title: A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

lead_sponsor: BeiGene

location_country:
Poland
Taiwan
Romania
Spain
Italy
Russian Federation
Australia
United Kingdom
Korea, Republic of
United States
France
China
Belgium
Japan
Germany
Czechia

location_facility: The First Affiliated Hospital of Zhengzhou University - Oncology

location_facility: Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori

location_facility: China Medical University Hospital - Oncology - Taichung

location_facility: Smilow Cancer Hospital at Yale-New Haven - Neurology

location_facility: The First Affiliated Hospital of Xiamen University - Oncology

location_facility: National Hospital Organization Kyushu Cancer Center - GI and Medical Oncology

location_facility: Tianjin Cancer Hospital - Gastroinstinal Oncology

location_facility: Beatson West of Scotland Cancer Centre - Oncology

location_facility: University Hospital, Kyoto Prefectural Univ of Medicine - Gastroenterology

location_facility: AOU Città della Salute e della Scienza di Torino - Molinette

location_facility: Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica

location_facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology

location_facility: Arkhangelsk Regional Clinical Oncological Dispensary

location_facility: Quanzhou First Hospital - Radiotherapy/Nuclear Medicine

location_facility: Kyushu Medical Center - Gastroenterological Surgery

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Wuxi Fourth People's Hospital - Oncology

location_facility: Guangdong Province Traditional Chinese Medical Hospital

location_facility: University of Texas Health Science Center of San Antonio

location_facility: The first Affiliated Hospital of guangzhou University of traditional chinese medicine - Oncology

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Fujian Provincial Cancer Hospital - Oncology

location_facility: Chi Mei Medical Center - YongKang - Chi Mei Medical Center

location_facility: Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi

location_facility: Gachon University Gil Medical Center - Oncology

location_facility: The Affiliated Hospital of Xuzhou Medical University - Radiology

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: Hiroshima University Hospital - Gastrointestinal Surgery

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospi

location_facility: Orenburg Regional Clinical Oncology Center

location_facility: Maidstone and Tunbridge Wells NHS Trust - Kent Oncology Centre

location_facility: Institut Hospitalier Franco-Britannique (IHFB) - Levallois-Perret - 4 Rue Kleber

location_facility: Harbin Medical University Cancer Hospital - Oncology

location_facility: Saitama Cancer Center - Gastroenterology

location_facility: Rostov Research Institute of Oncology (RRIO)

location_facility: Seoul National University Bundang Hospital - Hematology/Oncology

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

location_facility: Sir Run Run Shaw Hospital, Zhejiang University

location_facility: CHA Bundang Medical Center, CHA University - Oncology

location_facility: SLK Kliniken Heilbronn GmbH - Klinik für Radiologie, Minimalinvasive Therapien und Nuklearmedizin

location_facility: Nantong Tumor Hospital - Medical Oncology

location_facility: Chonnam National University Hwasun Hospital - Hematology and Oncology Clinic

location_facility: Korea University Guro Hospital - Hematology-Oncology

location_facility: Hospital Regional Universitario de Málaga

location_facility: The Christie NHS Foundation Trust - Oak Road Treatment Centr

location_facility: The First Saint-Petersburg State Medical University named after Academician I.P. Pavlov

location_facility: Hopital Saint-Antoine / Service d'Hepato-Gastro-Enterologie

location_facility: Kobe City Medical Center General Hospital - Medical Oncology

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

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca

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

location_facility: Russian Academy of Medical Sciences (RAMS)

location_facility: Anhui Medical University - The Second Hospital

location_facility: Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology

location_facility: SMG-SNU Boramae Medical Center - Oncology

location_facility: Ballarat Oncology & Haematology Services

location_facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology

location_facility: Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie

location_facility: Guangxi Medical University Affiliated tumor hospital

location_facility: Medical University of South Carolina Hollings Cancer Center

location_facility: Keimyung University Dongsan Medical Center

location_facility: Groupe Hospitalier Paris Saint Joseph - Oncologie

location_facility: Hopital Europeen Georges Pompidou - Digestive Oncology

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Chi Mei Hospital, Liouying - Department of Oncology

location_facility: National Cancer Center Hospital East - Gastrointestinal Oncology

location_facility: Osaka International Cancer Institute - Clinical Oncology

location_facility: Osaka University Hospital - Medical Oncology

location_facility: Kanagawa Cancer Center - Gastroenterological surgery

location_facility: CHU De BesanÃ§on-Jean Minjoz - Oncologie MÃ©dicale

location_facility: Institut Jules Bordet - Oncologie Médicale

location_facility: Kansai Rosai Hospital - Gastroenterological Surgery

location_facility: Hospital Universitario Central de Asturias

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Peking Union Medical College Hospital - Oncology

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: The First People's Hospital of Changzhou - Oncology

location_facility: National Cancer Center Hospital - Gastrointestinal Oncology

location_facility: Samsung Medical Center - Hematology-Oncology

location_facility: Clinical Research Center Sp. z o.o., Medic-R Sp. K.

location_facility: Shandong Cancer Hospital - oncology - Oncology

location_facility: Kaohsiung Veterans General Hospital - Thoracic Surgery

summary: The purpose of this study is to evaluate the efficacy and safety of Tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).


title: Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial

acronym: EMERALD

summary: This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Bidard FC, Kaklamani VG, Neven P, Streich G, Montero AJ, Forget F, Mouret-Reynier MA, Sohn JH, Taylor D, Harnden KK, Khong H, Kocsis J, Dalenc F, Dillon PM, Babu S, Waters S, Deleu I, García Sáenz JA, Bria E, Cazzaniga M, Lu J, Aftimos P, Cortés J, Liu S, Tonini G, Laurent D, Habboubi N, Conlan MG, Bardia A. Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. J Clin Oncol. 2022 Oct 1;40(28):3246-3256. doi: 10.1200/JCO.22.00338. Epub 2022 May 18.

ReferenceCitation: Bardia A, Aftimos P, Bihani T, Anderson-Villaluz AT, Jung J, Conlan MG, Kaklamani VG. EMERALD: Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer. Future Oncol. 2019 Oct;15(28):3209-3218. doi: 10.2217/fon-2019-0370. Epub 2019 Aug 20.

ipd_sharing: Yes

lead_sponsor: Stemline Therapeutics, Inc.

location_country:
Denmark
Portugal
Spain
Greece
Austria
Australia
Ireland
Argentina
Canada
Italy
United Kingdom
Hungary
Korea, Republic of
United States
France
Israel
Belgium

location_facility: Centre François Baclesse Service Pharmacie

location_facility: Cliniques Universitaires Saint-Luc - Oncology

location_facility: US Oncology - Rocky Mountain Cancer Centers - Midtown

location_facility: Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute

location_facility: Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS)

location_facility: Rabin Medical Center - Beilinson Hospital - Davidoff Cancer

location_facility: AZ Nikolaas - Campus Sint-Niklaas Moerland

location_facility: Policlinico Universitario Campus Bio-medico, Università Campus Bio-medico di Roma,

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

location_facility: Piedmont Cancer Institute, P.C. - Oncology

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Hospital Clínico Universitario de Valencia

location_facility: New York University Clinical Cancer Center

location_facility: McGill University Health Centre - Cedars Cancer Center - Oncology

location_facility: INDC Entité Jolimontoise - CH de Jolimont-Lobbes

location_facility: "Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques"

location_facility: DiMI, Dipartimento di Medicina interna e Specialità mediche,

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Texas Oncology - The Woodlands, Gynecologic Oncology

location_facility: Saint Barnabas Medical Center - Cancer Center

location_facility: Mass General North Shore Cancer Center - Oncology

location_facility: CHU de Quebec - Hopital du Saint Sacrement

location_facility: UC Davis Medical Center, Investigational Drug Service

location_facility: Pikeville Medical Center - Oncology/Hematology

location_facility: Texas Oncology - Central Austin Cancer Center

location_facility: AOU Maggiore della Carità - SC Oncologia

location_facility: Cancer Therapy and Research Center at UTHSCSA

location_facility: Hopital Trousseau - Service d'oncologie mÃ©dicale

location_facility: University General Hospital Of Patras - Dpt Of Medicine, Division Oncology

location_facility: Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System

location_facility: Clinical Research Facility, St. James's Hospital

location_facility: Brig Center For Cancer Care And Survivorship

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Instituto Português Oncologia Francisco Gentil do Porto

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Oncol.Med. Addarii-Zamagni

location_facility: Azienda Ospedaliero-Universitaria di Parma

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

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

location_facility: Fundacion CENIT para la Investigación en Neurociencias - Clinic

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Instituto Português de Oncologia de Coimbra

location_facility: Chicago Association for Research and Education in Science

location_facility: Hôpital Privé Jean Mermoz Département Pharmacie

location_facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology

location_facility: Centre Hospitalier de l'Ardenne - Site de Libramont

location_facility: Hôpital René Huguenin - Institut Curie - Oncologie médicale

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Senhora da Oliveira - Guimarães, E.P.E.

location_facility: Tel Aviv Sourasky Medical Center - Oncology

location_facility: PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Mass General Cancer Center at Newton Wellesley - Oncology

location_facility: Centre De Lutte Contre Le Cancer - Institut Curie - DÃ©partement d'Oncologie MÃ©dica

location_facility: Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital

location_facility: "Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques"

location_facility: New Mexico Oncology Hematology Consultants - Oncology

location_facility: US Oncology Research-- Investigational Product Center

location_facility: Benaroya Research Institute at Virginia Mason

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Recruiting

acronym: PROTEUS

title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

lead_sponsor: Janssen Research & Development, LLC

type: Other Identifier

type: EudraCT Number

source: euctr

ReferenceCitation: Ravi P, Kwak L, Xie W, Kelleher K, Acosta AM, McKay RR, Kibel AS, Taplin ME. Neoadjuvant Novel Hormonal Therapy Followed by Prostatectomy versus Up-Front Prostatectomy for High-Risk Prostate Cancer: A Comparative Analysis. J Urol. 2022 Oct;208(4):838-845. doi: 10.1097/JU.0000000000002803. Epub 2022 Sep 9.

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

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

location_facility: Emory University - Winship Cancer Institute

location_facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo

location_facility: Praxisgemeinschaft f. Onkologie u. Urologie - Germany

location_facility: Miami Cancer Institute at Baptist Health / Baptist Health Medical Group

location_facility: Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Ochsner LSU Health Shreveport - Regional Urology

location_facility: Kobe City Medical Center General Hospital

location_facility: University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center

location_facility: Samodzielny Publiczny Wielospecjalistyczny Zakład Opieki Zdrowotnej MSWiA w Bydgoszczy

location_facility: St. Antonius Ziekenhuis (St. Antonius Hospital)

location_facility: Oklahoma University Health Science Center

location_facility: Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará

location_facility: Mayo Clinic - Division Of Hematology/oncology

location_facility: Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia

location_facility: Ospedale Molinette, AO Città della Salute e della Scienza di

location_facility: Fakultni nemocnice Plzen, Urologicka klinika

location_facility: Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

location_facility: UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento

location_facility: CHU de Québec-Université Laval-Hôpital de l'Enfant-Jésus

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Universidade do Estado do Rio de Janeiro - UERJ

location_facility: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: CAMC Memorial Hospital, Charleston Area Medical Center Physicians

location_facility: Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre

location_facility: University of Washington School of Medicine

location_facility: Kliniken Nordoberpfalz, Klinik für Urologie

location_facility: Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)

location_facility: Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

location_facility: ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti

location_facility: Clinica di Urologia Policlinico di Modena - Università di Modena e reggio Emilia

location_facility: National Hospital Organizaiton Shikoku Cancer Center

location_facility: CHUM - Centre hospitalier universitaire de Montreal

location_facility: Universitätsklinikum Schleswig Holstein Campus Lübeck

location_facility: Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Ralph H. Johnson Veterans Affairs Medical Center

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

location_facility: Great Lakes Physician PC d/b/a Western New York Urology Associates

summary: The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.


acronym: MAGNITUDE

title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
South Africa
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
Puerto Rico
Israel
Turkey
Mexico
Malaysia
Sweden
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Korea, Republic of
France
Netherlands

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: State Institution National Cancer Institute

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

location_facility: Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

location_facility: Drug clinical trial ethics committee of Ningbo First Hospital

location_facility: Instituto de Ensino E Pesquisa Sao Lucas

location_facility: Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia

location_facility: PERSONAL - Oncologia de Precisão e Personalizada

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Instituto Joinvilense De Hematologia e Oncologia

location_facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

location_facility: Centro de Tratamento de câncer Medradius

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

location_facility: British Columbia Cancer Agency (BCCA) - Vancouver Centre

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval

location_facility: Fundacao do ABC - Centro Universitario FMABC

location_facility: Consultorio de Especialidad en Urologia Privado

location_facility: Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: Champalimaud Foundation Champalimaud Centre

location_facility: Grand Hôpital de Charleroi, site Notre Dame

location_facility: Southwest Hospital, The Third Military Medical University

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Mexico Centre for Clinical Research, S.A. de C.V.

location_facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

location_facility: Tianjin Medical University Cancer Hospital

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: St. Antonius Ziekenhuis (St. Antonius Hospital)

location_facility: Irmandade Santa Casa de Misericordia de Sao Paulo

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: Fujian Medical University Union Hospital

location_facility: Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Mayo Clinic - Division Of Hematology/oncology

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: Fakultni nemocnice Plzen, Urologicka klinika

location_facility: Adult Pediatric Urology & Urogynecology, P.C

location_facility: Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

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

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Institut Regional du Cancer de Montpellier Val d'Aurelle

location_facility: ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

location_facility: Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Municipal non-profit enterprise 'Regional Center of Oncology'

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

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Beijing Cancer Hospital of Peking University

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Private Medical Institution Euromedservice

location_facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

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

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás

location_facility: Southern Alberta Institute of Urology / Prostate Cancer Centre

location_facility: Tambov Regional Oncology Clinical Dispansary

location_facility: Cukurova University, Faculty of Medicine

location_facility: Pomorski Uniwersytet Medyczny w Szczecinie

location_facility: Oncologia Medica A - Ist Naz Tumori G Pascale

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

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

location_facility: MC Haaglanden Lok Antoniushove - Afd.Interne - INT

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Seoul National University Bundang Hospital

location_facility: Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

location_facility: Clinical Diagnostic Centre of Nizhny Novgorod Region

location_facility: Thomayerova nemocnice, Onkologicka klinika

location_facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

location_facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: The Fifth People's Hospital of Shanghai, Fudan University

location_facility: Kansas City Veterans Affairs Medical Center

location_facility: A.O.U. Città della Salute e della Scienza

location_facility: Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria

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

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

location_facility: Specialized Hospital for Active Treatment in Oncology EAD

location_facility: Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)

location_facility: Istituto Oncologico Veneto Iov Irccs Padova

location_facility: Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma

summary: The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.


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

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

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

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

ipd_sharing: No

lead_sponsor: Innovent Biologics (Suzhou) Co. Ltd.

location_country:
Spain
Australia
Hungary
United States
France
China
Belgium

location_facility: University Hospital Marqués de Valdecilla

location_facility: Consorci Hospital General Universitari de València

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

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

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Parc Taulí Sabadell Hospital Universitari

location_facility: IACT Health - John B. Amos Cancer center

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

intervention_type: Biological


acronym: DUO-O

title: A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

lead_sponsor: AstraZeneca

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

location_country:
Denmark
Poland
Brazil
Romania
Spain
Italy
Austria
Canada
Finland
Hungary
Korea, Republic of
United States
France
China
Peru
Belgium
Japan
Germany
Turkey
Bulgaria

summary: This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.


title: A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)

summary: Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

status: Enrolling by invitation

lead_sponsor: United Therapeutics

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Romania
Czechia
Poland
Portugal
Austria
Australia
Argentina
Israel
Turkey
Mexico
Singapore
Brazil
Canada
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Korea, Republic of
France
Chile
Netherlands

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

location_facility: University General Hospital of Alexandroupolis

location_facility: Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology

location_facility: Washington University School of Medicine

location_facility: SMBD Jewish General Hospital d/b/a Jewish General Hospital

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35

location_facility: Hospital Clinic de Barcelona, C/ Villarroel, 170

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital

location_facility: Hospital PROVINCIAL "Dr. Jose Maria Cullen"

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street

location_facility: Clinical Center of Serbia, Koste Todorovica 8

location_facility: Sentara Cardiovascular Research Institute

location_facility: Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

location_facility: Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1

location_facility: AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20

location_facility: Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6

location_facility: Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre, Service de Pneumologie, 78 Avenue du General Leclerc

location_facility: Medical College of Wisconsin/Froedtert Hospital

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

location_facility: Unidad de Investigacion Clinica en Medicina, S.C.

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital

location_facility: MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.

location_facility: Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21

location_facility: CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2

location_facility: Premium Clinic Wrocław CM, Podwale 83/17

location_facility: Weill-Cornell-New York Presbyterian Hospital

location_facility: Centro Hospitalar e Universitário de Coimbra, E.P.E.

location_facility: Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1

location_facility: Uludag Universitesi Tip Fakültesi, Gorukle Kampusu

location_facility: Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia

location_facility: Gachon University Hospital Gil Medical Center

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4

location_facility: Tel Aviv Sourasky Medical Center, 6 Weizmann St.

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie

location_facility: University Health Network-Toronto General Hospital

location_facility: CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan

location_facility: UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49

location_facility: Hospital Privado Centro Medico de Cordoba S.A

location_facility: Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80

location_facility: Meir Medical Center, 59 Tshernichovski st.

location_facility: CE Dniprop RCC&C Center of Dniprop RC Dept of Card SI DMA of MOHU, Chair of Internal Medicine 3, 28, Knyazya Volodymyra Velykogo St.

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council Lviv Clinical Hospital, Dept of Cardiology, D.Halytskyi Lviv NMU, Ch of Internal Medicine #1, 7, Chernihivska str.

location_facility: Royal Free London NHS Foundation Trust, Pond Street

location_facility: Hadassah Ein Kerem Medical Center, Kiryat Hadassah

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente

location_facility: University Clinic for Pulmonary Diseases, Jordanovac 104

location_facility: The Ohio State University Wexner Medical Center

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.

location_facility: Beijing Shijitan Hospital, Capital Medical University

location_facility: Fuwai Hospital, Chinese Academy of Medical Sciences

location_facility: Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.

location_facility: Carilion Clinic Pulmonary and Sleep Medicine

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a

location_facility: Copenhagen University Hospital (Rigshospitalet)

location_facility: University of Iowa Hospitals and Clinics

location_facility: Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258

location_facility: Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

location_facility: Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10

location_facility: Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova

location_facility: "Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue

location_facility: Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2

location_facility: Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41

location_facility: University of Cincinnati-Medical Science Building

location_facility: University of California Davis Medical Center

location_facility: The Lady Davis Carmel Medical Center, 7 Michal st.

location_facility: The Methodist Hospital Research Institute

location_facility: Xiangya Hospital Central South University

location_facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13

location_facility: UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu

location_facility: Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor

location_facility: NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18

location_facility: CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond

location_facility: CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne

status_simplified: Unknown


title: A Phase 2/3 Randomized, Controlled, Open-Label Study of KRT 232 in Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera MF (Post-PV-MF), Or Post Essential Thrombocythemia MF (Post-ET-MF) Who Are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment

acronym: BOREAS

summary:
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.

This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time.

ReferenceType: background

ReferenceCitation: Al-Ali, H.K.; Delgado, R.G.; Lange, A.; Pluta, A.; McLornan, D.; Vachhani, P.; Damaj, G.L.; Jost, P.J.; Rejto, L.; Hus, M.; et al. KRT-232, A First-In-Class, Murine Double Minute 2 Inhibitor, for Myelofibrosis Relapsed or Refractory to Janus-Associated Kinase Inhibitor Treatment. Eha. Libr. 2020, 295035, S215

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
United States
Philippines
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Brazil
Canada
Hungary
Germany
Bulgaria
Thailand
Korea, Republic of
France

location_facility: Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

location_facility: Washington University School of Medicine

location_facility: Hospital das Clínicas da Universidade de São Paulo

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord - Pesaro

location_facility: Ramathibodi Hospital - Mahidol University - Hematology

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

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii

location_facility: Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hopital Paul Brousse - Aphp Hôpitaux Universitaires Paris Su

location_facility: H. São Francisco Xavier-Centro Hospitalar Lisboa Ocidental

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS

location_facility: UKE - Universitätsklinikum Hamburg-Eppendorf

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

location_facility: UNICAMP - Universidade Estadual de Campinas Hemocentro

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska, Sofia

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: Inonu University Turgut Ozal Medical Center

location_facility: Centre Hospitalier Regional Universitaire Brest Hopital Morvan

location_facility: AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: H. Infante Dom Pedro. Centro Hospitalar do Baixo Vouga

location_facility: Assaf Harofeh Medical Center - Hematology

location_facility: Centre Hospitalier Universitaire of Caen Normandie - Côte de Nacre

location_facility: University of the Philippines - Philippine General Hospital

location_facility: Perpetual Succour Hospital - Hemat/Transfusion Med

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Complejo Hospitalario de Navarra - H. de Navarra, Hematología C/ de Irunlarrea, 3, Pamplona

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

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich

location_facility: Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa

location_facility: Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością Medic-R sp. k.

location_facility: Center Hospitalier Universitaire d'Angers

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica

location_facility: New York Presbyterian/Weill Cornell Medical Center

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Klinikum Rechts der Isar der Technischen Universität München Apotheke

location_facility: Specialized Hospital for Active Therapy of Hematological Disorders

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Arcispedale S. Maria Nuova, AO di Reggio Emilia

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Keimyung University Dongsan Medical Center

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Tel Aviv Sourasky Medical Center - Oncology

location_facility: Srinagarind Hospital (KhonKaen University)

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Azienda Ospedaliero Universitaria Policlinico - Vittorio Emanuele

location_facility: Acibadem City Clinic Tokuda Hospital, Sofia

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi, Plovdiv

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Brookdale University Hospital and Medical Center

