summary: This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of 19-JAN-2023, the study was unblinded and all study participants stopped ongoing treatment with pembrolizumab/placebo and will continue to receive Standard of Care treatment until meeting protocol-specified discontinuation criteria if deriving clinical benefit. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.

location_facility: Niagara Health System - St. Catharines ( Site 0107)

location_facility: Radomskie Centrum Onkologii ( Site 1701)

location_facility: Velindre Cancer Centre Hospital ( Site 1322)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 1500)

location_facility: Weill Cornell Medical College ( Site 0263)

location_facility: TYKS T-sairaala Syopatautien pkl ( Site 1019)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0106)

location_facility: Yokohama City University Medical Center ( Site 0735)

location_facility: Szpital Uniwersytecki w Krakowie ( Site 1707)

location_facility: Hospital Sao Vicente de Paulo ( Site 2303)

location_facility: Universitaetsklinikum Freiburg ( Site 1200)

location_facility: Keski-Suomen keskussairaala ( Site 1017)

location_facility: Carolina Urologic Research Center ( Site 0259)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 1103)

location_facility: Alaska Clinical Research Center ( Site 0274)

location_facility: Winship Cancer Institute of Emory University ( Site 0209)

location_facility: Centro Di Riferimento Oncologico ( Site 1511)

location_facility: Franciscus Gasthuis en Vlietland ( Site 1605)

location_facility: Azienda Ospedaliera Cannizzaro ( Site 1501)

location_facility: Severance Hospital Yonsei University Health System ( Site 0402)

location_facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 2706)

location_facility: Centre D Oncologie de Gentilly ( Site 1107)

location_facility: Seoul National University Bundang Hospital ( Site 0401)

location_facility: University Hospital Waterford ( Site 1303)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1716)

location_facility: Nara Medical University Hospital ( Site 0744)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 2708)

location_facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 1210)

location_facility: St. Vincent Frontier Cancer Center-Research ( Site 0213)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0109)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 1212)

location_facility: Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 2102)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 2506)

location_facility: Nippon Medical School Hospital ( Site 0738)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 0602)

location_facility: Hospital 12 de Octubre de Madrid ( Site 1903)

location_facility: Clinica Universidad Catolica del Maule ( Site 2407)

location_facility: Centro Investigación del Cáncer James Lind ( Site 2401)

location_facility: Hamamatsu University Hospital ( Site 0748)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 2607)

location_facility: Hospital Militar Central [Lima, Peru] ( Site 2704)

location_facility: Peter MacCallum Cancer Centre ( Site 0306)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 1211)

location_facility: Seoul National University Hospital ( Site 0405)

location_facility: Centro Oncologico Internacional. SEDNA ( Site 2609)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1114)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2509)

location_facility: Zhejiang Provincial People's Hospital ( Site 0809)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0241)

location_facility: Herlev og Gentofte Hospital. ( Site 1004)

location_facility: Royal Cornwall Hospitals NHS Trust ( Site 1317)

location_facility: Dokkyo Medical University Saitama Medical Center ( Site 0736)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0101)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1201)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0269)

location_facility: Assaf Harofeh Medical Center ( Site 1405)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 1901)

location_facility: National Cheng Kung University Hospital ( Site 0503)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0270)

location_facility: Institucion Prestadora de Servicios de Salud Clinica de la Costa LTDA ( Site 2504)

location_facility: Riverina Cancer Care Center ( Site 0302)

location_facility: Smilow Cancer Center at Yale-New Haven ( Site 0250)

location_facility: Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 0900)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna

location_facility: SBIH City clinical hospital named after D.D. Pletniov ( Site 1813)

location_facility: Hospital San Lucas Cardiologica del Sureste ( Site 2606)

location_facility: Krankenhaus der Barmherzigen Brüder Wien ( Site 0904)

location_facility: Centre Georges Francois Leclerc ( Site 1112)

location_facility: City of Hope Medical Center ( Site 0217)

location_facility: Odense Universitetshospital ( Site 1003)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 2105)

location_facility: Konya Necmettin Erbakan University Medical Faculty ( Site 2104)

location_facility: Pontificia Universidad Catolica de Chile ( Site 2402)

location_facility: Associated Medical Professionals of NY ( Site 0251)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1810)

location_facility: Tallaght University Hospital ( Site 1301)

location_facility: National Taiwan University Hospital ( Site 0500)

location_facility: Yamaguchi University Hospital ( Site 0746)

location_facility: Boca Raton Clinical Research QTO ( Site 2611)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 1512)

location_facility: Tri-State Urologic Services PSC, Inc. ( Site 0253)

location_facility: Urology Associates [Nashville, TN] ( Site 0233)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2305)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1700)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1508)

location_facility: Seattle Cancer Care Alliance ( Site 0258)

location_facility: Tokyo Women's Medical University Hospital ( Site 0739)

location_facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 1603)

location_facility: Hospital Universitario Lucus Augusti ( Site 1905)

location_facility: Ankara Universitesi Tip Fakultesi. ( Site 2101)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1509)

location_facility: Saitama Medical University International Medical Center ( Site 0737)

location_facility: Gallipoli Medical Research Foundation ( Site 0309)

location_facility: Universitaetsspital Zuerich ( Site 2001)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1318)

location_facility: Cotton-O'Neil Cancer Center ( Site 0228)

location_facility: A.O. Verona-Ospedale Civile Maggiore Borgo-Trento ( Site 1504)

location_facility: Springfield Clinic [Springfield, IL] ( Site 0240)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1709)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 1320)

location_facility: Tampereen yliopistollinen sairaala ( Site 1022)

