acronym: LATTICE

title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease

location_country:
Croatia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Portugal
Russian Federation
Australia
Israel
Mexico
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Ireland
Korea, Republic of
France
Netherlands

location_facility: Republican Clinical Hospital Ministry of Health Republic of Tatarstan

location_facility: Indiana University Health University Hospital

location_facility: US Digestive Disease Associates - Wyomissing

location_facility: Clinica Medica Azienda Ospedaliera Universitaria

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz

location_facility: Digestive Disease Specialists - Ambulatory Endoscopy Center - North

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Faculdade de Medicina de Sao Jose do Rio Preto Hospital de Base

location_facility: H-T. Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: The Medical Research Center of Connecticut

location_facility: New York-Presbyterian Columbia University Medical Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University of Florida Health - Jacksonville

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Southern Star Research Institute - Medical Center Office

location_facility: ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario

location_facility: Multidisciplinary Consultative and Diagnostic Center

location_facility: Intesto Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern

location_facility: Polo Universitario - LAzienda Ospedaliera Luigi Sacco

location_facility: Vanderbilt Inflammatory Bowel Disease Clinic

location_facility: Hunter Holmes McGuire Veterans Administration Medical Center

location_facility: Wisconsin Center for Advanced Research, GI Associates

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: Digestive Health Associates of Texas - Richardson

location_facility: Desarrollo Etico en Investigacion Clinica

location_facility: Warrington and Halton Hospitals NHS Foundation Trust

location_facility: Hospital Universitario Professor Edgard Santos

location_facility: Centrum Medyczne Szpital Swietej Rodziny

location_facility: Spring Gastroenterology Associates - Houston

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: University of Mississippi Medical Center

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Florida Medical Clinic - Clinical Research Division

location_facility: Gastroenterology Research of San Antonio

location_facility: South Edmonton Gastroenterology Research Clinic

location_facility: Hospital das Clinicas da Faculdade de Medicina de Botucatu

location_facility: Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord

location_facility: University of Miami Miller School of Medicine

location_facility: University of Iowa Hospitals and Clinics

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: Kaiser Permanente Colorado Institute for Health Research

location_facility: Advanced Research Institute - New Port Richey

location_facility: New York Langone Long Island Clinical Research Associates

location_facility: Hospital da Senhora da Oliveira - Guimaraes

summary: The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.


status: Active, not recruiting

primary_purpose: Treatment

intervention_type: Drug

title: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer

study_completion_date_type: Anticipated

lead_sponsor: Eisai Inc.

type: EudraCT Number

type: Other Identifier

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Makker V, Colombo N, Casado Herráez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D; Study 309-KEYNOTE-775 Investigators. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. N Engl J Med. 2022 Feb 3;386(5):437-448. doi: 10.1056/NEJMoa2108330. Epub 2022 Jan 19.

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
United States
Japan
Poland
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Brazil
Canada
Germany
Taiwan
Ireland
New Zealand
Korea, Republic of
France
Colombia

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej Curie

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida

location_facility: Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o.

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Texas Oncology-San Antonio Medical Center

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Tomsk National Research Medical Center of Russian Academy of Sciences

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Hospital Universitario y Politecnico La Fe de Valencia

location_facility: Instituto de Investigaciones Metabolicas

location_facility: Centre de Lutte Contre le Cancer Francois Baclesse

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals

location_facility: Investigacion Onco Farmaceutica S de RL de CV

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA

location_facility: Hospital General Universitari Vall d Hebron

location_facility: Instituto do Cancer de Sao Paulo - ICESP

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II

location_facility: Faculdade de Medicina da Universidade Federal de Minas Gerais

location_facility: SPb SBHI City Clinical Oncological Dispensary

location_facility: Chang Gung Medical Foundation. Linkou Branch

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

location_facility: Georgia Cancer Center at Augusta University

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH

location_facility: Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital

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

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM

location_facility: Florence Nightingale Gayrettepe Hastanesi

location_facility: Institut Regional du Cancer de Montpellier - ICM

location_facility: Azienda Ospedaliera per l Emergenza Cannizzaro

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Alivia Clinica de Alta Especialidad S.A. de C.V.

location_facility: FSBI-FRCC of Special Types Med. Care & Technologies FMBA of Russia

location_facility: Pomorski Uniwersytet Medyczny w Szczecinie

location_facility: Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Mordovia Republican Oncological Dispensary

location_facility: Clinica Colsanitas S.A. - Sede Clinica Universitaria Colombia

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont

location_facility: John Theurer Cancer Center at Hackensack University Med Ctr

location_facility: Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie

location_facility: Szpital Kliniczny im Ks Anny Mazowieckiej

location_facility: Groupe Hospitalier Broca Cochin Hotel Dieu

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina

summary: This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS

acronym: DUPLEX

summary: To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).

ReferenceCitation: Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2:CD003233. doi: 10.1002/14651858.CD003233.pub3. Review.

ipd_sharing: No

lead_sponsor: Travere Therapeutics, Inc.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Hong Kong
Portugal
Australia
Argentina
Sweden
Brazil
Canada
Germany
Denmark
Taiwan
Estonia
New Zealand
Korea, Republic of
France


title: A Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema

acronym: KITE

summary: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).

status: Completed

study_completion_date_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on ww.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Lithuania
Belgium
Czechia
Poland
Russian Federation
India
Turkey
Norway
Sweden
Malaysia
Singapore
Slovakia
Lebanon
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Latvia
Estonia
Korea, Republic of
France

status_simplified: Completed


title: A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)

summary: A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma

status: Terminated

lead_sponsor: Idera Pharmaceuticals, Inc.

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Sweden
United States
France
Germany
Czechia

location_facility: University of California, Los Angeles (UCLA)

location_facility: Alberta Health Services Cross Cancer Institute

location_facility: University of California, San Diego (UCSD) - Moores Cancer Center

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: University of Alabama at Birmingham (UAB)

location_facility: Consorci Hospital General Universitari de Valencia

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: Istituto Nazionale di Tumori IRCCS "Fondazione Sen. G. Pascale"

location_facility: Fakultni nemocnice Olomouc - Oncology clinic

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

location_facility: Medizinische Hochschule Hannover - Klinik for Dermatologie, Allergologie und Venerologie

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

location_facility: The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universität Würzburg

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

location_facility: Azienda Ospedaliero-Universitaria di Modena

location_facility: Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Hospital Universitari Quiron Dexeus Barcelona

location_facility: Mount Sinai Medical Center of Florida, Inc.

location_facility: Azienda Ospedaliero Universitaria Senese

location_facility: University of Florida Health Cancer Center - Orlando Health

status_simplified: Unknown


title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease

summary: This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: Yes

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 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:
Taiwan
Brazil
Spain
Italy
Russian Federation
Australia
Canada
Lithuania
Hungary
United States
France
China
Peru
Colombia
Japan
Germany

location_facility: Central Clinical Hospital #2 N.A. Semashko OAO RJHD

location_facility: Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi

location_facility: Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)

location_facility: IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: Hospital Universitari Quiron Dexeus;; Servicio Neurología

location_facility: Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Universitätsklinikum Essen, Elisabeth-Krankenhaus, Klinik für Geriatrie, Haus Berge, Contilia GmbH

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: City Psychiatric Hospital #3 of Skvortsov-Stepanov

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

location_facility: Global Medical Institues, LLC; Central Miami Medical Institute

location_facility: National Taiwan University Hospital; Neurology

location_facility: Tianjin Medical University General Hospital

location_facility: National Clinical Research Inc.-Richmond

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Center for Diagnosis and Research on Alzheimer's disease

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: Chang Gung Memorial Foundation - Kaohsiung - Neurology

location_facility: Josephson Wallack Munshower Neurology PC

location_facility: Alzheimer's Research and Treatment Center

location_facility: The Second Affiliated Hospital, Zhejiang University

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

location_facility: Universidade Federal de Sao Paulo - UNIFES

location_facility: Neurological Associates of Long Island, PC

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

location_facility: Advanced Memory Research Institute of NJ

location_facility: Servicio de Neurología Hospital Viamed Montecanal.

location_facility: Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia

location_facility: IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA

location_facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

location_facility: Hospital Ruber Internacional; Servicio de Neurología

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie

location_facility: Neurology Specialists of Monmouth County, PA

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Medical Corporation Hakuyokai Kashiwado Hospital

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Tokyo Bay Advanced Medical and Makuhari Clinic

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

location_facility: Hospital das Clinicas - FMUSP_X; Neurologia

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Universitätsklinikum Rostock Zentrum für Nervenheilkunde

location_facility: The Second Affiliated Hospital to Nanchang University

location_facility: HammondCare Aged Psychiatry Clinical Trials

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: National Center of Neurology and Psychiatry

location_facility: Hospital Nacional Cayetano Heredia; Servicio de Neurologia

location_facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría

location_facility: Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Chang Gung Memorial Foundation - Linkou - Neurology

location_facility: Fujian Medical University Union Hospital

location_facility: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria

location_facility: Beijing Tian Tan Hospital,Capital Medical University

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

location_facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky

location_facility: Gerontopole; Centre de Recherche clinique

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Hospital Universitario Reina Sofia; Servicio de Neurologia

location_facility: The First Affiliated Hospital, Chongqing Medical University

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: Australian Alzheimer's Research Foundation

location_facility: Taipei Veterans General Hospital-Neurology

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Guangdong Provincial People's Hospital; Breast

location_facility: Hospital San Pedro; Servicio de Neurología

location_facility: Hospital General Universitario de Albacete; Servicio de Neurología

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Vilnius University Hospital Santariskiu Clinics; Neurology

location_facility: California Neuroscience Research Medical Group, Inc

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

location_facility: Institute Universitaire de Geriatrie de Montreal

location_facility: Neurology Consultants of Dallas; Research Department

location_facility: Kaohsiung Medical University Hospital; Neurology

location_facility: The Medical Arts Health Research Group - West Vancouver

location_facility: UVaMID Hospital Santa Caterina;; Servicio de Neurología

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología

location_facility: Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: Center for Advanced Research & Education

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie

location_facility: Universitätsklinikum Hamburg-Eppendorf Zentrum f.Psychosoz.Medizin Klinik f.Psychiatrie

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Tokyo Medical and Dental University Hospital

location_facility: IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

location_facility: The First Affiliated Hospital of Wenzhou Medical College

location_facility: University of Mississippi Medical Center

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: China Medical University Hospital; Neurology

location_facility: Semmelweis University; Department of Neurology

location_facility: Hospital Virgen del Rocío; Servicio de Neurología

location_facility: Tangdu Hospital, The Fourth Military Medical University; Neurology Department

location_facility: Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica

location_facility: NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Universitätsklinikum Düsseldorf; Klinik für Neurologie

location_facility: Sun Yat-sen Memorial Hospital; Neurology

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: Clinica Internacional; Unidad De Investigacion

location_facility: Beijing Anding Hospital, Capital Medical University

location_facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze

location_facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría

location_facility: Hôpital Avicenne; Centre de Recherche Clinique

location_facility: Policlinico Universitario Agostino Gemelli; UOC Neurologia

location_facility: University of California, Davis; Alzheimers Disease Center, Department of Neurology

location_facility: Ohio State University; College of Medicine

location_facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

location_facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Oregon Center for Clinical Investigations, Inc

location_facility: Southern Illinois University, School of Medicine

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: SBHI SR Region Specialized Psychiatric Hospital #2

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

location_facility: Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia


title: A Phase 2 Placebo-Controlled, Double-Blind, Enriched Enrollment Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 (Vixotrigine) in Treating Pain Experienced by Subjects With Confirmed Small Fiber Neuropathy That is Idiopathic or Associated With Diabetes Mellitus

summary:
The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or associated with diabetes mellitus. A secondary endpoint that relates to the primary objective is the change from Randomization to Week 12 of the double-blind period in mean average daily pain score.

The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient global impression, use of rescue medication, and SFN symptoms in participants treated with BIIB074; to investigate the safety and tolerability of BIIB074 in participants with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.

lead_sponsor: Biogen

location_country:
Denmark
Poland
Spain
Greece
Italy
Netherlands
United Kingdom
Canada
Switzerland
Hungary
France
Germany
Bulgaria
Czechia

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: CHU Clermond Ferrand - Hopital Gabriel Montpied

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

location_facility: Hospital General Universitario de Alicante

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

location_facility: Hausarzt- und Diabetologische Schwerpunktpraxis

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt

location_facility: CHUV - Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Nemocnice Pardubickeho kraje a.s. Pardubicka nemocnice

location_facility: Azienda Ospedaliero Univeraitaria Pisana

location_facility: Gemeinschaftspraxis Diabeteszentrum Dortmund Dr.med. Klaus Busch

location_facility: Regionalna Poradnia Diabetologiczna Zytkiewicz-Jaruga,Stasinska


type: Registry Identifier

title: A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

acronym: IMROZ

summary:
Primary Objective:

-To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant.

