title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

lead_sponsor: Eli Lilly and Company

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Latvia
Korea, Republic of
France
Netherlands

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: Acibadem Universitesi - Acibadem Kozyatagi Hastanesi

location_facility: Jiangsu Province Hospital of Chinese Medicine

location_facility: Nizhny Novgorod Regional Hospital N.A. Semashko

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

location_facility: Azienda Ospedaliera Santa Maria Della Misericordia

location_facility: Private Practice - Dr. Korczowski Bartosz

location_facility: Tianjin Medical University General Hospital

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

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -

location_facility: L2IP - Instituto de Pesquisas Clinicas Ltda.

location_facility: Ivano-Frankivsk State Medical University

location_facility: HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen

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

location_facility: Clinical Trials Center of Medical Institute

location_facility: University of Texas Health Services Center - Houston

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli

location_facility: Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

location_facility: Clinical Center Kragujevac Gastroenterohepatology Clinic

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Baylor Scott & White Center for Inflammatory Bowel Diseases

location_facility: Krajska zdravotni, a.s.-Masarykova nemocnice Usti nad Labem

location_facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: Kharkiv Regional Council Regional Clinical Hospital

location_facility: Care Access Research LLC - Salt Lake City

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Advanced Biomedical Research of America - South Eastern Avenue

location_facility: PanAmerican Clinical Research Mexico S.A. de C.V.

location_facility: NonState Healthcare Institution Central Clinical Hospital

location_facility: National Hospital Organization Hirosaki General Medical Center

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: University of Texas Medical Branch at Galveston

location_facility: Affiliated Hospital of Jiangsu University

location_facility: Azienda ospedaliero-universitaria Mater Domini

location_facility: Hacettepe University Faculty of Medicine

location_facility: National Center for Global Health and Medicine

location_facility: Lovelace Scientific Resources - Albuquerque

location_facility: SR Kalla Memorial Gastro & General Hospital

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual

location_facility: Multidisciplinary Medical Clinic "Anthurium"

location_facility: MGG Group, Inc.., Co., Chevy Chase Clinical Research

location_facility: Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

location_facility: Synexus North East Clinical Research Centre

location_facility: International Institute of Clinical Trials LLC

location_facility: Hospital Universitario Nuestra Señora de la Candelaria

location_facility: Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy

location_facility: PanAmerican Clinical Research S.A.de C.V. Guadalajara

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Synexus Clinical Research GmbH-Leipzig Research Centre

location_facility: Mustafa Kemal Universitesi Tayfur Ata Sokmen Tip Fakultesi

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: Kyunghee University Hospital at Gangdong

location_facility: CHU de Poitiers- Service d'Hépato-gastro-entérologie,

location_facility: Inonu Universitesi Turgut Ozal Tıp Merkezi

location_facility: Gastroenterology Associates of Pensacola, PA

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

location_facility: USPA Advance Concept Medical Research Group LLC.

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: Research Associates of South Florida, LLC

location_facility: University of Alabama-The Kirklin Clinic

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Hopital de Hautepierre - Service d'Hépatogastroentérolgie

location_facility: Southern Therapy and Advanced Research (STAR) LLC

location_facility: Academician I.P. Pavlov First St-Petersburg State Medical University

location_facility: The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA

location_facility: GastroIntestinal Biosciences Clinical Trials

location_facility: Gastroenterology and internal medicine research institute

location_facility: Johanna Etienne Krankenhaus-Klinik für Allgemeine Innere Medizin

location_facility: Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Università degli Studi c/o Spedali Civili

location_facility: Galilee Medical Center Department of Internal Medicine A

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

location_facility: Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

location_facility: Synexus Midlands Clinical Research Center

location_facility: Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

location_facility: Azienda Ospedaliera Universitaria Policlinico de Modena

location_facility: Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital

location_facility: Medical Centre of Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV

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

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

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Instituto de Investigaciones Clínicas para la Salud

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

location_facility: Associacao Paranaense de Cultura - PUCPR

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

location_facility: State Scientific Centre of Coloproctology

location_facility: Azienda Ospedaliera Policlinico Consorziale

location_facility: Gastroenterology Associates of the Piedmont

location_facility: Gujarat Hospital - Gastro and Vascular Centre

location_facility: The First People's Hospital of Yunnan Province

location_facility: Kyoto Furitsu Medical University Hospital

location_facility: The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Velocity Clinical Research/Gut Whisperer

location_facility: MUDr. Radka Koskova, s.r.o., Gastroenterologicka ambulance

location_facility: Xiangya Hospital Central South University

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Hospital Universitario Central de Asturias

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Kyungpook National University Medical Center Chilgok Hospital

location_facility: Nickalus Children's Hospital Research Institute

location_facility: Gastroenterology Consultants of Clearwater

location_facility: Scientific Centre of Reconstructive and Restorative Surgery

location_facility: St. Marienkrankenhaus-Medizinische Klinik I

location_facility: Saint-Petersburg City Hospital of Saint Elizabeth

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Eskisehir Osmangazi University Gastroenterology

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: University Medical Center "Bezanijska kosa"

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Oblastni nemocnice Nachod-Endoskopicke centrum

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway

location_facility: Endomedix Diagnosztikai Központ - Miskolc

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: University of Oklahoma Health Sciences Center

location_facility: Spitalul Universitar de Urgență București

location_facility: CHU Amiens Picardie Site Sud - Service d'Hepato-gastro-entérologie

location_facility: Synexus Manchester Clinical Research Centre

location_facility: Aakash Healthcare Super Speciality Hospital

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Konya Necmettin Erbakan Gastroenterology

location_facility: University Hospitals Cleveland Medical Center

location_facility: RCI Chernivtsi Regional Clinical Hospital

location_facility: University of Mississippi School of Medicine

location_facility: Advanced Clinical Research-Spokane Gastroenterology

location_facility: Tokyo Medical and Dental University Hospital

location_facility: The First Hospital Affiliated to AMU (Southwest Hospital)

location_facility: Shengjing Hospital of China Medical University

location_facility: Krankenhaus der Barmherzigen Schwestern Wien

location_facility: Practice Dr.med. Denger and Dr.med. Pfitzner

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: The First People's Hospital of Changzhou

location_facility: The First Hospital of China Medical University

location_facility: Okayama Saiseikai General Hospital Outpatient Center

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Synexus Polska Sp. z o.o. Oddzial w Poznaniu

location_facility: West China Hospital of Sichuan University

location_facility: Università di Cagliari - Presidio Policlinico Monserrato

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: National Hospital Organization Fukuyama Medical Center

location_facility: Complejo Hospitalario de Navarra NAVARRABIOMED UNIDAD EC

location_facility: Ruby Hall Clinic and Grant Medical Foundation

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Medical and Sanitary Division of Severstal

location_facility: Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine

location_facility: Paediatric Clinical Research Facility Royal Hospital for Children and Young People

location_facility: Centro de Alta Especialidad Reumatologia Inv del Potosi SC

location_facility: Caguas Gastroenterology and Hepatology Center, LLC

location_facility: Instituto de Pesquisa em Saúde - Fundação Universidade de Caxias do Sul

location_facility: Woodholme Gastroenterology Associates - Glen Burnie

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

location_facility: The Second Xiangya Hospital of Central South University

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

summary: The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.


