title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)

lead_sponsor: Merck Sharp & Dohme LLC

type: Registry Identifier

ReferenceCitation: Graff JN, Liang LW, Kim J, Stenzl A. KEYNOTE-641: a Phase III study of pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer. Future Oncol. 2021 Aug;17(23):3017-3026. doi: 10.2217/fon-2020-1008. Epub 2021 May 28.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Brazil
Canada
Hungary
Germany
Bulgaria
Taiwan
Ireland
New Zealand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Petz Aladár Megyei Oktató Kórház-Onkológiai Osztály ( Site 1324)

location_facility: Georgia Cancer Center at Augusta University ( Site 0026)

location_facility: Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)

location_facility: Pontificia Universidad Catolica de Chile ( Site 1047)

location_facility: LISOD - Israeli Oncological Hospital ""MedX-ray Internationa-Department of Clinical and Scientific (

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0034)

location_facility: Saitama Medical University International Medical Center ( Site 0708)

location_facility: Nara Medical University Hospital ( Site 0715)

location_facility: CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)

location_facility: Royal Marsden Hospital (Sutton) ( Site 0526)

location_facility: Institut De Cancerologie De L Ouest ( Site 0448)

location_facility: Gabrail Cancer Center-Research ( Site 0096)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)

location_facility: Vrije Universiteit Medisch Centrum ( Site 0479)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0452)

location_facility: Seoul National University Hospital ( Site 0171)

location_facility: W. G. Bill Hefner VA Medical Center ( Site 0029)

location_facility: Centre D Oncologie de Gentilly ( Site 0432)

location_facility: Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1036)

location_facility: Carolina Urologic Research Center ( Site 0070)

location_facility: Hamamatsu University Hospital ( Site 0720)

location_facility: Communal Non-Commercial Enterprise ""Prykarpatski Clinical Oncological Center"" of Ivano-Frankivsk R

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)

location_facility: Cancer & Hematology Centers of Western Michigan ( Site 0013)

location_facility: Canterbury Regional Cancer & Blood Service ( Site 0195)

location_facility: Haaglanden MC - locatie Antoniushove ( Site 0471)

location_facility: Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 1326)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 0330)

location_facility: Institut Regional du Cancer de Montpellier - ICM ( Site 0443)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0636)

location_facility: Kanazawa University Hospital ( Site 0701)

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1038)

location_facility: Centro de Diagnostico Urologico ( Site 1008)

location_facility: St. Joseph Heritage Healthcare ( Site 0069)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0624)

location_facility: Taichung Veterans General Hospital ( Site 0133)

location_facility: Az. Osp. Univ. Sta Maria della Misericordia di Udine ( Site 0460)

location_facility: Radboud University Medical Center ( Site 0470)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 0464)

location_facility: Hospital Provincial San Pedro Alcantara ( Site 0326)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0418)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 1203)

location_facility: Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)

location_facility: Universitaetsklinikum Goettingen ( Site 0345)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 1022)

location_facility: A.O. Universitaria di Modena ( Site 0454)

location_facility: Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0507)

location_facility: Azienda Ospedaliera Cannizzaro ( Site 0458)

location_facility: Universitaetsklinikum Muenster ( Site 0320)

location_facility: Ospedale Policlinico S. Orsola-Malpighi ( Site 0453)

location_facility: Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 1205)

location_facility: University of Colorado Cancer Center ( Site 0022)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 0482)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0465)

location_facility: Universitaetsklinikum des Saarlandes ( Site 0348)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0619)

location_facility: MD Anderson Cancer Center Madrid ( Site 0332)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0301)

location_facility: Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 0615)

location_facility: Hospital Clinico San Carlos ( Site 0324)

location_facility: Ivano-Frankivsk Regional Hospital-Urology department ( Site 1208)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0092)

location_facility: Froedtert Hospital & the Medical College of Wisconsin ( Site 0045)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)

location_facility: University of Massachusetts Worcester ( Site 0053)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0430)

location_facility: University of Miyazaki Hospital ( Site 0721)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 0559)

location_facility: Ankara University Hospital Cebeci ( Site 0613)

location_facility: Centro Di Riferimento Oncologico ( Site 0800)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)

location_facility: Centre Hospitalier de Valenciennes ( Site 0439)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)

location_facility: Gold Coast University Hospital ( Site 0150)

location_facility: University Hospitals Cleveland Medical Center ( Site 0036)

location_facility: Universitaetsklinik fuer Urologie ( Site 0307)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 0038)

location_facility: Kitasato University Hospital ( Site 0705)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 0530)

location_facility: CISSS de la Monteregie-Centre ( Site 0119)

location_facility: Hakodate Goryoukaku Hospital ( Site 0739)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)

location_facility: Nemocnice AGEL Novy Jicin a.s. ( Site 1304)

location_facility: Mount Sinai Hospital Medical Center ( Site 0042)

location_facility: Instituto Medico Alexander Fleming ( Site 1010)

location_facility: Monash Health-Monash Medical Centre ( Site 0147)

location_facility: Hospital Universitario Gregorio Maranon ( Site 0327)

location_facility: Oregon Health Sciences University ( Site 0031)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0568)

location_facility: Yamaguchi University Hospital ( Site 0717)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 0337)

location_facility: Instituto de Oncologia de Rosario ( Site 1015)

location_facility: Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 1303)

location_facility: CHU Amiens Picardie Site Sud Amiens ( Site 0438)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0540)

location_facility: Azienda Ospedaliera Santa Maria Terni ( Site 0456)

location_facility: Clinical Research Center of specialized types medical care-Oncology ( Site 0570)

location_facility: Municipal non-profit enterprise Kyiv City Clinical Oncology -Oncourology department ( Site 1204)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli ( Site 0801)

location_facility: MHAT Serdika-Second Department of Medical Oncology ( Site 0505)

location_facility: Hospital Universitario HM Sanchinarro ( Site 0322)

location_facility: SBHI Leningrad Regional Oncology Dispensary ( Site 0588)

location_facility: Instituto Valenciano de Oncologia ( Site 0331)

location_facility: Seoul National University Bundang Hospital ( Site 0175)

location_facility: Tallaght University Hospital ( Site 0730)

location_facility: Gallipoli Medical Research Foundation ( Site 0149)

location_facility: Noordwest Ziekenhuisgroep NWZ ( Site 0468)

location_facility: Sunnybrook Research Institute ( Site 0108)

location_facility: Associated Medical Professionals of NY ( Site 0060)

location_facility: Taipei Veterans General Hospital ( Site 0135)

location_facility: T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (

location_facility: Nippon Medical School Hospital ( Site 0709)

location_facility: Centro Oncologico de Integracion Regional. COIR ( Site 1007)

location_facility: Dokkyo Medical University Saitama Medical Center ( Site 0707)

location_facility: Yitzhak Shamir Medical Center ( Site 0547)

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1040)

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 0065)

location_facility: National Cheng Kung University Hospital ( Site 0134)

location_facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1032)

location_facility: Toho University Sakura Medical Center ( Site 0703)

location_facility: Fundacion de Investigacion de Diego ( Site 1121)

location_facility: CNPE Regional Center of Oncology-oncourology department ( Site 1202)

location_facility: Maastricht University Medical Centre ( Site 0467)

location_facility: Port Macquarie Base Hospital ( Site 0153)

location_facility: Inova Schar Cancer Institute ( Site 0006)

location_facility: St. Vincent Frontier Cancer Center ( Site 0016)

location_facility: National Cancer Center Hospital East ( Site 0702)

location_facility: Dnepropetrovsk Regional Clinical Oncology Hospital-Clinical oncological dispensary ( Site 1201)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)

location_facility: Fundacion Arturo Lopez Perez ( Site 1049)

location_facility: Presidio Ospedaliero S. Maria Delle Grazie-U.O.C. ONCOLOGIA ( Site 0802)

location_facility: Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 1325)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0081)

location_facility: Instituto de Investigaciones Clinicas ( Site 1000)

location_facility: Medical Oncology Ospedale San Donato ( Site 0461)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0716)

location_facility: Amphia Hospital Location Molengracht ( Site 0474)

location_facility: Provita Prolife Centrum Medyczne ( Site 0630)

location_facility: Universitaetsklinikum Schleswig Holstein. ( Site 0346)

location_facility: Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0462)

location_facility: China Medical University Hospital ( Site 0132)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 0441)

location_facility: Yokohama City University Medical Center ( Site 0706)

location_facility: Nagasaki University Hospital ( Site 0719)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCCOLOGY ( Site 0618)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0543)

location_facility: Franciscus Gasthuis en Vlietland ( Site 0489)

location_facility: Ege University Medicine of Faculty ( Site 0661)

location_facility: Centro Investigación del Cáncer James Lind ( Site 1041)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1321)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0546)

location_facility: Hiroshima Prefectural Hospital ( Site 0748)

location_facility: Princess Margaret Cancer Centre ( Site 0107)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 1064)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)

location_facility: Central Clinical Hospital with Polyclinic ( Site 0562)

location_facility: Centro Oncologico Riojano Integral ( Site 1005)

location_facility: Assuta Ashdod Medical Center ( Site 0550)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0455)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)

location_facility: Puerto Rico Medical Research Center LLC ( Site 1122)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)

location_facility: Ankara City Hospital-Medical Oncology ( Site 0616)

location_facility: National Taiwan University Hospital ( Site 0131)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)

location_facility: Institut Mutualiste Montsouris ( Site 0446)

location_facility: Medizinische Universität Wien ( Site 0375)

location_facility: Tri-State Urologic Services PSC, Inc. ( Site 0094)

summary:
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses.

Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS).

Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.


ipd_sharing: Yes

status: Recruiting

primary_purpose: Treatment

intervention_type: Biological

acronym: Pembrolizumab as adjuvant therapy for resectable high-risk LA cSCC

title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)

study_completion_date_type: Anticipated

type: Other Identifier

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

enrollment_type: Anticipated

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Poland
Portugal
Russian Federation
Australia
Argentina
Israel
Mexico
Norway
Brazil
Canada
Hungary
Germany
Greece
Ireland
New Zealand
France
Chile
Colombia

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1113)

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 1562)

location_facility: Winship Cancer Institute of Emory University ( Site 1512)

location_facility: A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 1526)

location_facility: The Royal Marsden Hospital-Institute of Cancer Research ( Site 1406)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601)

location_facility: The Ottawa Hospital Cancer Centre ( Site 0154)

location_facility: Centro de atencion e investigacion clinica en oncologia ( Site 0706)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0958)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1256)

location_facility: Universal Clinic Oberig-Oncology Center ( Site 1461)

location_facility: Istituto Europeo di Oncologia ( Site 0602)

location_facility: University of Kentucky School of Medicine & Hospitals ( Site 1542)

location_facility: Hospital Particular do Algarve ( Site 1005)

location_facility: Royal Cornwall Hospitals NHS Trust ( Site 1402)

location_facility: West Cancer Center - East Campus ( Site 1535)

location_facility: Massachusetts General Hospital ( Site 1518)

location_facility: Papageorgiou General Hospital ( Site 0451)

location_facility: Centro de Investigación Clínica de Alta Especialidad ( Site 0715)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1408)

location_facility: Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 1452)

location_facility: CHU Besancon - Hopital Jean Minjoz ( Site 0359)

location_facility: Fundacion Estudios Clinicos-Oncology ( Site 0026)

location_facility: Universitaetsklinikum Essen ( Site 0403)

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 15

location_facility: Hospital Universitario Ramon y Cajal ( Site 1251)

location_facility: S C Oncocenter Oncologie Medicala S R L ( Site 1106)

location_facility: GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1171)

location_facility: Azienda Ospedaliero Universitaria Pisana ( Site 0603)

location_facility: Providence Portland Medical Center ( Site 1530)

location_facility: Attikon University General Hospital of Athens ( Site 0454)

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0100)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0552)

location_facility: University College Hospital London ( Site 1400)

location_facility: Haddassah Medical Organization - Ein Kerem ( Site 0553)

location_facility: Centre Hospitalier Annecy Genevois ( Site 0361)

location_facility: European Interbalkan Medical Center ( Site 0455)

location_facility: Spitalul de Psihiatrie Titan Dr. Constantin Gorgos ( Site 1112)

location_facility: Guy s & St Thomas NHS Foundation Trust ( Site 1407)

location_facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 1515)

location_facility: University of Iowa Hospital and Clinics ( Site 1514)

location_facility: Centro de Investigación Oncológica del Norte ( Site 1652)

location_facility: Universitaetsklinikum Tuebingen ( Site 0409)

location_facility: Szent Imre Egyetemi Oktatokorhaz ( Site 0502)

location_facility: Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159)

location_facility: Monter Cancer Center-Medical Oncology ( Site 1565)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0850)

location_facility: Hospital Universitario Carlos Haya ( Site 1255)

location_facility: Centro Oncológico de Rosario ( Site 0003)

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0163)

location_facility: Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (

location_facility: Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 1451)

location_facility: Hospital Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009)

location_facility: Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 0959)

location_facility: Hospital de Especialidades Centro Medico de Occidente ( Site 0704)

location_facility: CHRU de Lille - Hopital Claude Huriez ( Site 0355)

location_facility: Fundación Cardiovascular de Colombia ( Site 0207)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0370)

location_facility: Onco-Hematologia de Occidente ( Site 0716)

location_facility: Stanford University Medical Center ( Site 1503)

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0103)

location_facility: Centro Medico Privado CEMAIC ( Site 0024)

location_facility: Hospital Sao Vicente de Paulo ( Site 0105)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1000)

location_facility: The University of Texas-MD Anderson Cancer Center ( Site 1536)

location_facility: Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0365)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 1164)

location_facility: New Zealand Clinical Research (Auckland) ( Site 0800)

location_facility: City of Hope Medical Center ( Site 1505)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1258)

location_facility: Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0354)

location_facility: Centro Oncologico Riojano Integral ( Site 0002)

location_facility: Universitatsklinikum Giessen und Marburg GmbH ( Site 0413)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152)

location_facility: Inova Schar Cancer Institute ( Site 1538)

location_facility: Centre Hospitalier de Valence ( Site 0377)

location_facility: Consultorios de Medicina Especializada del Sector Privado ( Site 0701)

location_facility: Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0201)

location_facility: University of California Davis Comprehensive Cancer Center ( Site 1560)

location_facility: University of Colorado Cancer Center ( Site 1506)

location_facility: Instituto Portugues de Oncologia de Lisboa ( Site 1003)

location_facility: Uniwersyteckie Centrum Kliniczne-Klinka Chirurgii Onkologicznej ( Site 0960)

location_facility: Gold Coast University Hospital ( Site 0054)

location_facility: Altay Regional Oncology Dispensary ( Site 1168)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 0350)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1252)

location_facility: Boca Raton Regional Hospital ( Site 1551)

location_facility: Vanderbilt Ingram Cancer Center ( Site 1543)

location_facility: Soroka University Medical Center ( Site 0555)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0951)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0204)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0703)

location_facility: Hadassah Medical-Oncology department ( Site 1173)

location_facility: Oncologos del Occidente S.A. ( Site 0206)

location_facility: Spitalul Universitar CF Cluj-Napoca ( Site 1103)

location_facility: Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 0500)

location_facility: Hifu Terramed Conformal SRL ( Site 1111)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 1653)

location_facility: C.H.U. de Nimes. Hopital Caremeau ( Site 0368)

location_facility: Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 0056)

location_facility: Medizinische Hochschule Hannover ( Site 0405)

location_facility: McGill University Health Centre ( Site 0162)

location_facility: MUSC Hollings Cancer Center ( Site 1533)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1101)

location_facility: Smilow Cancer Center at Yale-New Haven ( Site 1507)

location_facility: Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158)

location_facility: Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1450)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0600)

location_facility: Hospital Clinic i Provincial Barcelona ( Site 1253)

summary: This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

summary: This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's Disease.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Yoshida K, Moein A, Bittner T, Ostrowitzki S, Lin H, Honigberg L, Jin JY, Quartino A. Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2020 Jan 22;12(1):16. doi: 10.1186/s13195-020-0580-2.

lead_sponsor: Genentech, Inc.

location_country:
Spain
United Kingdom
Canada
United States
France
Germany

location_facility: Zentralinstitut fuer Seelische Gesundheit

location_facility: University of British Columbia Hospital; Division of Neurology

location_facility: Royal Sussex County Hospital, CIRU Level 5

location_facility: Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine

location_facility: Univ Berlin; Klin fur Psychi & Psycho Charite

location_facility: West London Research Unit; Brentford Lodge

location_facility: Univ of CA San Diego; Neurosciences Comp.Alzheimer's

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Clinica Ruber, 4 planta; Servicio de Neurologia

location_facility: Florida Atlantic University; College of Medicine

location_facility: Camden Mews Day Hospital; Camden and Islington

location_facility: Hopital Hautepierre; Centre dInvestigation Clinique

location_facility: Hospital Universitario Virgen de la Macarena;

location_facility: Universitätsklinik Tübingen; Psychiatrie und Psychotherapie

location_facility: University of California Davis Medical System

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric

location_facility: Providence Care Centre; Mental Health Site

location_facility: Villa Sauer, Praxis für; Neurologie und Psychiatrie

location_facility: The National Hospital for Neurology & Neurosurgery; Dementia Research Center

location_facility: Studienambulanz emovis GmbH; St. Joseph Krankenhaus

location_facility: Clinical Neuroscience Research Associates, Inc.

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Investigational Drug Service; Univ of Rochester Medical Ctr

location_facility: Moorgreen Hospital; Memory Assessment & Rsch Ctr

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: IU Healthy Partners Adult Neurology Clinic

location_facility: University of Rochester Medical Center; Monroe Community Hospital

location_facility: Miami Jewish Health Systems; Clinical Research

location_facility: Great Western Hosp.; Kingshill Research Ctr

location_facility: Toronto Memory Program (Neurology Research Inc.)

intervention_type: Drug

status_simplified: Completed


title: A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

summary: This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.

ReferenceCitation: Schöffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D'Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. doi: 10.1016/S0140-6736(15)01283-0. Epub 2016 Feb 10.

lead_sponsor: Eisai Inc.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Singapore
Brazil
Canada
Germany
Denmark
New Zealand
Thailand
Korea, Republic of
France
Netherlands


title: First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy

summary:
This is a non-interventional/observational cohort of NSCLC unresectable stage III patients treated with durvalumab.

The study will be carried out as a retrospective review of established medical records for a subset of unresectable stage III patients treated with durvalumab.

status: Active, not recruiting

study_type: Observational

time_perspective: Other

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

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

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

lead_sponsor: AstraZeneca

location_country:
United Kingdom
Italy
Australia
Netherlands
Switzerland
France
Israel
Belgium
Norway
Germany


title: A Non-Interventional, Multicenter, Multiple Cohort Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice

acronym: IMreal

summary: This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice.

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Hoffmann-La Roche

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Belgium
Philippines
Romania
Poland
Portugal
Slovenia
Austria
Russian Federation
Argentina
Israel
Mexico
Singapore
Egypt
Kuwait
Brazil
Lebanon
Hungary
China
Bulgaria
Oman
Estonia
France
Chile
Colombia
Netherlands
United Arab Emirates

location_facility: Grande Ospedale Metropolitano; Oncologia Medica

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: University Clinical Emergency Hospital Bucharest

location_facility: Centrul Medical Focus; Oncologie medicala

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Hospital Universitario Infanta Cristina; Servicio de Oncologia

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

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: INSTITUTE OF ONCOLOGY LJUBLJANA; Lung Cancer Unit

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Royal United Hospital; Oncology Department

location_facility: Onze Lieve Vrouwe Gasthuis, locatie Oost

location_facility: ELO Pesquisa Clínica, Ensino e Consultoria Médica

location_facility: Tianjin Medical University General Hospital

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

location_facility: Tver Regional Oncology Clinical Dispensary

location_facility: Centro Clinico Champalimaud; Unidade de Pulmao

location_facility: Hospital General de Mataro; Servicio de Oncologia

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST

location_facility: Umhat Dr Georgi Stranski; Clinic of Chemotherapy

location_facility: Ospedale S.S. Trinità Nuovo; Divisione Oncologia

location_facility: Sanador Medical Center; Medical Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Ospedale Civile SS. Antonio E Biagio DI Alessandria; Oncologia

location_facility: Univerzitetni klinični center Maribor; Oddelek za onkologijo

location_facility: WZZOZ Centrum Leczenia Chorob Pluc i Rehabilitacji; O. Pulmonologii i Chemioterapii Nowotworow Pluc

location_facility: Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor

location_facility: Hospital Clinico de Granada; Servicio de Oncologia

location_facility: Centro Medico Teknon; Servicio de Oncologia

location_facility: Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie

location_facility: Hospital Pulido Valente; Servico de Pneumologia

location_facility: Service de pneumologie Clinique médico-chirurgicale Tessier

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

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

location_facility: Clinique Tivoli; Chimiotherapie Radiotherapie

location_facility: Saint George Hospital; Haematology-Oncology

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

location_facility: Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica

location_facility: Klinikum Klagenfurt; Abteilung für Pulmologie

location_facility: Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

location_facility: University of Pecs; 1St Department of Medicine

location_facility: Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta

location_facility: Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum

location_facility: SBIH Kaluga Region Clinical Oncology Dispensary

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: MHAT Sveta Sofia; Department of medical oncology

location_facility: Complejo Hospitalario de Navarra; Servicio de Oncologia

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

location_facility: Multi profiled Hospital for active treatment Park Hospital; Department of medicinal oncology

location_facility: Hospital Clinico Universitario de Valladolid; Servicio de Oncologia

location_facility: Tokuda Hospital; Medical Oncology Department

location_facility: Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej

location_facility: Centre Hospitalier de Valence; Pneumologie

location_facility: Centre Hospitalier Du Mans; Maladies Respiratoires

location_facility: Hopital De La Maison Blanche;Maladies Respiratoires

location_facility: Hospital General Universitario de Guadalajara; Servicio de Oncologia

location_facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Maidstone Hospital; Kent Oncology Centre

location_facility: Az. Osp. Monaldi; 1 Pneumologia Oncologica

location_facility: International Medical Center; Oncology Department

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

location_facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

location_facility: Uniwersyteckie Centrum Kliniczne im. K. Gibinskiego SUM; Oddzial Onkologii Klinicznej

location_facility: Azienda Ospedaliero Universitaria Di Sassari;Oncologia

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale; U.O.C. Oncologia Medica Toraco Polmonare

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

location_facility: Complex Oncology Center Burgas; Department of medical oncology

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

location_facility: Hospital Italiano de Buenos Aires; Hepatología

location_facility: Centre Georges Francois Leclerc; Oncologie 3

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

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: Chinese General Hospital and Medical Center

location_facility: ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic

location_facility: Clinique Mutualiste L Estuaire; Oncologie

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi

location_facility: Dolnoslaskie Centrum Onkologii; VII Onkologia Kliniczna

location_facility: Casa di Cura La Maddalena; Oncologia Medica

location_facility: Hospital Pedro Hispano; Servico de Oncologia

location_facility: Centrum Pulmonologii i Torakochirurgii; Oddzial Pulmonologiczny z Pododdzialem Chemioterapii

location_facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

location_facility: Southern Medical University Nanfang Hospital

location_facility: National Cancer Institute; Department of Thoracic Surgery and Oncology

location_facility: Chi Alpes Du Sud Site De Gap; Pneumologie

location_facility: Semmelweis Egyetem, AOK, Pulmonologiai Klinika

location_facility: Hopital Simone Veil Eaubonne; Hopital De Jour

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

location_facility: Centrum Onkologii im. Prof. Franciszka Łukaszczyka; Oddział Onkologii Klinicznej Odcinka A

location_facility: Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors

location_facility: Hopital Louis Pasteur; Oncologie Hematologie

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

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Hopital Gabriel Montpied; Service de Pneumologie

location_facility: University Hospital Palmed; Medical Oncology Ward

location_facility: Ospedale Mater Salutis; Dept of Oncology

location_facility: Ch Bretagne Atlantique; Pneumologie-Oncologie

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica

location_facility: Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Hospital General de Segovia; Servicio de Oncologia

location_facility: Complejo Hospitalario Torrecardenas; Servicio de Oncologia

location_facility: Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu; Oddział Chemioterapii

location_facility: Huddersfield Royal Infirmary; The Learning Centre

location_facility: Ospedale Maggiore Policlinico; U.O.C. di Oncologia Medica

location_facility: Middle East Institute of Health Hospital

location_facility: Polyclinique Kenval ; Radiotherapie Oncologie

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Hospital Infanta Sofia; Servico de Oncologia

location_facility: Great Western Hospitals NHS Foundation Trust.

location_facility: Wojewodzki Szpital Zespolony; Oddział Onkologii

location_facility: Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd

location_facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

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

location_facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Centrum Onkologii im. Prof. Franciszka Łukaszczyka; Oddział Onkologii Klinicznej Odcinka B

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

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Heartlands Hospital; Department Of Medicine

location_facility: Ospedale Oncologico A.Businco; Div. Oncologia Medica II

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

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

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: St James Hospital; Dept of Oncology/Hematology

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: CHG Henri Dufaut médecine interne-onco-hematologie

location_facility: Hospital Universitario Austral; Hepatología

location_facility: Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: Ospedale Di Circolo E Fondazione Macchi; Oncologia Medica

location_facility: Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza

location_facility: Airedale General Hospital; Research Office Ward 12

location_facility: Sultan Qaboos Comprehensive Cancer Care & Research Center

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

location_facility: North Estonia Medical Centre Foundation; Oncology Centre

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Complex Oncological Center-Ruse EOOD; Department of Medical Oncology

location_facility: Complejo Hospitalario de Orense; Servicio de Oncologia

location_facility: Wilhelminenspital; Ii. Medizinische Abt.

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Hospital Generla de Ciudad Real; Servicio de Oncologia

location_facility: Centrum Onkologii w Gliwicach; II Klinika Radioterapii i Chemioterapii

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

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

location_facility: DOLNOŚLĄSKIE CENTRUM ONKOLOGII, PULMONOLOGII I HEMATOLOGII; Oddział Onkologii Klinicznej


title: A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of BMS-986177, an Oral Factor XIa Inhibitor, for the Prevention of New Ischemic Stroke or New Covert Brain Infarction in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA)

acronym: AXIOMATIC-SSP

summary: The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.

primary_purpose: Prevention

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Greece
Finland
Korea, Republic of
France
Chile

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: University of Illinois Hospital & Health Sciences System

intervention_type: Other


title: A Placebo Controlled, Multicenter, Randomized Double Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction

summary: The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention with stent placement after ST segment elevation MI (STEMI).

ReferenceCitation: Wei X, Chen S, Xie T, Chen H, Jin X, Yang J, Sahar S, Huang H, Zhu S, Liu N, Yu C, Zhu P, Wang W, Zhang W. An MMP-degradable and conductive hydrogel to stabilize HIF-1α for recovering cardiac functions. Theranostics. 2022 Jan 1;12(1):127-142. doi: 10.7150/thno.63481. eCollection 2022.

ReferenceCitation: Rao SV, Zeymer U, Douglas PS, Al-Khalidi H, White JA, Liu J, Levy H, Guetta V, Gibson CM, Tanguay JF, Vermeersch P, Roncalli J, Kasprzak JD, Henry TD, Frey N, Kracoff O, Traverse JH, Chew DP, Lopez-Sendon J, Heyrman R, Krucoff MW. Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction. J Am Coll Cardiol. 2016 Aug 16;68(7):715-23. doi: 10.1016/j.jacc.2016.05.053.

ReferenceCitation: Frey N, Linke A, Süselbeck T, Müller-Ehmsen J, Vermeersch P, Schoors D, Rosenberg M, Bea F, Tuvia S, Leor J. Intracoronary delivery of injectable bioabsorbable scaffold (IK-5001) to treat left ventricular remodeling after ST-elevation myocardial infarction: a first-in-man study. Circ Cardiovasc Interv. 2014 Dec;7(6):806-12. doi: 10.1161/CIRCINTERVENTIONS.114.001478. Epub 2014 Oct 28.

lead_sponsor: Bellerophon BCM LLC

location_country:
Poland
Spain
Australia
Canada
United States
France
Israel
Belgium
Germany

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Oddzial Kardiologiczny Wojewodzki Specjalistyczny Szpital im. Bieganskiego w Lodzi

location_facility: Samodzileny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Royal Perth Hospital - Dept. of Cardiology

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Carl and Edyth Lindner Center for Research and Education @ Christ Hospital

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Hadassah University Medical Center Jerusalem-Cardiology

location_facility: Vivantes Netzwerk fur Gesundheit GmbH, Kinikum Neukolln

location_facility: Montefiore Medical Center Weiler Division

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

location_facility: I Klinika Kardiologii i Elektrokardiologii lnterwencyjnej oraz Nadcisnienia Tetniczego CM UJ

location_facility: Centre Hospitalier Universitaire de Nice Hopital Pasteur

location_facility: Klinik fur Kardiologie and Angiologie Universitatsklinikum

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Universitatsklinikum Jena, Klinik fur Innere Medizin, Kardiologie

location_facility: Stadtische Kliniken Neuss - Lukaskrankenhaus

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie

location_facility: Queen Elizabeth II Health Science Centre

location_facility: Centrum Interwencyjnego Leczenia Chorob Serca i Naczyn z Pododdzialem Kardiologii Interwencyjnej

location_facility: Hospital Clinico de Santiago de Compostela

location_facility: Krankenhaus Barmherzige Brüder Abt.Kardiologie und Pneumologie

intervention_type: Device


acronym: PACE

title: A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients With Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia

lead_sponsor: Ariad Pharmaceuticals

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre PD, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Müller MC, Gambacorti-Passerini C, Lustgarten S, Rivera VM, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes TP, Shah NP, Kantarjian HM. Ponatinib efficacy and safety in Philadelphia chromosome-positive leukemia: final 5-year results of the phase 2 PACE trial. Blood. 2018 Jul 26;132(4):393-404. doi: 10.1182/blood-2016-09-739086. Epub 2018 Mar 22.

ReferenceCitation: Januzzi JL, Garasic JM, Kasner SE, McDonald V, Petrie MC, Seltzer J, Mauro M, Croce K, Berman E, Deininger M, Hochhaus A, Pinilla-Ibarz J, Nicolini F, Kim DW, DeAngelo DJ, Kantarjian H, Xu J, Hall T, Srivastava S, Naranjo D, Cortes J. Retrospective analysis of arterial occlusive events in the PACE trial by an independent adjudication committee. J Hematol Oncol. 2022 Jan 6;15(1):1. doi: 10.1186/s13045-021-01221-z. Erratum in: J Hematol Oncol. 2022 Mar 23;15(1):33.

ReferenceCitation: Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre P, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DiPersio J, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Müller MC, Gambacorti-Passerini C, Wong S, Lustgarten S, Rivera VM, Clackson T, Turner CD, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes T, Goldman JM, Shah NP, Kantarjian H; PACE Investigators. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med. 2013 Nov 7;369(19):1783-96. doi: 10.1056/NEJMoa1306494. Epub 2013 Nov 1.

ReferenceCitation: O'Hare T, Zabriskie MS, Eiring AM, Deininger MW. Pushing the limits of targeted therapy in chronic myeloid leukaemia. Nat Rev Cancer. 2012 Jul 24;12(8):513-26. doi: 10.1038/nrc3317. Review. Erratum in: Nat Rev Cancer. 2012 Dec;12(12):886.

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

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Sweden
Korea, Republic of
France
Singapore
Belgium
Germany

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

summary: The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the (T)hreonine-315-(I)soleucine (T315I) mutation.


acronym: FLU D-QIV-003

title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2321138A When Administered in Children

lead_sponsor: GlaxoSmithKline

ReferenceCitation: Domachowske JB, Pankow-Culot H, Bautista M, Feng Y, Claeys C, Peeters M, Innis BL, Jain V. A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years. J Infect Dis. 2013 Jun 15;207(12):1878-87. doi: 10.1093/infdis/jit091. Epub 2013 Mar 7.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
United States
France
Philippines
Germany
Czechia

summary: This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.


title: A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)

acronym: VALOR

summary: This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.

ReferenceCitation: Ravandi F, Ritchie EK, Sayar H, Lancet JE, Craig MD, Vey N, Strickland SA, Schiller GJ, Jabbour E, Erba HP, Pigneux A, Horst HA, Recher C, Klimek VM, Cortes J, Roboz GJ, Odenike O, Thomas X, Havelange V, Maertens J, Derigs HG, Heuser M, Damon L, Powell BL, Gaidano G, Carella AM, Wei A, Hogge D, Craig AR, Fox JA, Ward R, Smith JA, Acton G, Mehta C, Stuart RK, Kantarjian HM. Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2015 Sep;16(9):1025-1036. doi: 10.1016/S1470-2045(15)00201-6. Epub 2015 Jul 30.

ipd_sharing_description: De-identified data of individual participants experiencing Serious Adverse Events

lead_sponsor: Sunesis Pharmaceuticals

location_country:
Poland
Spain
Italy
Austria
Australia
New Zealand
Canada
United Kingdom
Hungary
Korea, Republic of
United States
France
Belgium
Germany
Czechia

location_facility: CHU Nantes Hotel Dieu, Service d'hematologie clinique

location_facility: CHU de Bordeaux- Hopital Haut-Leveque, Centre Francois Magendle

location_facility: Ospedaliera Universitaria San Martino di Genova

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Universitatsklinikum Hamburg-Eppendorf; ll. Medizinische Klinik und Poliklinik; Onkologie, Hamatologie und Knochenmarktransplantation

location_facility: Rush University Medical Center, Division of Hematology/Oncology

location_facility: Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital

location_facility: Department of Haematology, University Hospital of Wales

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Szpital Kliniczny Przemiemienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Ospedale "A. Perrino", U.O. Compessa di Ematologia

location_facility: kaposi Mor Oktato Korhaz Belgyogyaszati Osztaly

location_facility: The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia

location_facility: Hopital Avicenne- Departement Onco-hematologie

location_facility: University Hospital for Internal Medicine V, Innsbruck Medical University

location_facility: Department of Clinical Haematology and BMT Service, Royal Melbourne Hospital

location_facility: Central Manchester University Hospitals NHS Trust, Manchester Royal Infirmary

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: St. Francis Medical Group Oncology and Hematology Specialists

location_facility: CHU Angers, Service des maladies du sang

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen lll, Medizinische Klinik

location_facility: New York Medical College, Division of Oncology/Hematology

location_facility: Haematology Research, Auckland District Health Board, Auckland City Hospital

location_facility: ZNA Stuivenberg, Lange Beeldekensstraat 267

location_facility: Ellis Fischel Cancer Center, University of Missouri Health Care

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Division of Hematology, Vancouver General Hospital

location_facility: Dept. of Hematology, Asan Medical Center

location_facility: Queen's Centre for Oncology and Hematology, Castle Hill Hospital

location_facility: Universitatsklinik Graz, Universitatsklinik fur Innere Medizin, Abteilung fur Hamatologie

location_facility: Fondazione IRCCS, Policlinico S. Matteo - Dipartimento di Ematologia

location_facility: Azienda Ospedaliero-Universitaria Sant'Anna, Sezione di Ematologia, Dipartmento di Science Biomediche e Terapie Avanzate

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Landeskrankenhaus Salzburg, Universitaetsklinik fur innere Medizin lll, Universitaetsklinikum der PMU

location_facility: Fakultni nemocnice Hradec Kralove, 2. Interni klinika-oddeleni klinicke hematologie

location_facility: Klinikum St. Georg gGmbH; Klinik fur Internistische Onkologie/Hamatologie

location_facility: Department of Haematology, Royal Liverpool University Hospital

location_facility: Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia University

location_facility: George Washington University-Medical Faculty Associates

location_facility: CHU Lille, Service des maladies du sang, Hopital Huriez

location_facility: AKH Wien / MedUniWien Universtatsklinik fur Innere Medizin 1

location_facility: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

location_facility: Hospital Universitari Politecnic la Fe Hematology Department

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: SLK-Kliniken Heilbronn GmbH, Medizinische Klinik

location_facility: Szegedi Tudomanyegyetem, 11. Belgyogyaszati Klinika

location_facility: AORN "A. Cardarelli", U.O.S.C. Ematologia con TMO

location_facility: Andrew Love Cancer Center, Geelong Hospital, Barwon Health

location_facility: Fakultni nemocnice Kralovske Vinohrady, Oddeleni klinicke hematologie

location_facility: Service d'hematologie- Hopital Purpan- CHU de Toulouse

location_facility: Department of Haematology, Waikato Hospital

location_facility: Leicester Royal Infirmary, University Hospitals of Leicester, NHS Trust

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: UZ Leuven, campus Gasthuisberg, Department of Haematology

location_facility: University of Iowa Hospitals and Clinics

location_facility: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

location_facility: Regional Cancer Treatment Service, Palmerston North Hospital

location_facility: Centro Oncologico MD Anderson International Espana

location_facility: Fakultni nemocnice Brno, Interni hematoonkologicka klinika

location_facility: Klinikum Frankfurt am Main-Hochst, Department of Hematology and Oncology, Klinikum Frankfurt Academic Hospital of the University of Frankfurt

location_facility: Medizinische Hochschule Hannover, Abteilung Hamatologie

location_facility: University of Debrecen Medical and Health Sciences Center

location_facility: North Shore Long Island Jewish Health System

location_facility: Haematology Department, Gosford Hospital

location_facility: Staedtisches Krankenhaus Kiel GmbH, Infektionsambulanz der 2. Medizinischen Klinik

location_facility: HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program

location_facility: Department of Haematology, Guy's Hospital

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie - Pavillon Marcel Berard - Bat. 1G - 1er etage, 165 Chemin du grand Revoyet

location_facility: Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Azienda Ospedaliero-Universitaria Maggiore Della Carita, Struttura Complessa Direzione Universitaria Ematologia


title: A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple-Negative Breast Cancer

ReferenceCitation: Diéras V, Campone M, Yardley DA, Romieu G, Valero V, Isakoff SJ, Koeppen H, Wilson TR, Xiao Y, Shames DS, Mocci S, Chen M, Schmid P. Randomized, phase II, placebo-controlled trial of onartuzumab and/or bevacizumab in combination with weekly paclitaxel in patients with metastatic triple-negative breast cancer. Ann Oncol. 2015 Sep;26(9):1904-1910. doi: 10.1093/annonc/mdv263. Epub 2015 Jul 22.

location_country:
Spain
United Kingdom
United States
France
Belgium
Germany

location_facility: Klinikum rechts der Isar der TU München; Frauenklinik

location_facility: Can Care Assoc Med Group Inc; Beach Cities Offices

location_facility: Sharp Healthcare; Oncology Research Program

location_facility: Centre Francois Baclesse; Gastro-Enterologie

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia

location_facility: St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

location_facility: Mount Vernon Hospital; Centre For Cancer Treatment

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Instituto Catalán de Oncología; Servicio de Farmacia

location_facility: Hospital Universitario Puerta del Mar; Servicio de Oncologia

summary: This is a randomized, Phase II, double-blind, multicenter, placebo-controlled trial designed to preliminarily estimate the efficacy and evaluate the safety and tolerability of onartuzumab (MetMAb) + bevacizumab + paclitaxel and onartuzumab + placebo + paclitaxel versus placebo + bevacizumab + paclitaxel in participants with metastatic or locally recurrent, triple-negative breast cancer who either have not received treatment (first-line) or have progressed after one conventional cytotoxic chemotherapy regimen (second-line).


title: A Double-blind, Randomized, Placebo-controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction

acronym: REMINDER

summary: Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity.

ReferenceCitation: Montalescot G, Pitt B, Lopez de Sa E, Hamm CW, Flather M, Verheugt F, Shi H, Turgonyi E, Orri M, Vincent J, Zannad F; REMINDER Investigators; REMINDER Investigators. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: the Randomized Double-Blind Reminder Study. Eur Heart J. 2014 Sep 7;35(34):2295-302. doi: 10.1093/eurheartj/ehu164. Epub 2014 Apr 29.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Poland
Spain
Greece
United Kingdom
Netherlands
Canada
Hungary
France
Germany
Slovakia
Czechia

location_facility: Hôpital Henri Mondor - Pysiologie explorations fonctionnelles

location_facility: Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ w Oswiecimiu G.V.M CARINT Sp. zo.o.

location_facility: Chu Rangueil Service de Cardiologie, A - Bat H1

location_facility: Blackpool Victoria Hospital NHS Trust , Cardiac Research ,Lancashire Cardiac Centre

location_facility: Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurimont

location_facility: Hospital General Universitario de Valencia

location_facility: ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Kardiologia

location_facility: Service Cardiologie Hopital Robert Boulin

location_facility: General Hospital of Athens "Georgios Gennimatas"

location_facility: Walter C Mackenzie Health Sciences Centre (WCM)

location_facility: Vancouver General Hospital, Vancouver Coastal Health Authority

location_facility: HOSPITAL CLINICO SAN CARLOS- Universidad Complutense de Madrid

location_facility: Vancouver General Hospital - Centennial Pavilion

location_facility: Georg-August-Universitaet Goettingen, Zentrum f. Innere Medizin / Kardiologie u. Pneumologie

location_facility: Petz Aladar Megyei Oktato Korhaz, Kardiologiai Osztaly

location_facility: Nemocnice Na Homolce - kardiologicke oddeleni

location_facility: Narodny ustav srdcovych a cievnych chorob, a.s.

location_facility: "Hospital Clinic i Provincial de Barcelona,Instituto Clinic del Torax

location_facility: I.Interni klinika-kardiologie FN Olomouc

location_facility: Service Cardiologie, Centre Hospitalier de Cannes

location_facility: Centre de Sante et de Services Sociaux de Chicoutimi (CSSSC) (Complexe Hospitalier de la Sagamie)

location_facility: Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny We Wroclawiu

location_facility: University Hospital of Leicester (UHL) NHS Trust

location_facility: Onze Lieve Vrouwe Gasthuis, Locatie Oosterpark

location_facility: Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

location_facility: Sankt Johannes Hospital Medizinische Klinik I

location_facility: Universitaets-Herzzentrum Freiburg Bad Krozingen

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: I. Interni klinika - kardiologie FN Olomouc

location_facility: Katedra i Klinika Kardiologii i Chorob Wewnetrznych

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob, a.s.

location_facility: Clinical Trials Unit, Morriston Hospital

location_facility: Staedtisches Klinikum Muenchen GmbH Klinikum Neuperlach

location_facility: The Queens Medical Research Institute- University of Edinburgh

location_facility: Hospital Del Sas de Jerez de La Frontera


acronym: RETAIN

title: A 2 Year Randomized, Single-masked, Multicenter, Controlled Phase IIIb Trial Assessing the Efficacy and Safety of 0.5 mg Ranibizumab in Two "Treat and Extend" Treatment Algorithms vs. 0.5 mg Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Prünte C, Fajnkuchen F, Mahmood S, Ricci F, Hatz K, Studnička J, Bezlyak V, Parikh S, Stubbings WJ, Wenzel A, Figueira J; RETAIN Study Group. Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study. Br J Ophthalmol. 2016 Jun;100(6):787-95. doi: 10.1136/bjophthalmol-2015-307249. Epub 2015 Oct 9.

location_country:
Poland
Portugal
Spain
Greece
Ireland
Italy
United Kingdom
Czech Republic
Switzerland
Hungary
France
Belgium
Netherlands

summary: The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.


title: A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

ReferenceCitation: Bekaii-Saab TS, Valle JW, Van Cutsem E, Rimassa L, Furuse J, Ioka T, Melisi D, Macarulla T, Bridgewater J, Wasan H, Borad MJ, Abou-Alfa GK, Jiang P, Lihou CF, Zhen H, Asatiani E, Féliz L, Vogel A. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol. 2020 Oct;16(30):2385-2399. doi: 10.2217/fon-2020-0429. Epub 2020 Jul 17.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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 applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Denmark
Spain
Ireland
Austria
Italy
Netherlands
Canada
Finland
Switzerland
United Kingdom
Sweden
United States
France
China
Israel
Belgium
Japan
Germany
Norway

location_facility: Mount Sinai Medical Center Comprehensive Cancer Center

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Tianjin Medical University Cancer Institute Hospital

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)

location_facility: Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo

location_facility: Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica

location_facility: Chu Ucl Namur University Hospital Mont-Godinne

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

location_facility: Centro Ricerche Cliniche Di Verona (Crc)

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Klinikum Der Johann Wolfgang Goethe University

location_facility: L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA ï¿½ MALPIGHI

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

location_facility: Hospital General Universitario de Valencia

location_facility: Georgetown University - Lombardi Comprehensive Cancer Center

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

location_facility: Irccs Azienda Ospedaliera Universitaria San Martino

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Kent Oncology Centre - Maidstone Hospital

location_facility: Karolinska Institute Universitetssjukhuset Solna

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano

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

location_facility: Greenville Hospital System University Medical Center Institute For Translational Oncology Research

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: West Virginia University Cancer Institute

location_facility: University College London Hospitals (Uclh)

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Winship Cancer Institute of Emory University

location_facility: Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci

location_facility: Comprehensive Cancer Centers of Nevada - Twain

location_facility: University Hospital Coventry and Warwickshire

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Chu Vandoeuvre-Les-Nancy Hopital Brabois

location_facility: Istituto Nazionale Tumori Regina Elena Irccs

location_facility: Baylor Scott and White Research Institute

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centre Hospitalier Universitaire de Nantes

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

location_facility: University of Calgary - Cumming School of Medicine

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Hospital Regional Universitario de Malaga

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Tongji Hospital Huazhong University of Science and Technology

location_facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

location_facility: Nova Scotia Health Authority/Qeii Health Sciences Centre

location_facility: Hopital Europeen Georges Pompidou (Hegp)

location_facility: Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori


title: ENGOT-0V44 The FIRST (First-line Ovarian Cancer Treatment With Niraparib Plus TSR-042) Study: A Randomized, Double-blind, Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

acronym: FIRST

summary: Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance of disease response. Given the unmet medical need of participants with advanced or metastatic ovarian cancer, this study design will enable investigators to provide participants with current SOC for ovarian cancer for the duration of the study. This is a global, multicenter, randomized, double-blind, controlled Phase 3 study that will primarily compare progressive survival rate of PD-L1 positive patients and also to compare progression-free survival (PFS) of all participants with Stage III or IV high-grade nonmucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab, and niraparib to SOC platinum-based combination therapy. The currently recommended SOC therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab. Participants will receive SOC during the chemotherapy Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent bevacizumab use must be determined prior to randomization at cycle 2. Approximately 1228 participants will be enrolled into the study and the duration of the study will be approximately 78 months.

lead_sponsor: Tesaro, Inc.

location_country:
Denmark
Poland
Romania
Belarus
Spain
Greece
Italy
Netherlands
United Kingdom
Canada
Finland
Ukraine
United States
France
Israel
Belgium
Norway
Germany
Czechia


title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus.

acronym: PROFILE 1014

summary: This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

ReferenceCitation: Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.

ReferenceCitation: Wilner KD, Usari T, Polli A, Kim EE. Comparison of cardiovascular effects of crizotinib and chemotherapy in ALK-positive advanced non-small-cell lung cancer. Future Oncol. 2019 Apr;15(10):1097-1103. doi: 10.2217/fon-2018-0869. Epub 2019 Jan 17.

ReferenceCitation: Solomon BJ, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Tang Y, Wilner KD, Blackhall F, Mok TS. Final Overall Survival Analysis From a Study Comparing First-Line Crizotinib Versus Chemotherapy in ALK-Mutation-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Aug 1;36(22):2251-2258. doi: 10.1200/JCO.2017.77.4794. Epub 2018 May 16.

ReferenceCitation: Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.

ReferenceCitation: Solomon BJ, Cappuzzo F, Felip E, Blackhall FH, Costa DB, Kim DW, Nakagawa K, Wu YL, Mekhail T, Paolini J, Tursi J, Usari T, Wilner KD, Selaru P, Mok TS. Intracranial Efficacy of Crizotinib Versus Chemotherapy in Patients With Advanced ALK-Positive Non-Small-Cell Lung Cancer: Results From PROFILE 1014. J Clin Oncol. 2016 Aug 20;34(24):2858-65. doi: 10.1200/JCO.2015.63.5888. Epub 2016 Mar 28.

ReferenceCitation: Solomon BJ, Mok T, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Iyer S, Reisman A, Wilner KD, Tursi J, Blackhall F; PROFILE 1014 Investigators. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014 Dec 4;371(23):2167-77. doi: 10.1056/NEJMoa1408440. Erratum in: N Engl J Med. 2015 Oct 15;373(16):1582.

ReferenceCitation: Ou SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62. doi: 10.1586/era.11.186. Review.

lead_sponsor: Pfizer

location_country:
Luxembourg
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
South Africa
Hong Kong
Portugal
Austria
Australia
Russian Federation
India
Mexico
Norway
Singapore
Brazil
Canada
Switzerland
China
Germany
Taiwan
Ireland
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility: Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka

location_facility: Centro Hospitalar de Lisboa Norte - Hospital Pulido Valente

location_facility: Thoraxklinik am Universitaetsklinikum Heidelberg

location_facility: Ospedale Niguarda Ca'Granda, Divisione Oncologia Medica Falck

location_facility: Academisch Ziekenhuis Maastricht / afdeling longziekten en tuberculose

location_facility: First Saint-Petersburg State Medical University n.a. I.P. Pavlov

location_facility: Washington University Center for Advanced Medicine Infusion Center Pharmacy

location_facility: Oslo universitetssykehus HF - Radiumhospitalet

location_facility: Oncology Center, Guangdong General Hospital

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: S.C. Farmacia Ospedaliera , Azienda Ospedaliero Universitaria San Luigi Gonzaga

location_facility: Oncologia Medica, Azienda Ospedaliero- Universitaria di Parma

location_facility: Universitair Ziekenhuis Gent (U.Z. Gent)

location_facility: Department of Oncology and Medical Radiology, SI "DMA of MOH, Ukraine

location_facility: APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques

location_facility: National Hospital organization Kyushu Cancer Center

location_facility: Fundacao Pio XII Hospital de Cancer de Barretos

location_facility: Tata Memorial Centre, Tata Memorial Hospital,

location_facility: Institut Jules Bordet, Centre des Tumeurs de l'ULB

location_facility: Unità Operativa Farmacia Ospedaliera PO di Livorno

location_facility: Mount Vernon Hospital, Mount Vernon Cancer Centre

location_facility: Lviv State Oncologic Regional Treatment and Diagnostic Center

location_facility: Ospedale Civile Azienda USL Toscana Nord Ovest

location_facility: Department of Pulmonary Diseases AZ Delta

location_facility: Centro Hospitalar e Universitario de Coimbra - Hospital Geral

location_facility: Peter MacCallum Cancer Centre, Department of Haematology and Medical Oncology

location_facility: Samsung Medical Center, Sungkyunkwan Univ. School of Medicine

location_facility: Hospital Clinico Universidad de Chile, Seccion de Oncologia

location_facility: Loma Linda University Cancer Center (LLUCC)-Schuman Pavilion

location_facility: Azienda Ospedaliero-Universitaria "Mater Domini"

location_facility: National Hospital Organization Yamaguchi-Ube Medical Center

location_facility: Rondebosch Oncology Centre, Rondebosch Medical Centre

location_facility: Azienda Ospedaliera San Camillo Forlanini-Padiglione Flaiani

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Istituto Regina Elena, Struttura Complessa Oncologia Medica A

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Institut universitaire de cardiologie et de pneumologie de Quebec (IUCPQ)

location_facility: Department of Clinical Oncology, Queen Elizabeth Hospital

location_facility: Universitair Ziekenhuis Brussel / Medische Oncologie

location_facility: NSLIJ Health System/Monter Cancer Center

location_facility: R.S. McLaughlin Durham Regional Cancer Centre

location_facility: The Christie Hospital NHS Foundation Trust, Department of Medical Oncology

location_facility: Hopital Arnaud de Villeneuve / CHU de Montpellier

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Chang Gung Medical Foundation, Kaohsiung Branch

location_facility: Research Pharmacy, Georgetown University Medical Center

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: UT Southwestern University Hospital - William P. Clements, Jr.

location_facility: City Multiple-Discipline Clinical Hospital #4,

location_facility: Instituto Português de Oncologia de Lisboa, Prof. Francisco Gentil E.P.E.

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Kyiv City Clinical Oncologic Center/Department of Chemotherapy

location_facility: Chang Gung Medical Foundation, LinKou Branch

location_facility: Shanghai Chest Hospital/Department of Pulmonary Medicine

location_facility: Karmanos Cancer Institute at Farmington Hills

location_facility: Centre Hospitalier Universitaire de Liege

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

location_facility: McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Unità Operativa di Oncologia Medica Azienda USL Città di Bologna

location_facility: Hospital Universitario Virgen de La Victoria

location_facility: Charite - Universitaetsmedizin Berlin, Campus Mitte

location_facility: The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital),

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: City Multiple-Discipline Clinical Hospital #4

location_facility: Satakunnan keskussairaala/Keuhkosairauksien osasto A4

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

location_facility: Samara Regional Clinical Oncology Dispensary

location_facility: Lynn Cancer Institute Center for Hematology Oncology

location_facility: Shanghai Pulmonary Hospital/Dept. of Oncology

location_facility: Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria

location_facility: Struttura Operativa Complessa Oncologia Medica A Centro di Riferimento Oncologico

location_facility: Hematology-Oncology Associates of Northern New Jersey

location_facility: UT Southwestern University Hospital - Zale Lipshy

location_facility: SC Oncologia Medica, Ospedale Santa Maria della Misericordia

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: UT Southwestern Medical Center - Simmons Cancer Center Pharmacy

location_facility: Unità Operativa di Farmacia - Campus Salvatore venuta

location_facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz

location_facility: Russian Oncological Research Center N.N. Blokhin

location_facility: Farmacia Istituto Europeo di Oncologia IRCCS, U.O. Farmacia

location_facility: Clinica Anglo Americana/Centro de Investigacion Oncologia CAA

location_facility: Kyushu University Hospital Respiratory Medicine

location_facility: Taichung Veterans General Hospital, Comprehensive Cancer Center

location_facility: NHS Greater Glasgow and Clyde Health Board, Beatson West of Scotland Cancer Centre,

location_facility: IRCCS -Arcispedale S. Maria Nuova Tecnologie Avanzate e Modelli Assistenziali in Oncologia

location_facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

location_facility: Nouvel Hopital Civil - HSU - Pôle de Pathologie Thoracique - Service de Pneumologie

location_facility: Grand Hopital de Charleroi -Site Notre Dame

location_facility: Oncology Department, West China Hospital of Sichuan University

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale Tumori, Struttura Complessa di Medicina Oncologica 1