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven

location_facility: Sociedad de Metabolismo y Corazón S.C. - Oncology

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum

location_facility: Gaziantep University Faculty of Medicine

location_facility: University Multiprofile Hospital for Active Treatment Saint Ivan Rilski, Sofia

location_facility: Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Hématologie Clinique


type: Registry Identifier

title: A Non-interventional, Post-authorization Safety Study of Patients With Relapsed or Refractory Mantle Cell Lymphoma to Further Investigate and Characterize the Association of Lenalidomide With Tumor Flare Reaction and High Tumor Burden

summary: The purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Celgene

location_country: Spain Italy Austria Greece Netherlands France Germany

location_facility: General Anti-Cancer Hospital "Agios Savvas"

location_facility: Praxis fuer Haematolgie, Onkologie und Palliativmedizin

location_facility: Centre Hospitalier de Versailles André Mignot

location_facility: Policlinico Umberto I , Universita La Sapienza

location_facility: Private hospital "Iatriko Psychikou", Athens

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

location_facility: Klinikum Garmisch-Partenkirchen Gmbh - Zentrum Fuer Innere Medizin

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Theageneio General Hospital, Thessaloniki

location_facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere)

location_facility: Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo

location_facility: Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Azienda Ospedaliero - Universiaria di Parma

location_facility: CHU de Caen, institut d'hematologie de basse Nomandie

location_facility: Arcispedale Santa Maria Nuova - AUSL Reggio Emilia

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia

location_facility: Presidio Ospedaliero Molinette - A.O.U. Citta della Salute e della Scieza

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

location_facility: Ospedale Policlinico San Martino - IRCCS

location_facility: LKH Graz Medizinische Universitätsklinik

location_facility: General University Hospital of Athens "LAIKO", Athens

location_facility: Hospital Clínico Universiatrio de Salamanca

location_facility: HagaZiekenhuis van Den Haag - Juliana Kinderziekenhuis (JKZ) - Leyweg

location_facility: General University Hospital of Alexandroupolis

location_facility: Salzburger Landeskliniken - Universitaetsklinikum Salzburg

location_facility: Ospedale di Busto Arsizio - ASST Valle Olona

location_facility: Fondazione IRCCS Ca' Cranda, Ospedale Maggiore Policinico


title: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Khushalani NI, Diab A, Ascierto PA, Larkin J, Sandhu S, Sznol M, Koon HB, Jarkowski A, Zhou M, Statkevich P, Geese WJ, Long GV. Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design. Future Oncol. 2020 Oct;16(28):2165-2175. doi: 10.2217/fon-2020-0351. Epub 2020 Jul 29.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Sweden
Brazil
Canada
Switzerland
Germany
Greece
Ireland
New Zealand
Finland
France
Chile
Netherlands

location_facility: Instituto Medico Especialazado Alexander Fleming

location_facility: Washington University School Of Medicine

location_facility: Dermatovenerologicka klinika 3. LF UK a FNKV

location_facility: Winship Cancer Institute, Emory University

location_facility: Nationales Centrum Fuer Tumorerkrakungen (Nct) Heidelberg

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Instituto Nazionale Tumori Fondazione G. Pascale

location_facility: Allina Health dba Virginia Piper Cancer Institute Fridley

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza

summary: The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread


title: A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-2)

summary: The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD.

status: Terminated

study_completion_date_type: Actual

lead_sponsor: Chengdu Kanghong Biotech Co., Ltd.

location_country:
Denmark
United Kingdom
Italy
Latvia
Hungary
United States
France
China
Israel
Bulgaria
Slovakia
Czechia


title: A Phase I/II Study of Paclitaxel Plus Carboplatin and Durvalumab (MEDI4736) With or Without Oleclumab (MEDI9447) for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

acronym: SYNERGY

summary:
The combination of chemotherapy with PD-1 immune checkpoint blockade agents demonstrated promising results especially in the neo-adjuvant and early metastatic setting in TNBC. However, a substantial proportion of patients do not derive benefit from this approach.

CD73 is an adenosine-generating enzyme overexpressed in several cancers and associated with poor prognosis and reduced anti-tumor immunity in TNBC. Monoclonal antibodies directed against CD73 could help to reprogram the tumor microenvironement by decreasing the adenosine mediated immunosuppression, particularly as a synergistic immunotherapeutic combination with immune checkpoint blockade.

The SYNERGY trial investigates the role of an anti-CD73 (MEDI9447) in a randomized phase II trial evaluating the efficacy and safety of the combination of chemotherapy (paclitaxel + carboplatin) with immunotherapy (durvalumab [anti-PD-L1] +/- MEDI9447 [anti-CD73]) in previously untreated locally recurrent inoperable or metastatic TNBC.

A large translational research program is planned including baseline and dynamic biomarkers

lead_sponsor: Jules Bordet Institute

location_country: France Belgium

location_facility:
CHU Besançon
Institut Bergonié
CHU UCL Namur Sainte-Elisabeth
Cliniques universitaires Saint Luc
Sint-Augustinus, GZA Ziekenhuizen
Centre Georges François Leclerc
Centre Jean Perrin
Centre Antoine Lacassagne
Grand Hôpital de Charleroi
CHU Poitiers
Hôpital Saint Louis
Institut Paoli-Calmettes
Institut Jules Bordet
Centre Henri Becquerel
Institut Curie
UZ Leuven Gasthuisberg
Clinique St Pierre
Hôpitaux Universitaires de Strasbourg


acronym: SOLOIST-WHF

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients With Type 2 Diabetes POST Worsening Heart Failure

lead_sponsor: Lexicon Pharmaceuticals

ReferenceCitation: Szarek M, Bhatt DL, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Banks P, Tesfaye E, Ezekowitz JA, Verma S, Pitt B; SOLOIST-WHF committees and investigators. Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure : A Randomized Trial. Ann Intern Med. 2021 Aug;174(8):1065-1072. doi: 10.7326/M21-0651. Epub 2021 Jun 22.

