos Respirar Sul Fluminense

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

location_facility: University of Florida Health Shands Hospital

location_facility: Dr. Syed Anees Medicine Professional Corporation

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Centro de Prevención y Rehabilitación de Enfermedades Pulmon

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: University of Utah Health Sciences Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: The Second Xiangya Hospital Of Central South University

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Second Affiliated Hospital of Xi'an JiaoTong University

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Affiliated Hospital, Xuzhou Medical college

location_facility: The University of Texas Health Science Center at Houston

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: Washington University School of Medicine

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Kobe City Hospital Organization Kobe City Medical Center West Hospital

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Koranyi National Institute For Pulmonolgy

location_facility: The First Affiliated Hospital of Ningbo University

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Clinical Trials Center of Middle Tennessee, LLC

location_facility: Premier Pulmonary Critical Care and Sleep Medicine

location_facility: Hospital das Clinicas da Universidade Federal HC-UFMG

location_facility: Centro de Investigacion Integral MEDIVEST S.C

location_facility: Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks

location_facility: Kobe City Medical Center General Hospital

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Minnesota Lung Center and Sleep Institute


title: A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation

summary: This study will evaluate the efficacy, pharmacodynamics (PD) and safety of ELX/TEZ/IVA in participants 6 years of age and older with a non-F508del ELX/TEZ/IVA-responsive cystic fibrosis transmembrane conductance regulator gene (CFTR) mutation.

status: Completed

study_completion_date_type: Actual

location_facility: Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

location_facility: Universitair Ziekenhuis Antwerpen (UZA) - Antwerp University Hospital

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Centre Hospitalier Universitaire De Nantes - G. R. Laennec

location_facility: Klinik fur Kinder- und Jugendmedizin, Universitatsklinikum Munster

location_facility: National Koranyi Institute for TBC and Pulmonology

location_facility: University of Alberta Hospital, Edmonton Clinic

location_facility: Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin (CF)

location_facility: Charite Paediatric Pulmonology Department

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie

location_facility: Azienda Ospedaliera Universitaria Federico II (Adults)

location_facility: Klinikum Innenstadt, University of Munich

location_facility: Academisch Medisch Centrum (Academic Medical Centre)

location_facility: Instytut Matki i Dziecka, Klinika Mukowiscydozy IMiD, Oddział Chorób Płuc SZPZOZ im.Dzieci Warszawy w Dziekanowie Leśnym

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Azienda Ospedaliera di Verona - Ospedale Civile Maggiore

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Universitätsklinikum Tübingen Klinik für Kinder- und Jugendmedizin

location_facility: Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

location_facility: Institute of Tuberculosis and Lung Diseases

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Centre Hospitalier Universitaire De Reims, Hopital Sebastopol

location_facility: Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo

location_facility: Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Oslo University Hospital, Department of Paediatric Medicine

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Pediatric Hospital Polanki named of Maciej Płażyński

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

status_simplified: Completed


title: Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group

acronym: COLUMBUS-AD

summary: The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).

ipd_sharing_description: Access to de-identified patient-level data in response to scientifically valid research proposals will be provided 30 days after CHMP opinion. All requests from qualified researchers for access to Columbus AD clinical data and information will be managed through a dedicated Pierre Fabre portal.

lead_sponsor: Pierre Fabre Medicament

collaborators: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Germany
Poland
Argentina
Australia
Brazil
Czechia
Canada
Serbia
France
Portugal
Hungary
Switzerland
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Greece
South Africa
Sweden

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

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

location_facility: Adelaide Oncology & Haematolog, Calvary North Adelaide Hospital

location_facility: IDI-Istituto Dermopatico dell'Immacolata IRCCS

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: CIUSSS du Centre Ouest de l'lle de Montreal

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

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Institute of Oncology and Radiology of Serbia

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

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: CHU de Grenoble - Hôpital André Michallon

location_facility: AMO - Assistência Multidisciplinar em Oncologia

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

location_facility: Hospital General Universitario de Valencia

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: Hospital Regional Universitario de Malaga

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

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

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

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

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

location_facility: Anticancer Hospital of Thessaloniki " Theagenio"

location_facility: Azienda Sanitaria Ospedaliera S.Croce e Carle

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie

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

location_facility: Centre Hospitalier de Pau - Hôpital François Mitterrand

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

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Landeskrankenhaus - Universitaetsklinikum Graz

location_facility: Azienda Sanitaria Universitaria Friuli Centrale

location_facility: Azienda Ospedaliero Universitaria Pisana


title: A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).

acronym: SAFFRON

summary: Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Chile
Canada
France
Hong Kong
Switzerland
United States
Belgium
China
Malaysia
Philippines
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel


type: Other Identifier

title: A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

acronym: DUET-UC

summary: The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
Taiwan
New Zealand
Australia
Brazil
Japan
Croatia
Chile
Czechia
Canada
France
Slovenia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Belgium
Estonia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Jordan
Bulgaria
Israel

