intervention_type: Radiation

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Greece
Australia
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Argentina
Canada
Korea, Republic of
South Africa
Netherlands
Hungary
China
Portugal
Germany
United States
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: First Affiliated Hospital of Dalian Medical University

location_facility: Uniwersytet Medyczny w Lublinie - Katedra i Klinika Urologii i Onkologii Urologicznej

location_facility: FSBHI RSCRST n.a. Ac. Granov A.M. of MoH

location_facility: The Third Xiangya Hospital of Central Sourth University

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

location_facility: General Hospital of Western Theater Command PLA

location_facility: Adult Pediatric Urology & Urogynecology, P.C

location_facility: State Institution Academy Of Medical Sciences Of Ukraine

location_facility: Consultorio Privado Dr Jose Arturo Rodriguez Rivera

location_facility: Severo-Zapadnyy Gosudarstvennyy Meditsinskiy Universitet Im. I. I. Mechnikova

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

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Institut Regional du Cancer de Montpellier

location_facility: Pusan National University Yangsan Hospital

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: St.Marianna University School of Medicine

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,

location_facility: Marien-Krankenhaus GmbH Bergisch Gladbach

location_facility: Centro Hospitalar e Universitario de Coimbra

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani

location_facility: The Male/Female Health and Research Centre

location_facility: N.N. Petrov Research Institute Of Oncology

location_facility: Hygeia Diagnostic & Therapeutic Center Of Athens

location_facility: Attikon University General Hospital of Attica

location_facility: Acharya Tulsi Regional Cancer Treatment Research Institute

location_facility: Istanbul Medeniyet University Goztepe Training and Research Hospital

location_facility: Oleksandrivska Clinical Hospital of Kyiv City, Infectional Department #2

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

location_facility: Fundação Hospitalar São Francisco de Assis

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

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

location_facility: Jehangir Clinical Development Center Pvt Ltd

location_facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

location_facility: T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi

location_facility: Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)

location_facility: Kliniken Nordoberpfalz AG/Klinikum Weiden

location_facility: 'Papageorgiou' General Hospital of Thessaloniki

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Ryazan State Medical University named after I.P.Pavlov

location_facility: Waldkrankenhaus St. Marien -Urologische Universitätsklinik

location_facility: The Julius Center - Utrecht Science Park - Stratenum

location_facility: Winship Cancer Institute of Emory University

location_facility: Columbia University Medical Center, Herbert Irving Pavilion

location_facility: Wuhan Tongji Hospital, Tongji Medical College

location_facility: Fondazione del Piemonte per I'Oncologia IRCC Candiolo

location_facility: Polyclinique de Limoges - Francois Chenieux

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Centro Oncologico Riojano Integral (Cori)

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo

location_facility: Centre Hospitalier Universitaire de Sherbrooke

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

location_facility: MIH V.I. Shapoval Regional Clinical Centre of Urology and Nephrology

location_facility: CEDIC Centro de Investigaciones Clinicas

location_facility: Indira Gandhi Institute of Medical Sciences

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

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

location_facility: Aakash Healthcare Super Speciality Hospital

location_facility: Centro De Estudio Y Prevencion Del Cancer

location_facility: Fundacao Pio Xii - Hospital De Cancer De Barretos

location_facility: Post Graduate Institute of Medical Education & Research (PGIMER)

location_facility: N. N. Blokhin Russian Academy of Medical Sciences

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: H. Santa Maria - Centro Hospitalar de Lisboa Norte

location_facility: University of California Irvine Medical Center

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: A. Tsyb Medical Radiological Research Center

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Centro de Investigacion Clinica Chapultepec

location_facility: Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: CRYPTEX Investigacion clinica S.A De C.V

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

location_facility: Universitätsklinikum Salzburg - Landeskrankenhaus

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centro Regional Integrado de Oncologia - Crio

location_facility: Rajiv Gandhi Cancer Institute & Research Centre

location_facility: P.L. Shupyk National Medical Academy of Post-Graduate Education

location_facility: Chernihivskyi oblasnyi onkolohichnyi dyspanser

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Fundação Faculdade de Medicina de São José Do Rio Preto

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.

location_facility: Krasnoyarsk Regional Oncology Dispensary

location_facility: The First Affiliated Hospital of NanChang University

location_facility: West China Hospital of Sichuan University

location_facility: Shengjing Hospital of China Medical University

location_facility: Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital

location_facility: State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio

location_facility: Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

location_facility: ASL Napoli 2 Nord-SM delle Grazie Hospital

location_facility: Sujan Surgical Cancer Hospital & Amravati Cancer Foundation

title: A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

summary: The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy.


type: EudraCT Number

title: Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-LUNG01)

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Puerto Rico
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Spain

location_facility: Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

location_facility: Chi Mei Medical Center CMMC - Liouying Branch

location_facility: ASL 3 Genovese Oncologia Medica Villa Scassi

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Instituicao de Fisioterapeutas Ocupacionais

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

location_facility: The Catholic University of Korea, Seoul St. Marys Hospital

location_facility: Seoul National University Boramae Medical Center

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Portsmouth Hospitals University NHS Trust

location_facility: Ft. Wayne Medical Oncology and Hematology

location_facility: National Cheng Kung University Hospital NCKUH

location_facility: Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: University Health Network - Princess Margaret Hospital

location_facility: Saitama Medical University International Medical Center

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Institutul Oncologic Profesor Doctor Alexandru Trestioreanu

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Stadtspital Waid ; Triemli, Site Triemli - clinic for Medical oncology & hematology

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Prince of Wales Hospital / The Chinese University of Hong Kong

location_facility: Crown Princess Mary Cancer Centre Westmead Hospital

location_facility: Hospital General Universitario de Valencia

location_facility: FN Olomouc â€" Klinika plicnich nemoci a onkologie

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Memorial Healthcare System- Memorial Cancer Institute

location_facility: MUHC-Glen Site and MUHC Research Institute

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Hospital Puerte de Hierro de Majadahonda

location_facility: Azienda Ospedaliero- Universitaria Policlinico S. Orsola-Malpighi