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 1102)

location_facility: Omsk Clinical Oncology Dispensary ( Site 1809)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 1800)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0502)

location_facility: Sociedad Medica Aren y Bachero Limitada ( Site 2403)

location_facility: Taipei Veterans General Hospital ( Site 0501)

location_facility: Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 1720)

location_facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 0834)

location_facility: The Sidney Kimmel Comprehensive Cancer Center ( Site 0204)

location_facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 1117)

location_facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 1805)

location_facility: Nasz Lekarz Przychodnie Medyczne ( Site 1718)

location_facility: Fundacao Dr Amaral Carvalho ( Site 2302)

location_facility: Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1721)

location_facility: St Vincents University Hospital ( Site 1300)

location_facility: Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2100)

location_facility: Chulalongkorn Hospital, Medical Oncology Unit ( Site 0600)

location_facility: Vrije Universiteit Medisch Centrum ( Site 1601)

location_facility: CISSS de la Monteregie-Centre ( Site 0105)

location_facility: Osaka City University Hospital ( Site 0741)

location_facility: John Flynn Hospital & Medical Centre ( Site 0308)

location_facility: Universitaetsklinikum der Technischen Universitaet Dresden ( Site 1204)

location_facility: Hadassah Ein Kerem Medical Center ( Site 1404)

location_facility: Aalborg Universitetshospital ( Site 1000)

location_facility: Kitasato University Hospital ( Site 0734)

location_facility: University Hospital Limerick ( Site 1305)

location_facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 2306)

location_facility: Peking University First Hospital ( Site 0800)

location_facility: Azienda Ospedaliera Santa Maria ( Site 1502)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 0236)

location_facility: Port Macquarie Base Hospital ( Site 0301)

location_facility: Sapporo Medical University Hospital ( Site 0730)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0504)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0901)

location_facility: Clinica de Oncologia Reichow ( Site 2308)

location_facility: Hospital Clinico San Carlos ( Site 1906)

location_facility: Istituto Nazionale dei Tumori ( Site 1510)

location_facility: Toho University Sakura Medical Center ( Site 0732)

location_facility: Isala Klinieken, Locatie Sophia ( Site 1604)

location_facility: Staedtisches Klinikum Braunschweig gGmbH ( Site 1217)

location_facility: Providence Alaska Medical Center ( Site 0276)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0404)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 2608)

location_facility: Radboud University Medical Center ( Site 1606)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 2304)

location_facility: Hartford HealthCare Medical Group ( Site 0212)

location_facility: Chonnam National University Hwasun Hospital ( Site 0406)

location_facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1717)

location_facility: CHUV (centre hospitalier universitaire vaudois) ( Site 2002)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1503)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 2700)

location_facility: Hospital Virgen de la Macarena ( Site 1904)

location_facility: Administradora Country SA - Clinica del Country ( Site 2507)

location_facility: Medizinische Universitaet Wien ( Site 0903)

location_facility: Institut Jean Godinot-Clinical Research Unit ( Site 1118)

location_facility: Clinica Peruano Americana S.A. ( Site 2702)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1902)

title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Japan
Thailand
Turkey
Chile
Canada
France
Colombia
Denmark
Switzerland
United States
China
Peru
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: Personalized Therapy Study - Attain Stability Quad Post-Approval Study

acronym: ASQ

summary: The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Medtronic

location_country:
Italy
Portugal
Slovakia
United Kingdom
Switzerland
United States
Spain
Greece
France

location_facility: CHRU Brest - Hôpital de la Cavale Blanche

location_facility: Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General

location_facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Générale de Santé - Hôpital Privé Saint Martin

location_facility: Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

location_facility: Azienda ospedaleria Santa Maria della Misericordia di Udine

location_facility: Centro Hospitalar Universitário de São João

location_facility: Cardiology Associates of Northeast Arkansas

location_facility: Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: UPMC Heart and Vascular Institute at UPMC Hamot

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca Granda

location_facility: Cardiovascular Institute of Northwest Florida

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: New York-Presbyterian Hospital/Columbia University Medical Center

location_facility: Heart Rhythm Consultants P.A. (Sarasota Memorial Research)

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)

location_facility: Cardiovascular Consultants Medical Group (Van Nuys)

location_facility: Presidio Ospedaliero Centrale - SS. Annunziata

location_facility: Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: North Memorial Heart and Vascular Institute

location_facility: Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Centre hospitalier de la région d'Annecy

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

type: EudraCT Number

title: A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With Established Cardiovascular Disease

acronym: Lp(a)HORIZON

summary: This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Tsimikas S, Reeves RR, Patel MP. Always Present, But Now Rediscovered: Lp(a) as a Predictor of Long-Term Outcomes in PCI. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2069-2072. doi: 10.1016/j.jcin.2021.08.032. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Plakogiannis R, Sorbera M, Fischetti B, Chen M. The Role of Antisense Therapies Targeting Lipoprotein(a). J Cardiovasc Pharmacol. 2021 Jul 1;78(1):e5-e11. doi: 10.1097/FJC.0000000000001045.

publisher_dissemination: Wolters Kluwer Health

ipd_sharing: Yes

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient -level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with the applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Slovenia
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Iceland
India
Romania
Belgium
China
Peru
Puerto Rico
Italy
Guatemala
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

intervention_type: Drug


lead_sponsor: Regeneron Pharmaceuticals

summary:
The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT).

The secondary objectives of the study are:

To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT
To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT
To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT
To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT
To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT
To assess cemiplimab pharmacokinetics and immunogenicity in human serum

sponsor_collaborators:
Regeneron Pharmaceuticals
Sanofi

location_facility: Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)

location_facility: University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center

location_facility: Osaka International Cancer Institute - Clinical Oncology

location_facility: A. Gemelli University Hospital, Catholic University of the Sacred Heart

location_facility: Universitair Ziekenhuis Leuven Gasthuisberg Campus

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

location_facility: Sarah Cannon Research Institute - Tennessee Oncology

location_facility: University of Missouri Health Care - University Physicians - Medicine Specialty Clinic

location_facility: Hospital General Universitario Gregorio Maranon (HGUGM)

location_facility: The Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: U.O.S.C Di Oncologia Medica E Terapie Innovative

location_facility: Ashford Cancer Centre Research-Adelaide Cancer Centre

location_facility: Wide Bay Hospital and Health Service - Cancer Care Services - Hervey Bay

location_facility: Michigan Medicine- University of Michigan

location_facility: The Lothian University Hospitals NHS Lothian - Western General Hospital (WGH)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: Genesis Care hospital San Francisco de Asis

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: NCT Dermatoonkologie -Hautklinik Heidelberg

location_facility: Cancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC)

location_facility: The Townsville Hospital and Health Service

location_facility: Olivia Newton -John Cancer Wellness & Research Centre

location_facility: State Healthcare Institution Oncology Dispensary 2 Ministry of Healthcare of Krasnodar Region