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH

location_facility: University Hospital Alexandrovska - Clinic of Nephrology

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont

location_facility: GIRI Gastrointestinal Research Institute

location_facility: Gastroenterologische Spezialpraxis - Berlin-Karlshorst

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.

location_facility: Praxis fur Innere Medizin und Gastroenterologie

location_facility: Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio

location_facility: Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk

location_facility: Multriprofile Hospital for Active Treatment Hristo Botev

location_facility: University of Kentucky Chandler Medical Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Worthwhile Clinical Trials Lakeview Hospital

location_facility: Gastroenterology and Internal Medicine Research Institute (GIRI)

location_facility: Herlev Hospital, University of Copenhagen

location_facility: Japan Community Health Care Organization Osaka Hospital

location_facility: National Taiwan University Hospital, Division of Infectious Diseases

location_facility: The Hospital of Hyogo College of Medicine

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnia

location_facility: London Health Sciences Centre - University Campus

location_facility: Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd

location_facility: Toronto Immune & Digestive Health Institute Inc.

location_facility: Tokyo Medical and Dental University Hospital

location_facility: St George's University Hospital NHS Foundation Trust

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

location_facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska

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

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Irmandade da Santa Casa da Misericórdia de Santos

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

location_facility: Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato

location_facility: Centro Hospitalar de Lisboa Norte Hospital Santa Maria

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Közp.

location_facility: Centrum Zdrowia Matki, Dziecka i Młodzieży

location_facility: Gastroenterology Department ENDOMED, s.r.o.

location_facility: Sotiria General State Hospital of Chest Diseases

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale

location_facility: Charite - Universitaetsmedizin Berlin (CCM)

location_facility: Gastroenterology Clinic Of San Antonio P A

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Gastroenterologische Praxis Balsiger und Seibold

location_facility: University North Carolina at Chapel Hill

location_facility: Gastroenterolgy Associates of Central GA

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: National Hospital Organization Hirosaki General Medical Center

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: Oslo University Hospital HF Ullevål sykehus

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E

location_facility: Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele

location_facility: Great Lakes Gastroenterology Research, LLC


title: A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab vs. Dalteparin on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With GI/GU Associated VTE

acronym: MAGNOLIA

summary: This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)

lead_sponsor: Anthos Therapeutics, Inc.

sponsor_collaborators:
Anthos Therapeutics, Inc.
Itreas

location_country:
Germany
Ireland
Australia
Czechia
Canada
France
Hungary
Switzerland
United States
Latvia
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Sweden

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University of Miami Health System/Sylvester Comprehensive Cancer Center

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: National Cheng Kung University (NCKU) Hospital

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: Universit degli Studi di Perugia - Azienda Ospedaliera di Perugia

location_facility: Hospital Universitario Central de Asturia

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Onze Lieve Vrouwe Gasthuis, Locatie Oost

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

location_facility: University of Pennsylvania - Penn Blood Disorders Center

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Castle Hill Hospital, Department of Oncology & Haematology

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo

location_facility: University of Oklahoma Health Sciences Center

location_facility: Winship Cancer Institute of Emory University

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Hamilton Health Sciences, Juravinski Hospital and Cancer Centre

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: Complejo Hospitalario Universitario de Ourense

location_facility: Queen Elizabeth University Hospital Campus

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: Seoul National University Bundang Hospital

location_facility: Daegu Catholic University Medical Center

location_facility: CHU Clermont Ferrand - Hopital Gabriel Montpied

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS.

location_facility: CHU de Nancy - Hôpital de Brabois Adultes

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: Centre Hospitalier Intercommunal de Toulon

location_facility: SoonChunHyang University Hospital Bucheon

location_facility: Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: CHU de Rouen - Hôpital de Bois Guillaume

location_facility: Presidio Ospedaliero di Castelfranco Veneto

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Spaarne Gasthuis (Kennemer Gasthuis) - Haarlem-Zuid

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Yongin Severance Hospital, Yonsei University Health System


title: A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab Relative to Apixaban on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With Cancer Associated VTE

acronym: ASTER

summary: This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)

location_country:
Germany
Ireland
Australia
Japan
Czechia
Canada
France
Hungary
Switzerland
United States
Latvia
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Sweden

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: Complejo Hospitalario Universitario de Orense

location_facility: Universit degli Studi di Perugia - Azienda Ospedaliera di Perugia

location_facility: Msdyrt Midericordiae University Hospital

location_facility: Oslo University Hospital, Dep of Haematology

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Onze Lieve Vrouwe Gasthuis, Locatie Oost

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: University of Pennsylvania - Penn Blood Disorders Center

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Castle Hill Hospital, Department of Oncology & Haematology

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo

location_facility: University of Oklahoma Health Sciences Center

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Hamilton Health Sciences, Juravinski Hospital and Cancer Centre

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: Queen Elizabeth University Hospital Campus

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Pauls Stradins Clinical University Hospital

location_facility: University of Kentucky, Markey Cancer Center