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: OncoCare Cancer Centre - Gleneagles Medical Centre Location

location_facility: Yonsei University Health System - Severance Hospital

location_facility: Oddział Onkologii Wojewódzki Szpital Specjalistyczny Słupsk

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Federal State Budgetary Institution - N.N. Blokhin National Medical Research Center of Oncology

location_facility: St. Vincents Hospital The Catholic University of Korea

location_facility: Kyungpook National University Chilgok Hospital

location_facility: The Center for Cancer and Blood Disorders

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: N.N. Petrov Research Institute of Oncology

location_facility: University Hospitals Cleveland Medical Center

location_facility: National Taiwan University Hospital NTUH

location_facility: Hospital Clinico Universitario Lozano Bleza

location_facility: CHU de Poitier Pole regional de Cancerologie

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: University Hospital of Nantes - Thoracic Oncology

location_facility: Hospital Universitario Jose Eleuterio Gonzalez

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)

summary: This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).

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

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

lead_sponsor: AstraZeneca

location_country:
United States
Brazil
Chile
Peru
Netherlands
Germany
France
Japan
Poland
Hungary
Belgium
Argentina
Russian Federation
Spain
Turkey
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan


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

lead_sponsor: Hoffmann-La Roche

location_country:
Greece
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Thailand
Argentina
Korea, Republic of
Kenya
South Africa
Switzerland
Hungary
Portugal
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: Rambam Health Corporation; Oncology Institute

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

location_facility: Affiliated Drum Tower Hospital of Nanjing University Medical School; Nanjing Shi

location_facility: St John of God Hospital; Bendat Cancer Centre

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Universitätsklinikum Essen Klinik f.Strahlentherapie

location_facility: AKH - Medizinische Universität Wien; Department for Internal Medicine I

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: Städtisches Klinikum Dresden; IV. Medizinische Klinik

location_facility: Hopital Du Haut-Leveque; Gastro-Enterologie

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

location_facility: ASU FC S. M. DELLA MISERICORDIA; Oncologia

location_facility: SP ZOZ MSWiA z Warm-Maz Centrum Oncologii w Olsztynie; ZAKŁAD I ODDZIAŁ KLINICZNY RADIOTERAPII

location_facility: Affiliated Hospital of Bengbu Medical College

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Fakultni nemocnice Kralovske Vinohrady; Radioterapeuticka a onkologicka klinika

location_facility: Chu La Miletrie; Gastro Enterologie Endoscopies

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

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

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie; Odd. Onk. Klin. i Immunoonk.

location_facility: Petz Aladar Megyei Oktato Korhaz; Oncoradiologia

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

location_facility: Changzhou Tumor Hospital, Changzhou Fourth People's Hospital

location_facility: Hospital Regional Universitario Carlos Haya

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

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hopital Cote De Nacre; Gastro Enterologie

location_facility: European Hospital Georges Pompidou (HEGP)

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica

location_facility: Universitätsklinikum Klinik u.Poliklinik f.Strahlentherapie

location_facility: The Affiliated Hospital of Xuzhou Medical College

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

location_facility: University of Pennsylvania Health System; Cancer Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: Universität Tübingen; Med. Klinik; Innere Medizin I

location_facility: Oncology Unit, Faculty of Medicine, Vajira Hospital; Department of Medicine

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Washington University School of Medicine; Medical Oncology

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ŚW. JANA Z DUKLI; II Oddział Onkologii Klinicznej

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddział Onkologiczny

location_facility: Saitama Medical University International Medical Center

location_facility: NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Klinikum Klagenfurt am Wörthersee; Abteilung für Innere Medizin und Onkologie

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology

location_facility: Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: Klinikum der Philipps-Universität Marburg

location_facility: Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii

location_facility: AUSL-IRCCS di Reggio Emilia; Oncologia Medica

location_facility: Affiliated Hospital of Jining Medical University

location_facility: Vinnytsya Regional Clinical Oncology Dispensary

location_facility: Taipei Veterans General Hospital; Department of Oncology

location_facility: Clatterbridge Cancer Centre; Clatterbridge Cancer Centre

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

location_facility: Instituto de Ensino e Pesquisa Clinica do Ceara

location_facility: IPO do Porto; Servico de Oncologia Medica

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

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: The First People's Hospital of Lian Yun Gang

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Instituto de Investigaciones Metabolicas (Idim)

location_facility: Subei People's Hospital of Jiangsu province; Respiratory

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

location_facility: CI of Kherson Regional Council Kherson Regional Oncology Dispensary

location_facility: Hopital Rangueil; Gastro Enterologie Et Nutrition

location_facility: Szpital Morski im. PCK; Poradnia Onkologiczna

location_facility: Ospedale Degli Infermi - Faenza; Oncologia Medica

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie

location_facility: Boao Evergrande international Hoapital in a affiliation with Brigham and Woman's Hospital

location_facility: Austin Health; Cancer Clinical Trial Centre

location_facility: The First Affiliated Hospital to Henan University of Science and Technology

location_facility: National Taiwan University Hospital; Oncology

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279

location_facility: National Cheng Kung University Hospital; Oncology

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

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

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

location_facility: Szegedi Tudományegyetem; Onkoterápiás Klinika

location_facility: Hopital Timone Adultes; Oncologie Digestive

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Med. Fak. d. Otto-von-Guericke-Universität; Unik. für Gastroenter., Hepat. und Infekt.

location_facility: Scientific Research Institute n.a. N.N. Petrov

location_facility: China Medical University Hospital; Oncology and Hematology

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: University of Pretoria Oncology Department; Medical Oncology