Secondary Objectives:

To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms:
Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria.
Minimal residual disease (MRD) negativity rate in patients with CR.
Very good partial response or better rate, as defined by the IMWG criteria.
Overall survival (OS).
To evaluate the overall response rate (ORR) as per IMWG criteria.
To evaluate the time to progression (TTP) overall and by MRD status.
To evaluate PFS by MRD status.
To evaluate the duration of response (DOR) overall and by MRD status.
To evaluate time to first response (TT1R).
To evaluate time to best response (TTBR).
To evaluate progression-free survival on next line of therapy (PFS2).
To evaluate the sustained MRD negativity >12 months rate.
To evaluate safety.
To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only).
To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (IVRd and crossover arms).
To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.

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://vivli.org

lead_sponsor: Sanofi

location_country:
Spain
Italy
Lithuania
United States
Belgium
Japan
Czechia
Poland
Portugal
Russian Federation
Australia
Turkey
Mexico
Sweden
China
Germany
Denmark
Taiwan
Greece
New Zealand
France

location_facility:
Investigational Site Number :2030003
Investigational Site Number :0360005
Investigational Site Number :2030004
Investigational Site Number :3800001
Investigational Site Number :2500006
Investigational Site Number :7240003
Investigational Site Number :1560004
Investigational Site Number :2080003
Investigational Site Number :7920006
Investigational Site Number :2500002
Investigational Site Number :5540003
Investigational Site Number :0360003
Investigational Site Number :7920007
Investigational Site Number :6200005
Investigational Site Number :6200002
Investigational Site Number :2760005
Investigational Site Number :0360008
Investigational Site Number :7920008
Investigational Site Number :4400001
Investigational Site Number :3920002
Investigational Site Number :7240004
Investigational Site Number :2080004
Investigational Site Number :4840001
Investigational Site Number :2500007
Investigational Site Number :6430002
Investigational Site Number :1560014
Investigational Site Number :2500009
Investigational Site Number :2500012
Investigational Site Number :3800005
Investigational Site Number :3920010
Investigational Site Number :6160004
Investigational Site Number :6430001
Investigational Site Number :7920004
Investigational Site Number :2500010
Investigational Site Number :2500005
Investigational Site Number :8400004
Investigational Site Number :3920005
Investigational Site Number :3920007
Investigational Site Number :7920005
Investigational Site Number :1560003
Investigational Site Number :2500003
Investigational Site Number :0360002
Investigational Site Number :8400007
Investigational Site Number :2030007
Investigational Site Number :0360006
Investigational Site Number :2030001
Investigational Site Number :3000002
Investigational Site Number :2760001
Investigational Site Number :1560008
Investigational Site Number :6200003
Investigational Site Number :2760003
Investigational Site Number :1560012
Investigational Site Number :0360004
Investigational Site Number :1560006
Investigational Site Number :2030002
Investigational Site Number :1580003
Investigational Site Number :6160002
Investigational Site Number :7520001
Investigational Site Number :7520002
Investigational Site Number :1560005
Investigational Site Number :7240005
Investigational Site Number :3920003
Investigational Site Number :1580002
Investigational Site Number :1560007
Investigational Site Number :5540001
Investigational Site Number :3920009
Investigational Site Number :1560002
Investigational Site Number :1580001
Investigational Site Number :3800004
Investigational Site Number :0560001
Investigational Site Number :3800002
Investigational Site Number :7240001
Investigational Site Number :6160003
Investigational Site Number :1560001
Investigational Site Number :3920006
Investigational Site Number :1560009
Investigational Site Number :6200001
Investigational Site Number :7920003
Investigational Site Number :6200006
Investigational Site Number :3000003
Investigational Site Number :5540002
Investigational Site Number :3800003
Investigational Site Number :8400001
Investigational Site Number :2500008
Investigational Site Number :8400006
Investigational Site Number :2760004
Investigational Site Number :3920008
Investigational Site Number :0360001
Investigational Site Number :2500011
Investigational Site Number :1560011
Investigational Site Number :7920001
Investigational Site Number :1560013
Investigational Site Number :2030006
Investigational Site Number :7920002
Investigational Site Number :3920001
Investigational Site Number :2080002
Investigational Site Number :3920004
Investigational Site Number :4400002
Investigational Site Number :2500004
Investigational Site Number :3000001
Investigational Site Number :8400005
Investigational Site Number :2500001
Investigational Site Number :0360007
Investigational Site Number :6160001


acronym: SENSCIS (TM)-ON

title: An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)

lead_sponsor: Boehringer Ingelheim

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Argentina
India
Israel
Mexico
Norway
Malaysia
Sweden
Brazil
Canada
Switzerland
China
Germany
Denmark
Greece
Finland
Thailand
France
Chile
Netherlands

location_facility: Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

location_facility: Washington University School of Medicine

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks

location_facility: Post Graduate Institute of Medical Education and Research

location_facility: The University of Texas Health Science Center at Houston

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: CEMER-Centro Medico De Enfermedades Respiratorias

location_facility: The First Hospital of Chinese Medical University

location_facility: Specialist Allergy-Internist Center ALL-MED

location_facility: National Hospital Organization Himeji Medical Center

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Clinical Rheumatology Research Center Sahlgrenska

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: B.J. Medical College and Sasoon General Hospital

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: ULSAM, EPE - Hospital Conde de Bertiandos

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: University of Florida College of Medicine

location_facility: University of Utah Health Sciences Center

location_facility: Institute of Rheumatology Tokyo Women's Medical University

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli

location_facility: University of Iowa Hospitals and Clinics

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: EMED, Center of Medical Services,Private Prac,Rzeszow

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Azienda Universitaria-Universita' La Sapienza

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: University of Texas Southwestern Medical Center

summary: The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).


title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Prodromal to Mild Alzheimer's Disease

lead_sponsor: Genentech, Inc.

ReferenceCitation: Teng E, Manser PT, Pickthorn K, Brunstein F, Blendstrup M, Sanabria Bohorquez S, Wildsmith KR, Toth B, Dolton M, Ramakrishnan V, Bobbala A, Sikkes SAM, Ward M, Fuji RN, Kerchner GA; Tauriel Investigators. Safety and Efficacy of Semorinemab in Individuals With Prodromal to Mild Alzheimer Disease: A Randomized Clinical Trial. JAMA Neurol. 2022 Aug 1;79(8):758-767. doi: 10.1001/jamaneurol.2022.1375.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Sweden
United States
France
Belgium
Germany

location_facility: The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

location_facility: JBN Medical Diagnostic Services; Clinical Trials Division

location_facility: Empire Neurology PC; MS Center of Northeastern NY

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: Alzheimer's Research and Treatment Center

location_facility: Neurologisch-psychiatrische Praxis am Brosepark

location_facility: Az. Osp. C. Panico; Rep. Ematologia E Trapianto

location_facility: Azienda Ospedaliero Universitaria San Martino; Dip. di Neuroscienze Oftalmologia e Genetica

location_facility: Advanced Memory Research Institute of NJ

location_facility: IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research

location_facility: Health Partners Institute for Education and Research

location_facility: Sahlgrenska Univ Hospital Mölndal; Department of Nephrology

location_facility: Hospital de Cantoblanco; Servicio de Geriatria

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Eastern Clinical Research Unit; Pharmacy

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: HammondCare Aged Psychiatry Clinical Trials

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER

location_facility: Senior Sp. Z O.O. Poradnia Psychogeriatryczna

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

location_facility: Hospital Universitario Reina Sofia; Servicio de Neurologia

location_facility: Hospital Perpetuo Socorro, Servicio de Geriatria

location_facility: New Orleans Center For Clinical Research

location_facility: Klinikum Bayreuth; Krankenhaus Hohe Warte

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Center For Clinical and Basic Research (Ccbr); Site Management Organisation

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Universitätsklinik Tübingen; Psychiatrie und Psychotherapie

location_facility: CHU Hautepierre; ACTR Association Recherche Clinique Rhumatologie

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: Stanford Neuroscience Health Center (SNHC)

location_facility: Studienambulanz emovis GmbH; St. Joseph Krankenhaus

location_facility: Neuropsychiatric Research; Center of Southwest Florida

location_facility: Clinical Neuroscience Research Associates, Inc.

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage

location_facility: Parkwood Institute, Mental Health Care Building

location_facility: Southern Illinois University, School of Medicine

location_facility: Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders

location_facility: Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Neurologie

summary: This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label Semorinemab treatment.


title: A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

acronym: TULIP

summary: The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.

lead_sponsor: Byondis B.V.

location_country:
Denmark
Spain
Italy
United Kingdom
Canada
Sweden
United States
France
Singapore
Belgium
Netherlands

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Hospital Universitari Vall d'Hebron Vall d' Hebron Institute of Oncology (VHIO)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Texas Oncology PA (Texas Oncology-Dallas Presbyterian Hospital)

location_facility: Hospital General Universitario de Alicante

location_facility: BC Cancer Agency Centre for the Southern Interior

location_facility: Istituto Nazionale dei Tumori Regina Elena

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Texas Oncology- Baylor Charles A. Sammor

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori


title: Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia

summary: This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.

lead_sponsor: Arog Pharmaceuticals, Inc.

location_country:
Spain
Italy
Canada
United States
France
Germany

location_facility: Hospital Universitario y Politecnico La Fe

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

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

location_facility: Hospital Universitario Central de Asturias (HUCA)

location_facility: IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Institut Universitaire du Cancer Toulouse

location_facility: Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: AO Ospedali Riuniti Villa Sofia-Cervello

location_facility: Hospital Center of Versailles (Le Chesnay)

location_facility: Policlinico GB Rossi, University Hospital Verona

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Ospedale Santa Maria delle Croci di Ravenna


intervention_type: Biological

acronym: NAC/Adj GEJ Adenocarcinoma with Chemo (XP/FP) vs Chemo + Pembro Study

title: A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)

lead_sponsor: Merck Sharp & Dohme LLC

ReferenceCitation: Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304. Review.

ReferenceCitation: Bang YJ, Van Cutsem E, Fuchs CS, Ohtsu A, Tabernero J, Ilson DH, Hyung WJ, Strong VE, Goetze TO, Yoshikawa T, Tang LH, Hwang PMT, Webb N, Adelberg D, Shitara K. KEYNOTE-585: Phase III study of perioperative chemotherapy with or without pembrolizumab for gastric cancer. Future Oncol. 2019 Mar;15(9):943-952. doi: 10.2217/fon-2018-0581. Epub 2019 Feb 19.

location_country:
United Kingdom
Italy
Lithuania
Ukraine
United States
Belgium
Philippines
Japan
Poland
Russian Federation
Israel
Malaysia
Singapore
Brazil
Canada
Guatemala
China
Germany
Taiwan
Latvia
Estonia
Korea, Republic of
France
Chile

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035)

location_facility: CHU UCL Namur Site de Godinne ( Site 0485)

location_facility: Ninewells Hospital and Medical School ( Site 0406)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 0526)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 0496)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0185)

location_facility: National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0285)

location_facility: Medizinische Hochschule Hannover ( Site 0449)

location_facility: The Royal Marsden Foundation Trust ( Site 0405)

location_facility: Szpital Uniwersytecki w Krakowie ( Site 0352)

location_facility: Osaka International Cancer Institute ( Site 0161)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344)

location_facility: National Cancer Centre Singapore ( Site 0097)

location_facility: Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)

location_facility: Osaka General Medical Center ( Site 0159)

location_facility: Chonnam National University Hwasun Hospital ( Site 0083)

location_facility: Aichi Cancer Center Hospital ( Site 0165)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)

location_facility: Instituto do Cancer do Ceara ( Site 0311)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0383)

location_facility: Virginia Cancer Specialists, PC ( Site 0010)

location_facility: Ibaraki Prefectural Central Hospital ( Site 0177)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469)

location_facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)

location_facility: Klinikum der Universitaet in Muenchen ( Site 0446)

location_facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353)

location_facility: Hospital Clinico Universidad de Chile ( Site 0287)

location_facility: Korea University Anam Hospital ( Site 0084)

location_facility: Kaluga Regional Clinical Oncology Center ( Site 0345)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349)

location_facility: University of Utah, Huntsman Cancer Institute ( Site 0012)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0260)

location_facility: Iwate Medical University Hospital ( Site 0184)

location_facility: Institut du Cancer de Montpellier ( Site 0473)

location_facility: CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474)

location_facility: Kochi Health Sciences Center ( Site 0189)

location_facility: Kumamoto University Hospital ( Site 0164)

location_facility: Kobe City Medical Center General Hospital ( Site 0181)

location_facility: Leningrad Regional Oncology Center ( Site 0335)

location_facility: Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018)

location_facility: CHU Reims - Hopital Robert Debre ( Site 0465)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354)

location_facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0302)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0400)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305)

location_facility: Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)

location_facility: National University Hospital ( Site 0095)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0186)

location_facility: National Cheng Kung University Hospital ( Site 0067)

location_facility: National Taiwan University Hospital ( Site 0063)

location_facility: CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019)

location_facility: Niigata Cancer Center Hospital ( Site 0169)

location_facility: Weill Cornell Medical Center ( Site 0023)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308)

location_facility: Sunnybrook Research Institute ( Site 0032)

location_facility: Kansai Medical University Hospital ( Site 0190)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040)

location_facility: Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454)

location_facility: Nacionalinis Vezio Institutas ( Site 0569)

location_facility: City Clinical Hosp.4 of DCC ( Site 0325)

location_facility: Gachon University Gil Medical Center ( Site 0087)

location_facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 0589)

location_facility: Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)

location_facility: Imperial College Healthcare NHS Trust ( Site 0402)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 0171)

location_facility: Seoul National University Hospital -SNUH- ( Site 0080)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 0591)

location_facility: National Cancer Center Hospital East ( Site 0178)

location_facility: Instituto Clinico del Sur. ICOS ( Site 0290)

location_facility: IRCCS Policlinico San Donato ( Site 0433)

location_facility: Universitaetsklinikum Freiburg ( Site 0450)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0089)

location_facility: Riga East Clinical University Hospital ( Site 0550)

location_facility: Royal Free London NHS Foundation Trust ( Site 0403)

location_facility: University Malaya Medical Centre ( Site 0143)

location_facility: Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445)

location_facility: Hospital Israelita Albert Einstein ( Site 0309)

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)

location_facility: Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0461)

location_facility: St. Marianna University School of Medicine Hospital ( Site 0187)

location_facility: Seoul National University Bundang Hospital ( Site 0085)

location_facility: A.O.U. Santa Maria della Misericordia di Udine ( Site 0434)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 0363)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0064)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0319)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 0431)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301)

location_facility: Osaka Medical College Hospital ( Site 0168)

location_facility: SMG-SNU BORAMAE Medical Center ( Site 0086)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066)

location_facility: CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0432)

location_facility: The Christie NHS Foundation Trust ( Site 0397)

location_facility: Institut Mutualiste Montsouris ( Site 0463)

location_facility: Roswell Park Cancer Institute ( Site 0001)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0038)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)

location_facility: Severance Hospital Yonsei University Health System ( Site 0081)

location_facility: National Cancer Center Hospital ( Site 0179)

location_facility: CISSS de la Monteregie-Centre ( Site 0039)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0183)

location_facility: Taipei Medical University Shuang Ho Hospital ( Site 0068)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0304)

location_facility: City clinical oncological dispensary ( Site 0336)

location_facility: Kyiv City Clinical Oncology Center ( Site 0590)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0286)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 0407)

location_facility: The University of Chicago Medical Center ( Site 0004)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0172)

location_facility: CHU Toulouse - Hopital Rangueil ( Site 0470)

location_facility: Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 0337)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430)

location_facility: Blokhin National Medical Oncology ( Site 0494)

location_facility: Hokkaido University Hospital ( Site 0160)

location_facility: Toyama Prefectural Central Hospital ( Site 0163)

summary:
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

The primary study hypotheses are that:

Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and
Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.


acronym: CheckMate 914

title: A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Singapore
Brazil
Canada
Switzerland
China
Germany
France
Chile
Colombia
Netherlands

location_facility: Klinikum Nuernberg Nord, Urologische Klinik

location_facility: Erlanger Oncology & Hematology - Univ. of TN

summary: The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.


title: A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

lead_sponsor: Regeneron Pharmaceuticals

design_allocation: Non-Randomized

ReferenceCitation: Stratigos AJ, Sekulic A, Peris K, Bechter O, Prey S, Kaatz M, Lewis KD, Basset-Seguin N, Chang ALS, Dalle S, Orland AF, Licitra L, Robert C, Ulrich C, Hauschild A, Migden MR, Dummer R, Li S, Yoo SY, Mohan K, Coates E, Jankovic V, Fiaschi N, Okoye E, Bassukas ID, Loquai C, De Giorgi V, Eroglu Z, Gutzmer R, Ulrich J, Puig S, Seebach F, Thurston G, Weinreich DM, Yancopoulos GD, Lowy I, Bowler T, Fury MG. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):848-857. doi: 10.1016/S1470-2045(21)00126-1. Epub 2021 May 14.

ReferenceCitation: Li R, Lee G, Huang M, El-Sherief A. Rare basal cell metastasis of a basal-squamous skin collision tumour to the lung and axillary lymph node. BMJ Case Rep. 2019 Oct 3;12(10). pii: e231487. doi: 10.1136/bcr-2019-231487.

location_country:
Spain
Greece
Austria
Italy
Canada
Switzerland
United States
France
Belgium
Germany

location_facility: Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-André - Hôpital Saint-André

location_facility: Hospital Clinic I Provincialde Barcelona

location_facility: Washington University School of Medicine

location_facility: London Regional Cancer Program, London Hsc

location_facility: New York University School Of Medicine, Kaplan Comprehensive Cancer Center

location_facility: The University of Arizona Cancer Centre at Dignity Health

location_facility: Medizinische Universitaet Innsbruck, Universitaetsklinik fuer Dermatologie, Venerologie und Allergologie

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Clinical Research Center of the Carolinas

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Odette Cancer Center-Sunnybrook Health Sciences Centre

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: Mayo Clinic Arizona - Mayo Clinic Hospital

location_facility: UCSF Helen Dillion Family Cancer Care Center

location_facility: Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna

location_facility: U.O.S.C Di Oncologia Medica E Terapie Innovative

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University of Colorado Hospital, Anschutz Outpatient Pavilion

location_facility: James Cancer Hospital and Solove Research Institute

location_facility: Andreas Sygros Hosptial-University of Athen

location_facility: Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine

location_facility: Klinik Fur Dermatologie Und Allergollogie

location_facility: U.O.Dermatologia Azienda Sanitaria Firenze Universita' Firenze

location_facility: Atlantic Health System / Morristown Medical Center

location_facility: National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine

location_facility: Hauttumorcentrum der Charite (HTCC)-Charite Universitatsmedizin Berlin

location_facility: University General Hospital of Ioannina - Dermatology and Venereology Department

location_facility: Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

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

summary: The primary objective is to estimate the objective response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with cemiplimab as a monotherapy


acronym: STARDUST

title: Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab

lead_sponsor: Janssen-Cilag Ltd.

ReferenceCitation: Kucharzik T, Wilkens R, D'Agostino MA, Maconi G, Le Bars M, Lahaye M, Bravata I, Nazar M, Ni L, Ercole E, Allocca M, Machkova N, de Voogd FAE, Palmela C, Vaughan R, Maaser C; STARDUST Intestinal Ultrasound study group. Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 Jul 14:S1542-3565(22)00649-8. doi: 10.1016/j.cgh.2022.05.055. Online ahead of print.

ReferenceCitation: Danese S, Vermeire S, D'Haens G, Panés J, Dignass A, Magro F, Nazar M, Le Bars M, Lahaye M, Ni L, Bravata I, Lavie F, Daperno M, Lukáš M, Armuzzi A, Löwenberg M, Gaya DR, Peyrin-Biroulet L; STARDUST study group. Treat to target versus standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST): an open-label, multicentre, randomised phase 3b trial. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):294-306. doi: 10.1016/S2468-1253(21)00474-X. Epub 2022 Feb 1. Erratum in: Lancet Gastroenterol Hepatol. 2022 Apr;7(4):e8.

location_country:
Denmark
Portugal
Spain
Italy
United Kingdom
Netherlands
Sweden
France
Belgium
Germany
Slovakia
Czechia

location_facility: Gastroenterology and Hepatology Center Nitra, KM Management spol. s r.o.

location_facility: University Hospital in Bratislava, St. Cyril and Method Hospital

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

location_facility: St George's University Hosptial NHS Foundation Trust

location_facility: County Durham and Darlington NHS Foundation Trust

location_facility: Policlinico di Bari Ospedale Giovanni XXIII

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Centro Hospitalar Lisboa Central, EPE - Hospital Santo Antonio dos Capuchos

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

location_facility: Gastroenterology Department ENDOMED, s.r.o.

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Gastroenterology Department GASTROMART s.r.o.

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

location_facility: Fondazione Policlinico Gemelli Università Cattolica

location_facility: Centro Hospitalar e Universitário do Algarve

summary: The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled with early endoscopic assessment versus a clinically driven (routine care) approach in achieving endoscopic response.


title: Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies

acronym: ARCS-Multi

summary:
The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors.

The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.

Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule).

Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.

ipd_sharing_description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Spain
Italy
United Kingdom
Australia
Canada
Switzerland
Korea, Republic of
United States
France
Singapore
Belgium
Netherlands

location_facility: Washington University School of Medicine

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Hospital General Universitario Gregorio Marañón | Oncología

location_facility: ASST Grande Ospedale Metropolitano Niguarda

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


acronym: DARZALEX

title: A Phase 1b/2, Open-Label, Randomized Study of Daratumumab Administered in Combination With Atezolizumab Compared With Atezolizumab Alone in Subjects With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Spain
Hungary
United States
France

summary: The purpose of the study is to compare the overall response rate (ORR) in non-small cell lung cancer (NSCLC) participants treated with daratumumab in combination with atezolizumab versus atezolizumab alone.


acronym: PIONEER 8

title: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)

lead_sponsor: Novo Nordisk A/S

ReferenceType: result

ReferenceCitation: Zinman B, Aroda VR, Buse JB, Cariou B, Harris SB, Hoff ST, Pedersen KB, Tarp-Johansen MJ, Araki E; PIONEER 8 Investigators. Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. Diabetes Care. 2019 Dec;42(12):2262-2271. doi: 10.2337/dc19-0898. Epub 2019 Sep 17.

ReferenceCitation: Pratley RE, Crowley MJ, Gislum M, Hertz CL, Jensen TB, Khunti K, Mosenzon O, Buse JB. Oral Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Diabetes Ther. 2021 Apr;12(4):1099-1116. doi: 10.1007/s13300-020-00994-9. Epub 2021 Mar 4.

ReferenceCitation: Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

ReferenceCitation: Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13. Review.

ReferenceCitation: Husain M, Bain SC, Jeppesen OK, Lingvay I, Sørrig R, Treppendahl MB, Vilsbøll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

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

location_country:
Poland
Greece
Russian Federation
Canada
Puerto Rico
India
United States
France
Mexico
Japan

summary: This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated with insulin. All subjects should continue their pre-trial insulin therapy (basal, basal-bolus or premixed regimen including combinations of soluble insulins) throughout the trial. Subjects treated with metformin in addition to insulin treatment must continue their metformin treatment throughout the entire trial.


acronym: Project blue

title: A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION)

lead_sponsor: EMD Serono Research & Development Institute, Inc.

ReferenceCitation: Paik PK, Felip E, Veillon R, Sakai H, Cortot AB, Garassino MC, Mazieres J, Viteri S, Senellart H, Van Meerbeeck J, Raskin J, Reinmuth N, Conte P, Kowalski D, Cho BC, Patel JD, Horn L, Griesinger F, Han JY, Kim YC, Chang GC, Tsai CL, Yang JC, Chen YM, Smit EF, van der Wekken AJ, Kato T, Juraeva D, Stroh C, Bruns R, Straub J, Johne A, Scheele J, Heymach JV, Le X. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med. 2020 Sep 3;383(10):931-943. doi: 10.1056/NEJMoa2004407. Epub 2020 May 29.

ReferenceCitation: Xiong W, Hietala SF, Nyberg J, Papasouliotis O, Johne A, Berghoff K, Goteti K, Dong J, Girard P, Venkatakrishnan K, Strotmann R. Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations. Cancer Chemother Pharmacol. 2022 Jul;90(1):53-69. doi: 10.1007/s00280-022-04441-3. Epub 2022 Jun 30.

ReferenceCitation: Xiong W, Papasouliotis O, Jonsson EN, Strotmann R, Girard P. Population pharmacokinetic analysis of tepotinib, an oral MET kinase inhibitor, including data from the VISION study. Cancer Chemother Pharmacol. 2022 May;89(5):655-669. doi: 10.1007/s00280-022-04423-5. Epub 2022 Apr 6.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

location_country:
Poland
Taiwan
Spain
Italy
Austria
Netherlands
Switzerland
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany

location_facility: Hospital General Universitario Santa Lucia

location_facility: Wenatchee Valley Hospital & Clinics - ATTN: Jay Johnson

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Universitair Medisch Centrum Groningen (UMCG) - Parent

location_facility: Chonnam National University Hwasun Hospital

location_facility: Memorial Sloan Kettering Cancer Center, West Harrison Regional Outpatient Pavilion

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: Hospital de Especialidades de Jerez de la Frontera - Servicio de Oncologia

location_facility: The Affiliated Cancer Hospital of Xinjiang Medical university

location_facility: NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o

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

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

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Pulmonology & Tuberculosis

location_facility: Seconda Università degli Studi di Napoli

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Regional Cancer Care Associates East Brunswick

location_facility: Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Centre Hospitalier Départemental Les Oudairies

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

location_facility: Hackensack University Medical Center PARTNER

location_facility: H. Lee Moffitt Cancer Center and Research Institute, Inc

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Kyungpook National University Medical Center

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Somerset Hematology Oncology Associates - Somerville Location

location_facility: Universitaetsspital Zuerich - Klinik fuer Onkologie

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie

location_facility: Seoul National University Bundang Hospital

location_facility: Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej

location_facility: Inselspital - Universitaetsspital Bern - Klinik und Poliklinik für Medizinische Onkologie

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: Centre Hospitalier Intercommunal de Créteil

summary: This study will look at how effective the study drug (tepotinib) is at stopping the growth and spread of lung cancer. This study will also measure a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug.


primary_purpose: Other

acronym: MELTEMI

title: A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)

lead_sponsor: AstraZeneca

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

location_country:
Poland
Spain
United Kingdom
Russian Federation
Australia
Argentina
Canada
Ukraine
United States
Chile
France
Turkey
Germany
Bulgaria
Czechia

summary: The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).


title: A Biomarker-Directed Phase 2 Trial of SY-1425, a Selective Retinoic Acid Receptor Alpha Agonist, in Adult Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

summary: The purpose of this study is to determine the activity of SY-1425 in relapsed/refractory acute myeloid leukemia (AML) patients (SY-1425 administered as a monotherapy or in combination with azacitidine), relapsed/refractory higher-risk myelodysplastic syndrome (MDS) patients (SY-1425 administered as a monotherapy or in combination with daratumumab), newly diagnosed treatment naïve AML patients who are unlikely to tolerate standard intensive chemotherapy (SY-1425 administered as a monotherapy or in combination with azacitidine), or lower-risk myelodysplastic syndrome (MDS) patients (SY-1425 administered as a monotherapy).

lead_sponsor: Syros Pharmaceuticals

location_country:
United States
France

location_facility: Centre Hospitalier Universitiaire Hopital Avicenne

location_facility: Nice Hospital, Archet Hospital 1 Clinical Hematology Service

location_facility: Hôpital Haut Leveque, Centre Francois Magendie

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot


title: A Randomized, Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)

summary: The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who are not eligible for HSCT or in adults ≥ 65 years old with previously untreated AML who are not eligible for HSCT, with intermediate or poor cytogenetic risk.

ReferenceCitation: Zeidan AM, Boss I, Beach CL, Copeland WB, Thompson E, Fox BA, Hasle VE, Ogasawara K, Cavenagh J, Silverman LR, Voso MT, Hellmann A, Tormo M, O'Connor T, Previtali A, Rose S, Garcia-Manero G. A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for higher-risk myelodysplastic syndromes. Blood Adv. 2022 Apr 12;6(7):2207-2218. doi: 10.1182/bloodadvances.2021005487.

ReferenceCitation: Zeidan AM, Boss I, Beach CL, Copeland WB, Thompson E, Fox BA, Hasle VE, Hellmann A, Taussig DC, Tormo M, Voso MT, Cavenagh J, O'Connor T, Previtali A, Rose S, Silverman LR. A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for older patients with AML. Blood Adv. 2022 Apr 12;6(7):2219-2229. doi: 10.1182/bloodadvances.2021006138.

lead_sponsor: Celgene

location_country:
Poland
Portugal
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
United States
France
Belgium
Germany

location_facility: Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku

location_facility: Centre Hospitalier Universitaire d' Angers

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku

location_facility: Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Oddzial Hematologii Onkologicznej Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologicz

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

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: Oddzial Hematologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW

location_facility: Ipo Instituto Portugues De Oncologia Porto

location_facility: Policlinico Agostino Gemelli - Istituto di Ematologia

location_facility: Salzburger Landkliniken St. Johanns-Spital

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Complejo Hospitalario San Pedro de Alcantara

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Katedra i Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

location_facility: I.R.C.C.S. Policlinico San Matteo - Universita di Pavia

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

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

location_facility: Medizinische Hochschule HannoverZentrum Innere Medizin


title: A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease

acronym: ExpeditionPRO

summary: The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).

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: Eli Lilly and Company

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
Finland
Canada
Sweden
Puerto Rico
United States
France
Japan
Germany

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Dean Foundation for Health Research and Education

location_facility: Johns Hopkins University School of Medicine

location_facility: University of Texas Health Services Center - Houston

location_facility: Healthy Perspectives Innovative Mental Health Services, PL

location_facility: Univ of Texas Health Science Center at San Antonio

location_facility: Northeastern Pennsylvania Memory & Alzheimer's Center

location_facility: Instituto de Neurologia Dra. Ivonne Fraga

location_facility: Memory Enhancement Center of America, Inc.

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Advanced Memory Research Institute of New Jersey

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: New England Institute for Clinical Research

location_facility: Premiere Research Institute at Palm Beach Neurology

location_facility: Metrolina Neurological Research Institute


title: Efficacy, Safety and Immunogenicity of GSK Biologicals' HZ/su Vaccine GSK1437173A in a Phase IIIb, Open-label, Long-term Follow-up Study (ZOE-LTFU) of Studies 110390/113077 (ZOSTER-006/022) and Assessment of Additional Doses in Older Adults

summary: The purpose of this study is a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1 or 2 additional doses in two subgroups of older adults.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Strezova A, Diez-Domingo J, Al Shawafi K, Tinoco JC, Shi M, Pirrotta P, Mwakingwe-Omari A; Zoster-049 Study Group . Long-term Protection Against Herpes Zoster by the Adjuvanted Recombinant Zoster Vaccine: Interim Efficacy, Immunogenicity, and Safety Results up to 10 Years After Initial Vaccination. Open Forum Infect Dis. 2022 Oct 23;9(10):ofac485. doi: 10.1093/ofid/ofac485. eCollection 2022 Oct.

ReferenceCitation: Boutry C, Hastie A, Diez-Domingo J, Tinoco JC, Yu CJ, Andrews C, Beytout J, Caso C, Cheng HS, Cheong HJ, Choo EJ, Curiac D, Di Paolo E, Dionne M, Eckermann T, Esen M, Ferguson M, Ghesquiere W, Hwang SJ, Avelino-Silva TJ, Kosina P, Liu CS, Markkula J, Moeckesch B, Murta de Oliveira C, Park DW, Pauksens K, Pirrotta P, Plassmann G, Pretswell C, Rombo L, Salaun B, Sanmartin Berglund J, Schenkenberger I, Schwarz T, Shi M, Ukkonen B, Zahaf T, Zerbini C, Schuind A, Cunningham AL; Zoster-049 Study Group. The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70. Clin Infect Dis. 2022 Apr 28;74(8):1459-1467. doi: 10.1093/cid/ciab629.

lead_sponsor: GlaxoSmithKline

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


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N-Acetylcysteine in Patients With Idiopathic Pulmonary Fibrosis With Background Treatment of Pirfenidone

summary: This is a Phase 2, randomized, double-blind, placebo-controlled safety and tolerability study of N-acetylcysteine or placebo in participants with mild to moderate idiopathic pulmonary fibrosis (IPF) receiving background pirfenidone therapy.

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
United Kingdom
Italy
Austria
Sweden
France
Belgium
Germany


acronym: ARCHES

title: A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

lead_sponsor: Astellas Pharma Global Development, Inc.

ReferenceCitation: Armstrong AJ, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore ND, Rosbrook B, Sugg J, Baron B, Chen L, Stenzl A. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2019 Nov 10;37(32):2974-2986. doi: 10.1200/JCO.19.00799. Epub 2019 Jul 22.

ReferenceCitation: Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.

ReferenceCitation: Armstrong AJ, Azad AA, Iguchi T, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Alcaraz A, Alekseev B, Shore ND, Gomez-Veiga F, Rosbrook B, Zohren F, Yamada S, Haas GP, Stenzl A. Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2022 May 20;40(15):1616-1622. doi: 10.1200/JCO.22.00193. Epub 2022 Apr 14.

ReferenceCitation: Stenzl A, Dunshee C, De Giorgi U, Alekseev B, Iguchi T, Szmulewitz RZ, Flaig TW, Tombal B, Morlock R, Ivanescu C, Ramaswamy K, Saad F, Armstrong AJ. Effect of Enzalutamide plus Androgen Deprivation Therapy on Health-related Quality of Life in Patients with Metastatic Hormone-sensitive Prostate Cancer: An Analysis of the ARCHES Randomised, Placebo-controlled, Phase 3 Study. Eur Urol. 2020 Oct;78(4):603-614. doi: 10.1016/j.eururo.2020.03.019. Epub 2020 Apr 23.

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

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Poland
Russian Federation
Australia
Argentina
Israel
Sweden
Slovakia
Canada
Germany
Denmark
Taiwan
New Zealand
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility:
Site DK45005
Site FR33003
Site DE49013
Site KR82003
Site ES34014
Site KR82004
Site ES34019
Site JP81003
Site US10012
Site US10014
Site ES34007
Site IL97206
Site DE49002
Site US10015
Site RU70016
Site JP81002
Site US10020
Site RO40011
Site CL56003
Site IT39007
Site AU61008
Site FR33007
Site FI35804
Site NZ64005
Site FR33006
Site US10068
Site IT39012
Site JP81001
Site NZ64008
Site BE32005
Site US10050
Site SE46002
Site BE32012
Site US10060
Site US10004
Site US10013
Site IT39008
Site TW88601
Site US10009
Site JP81014
Site CA15022
Site IT39003
Site US10002
Site RO40002
Site DK45003
Site SE46001
Site BE32001
Site FR33010
Site DE49004
Site PL48010
Site PL48005
Site FR33015
Site RO40006
Site NL31009
Site CA15024
Site CA15021
Site NZ64004
Site PL48007
Site RU70013
Site FI35801
Site AU61006
Site KR82001
Site PL48011
Site RO40009
Site US10054
Site ES34013
Site NZ64002
Site KR82007
Site NL31010
Site SE46007
Site JP81013
Site DK45002
Site DK45001
Site US10036
Site AU61013
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Site AU61015
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Site US10035
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Site CA15016
Site AR54007
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Site US10017
Site JP81016
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Site JP81018
Site ES34010
Site AU61001
Site US10029
Site IT39005
Site US10040
Site AU61017
Site NL31003
Site FI35807
Site SK42103
Site IT39009
Site JP81012
Site US10045
Site IL97211
Site NL31005
Site SE46006
Site RO40007
Site JP81011
Site AU61004
Site TW88606
Site RU70009
Site SK42110
Site US10046
Site SK42101
Site TW88607
Site FR33014
Site RO40003
Site RU70003
Site RU70012
Site FR33011
Site US10008
Site GB44002
Site CL56001
Site ES34020
Site CA15020
Site DE49014
Site NL31008
Site BE32008
Site ES34011
Site FR33005
Site IT39006
Site US10026
Site PL48003
Site SE46004
Site ES34001
Site IL97205
Site US10044
Site JP81006
Site US10011
Site US10018
Site PL48001
Site JP81015
Site US10055
Site CA15004
Site BE32007
Site CA15013
Site JP81020
Site SK42102
Site JP81007
Site RU70014
Site SK42106
Site RU70007
Site SK42109
Site IL97201
Site FR33012
Site US10007
Site FR33013
Site NL31002
Site NL31006
Site CL56004
Site ES34006
Site RU70005
Site SK42107
Site IT39004
Site JP81010
Site JP81004
Site ES34004
Site RU70001
Site US10048
Site RO40008
Site NL31007
Site CL56007
Site AR54010
Site NZ64003
Site AU61009
Site IT39011
Site JP81017
Site US10056
Site CL56002
Site JP81019
Site IL97202
Site FI35803
Site KR82002
Site DK45004
Site TW88605
Site FR33009
Site FR33001
Site JP81008
Site ES34012
Site CA15003
Site CL56005
Site RU70006
Site CA15023
Site DK45008
Site US10034
Site AU61007
Site AR54002

summary: The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.