ReferenceCitation: Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Greece
Latvia
New Zealand
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility:
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Investigational Site Number 8400047
Investigational Site Number 2760033
Investigational Site Number 5280005
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Investigational Site Number 2460002
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Investigational Site Number 2460003
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Investigational Site Number 3760004
Investigational Site Number 7920002
Investigational Site Number 5280001
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Investigational Site Number 6160005
Investigational Site Number 4400001
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Investigational Site Number 6160003
Investigational Site Number 0560002
Investigational Site Number 2500013
Investigational Site Number 7520004
Investigational Site Number 7240007
Investigational Site Number 3760005
Investigational Site Number 2760007
Investigational Site Number 6430004
Investigational Site Number 0760017
Investigational Site Number 6160024
Investigational Site Number 6200008
Investigational Site Number 7030002
Investigational Site Number 0760013
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Investigational Site Number 6200001
Investigational Site Number 4280003
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Investigational Site Number 1240001
Investigational Site Number 6430003
Investigational Site Number 5280007
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Investigational Site Number 0560006
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Investigational Site Number 5540007
Investigational Site Number 7920003
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Investigational Site Number 5280002
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Investigational Site Number 0320018
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Investigational Site Number 6160020
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Investigational Site Number 3480009
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Investigational Site Number 8260007
Investigational Site Number 0760002
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Investigational Site Number 0320010
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Investigational Site Number 8260003
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Investigational Site Number 0320008
Investigational Site Number 0320020
Investigational Site Number 0760008
Investigational Site Number 0320030
Investigational Site Number 3760002
Investigational Site Number 6430016
Investigational Site Number 0320028
Investigational Site Number 2500005
Investigational Site Number 8400134
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Investigational Site Number 6420013
Investigational Site Number 3480015
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Investigational Site Number 2460005
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Investigational Site Number 6420001
Investigational Site Number 3760003
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Investigational Site Number 1520012
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Investigational Site Number 5280003
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Investigational Site Number 4400004
Investigational Site Number 7240020
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Investigational Site Number 7240006
Investigational Site Number 7240002
Investigational Site Number 8260005
Investigational Site Number 0320015
Investigational Site Number 7240005

summary:
Primary Objective:

To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF)

Secondary Objectives:

To compare the effects of sotagliflozin to placebo on:

The total occurrences of HHF and urgent visit for HF
The occurrence of CV death
The occurrence of all-cause mortality
The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke
Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score
Change in estimated glomerular filtration rate (eGFR)


title: A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer

summary: The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.

location_country:
Poland
Taiwan
Brazil
Belarus
Spain
Italy
Russian Federation
United Kingdom
Korea, Republic of
France
United States
Turkey
Belgium

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

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: AZ Nikolaas - Campus Sint-Niklaas Moerland

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Pusan National University Yangsan Hospital

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center

location_facility: AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto

location_facility: Weill Cornell Medical College - NY Presbyterian Hospital

location_facility: State Institution N.N. Alexandrov Republican Scientific and

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica

location_facility: Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro

location_facility: University College London Hospitals Nhs Foundation Trust / Division Of Gi Services

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

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

location_facility: Minsk city Clinical Oncological Dispensary

location_facility: Private Medical Institution Euromedservice

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: White Plains Hospital Center for Cancer Care

location_facility: H. Clinico Universitario de Santiago de Compostela

location_facility: Adnan Menderes University Training and Research Hospital

location_facility: Azienda Ospedaliero Universitaria S.Maria Della Misericordia

location_facility: Institut de Cancerologie de Ouest (ICO) Site Paul Papin

location_facility: Istanbul Medeniyet University Goztepe Training and Research Hospital

location_facility: Tambov Regional Oncology Clinical Dispansary

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: Gomel Regional Clinical Oncology Dispensary

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Clinical Diagnostic Centre of Nizhny Novgorod Region

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

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Necmettin Erbakan University Meram Medical Faculty

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

location_facility: Azienda Socio Sanitaria Territoriale (ASST) della Valtellin


title: A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

ReferenceCitation: Van Cutsem E, Kato K, Ajani J, Shen L, Xia T, Ding N, Zhan L, Barnes G, Kim SB. Tislelizumab versus chemotherapy as second-line treatment of advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302): impact on health-related quality of life. ESMO Open. 2022 Aug;7(4):100517. doi: 10.1016/j.esmoop.2022.100517. Epub 2022 Jul 1.

ReferenceCitation: Shen L, Kato K, Kim SB, Ajani JA, Zhao K, He Z, Yu X, Shu Y, Luo Q, Wang J, Chen Z, Niu Z, Zhang L, Yi T, Sun JM, Chen J, Yu G, Lin CY, Hara H, Bi Q, Satoh T, Pazo-Cid R, Arkenau HT, Borg C, Lordick F, Li L, Ding N, Tao A, Shi J, Van Cutsem E; RATIONALE-302 Investigators. Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomized Phase III Study. J Clin Oncol. 2022 Sep 10;40(26):3065-3076. doi: 10.1200/JCO.21.01926. Epub 2022 Apr 20.

location_country:
Taiwan
Spain
Italy
United Kingdom
Korea, Republic of
United States
France
China
Belgium
Japan
Germany

location_facility: The Royal Marsden NHS Foundation Trust - Haemato-Oncology

location_facility: Chonnam National University Hwasun Hospital

location_facility: AO Citta della Salute e della Scienza di Torino - Presidio O

location_facility: Comprehensive Cancer Center-Gustave Roussy

location_facility: Northwestern Medicine Cancer Center Warrenville

location_facility: Universitatsklinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Harbin Medical University Cancer Hospital

location_facility: AOU - Seconda Università degli Studi di Napoli

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: A.O.U. Pisana, Stabilimento di Santa Chiara

location_facility: Fujian Medical University Union Hospital

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Universitat Leipzig, UKL AoR, Universitares Krebszentrum Leipzig (UCCL)

location_facility: Ospedale Guglielmo da Saliceto, AUSL Piacenza

location_facility: Universitaetsmedizin Mannheim, II. Medizinische Klinik

location_facility: The First Hospital, Sun Yat-sen University

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital)

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital

location_facility: The First People's Hospital Of Changzhou

location_facility: St. Marianna University School of Medicine Hospital

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Anhui Medical University - The Second Hospital

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Sichuan Academy of Medical Sciences& Sichuan Provincial People's Hospital

location_facility: Fourth Hospital of Hebei Medical University

location_facility: Seoul National University Bundang Hospital

location_facility: Charite - Universitatsmedizin Berlin /Campus Virchow Klinikum (CVK) - Med. Klinik m. S. Hamatologie, Onkologie und Tumorimmunologie (CC14)

location_facility: Centre Hospitalier Universitaire (CHU) de Liege - Site du Sart Tilman

location_facility: Hamatologisch-Onkologische Praxis Eppendorf (HOPE)

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Universitatsklinikum Koln, Innere Medizin I

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Hospital Universitario Virgen de la Arrixaca

summary: The purpose of this study is to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that has progressed during or after first line therapy.


title: A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

lead_sponsor: Merck Sharp & Dohme LLC

ReferenceCitation: Romero Román A, Campo-Cañaveral de la Cruz JL, Macía I, Escobar Campuzano I, Figueroa Almánzar S, Delgado Roel M, Gálvez Muñoz C, García Fontán EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martínez Téllez E, Partida González C, Jiménez López MF, Jiménez Maestre U, Mongil Poce R, Sánchez Lorente D, Álvarez Kindelán A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
Belgium
Japan
South Africa
Poland
Russian Federation
Australia
Argentina
Malaysia
Brazil
Canada
China
Germany
Taiwan
Ireland
Latvia
Estonia
Korea, Republic of
France

location_facility: LKI Lungenfachklinik Immenhausen ( Site 0268)

location_facility: The First Affiliated Hospital of Zhejiang University ( Site 0804)

location_facility: Hospital de Caridade de Ijui ( Site 0153)

location_facility: Szpital Specjalistyczny w Prabutach Sp. z o.o. ( Site 0483)

location_facility: Hwa Mei Hospital University of Chinese Academy of Sciences ( Site 0802)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0005)

location_facility: Azienda Ospedaliera dei Colli V. Monaldi ( Site 0301)

location_facility: SC Radiotherapy Center Cluj SRL ( Site 0509)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0381)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0458)

location_facility: Zhongshan Hospital of Fudan University ( Site 0808)

location_facility: Nacionalinis Vezio Institutas ( Site 0931)

location_facility: Emily Couric Clinical Cancer Center ( Site 0013)

location_facility: Tokyo Medical University Hospital ( Site 0771)

location_facility: Helen F. Graham Cancer Center & Research Institute ( Site 0015)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0258)

location_facility: Pauls Stradins Clinical University Hospital ( Site 0911)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 0491)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530)

location_facility: Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053)

location_facility: City Clinical Hosp.4 of DCC ( Site 0607)

location_facility: Fukushima Medical University Hospital ( Site 0772)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0822)

location_facility: National Taiwan University Hospital ( Site 0721)

location_facility: Zhejiang Cancer Hospital.... ( Site 0814)

location_facility: Hospital Alemao Oswaldo Cruz ( Site 0158)

location_facility: Kyiv City Clinical Oncological Center ( Site 0601)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0488)

location_facility: Hospital Universitari Vall d Hebron ( Site 0389)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0314)

location_facility: Hiroshima University Hospital ( Site 0762)

location_facility: Centre Hospitalier Annecy Genevois ( Site 0242)

location_facility: Centrul Medical Medicover Victoria ( Site 0514)

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487)

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0493)

location_facility: Spitalul clinic Judetean de urgenta Constanta ( Site 0508)

location_facility: Azienda Ospedaliera San Gerardo ( Site 0308)

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 0484)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)

location_facility: Princess Margaret Cancer Centre ( Site 0109)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 0307)

location_facility: MI KhRC Kherson Regional Oncology Dispensary ( Site 0614)

location_facility: HELIOS Klinikum Emil von Behring ( Site 0280)

location_facility: Evangelische Lungenklinik Berlin ( Site 0274)

location_facility: UPMC Hillman Cancer Centers ( Site 0041)

location_facility: AOU San Luigi Gonzaga di Orbassano ( Site 0313)

location_facility: Instituto do Cancer do Ceara ( Site 0152)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 0524)

location_facility: UMass Memorial Medical Center ( Site 0030)

location_facility: Hospital Universitario de Girona Doctor Josep Trueta ( Site 0386)

location_facility: UPMC Pinnacle Health System - East Location ( Site 0063)

location_facility: Heartlands Hospital in Birmingham ( Site 0455)

location_facility: Southeastern Regional Medical Center ( Site 0051)

location_facility: VA Pittsburgh Healthcare System ( Site 0052)

location_facility: Fudan University Shanghai Cancer Center ( Site 0813)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0515)

location_facility: Hôpital Avicenne - Service d oncologie medicale ( Site 0249)

location_facility: Tianjin Medical University General Hospital ( Site 0806)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0311)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0501)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0605)

location_facility: Zaporizhzhya Regional Clinical Oncology Center ( Site 0606)

location_facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0723)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 0603)

location_facility: Pacific Cancer Medical Center, Inc. ( Site 0004)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0504)

location_facility: China Medical University Hospital ( Site 0724)

location_facility: IRCCS Ospedale San Raffaele di Milano ( Site 0303)

location_facility: Spitalul Judetean de Urgenta .Sf. Ioan cel Nou. ( Site 0503)

location_facility: White Plains Hospital Center for Cancer Care ( Site 0007)

location_facility: Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076)

location_facility: Riga East Clinical University Hospital ( Site 0912)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110)

location_facility: National Medical Research Radiology Centre ( Site 0535)

location_facility: S.C.R.T.C.Radiology Therapeutic Center SRL ( Site 0511)

location_facility: University of Arizona Cancer Center ( Site 0012)

location_facility: Stony Brook University Medical Center - Cancer Center ( Site 0019)

location_facility: Medical Rehabilitation Center ( Site 0534)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0060)

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0725)

location_facility: Hospital Privado de Comunidad. ( Site 0130)

location_facility: OHSU Center for Health & Healing ( Site 1006)

location_facility: Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159)

location_facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223)

location_facility: McGill University Health Centre ( Site 0111)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0273)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 0609)

location_facility: Zentralklinik Bad Berka GmbH ( Site 0264)

location_facility: Sun Yat-Sen University Cancer Center ( Site 0816)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0101)

location_facility: S C Oncocenter Oncologie Medicala S R L ( Site 0505)

location_facility: Banner MD Anderson Cancer Center ( Site 0028)

location_facility: Plymouth Hospitals NHS Trust ( Site 0443)

location_facility: Ashland-Bellefonte Cancer Center ( Site 0021)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0145)

location_facility: ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0315)

location_facility: University Malaya Medical Centre ( Site 0781)

location_facility: Municipal Clinical Oncology Center ( Site 0523)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801)

location_facility: Western Regional Medical Center, Inc. ( Site 0050)

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074)

location_facility: Peking Union Medical College Hospital ( Site 0809)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0529)

location_facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078)

location_facility: St Joseph Heritage Healthcare ( Site 0040)

location_facility: Peking University Third Hospital ( Site 0812)

location_facility: St. Peter's Hospital Cancer Care Center ( Site 0039)

location_facility: Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817)

location_facility: Providence Saint Joseph Medical Center ( Site 0061)

location_facility: Memorial Sloan Kettering Cancer Center Westchester ( Site 0079)

location_facility: Hospital Universitario Austral ( Site 0127)

location_facility: Taipei Veterans General Hospital ( Site 0722)

location_facility: Juntendo University Hospital ( Site 0768)

location_facility: Tri-Service General Hospital ( Site 0726)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0382)

location_facility: Universitaetsklinikum Leipzig AOeR ( Site 0277)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0267)

location_facility: Inova Schar Cancer Institute ( Site 0032)

location_facility: Florence Nightingale Krankenhaus ( Site 0874)

location_facility: HP of the Univ. of Occupational and Environmental Health, Japan ( Site 0770)

location_facility: Virginia Cancer Specialists, PC ( Site 0080)

location_facility: Cherkassy Regional Oncological Center ( Site 0613)

location_facility: Universitaetsklinikum Schleswig Holstein ( Site 0871)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0150)

location_facility: St. Marianna University School of Medicine Hospital ( Site 0769)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 0705)

location_facility: Saint Francis Cancer Center ( Site 0096)

location_facility: Centre Hospitalier Metropole Savoie Site de Chambery ( Site 0245)

location_facility: Euroclinic Hospital Bucharest ( Site 0510)

location_facility: University of Nebraska Medical Center ( Site 0047)

location_facility: SMG-SNU Boramae Medical Center ( Site 0707)

location_facility: Northwest Oncology and Hematology ( Site 0001)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0383)

location_facility: Southwestern Regional Medical Center, Inc. ( Site 0054)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 0388)

location_facility: Hospital Privado Universitario de Córdoba ( Site 0139)

location_facility: Hospital Provincial del Centenario ( Site 0131)

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 0241)

location_facility: Hospital de la Santa Creu i Sant Pau ( Site 0385)

location_facility: Katholisches Klinikum Koblenz Haus Marienhof ( Site 0873)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 0572)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0533)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 1100)

location_facility: University of Arizona Cancer Center - Dignity Health ( Site 0062)

location_facility: Nottingham City Hospital Campus ( Site 0441)

location_facility: Aichi Cancer Center Hospital ( Site 0765)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0456)

location_facility: National Cancer Center Hospital ( Site 0767)

location_facility: John Wayne Cancer Institute ( Site 0049)

location_facility: Miami Cancer Institute-Baptist Hospital ( Site 0068)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 0526)

location_facility: National Cancer Center Hospital East ( Site 0761)

location_facility: MI Odessa Regional Oncological Centre ( Site 0608)

location_facility: University of Iowa Hospital and Clinics ( Site 0010)

location_facility: IRST-Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori ( Site 0300)

location_facility: Harry & Jeanette Weinberg Cancer Institute ( Site 0081)

location_facility: Centro Regional Integrado de Oncologia ( Site 0160)

location_facility: Providence Regional Cancer Partnership ( Site 0065)

location_facility: Stanford University, Stanford Cancer Center ( Site 0046)

summary: This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).