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Ankara University Faculty of Medicine Cebeci Hospital

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Van Yuzuncu Yil University Hospital; Medical Oncology

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Viszeralonkologisches Zentrum

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

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

location_facility: CHU Dijon Bourgogne Hôpital François Mitterand

location_facility: Istanbul University Cerrahpaşa-Cerrahpaşa Medical Faculty; Medikal Onkoloji Departmani

source: euctr

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

summary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).


title: A Phase 2, Randomized Study of Neoadjuvant Nivolumab Plus Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab Plus Ipilimumab Followed by Either Adjuvant Nivolumab or Postsurgical Observation Depending on Pathologic Response Compared With Adjuvant Nivolumab in Treatment-Naive Patients With Resectable Clinically Detectable Stage III Melanoma

acronym: CheckMate 7UA

summary: The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.

study_start_date_type: Anticipated

status: Withdrawn

enrollment_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Brazil
Sweden
Switzerland
Netherlands
Germany
France
Poland
Australia
Belgium
Russian Federation
Spain
Denmark
United States
United Kingdom

intervention_type: Biological

status_simplified: Unknown


title: A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients With DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTEN Deficiency.

summary: This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.

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:
Peru
Australia
Belgium
Russian Federation
Taiwan
India
France
Japan
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
South Africa
Chile
Hong Kong
Netherlands
Philippines
Vietnam
Bulgaria
Hungary
China
Germany
United States
United Kingdom
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

intervention_type: Other


type: Other Identifier

title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)

acronym: PERSEUS

summary:
Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS)

Secondary Objectives:

To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168

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. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
Spain
Croatia
France
Japan
Poland
Norway
Argentina
Canada
Turkey
Colombia
Chile
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Czechia
Israel
Belarus
Estonia
Latvia

location_facility:
Investigational Site Number :1240002
Investigational Site Number :6420004
Investigational Site Number :8400150
Investigational Site Number :3800003
Investigational Site Number :7240001
Investigational Site Number :0560007
Investigational Site Number :2500012
Investigational Site Number :3920008
Investigational Site Number :8260012
Investigational Site Number :0320003
Investigational Site Number :8400029
Investigational Site Number :8260001
Investigational Site Number :3000004
Investigational Site Number :8400033
Investigational Site Number :2030001
Investigational Site Number :7240015
Investigational Site Number :3560005
Investigational Site Number :8040020
Investigational Site Number :3480202
Investigational Site Number :2330001
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Investigational Site Number :1240007
Investigational Site Number :3920011
Investigational Site Number :6430017
Investigational Site Number :7240005
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Investigational Site Number :6160004
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Investigational Site Number :1000008
Investigational Site Number :6430006
Investigational Site Number :7920005
Investigational Site Number :8040007
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Investigational Site Number :4840004
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Investigational Site Number :6430001
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Investigational Site Number :6160006
Investigational Site Number :8040008
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Investigational Site Number :1000004
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Investigational Site Number :1240001
Investigational Site Number :3560002
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Investigational Site Number :3560004
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Investigational Site Number :1560001
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Investigational Site Number :2030004
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Investigational Site Number :1240004
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Investigational Site Number :2030002
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Investigational Site Number :3760002
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Investigational Site Number :6160002
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Investigational Site Number :7240003
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Investigational Site Number :7560002
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Investigational Site Number :8040002
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Investigational Site Number :1560005
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Investigational Site Number :6430004
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Investigational Site Number :7920002
Investigational Site Number :1560004
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Investigational Site Number :6430009
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Investigational Site Number :1560008
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Investigational Site Number :3760008
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Investigational Site Number :7240007
Investigational Site Number :6160007
Investigational Site Number :4280003
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Investigational Site Number :3800006
Investigational Site Number :1560027
Investigational Site Number :1560021
Investigational Site Number :0560002
Investigational Site Number :8400005


title: A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

summary: The objectives of this study are to evaluate the safety and efficacy of Zimura intravitreal administration in patients with geographic atrophy secondary to age-related macular degeneration (AMD)

status: Active, not recruiting

lead_sponsor: IVERIC bio, Inc.

location_country:
Italy
Austria
Brazil
United Kingdom
Germany
Croatia
Czechia
France
Israel
Poland
Hungary
Argentina
Australia
Belgium
Spain
Estonia
United States
Latvia
Canada
Colombia

location_facility: Jules Stein Eye Institute/David Geffen School of Medicine

location_facility: University of Miami - Bascom Palmer Eye Institute

location_facility: Southern California Desert Retina Consultants

location_facility: University of Bonn, Dept of Ophthalmology

location_facility: Centre Ophtalmologique d'Imagerie et de Laser

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli UOC Oculistica

location_facility: Canadian Centre for Advanced Eye Therapeutics Inc.

location_facility: University of Utah, John A. Moran Eye Center

location_facility: Northern California Retina Vitreous Associates

location_facility: Retina Consultants of Southern California

location_facility: Vision Research Center Eye Associates of New Mexico

location_facility: Retina Vitreous Surgeons of Central New York, PC

location_facility: Azienda Sanitaria Universitaria Integrata

location_facility: Organización Médica de Investigación S.A.

location_facility: Szabolcs-Szatmar-Bereg County Hospital and University Teaching Hospital

location_facility: Instituto Clinico Quirurgico de Oftalmologia

location_facility: Debrecen University Clinical Center, Dept of Ophthalmology

location_facility: Retina Consultants of Southern Colorado, P.C.

location_facility: Centre d'exploration ophtalmologique de l'Odeon

location_facility: Department of Ophthalmology, Rabin Medical Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Magyar Honvedseg EgeszsegUgyi Kozpont. Szemeszeti Osztaly

location_facility: Markusovszky Egyetemi Oktatokorhaz Szerneszeti Osztalya

location_facility: Ospedale Clinicizzato Universita di Chieti "Ss Annunziata"

location_facility: University of South Florida/Ophthalmology

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Centro de Diagnóstico y Cirugía Ocular "Oftalmólogos Especialistas"

location_facility: Retina Research Institute at New England Retinal Consultants

location_facility: Pauls Stradinis Clinical University Hospital

location_facility: Semmelweis University, Dept of Ophthalmology

location_facility: Klinika Okulistyczna OFT ALMIKA Sp. z o. o.

location_facility: Retina and Vitreous Center of Southern Oregon

location_facility: Ophthalmic Consultants of the Capital Region

location_facility: Nuovo Arcispedale Sant' Anna (A.O.U. di Ferrara)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: Centro Privado de Oftalmologia - OFTAR Mendoza SRL

location_facility: Centro Medico Micro Diagnostico y Microcirugla Ocular

location_facility: University Retina and Macula Associates, PC

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Scheie Eye Institute, University of Pennsylvania

location_facility: Fundacion OJlalmologica Nacional - FUNDONAL


title: A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis

acronym: GEMINI 2

summary:
Primary Objective:

To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS

Secondary Objective:

To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168

location_country:
Greece
Belgium
Russian Federation
Ukraine
India
Croatia
France
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Chile
Switzerland
Netherlands
Hungary
Puerto Rico
Portugal
United States
Germany
United Kingdom
Brazil
Serbia
Czechia
Israel
Spain
Turkey
Latvia

location_facility:
Investigational Site Number :1240002
Investigational Site Number :4100002
Investigational Site Number :0320005
Investigational Site Number :0320002
Investigational Site Number :7240001
Investigational Site Number :0320001
Investigational Site Number :8400063
Investigational Site Number :0320003
Investigational Site Number :8400029
Investigational Site Number :3000004
Investigational Site Number :7240009
Investigational Site Number :2030001
Investigational Site Number :8040020
Investigational Site Number :7240005
Investigational Site Number :2500011
Investigational Site Number :6430006
Investigational Site Number :7920005
Investigational Site Number :8040007
Investigational Site Number :8400004
Investigational Site Number :3000001
Investigational Site Number :3480105
Investigational Site Number :3480106
Investigational Site Number :8400047
Investigational Site Number :6430001
Investigational Site Number :8400139
Investigational Site Number :7030003
Investigational Site Number :7030002
Investigational Site Number :1520003
Investigational Site Number :3000007
Investigational Site Number :8400127
Investigational Site Number :2030005
Investigational Site Number :4100003
Investigational Site Number :8040019
Investigational Site Number :6430011
Investigational Site Number :2500007
Investigational Site Number :3560008
Investigational Site Number :7560004
Investigational Site Number :7030001
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Investigational Site Number :1520006
Investigational Site Number :1520005
Investigational Site Number :6880002
Investigational Site Number :8400100
Investigational Site Number :8260003
Investigational Site Number :2500004
Investigational Site Number :3560002
Investigational Site Number :7240002
Investigational Site Number :8260016
Investigational Site Number :6430007
Investigational Site Number :8040018
Investigational Site Number :7240006
Investigational Site Number :1910002
Investigational Site Number :8400106
Investigational Site Number :6200001
Investigational Site Number :8400034
Investigational Site Number :8400069
Investigational Site Number :3480102
Investigational Site Number :3000009
Investigational Site Number :8040003
Investigational Site Number :1910001
Investigational Site Number :8400032
Investigational Site Number :8400051
Investigational Site Number :7240008
Investigational Site Number :8400036
Investigational Site Number :1240014
Investigational Site Number :0760002
Investigational Site Number :7920004
Investigational Site Number :7560003
Investigational Site Number :3760001
Investigational Site Number :6880006
Investigational Site Number :8400089
Investigational Site Number :4100006
Investigational Site Number :2760014
Investigational Site Number :4100001
Investigational Site Number :3000003
Investigational Site Number :8400007
Investigational Site Number :0560001
Investigational Site Number :2500005
Investigational Site Number :2500001
Investigational Site Number :7240004
Investigational Site Number :2760005
Investigational Site Number :7920001
Investigational Site Number :2030002
Investigational Site Number :8400057
Investigational Site Number :8400097
Investigational Site Number :5780001
Investigational Site Number :8400128
Investigational Site Number :8400046
Investigational Site Number :7920006
Investigational Site Number :0560005
Investigational Site Number :3760002
Investigational Site Number :6880004
Investigational Site Number :8400035
Investigational Site Number :1520004
Investigational Site Number :2500010
Investigational Site Number :8400008
Investigational Site Number :8400126
Investigational Site Number :6430012
Investigational Site Number :6430005
Investigational Site Number :3760006
Investigational Site Number :7240003
Investigational Site Number :8400088
Investigational Site Number :2760012
Investigational Site Number :6430003
Investigational Site Number :6200002
Investigational Site Number :7920003
Investigational Site Number :7560002
Investigational Site Number :3560007
Investigational Site Number :0560004
Investigational Site Number :1240005
Investigational Site Number :1520002
Investigational Site Number :0760001
Investigational Site Number :3000002
Investigational Site Number :1520001
Investigational Site Number :5780002
Investigational Site Number :6430002
Investigational Site Number :2500006
Investigational Site Number :6200004
Investigational Site Number :3480103
Investigational Site Number :8400071
Investigational Site Number :5280001
Investigational Site Number :8040002
Investigational Site Number :8400081
Investigational Site Number :3000006
Investigational Site Number :8400025
Investigational Site Number :8400016
Investigational Site Number :4280002
Investigational Site Number :6880001
Investigational Site Number :8040022
Investigational Site Number :8260009
Investigational Site Number :0760007
Investigational Site Number :6430004
Investigational Site Number :6430010
Investigational Site Number :2760015
Investigational Site Number :6200006
Investigational Site Number :8040005
Investigational Site Number :8040006
Investigational Site Number :6200011
Investigational Site Number :7920002
Investigational Site Number :2030008
Investigational Site Number :6880005
Investigational Site Number :0320004
Investigational Site Number :2500019
Investigational Site Number :8400009
Investigational Site Number :2500003
Investigational Site Number :2760020
Investigational Site Number :3760004
Investigational Site Number :6200010
Investigational Site Number :3760003
Investigational Site Number :7030004
Investigational Site Number :8400151
Investigational Site Number :8400070
Investigational Site Number :7240007
Investigational Site Number :2500017
Investigational Site Number :2760003
Investigational Site Number :8400129
Investigational Site Number :2500002
Investigational Site Number :8400015
Investigational Site Number :8400039
Investigational Site Number :4280003
Investigational Site Number :8400110
Investigational Site Number :0560002


title: A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease

acronym: OSCAR

summary: OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study is being conducted in 2 parts (Part 1 and Part 2). Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease in Part 1. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to [<=] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care.

status: Completed

study_completion_date_type: Actual

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
United States
Brazil
Chile
India
Peru
South Africa
Mexico
Netherlands
France
Japan
Poland
Belgium
Argentina
Russian Federation
Spain
Canada
United Kingdom
Colombia

status_simplified: Completed


title: A Phase III, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination With Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment

summary: This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.

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

location_country:
Italy
United States
Germany
France
Japan
Greece
Poland
Argentina
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom
Korea, Republic of

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: A.O. Universitaria Ospedale Consorziale Policlinico Di Bari; U.O. Oncologia Medica Universitaria

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

location_facility: Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Branch of the company "Hadassah Medical LTD"

location_facility: Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Pusan National University Yangsan Hospital

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

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

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Centre Oscar Lambret; Chir Cancerologie General

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Centre Leon Berard; Departement Oncologie Medicale

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

location_facility: FSI Russian Centre of Radiology and Surgical Technologies

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

location_facility: Hospital Universitario de Burgos; Oncología

location_facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

location_facility: City Clinical Oncological Hospital No. 1 of the Moscow City Health Department

location_facility: New York Oncology Hematology,P.C.-Albany

location_facility: St-Petersburg Regional Oncology Dispensary; Oncology

location_facility: SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: TSBHI Altai Territorial oncological dispensary

location_facility: Uniklinik-Eppendorf; Klinik U Poliklinik F Urologie

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

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

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS); Day Hospital Oncologico Multidisciplinare

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: National Medical Research Center for Surgery named after A.V. Vishnevsky

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Centrum Onkologii im. Prof. Franciszka Łukaszczyka; Ambulatorium Chemioterapii

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Athens Medical Center; Dept. of Oncology

location_facility: Memorial Sloan Kettering Cancer Center - Commack

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

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

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

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: Wojskowy Instytut Medyczny; Klinika Onkologii

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

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Azienda Ospedaliera S. Maria - Terni; Oncologia

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

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

location_facility: Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

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

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building

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

location_facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet; Urologie und Kinderurologie

location_facility: A.O.U di Verona Policlinico G.B. Rossi; Centro Ricerche Cliniche

location_facility: Institut Gustave Roussy; Oncologie Medicale

location_facility: Private Healthcare Institution Clinical Hospital RZhD Medicine

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

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

location_facility: Virginia Cancer Specialists - Gainsville

location_facility: Hospital Alvaro Cunqueiro; Servicio de Oncologia

location_facility: Tokyo Women's Medical University Hospital

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); SOC Oncologia Medica A


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

lead_sponsor: Takeda

location_country:
Italy
France
Poland
United States
Canada

acronym: PEVENAZA

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: University of Miami Miller School of Medicine

location_facility: University of North Carolina at Chapel Hill

location_facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: AdventHealth (Florida Hospital) - Transplant Institute

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

location_facility: Joe Arrington Cancer Research and Treatment Center

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

location_facility: University Hospitals Cleveland Medical Center

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

location_facility: Institut dHematologie de Basse Normandie

location_facility: Ospedale Santa Maria Della Misericordia Di Perugia

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

type: Registry Identifier

title: A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy

summary: The purpose of this study is to determine whether the combination of pevonedistat + venetoclax + azacitidine improves event-free survival (EFS) compared with venetoclax + azacitidine in patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy.


lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
Austria
United States
Germany
Finland
France
Japan
Australia
Puerto Rico
Spain
Canada

acronym: DOR/ISL Blinded Label Switch

location_facility: Clinique de Medecine Urbaine du Quartier Latin ( Site 2804)

location_facility: The Crofoot Research Center, Inc. ( Site 2715)

location_facility: Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400)

location_facility: Medizinische Hochschule Hannover ( Site 3012)

location_facility: Holdsworth House Medical Practice ( Site 3800)

location_facility: Taylor Square Private Clinic ( Site 3804)

location_facility: Holdsworth House Medical Practice - Brisbane ( Site 3810)

location_facility: ICH Study Center GmbH & Co.KG ( Site 3009)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 3500)

location_facility: A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507)

location_facility: Universitaetsklinikum Essen ( Site 3007)

location_facility: Hospital Universitario La Paz ( Site 3604)

location_facility: Hospital Universitario Infanta Leonor ( Site 3606)

location_facility: Zuckerberg San Francisco General Hospital UCSF ( Site 2743)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 3603)

location_facility: Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812)

location_facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501)

location_facility: Centre Hospitalier Regional du Orleans ( Site 3108)

location_facility: Social Medical Center - Otto Wagner Hospital ( Site 3404)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 7201)

location_facility: National Hospital Organization Osaka National Hospital ( Site 7202)

location_facility: Hospital Universitari Vall d Hebron ( Site 3602)

location_facility: MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002)

location_facility: Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010)

location_facility: ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003)

location_facility: Azienda Ospedaliera San Paolo ( Site 3503)

location_facility: Prahran Market Clinic (PMC) ( Site 3806)

location_facility: CHU de Nice Hopital Archet 1 ( Site 3103)

location_facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 3121)

location_facility: Infectious Disease Specialists Of Atlanta PC ( Site 2719)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 2700)

location_facility: Hospital 12 de Octubre de Madrid ( Site 3605)

location_facility: Hennepin County Medical Center ( Site 2733)

location_facility: Helsinki University Hospital ( Site 3200)

location_facility: North Texas ID Consultants, PA ( Site 2707)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 3601)

location_facility: Chatham County Health Department ( Site 2731)

location_facility: DCOL Center for Clinical Research ( Site 2769)

location_facility: CHU de Nancy Hopital Brabois Adultes ( Site 3128)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 7203)

location_facility: Midway Immunology and Research ( Site 2759)

location_facility: Vancouver ID Research and Care Centre Society ( Site 2800)

location_facility: Kaiser Permanente Los Angeles Medical Center ( Site 2775)

location_facility: Hope Clinical Research, Inc. ( Site 2902)

location_facility: Universita' Vita Salute. Ospedale San Raffaele ( Site 3502)

location_facility: University of California, Davis, Division of ID Research ( Site 2702)

location_facility: Klinikum rechts der Isar der Technischen Universitat ( Site 3005)

location_facility: Centre Hospitalier de Tourcoing ( Site 3100)

location_facility: Clinical Research Puerto Rico Inc ( Site 2900)

location_facility: Hospital Universitari de Bellvitge ( Site 3612)

location_facility: Hospital Universitario Ramon y Cajal ( Site 3611)

location_facility: Hospital Clinic i Provincial ( Site 3600)

location_facility: Triple O Research Institute, P.A. ( Site 2755)

location_facility: CAIMED Center - Ponce School of Medicine ( Site 2903)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 3609)

title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV- 1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

summary: This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.


ReferenceType: derived

ReferenceCitation: Jaber T, Dadu R, Hu MI. Medullary thyroid carcinoma. Curr Opin Endocrinol Diabetes Obes. 2021 Oct 1;28(5):540-546. doi: 10.1097/MED.0000000000000662. Review.

family: Jaber

full_name: Tania Jaber

given: Tania

sequence: first

family: Dadu

full_name: Ramona Dadu

given: Ramona

sequence: additional

family: Hu

full_name: Mimi I. Hu

given: Mimi I.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Current Opinion in Endocrinology, Diabetes & Obesity

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Medullary thyroid carcinoma

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.

lead_sponsor: Loxo Oncology, Inc.

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

location_facility: University of California, Davis - Health Systems

location_facility: National Medical Research Center of Endocrinology of Ministry of Health Dept

location_facility: London Health Science Centre - Victoria Hospital

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Los Angeles Biomedical Research Institute at Harbor - UCLA Medical

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: Institut de cancérologie Strasbourg Europe

location_facility: Grupo COI - Clínicas Oncológicas Integradas

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Swietokrzyskie Centrum Onkologii w Kielcach

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek

location_facility: I.F.O. Istituto Nazionale Tumori Regina Elena

location_facility: Azienda Ospedaliero-Universitaria S.Giovanni Battista

location_facility: Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (policlinic, hospital)

location_facility: Studiengesellschaft Hämato-Onkologie Hamburg - Prof Laack & Partner

location_facility: Beijing Tongren Hospital affiliated to Capital Medical Unive

location_facility: Chonnam National University Hwasun Hospital

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Ospedale San Luca, IRCCS Istituto Auxologico

location_facility: Azienda Ospedlaliero-Univeristaria Pisana, Stabilimento Ospedaliero di Cisanello

location_facility: National medical research center of radiology Obninsk

location_facility: Seoul National University Bundang Hospital

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Ruby Hall Clinic and Grant Medical Foundation

location_facility: Harbin Medical University Cancer Hospital

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: University of Cincinnati Cancer Institute

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: University General Hospital of Heraklion

location_facility: Hopital Pitie Salpetriere -Unité Thyroïde-Tumeurs Endocrines

location_facility: Post Graduate Institute of Medical Education & Research

title: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)

summary: The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.


lead_sponsor: Galderma R&D

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
France
Poland
Hungary
Belgium
Spain
Denmark
Canada
United Kingdom
Korea, Republic of

acronym: A long-term study to assess the safety and efficacy of nemolizumab in subjects with PN

location_facility: Galderma Investigational Galderma Investigational Site

location_facility: Galderma I Galderma Investigational Site

title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

summary: The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).


location_country:
Chile
Germany
France
Japan
Korea, Republic of
Poland
Hungary
Ireland
Spain
United States
United Kingdom
Canada
Taiwan
Colombia
Ukraine

location_facility: Seoul National University Bundang Hospital ( Site 2409)

location_facility: Gynaekologisch-onkologische Praxis Hannover ( Site 1207)

location_facility: Memorial Sloan-Kettering Cancer Center ( Site 0156)

location_facility: Hochwaldkrankenhaus Bad Nauheim ( Site 1211)

location_facility: Gachon University Gil Medical Center ( Site 2408)

location_facility: Virginia Oncology Associates ( Site 0164)

location_facility: St Vincents University Hospital ( Site 0900)

location_facility: CI Krivorizhskiy oncology dispensery ( Site 1504)

location_facility: Fundacion Arturo Lopez Perez ( Site 0500)

location_facility: Chernihiv Medical Center of Modern Oncology ( Site 1520)

location_facility: Gynaekologisches Zentrum-Schwerpunkt Gyn. Onkologie ( Site 1205)

location_facility: Regionalny Szpital Specjalistyczny Latawiec ( Site 1917)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1913)

location_facility: Princess Margaret Cancer Centre ( Site 0005)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1600)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 2300)

location_facility: Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 1909)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 0160)

location_facility: National Cheng Kung University Hospital ( Site 2303)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 1506)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1912)

location_facility: Blackpool Victoria Hospital ( Site 0921)

location_facility: Mercy Clinic Oncology and Hematology ( Site 0110)

location_facility: Sana Klinikum Offenbach Klinik fuer Gynakologie und Geburtshilfe ( Site 1206)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 2304)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1508)

location_facility: Massachusetts General Hospital ( Site 0155)

location_facility: St. Joseph Heritage Healthcare ( Site 0104)

location_facility: Virginia Oncology Associates ( Site 0153)

location_facility: Universitaetsklinikum Erlangen ( Site 1201)

location_facility: Severance Hospital Yonsei University Health System ( Site 2401)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 1605)

location_facility: Aichi Cancer Center Hospital ( Site 2202)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1512)

location_facility: Universitaetsklinikum AoeR Duesseldorf ( Site 1210)

location_facility: Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0609)

location_facility: Texas Oncology - San Antonio Stone Oak ( Site 0166)

location_facility: Fukushima Medical University Hospital ( Site 2201)

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0601)

location_facility: Medical center of the Limited Liability Company Yulis ( Site 1517)

location_facility: Hyogo College of Medicine Hospital ( Site 2203)

location_facility: The Christie NHS Foundation Trust ( Site 0914)

location_facility: University of Miami Sylvester CC ( Site 0146)

location_facility: Texas Oncology-San Antonio Medical Center ( Site 0158)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1608)

location_facility: Hospital Clinic I Provincial de Barcelona ( Site 0702)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0510)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 1502)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0161)

location_facility: John Wayne Cancer Institute ( Site 0111)

location_facility: Instituto Oncologico Baselga.Hospital Quiron. ( Site 0707)

location_facility: Zhytomyr Regional Oncology Center ( Site 1515)

location_facility: Seoul National University Hospital ( Site 2403)

location_facility: Virginia Oncology Associates ( Site 0163)

location_facility: Hospital General Arnau de Vilanova de Valencia ( Site 0706)

location_facility: Hospital Universitario Reina Sofia ( Site 0705)

location_facility: Medical Centre Consilium Medical ( Site 1514)

location_facility: Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe ( Site 1200)

location_facility: The Center For Cancer And Blood Disorders ( Site 0151)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 1001)

location_facility: Clinica Universitaria Navarra - Madrid ( Site 0700)

location_facility: Universitaetsklinikum Mannheim GmbH ( Site 1213)

location_facility: Orszagos Onkologiai Intezet ( Site 1602)

location_facility: Texas Oncology-San Antonio Northeast ( Site 0165)

location_facility: Texas Oncology-New Braunfels ( Site 0168)

location_facility: Medical Centre LLC Oncolife ( Site 1510)

location_facility: CSSS de Laval- Hopital de la Cite de la Sante ( Site 0011)

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 1607)

location_facility: Virginia Piper Cancer Institute ( Site 0157)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0501)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 1009)

location_facility: China Medical University Hospital ( Site 2302)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 1203)

location_facility: YVMH dba Virginia Mason Memorial/North Star Lodge Cancer Center ( Site 0128)

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

location_facility: McGill University Health Centre ( Site 0002)

location_facility: SI-Zaytsev institute of general and urgent surgery-NAMS ( Site 1518)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0003)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1601)

location_facility: Georgia Cancer Center at Augusta University ( Site 0129)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2204)

location_facility: Hospital Universitari Vall d Hebron ( Site 0701)

location_facility: Kyungpook National University Chilgok Hospital ( Site 2402)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1604)

location_facility: CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 1007)

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 22

title: An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009)

summary:
The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are:

Olaparib plus pembrolizumab prolongs progression-free survival (PFS) compared with chemotherapy plus pembrolizumab.
Olaparib plus pembrolizumab is non-inferior to chemotherapy plus pembrolizumab in terms of overall survival (OS).
Olaparib plus pembrolizumab prolongs OS compared with chemotherapy plus pembrolizumab.


ReferenceCitation: Gaspar N, Venkatramani R, Hecker-Nolting S, Melcon SG, Locatelli F, Bautista F, Longhi A, Lervat C, Entz-Werle N, Casanova M, Aerts I, Strauss SJ, Thebaud E, Morland B, Nieto AC, Marec-Berard P, Gambart M, Rossig C, Okpara CE, He C, Dutta L, Campbell-Hewson Q. Lenvatinib with etoposide plus ifosfamide in patients with refractory or relapsed osteosarcoma (ITCC-050): a multicentre, open-label, multicohort, phase 1/2 study. Lancet Oncol. 2021 Sep;22(9):1312-1321. doi: 10.1016/S1470-2045(21)00387-9. Epub 2021 Aug 17.

family: Gaspar

full_name: Nathalie Gaspar

given: Nathalie

family: Venkatramani

full_name: Rajkumar Venkatramani

given: Rajkumar

family: Hecker-Nolting

full_name: Stefanie Hecker-Nolting

given: Stefanie

family: Melcon

full_name: Soledad Gallego Melcon

given: Soledad Gallego

family: Locatelli

full_name: Franco Locatelli

given: Franco

family: Bautista

full_name: Francisco Bautista

given: Francisco

family: Longhi

full_name: Alessandra Longhi

given: Alessandra

family: Lervat

full_name: Cyril Lervat

given: Cyril

family: Entz-Werle

full_name: Natacha Entz-Werle

given: Natacha

family: Casanova

full_name: Michela Casanova

given: Michela

family: Aerts

full_name: Isabelle Aerts

given: Isabelle

family: Strauss

full_name: Sandra J Strauss

given: Sandra J

family: Thebaud

full_name: Estelle Thebaud

given: Estelle

family: Morland

full_name: Bruce Morland

given: Bruce

family: Nieto

full_name: Adela Cañete Nieto

given: Adela Cañete

family: Marec-Berard

full_name: Perrine Marec-Berard

given: Perrine

family: Gambart

full_name: Marion Gambart

given: Marion

family: Rossig

full_name: Claudia Rossig

given: Claudia

family: Okpara

full_name: Chinyere E Okpara

given: Chinyere E

family: He

full_name: Cixin He

given: Cixin

family: Dutta

full_name: Lea Dutta

given: Lea

family: Campbell-Hewson

full_name: Quentin Campbell-Hewson

given: Quentin

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Gaspar N, Campbell-Hewson Q, Huang J, Okpara CE, Bautista F. OLIE, ITCC-082: a Phase II trial of lenvatinib plus ifosfamide and etoposide in relapsed/refractory osteosarcoma. Future Oncol. 2021 Nov;17(32):4249-4261. doi: 10.2217/fon-2021-0743. Epub 2021 Aug 12.

name: Department of Childhood & Adolescent Oncology, Gustave Roussy Cancer Campus, Villejuif, France

name: The Great North Children’s Hospital, Royal Victoria Infirmary, Newcastle Upon Tyne, UK

name: Biostatistics, Eisai Inc., Woodcliff Lake, NJ 07677, USA

name: Clinical Research, Eisai Ltd., Hatfield, UK

name: Pediatric Oncology Department, Hospital del Niño Jesús, Madrid, Spain

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

location_country:
Finland
Australia
Belgium
Taiwan
France
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Ireland
United States
United Kingdom
Italy
Austria
Czechia
Israel
New Zealand
Spain

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: University of Mississippi Medical Center

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Severance Hospital Yonsei University Health System

location_facility: Schneider Children's Medical Center of Israel

location_facility: Drottning Silvias Barn Och Ungdomssjukhus

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Princess Maxima Center for Pediatric Oncology

location_facility: Hospital Universitario Fundacion Jimenez Diaz

title: A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination With Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed or Refractory Osteosarcoma (OLIE)

summary: This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents, and Young Adults with Relapsed or Refractory Osteosarcoma.


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

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

location_facility: Texas Oncology Odessa-West Texas Cancer Center

location_facility: Eastern Connecticut Hematology & Oncology Assoc.

location_facility: Intergrated Clinical Oncology Network Pty Ltd (ICON)

location_facility: Grand Hôpital de Charleroi, site Notre Dame

location_facility: Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Third Military Medical University Daping Hospital Cancer Center

location_facility: First affiliated Hospital of Zhejiang University

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

location_facility: The First Affiliated Hospital of Nanjing Medical University

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

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

location_facility: Flinders Centre for Innovation in Cancer

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

location_facility: Beijing Luhe Hospital, Capital Medical University

location_facility: Frederick Health Hospital - James M Stockman Cancer Institute

location_facility: Instituto de Medicina Integral Professor Fernando Figueira

location_facility: Instituto do Cancer do Estado de Sao Paulo ICESP

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Instituto de Investigaciones Metabólicas

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

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Northwestern University Feinberg School of Medicine

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Medizinische Fakultät Carl Gustav Carus Technische Universität Dresden

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

location_facility: Beijing Tiantan Hospital, Capital Medical University

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

location_facility: National Hospital Organizaiton Shikoku Cancer Center

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

location_facility: Ospedale Santa Chiara AO Universitaria Pisana

location_facility: Eastern Theater General Hospital, Qinhuai District Medical Area

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

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

location_facility: The Center for Cancer and Blood Disorders

location_facility: Central South University Xiangya Hospital The First Affiliated Hospital of Hunan Medical College

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

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

location_facility: BP - Beneficencia Portuguesa de São Paulo

title: A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations

summary: The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations.


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

lead_sponsor: Regeneron Pharmaceuticals

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

location_facility:
Regeneron Study Site
Regeneron Research Site
Regeneron Research Sites
Regeneron Research Facility

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

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

The secondary objectives of the study are:

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


title: A Phase 3, Multicenter, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Fedratinib Compared to Best Available Therapy (BAT) in Subjects With DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) and Previously Treated With Ruxolitinib

summary: A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in subjects with DIPSS (Dynamic International Prognostic Scoring System)-intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) and previously treated with ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least 35% spleen volume reduction in the fedratinib and the BAT arms.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
Italy
Austria
Netherlands
Spain
France
Czechia
Poland
Hungary
Australia
Belgium
Ireland
China
Russian Federation
Germany
United Kingdom
Korea, Republic of

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin

location_facility: Centre Hospitalier Universitaire de Nimes - Hopital Universitaire Caremeau

location_facility: Szegedi Tudomanyegyetem - Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency

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

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

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese

location_facility: IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Salzburger Landkliniken St. Johanns-Spital

location_facility: FSBI Hematology Research Center Ministry of Healthcare of the Russian Federation

location_facility: Instytut Hematologii i Transfuzjologii w Warszawie

location_facility: Chinese Academy of Medical Sciences & Peking Union Medical College

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

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: Azienda Ospedaliera S. Andrea - Università La Sapienza

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Seoul St Marys Hospital College of Medicine The Catholic University of Korea

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Seoul National University Bundang Hospital

location_facility: Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University of Heidelberg - Universitatsklinikum Mannheim

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

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

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Soon Chun Hyang University Hospital Seoul

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: Novosibirsk State Medical University (NSMU)

location_facility: Instituto Catalan de Oncologia de Girona

location_facility: Policlinico Umberto I - Universita La Sapienza

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Fujian Medical University Union Hospital

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine