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.

name: Portland VA Health Care System, 3710 SW US Veterans Hospital Road, P3HOC, Portland, OR 97239, USA

name: Knight Cancer Institute, 3485 SW Bond Avenue, Portland, OR 97239, USA

family: Graff

full_name: Julie N Graff

given: Julie N

name: MSD China, Building 21 Rongda Road, Chaoyang District, Beijing, China

family: Liang

full_name: Li Wen Liang

given: Li Wen

name: Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA

family: Kim

full_name: Jeri Kim

given: Jeri

name: Hoppe-Seylerstrasse 3, University of Tuebingen Medical Center, Tuebingen, D-72076, Germany

family: Stenzl

full_name: Arnulf Stenzl

given: Arnulf

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

location_facility: Fundacion Arturo Lopez Perez ( Site 1049)

location_facility: Hakodate Goryoukaku Hospital ( Site 0739)

location_facility: University of Miyazaki Hospital ( Site 0721)

location_facility: Hospital Universitario HM Sanchinarro ( Site 0322)

location_facility: Yamaguchi University Hospital ( Site 0717)

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

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

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

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

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

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

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0418)

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

location_facility: Seoul National University Hospital ( Site 0171)

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

location_facility: Cambridge University Hospitals NHS Trust ( Site 0540)

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

location_facility: Instituto Medico Alexander Fleming ( Site 1010)

location_facility: Gold Coast University Hospital ( Site 0150)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli ( Site 0801)

location_facility: Toho University Sakura Medical Center ( Site 0703)

location_facility: Seoul National University Bundang Hospital ( Site 0175)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)

location_facility: Medical Oncology Ospedale San Donato ( Site 0461)

location_facility: Hospital Clinico San Carlos ( Site 0324)

location_facility: MD Anderson Cancer Center Madrid ( Site 0332)

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

location_facility: Hamamatsu University Hospital ( Site 0720)

location_facility: Fundacion de Investigacion de Diego ( Site 1121)

location_facility: Universitaetsklinikum des Saarlandes ( Site 0348)

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

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

location_facility: Gallipoli Medical Research Foundation ( Site 0149)

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

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

location_facility: Universitaetsklinikum Goettingen ( Site 0345)

location_facility: Institut Mutualiste Montsouris ( Site 0446)

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

location_facility: University Hospitals Cleveland Medical Center ( Site 0036)

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

location_facility: Instituto Valenciano de Oncologia ( Site 0331)

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

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

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

location_facility: Centre Hospitalier de Valenciennes ( Site 0439)

location_facility: Inova Schar Cancer Institute ( Site 0006)

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

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

location_facility: St. Joseph Heritage Healthcare ( Site 0069)

location_facility: Assuta Ashdod Medical Center ( Site 0550)

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

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

location_facility: Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)

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

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

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

location_facility: Omsk Clinical Oncology Dispensary ( Site 0568)

location_facility: Medizinische Universitaet Wien ( Site 0375)

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

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

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

location_facility: Princess Margaret Cancer Centre ( Site 0107)

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

location_facility: Nippon Medical School Hospital ( Site 0709)

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

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

location_facility: SBHI Leningrad Regional Oncology Dispensary ( Site 0588)

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

location_facility: Nagasaki University Hospital ( Site 0719)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0452)

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

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

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

location_facility: Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)

location_facility: Assaf Harofe Medical Center Nephrology division ( Site 0547)

location_facility: Nara Medical University Hospital ( Site 0715)

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

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

location_facility: Hospital Universitario Gregorio Maranon ( Site 0327)

location_facility: Pontificia Universidad Catolica de Chile ( Site 1047)

location_facility: Kitasato University Hospital ( Site 0705)

location_facility: Maastricht University Medical Centre ( Site 0467)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0455)

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

location_facility: Franciscus Gasthuis en Vlietland ( Site 0489)

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

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 0559)

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

location_facility: Taipei Veterans General Hospital ( Site 0135)

location_facility: Noordwest Ziekenhuisgroep NWZ ( Site 0468)

location_facility: National Cancer Center Hospital East ( Site 0702)

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

location_facility: Cherkasy Regional Oncology Dispensary ( Site 1203)

location_facility: National Cheng Kung University Hospital ( Site 0134)

location_facility: Centro Di Riferimento Oncologico ( Site 0800)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)

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

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

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

location_facility: Centro de Diagnostico Urologico ( Site 1008)

location_facility: Universitaetsklinikum Schleswig Holstein. ( Site 0346)

location_facility: Azienda Ospedaliera Cannizzaro ( Site 0458)

location_facility: Hiroshima Prefectural Hospital ( Site 0748)

location_facility: Yokohama City University Medical Center ( Site 0706)

location_facility: Sunnybrook Research Institute ( Site 0108)

location_facility: University of Massachusetts Worcester ( Site 0053)

location_facility: Mount Sinai Hospital Medical Center ( Site 0042)

location_facility: University of Colorado Cancer Center ( Site 0022)

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

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

location_facility: National Taiwan University Hospital ( Site 0131)

location_facility: Radboud University Medical Center ( Site 0470)

location_facility: China Medical University Hospital ( Site 0132)

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

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

location_facility: Centro Oncologico Riojano Integral ( Site 1005)

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

location_facility: Gabrail Cancer Center-Research ( Site 0096)

location_facility: Ankara University Hospital Cebeci ( Site 0613)

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

location_facility: Universitaetsklinik fuer Urologie ( Site 0307)

location_facility: Hospital Provincial San Pedro Alcantara ( Site 0326)

location_facility: Kanazawa University Hospital ( Site 0701)

location_facility: Amphia Hospital Location Molengracht ( Site 0474)

location_facility: Tallaght University Hospital ( Site 0730)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 0615)

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

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

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

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

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

location_facility: Universitaetsklinikum Muenster ( Site 0320)

location_facility: Instituto de Oncologia de Rosario ( Site 1015)

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

location_facility: Vrije Universiteit Medisch Centrum ( Site 0479)

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

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

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

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

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

location_facility: Port Macquarie Base Hospital ( Site 0153)

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

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0092)

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

location_facility: Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)

location_facility: Provita Prolife Centrum Medyczne ( Site 0630)

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

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

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

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

location_facility: Carolina Urologic Research Center ( Site 0070)

location_facility: Azienda Ospedaliera Santa Maria Terni ( Site 0456)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0430)

location_facility: Haaglanden MC - locatie Antoniushove ( Site 0471)

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)

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.


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.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Actual

ipd_sharing: Yes

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

lead_sponsor_type: industriel

status_simplified: Ongoing


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.

status: Recruiting

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Hoffmann-La Roche

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

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Heartlands Hospital; Department Of Medicine

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

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

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

location_facility: Casa di Cura La Maddalena; Oncologia Medica

location_facility: Clinique Mutualiste L Estuaire; Oncologie

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Royal United Hospital; Oncology Department

location_facility: Great Western Hospitals NHS Foundation Trust.

location_facility: Az. Osp. Monaldi; 1 Pneumologia Oncologica

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

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Wilhelminenspital; Ii. Medizinische Abt.

location_facility: Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica

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

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Hopital Louis Pasteur; Oncologie Hematologie

location_facility: Tianjin Medical University General Hospital

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

location_facility: Sanador Medical Center; Medical Oncology

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

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

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

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

location_facility: Centre Hospitalier Du Mans; Maladies Respiratoires

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

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Clinique Tivoli; Chimiotherapie Radiotherapie

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

location_facility: Middle East Institute of Health Hospital

location_facility: Onze Lieve Vrouwe Gasthuis, locatie Oost

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

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Hopital De La Maison Blanche;Maladies Respiratoires

location_facility: Umhat Dr Georgi Stranski; Clinic of Chemotherapy

location_facility: University of Pecs; 1St Department of Medicine

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Hospital Generla de Ciudad Real; Servicio de Oncologia

location_facility: Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST

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

location_facility: Maidstone Hospital; Kent Oncology Centre

location_facility: Tver Regional Oncology Clinical Dispensary

location_facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

location_facility: ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic

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

location_facility: Dolnoslaskie Centrum Onkologii; VII Onkologia Kliniczna

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

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

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

location_facility: SK Przemienienia Panskiego UM im.K.Marcinkowskiego

location_facility: SBIH Kaluga Region Clinical Oncology Dispensary

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

location_facility: Univerzitetni klinični center Maribor; Oddelek za onkologijo

location_facility: Complejo Hospitalario de Navarra; Servicio de Oncologia

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

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

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

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Hospital Universitario Infanta Cristina; Servicio de Oncologia

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

location_facility: Hospital General de Segovia; Servicio de Oncologia

location_facility: Ospedale Mater Salutis; Dept of Oncology

location_facility: Klinikum Klagenfurt; Abteilung für Pulmologie

location_facility: Hopital Simone Veil Eaubonne; Hopital De Jour

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

location_facility: Grande Ospedale Metropolitano; Oncologia Medica

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Ch Bretagne Atlantique; Pneumologie-Oncologie

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

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

location_facility: Centro Clinico Champalimaud; Unidade de Pulmao

location_facility: Hospital Pulido Valente; Servico de Pneumologia

location_facility: Hospital Clinico de Granada; Servicio de Oncologia

location_facility: Hospital Italiano de Buenos Aires; Hepatología

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

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

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

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

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

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

location_facility: Airedale General Hospital; Research Office Ward 12

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

location_facility: Chinese General Hospital and Medical Center

location_facility: Dolnośląskie Centrum Chorób Płuc we Wrocławiu; Oddział Onkologii Klinicznej VII

location_facility: International Medical Center; Oncology Department

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

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

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

location_facility: Service de pneumologie Clinique médico-chirurgicale Tessier

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Complejo Hospitalario Torrecardenas; Servicio de Oncologia

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

location_facility: Hospital Infanta Sofia; Servico de Oncologia

location_facility: Complex Oncology Center Burgas; Department of medical oncology

location_facility: Chi Alpes Du Sud Site De Gap; Pneumologie

location_facility: Hospital Pedro Hispano; Servico de Oncologia

location_facility: Huddersfield Royal Infirmary; The Learning Centre

location_facility: Hopital Gabriel Montpied; Service de Pneumologie

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

location_facility: Hospital General Universitario de Guadalajara; Servicio de Oncologia

location_facility: Southern Medical University Nanfang Hospital

location_facility: St James Hospital; Dept of Oncology/Hematology

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

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

location_facility: Polyclinique Kenval ; Radiotherapie Oncologie

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

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

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

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

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Centre Hospitalier de Valence; Pneumologie

location_facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Centro Medico Teknon; Servicio de Oncologia

location_facility: Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

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

location_facility: Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum

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

location_facility: Ospedale Di Circolo E Fondazione Macchi; Oncologia Medica

location_facility: INSTITUTE OF ONCOLOGY LJUBLJANA; Lung Cancer Unit

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

location_facility: Semmelweis Egyetem, AOK, Pulmonologiai Klinika

location_facility: Hospital General de Mataro; Servicio de Oncologia

location_facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: University Hospital Palmed; Medical Oncology Ward

location_facility: Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: Hospital Clinico Universitario de Valladolid; Servicio de Oncologia

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

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

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

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

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

location_facility: Complejo Hospitalario de Orense; Servicio de Oncologia

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

location_facility: CHG Henri Dufaut médecine interne-onco-hematologie

intervention_type: Drug


title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-α] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment

summary: Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: Undecided

lead_sponsor: Abivax S.A.

location_country:
Italy
Austria
United States
Serbia
United Kingdom
Spain
Germany
France
Czechia
Poland
Slovakia
Hungary
Belgium
Belarus
Canada
Slovenia
Ukraine

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Vitebsk regoinal clinical specialized center

location_facility: Atlanta Center for Gastroenterology, P.C

location_facility: Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela

location_facility: Allen Whey Khye Lim Professional Corporation

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: CNE Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: CI City Clinical Hospital #6 Dept of Gastroenterology

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern

status_simplified: Completed


type: EudraCT Number

type: Registry Identifier

type: Other Identifier

title: A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

summary:
This study will compare DS-8201a to physician choice standard treatment.

Participants must have HER2-low breast cancer that has been treated before.

Participants' cancer:

Cannot be removed by an operation
Has spread to other parts of the body

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Italy
Austria
United States
Sweden
Switzerland
Spain
Germany
France
Japan
Greece
Israel
Hungary
Belgium
Russian Federation
China
Canada
United Kingdom
Korea, Republic of
Taiwan
Portugal

location_facility: Centre Hospitalier Wallonie picarde - Site IMC

location_facility: AKH - Medizinische Universität Wien (4305)

location_facility: Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario

location_facility: Hospital Universitario Clinico San Carlos

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

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Cancer Treatment Centers of America at Western Regional Medical Center

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

location_facility: Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)

location_facility: Ironwood Cancer & Research Centers - Chandler II

location_facility: SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"

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

location_facility: SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement

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

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Severance Hospital, Yonsei University Health System

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: University of California at San Francisco (PARENT)

location_facility: Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE

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

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

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Hospital Clinico Universitario Virgen de la Victoria

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

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Seoul National University Bundang Hospital

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: The Methodist Hospital Research Institute

location_facility: Cancer Care Associates Medical Group, Inc. TORI

location_facility: Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA

location_facility: Klinikum der Universitaet Muenchen - Campus Grosshardern

location_facility: Cancer Treatment Centers of America-Georgia

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

location_facility: University of Pittsburgh Medical Center Health System

location_facility: General Hospital of Ningxia Medical University

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Harbin Medical University Cancer Hospital

location_facility: General Oncology Hospital of Kifissia " Agioi Anargyroi"

location_facility: The Affiliated Drum Tower Hospital of Nanjing University

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Karolinska universitetssjukhuset - Solna

location_facility: Florida Cancer Specialists (South Region)

location_facility: Eastern Connecticut Hematology/Oncology Assoc.

location_facility: McGill University - Dept. Oncology Clinical Research Program

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

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

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Memorial Healthcare System MRH Cancer Center

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Brig Center for Cancer Care and Survivorship

location_facility: Complejo Hospitalario Universitario A Coruña

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

location_facility: Sylvester Comprehensive Cancer Center - Deerfield Beach

location_facility: Nottingham University Hospitals City Campus

location_facility: CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

location_facility: University General Hospital of Heraklion

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics


title: A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

acronym: NATALEE

summary: A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer

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 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:
Italy
Austria
Brazil
Spain
Germany
France
Korea, Republic of
Poland
Romania
Hungary
Argentina
Australia
Belgium
China
Ireland
Russian Federation
United States
United Kingdom
Canada
Taiwan

location_facility: Center for Cancer and Blood Disorders Research Department

location_facility: Seattle Cancer Care Alliance Medical Oncology

location_facility: Metro Minnesota CCOP Metro Minneapolis CCOP

location_facility: Orlando Health, Clinical Trials Orlando Health Inc

location_facility: Valley Breast Care and Women s Health Center

location_facility: UCLA Pasadena Health Care Hematology Oncology

location_facility: St. Jude Heritage Medical Group Dept.of Virginia K Crosson Ctr

location_facility: Southern California Oncology Research Alliance SCORA

location_facility: Cancer Treatment Centers of America Eastern Regional Medical Center

location_facility: UCLA Santa Monica Hematology / Oncology Regulatory-2

location_facility: Eastern Connecticut Hematology and Oncology Associates Regulatory

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center

location_facility: Central Coast Medical Oncology Corporation Onc Dept

location_facility: UCLA Porter Ranch Hematology and Oncology

location_facility: Holy Cross Hospital - Ft. Lauderdale CLCZ696BUS01

location_facility: University of California San Francisco Gynecologic Oncology

location_facility: Winship Cancer Institute of Emory University

location_facility: MD Anderson Cancer Center/University of Texas

location_facility: University of Alabama at Birmingham/ Kirklin Clinic

location_facility: Comprehensive Blood and Cancer Center SC-2

intervention_type: Other


title: A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

summary: A study to evaluate nivolumab + chemotherapy or nivolumab/ BMS-986205 + chemotherapy followed by continued Immuno-Oncology therapy after radical cystectomy (RC) compared with neoadjuvant standard of care (SOC) chemotherapy alone in patients with muscle-invasive bladder cancer (MIBC)

ReferenceType: derived

ReferenceCitation: Sonpavde G, Necchi A, Gupta S, Steinberg GD, Gschwend JE, Van Der Heijden MS, Garzon N, Ibrahim M, Raybold B, Liaw D, Rutstein M, Galsky MD. ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer. Future Oncol. 2020 Jan;16(2):4359-4368. doi: 10.2217/fon-2019-0611. Epub 2019 Dec 11.

name: Dana-Farber Cancer Institute, Genitourinary Oncology Division, Boston, MA 02215, USA

family: Sonpavde

full_name: Guru Sonpavde

given: Guru

sequence: first

name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

family: Necchi

full_name: Andrea Necchi

given: Andrea

sequence: additional

name: Department of Medicine, Masonic Cancer Center, University of Minnesota, Minneapolis, MN 55455, USA

family: Gupta

full_name: Shilpa Gupta

given: Shilpa

name: Department of Urology NYU Langone Health, New York University, New York, NY 10017, USA

family: Steinberg

full_name: Gary D Steinberg

given: Gary D

name: Department of Urology, Technical University of Munich, Munich, Germany

family: Gschwend

full_name: Juergen E Gschwend

given: Juergen E

name: Department of Medical Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands

family: Van Der Heijden

full_name: Michiel Simon Van Der Heijden

given: Michiel Simon

name: Bristol-Myers Squibb, Princeton, NJ 08540, USA

family: Garzon

full_name: Nathalie Garzon

given: Nathalie

family: Ibrahim

full_name: Mohammed Ibrahim

given: Mohammed

family: Raybold

full_name: Bradley Raybold

given: Bradley

family: Liaw

full_name: Danny Liaw

given: Danny

family: Rutstein

full_name: Mark Rutstein

given: Mark

name: Department of Medicine, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY 10029, USA

family: Galsky

full_name: Matt D Galsky

given: Matt D

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Norway
Argentina
Canada
Korea, Republic of
Colombia
Chile
Netherlands
Singapore
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain

location_facility: Hospital Clinico de la Universidad De Chile

location_facility: Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha

location_facility: Cancer Center At Milford Regional Medical Center

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: Universitaetsmedizin Der Johannes Gutenberg-Universitaet

location_facility: Centro de Investigacion Clinica Bradford Hill

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Columbia University Medical Center (Cumc)

location_facility: Klinikum Nuernberg Nord, Urologische Klinik

location_facility: ICANS-Institut de cancerologie Strasbourg Europe

location_facility: Pontificia Universidad Catolica de Chile

location_facility: Texas Oncology-Central Austin Cancer Center

location_facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists

location_facility: Oncocentro Servico Medicos e Hospitalares Ltda

location_facility: Hospital De Base Da Faculdade De Medicina De Rio Preto

location_facility: University General Hospital of Athens Attikon


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


location_country:
Finland
Belgium
Denmark
Croatia
France
Poland
Slovakia
Kuwait
Norway
Argentina
Canada
Slovenia
Turkey
Sweden
Netherlands
Bulgaria
Hungary
Ireland
Portugal
United Kingdom
Italy
Brazil
Mexico
Czechia
Spain
Estonia

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken

location_facility: ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla

location_facility: Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla

location_facility: Shat Np Sveti Naum; 3Rd Clinic of Neurology

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Gazi University Medical Faculty; Departmant of Neurology.

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

location_facility: Fakultni nemocnice u sv. Anny; Neurologicka klinika

location_facility: Sykehuset Buskerud HF; Nevrologisk avdeling

location_facility: Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Hospital General de Castellon; Servicio de Neurología

location_facility: Mustafa Kemal UTF; Department of norology

location_facility: Azienda Ospedaliera di Padova; Clinica Neurologica

location_facility: Cork University Hospital; Clinical Research Facility

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Hospital Puerta del Mar; Sevicio de Neurologia

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: London Health Sciences Centre Uni Campus

location_facility: Hospital Beatriz Angelo; Servico de Neurologia

location_facility: Ospedale Dimiccoli Barletta; Dipartimento Testa-Collo - UO Neurologia

location_facility: Fondazione Istituto S. Raffaele - Giglio; UO Neurologia

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: East Tallinn Central Hospital; Neurology Department

location_facility: HIA de Toulon hôpital militaire; Neurologie

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis

location_facility: Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: Rigshospitalet Glostrup; Neurologisk Klinik

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Groupe Hospitalier Pitié- Salpétrière; Service Neurologie

location_facility: Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia

location_facility: AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale

location_facility: Nemocnice Jihlava; NEU-Neurologicke oddeleni

location_facility: Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Centralsjukhuset; Neurologi och rehabiliteringskliniken

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny

location_facility: VALEOMED Diagnosztikai Központ; VALEOMED Diagnosztikai Központ

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: CHU de Rouen Hopital; Service de Neurologie

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

location_facility: CHU de Nîmes Hopital Caremeau; Service de Neurologie

location_facility: AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla

location_facility: Hospital Universitario La Paz; Servicio de Neurologia

location_facility: VFN Praha Poliklinika Rs Centrum - Budova A

location_facility: Montreal Neurological Institute and Hospital

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

location_facility: Odense Universitetshospital, Neurologisk Afdeling N; Neurologisk Ambulatorium N5; Skleroseklinikken

location_facility: Jahn Ferenc Del-Pesti Korhaz es Rendelointezet

location_facility: Karolinska Universitetssjukhuset Solna; Neurology

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: Unidad de investigacion en salud (UIS); Neurociencias

location_facility: Hospital Universitario Central de Asturias; Servicio de Neurología

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Neurologia

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla

location_facility: Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Haukeland universitetssykehus; Nevrologisk avdeling

location_facility: Hopital Central - CHU de Nancy; Service de Neurologie

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia

location_facility: AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B - Amb. Sclerosi Multipla

location_facility: AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia

location_facility: AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica

location_facility: IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

source: euctr

title: A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials

summary: This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).


title: Randomized Phase 3 Study Evaluating the Efficacy and the Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patient With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma

summary: This study evaluates the efficacy of Oral azacitidine versus single-agent Investigator's Choice Therapy in patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.

lead_sponsor: The Lymphoma Academic Research Organisation

location_country:
Austria
France
Belgium
Denmark
United Kingdom

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: CHU de Clermont-Ferrand - Hôpital Estaing

location_facility: Université Catholique de Louvain Saint-Luc

location_facility: University Hospital for Internal Medicine - University Hospital Graz

location_facility: CHU Haut-Lévèque - Centre François Magendie

location_facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme


title: Real-life Effectiveness of Vortioxetine in Patients With Major Depressive Disorder: Non-interventional, Multi-national, Prospective Cohort Study to Assess Real-life Effectiveness of Vortioxetine

acronym: RELIEVE

summary:
Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences.

Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tolerated antidepressant, there is a need to determine the effectiveness of vortioxetine in real life routine practice.

The study aim is to examine the real-life effectiveness of vortioxetine on functioning, depressive symptom relief, cognition and quality of life.

This is an observational, multi-national, study in patients with MDD initiating treatment with vortioxetine. Information will be collected by the physician, from the patient and their medical record at three time points - baseline, week 12 and week 24 (end of follow-up). This study will be conducted in six countries. In total 2,100 patients are planned for enrolment.

lead_sponsor: H. Lundbeck A/S

location_country:
Italy
United States
Canada
France

location_facility: Università degli Studi di Brescia (IT0029)

location_facility: Dr Lousqui Charles MD, Office of (FR0033)

location_facility: Disturbi Depressivi Ospedale Luigi Sacco Polo Universitario Psichiatria 2 - CTDD (IT0033)

location_facility: Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana (IT0035)

location_facility: CHU Clermont-Ferrand, Hopital Gabriel Montpied (FR0037)

location_facility: Dr. Norbert Rigaud Md, Office Of (FR0028)

location_facility: Centre Hospitalier De Martigues (FR0064)

location_facility: Southern Illinois Associates LLC (US0079)

location_facility: Pneumology Clinic - AO San Gerardo (IT0017)

location_facility: International Research Associates LLC (US0060)

location_facility: Millenia Psychiatry and Research, Inc. (US0015)

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga (IT0004)

location_facility: Viking Clinical Research Center LLC (US0033)

location_facility: Hopital Albert Michallon- CHU Grenoble Alpes (FR0021)

location_facility: Casa di Cura Villa San Benedetto Menni, Suore Ospedaliere (IT0025)

location_facility: Centre Hospitalier Universitaire de Nimes (FR0018)

location_facility: Universita Degli Studi Magna Graecia Di Catanzaro (IT0006)

location_facility: Azienda Ospedaliera San Paolo - Universita Degli Studi Di Milano (IT0014)

location_facility: Dr Philippe Marmor, MD, Office of (FR0035)

location_facility: Chatham-Kent Clinical Trials Research Centre (CA0007)

location_facility: Start Clinic For Mood And Anxiety Disorders (CA0006)

location_facility: Dr. Dominique Januel, MD Office of (FR0044)

location_facility: Harmonex Neuroscience Research Inc (US0072)

location_facility: Queen's University-Hotel Dieu Hospital (CA0011)

location_facility: St. Joseph's Health Care London - Parkwood Institute (Regional Mental Health Care London and Parkwood Hospital) (CA0004)

location_facility: Northwest Behavioral Research Center (US0007)

location_facility: North County Clinical Research (Nccr) (US0071)

location_facility: University Of Kansas Cancer Center (US0078)

location_facility: Universita Cattolica del Sacro Cuore (University of Sacred Heart Policlinico A. Gemelli) (IT0018)

location_facility: Dr. Philippe Remaud MD, Office of (FR0010)

location_facility: Professional Health Care of Pinellas (US0050)

location_facility: Center For Advanced Improvement (US0011)

location_facility: Universita Degli Studi Di Catania - Azienda Policlinico (IT0030)

location_facility: St. Charles Psychiatric Associates - Midwest Research Group (US0039)

location_facility: Dipartimento Salute Mentale ASL Lecce (IT0009)

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer - Hôpital Sainte Musse (FR0019)

location_facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur - Clinique de Psychiatrie et de Psychologie Medicale (FR0041)

location_facility: Rochester Center For Behavioral Medicine (US0059)

location_facility: Quest Therapeutics Of Avon Lake (US0002)

location_facility: Policlinico Universitario Di Messina (IT0031)

location_facility: Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0034)

location_facility: Azienda Toscana nord ovest zona Apuane (IT0039)

location_facility: Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma (IT0032)

location_facility: Pharmacology Research Institute (US0045)

location_facility: Chokka Center For Integrative Health (CA0001)

location_facility: DSM Giulianova - ospedale di Giulianova (IT0019)


title: COMBI-APlus: Open-label, Phase IIIb Study of Dabrafenib in COMBInation With Trametinib in the Adjuvant Treatment of Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes of an Adapted Pyrexia AE-management Algorithm (Plus)

acronym: COMBI-APlus

summary:
This is an open-label Phase IIIb study of dabrafenib in combination with trametinib in the adjuvant treatment of melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm, as well as safety, efficacy and health-related outcomes.

Approximately 600 subjects will be enrolled to receive dabrafenib (150 mg BID) and trametinib (2 mg once daily) combination therapy for 12 months. At enrollment, subjects will be instructed on the pyrexia management algorithm.

This study consists of two Periods for Enrolled subjects:

Treatment Period - subjects will receive up to 12 months of treatment.
Follow-up Period - subjects will be followed through 24 months from their first dose date for relapse, and through end of study for overall survival. Follow-up will start once treatment is complete or is prematurely discontinued and continue through the end of the study, regardless of disease recurrence.

location_country:
Finland
Greece
Australia
Russian Federation
France
Japan
Lithuania
Poland
Slovakia
Norway
Argentina
Canada
Slovenia
Sweden
Hungary
Portugal
United Kingdom
Italy
Brazil
Czechia
Israel
Turkey
Latvia


location_country:
Italy
United States
Brazil
Hong Kong
Spain
Germany
France
Japan
Belgium
Australia
China
Canada
United Kingdom
Korea, Republic of
Taiwan

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

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

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Azienda Ospealiera della Provincia di Lecco

location_facility: Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), U.O Oncologia Medica

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Institut de cancérologie de l'ouest, site René Gauducheau

location_facility: North Shore Hematology Oncology Associates, PC

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

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

location_facility: Clinique Victor Hugo - Centre Jean Bernard

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

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

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Hospital General Universitario Gregorio Maranon

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

location_facility: Houston Methodist Hospital / Houston Methodist Cancer Center

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Wake Forest University Baptist Medical Center

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Seoul National University Bundang Hospital

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Harbin Medical University Cancer Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Peninsula and South Eastern Haematology & Oncology Group

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Complejo Hospitalario Universitario A Coruña

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

location_facility: Nottingham University Hospitals City Campus

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

location_facility: Vanderbilt Breast Center at One Hundred Oaks

location_facility: Koo Foundation, Sun Yat-Sen Cancer Center

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

summary: This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.


location_country:
Italy
Brazil
Germany
France
Czechia
Greece
Israel
Japan
Belgium
Australia
Spain
Turkey
United States
United Kingdom
Korea, Republic of

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

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

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Azienda Ospealiera della Provincia di Lecco

location_facility: Konya Necmettin Erbakan University Meram Faculty of Medicine

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: North Shore Hematology Oncology Associates, PC

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Sociedade Beneficiente de Senhoras Hospital Sírio Libanês

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: Smilow Cancer Hospital at Yale New Haven

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

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

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Kartal Lutfi Kirdar Research and Training Hospital

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital de Especialidades de Jerez de la Frontera

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Hadassah University Hospital - Ein Kerem

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

location_facility: Kapiolani Medical Center for Women and Children/Univ of HI

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

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

location_facility: Ankara Yildirim Beyazit Uni. Med. Fac.Ankara City Hospital

location_facility: The Methodist Hospital Research Institute

location_facility: Klinikum der Universitaet Muenchen - Campus Grosshardern

location_facility: CliniOnco - Tratamento Integrado do Câncer

location_facility: Adana Numune Training and Research Hospital

location_facility: Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

location_facility: General Oncology Hospital of Kifissia " Agioi Anargyroi"

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Istanbul Medeniyet Uni Goztepe Training & Research Hospital

location_facility: Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital

location_facility: AMO - Assistência Multidisciplinar em Oncologia

location_facility: St. Marianna University School of Medicine Hospital

location_facility: University General Hospital of Heraklion

title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1

summary:
This study will compare DS 8201a to standard treatment.

Participants must have HER2 breast cancer that has been treated before.

Their cancer:

cannot be removed by an operation
has spread to other parts of the body


title: A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

ReferenceCitation: Pérez-García J, Soberino J, Racca F, Gion M, Stradella A, Cortés J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25. Review.

name: IOB Institute of Oncology, Quironsalud Group, Madrid & Barcelona, Spain

name: Medica Scientia Innovation Research (MedSIR), Barcelona, Spain

family: Pérez-García

full_name: José Pérez-García

given: José

family: Soberino

full_name: Jesús Soberino

given: Jesús

family: Racca

full_name: Fabricio Racca

given: Fabricio

name: Hospital Universitario Ramón y Cajal, Madrid, Spain

family: Gion

full_name: María Gion

given: María

name: Institut Català d’Oncologia, Hospitalet de Llobregat, Barcelona, Spain

family: Stradella

full_name: Agostina Stradella

given: Agostina

name: Vall d´Hebron Institute of Oncology (VHIO), Barcelona, Spain

family: Cortés

full_name: Javier Cortés

given: Javier

journal_name: Expert Opinion on Biological Therapy

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

location_country:
Peru
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Thailand
Argentina
Korea, Republic of
Hong Kong
Switzerland
Singapore
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain

location_facility: Queen Elizabeth Hospital Department of Clinical Oncology

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H

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

location_facility: Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica

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

location_facility: Hospital Universitario de Fuenlabrada; Servicio de Oncologia

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Chernivtsi Regional Clinical Oncology Dispensary

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

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: CRLCC-Francois Baclesse; Oncologie Médicale

location_facility: Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Armoricain de Radiotherapie, de Imagerie Medicale et de Oncologie (CARIO)

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: Taipei Medical University -Shuang Ho Hospital

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: General Hospital Hietzing, KLI; Dept. Obstet&Gynecol

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Gemeinschaftspraxis für Onkologie und Hämatologie

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: Sumy Reg. Clin. Oncological Dispensary; Thoracall Department

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Klinikum der Universität München; Frauenklinik - Onkologie II

location_facility: Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: LCC Center of Palliative Medicine - Devita

location_facility: INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology

location_facility: National Medical Research Center for Oncology

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

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia

location_facility: Beaumont Hospital; Cancer Clinical Trials Unit

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: University of Maryland Greenebaum Comprehensive Cancer Center

location_facility: Transkarpathian Regional Oncology Clinic; Chemotherapy

location_facility: Box Hill Hospital; Eastern Clinical Research Unit

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: The 900th Hospital of PLA joint service support force

location_facility: King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University

location_facility: Chi De Cornouaille; Oncologie Hospitalisation

location_facility: Hospital Mutua de Terrassa; Servicio de Oncologia

location_facility: Centre Hospitalier de Mont de Marsan - Hopital Layne

location_facility: Hospital Universitario Virgen de la Macarena;

location_facility: Regional Oncology Dispensary; Dept of Chemotherapy

location_facility: The Affiliated Hospital of Medical College Qingdao University

location_facility: Hospital General De Catalunya; Servicio de Oncologia

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Sjællands Universitetshospital, Næstved; Onkologisk Afdeling

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: Municipal Institution Odesa Regional Oncology Dispensary

location_facility: Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

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

location_facility: Hopital Prive Drome Ardeche; Hopital De Jour

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

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

location_facility: Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

location_facility: St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Infanta Sofia; Servico de Oncologia

location_facility: Kantonsspital Olten; Medizinische Klinik

location_facility: Fairview Southdale Medical Oncology Clinic

location_facility: Federal State Institution Medical Radiology Research Center

location_facility: Ospedale Degli Infermi - Faenza; Oncologia Medica

location_facility: Austin Hospital Olivia Newton John Cancer Centre

location_facility: NHS Greater Glasgow and Clyde; Beatson West of Scotland Cancer Centre

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

location_facility: Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg

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

location_facility: Princess Alexandra Hospital; Cancer Trials Unit

location_facility: The Second Affiliated Hospital of Zhejiang University College

location_facility: Klinikum Kreuzschwestern Wels; Iv. Interne Abt.

location_facility: Fujian Medical University Union Hospital

location_facility: CH Annecy Genevois site Annecy; Oncologie

location_facility: CHU de Grenoble - Hôpital André Michallon

location_facility: Monument Health Rapid City Hospital, Inc.

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

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

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

location_facility: Regional Oncology Center; Department of Mammology

location_facility: Centro Oncologico de Galicia COG; Medical Oncology

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

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

location_facility: BIH at Omsk Region "Clinical Oncology Dispensary", Outpatient clinic

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Sun yat-sen University Cancer Center; Internal Medicine of Oncology

location_facility: Centro de Oncologia e; Investigacion Buenos Aires - COIBA

location_facility: GUZ Kaluga Regional Oncological Dispensary

location_facility: Centro Di Riferimento Oncologico; SOC Oncologia Medica C

location_facility: Saitama Medical University International Medical Center

location_facility: ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik

location_facility: Hospital de Torrevieja; Servicio de Oncologia

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica

location_facility: AKH - Medizinische Universität Wien; Department of Oncology

location_facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

location_facility: Nemocnice Horovice, NH Hospital a.s.; Oncology Department

location_facility: Intermountain Precision Genomics Cancer Research Clinic-Dixie

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: The 307th Hospital of Chinese People's Liberation Army

location_facility: Ospedale Santa Maria Annunziata; Oncologia

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

location_facility: Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

location_facility: Seoul National University Bundang Hospital

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Medical University Innsbruck; Frauenklinik Innsbruck, Dept Gyn

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Wojskowy Inst.Medyczny Mon; Klinika Onkologii

location_facility: Harbin Medical University Cancer Hospital

location_facility: Calderdale and Huddersfield NHS Foundation Trust

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital

location_facility: Chiang Rai Prachanukroh Hospital; Department Of Medicine

location_facility: "Filantropia" Clinical Hospital; Gynecological Oncology

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

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: St. Luke's Internat. Hospital, Breast Surgical Oncology

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Beijing Hospital; Internal Medicine-Oncology

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

location_facility: Advocate Illinois Masonic Outpatient Center for Advanced Care

location_facility: CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: Albertinen-Krankenhaus Klinik f.Gynäkologie und Geburtshilfe

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: CCCH City Oncological Center SHEI Uzhgorod NU

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Hospital de Donostia.; Servicio de Oncología Radioterápica

location_facility: Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy

location_facility: NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: University of Maryland; St. Joseph Medical Center

location_facility: Centro Integral Oncológico Clara Campal Ensayos Clínicos START

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Hospital Infanta Cristina; Servicio de Oncologia

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Rochester General Hospital; Lipson Cancer and Blood Center

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: Hospital Universitario Rey Juan Carlos de Móstoles; Servicio de Neurología

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

location_facility: Southeastern Medical Oncology Center - Goldsboro

location_facility: Hadassah Med Org Kiryat; Oncology Institute

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Siriraj Hospital; Clinical Research Center, Pharmacy Department

location_facility: Universidade de Caxias do Sul - Rio Grande do Sul

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Non-state Healthcare Institution "Road Clinical Hospital of JSC Russian Railways"

location_facility: Belgorod Regional Oncology Dispensary; Chemotherapy

location_facility: Des Moines Oncology Research Association

location_facility: Nizhny Novgorod Regional Clinical Oncology Center

location_facility: Municipal Institution Odesa Regional Clinical Hospital

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Hospital Universitari Sant Joan de Reus; Planta baja, color lila

location_facility: Vinnytsya Regional Clinical Oncology Dispensary

location_facility: Severance Hospital; Yonsei University Health System

location_facility: Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie

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

location_facility: The First Affiliated Hospital of Xian Jiao Tong University

location_facility: Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Municipal Institution Kirovograd Regional Oncology Dispensary

location_facility: John Muir Health Clinical Research Center

location_facility: Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología

location_facility: Hospital Ruber Internacional;Servicio de Oncologia

location_facility: Icon Cancer Foundation; Icon Cancer Care Southport

location_facility: National University Hospital; Medical Oncology

location_facility: Mackay Memorial Hospital - Taipei Branch

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala

location_facility: Policlinico Universitario Campus Biomedico Di Roma

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

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Icon Cancer Foundation; Icon Cancer Care Chermside

location_facility: Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: SHI Volgograd Regional Clinical Oncological Dispensary#1

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


title: A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Treated With Gemcitabine Followed by Brentuximab Vedotin Maintenance

summary: This study is an open label, multicenter phase 2 study. The primary objective of the study is to determine the efficacy of brentuximab vedotin in patients treated by gemcitabine for relapsed or refractory peripheral T-cell lymphoma in term of overall response rate assessed after 4 cycles of treatment according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response).

location_country: Belgium France

location_facility: Centre François Magendie - Hôpital du Haut Lévêque

location_facility: CHU de Poitiers - Hôpital de la Milétrie

intervention_type: Procedure