ipd_sharing: Yes

status: Recruiting

primary_purpose: Treatment

intervention_type: Drug

title: A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination With Carfilzomib and Dexamethasone (DKd) Compared With Carfilzomib and Dexamethasone (Kd) in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab to Evaluate Daratumumab Retreatment

study_completion_date_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

type: EudraCT Number

type: Other Identifier

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

enrollment_type: Anticipated

location_country:
Denmark
Poland
Brazil
Spain
Greece
Italy
Netherlands
Russian Federation
Canada
United States
France
Belgium
Germany

location_facility: Karmanos Cancer Institute - Wayne State University

location_facility: Washington University School of Medicine

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Universitätsmedizin der Johannes gutenberg-Universität; III. Med. Klinik - Germany

location_facility: Weill Medical College of Cornell University

location_facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center

location_facility: Anticancer Hospital of Thessaloniki 'Theageneio'

location_facility: Universita Degli Studi di Roma 'Tor Vergata'

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: IRCCS Azienda Ospedaliera San Martino - IST

location_facility: Oncology Institute of Hope and Innovation

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Hospital Das Clinicas Da Universidade Federal De Goias

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

location_facility: Hopitaux Universitaires Est Parisien Hopital Saint Antoine

location_facility: Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I

location_facility: University of Athens - Evaggelismos Hospital (Evangelismos Hospital)

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Asst Ovest Milanese - Ospedale Di Legnano

location_facility: Centre Hospitalier Lyon-Sud Service d'hematologie

location_facility: Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii

location_facility: Praxisklinik für Haematologie und Onkologie Koblenz

location_facility: Instituto de Ensino e Pesquisa São Lucas

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

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy

location_facility: Albert Schweitzer ziekenhuis-lokatie Dordwijk

location_facility: Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

location_facility: Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

location_facility: Fentre F Magendie, Hôpital Haut Leveque, CHU Bordeaux

summary: The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)

acronym: COAST

summary: The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

status: Active, not recruiting

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Herbst RS, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez-Hernandez A, Dakhil S, Camidge DR, Winzer L, Soo-Hoo Y, Cooper ZA, Kumar R, Bothos J, Aggarwal C, Martinez-Marti A. COAST: An Open-Label, Phase II, Multidrug Platform Study of Durvalumab Alone or in Combination With Oleclumab or Monalizumab in Patients With Unresectable, Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Oct 10;40(29):3383-3393. doi: 10.1200/JCO.22.00227. Epub 2022 Apr 22.

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.

lead_sponsor: MedImmune LLC

location_country:
Poland
Taiwan
Hong Kong
Portugal
Spain
Italy
Canada
United States
France


title: A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy

summary: This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.

ReferenceCitation: Kelley RK, Rimassa L, Cheng AL, Kaseb A, Qin S, Zhu AX, Chan SL, Melkadze T, Sukeepaisarnjaroen W, Breder V, Verset G, Gane E, Borbath I, Rangel JDG, Ryoo BY, Makharadze T, Merle P, Benzaghou F, Banerjee K, Hazra S, Fawcett J, Yau T. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Aug;23(8):995-1008. doi: 10.1016/S1470-2045(22)00326-6. Epub 2022 Jul 4.

ReferenceCitation: Kelley RK, W Oliver J, Hazra S, Benzaghou F, Yau T, Cheng AL, Rimassa L. Cabozantinib in combination with atezolizumab versus sorafenib in treatment-naive advanced hepatocellular carcinoma: COSMIC-312 Phase III study design. Future Oncol. 2020 Jul;16(21):1525-1536. doi: 10.2217/fon-2020-0283. Epub 2020 Jun 3.

lead_sponsor: Exelixis

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Philippines
Romania
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Singapore
Brazil
Canada
Switzerland
Hungary
China
Germany
Taiwan
Ireland
Georgia
New Zealand
Thailand
Korea, Republic of
France
Colombia
Netherlands

location_facility:
Exelixis Clinical Site #29
Exelixis Clinical Site #31
Exelixis Clinical Site #188
Exelixis Clinical Site #201
Exelixis Clinical Site #13
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intervention_type: Biological

acronym: Phase III study of pembrolizumab for high-risk early-stage ER+/HER2– breast cancer

title: A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756)

lead_sponsor: Merck Sharp & Dohme LLC

type: Registry Identifier

location_country:
Spain
United Kingdom
Ukraine
United States
Costa Rica
Belgium
Japan
Poland
Portugal
Russian Federation
Australia
Puerto Rico
Israel
Brazil
Canada
Hungary
China
Germany
Taiwan
Ireland
New Zealand
Korea, Republic of
France
Colombia

location_facility: Medical University of South Carolina ( Site 0053)

location_facility: Centro de Investigacion Clinica del Country ( Site 0402)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1801)

location_facility: Bialostockie Centrum Onkologii ( Site 1819)

location_facility: Imelda Ziekenhuis Bonheiden ( Site 0703)

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 2905)

location_facility: MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 2607)

location_facility: Fudan University Shanghai Cancer Center ( Site 3205)

location_facility: Hospital Geral de Santo Antonio ( Site 2503)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 3209)

location_facility: Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 0205)

location_facility: Khmelnitskiy Regional Onkology Dispensary ( Site 2704)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1360)

location_facility: Arizona Oncology Associates PC- HOPE ( Site 8008)

location_facility: Ruijin Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3215)

location_facility: Colchester General Hospital ( Site 1508)

location_facility: Instituto Oncologico Baselga.Hospital Quiron. ( Site 1352)

location_facility: MGH - North Shore Cancer Center ( Site 0081)

location_facility: Medizinische Management GmbH ( Site 1012)

location_facility: CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0101)

location_facility: UPR Comprehensive Cancer Center ( Site 6200)

location_facility: Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0111)

location_facility: Fukushima Medical University Hospital ( Site 2610)

location_facility: Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 2904)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 1705)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0209)

location_facility: Kumamoto University Hospital ( Site 2602)

location_facility: Wojewodzkie Centrum Onkologii Copernicus ( Site 1817)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 2502)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 2402)

location_facility: University of Colorado Cancer Center ( Site 0008)

location_facility: University of Texas-MD Anderson Cancer Center ( Site 0083)

location_facility: Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 2721)

location_facility: Hospital Clinico San Carlos ( Site 1354)

location_facility: Universitaetsklinikum Erlangen ( Site 1001)

location_facility: Fujian Medical University Union Hospital-1 Bingfanglou-Oncology ( Site 3207)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2716)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2603)

location_facility: Jessa Ziekenhuis Campus Virga Jesse ( Site 0704)

location_facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 0066)

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)

location_facility: Centre Hospitalier Regional de Trois-Rivieres ( Site 0106)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 1905)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0903)

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

location_facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 1000)

location_facility: Hyogo College of Medicine Hospital ( Site 2600)

location_facility: Clínica Vida Fundación - Sede Poblado ( Site 0405)

location_facility: Orchard Healthcare Research Inc. ( Site 0020)

location_facility: Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego ( Site 1814)

location_facility: Szpitale Pomorskie Sp. z o.o. ( Site 1818)

location_facility: Hospital Clinic I Provincial de Barcelona ( Site 1353)

location_facility: OHSU Knight Cancer Institute ( Site 0051)

location_facility: CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 0919)

location_facility: Fundacion Universitaria Sanitas ( Site 0403)

location_facility: Saitama Medical University International Medical Center ( Site 2606)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1901)

location_facility: Medical Rehabilitation Center ( Site 1912)

location_facility: Sana Klinikum Offenbach GmbH ( Site 1002)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1903)

location_facility: Severance Hospital Yonsei University Health System ( Site 2201)

location_facility: Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204)

location_facility: Centre Georges Francois Leclerc ( Site 0920)

location_facility: Kitasato University Hospital ( Site 2616)

location_facility: Mayo Clinic and Medical School (Rochester) ( Site 0029)

location_facility: Massachusetts General Hospital ( Site 0024)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 2719)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1810)

location_facility: Medical center of the Limited Liability Company Yulis ( Site 2720)

location_facility: MVZ Nordhausen gGmbH - Praxis Dr. Grafe ( Site 1005)

location_facility: National Cancer Center Hospital East ( Site 2613)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2604)

location_facility: UZ Antwerpen - Medical Oncology ( Site 0709)

location_facility: Kadlec Clinic Hematology and Oncology ( Site 0070)

location_facility: Hospital Teresa Herrera - Chuac ( Site 1358)

location_facility: Hospital Universitario 12 de Octubre ( Site 1356)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 3220)

location_facility: Central Clinical Hospital with outpatient Clinic ( Site 1907)

location_facility: Nottingham University Hospitals NHS Trust ( Site 1504)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 2611)

location_facility: Texas Oncology-Austin Central ( Site 8004)

location_facility: Midwestern Regional Medical Center, Inc. ( Site 0077)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0406)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1900)

location_facility: Bon Secours St. Francis Medical Center Oncology Research ( Site 0064)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 2403)

location_facility: St. Georges University Hospital NHS Foundation Trust ( Site 1505)

location_facility: Complejo Hospitalario de Jaen ( Site 1364)

location_facility: Birmingham & Solihull Heartlands Hospital NHS ( Site 1506)

location_facility: Princess Margaret Cancer Centre ( Site 0112)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208)

location_facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 3213)

location_facility: Instituto Nacional de Cancer - INCA HC III ( Site 0200)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 1503)

location_facility: El Camino Hospital Cancer Center ( Site 0004)

location_facility: St. Vincent Frontier Cancer Center ( Site 0033)

location_facility: Texas Oncology-Dallas Presbyterian Hospital ( Site 8002)

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009)

location_facility: Cliniques Universitaires Saint-Luc ( Site 0701)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 3219)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0114)

location_facility: Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 1006)

location_facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0208)

location_facility: National Cheng Kung University Hospital ( Site 2400)

location_facility: MI Odesa Regional Clinical Hospital ( Site 2701)

location_facility: MI Odessa Regional Oncological Centre ( Site 2714)

location_facility: CHU UCL Namur Site de Godinne ( Site 0706)

location_facility: The First Affiliated Hospital of Zhejiang University ( Site 3203)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2915)

location_facility: Capital & Coast District Health Board - Wellington Hospital ( Site 2301)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0207)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 2907)

location_facility: Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1700)

location_facility: Aichi Cancer Center Hospital ( Site 2601)

location_facility: Weill Cornell Medical College ( Site 0043)

location_facility: Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (

location_facility: Ryazan Regional Clinical Oncology Dispensary ( Site 1910)

location_facility: Northwest Cancer Specialists, P.C. ( Site 8000)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 2702)

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 1004)

location_facility: Virginia Oncology Associates ( Site 8001)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 1803)

location_facility: Fourth Hospital Of Hebei Medical University ( Site 3216)

location_facility: Hospital Clinico Universitario de Valencia ( Site 1355)

location_facility: The University of Chicago Medical Center ( Site 0080)

location_facility: Instytut Centrum Zdrowia Matki Polki ( Site 1821)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2707)

location_facility: Hospital Ruber Internacional ( Site 1370)

location_facility: Goshen Center for Cancer Care ( Site 0021)

location_facility: Texas Oncology-Memorial City ( Site 8012)

location_facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1807)

location_facility: Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076)

location_facility: CISSS de la Monteregie-Centre ( Site 0108)

location_facility: Harbin Medical University Cancer Hospital ( Site 3200)

location_facility: Institut Curie - Centre Rene Huguenin ( Site 0917)

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2700)

location_facility: The First Hospital of Jilin University ( Site 3201)

location_facility: Chaim Sheba Medical Center. ( Site 1707)

location_facility: Baptist MD Anderson Cancer Center ( Site 0014)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1909)

location_facility: Peter MacCallum Cancer Centre ( Site 2102)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1800)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1367)

location_facility: National Taiwan University Hospital ( Site 2404)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 0925)

location_facility: Zhejiang Provincial People's Hospital ( Site 3225)

location_facility: Maryland Oncology Hematology, P.A. ( Site 8007)

location_facility: Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000)

location_facility: Zhejiang Cancer Hospital.... ( Site 3210)

location_facility: Shaare Zedek Medical Center ( Site 1708)

location_facility: Hospital Metropolitano - Sede Lindora ( Site 4203)

location_facility: China Medical University Hospital ( Site 2401)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 1008)

location_facility: UC Davis Comprehensive Cancer Center ( Site 0073)

location_facility: James Graham Brown Cancer Center ( Site 0022)

location_facility: Canterbury Regional Cancer & Blood Services ( Site 2303)

location_facility: Southeastern Regional Medical Center, Inc. ( Site 0075)

location_facility: Orszagos Onkologiai Intezet ( Site 2908)

location_facility: Gynaekologisch-onkologische Praxis Hannover ( Site 1013)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1820)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1363)

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0210)

location_facility: Hospital General Arnau de Vilanova de Valencia ( Site 1369)

location_facility: Caritas Klinikum Saarbruecken St. Theresia ( Site 1009)

location_facility: MercyOne Waterloo Cancer Center ( Site 0016)

location_facility: Associacao Hospitalar Moinhos de Vento ( Site 0201)

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26

location_facility: Seoul National University Hospital ( Site 2200)

summary:
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.

The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.


title: A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor

summary: Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral or indirect subcutaneous/intravenous anticoagulant

lead_sponsor: Alexion Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Czechia
Poland
Portugal
Austria
Israel
Norway
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Greece
Latvia
Estonia
Finland
France
Netherlands


title: A Phase II Study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS With High-risk ER+/HER2- Early Breast Cancer

acronym: Appalaches

summary: Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer.

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

location_country:
Poland
Portugal
Jordan
Spain
Italy
United Kingdom
France
Belgium
Germany

location_facility: Fundacion Instituto Valenciano De Oncologia

location_facility: Faenza Hospital Unit - Ospedale degli Infermi

location_facility: Azienda Ospedaliero - Universitaria Policlinico di Modena

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust - Blackpool Victoria Hospital-NHS Fundation Trust

location_facility: AULSS 9 - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

location_facility: Riccione Hospital Unit - Ospedale Cervesi di Cattolica

location_facility: NHS Borders - Borders General Hospital Melrose By-pass

location_facility: Onkologie Haematologie Gemeinschaftspraxis - Studienzentrum Onkologie Ravensburg

location_facility: Azienda Ospedaliero Universitaria - Ospedali Riuniti

location_facility: Barts Health NHS Trust - St. Bartholomew'S Hospital

location_facility: Institut Jules Bordet-Hopital Universitaire ULB

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Sant'Anna

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska - Curie's National Institute of Oncology - National Research Institute

location_facility: Centro Hospitalar do Porto-- Hospital de Santo Antonio

location_facility: Hospital prive du Confluent - Centre Catherine de Sienne

location_facility: CHU de Lyon - Hopital De La Croix Rousse

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital De Mataro

location_facility: ORTENAU KLINIKUM Offenburg-Gengenbach - Klinikum Offenburg Ebertplatz

location_facility: AUSL Romagna - Rimini Hospital Unit - Infermi Hospital

location_facility: Rimini Hospital Unit - Ospedale Sacra Famiglia

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Hospital Clinico Universitario De Valencia

location_facility: Instituto Portugues De Oncologia - Instituto Portugues de Oncologia do Porto

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST


title: An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials

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

ReferenceCitation: Blauvelt A, Langley RG, Lacour JP, Toth D, Laquer V, Beissert S, Wollenberg A, Herranz P, Pink AE, Peris K, Fangel S, Gjerum L, Corriveau J, Saeki H, Warren RB, Simpson E, Reich K. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022 Oct;87(4):815-824. doi: 10.1016/j.jaad.2022.07.019. Epub 2022 Jul 19.

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

lead_sponsor: LEO Pharma

location_country:
Poland
Spain
Italy
United Kingdom
Canada
France
United States
Belgium
Japan
Germany
Czechia

location_facility:
LEO Pharma Investigational Site
LEO Pharma Investigational Site 1
LEO Pharma Investigational Site 2


title: Observational Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022 and HZ Efficacy, Immunogenicity and Safety of HZ/su by Frailty Status

summary:
As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study participants completed quality of life (QoL) questionnaires. The only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study.

The purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Curran D, Kim JH, Matthews S, Dessart C, Levin MJ, Oostvogels L, Riley ME, Schmader KE, Cunningham AL, McNeil SA, Schuind AE, Andrew MK; Zoster-064 Study Group. Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals. J Am Geriatr Soc. 2021 Mar;69(3):744-752. doi: 10.1111/jgs.16917. Epub 2020 Nov 16.

lead_sponsor: GlaxoSmithKline

location_country:
Taiwan
Brazil
Hong Kong
Spain
Italy
United Kingdom
Australia
Estonia
Canada
Finland
Sweden
Korea, Republic of
United States
France
Mexico
Japan
Germany
Czechia

intervention_type: Other

status_simplified: Completed


title: Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)

ReferenceCitation: Long GV, Luke JJ, Khattak MA, de la Cruz Merino L, Del Vecchio M, Rutkowski P, Spagnolo F, Mackiewicz J, Chiarion-Sileni V, Kirkwood JM, Robert C, Grob JJ, de Galitiis F, Schadendorf D, Carlino MS, Mohr P, Dummer R, Gershenwald JE, Yoon CH, Wu XL, Fukunaga-Kalabis M, Krepler C, Eggermont AMM, Ascierto PA; KEYNOTE-716 Investigators. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma (KEYNOTE-716): distant metastasis-free survival results of a multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol. 2022 Nov;23(11):1378-1388. doi: 10.1016/S1470-2045(22)00559-9. Epub 2022 Oct 18.

ReferenceCitation: Luke JJ, Rutkowski P, Queirolo P, Del Vecchio M, Mackiewicz J, Chiarion-Sileni V, de la Cruz Merino L, Khattak MA, Schadendorf D, Long GV, Ascierto PA, Mandala M, De Galitiis F, Haydon A, Dummer R, Grob JJ, Robert C, Carlino MS, Mohr P, Poklepovic A, Sondak VK, Scolyer RA, Kirkwood JM, Chen K, Diede SJ, Ahsan S, Ibrahim N, Eggermont AMM; KEYNOTE-716 Investigators. Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial. Lancet. 2022 Apr 30;399(10336):1718-1729. doi: 10.1016/S0140-6736(22)00562-1. Epub 2022 Apr 1.

ReferenceCitation: Luke JJ, Ascierto PA, Carlino MS, Gershenwald JE, Grob JJ, Hauschild A, Kirkwood JM, Long GV, Mohr P, Robert C, Ross M, Scolyer RA, Yoon CH, Poklepovic A, Rutkowski P, Anderson JR, Ahsan S, Ibrahim N, M Eggermont AM. KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma. Future Oncol. 2020 Jan;16(3):4429-4438. doi: 10.2217/fon-2019-0666. Epub 2019 Dec 24.

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Australia
Canada
Switzerland
United States
Chile
France
Israel
Belgium
Japan
Germany
South Africa

location_facility: Inova Schar Cancer Institute ( Site 0014)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 0801)

location_facility: Moffitt McKinley Outpatient Center ( Site 0131)

location_facility: Hospital General Universitari Vall d Hebron ( Site 0456)

location_facility: UPMC Hillman Cancer Centers ( Site 0043)

location_facility: Hospital General Universitario de Valencia ( Site 0451)

location_facility: Melanoma Institute Australia ( Site 0856)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 0612)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0400)

location_facility: Azienda Ospedaliero Universitaria Senese ( Site 0401)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0306)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0161)

location_facility: Instituto Clinico Oncologico del Sur ( Site 0203)

location_facility: Royal Marsden Hospital - Fulham Road London ( Site 0613)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0769)

location_facility: Ashford Cancer Centre Research ( Site 0860)

location_facility: Centre Hospitalier Universitaire Vaudois ( Site 0553)

location_facility: IDI - Istituto Dermopatico dell'Immacolata ( Site 0405)

location_facility: National Cancer Center Hospital ( Site 0910)

location_facility: Hospital de Caridade de Ijui ( Site 0156)

location_facility: Charlotte Maxeke Johannesburg Academic Hospital ( Site 0811)

location_facility: Sociedad Medica Aren y Bachero Limitada ( Site 0207)

location_facility: Hospital Universitario Virgen Macarena ( Site 0455)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 0556)

location_facility: Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0759)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0142)

location_facility: Sunnybrook Research Institute ( Site 0060)

location_facility: Hospital de Clinicas de Rio Preto ( Site 0162)

location_facility: Kliniczny Szpital Wojewodzki Nr 1 ( Site 0758)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 0812)

location_facility: University of Texas-MD Anderson Cancer Center ( Site 0134)

location_facility: Chaim Sheba Medical Center. ( Site 0652)

location_facility: Hospital Clinic de Barcelona ( Site 0452)

location_facility: John Wayne Cancer Institute ( Site 0026)

location_facility: Tasman Oncology Research Pty Ltd ( Site 0858)

location_facility: Seattle Cancer Care Alliance ( Site 0044)

location_facility: Universitaetsspital Zuerich ( Site 0551)

location_facility: Christie NHS Foundation Trust ( Site 0604)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0457)

location_facility: Medizinische Hochschule Hannover ( Site 0358)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 0770)

location_facility: Princess Alexandra Hospital ( Site 0857)

location_facility: Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego ( Site 0757)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047)

location_facility: Oregon Health & Science University ( Site 0032)

location_facility: Princess Margaret Cancer Centre ( Site 0059)

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0357)

location_facility: Addenbrooke's Hospital in Cambridge ( Site 0600)

location_facility: Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie ( Site 0361)

location_facility: Children's Hospital of Pittsburgh UPMC ( Site 0144)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0200)

location_facility: Hopital Maisonneuve Rosemont ( Site 0056)

location_facility: University of Colorado Cancer Center ( Site 0027)

location_facility: West Cancer Center - East Campus ( Site 0022)

location_facility: Winship Cancer Institute of Emory University ( Site 0046)

location_facility: University of Wisconsin Hospital and Clinics ( Site 0030)

location_facility: Shamir Medical Center-Assaf Harofeh ( Site 0657)

location_facility: Universitaetsklinikum in Mannheim ( Site 0351)

location_facility: Hopital Ambroise Pare Boulogne ( Site 0316)

location_facility: Massachusetts General Hospital ( Site 0126)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0408)

location_facility: CHU Amiens Picardie Hopital Nord ( Site 0317)

location_facility: Oncological Institute of Southern Switzerland ( Site 0557)

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0359)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0754)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0154)

location_facility: Beth Israel Deaconess Medical Center ( Site 0141)

location_facility: The Angeles Clinic and Research Institute ( Site 0029)

location_facility: University of Tennessee Medical Center Knoxville ( Site 0116)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0360)

location_facility: Universitaetsklinikum Hamburg Eppendorf (UKE) ( Site 0352)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0151)

location_facility: Centro Oncologico Antofagasta ( Site 0206)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0751)

location_facility: Cliniques Universitaires Saint-Luc ( Site 0251)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0454)

location_facility: Guy s & St Thomas NHS Foundation Trust ( Site 0601)

location_facility: IRCCS A.O.U. San Martino - IST ( Site 0404)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0753)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 0407)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0155)

location_facility: The University of Chicago Medical Center ( Site 0007)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0406)

location_facility: McGill University Health Centre ( Site 0062)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 0807)

location_facility: Hospital Sao Vicente de Paulo ( Site 0158)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0304)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0055)

location_facility: Dana Farber Cancer Institute ( Site 0124)

location_facility: Universitaetsklinikum Tuebingen ( Site 0353)

location_facility: CHU de Quebec - Hotel-Dieu de Quebec ( Site 0061)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0651)

location_facility: University of Arizona Cancer Center ( Site 0121)

location_facility: University of Iowa Hospital and Clinics ( Site 0001)

location_facility: Advocate Medical Group-Park Ridge ( Site 0025)

location_facility: Instituto Nacional do Cancer II ( Site 0160)

location_facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 0403)

location_facility: Mayo Clinic [Rochester, MN] ( Site 0016)

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 0137)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0301)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0201)

location_facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 0004)

location_facility: Jessa Ziekenhuis Campus Virga Jesse ( Site 0256)

location_facility: Klinikum der Universitaet in Wuerzburg ( Site 0356)

summary:
This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo.

Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.


title: An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

summary:
The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy.

This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy.

In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.

ReferenceCitation: Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Durán I, Lee JL, Matsubara N, Vulsteke C, Castellano D, Wu C, Campbell M, Matsangou M, Petrylak DP. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021 Mar 25;384(12):1125-1135. doi: 10.1056/NEJMoa2035807. Epub 2021 Feb 12.

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

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Denmark
Taiwan
Portugal
Spain
Italy
Austria
Australia
Netherlands
Argentina
Canada
Russian Federation
Switzerland
United Kingdom
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: White Plains Hospital Center for Cancer Care - Oncology Site

location_facility: Sidney Kimmel Center for Prostate and Urologic Cancers

location_facility: UCI Chao Family Comprehensive Cancer Center

location_facility: Benaroya Research Institute at Virginia Mason


acronym: NAVIGATOR

title: A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)

lead_sponsor: AstraZeneca

ReferenceCitation: Menzies-Gow A, Corren J, Bourdin A, Chupp G, Israel E, Wechsler ME, Brightling CE, Griffiths JM, Hellqvist Å, Bowen K, Kaur P, Almqvist G, Ponnarambil S, Colice G. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021 May 13;384(19):1800-1809. doi: 10.1056/NEJMoa2034975.

ReferenceCitation: Menzies-Gow A, Colice G, Griffiths JM, Almqvist G, Ponnarambil S, Kaur P, Ruberto G, Bowen K, Hellqvist Å, Mo M, Garcia Gil E. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020 Oct 13;21(1):266. doi: 10.1186/s12931-020-01526-6.

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

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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

location_country:
Taiwan
Brazil
Saudi Arabia
United Kingdom
Austria
Australia
Russian Federation
Argentina
Canada
Vietnam
Ukraine
Korea, Republic of
United States
France
Israel
South Africa
Japan
Germany

summary: A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma


title: A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen.

summary: The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.

ReferenceType: result

ReferenceCitation: Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin Ther. 2004 May;26(5):724-36.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Denmark
United Kingdom
Ireland
Australia
Finland
Sweden
France
Belgium
Norway
Netherlands


title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination With Azacitidine in Subjects ≥ 18 Years of Age With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

acronym: AGILE

summary: Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.

ReferenceCitation: Montesinos P, Recher C, Vives S, Zarzycka E, Wang J, Bertani G, Heuser M, Calado RT, Schuh AC, Yeh SP, Daigle SR, Hui J, Pandya SS, Gianolio DA, de Botton S, Döhner H. Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia. N Engl J Med. 2022 Apr 21;386(16):1519-1531. doi: 10.1056/NEJMoa2117344.

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Poland
Taiwan
Brazil
Spain
Italy
Austria
Australia
Netherlands
Canada
Russian Federation
United Kingdom
Korea, Republic of
United States
France
China
Israel
Mexico
Japan
Germany
Czechia

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

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

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

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: ASST dei Sette Laghi - Ospedale Di Circolo E Fondazione Macchi

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Institut dHematologie de Basse Normandie

location_facility: Hospital Universitario Vall d'Hebron - PPDS

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

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Severance Hospital Yonsei University Health System

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Centre Hospitalier de Versailles CHV Hopital Andre Mignot

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Unicamp Universidade Estadual de Campinas

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Hospital Universitario Germans Trias i Pujol


title: An Open-Label, Multicenter Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study

lead_sponsor: Hoffmann-La Roche

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
New Zealand
Thailand
Korea, Republic of
France
Chile
Netherlands

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

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Sunnybrook Odette Cancer Centre; Clinical Trials

location_facility: Washington University School of Medicine

location_facility: Klinikum d.Universität München Campus Großhadern

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

location_facility: Beth Israel Medical Center; Division of Digestive Diseases

location_facility: Chonnam National University Hwasun Hospital

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: The Cancer Institute Hospital of JFCR, Respiratory Medicine

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Oddział Onkologii Klinicznej i Chemioterapii Szpitala ELBLĄSKA

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

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

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: Kaiser Permanente - San Diego (Zion Ave)

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

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: University of Washington Seattle Cancer Care Alliance

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

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

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

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

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Princess AleXandra Hospital; Department of Medical Oncology

location_facility: Lakeridge Health Corporation-Oshawa; Oncology clinic

location_facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

location_facility: Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice

location_facility: Dana Farber Cancer Inst. ; Dept. of Medical Oncology

location_facility: Clinic for Pulmonology, Clinical Center of Serbia

location_facility: Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale

location_facility: Charing Cross Hospital; Medical Oncology.

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

location_facility: Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy

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

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

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: University Of Chicago Medical Center; Section Of Hematology/Oncology

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Changhua Christian Hospital; Internal Medicine

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Okayama University Hospital; Respiratory and Allergy Medicine

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung

location_facility: US oncology research at Minnesota Oncology

location_facility: Semmelweis Egyetem X; Pulmonologiai Klinika

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

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

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

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Georgetown University Medical Center Lombardi Cancer Center

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

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: China Medical University Hospital; Urology

location_facility: Rocky Mountain Cancer Ctr - Denver (Williams)

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

location_facility: Seoul National University Bundang Hospital

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

location_facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie

location_facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

location_facility: Northwestern University; Robert H. Lurie Comp Can Ctr

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Centre Medico-Chirurgical Foch; Service de Pneumologie

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

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Iwate Medical University Hospital; Urology

location_facility: Royal Free Hospital; Oncology & Haematology

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Virginia Oncology Associates - Lake Wright Cancer Center

location_facility: Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: H. Lee Moffitt Cancer Center and Research Inst.

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department

location_facility: Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique

location_facility: Northwest Cancer Specialists - Portland (N Broadway)

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

summary: This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first.


ipd_sharing: No

acronym: ECZTRA 1

title: A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

ReferenceCitation: Blauvelt A, Gooderham M, Bhatia N, Langley RG, Schneider S, Zoidis J, Kurbasic A, Armstrong A, Silverberg JI. Tralokinumab Efficacy and Safety, with or without Topical Corticosteroids, in North American Adults with Moderate-to-Severe Atopic Dermatitis: A Subanalysis of Phase 3 Trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 Nov;12(11):2499-2516. doi: 10.1007/s13555-022-00805-y. Epub 2022 Sep 24.

ReferenceCitation: Simpson EL, Merola JF, Silverberg JI, Reich K, Warren RB, Staumont-Sallé D, Girolomoni G, Papp K, de Bruin-Weller M, Thyssen JP, Zachariae R, Olsen CK, Wollenberg A. Safety of tralokinumab in adult patients with moderate-to-severe atopic dermatitis: pooled analysis of five randomized, double-blind, placebo-controlled phase II and phase III trials. Br J Dermatol. 2022 Sep 9. doi: 10.1111/bjd.21867. [Epub ahead of print]

ReferenceCitation: Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, Spelman L, Katoh N, Saeki H, Poulin Y, Lesiak A, Kircik L, Cho SH, Herranz P, Cork MJ, Peris K, Steffensen LA, Bang B, Kuznetsova A, Jensen TN, Østerdal ML, Simpson EL; ECZTRA 1 and ECZTRA 2 study investigators. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021 Mar;184(3):437-449. doi: 10.1111/bjd.19574. Epub 2020 Dec 30.

location_country:
Spain
United States
France
Japan
Germany

location_facility: Hôpital Charles Nicolle, Clinique Dermatologique

location_facility: Hospital Universitario de la Princesa, Servicio Dermatología

location_facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Dermatologie

location_facility: Hospital Universitario La Paz, Servicio Dermatología

location_facility: Centre Hospitalier Universitaire, Clinique dermatologique 7 eme nord

location_facility: Klinikum Bielefeld Rosenhöhe, Hautklinik

location_facility: Center for Dermatology and Laser Surgery

location_facility: Hospital de Basurto, Servicio Dermatología

location_facility: Klinikum Augsburg, Klinik für Dermatologie und Allergologie

location_facility: Clínica Universitaria de Navarra, Servicio Dermatología

location_facility: Hôpital de l'Archet II, Service de Dermatologie- Vénérologie

location_facility: CHRU de Brest - Hôpital Morvan, Service de Dermatologie

location_facility: Hospital Clinic de Barcelona, Dermatology Department

location_facility: Facharztpraxis für Dermatologie, Allergologie, Venerologie und Umweltmedizin

location_facility: Hospital Reina Sofía, Servicio Dermatología

location_facility: Hospital de Fuenlabrada, Servicio Dermatología

location_facility: University at Buffalo Department of Dermatology

location_facility: Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Dermatologie und Venerologie

location_facility: Hospital Germans Trias i Pujol, Servicio Dermatología

location_facility: Hôpital St ANDRE, CHU de BORDEAUX, Service de Dermatologie

location_facility: Universitätsklinikum Münster Klinik und Poliklinik für Hautkrankheiten Münster, Zentrale Studienkoordination für innovative Dermatologie

location_facility: CHU de Toulouse Hôpital Larrey, Service de Dermatologie

location_facility: Hospital de Cruces, Servicio Dermatología

location_facility: University Hospitals Cleveland Medical Center

location_facility: Universitätsklinikum Essen (AöR), Klinik für Dermatologie, Venerologie und Allergologie

location_facility: C.H.U. de Saint-Etienne - Hôpital Nord, Service de dermatologie

location_facility: Niesmann, Hautzentrum im Jahrhunderthaus

location_facility: Dermtology Treatment and Research Center

location_facility: Georgia Pollens Clinical Research Centers, Inc.

location_facility: Universitätsklinikum Leipzig, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

location_facility: Hospital Virgen de la Macarena, Servicio Dermatología

location_facility: Hospital Universitario y Politécnico La Fe, Servicio Dermatología

location_facility: Hospital Infanta Leonor, Servicio Dermatología

location_facility: Research Institute of the Southeast, LLC

location_facility: SRH Wald-Klinikum Gera, Klinik für klinische Studien

location_facility: Hospital de la Santa Creu i Sant Pau, Servicio Dermatología

location_facility: Medizinische Hochschule Hannover, Klinik für Dermatologie, Allergologie und Venerologie

location_facility: LMU München, Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Hôpital Claude Huriez-CHRU, Service de dermatologie

location_facility: Hôpital Robert Debré, Service de Dermatologie

location_facility: Cabinet Médical, Le Bateau Blanc-Immeuble A

location_facility: Hôpital Saint vincent de paul, Clinique de Dermatologie

location_facility: Universitätsklinikum Bonn, Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Charité - Universitätsmedizin Berlin, Klinik für Dermatologie, Allergologie und Venerologie

summary:
Primary objective:

To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (AD).

Secondary objectives:

To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo.

Maintenance objective:

To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.


title: A Two-part, Open-label, Randomized, Phase 2/3 Study of Dinutuximab and Irinotecan Versus Irinotecan for Second Line Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer

lead_sponsor: United Therapeutics

ReferenceCitation: Edelman MJ, Dvorkin M, Laktionov K, Navarro A, Juan-Vidal O, Kozlov V, Golden G, Jordan O, Deng CQ, Bentsion D, Chouaid C, Dechev H, Dowlati A, Fernández Núñez N, Ivashchuk O, Kiladze I, Kortua T, Leighl N, Luft A, Makharadze T, Min Y, Quantin X; DISTINCT study investigators. Randomized phase 3 study of the anti-disialoganglioside antibody dinutuximab and irinotecan vs irinotecan or topotecan for second-line treatment of small cell lung cancer. Lung Cancer. 2022 Apr;166:135-142. doi: 10.1016/j.lungcan.2022.03.003. Epub 2022 Mar 4.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
Philippines
Poland
Hong Kong
Russian Federation
Australia
India
Malaysia
Slovakia
Canada
Hungary
Bulgaria
Taiwan
Georgia
Thailand
Korea, Republic of
France

location_facility: L'Institut Universitaire de Cardiologie et de pneumologie de Quebec

location_facility: Spartanburg Medical Center/Gibbs Cancer Center and Research Institute

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów

location_facility: Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dr. Tota Venkova AD, Gabrovo

location_facility: Hospital of Lithuanian University of Health Sciences (LSMU) Kauno Klinikos

location_facility: Chonnam National University Hwasun Hospital

location_facility: First Department for Medical Oncology, Multiprofile Hospital for Active Treatement Serdika EOOD, Sofia

location_facility: University of Wisoncsin - Carbone Cancer Ctr

location_facility: Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie

location_facility: Keimyung University Dongsan Medical Centre

location_facility: Federal State Budgetary Institution, Natiоnal Medical Research Center of Oncology n.a. N.N. Blokhin of Ministry of Healthcare of the Russian Federation

location_facility: Department of Medical Oncology, Complex Oncology Center - Burgas EOOD, Burgas

location_facility: First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD

location_facility: Ospedale Santa Maria della Misericordia, Perugia

location_facility: Regional Communal Nonprofit Enterprise, Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary, Surgery Department, State Higher Educational Establishment of Ukraine, Bukovinian State Medical University, Department of Onc and Radiology

location_facility: Region Budgetary Healthcare Institution, Kursk Regional Clinical Oncology Dispensary of Healthcare Committee of Kursk Region

location_facility: Semmelweis Egyetem AOK Pulmonologiai Klinika

location_facility: Institut de Cancérologie de l'Ouest - Centre Paul Papin

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Federal State Budgetary Institution, Scientific Research Institute of Oncology n.a. Petrov

location_facility: Institute of Oncology Prof. Dr. I.Chiricuta Cluj-Napoca

location_facility: Pusan National University Yangsan Hospital

location_facility: State Budgetary Healthcare Institution of Novosibirsk Region, Сity Clinical Hospital #1

location_facility: Samodzielny Specjalistyczny ZespółZakładów Opieki Zdrowotnej im. dr. Teodora Dunina

location_facility: Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza

location_facility: The University of Texas Health Science Center at Tyler, Office of Clinical Studies

location_facility: Cross Cancer Institute - Clinical Trials Unit

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council," Municipal Institution "Multifield Dnipropetrovsk City Hospital #4" of Dnipropetrovsk Regional Council, Department of Chemotherapy

location_facility: Medical Oncology Clinic, Multiprofile Hospital for Active Treatment (MHAT) for Female's Health - Nadezhda OOD, Sofia

location_facility: Clinic of Oncology, UMHAT Dr. Georgi Stranski - Pleven

location_facility: Mid North Coast Cancer Institute Coff Habour Health Campus

location_facility: State Budgetary Healthcare Institution of Moscow, Moscow City Oncology Hospital #62 of Moscow Healthcare Department

location_facility: High Technology Medical Center, University Clinic

location_facility: Complexo Hospitalario Universitario de Ourense (CHUO)

location_facility: Department of Medicine, Faculty of Medicine

location_facility: Budgetary Healthcare Institution of Omsk Region, Clinical Oncology Dispensary

location_facility: Camden Clark Medical Center / Regional Cancer Center

location_facility: Seoul National University Boramae Medical Center

location_facility: A.O.U. San Luigi Gonzaga, Orbassano (Torino)

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary"

location_facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau

location_facility: State Budgetary Healthcare Institution, Samara Regional Clinical Oncology Dispensary

location_facility: Service de Pneumologie aiguë et Cancérologie Thoracique Centre hospitalier Lyon-Sud

location_facility: Hospital General Universitário Gregorio Marañón

location_facility: Kaiser Permanente Northwest Center for Health Research CRSS

location_facility: LTD ''Accad. F. Todua Medical Center-Research Institute of Clinical Medicine''

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Physicians' Clinic of Iowa Hematology and Oncology

location_facility: Municipal Nonprofit Institution "Cental Municipal Clinical Hospital" of Uzhgorod City Council, Municipal Oncology Centre

location_facility: Cancer Treatment Centers of America at Southwestern RMC

location_facility: Emergency County Hospital Satu-Mare, Medical Oncology Clinic

location_facility: Municipal Nonprofit Institution "Odessa Regional Oncology Dispensary" of Odessa Regional Council, Municipal Institution Odesa Regional Oncology Dispensary, Hospital of Day Stay (Unit of Dispensary-Polyclinic Department)

location_facility: Kyungpook National University Medical Center

location_facility: State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital

location_facility: Szpital Specjalistyczny w Prabutach Sp. z o.o

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

location_facility: State Budgetary Healthcare Institution of Sverdlovsk Region, Sverdlovsk Regional Oncology Dispensary

location_facility: State Budgetary Healthcare Institution of Yaroslavl Region, Regional Oncology Hospital

location_facility: Winship Cancer Institute, Emory University

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: Institut Paoli-Calmettes, Service Dòncologie Médicale

location_facility: Szpital Chorób Płuc im Św. Józefa w Pilchowicach

location_facility: Koranyi National Institute of Pulmonology - Horváth

location_facility: State Budgetary Healthcare Institution of Novosibirsk Region, Novosibirsk Regional Oncology Dispensary

location_facility: Seoul National University Bundang Hospital

location_facility: Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich

location_facility: Mater Misericordiae Limited and Mater Medical Research Institute Limited

location_facility: Saint-Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary

location_facility: The University of New Mexico Comprehensive Cancer Center

location_facility: Division of Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena

location_facility: State Budgetary Healthcare Institution, Orenburg Regional Clinical Oncology Dispensary

location_facility: Medical Oncology Department, University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Sofia

location_facility: Hospital Regional de Málaga (H. Carlos Haya)

location_facility: Istituto Europeo di Oncologia (IEO), Milano

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Semmelweis Tagkórház, Tüdőgyógyászati Osztály

location_facility: Radiation Oncology, Campus Bio-Medico University

location_facility: Municipal Nonprofit Institution "Podilsky Regional Oncology Center" of Vinnytsa City Council, Podilsky Regional Oncology Сenter, Department of Chemotherapy

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

location_facility: State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary

location_facility: Hospital Universitario Madrid Norte Sanchinarro

location_facility: St. Jacob´s Hospital Bardejov - Department of Clinical Oncology

location_facility: Eastern Connecticut Hematology and Oncology Assoc

location_facility: URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse

location_facility: Institut Regional du Cancer de Montpellier

location_facility: Centrum Onkologii-Instytut im. Sklodowskiej-Curie

location_facility: Fox Chase Cancer Center Office of Clinical Research

location_facility: Koranyi National Institute of TBC and Pulmonology

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

location_facility: Medical Oncology Department, Specialized Hospital for Active Treatment of Oncology Sveti Mina EOOD - Blagoevgrad

location_facility: Medical Oncology Department, Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagiurishte

location_facility: Horizon Health Network - The Moncton Hosoital

location_facility: State Budgetary Healthcare Institution, Saint-Petersburg Clinical Scientific Practical Center of Specialized Kinds of Medical Care (Oncological)

location_facility: Instituto Catalán de Oncología (ICO) - Josep Trueta

location_facility: Communal Non-profit Enterprise "Kyiv City Clinical Oncology Center" of Executive body of Kyiv City Council, Kyiv City Clinical Oncology Center by Main Department of Health Protection Kyiv, Hospital of Day Stay for Oncology Patients

location_facility: Windsor Regional Hospital Cancer Program

location_facility: Dipartimento di Oncologia, ARNAS Garibaldi

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: Clinic for Chemotherapy, Specialized Hospital for Active Treatment in Oncology EAD, Sofia

location_facility: Hospital Universitario Marqués de Valdecilla

summary: This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period <3 months or ≥3 months).