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

location_facility: Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board

location_facility: Narodowy Instytut Onkologii im. Marii Sk¿odowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach

location_facility: Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna

location_facility: Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

location_facility: The Christie - The Christie NHS Foundation Trust

location_facility: Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

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

location_facility: Federal State Budgetary Institution Rostov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation

location_facility: Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I

location_facility: Stanford Cancer Institute, Stanford Medicine at Stanford University

location_facility: Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

location_facility: Centre Hospitalier Universitaire de Nice,Hopital l Archet

location_facility: Hospital Universitario Virgen Macarena-merge

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

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

location_facility: Genesis Care Tugun - John Flynn Private Hospital

location_facility: University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute

location_facility: Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

location_facility: Velindre NHS Trust, Velindre Cancer Centre

location_facility: University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre

location_facility: Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

location_facility: Hospital Universitario y Politecnico La Fe-merge

location_facility: Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon

location_facility: Central Coast Cancer Centre-Gosford and Wyong Hospitals

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

location_facility: SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary

location_facility: University of Athens - Hospital of Venereology Dermatology Diseases Andreas Syggros

location_facility: Universita di Firenze - Azienda Sanitaria Firenze

location_facility: AOU Citta della Salute e della Scienza di Torino

location_facility: George Washington University School of Medicine and Health Sciences

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: National Cancer Center Hospital - Gastrointestinal Oncology

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute

location_facility: St George's Hospital - St George's University Hospitals NHS Foundation Trust

location_facility: Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: University College Cork-Cork University Maternity Hospital

location_facility: Hospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USP

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: University Health Network- Princess Margaret Cancer Center

location_facility: Centre Hospitalier Universitaire (CHU) de Dijon - Hopital du Bocage

status: Recruiting

title: A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

source: euctr

enrollment_type: Anticipated

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

location_country:
Germany
Ireland
Italy
Poland
New Zealand
United Kingdom
Australia
Brazil
Japan
Belgium
United States
Spain
Greece
Canada
Russian Federation
France


title: A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk

summary: This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.

ReferenceCitation: Labriola MK, George DJ. Setting a new standard for long-term survival in metastatic kidney cancer. Cancer. 2022 Jun 1;128(11):2058-2060. doi: 10.1002/cncr.34177. Epub 2022 Apr 5. No abstract available.

publisher_dissemination: Wiley

ReferenceCitation: Mar N, Kaakour D, Rezazadeh Kalebasty A. Renal Cell Carcinoma-Lessons in Diversity, Breakthroughs, and Challenges. JCO Oncol Pract. 2022 Mar;18(3):197-199. doi: 10.1200/OP.21.00446. Epub 2021 Sep 22. No abstract available.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Hofmann F, Hwang EC, Lam TB, Bex A, Yuan Y, Marconi LS, Ljungberg B. Targeted therapy for metastatic renal cell carcinoma. Cochrane Database Syst Rev. 2020 Oct 14;10(10):CD012796. doi: 10.1002/14651858.CD012796.pub2.

oa_host_type: repository

evidence: oa repository (via OAI-PMH title and first author match)

host_type: repository

repository_institution: Aberdeen University - Aberdeen University Research Archive

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central;aura.abdn.ac.uk

unpaywall_oa_status: green

lead_sponsor: Exelixis

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Hungary
Hong Kong
United States
Belgium
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Israel

location_facility:
Exelixis Clinical Site #148
Exelixis Clinical Site #96
Exelixis Clinical Site #134
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Exelixis Clinical Site #25
Exelixis Clinical Site #60
Exelixis Clinical Site #163
Exelixis Clinical Site #94
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Exelixis Clinical Site #64
Exelixis Clinical Site #92
Exelixis Clinical Site #168
Exelixis Clinical Site #72
Exelixis Clinical Site #125
Exelixis Clinical Site #56
Exelixis Clinical Site #99
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Exelixis Clinical Site #89
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Exelixis Clinical Site #27
Exelixis Clinical Site #86
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Exelixis Clinical Site #84
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Exelixis Clinical Site #171
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Exelixis Clinical Site #121
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acronym: PRIMIS

lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

ReferenceType: background

ReferenceCitation: Trauner M, Chung C, Sterling K, Liu X, Lu X, Xu J, Tempany-Afdhal C, Goodman ZD, Farkkila M, Tanaka A, Trivedi P, Kowdley KV, Bowlus CL, Levy C, Myers RP. PRIMIS: design of a pivotal, randomized, phase 3 study evaluating the safety and efficacy of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic patients with primary sclerosing cholangitis. BMC Gastroenterol. 2023 Mar 15;23(1):75. doi: 10.1186/s12876-023-02653-2.

ReferenceCitation: Trauner M, Levy C, Tanaka A, Goodman Z, Thorburn D, et al. A Phase 3 Randomized, Double-blind, Placebo-controlled Study Evaluation the Efficacy and Safety of Cilofexor in Patients With Non-cirrhotic Patients With Primary Sclerosing Cholangitis. J Hepatol. 2023 June;78(S1):S12-S13.

location_facility: Azienda Ospedaliero Universitaria di Moderna, Ospedale di Baggiovara

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Rutgers New Jersey Medical School - Doctors Office Center

location_facility: Hospital Clinico Universitario Santiago de Compostela

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Dipartimento Gastroenterologico e dei Trapianti

location_facility: Universitätsmedizin Mannheim, II. Medizinische Klinik

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: IRCCS Ospedale Sollievo della Sofferenza

location_facility: Coral Sea Clinical Research Institute - Mackay

location_facility: William Osler Health System - Brampton Civic Hospital

location_facility: Michigan Medicine - University of Michigan

location_facility: University of Manitoba/Health Sciences Centre

location_facility: University of Colorado Denver and Hospital

location_facility: Aintree University Hospitals NHS Foundation Trust

location_facility: San Antonio Military Medical Center, Gastro/Hepatology

location_facility: The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: Centre Hospitalier Universitaire de Liège Site Sart Tilman

location_facility: University Hospital Birmingham NHS Foundation Trust

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Icahn School of Medicine at Mount Sinai Beth Israel

location_facility: Baylor Scott & White Medical Center at Fort Worth

location_facility: Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

location_facility: Walter Reed National Military Medical Center

location_facility: Azienda Ospedaliero-Universitaria Pisana - Unità Operativa Epatologia

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Helsinki University Hospital, Endoscopy Unit, Gastroenterology Outpatient clinic, Meilahden tomisairaala

location_facility: Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Hepatologie

location_facility: Hospital Universitari Politecnic La Fe de Valencia

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda Ospedaliera Universitaria Policlinico P. Giaccone

location_facility: Istituto Clinico Humanitas - Unita Operativa di Epatologia

location_facility: Chronic Viral Illness Service/McGill University Health Centre (MUHC)

location_facility: Intermountain Medical Center - Transplant Services

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil

location_facility: University of Chicago Medical Center (outpatient clinic)

location_facility: Northwell Health Center for Liver Diseases and Transplantation

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Turku University Hospital, Gastroenterology Outpatient Clinic

location_facility: Hospital General Universitario de Alicante

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Hopital Robert Debré - Centre Hospitalier Universitaire de Reims

location_facility: Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Ca'Granda Ospedale Maggiore Policlinico UOC Gastroenterologia ed Epatologia

location_facility: Southern Therapy and Advanced Research LLC

location_facility: Virginia Commonwealth University Clinical Research Services Unit

location_facility: Annette & Harold C. Simmons Transplant Institute @ Baylor University Medical Center at Dallas

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Vanderbilt University Medical Center - Digestive Disease Center

location_facility: The University of Vermont Medical Center

location_facility: University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)

location_facility: Center for Liver Disease and Transplantation, Columbia University Medical Center

location_facility: Northwestern Memorial Hospital; Clinical Research Unit

location_facility: Altman Clinical and Translational Research Institute (Clinic)

location_facility: Saint Louis University, Gastroenterology & Hepatology

location_facility: Sutter Pacific Medical Foundation - California Pacific Medical Center

location_facility: Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

location_facility: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

location_facility: Copenhagen University Hospital - Hvidovre

location_facility: Landeskrankenanstalten-Betriebsgesellscaft - KABEG, Klinikum Klagenfurt am Wörthersee

location_facility: Carolinas Medical Center - Center for Liver Disease

location_facility: University of California, San Francisco Liver Clinic

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: University of California, Davis Medical Center (study visits)

location_facility: Nottingham University Hospitals NHS Trust

status: Terminated

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis

type: Registry Identifier

study_completion_date_type: Actual

location_country:
Finland
Germany
Italy
New Zealand
Israel
United Kingdom
Denmark
Australia
Japan
Switzerland
Austria
Belgium
United States
Spain
Canada
France

status_simplified: Unknown


intervention_type: Biological

acronym: Étude de non-infériorité PK portant sur le ravulizumab SC comparé au ravulizumab IV.

lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously administered ravulizumab in adult participants with PNH who are clinically stable on eculizumab for at least 6 months.

ReferenceCitation: Yenerel MN, Sicre de Fontbrune F, Piatek C, Sahin F, Fureder W, Ortiz S, Ogawa M, Ozol-Godfrey A, Sierra JR, Szer J. Phase 3 Study of Subcutaneous Versus Intravenous Ravulizumab in Eculizumab-Experienced Adult Patients with PNH: Primary Analysis and 1-Year Follow-Up. Adv Ther. 2023 Jan;40(1):211-232. doi: 10.1007/s12325-022-02339-3. Epub 2022 Oct 22.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

status: Completed

title: A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab

location_country:
Finland
Italy
Australia
Brazil
Netherlands
Austria
Belgium
Sweden
United States
Spain
Turkey
Canada
Russian Federation
France

status_simplified: Completed


title: A Multicenter, Double-Blind, Randomized Phase 3 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination With Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)

summary:
This is a randomized, double-blind multi-center, phase III study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.

After the interim analysis conducted by the iDMC, an open-label assignment of experimental arm therapy will continue in regions outside of China, in order to further evaluate the efficacy and safety of sintilimab in combination with chemotherapy in subjects representing the western population with advanced esophageal squamous cell carcinoma

ReferenceCitation: Lu Z, Wang J, Shu Y, Liu L, Kong L, Yang L, Wang B, Sun G, Ji Y, Cao G, Liu H, Cui T, Li N, Qiu W, Li G, Hou X, Luo H, Xue L, Zhang Y, Yue W, Liu Z, Wang X, Gao S, Pan Y, Galais MP, Zaanan A, Ma Z, Li H, Wang Y, Shen L; ORIENT-15 study group. Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial. BMJ. 2022 Apr 19;377:e068714. doi: 10.1136/bmj-2021-068714.

evidence: open (via page says license)

publisher_dissemination: British Medical Journal

lead_sponsor: Innovent Biologics (Suzhou) Co. Ltd.

sponsor_collaborators:
Innovent Biologics (Suzhou) Co. Ltd.
Fortrea

location_country:
Hungary
Australia
Belgium
United States
China
Spain
France

location_facility: St. Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Parc Taulí Sabadell Hospital Universitari

location_facility: Consorci Hospital General Universitari de València

location_facility: IACT Health - John B. Amos Cancer center

location_facility: University Hospital Marqués de Valdecilla

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: Universite de Bourgogne - Faculte de Medecine - INSERM U866

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Complexo Hospitalario Universitario de Santiago


acronym: Spotlight

lead_sponsor: Astellas Pharma Global Development, Inc.

summary:
A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Why is this study being done?

SPOTLIGHT is a new clinical study for adult patients who have any of:

advanced unresectable gastric or GEJ cancer
metastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells.

For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death.

Patients will be assigned to one of two groups by chance and given either:

zolbetuximab with mFOLFOX6; or
a placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine.

The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.

location_facility: Precision Cancer Research -Dayton Physicians Network

location_facility: University of Maryland Medical Center(UMMC)Transplant Center

location_facility: University of California - San Francisco

location_facility: Cancer Treatment Centers of America, Atlanta

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer

location_facility: The Ohio State University Medical Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The Angeles Clinic and Research Institute

location_facility: Inova Dwight and Martha Schar Cancer Institute

location_facility: Rhode Island Hospital-Lifespan Cancer Institute

location_facility: Cancer Treatment Centers of America, Philadelphia

location_facility: MultiCare Regional Cancer Center - Gig Harbor

location_facility: The University of Arizona Medical Center

location_facility: University of Oklahoma Health Science Center

title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Germany
Poland
Australia
Brazil
Japan
Chile
Canada
France
Colombia
United States
Belgium
China
Peru
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Israel


title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Adult Subjects Infected With Human Metapneumovirus

acronym: STEP

summary: The purpose of this study is to determine in hospitalized adult participants infected with human metapneumovirus (hMPV - a virus closely related to respiratory syncytial virus (RSV) and has been identified as an important cause of acute respiratory infections, affecting all age groups) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal hMPV shedding using quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Argentina
Australia
Brazil
Japan
Netherlands
Sweden
United States
Korea, Republic of
Spain
Malaysia
Taiwan
Bulgaria
Ukraine
Russian Federation
France

location_facility: Clinical Emergency Hospital n.a. N.V. Solovyev

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: SUBARU Health Insurance Society Ota Memorial Hospital

location_facility: Tohoku Medical And Pharmaceutical University Hospital

location_facility: National Hospital Organization Ibarakihigashi

location_facility: State Health Care Institution of Voronezh region 'Voronezh regional clinical infectious hospital'

location_facility: Kobe City Medical Center General Hospital

location_facility: Kharkiv National Medical University, Regional Clinical Infectious Hospital

location_facility: Clinical Infectious Diseases Hospital n. a. S.P. Botkin

location_facility: Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

location_facility: Vinnytsia City Clinical Hospital #1, Department of Infectious Diseases #1

location_facility: 10 Wojskowy Szpital Kliniczny z Poliklinika

location_facility: Saint-Petersburg State Health Care Institution 'Vvedenskaya Hospital'

location_facility: Bukovian State Medical University, Dept. of Infectious Disease and Epidemiology

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Hospital Privado-Universitario de Cordoba

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo

location_facility: Wojewódzki Szpital Specjalistyczny im. św. Rafała w Czerwonej Górze

location_facility: Japanese Red Cross Nagasaki Genbaku Isahaya Hospital

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD

location_facility: Regional State Health Care Institution 'Clinical Hospital #1'

location_facility: Saint-Petersburg State Public Health Organization City Clinical Hospital #26

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

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik

location_facility: Seoul National University Bundang Hospital

location_facility: State Health Care Institution 'Engels city hospital #2'

location_facility: Northwestern University - Northwestern Memorial Hospital - Infectious Disease Center

location_facility: Japanese Red Cross Society Nagano Hospital

location_facility: National Hospital Organization Tenryu Hospital

location_facility: Hospital Interzonal General de Agudos Dr. Jose Penna

location_facility: Barwon Health - University Hospital Geelong

location_facility: MemorialCare Research Miller Children's and Women's Hospital Long Beach

location_facility: Samodzielny Publiczny Zespół Opieki Zdrowotnej w Proszowicach

location_facility: National Hospital Organization Higashinagoya National Hospital

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Soonchunhyang University Bucheon Hospital


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

acronym: REVERSE

summary: The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

lead_sponsor: Intercept Pharmaceuticals

location_country:
Germany
Poland
New Zealand
Hungary
United Kingdom
Australia
United States
Spain
Canada
Ukraine
Puerto Rico
France

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours

location_facility: Ralph H. Johnson Veterans Affairs Medical Center

location_facility: Objective GI d/b/a North Alabama GI Research Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Baylor Scott and White All Saints Medical Center

location_facility: Synexus Polska Sp. z o.o., Oddział w Poznaniu

location_facility: University of California, San Francisco-Fresno

location_facility: Methodist Healthcare University Hospital

location_facility: University at Buffalo, Clinical and Translational Research Center

location_facility: Synexus Polska Sp. Z.o.o., Oddział w Gdyni

location_facility: Tulane University Health Sciences Center

location_facility: University of Colorado Denver and Hospital

location_facility: Digestive Health Specialists of the Southeast

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Clinique de medecine Urbaine du Quartier Latin

location_facility: Medical Center of LLC Medbud-Clinic, Clinical Diagnostic Department

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital

location_facility: Royal Free Hospital NHS Foundation Trust

location_facility: Imperial College Healthcare NHS Trust, St Mary's Hospital

location_facility: Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

location_facility: Derby Teaching Hospitals NHS Foundation Trust

location_facility: UF Health Jacksonville-Gastroenterology Emerson

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: Walter Reed National Military Medical Center

location_facility: Synexus Polska Sp. z o.o., Oddział w Częstochowie

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: King's College Hospital NHS Foundation Trust

location_facility: UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute

location_facility: Hospital General Universitario de Valencia

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

location_facility: Gastroenterology Consultants of Southwest Virginia

location_facility: Carolinas Health Care System Center for Liver Disease

location_facility: London Health Sciences Centre-University Hospital

location_facility: Chronic Viral Illness/McGill University Health Centre (MUHC)

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: University of Louisville, Clinical Trials Unit

location_facility: Ichan School of Medicine at Mount Sinai Beth Israel

location_facility: Nepean Blue Mountains Local Health District, Nepean Hospital

location_facility: Center Hospitalier Universitaire Grenoble Alpes

location_facility: University of Calgary Liver Unit (Heritage Medical Research Clinic)

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: University of California, Davis Medical Center

location_facility: Washington University School of Medicine

location_facility: Synexus Polska Sp. z o.o., Oddział w Warszawie

location_facility: Hospital Universitari i Politécnic La Fe

location_facility: Diabetes & Endocrinology Consultants, PC

location_facility: The University of Texas Medical School at Houston

location_facility: The Pennsylvania State University and the Milton S. Hershey Medical Center

location_facility: CHU de Rouen-Centre Hospitalier Universitaire

location_facility: University of North Carolina at Chapel Hill, School of Medicine

location_facility: Vanderbilt University Medical Center - Digestive Disease Center

location_facility: The University of Vermont Medical Center

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Synexus Polska Sp. z.o.o., Oddział w Gdańsku

location_facility: Kyiv Railway Clinical Hospital №2 of branch "Health Center" of the Joint-Stock Company "Ukranian Railway", Day treatment department

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Charlotte Gastroenterology & Hepatology, PLLC

location_facility: Synexus Polska Sp. z o.o., Oddział w Katowicach

location_facility: Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads

location_facility: University of Mississippi Medical Center

location_facility: Synexus Polska Sp. z o.o., Oddział w Wrocławiu

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Carolinas Center for Liver Disease/Carolinas HealthCare System

location_facility: Synexus Polska Sp. z o.o., Oddział w Łodzi

location_facility: Southern Therapy and Advanced Research (STAR) LLC

location_facility: Centre Hospitalier Universitaire d'Angers


title: A Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients Who Have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)

summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.

lead_sponsor: Incyte Corporation

sponsor_collaborators:
Incyte Corporation
Merck Sharp & Dohme LLC

location_country:
Germany
Ireland
Italy
Hungary
Israel
Denmark
Australia
Japan
Netherlands
United Kingdom
United States
Korea, Republic of
Spain
Turkey
Taiwan
Canada
Russian Federation
France

location_facility: National Medical Research Radiological Centre

location_facility: University of California Irvine Medical Center

location_facility: Clinic of Bashkortostan State Medical University

location_facility: Centre de Lutte Contre le Cancer Francois Baclesse

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Klinikum rechts der Isar der Technischen Universitat

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Dokuz Eylul University Faculty of Medicine

location_facility: Severance Hospital Yonsei University Health System

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Yusen Logistics Co Ltd,. Haneda Logistics Center (MSD DC)

location_facility: Universitaetsklinikum Schleswig-Holstein. Campus Luebeck

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

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

location_facility: Medical University of South Carolina-Hollings Cancer Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital

location_facility: Marmara Universitesi Pendik Arastirma ve Uyg. Hastanesi

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Medical Hospital, Tokyo Medical And Dental University

location_facility: Oklahoma Cancer Specialists & Research Institute

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: University of Tennessee Medical Center Knoxville

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH

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

location_facility: Istituto Nazionale Tumori Fondazione Pascale


lead_sponsor: Merck KGaA, Darmstadt, Germany

summary: The main purpose of the study was to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2 years (24 months).

location_facility: Ospedale Binaghi, Università di Cagliari,ASL 8 - Centro Sclerosi Multipla

location_facility: Vseobecna fakultni nemocnice v Praze (11163)

location_facility: Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

location_facility: Centro Hospitalar do Porto E.P.E. Hospital de Santo António

location_facility: Hospital General Universitario Gregorio Marañón (5030)

location_facility: Seconda Univesità degli Studi di Napoli, AOU

location_facility: GM LCRN - Great Manchester Local Clinical Research Network

location_facility: Azienda Ospedaliera S. Camillo Forlanini (8025)

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Hospital Universitario Nuestra Senora de la Candelaria (4776)

location_facility: The Newcastle Hospitals NHS Foundation Trust

location_facility: Hospital de Sant Joan Despí Moisès Broggi

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

location_facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia

location_facility: Vilnius University Hospital Santariskiu Clinics

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Azienda Ospedaliera Sant'Andrea Università La Sapienza

location_facility: Instituto Nazionale Neurologico "Carlo Besta"

location_facility: Centre hospitalier de la Côte Basque - Saint Léon

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille - Centre Hospitalier Saint Philibert

title: A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad® (CLARIFY MS)

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

location_country:
Finland
Italy
Lithuania
Poland
Portugal
Slovakia
Hungary
Norway
Denmark
United Kingdom
Sweden
Netherlands
Austria
Belgium
Spain
Greece
Czechia
France


title: A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) or Placebo in Participants With Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.

location_country:
Germany
Ireland
Italy
Poland
Israel
United Kingdom
Australia
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Ukraine
Russian Federation
France

location_facility: National Medical Research Radiological Centre

location_facility: University of California Irvine Medical Center

location_facility: Clinic of Bashkortostan State Medical University

location_facility: GU Research Network-Urology Cancer Center

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II

location_facility: Barts Health NHS Trust - St Bartholomew's Hospital

location_facility: Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

location_facility: Klinikum rechts der Isar der Technischen Universitat

location_facility: GLOBE Badania Kliniczne Oddzial we Wroclawiu

location_facility: Severance Hospital Yonsei University Health System

location_facility: Szpital Sw. Elzbiety Mokotowskie Centrum Medyczne

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Kharkiv Regional Clinical Oncology Center

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: Universitaetsklinikum Schleswig-Holstein. Campus Luebeck

location_facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST

location_facility: Medical University of South Carolina-Hollings Cancer Center

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: Grand Hopital de Charleroi - Site Notre Dame - Oncology

location_facility: Medical Hospital, Tokyo Medical And Dental University

location_facility: Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego

location_facility: Hospital General Universitari Vall d Hebron

location_facility: Tennessee Oncology, PLLC/The Sarah Cannon Research Institute

location_facility: Xarxa Assistencial Universitaria Manresa

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: CHU de Strasbourg - Nouvel Hopital Civil

location_facility: Krankenhaus der Barmherzigen Brueder Trier

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov

location_facility: RMI Sumy Regional Clinical Oncology Dispensary

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC

location_facility: Consorci Hospitalari Parc Tauli de Sabadell

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: University of Tennessee Medical Center Knoxville

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

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: Chang Gung Medical Foundation - Kaohsiung

location_facility: Moncton Hospital - Horizon Health Network


lead_sponsor: AstraZeneca

summary: This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib [AZD6738]) and olaparib monotherapy versus olaparib in combination with an inhibitor of WEE1 (adavosertib [AZD1775]) in second or third line setting in patients with Triple-negative breast cancer (TNBC) prospectively stratified by presence/absence of qualifying tumour mutation in genes involved in the homologous recombination repair (HRR) pathway. Treatment arms are olaparib monotherapy, olaparib+ Ceralasertib and olaparib+adavosertib. The study subject population will be divided into Stratum A, Stratum B, and Stratum C. Due to the different schedules of administration of each of the treatment options as well as their different toxicity profiles, the study is not blinded. Study has two stage consent process- stage 1 consent (molecular screening for HRR defects) and stage 2 consent (main study). Patients with TNBC and with known qualifying BRCAm, non BRCAm HRRm and non HRRm status will be offered the option of consenting to the main part of the study within the 28-day screening period. Following the ISRC meeting on 17 April 2019 a recommendation was made to close the adavosertib+olaparib treatment arm across all biomarker strata. Patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd). Following the closure of this arm the total number of patients randomised will be lower (approximately 350 patients). Approximately 300 patients will be randomised (using randomisation ratio 1:1) to 2 ongoing treatment arms plus an additional 47 patients to a 3rd arm (olaparib+adavosertib) prior to the arm being discontinued.

ReferenceCitation: Smith G, Alholm Z, Coleman RL, Monk BJ. DNA Damage Repair Inhibitors-Combination Therapies. Cancer J. 2021 Nov-Dec 01;27(6):501-505. doi: 10.1097/PPO.0000000000000561.

title: A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-Related Genes (Including BRCA1/2) (VIOLETTE).

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.

location_country:
Germany
Ireland
Italy
Poland
Portugal
United Kingdom
Netherlands
Belgium
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
France


acronym: B-FAST

lead_sponsor: Hoffmann-La Roche

summary: This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.

ReferenceCitation: Peters S, Dziadziuszko R, Morabito A, Felip E, Gadgeel SM, Cheema P, Cobo M, Andric Z, Barrios CH, Yamaguchi M, Dansin E, Danchaivijitr P, Johnson M, Novello S, Mathisen MS, Shagan SM, Schleifman E, Wang J, Yan M, Mocci S, Voong D, Fabrizio DA, Shames DS, Riehl T, Gandara DR, Mok T. Atezolizumab versus chemotherapy in advanced or metastatic NSCLC with high blood-based tumor mutational burden: primary analysis of BFAST cohort C randomized phase 3 trial. Nat Med. 2022 Sep;28(9):1831-1839. doi: 10.1038/s41591-022-01933-w. Epub 2022 Aug 22.

license: cc-by

license_normalized: cc-by

location_facility: National Hospital Organization Yamaguchi - Ube Medical Center

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia

location_facility: Krakowski Szpital Specjalistyczny im sw.Jana Pawla II

location_facility: Hopital Bichat Claude Bernard; Oncologie Serv.

location_facility: CancerCare Manitoba; Department of Medical Oncology

location_facility: Rabin MC; Davidof Center - Oncology Institute

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

location_facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Henry Ford Health System; Hematology/Oncology

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Universitätsklinikum Essen; Innere Klinik (Tumorforschung)

location_facility: London Health Sciences Centre · Victoria Hospital; Department of Medicine

location_facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

location_facility: University Cancer & Blood Center, LLC; Research

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

location_facility: ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona

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

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

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

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Niigata University Medical & Dental Hospital

location_facility: Universitätsklinikum Düsseldorf; Klinik für Kardiologie, Pneumologie und Angiologie

location_facility: Chang Gung Medical Foundation - Linkou; Chest Dept

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: Bradford Hill Centro de Investigaciones Clinicas

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: The First Affiliated Hospital of Guangzhou Medical University Pharmacy

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

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: The second Xiangya hospital of central south university

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: The Prince Charles Hospital; Oncology Dept.

location_facility: Chonnam National University Hwasun Hospital

location_facility: Principal Military Clinical Hospital n.a. N.N. Burdenko

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: West China Hospital - Sichuan University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Marmara University Pendik Training and Research Hospital; Medikal Onkoloji

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Institute for Pulmonary Diseases of Vojvodina; Clinic for Pulmonary Oncology

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: National Cancer Centre; Medical Oncology

location_facility: Tennessee Oncology PLLC - Nashville (20th Ave)

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine

location_facility: Clinical Oncology Dispensary; Chemotherapy

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Yonsei University Health System/Severance Hospital

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

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Queen Mary Hospital; Medicine & Respiratory

location_facility: Medipol University Medical Faculty; Oncology Department

location_facility: Fudan Unviversity Shanghai Cancer Center

location_facility: The Second Affiliated Hospital to Nanchang University

location_facility: Hopital Bretonneau; Pneumologie Oncologie

location_facility: Hemato Oncología de Panamá Especializada

location_facility: University of Kentucky; Markey Cancer Center

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

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

title: A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Costa Rica
Japan
Thailand
Turkey
Chile
Canada
Serbia
France
Hong Kong
United States
Belgium
China
Peru
Italy
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Panama
Taiwan
Russian Federation
Israel

ipd_sharing: Undecided


title: A Prospective Non-interventional Post-authorization Safety Study (PASS) of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant ("Transplant Noneligible" [TNE])

summary: This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.

lead_sponsor: Celgene

location_country:
Germany
Ireland
Italy
Norway
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Spain
France

location_facility: Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH

location_facility: Midlands Regional Hospital , Hematology/Oncology

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital

location_facility: Medizinische Klinik II, DONAUISAR Klinikum Deggendorf, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover

location_facility: UOSD Ematologia Complesso Opsedaliero-Ospedale S. Spirito e Nuovo Regina Margherita

location_facility: Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital

location_facility: Dres. Neise & Lollert, Praxis für Hämatologie & Onkologie

location_facility: Betsi Cadwaladr University Health Board - Glan Clwyd Hospital

location_facility: Charité - Universitätsmedizin Berlin - Campus Charité Mitte

location_facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin

location_facility: Servizio immunoematologia e medicina trasfusionale-ASP

location_facility: Klinikum Nord, Klinik für Innere Medizin 5

location_facility: MVZ Mitte - Onkologische Schwerpunktpraxis

location_facility: Internistische Facharztzentrum mit Dialyse

location_facility: "S.C. di Ematologia e Centro Trapianti di Cellule Staminali Emopoietiche

location_facility: Northern Health and Social Care Trust -Antrim Area Hospital

location_facility: Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

location_facility: Ospedale Alessandria, Via Venezia, 16, 15121 Alessandria AL

location_facility: Dipartimento di Oncologia Medica e Chirurgica AORN S. Anna e S. Sebastiano

location_facility: Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: S.C. Ematologia, Dip.to Oncologico e Tecnologie Avanzate

location_facility: A.O Bianchi Melacrino Morelli - Presidio Riuniti

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 -

location_facility: Istituto di Ematologia ed Ocnologia Medica "Seràgnoli" AUO Sant'Orsola - Bologna

location_facility: Hôpital privé d'Antony - Ramsay Générale de Santé

location_facility: South Eastern Health and Social Care Trust - The Ulster Hospital

location_facility: Southmead Hospital -North Bristol NHS Trust

location_facility: UO Ematologia e Centro Trapianti di Midollo Osseo dell'Ospedale San Francesco di Nuoro

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: UO di Ematologia Osp. S. Carlo - Potenza


title: A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries

summary: This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). Approximately 1600 subjects will be enrolled in this study. This study will continue for 260 weeks (approximately 5 years).

ReferenceCitation: O'Donoghue ML, Giugliano RP, Wiviott SD, Atar D, Keech A, Kuder JF, Im K, Murphy SA, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Sabatine MS. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. Circulation. 2022 Oct 11;146(15):1109-1119. doi: 10.1161/CIRCULATIONAHA.122.061620. Epub 2022 Aug 29.

ReferenceCitation: Gaba P, O'Donoghue ML, Park JG, Wiviott SD, Atar D, Kuder JF, Im K, Murphy SA, De Ferrari GM, Gaciong ZA, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Giugliano RP, Sabatine MS. Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE. Circulation. 2023 Apr 18;147(16):1192-1203. doi: 10.1161/CIRCULATIONAHA.122.063399. Epub 2023 Feb 13.

ReferenceCitation: Katsiki N, Athyros VG, Mikhailidis DP, Mantzoros C. Proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors: Shaping the future after the further cardiovascular outcomes research with PCSK9 inhibition in subjects with elevated risk (FOURIER) trial. Metabolism. 2017 Sep;74:43-46. doi: 10.1016/j.metabol.2017.04.007. Epub 2017 Apr 20. No abstract available.

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: Germany Italy Portugal Denmark Sweden Belgium France

location_facility: Herz-GefÃ¤ÃŸ-Zentrum Nymphenburg am Klinikum Dritter Orden

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier

location_facility: Fondazione Toscana Gabriele Monasterio, Stabilimento Ospedaliero di Pisa

location_facility: Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

location_facility: Centre for Clinical and Basic Research Ballerup

location_facility: Cliniques universitaires de Bruxelles Hopital Erasme

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Centres Hospitaliers Jolimont - Hopital de Jolimont

location_facility: Centre Hospitalier de Pau - Hopital Francois Mitterrand

location_facility: Center for Clinical and Basic Research Aalborg

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

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

location_facility: Centre Hospitalier Universitaire de Tivoli

location_facility: Gesellschaft fur Wissens und Technologietransfer der Technischen Uni Dresden

location_facility: Centre Hospitalier Intercommunal Haute Saone

location_facility: Centre Hospitalier RÃ©gional Universitaire de Tours - HÃ´pital Trousseau

location_facility: Centre Hospitalier Regional Universitaire de Montpellier - Hopital Arnaud de Villeneuve

location_facility: Otto von Guericke UniversitÃ¤t Magdeburg

location_facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur

location_facility: Center for Clinical and Basic Research Vejle

location_facility: Deutsches Herzzentrum MÃ¼nchen des Freistaates Bayern

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: Centro Hospitalar Cova da Beira, EPE - Hospital Pero da Covilha

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Centro Hospitalar e Universitario de Coimbra EPE

location_facility: Deutsches Rotes Kreuz Kliniken Berlin KÃ¶penick

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo

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

location_facility: Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

location_facility: Universitaets-Herzzentrum Freiburg - Bad Krozingen


summary: The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).

ReferenceCitation: Kotani N, Wilkins JJ, Wade JR, Dang S, Sutaria DS, Yoshida K, Sundrani S, Ding H, Garcia J, Hinton H, Sane R, Chanu P. Characterization of exposure-response relationships of ipatasertib in patients with metastatic castration-resistant prostate cancer in the IPATential150 study. Cancer Chemother Pharmacol. 2022 Dec;90(6):511-521. doi: 10.1007/s00280-022-04488-2. Epub 2022 Oct 28.

ReferenceCitation: Sweeney C, Bracarda S, Sternberg CN, Chi KN, Olmos D, Sandhu S, Massard C, Matsubara N, Alekseev B, Parnis F, Atduev V, Buchschacher GL Jr, Gafanov R, Corrales L, Borre M, Stroyakovskiy D, Alves GV, Bournakis E, Puente J, Harle-Yge ML, Gallo J, Chen G, Hanover J, Wongchenko MJ, Garcia J, de Bono JS. Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2021 Jul 10;398(10295):131-142. doi: 10.1016/S0140-6736(21)00580-8.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Aarhus Universitetshospital, Urologisk Afd. K

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

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

location_facility: Royal Wolverhampton hospital; McHale Building

location_facility: Kaiser Permanente San Diego - Los Angeles

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

location_facility: Institut Mutualiste Montsouris; Oncologie

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

location_facility: Chaim Sheba medical center, Oncology division

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Consultorio de Especialidad en Urologia Privado

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

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

location_facility: Chang Gung Memorial Hospital-LinKou; Urology

location_facility: Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU

location_facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Blokhin Cancer Research Center; Urological Dept

location_facility: Niigata University Medical & Dental Hospital

location_facility: Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

location_facility: Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego

location_facility: Addenbrookes Nhs Trust; Oncology Clinical Trials Unit

location_facility: Urology Cancer Center & GU Research Network

location_facility: University Hospital of Patras Medical Oncology

location_facility: Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

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

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

location_facility: Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

location_facility: A.O. San Carlo Borromeo; U.O.C. Oncologia

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

location_facility: Semmelwies University of Medicine; Urology Dept.

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

location_facility: Hackensack Univ Medical Center; John Theurer Cancer Ctr

location_facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Centro Medico Culiacan SA de CV; Consultorio Medico 303 B

location_facility: China Medical University Hospital; Urology

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Hospital Clinic i Provincial; Servicio de Urología

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

location_facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

location_facility: Seoul National University Bundang Hospital

location_facility: Royal Marsden Hospital; Institute of Cancer Research

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: HUC; Servico de Urologia e Transplantacao Renal

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Woj. Wielospec. Centrum Onkologii i Traumatologii

location_facility: Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii

location_facility: KAOHSIUNG MEDICAL UNI CHUNG-HO HOSPITAL; Dept. Of Urology

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Lynn Cancer Institute/Boca Raton Regional Hospital

location_facility: CHU de Québec - Université Laval - Hôtel-Dieu de Québec

location_facility: SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego

location_facility: Ospedale di Trento-Presidio Ospedaliero Santa Chiara; Oncologia Medica

location_facility: Ospedale Area Aretina Nord; U.O.C. Oncologia

location_facility: Institut Catala d?Oncologia Hospital Germans Trias i Pujol

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Belinson Medical Center, Division of Oncology

location_facility: A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia

location_facility: Sykehuset Østfold Kalnes; Onkologisk seksjon

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

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer

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

location_country:
Ireland
Poland
Australia
Brazil
Costa Rica
Japan
Thailand
Canada
France
Portugal
Hungary
Denmark
United States
Belgium
China
Italy
Norway
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel