title: A Multicenter, Open Label, Expanded Access Trial Of Maraviroc

summary: To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

lead_sponsor: ViiV Healthcare

location_country:
Germany
Ireland
Argentina
Australia
Costa Rica
Chile
Canada
France
Portugal
Hong Kong
Switzerland
United States
Dominican Republic
India
Romania
Belgium
Malaysia
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
Taiwan

location_facility: Hopital Tenon, Service des Maladies Infectieuses

location_facility: Infectious Diseases Associates of Central Virginia

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Infectious Disease Associates of Memphis

location_facility: Clinical Research Unit, Infectious Diseases

location_facility: YR Gaitonde Centre for AIDS Research and Education (YRG CARE)

location_facility: Unita' Operativa Clinica Malattie Infettive, Dipartimento di Medicina Interna e Malattie Infettive

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos

location_facility: General Hospital of Athens G. Gennimatas

location_facility: Universitaetsklinikum Koeln, Klinik I fuer Innere Medizin,

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: South Dayton Acute Care Consultants Inc.

location_facility: University of Oklahoma - Schusterman Clinic

location_facility: IRCCS Lazzaro Spallanzani Istituto Nazionale per le Malattie Infettive

location_facility: Instituut voor Tropische Geneeskunde, Inwendige Geneeskunde

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: University Hepatitis Center at Bach & Godofsky, MD,PA

location_facility: Hospital Regional Lic. Adolfo Lopez Mateos

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Daniel Warner M.D., P.A. Consultive Medicine

location_facility: Fundacion Huesped, Departamento de Investigacion Clinica

location_facility: Kaiser Permanente-Northwest Region, Immune Deficiency Clinic

location_facility: Fund. de Gest. Sanitaria de L' Hospital de La Sta. Creu I Sant Pau

location_facility: Cliniques Universitaires Saint-Luc, Maladies Infectieuses

location_facility: North Shore University Hospital, Department of Infectious Disease

location_facility: Desert Medical Group, Clinical Research Center

location_facility: Instituto Nacional de Ciencias Medicas Y Nutricion Dr Salvador Zubiran

location_facility: University of Toledo - Health Science Campus

location_facility: Tarrant County Infectious Disease Associates

location_facility: Uni. Politecnica delle Marche, Ist. Malattie Infettive e Medicina P.

location_facility: Sozialmedizinisches Zentrum Baumgartner Hoehe / 2. Interne Lungenabteilung

location_facility: Garden State Infectious Disease Associates, PA

location_facility: Denver Infectious Disease Consultants, PLLC

location_facility: Kansas University Internal Medicine Midtown Clinic

location_facility: Department of Infectious Disease, E-Da Hospital

location_facility: Universitair Ziekenhuis Gent, Inwendige Geneeskunde

location_facility: Orange County Center for Special Immunology

location_facility: Brighton and Sussex University Hospitals NHS Trust, The Elton John Centre

location_facility: Centre Hospitalier Cochin Saint Vincent de Paul

location_facility: Clinica Malattie Infettive e Tropicali, Universita' degli Studi di Modena Reggio Emilia

location_facility: Azienda Ospedaliera San Giovanni Addolorata

location_facility: Canadian Immunodeficiency Research Collaborative

location_facility: The University of Texas Health Sciences Center at Houston

location_facility: Internal Medicine Associates of Lee County

location_facility: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

location_facility: Spitalul Clinic de Boli Infectioase Constanta

location_facility: IRCCS Lazzaro Spallanzani, Istituto Nazionale per le Malattie Infettive

location_facility: Hôpital Necker-Service des Maladies Infectieuses et Tropicales

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Gemeinschaftspraxis Dres. Rump und Usadel

location_facility: Fundación para el Desarrollo de la Lucha contra el SIDA

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Spitalul de Boli Infectioase si Tropicale Victor Babes

location_facility: Department of Medicine, St. John's Medical College Hospital

location_facility: The Office of Dr. Gordon E. Crofoot, MD.

location_facility: Policlinico Tor Vergata, Divisione Malattie Infettive

location_facility: Reparto di Malattie Infettive, Azienda Sanitaria Locale

location_facility: Centre Hospitalier Universitaire de Charleroi, Médecine Interne

location_facility: Istituto di Malattie Infettive e Tropicali

location_facility: Department of HIV Medicine (I D Clinic), Jaslok Hospital & Research Centre

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Medizinische Hochschule Hannover, Klinische Immunologie, Zentrum Innere Medizin

location_facility: Hopital Bichat-Claude Bernard, Service des Maladies Infectieuses

location_facility: Universita'Cattolica del Sacro Cuore Policlinico Gemelli

location_facility: Erlmed Corp ABA Lim-Keith Muiltispecialty Clinic Inc.

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: IRCCS Lazzaro Spallanzani Istituto Nazionale per la Malattie Infettive

location_facility: Universitaetsklinikum Essen, HIV-Ambulanz, Hautklinik

location_facility: Spitalul Clinic de Boli Infectioase Sf. Parascheva

location_facility: The Office of Dr. Zale P. Bernstein, MD.

location_facility: Dipartimento di Malattie Infettive e Tropicali, Universita' di Roma La Sapienza

location_facility: Arcispedale S. Anna Azienda Ospedaliera Universitaria di Ferrara

location_facility: Hopital Pellegrin - Service des Maladies Infectieuses et Medecine Interne

location_facility: Hospital Universitario Virgen de La Macarena

location_facility: The Office of Dr. Daniel R. Coulston, MD

location_facility: Complejo Hospitalario Nuestra Señora de Valme

location_facility: Chu Pontchaillou, Service des maladies infectieuses

location_facility: Department of Medicine Queen Elizabeth Hospital

location_facility: Maternal-Child and Adolescent Clinic of Infectious Diseases and Virology

location_facility: Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie

location_facility: Dipartimento di Scienze Cliniche, Divisione Clinicizzata Malattie Infettive

location_facility: Unita Operativa di Malattie Infettive e Tropicali

location_facility: SOD Malattie Infettive, La Piastra dei Servizi

location_facility: Clinica Universitaria di Malattie Infettive, Ospedale Amedeo di Savoia

location_facility: Instituto Dominicano de Estudios Virologicos

location_facility: Hamilton Health Sciences - McMaster University Medical Centre

location_facility: Institutul de Boli Infectioase "Prof. Matei Bals"

location_facility: Hopital de l'Hotel-Dieu, Service d'Hepato-Gastroenterologie

location_facility: Hospital General Universitario de Alicante

location_facility: Landeskrankenhaus Graz West / Abteilung fuer Innere Medizin 1

location_facility: Universita' degli Studi di Bari, Clinica Malattie Infettive, Policlinico

location_facility: The Office of Dr. Nicholaos C. Bellos, MD

location_facility: Community Research Initiative of New England

location_facility: Centre Hospitalier Universitaire Saint-Pierre, Maladies Infectieuses

location_facility: Clinical Alliance for Research & Education - Infectious Diseases

location_facility: Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde


title: A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease

summary: The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on patient general well-being, health-related quality of life (QoL), fistula healing, CD-related extra-intestinal manifestations, work performance, and overall activity.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Louis E, Lofberg R, Reinisch W, Camez A, Yang M, Pollack PF, Chen N, Chao J, Mulani PM. Adalimumab improves patient-reported outcomes and reduces indirect costs in patients with moderate to severe Crohn's disease: results from the CARE trial. J Crohns Colitis. 2013 Feb;7(1):34-43. doi: 10.1016/j.crohns.2012.02.017. Epub 2012 Apr 4.

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

lead_sponsor: Abbott

location_country:
Finland
France
Germany
Ireland
Italy
Portugal
Slovakia
Norway
United Kingdom
Denmark
Sweden
Switzerland
Austria
Belgium
Spain
Greece
Czech Republic

location_facility:
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intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Eisai Inc.

summary: The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer [OC], endometrial cancer [EC], non-small cell lung carcinoma [NSCLC], triple-negative breast cancer [TNBC]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A [OC and EC participants] and Part B [EC only]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202).

sponsor_collaborators:
Eisai Inc.
Bristol-Myers Squibb

location_facility: ICANS - Institut de cancérologie Strasbourg Europe

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Beatson West of Scotland Cancer Centre - PPDS

location_facility: The Christie NHS Foundation Trust - PPDS

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer

location_facility: University of Texas MD Anderson Cancer Centre

location_facility: Centre Leon Berard Centre Regional de Lutte Contre

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: EDOG Institut de Cancerologie de l'Ouest - PPDS

location_facility: Winship Cancer Institute, Emory University

location_facility: Lancashire Clinical Research Facility, Royal Preston Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Georgia Cancer Center at Augusta University

location_facility: University of Arkansas For Medical Sciences

location_facility: Arizona Clinical Research Center - Hunt - PPDS

status: Recruiting

title: A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

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

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
United States
Spain
United Kingdom
France

ipd_sharing: Yes

status_simplified: Ongoing


title: Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

summary: The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).

status: Active, not recruiting

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

lead_sponsor: Biogen

location_country:
Finland
Germany
Poland
Australia
Japan
Canada
France
Portugal
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Sweden

location_facility: National Clinical Research Inc.-Richmond

location_facility: AOU dell'Università degli studi della Campania Luigi Vanvitelli

location_facility: Georgetown University Clinical Research Unit (CRU)

location_facility: Brigham and Women's Hospital Department of Neurology

location_facility: Australian Alzheimer's Research Foundation

location_facility: Azienda Ospedaliera e Universitaria di Perugia

location_facility: University of Utah Health Sciences Center

location_facility: The National Hospital for Neurology and Neurosurgery Centre

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

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Jacksonville Center for Clinical Research

location_facility: Christian-Doppler-Klinik - Universitätsklinikum Salzburg

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Central Coast Neurosciences Research (Erina)

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: University of California San Diego Medical Center

location_facility: Studienzentrum fur Neurologie und Psychiatrie

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Advanced Memory Research Inst. of NJ, PC

location_facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

location_facility: Medical University of South Carolina (MUSC)

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Emory University Cognitive Neurology Clinic & ADRC

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

location_facility: SPZOZ Centralny Szpital Kliniczny UM w Lodzi

location_facility: Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

location_facility: Medical Research Health and Education Foundation, Inc

location_facility: Neuro Centrum Science GmbH, Geschaftführende Gesellschafterin Barbara Unsorg und Prüfarzt Dr. med. G

location_facility: Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

location_facility: NZOZ Wroclawskie Centrum Alzheimerowskie

location_facility: Ohio State University Wexner Medical Center

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Institut fur Regenerative Medizin-IREM Universitat Zurich, Campus Schlieren

location_facility: Queen Elizabeth University Hospital Campus

location_facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit

location_facility: Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra

location_facility: Seoul National University Bundang Hospital

location_facility: True North Clinical Research - Halifax Inc.

location_facility: Montreal Neurological Institute Clinical Research Unit

location_facility: Ascension Via Christi Research, a division of Ascension Via Christi Hospitals Wichita, Inc.

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Lehigh Center for Clinical Research, LLC

location_facility: Josephson, Wallack, Munshower Neurology, P.C.

location_facility: New York University Medical Center PRIME

location_facility: NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.

location_facility: University of Calgary - Heritage Medical Research Clinic

location_facility: CHU de Lyon - Hopital Neurologique Pierre Wertheimer

location_facility: Mary S. Easton Center for Alzheimer's Disease Research, UCLA

location_facility: California Neuroscience Research Medical Group Inc.

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: Northeastern Pennsylvania Memory and Alzheimer's Center

location_facility: Gastroenterology Associates of the Piedmont

location_facility: Alexian Brothers Medical Center - Neuroscience Research Institute

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Charite Universitaetsmedizin Berlin - Campus Berlin Buch

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Institut fuer Schlaganfall- und Demenzforschung (ISD)


acronym: MIRASOL

lead_sponsor: ImmunoGen, Inc.

summary: This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

sponsor_collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)

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

location_facility: Samodzielny publiczny szpital kliniczny nr 1

location_facility: USOR: Northwest Cancer Specialists, P.C.

location_facility: Hawaii Pacific Health - Kapiolani Medical Center for Women and Children

location_facility: Kaiser Permanente Oncology Clinical Trials

location_facility: Women's Care Florida / Women's Cancer Associates

location_facility: Florida Cancer Specialist South Division

location_facility: Grigoriev Institute for Medical Radiology NAMS of Ukraine

location_facility: Burnside War Memorial Hospital - The Brian Fricker Oncology Centre

location_facility: The Ohio State University Wexner Medical Center

location_facility: UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Centre Armoricain de radiothérapie, imagerie médicale et oncologie, CARIO

location_facility: Florida Cancer Specialist North Division

location_facility: Städtisches Klinikum Dessau, Zentrum für Klinische Studien

location_facility: St Bartholomew's Hospital-Barts Health NHS Trust

location_facility: University of Alabama at Birmingham (UAB) GYN Oncology

location_facility: State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek

location_facility: USOR: Maryland Oncology Hematology, P.A.

location_facility: Ulm University Hospital Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Institut de cancérologie de l'ouest, site Angers

location_facility: Oncology Clinics Victoria (OCV) - Cabrini Malvern Hospital Location

location_facility: Wojewódzki Szpital Specjalistyczny, Oddzial Kliniczny Ginekologii Onkologiczne

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: FirstHealth of the Carolinas Outpatient Cancer Center

location_facility: USOR: Arizona Oncology Associates, PC - HOPE

location_facility: IRCCS - Istituto Europeo di Oncologia (The European Institute of Oncology) (IEO)

location_facility: National Cancer Center - Center for Uterine Cancer

location_facility: Tennessee Oncology / Sarah Cannon Research Institute

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Oklahoma Cancer Specialists and Research Institute

location_facility: University Hospitals Coventry and Warwickshire

location_facility: USOR: Texas Oncology - McAllen South Second

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: BIH of Omsk Region "Clinical Oncology Dispensary"

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

location_facility: University of Ulsan College of Medicine - Asan Medical Center

location_facility: Women & Infants Hospital of Rhode Island

location_facility: Seoul National University Bundang Hospital

location_facility: Oncologia Azienda Osc-IRCCS Reggio Emilia

location_facility: Chernihiv Medical Center of Modern Oncology of Chernihiv Regional Council

location_facility: USOR: Willamette Valley Cancer Institute and Research Center

location_facility: Mammazentrum Hamburg am Krankenhaus Jerusalem

location_facility: Arizona Oncology Associates, PC - HAL - USOR

location_facility: USOR: OHC - Oncology_Hematology Care Clinical Trials, Inc.

location_facility: WK Physicians Network/Gynecologic Oncology Associates

location_facility: Communal non-profit enterprise "Cherkasy Regional Oncology Dispensary of Cherkasy oblast council"

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Princess Margaret Cancer Centre - University Health Network

location_facility: USOR: Texas Oncology - Fort Worth Cancer Center

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Communal non-profit enterprise "Khmelnytskyi Regional Antitumor Center" of Khmelnytskoyi Regional Council

location_facility: Mackay Memorial Hospital - Taipei Branch

location_facility: Szpital Kliniczny im. Ks. Anny Mazowieckiej

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Azienda Ospedaliera Città Della Salute E Della Scienza Di Torino

location_facility: Oncology Institute Vojvodina, Surgical Oncology Clinic

location_facility: USOR: Texas Oncology - The Woodlands, Gynecologic Oncology

location_facility: Prykarpatskyi Clinical Oncology Center of Ivano-Frankivsk Regional Council

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Centre Hospitalier de L'Universite de Montreal

title: MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

location_country:
Germany
Poland
Australia
Czechia
Canada
Serbia
France
Portugal
United States
Ukraine
Belgium
China
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


intervention_type: Procedure

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.

sponsor_collaborators:
Bristol-Myers Squibb
Nektar Therapeutics

location_facility:
Local Institution - 0075
Local Institution - 0102
Local Institution - 0021
Local Institution - 0011
Local Institution - 0009
Local Institution - 0071
Local Institution - 0077
Local Institution - 0035
Local Institution - 0130
Local Institution - 0044
Local Institution - 0105
Local Institution - 0103
Local Institution - 0101
Local Institution - 0096
Local Institution - 0039
Local Institution - 0058
Local Institution - 0124
Local Institution - 0005
Local Institution - 0157
Local Institution - 0148
Local Institution - 0129
Local Institution - 0106
Local Institution
Local Institution - 0107
Local Institution - 0026
Local Institution - 0074
Local Institution - 0204
Local Institution - 0097
Local Institution - 0046
Local Institution - 0158
Local Institution - 0110
Local Institution - 0036
Local Institution - 0042
Local Institution - 0132
Local Institution - 0054
Local Institution - 0149
Local Institution - 0104
Local Institution - 0070
Local Institution - 0177
Local Institution - 0069
Local Institution - 0037
Local Institution - 0023
Local Institution - 0033
Local Institution - 0139
Local Institution - 0176
Local Institution - 0085
Local Institution - 0109
Local Institution - 0174
Local Institution - 0053
Local Institution - 0025
Local Institution - 0167
Local Institution - 0131
Local Institution - 0060
Local Institution - 0051
Local Institution - 0006
Local Institution - 0154
Local Institution - 0111
Local Institution - 0119
Local Institution - 0082
Local Institution - 0150
Local Institution - 0083
Local Institution - 0161
Local Institution - 0117
Local Institution - 0059
Local Institution - 0178
Local Institution - 0136
Local Institution - 0040
Local Institution - 0038
Local Institution - 0028
Local Institution - 0091
Local Institution - 0064
Local Institution - 0052
Local Institution - 0151
Local Institution - 0108
Local Institution - 0065
Local Institution - 0049
Local Institution - 0004
Local Institution - 0050
Local Institution - 0048
Local Institution - 0133
Local Institution - 0122
Local Institution - 0029
Local Institution - 0057
Local Institution - 0018
Universitatsklinikum Carl Gustav Carus
Local Institution - 0041
Local Institution - 0080
Local Institution - 0113
Local Institution - 0015
Local Institution - 0027
Local Institution - 0007
Local Institution - 0002
Local Institution - 0160
Local Institution - 0068
Local Institution - 0020
Local Institution - 0062
Local Institution - 0022
Local Institution - 0100
Local Institution - 0013
Local Institution - 0056
Local Institution - 0045
Local Institution - 0137
Local Institution - 0123
Local Institution - 0162
Local Institution - 0098
Local Institution - 0088

title: A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus Bempegaldesleukin (NKTR-214), Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible

type: Other Identifier

ipd_sharing_description: Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html

location_country:
Germany
Poland
Argentina
Australia
Brazil
Czechia
Canada
France
United States
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
Russian Federation
Israel


lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.

ReferenceCitation: Han MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD009294. doi: 10.1002/14651858.CD009294.pub3.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Tokyo Medical and Dental University Hospital

location_facility: UOC Oncologia Ospedale Provinciale di Macerata

location_facility: Universitatsklinikum Schleswig Holstein Campus Lubeck

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: CIMET's Inamdar Multispeciality Hospital

location_facility: Ente Ecclesiastico Ospedale Generale Regionale F. Miulli

location_facility: Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP

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

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: University of Pittsburgh Medical Center - Cancer Centers

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

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

location_facility: Universirty of Sheffield Teaching Hospitals NHS Trust

location_facility: Saitama Medical University International Medical Center

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

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

location_facility: Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

location_facility: Meenakshi Mission Hospital and Research Center

location_facility: The Christie NHS Foundation Trust - Christie Hospital

location_facility: The Ohio State University- James Cancer Hospital

location_facility: Medical College of Wisconsin-Froedtert Hospital

location_facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: Emory University - Winship Cancer Institute

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Rajiv Gandhi Cancer Institute & Research Centre

location_facility: CUROS - Uberörtliche urologische Gemeinschaftspraxis

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital Central

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

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

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

location_facility: Klinikum rechts der Isar - III. Med. Klinik und Poliklinik

location_facility: Instituto de Medicina Integral Professor Fernando Figueira

location_facility: Praxisklinik Urologie Rhein/Ruhr - Germany

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Comite de Etica em Pesquisa em Seres Humanos do Hospital Pro-Cardiaco CEP HPC

title: A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

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


acronym: CheckMate 8HW

summary: The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

title: A Phase 3 Randomized Clinical Trial of Nivolumab Alone, Nivolumab in Combination With Ipilimumab, or Investigator's Choice Chemotherapy in Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer

location_country:
Germany
Ireland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Denmark
United States
Romania
Belgium
China
Puerto Rico
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Greece


title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

summary: The main purpose of the study is to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.

ipd_sharing: No

lead_sponsor: Galderma R&D

location_country:
Germany
Italy
Poland
Hungary
Singapore
Belgium
United States
Georgia
Bulgaria
Estonia
France

location_facility:
Galderma Investigational Site 8821
Galderma Investigational Site 6048
Galderma Investigational Site 6147
Galderma Investigational Site 6178
Galderma Investigational Site 6166
Galderma Investigational Site 8506
Galderma Investigational Site 6143
Galderma Investigational Site 8675
Galderma Investigational Site 6141
Galderma Investigational Site 8577
Galderma Investigational Site 8749
Galderma Investigational Site 8656
Galderma Investigational Site 8825
Galderma Investigational Site 5448
Galderma Investigational Site 6164
Galderma Investigational Site 8729
Galderma Investigational Site 6251
Galderma Investigational Site 5482
Galderma Investigational Site 6045
Galderma Investigational Site 6130
Galderma Investigational Site 8673
Galderma Investigational Site 8727
Galderma Investigational Site 6031
Galderma Investigational Site 6182
Galderma Investigational Site 6086
Galderma Investigational Site 6155
Galderma Investigational Site 5566
Galderma Investigational Site 8667
Galderma Investigational Site 6132
Galderma Investigational Site 6150
Galderma Investigational Site 6235
Galderma Investigational Site 6238
Galderma Investigational Site 6115
Galderma Investigational Site 8823
Galderma Investigational Site 8030
Galderma Investigational Site 6185
Galderma Investigational Site 6167
Galderma Investigational Site 6126
Galderma Investigational Site 8820
Galderma Investigational Site 5513
Galderma Investigational Site 8391
Galderma Investigational Site 8226
Galderma Investigational Site 8745
Galderma Investigational Site 6230
Galderma Investigational Site 6151
Galderma Investigational Site 6145
Galderma Investigational Site 6052
Galderma Investigational Site 6250
Galderma Investigational Site 6165
Galderma Investigational Site 8893
Galderma Investigational Site 6101
Galderma Investigational Site 6084
Galderma Investigational Site 8905
Galderma Investigational Site 8799
Galderma Investigational Site 6179
Galderma Investigational Site 6227
Galderma Investigational Site 6176
Galderma Investigational Site 5021
Galderma Investigational Site 8126
Galderma Investigational Site 8212
Galderma Investigational Site 6044
Galderma Investigational Site 6096
Galderma Investigational Site 8896
Galderma Investigational Site 6079
Galderma Investigational Site 5140
Galderma Investigational Site 8536
Galderma Investigational Site 6068
Galderma Investigational Site 5499
Galderma Investigational Site 8719
Galderma Investigational Site 5362
Galderma Investigational Site 6168
Galderma Investigational Site 6135
Galderma Investigational Site 6144
Galderma Investigational Site 5104
Galderma Investigational Site 8733
Galderma Investigational Site 8523
Galderma Investigational Site 6136
Galderma Investigational Site 8866
Galderma Investigational Site 6254
Galderma Investigational Site 5495
Galderma Investigational Site 6236
Galderma Investigational Site 8706
Galderma Investigational Site 8741
Galderma Investigational Site 5363
Galderma Investigational Site 6062
Galderma Investigational Site 6170
Galderma Investigational Site 8617
Galderma Investigational Site 6083
Galderma Investigational Site 5707
Galderma Investigational Site 8808
Galderma Investigational Site 6180
Galderma Investigational Site 6043
Galderma Investigational Site 5382
Galderma Investigational Site 8637
Galderma Investigational Site 5377
Galderma Investigational Site 6080
Galderma Investigational Site 6041
Galderma Investigational Site 6049
Galderma Investigational Site 6142
Galderma Investigational Site 6081
Galderma Investigational Site 8554
Galderma Investigational Site 6051
Galderma Investigational Site 6040
Galderma Investigational Site 6171
Galderma Investigational Site 8434
Galderma Investigational Site 6063
Galderma Investigational Site 8672
Galderma Investigational Site 6085
Galderma Investigational Site 6234
Galderma Investigational Site 6034
Galderma Investigational Site 6124
Galderma Investigational Site 8723
Galderma Investigational Site 6097
Galderma Investigational Site 8807
Galderma Investigational Site 5031
Galderma Investigational Site 6177
Galderma Investigational Site 6053
Galderma Investigational Site 8705
Galderma Investigational Site 8658
Galderma Investigational Site 8724
Galderma Investigational Site 5367
Galderma Investigational Site 6069
Galderma Investigational Site 5407
Galderma Investigational Site 8907
Galderma Investigational Site 6224
Galderma Investigational Site 6197
Galderma Investigational Site 5137
Galderma Investigational Site 8618
Galderma Investigational Site 5469
Galderma Investigational Site 6078
Galderma Investigational Site 6162
Galderma Investigational Site 6114
Galderma Investigational Site 6181
Galderma Investigational Site 6175
Galderma Investigational Site 8224
Galderma Investigational Site 6082
Galderma Investigational Site 8203
Galderma Investigational Site 5567
Galderma Investigational Site 6029
Galderma Investigational Site 8906
Galderma Investigational Site 6133
Galderma Investigational Site 8704
Galderma Investigational Site 6077
Galderma Investigational Site 8747
Galderma Investigational Site 8713
Galderma Investigation Site 6228
Galderma Investigational Site 6216
Galderma Investigational Site 8683
Galderma Investigational Site 5773
Galderma Investigational Site 8721
Galderma Investigational Site 5442
Galderma Investigational Site 6067
Galderma Investigational Site 8003
Galderma Investigational Site 6046
Galderma Investigational Site 8875
Galderma Investigational Site 6198
Galderma Investigational Site 8839
Galderma Investigational Site 8692
Galderma Investigational Site 6102
Galderma Investigational Site 6169
Galderma Investigational Site 6026
Galderma Investigational Site 6163
Galderma Investigational Site 6038


title: Careful Ventilation in Acute Respiratory Distress Syndrome

acronym: CAVIARDS

summary:
This is a multicenter randomized controlled clinical trial with an adaptive design assessing the efficacy of setting the ventilator based on measurements of respiratory mechanics (recruitability and effort) to reduce Day 60 mortality in patients with acute respiratory distress syndrome (ARDS).

The CAVIARDS study is also a basket trial; a basket trial design examines a single intervention in multiple disease populations. CAVIARDS consists of an identical 2-arm mechanical ventilation protocol implemented in two different study populations (COVID-19 and non-COVID-19 patients). As per a typical basket trial design, the operational structure of both the COVID-19 substudy (CAVIARDS-19) and non-COVID-19 substudy (CAVIARDS-all) is shared (recruitment, procedures, data collection, analysis, management, etc.).

lead_sponsor: Unity Health Toronto

collaborators: Canadian Institutes of Health Research (CIHR)

location_country:
Italy
Argentina
United States
Spain
Chile
Canada
France

location_facility: Centro de Educación Médica e Investigaciones Clínicas Dr Norberto Quirno (CEMIC)

location_facility: Pontificia Universidad Católica de Chile

location_facility: Centre hospitalier universitaire d'Angers

location_facility: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

location_facility: Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Complejo Médico Policía Federal Argentina Churruca Visca

location_facility: New York University Grossman School of Medicine

location_facility: Hopital de la Cavale Blanche - CHRU Brest

intervention_type: Other


title: A Randomized Phase 3 Study of Sitravatinib in Combination With Nivolumab Versus Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy SAPPHIRE

acronym: SAPPHIRE

summary: This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

lead_sponsor: Mirati Therapeutics Inc.

sponsor_collaborators:
Mirati Therapeutics Inc.
Bristol-Myers Squibb

location_country:
Germany
Italy
Hungary
Israel
United Kingdom
Netherlands
Switzerland
Belgium
United States
Spain
Canada
France

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco"

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

location_facility: Klinikverbund Kempten-Oberallgäu - Klinik Immenstadt - Klinikverbund Allgäu gGmbH

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo

location_facility: Eastern Connecticut Hematology and Oncology Associates

location_facility: Fort Wayne Medical Oncology and Hematology - Fort Wayne South Office

location_facility: Palo Verde Cancer Specialists - Glendale

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Regional Cancer Care Associates - Little Silver

location_facility: Providence Cancer Institute Franz Clinic

location_facility: SCRI - Florida Cancer Specialists - Panhandle Research Office

location_facility: University Cancer and Blood Center - LLC - Athens

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Comprehensive Blood and Cancer Center - Bakersfield

location_facility: Michael and Dianne Bienes Comprehensive Cancer Center

location_facility: Institut Régional du Cancer de Montpellier - Val d'Aurelle

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: University Wisconsin Carbone Cancer Center

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec-Universite Laval

location_facility: Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch Centrum

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Kansas City Care Health Center - Research Medical Campus

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

location_facility: SCRI - Florida Cancer Specialists - North Region Research Office

location_facility: Sisters of Charity of Leavenworth Health St. Mary's

location_facility: Mercy Clinic Oncology and Hematology - Coletta

location_facility: The Oncology Institute of Hope and Innovation - Tucson

location_facility: The Oncology Institute of Hope and Innovation - Thousand Oaks

location_facility: SCRI - Tennessee Oncology - Nashville - Centennial

location_facility: Virginia Cancer Institute - Reynolds Crossing

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: The Richard and Annette Bloch Cancer Care Pavilion and Westwood Medical Pavilion

location_facility: Torrance Memorial Physician Network - Cancer Care and Infusion Center

location_facility: Park Nicollet - Frauenshuh Cancer Center

location_facility: Martha-Maria Krankenhaus Halle-Dölau gGmbH, Studiensekretariat

location_facility: California Cancer Associates for Research and Excellence - San Marcos

location_facility: Texas Oncology - Beaumont Mamie Mcfaddin Ward Cancer Center

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Institut Català d'Oncologia Badalona, Hospital Universitari Germans Trias i Puj

location_facility: Pontchartrain Cancer Center - Covington Office

location_facility: Azienda Ospedaliero - Universitaria Pisana

location_facility: Tricounty Hematology and Oncology- Massillon

location_facility: Országos Korányi Tbc És Pulmonológiai Intézet

location_facility: The Oncology Institute of Hope and Innovation - Corona

location_facility: Horizon Health Network - The Moncton Hospital

location_facility: S.C Oncologia Medica, ASST Monza - Ospedale San Gerardo

location_facility: USOR - Consultants in Medical Oncology and Hematology PC - Abington Hematology/Oncology Associates

location_facility: Florida Cancer Affiliates - Ocala - Main

location_facility: Oregon Health and Science University Knight Cancer Institute

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: The Oncology Institute of Hope and Innovation - Whittier

location_facility: University of California Los Angeles - Jonsson Comprehensive Cancer Center

location_facility: Texas Oncology - Methodist Dallas Cancer Center

location_facility: Hospital Universitario Central de Asturias

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Hospital Regional Universitario de Málaga - Hospital Civil

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

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

location_facility: Maryland Oncology Hematology - Rockville Aquilino Cancer Center

location_facility: SCRI - Florida Cancer Specialists - West Palm Beach

location_facility: Froedtert Hospital - Medical College of Wisconsin

location_facility: Semmelweis Egyetem - Pulmonológiai Klinika

location_facility: The Ohio State University College of Medicine

location_facility: Rouen University Hôpital Charles-Nicolle

location_facility: Hospital Alvaro Cunqueiro - Clinico Universitario Vigo

location_facility: Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

location_facility: IRCCS Istituto Tumori "Giovanni Paolo II"

location_facility: ASST-SETTE LAGHI, Ospedale di Circolo e Fondazione Macchi

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

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Indiana University Health Arnett Cancer Care

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Northwest Georgia Oncology Centers - Marietta

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

location_facility: NEA Baptist Fowler Family Center for Cancer Care

location_facility: Windsor Regional Hospital Cancer Program

location_facility: Summit Medical Group - Florham Park Campus

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz - III. Medizinischen Klinik und Poliklinik

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hematology Oncology Associates of Fredericksburg

location_facility: MultiCare Institute for Research & Innovation


type: Registry Identifier

title: A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)

summary:
The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC).

The primary hypotheses for this study are that:

Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and
Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS).

With Amendment 3 (effective: September [Sep]-24-2021) participants discontinued lenvatinib and placebo; participants who remained on treatment in the study arms received open-label pembrolizumab.

With Amendment 3 the external Data Monitoring Committee was discontinued.

With Amendment 4 (effective: December-5-2022) Second Course will no longer be offered. Any participant receiving Second Course treatment prior to initiation of Amendment 4 will be able to complete treatment as planned.

With Amendment 4 study participation will end after the final administration of pembrolizumab. Participants who either complete 35 administrations of pembrolizumab or discontinue pembrolizumab will discontinue from the study following the safety follow-up visit. AEs and spontaneously reported pregnancies will be reported and followed per protocol. All participants in efficacy follow-up prior to initiation of Amendment 4 will stop efficacy assessments and be discontinued from the study. All participants in survival follow-up prior to initiation of Amendment 4 are considered to have completed the study and should have a final survival contact. The overall study ends when the last participant completes the last study-related contact or visit, withdraws from the study, or is lost to follow-up.

ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

lead_sponsor: Merck Sharp & Dohme LLC

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Canada
France
Hungary
Denmark
United States
China
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Seattle Cancer Care Alliance ( Site 0003)

location_facility: Maastricht Universitair Medisch Centrum - MUMC ( Site 0334)

location_facility: Medical Rehabilitation Center ( Site 0411)

location_facility: Universitaetsmedizin Goettingen ( Site 0281)

location_facility: China Medical University Hospital ( Site 0213)

location_facility: Aalborg Universitets Hospital ( Site 0684)

location_facility: Medical Hospital, Tokyo Medical And Dental University ( Site 0130)

location_facility: CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0102)

location_facility: Yamaguchi University Hospital ( Site 0135)

location_facility: Saitama Medical University International Medical Center ( Site 0125)

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0236)

location_facility: Sunnybrook Research Institute ( Site 0106)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0535)

location_facility: Nara Medical University Hospital ( Site 0133)

location_facility: Central Clinical Hospital with Polyclinic ( Site 0415)

location_facility: Ege Universitesi Tulay Aktas Onkoloji Hastanesi ( Site 0462)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0235)

location_facility: Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0305)

location_facility: Shaare Zedek Medical Center ( Site 0559)

location_facility: Xarxa Assistencial Universitaria Manresa ( Site 0354)

location_facility: Istituto Tumori Giovanni Paolo II ( Site 0306)

location_facility: National Cancer Center Hospital East ( Site 0128)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0504)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0459)

location_facility: Centro Oncológico de Rosario ( Site 0584)

location_facility: Clinical Hospital Saint Luka ( Site 0421)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 0284)

location_facility: University of Tsukuba Hospital ( Site 0126)

location_facility: Murmansk Regional Oncology Dispensary ( Site 0420)

location_facility: University College London Hospital NHS Foundation Trust ( Site 0380)

location_facility: Nottingham University Hospital NHS Trust ( Site 0383)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce

location_facility: Universitaetsklinikum Essen ( Site 0274)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0751)

location_facility: Fifth Medical Center of CPLA General Hospital ( Site 0732)

location_facility: Odense Universitetshospital ( Site 0682)

location_facility: Institut de Cancerologie Strasbourg Europe ( Site 0232)

location_facility: Nanjing Drum Tower Hospital ( Site 0737)

location_facility: Szpital Miejski im. Jana Pawła II w Bielsku-Białej ( Site 0542)

location_facility: Chonnam National University Hwasun Hospital ( Site 0194)

location_facility: St. Peter's Hospital Cancer Care Center ( Site 0042)

location_facility: Markusovszky Egyetemi Oktatokorhaz ( Site 0502)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0418)

location_facility: Antalya Memorial Hospital Department of Medical Oncology ( Site 0461)

location_facility: Peking University First Hospital ( Site 0726)

location_facility: Policlinico S. Orsola - Malpighi (Bologna) ( Site 0302)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0104)

location_facility: Nagasaki University Hospital ( Site 0136)

location_facility: Mercy Hospital Saint Louis - David C. Pratt Cancer Center ( Site 0095)

location_facility: Orszagos Onkologiai Intezet ( Site 0503)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0282)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0005)

location_facility: CHD Vendee-onco-hematologie ( Site 0251)

location_facility: The First Affiliated Hospital of Guangzhou Medical University ( Site 0749)

location_facility: Fudan University Shanghai Cancer Center ( Site 0721)

location_facility: Centro di Riferimento Oncologico CRO ( Site 0304)

location_facility: Zhongshan Hospital Fudan University ( Site 0725)

location_facility: Hirosaki University Hospital ( Site 0123)

location_facility: Zhejiang Provincial People's Hospital ( Site 0735)

location_facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0413)

location_facility: Centro Oncologico de Integracion Regional. COIR ( Site 0576)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 0424)

location_facility: Banner MD Anderson Cancer Center ( Site 0016)

location_facility: National Taiwan University Hospital ( Site 0211)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0217)

location_facility: Veterans Health Service Medical Center ( Site 0198)

location_facility: Urologica Praktyka Lekarska Adam Marcheluk ( Site 0543)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0738)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0774)

location_facility: Instituto de Investigaciones Metabolicas ( Site 0589)

location_facility: University of California Irvine Medical Center ( Site 0078)

location_facility: Instituto Medico Alexander Fleming ( Site 0578)

location_facility: Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0351)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0707)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0577)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0101)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 0249)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0507)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0454)

location_facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0585)

location_facility: Europejskie Centrum Zdrowia Otwock ( Site 0532)

location_facility: National Cheng Kung University Hospital ( Site 0215)

location_facility: Second Affiliated Hospital, Zhejiang University ( Site 0734)

location_facility: Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0457)

location_facility: Hospital Universitario Gregorio Maranon ( Site 0352)

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0307)

location_facility: Chungnam National University Hospital ( Site 0195)

location_facility: Queens Hospital-Purple Zone ( Site 0377)

location_facility: Kent and Canterbury Hospital ( Site 0390)

location_facility: Royal Stoke University Hospital Univ. Hosps of North Midlands NHST ( Site 0392)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0414)

location_facility: New England Cancer Specialists ( Site 0047)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 0378)

location_facility: Osaka City University Hospital ( Site 0132)

location_facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0271)

location_facility: Sun Yat-Sen University Cancer Center ( Site 0752)

location_facility: Kitasato University Hospital ( Site 0129)

location_facility: Staedtisches Krankenhaus Kiel GmbH ( Site 0285)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 0541)

location_facility: Baylor Scott & White Medical Center - Temple ( Site 0706)

location_facility: GBUZ Leningrad Regional Clinical Oncology Dispensary ( Site 0426)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0558)

location_facility: Aarhus Universitets hospital ( Site 0683)

location_facility: Assaf Harofeh Medical Center ( Site 0556)

location_facility: Thomas Jefferson University Hospital ( Site 0051)

location_facility: Ospedale Borgo Roma-Oncologia ( Site 0308)

location_facility: Austin Health-Austin Hospital ( Site 0154)

location_facility: Centre D Oncologie de Gentilly ( Site 0240)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0216)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0456)

location_facility: Sapporo Medical University Hospital ( Site 0122)

location_facility: Hospital Teresa Herrera - Chuac ( Site 0357)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 0309)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0301)

location_facility: Azienda Ospedaliera Santa Maria ( Site 0303)

location_facility: Peking University Third Hospital ( Site 0727)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0002)

location_facility: Hospital General Universitari Vall d Hebron ( Site 0358)

location_facility: John Wayne Cancer Institute ( Site 0017)

location_facility: Tokushima University Hospital ( Site 0134)

location_facility: Taipei Veterans General Hospital ( Site 0212)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 0743)

location_facility: Medical University of South Carolina-Hollings Cancer Center ( Site 0029)

location_facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 0509)

location_facility: Sakarya Universitesi Tip Fakultesi Arastirma Hastanesi ( Site 0460)

location_facility: Peninsula Health Frankston Hospital ( Site 0153)

location_facility: Harbin Medical University Cancer Hospital ( Site 0750)

location_facility: Korea University Anam Hospital ( Site 0197)

location_facility: Hospital Universitario HM Sanchinarro ( Site 0356)

location_facility: Saint Bartholomew s Hospital - London ( Site 0386)

location_facility: Seoul National University Hospital ( Site 0191)

location_facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 0746)

location_facility: Helios Kliniken Schwerin GmbH ( Site 0278)

location_facility: Taichung Veterans General Hospital ( Site 0214)

location_facility: Centre Hospitalier de la Cote Basque ( Site 0239)

location_facility: Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0277)


summary: The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.

location_facility:
Local Institution - 0075
Local Institution - 0021
Local Institution - 0011
Local Institution - 0009
Local Institution - 0071
Local Institution - 0077
Local Institution - 0035
Local Institution - 0072
Local Institution - 0044
Local Institution - 0095
Local Institution - 0039
Local Institution - 0096
Local Institution - 0058
Local Institution - 0005
Local Institution - 0014
Local Institution - 0034
Local Institution - 0016
Local Institution - 0008
Local Institution - 0078
Local Institution - 0026
Local Institution - 0074
Local Institution - 0019
Local Institution - 0097
Local Institution - 0046
Local Institution - 0036
Local Institution - 0042
Local Institution - 0031
Local Institution - 0054
Local Institution - 0024
Local Institution - 0069
Local Institution - 0037
Local Institution - 0033
Local Institution - 0023
Local Institution - 0053
Local Institution - 0025
Local Institution - 0066
Local Institution - 0060
Local Institution - 0006
Local Institution - 0082
Local Institution - 0067
Local Institution - 0081
Local Institution - 0040
Local Institution - 0038
Local Institution - 0091
Local Institution - 0061
Local Institution - 0043
Local Institution - 0065
Local Institution - 0004
Local Institution - 0050
Local Institution - 0010
The Reading Hosp Med Ctr Reg Cancer Ctr
Local Institution - 0017
Local Institution - 0030
Local Institution - 0029
Local Institution - 0084
Local Institution - 0003
Local Institution - 0018
Local Institution - 0041
Local Institution - 0092
Local Institution - 0080
Local Institution - 0015
Local Institution - 0027
Local Institution - 0002
Local Institution - 0032
Local Institution - 0073
Local Institution - 0012
Local Institution - 0068
Local Institution - 0020
Local Institution - 0062
Local Institution - 0001
Local Institution - 0094
Local Institution - 0100
Local Institution - 0086
Local Institution - 0013
Local Institution - 0056
Local Institution - 0045
Local Institution - 0093
Local Institution - 0088

title: A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors

location_country:
Italy
Poland
Portugal
Argentina
Romania
Austria
Mexico
United States
Spain
Greece
Chile
Czechia
Russian Federation
France


title: SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity

acronym: SELECT

summary: The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.

ReferenceType: result

ReferenceCitation: Ryan DH, Lingvay I, Colhoun HM, Deanfield J, Emerson SS, Kahn SE, Kushner RF, Marso S, Plutzky J, Brown-Frandsen K, Gronning MOL, Hovingh GK, Holst AG, Ravn H, Lincoff AM. Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) rationale and design. Am Heart J. 2020 Nov;229:61-69. doi: 10.1016/j.ahj.2020.07.008. Epub 2020 Jul 17.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

evidence: oa repository (via OAI-PMH doi match)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Edinburgh - Edinburgh Research Explorer

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery;pure.ed.ac.uk

publisher_dissemination: Elsevier

ReferenceCitation: Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.

oa_colors: green other

license: cc-by

license_normalized: cc-by

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repositories_concat: UCL Discovery;figshare.com

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lingvay I, Oral TK, Michelsen MM, Plutzky J, Tornoe CW, Ryan DH; SELECT Trial Investigators. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023 Dec 14;389(24):2221-2232. doi: 10.1056/NEJMoa2307563. Epub 2023 Nov 11.

oa_host_type: closed

ReferenceCitation: Leite AR, Angelico-Goncalves A, Vasques-Novoa F, Borges-Canha M, Leite-Moreira A, Neves JS, Ferreira JP. Effect of glucagon-like peptide-1 receptor agonists on cardiovascular events in overweight or obese adults without diabetes: A meta-analysis of placebo-controlled randomized trials. Diabetes Obes Metab. 2022 Aug;24(8):1676-1680. doi: 10.1111/dom.14707. Epub 2022 May 3.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

version: submittedVersion

repositories_concat: HAL

ReferenceCitation: Mares AC, Chatterjee S, Mukherjee D. Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. Curr Opin Cardiol. 2022 Jul 1;37(4):350-355. doi: 10.1097/HCO.0000000000000955. Epub 2022 Feb 16.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kanie T, Mizuno A, Takaoka Y, Suzuki T, Yoneoka D, Nishikawa Y, Tam WWS, Morze J, Rynkiewicz A, Xin Y, Wu O, Providencia R, Kwong JS. Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD013650. doi: 10.1002/14651858.CD013650.pub2.

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

location_country:
Finland
Germany
Ireland
Poland
Argentina
Algeria
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Czechia
Canada
Serbia
France
Colombia
Portugal
Hungary
Denmark
United States
Latvia
Ukraine
India
Romania
Belgium
Malaysia
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

acronym: LUCENT 2

summary: The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).

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

location_facility: The Affiliated Drum Tower Hospital of Nanjing University

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia

location_facility: M S Ramaiah Medical College and Hospitals

location_facility: No.1 Hospital Affiliated to Xinjiang Medical University

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

location_facility: Centre Hospitalier de Wallonie Picarde - Site Notre Dame

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Gastroenterology Associates of Pensacola, PA

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

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

location_facility: Renji Hospital Affliated to Shanghai Jiaotong University

location_facility: Escorts Heart Institute and Research Centre Ltd

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro

location_facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

location_facility: Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2

location_facility: Poona Medical Foundation. Ruby Hall Clinic

location_facility: Hospital Universitario Central de Asturias

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord

location_facility: The Affiliated Hospital of Medical College Qingdao Univ

location_facility: State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan"

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: Regional Hospital Dr Radivoj Simonovic Sombor

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Showa University Northern Yokohama Hospital

location_facility: HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Saint Petersburg State Medical University n.a. Pavlov I.P.

location_facility: Medical and Sanitary Division of Severstal

location_facility: Clinical Trials Center of Medical Institute

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Galilee Medical Center Department of Internal Medicine A

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

location_facility: Endomedix Diagnosztikai Központ - Miskolc

location_facility: Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways"

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Care Access Research LLC - Salt Lake City

location_facility: Shengjing Hospital of China Medical University

location_facility: Hospital Universitario Marqués de Valdecilla

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

location_facility: Melbourne Gastrointestinal Investigation Unit (MGIU)

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: Nizhny Novgorod Regional Hospital N.A. Semashko

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: Kunming Medical College Affiliated First Hospital

location_facility: Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre

location_facility: Azienda ospedaliero-universitaria Mater Domini

location_facility: Jiangsu Province Hospital of Chinese Medicine

location_facility: Nanjing Medical University - Nanjing Jiangning Hospital

location_facility: Research Associates of South Florida, LLC

location_facility: Bangalore Medical College and Research Institute

location_facility: Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: Carolina Digestive Diseases and Endoscopy Center

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

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

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

location_facility: Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Gastroenterology Research of San Antonio

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: National Hospital Organization Takasaki General Medical Centar

location_facility: Clinical Applications Laboratories, Inc.

location_facility: SR Kalla Memorial Gastro & General Hospital

location_facility: Xiangya Hospital Central South University

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital"

location_facility: Apollo Research and Innovations, Apollo Hospitals International Ltd

location_facility: UMC Utrecht, Dept. of Internal Medicine, MDL

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

location_facility: Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

location_facility: Centro de Investigación Clínica Acelerada

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital

location_facility: MNGI Digestive Health - Plymouth Endoscopy Center & Clinic

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

location_facility: Centro Para el Desarrollo de la Medicina y de Asistencia Med

location_facility: Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica

location_facility: Ishida Clinic of IBD and Gastroenterology

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

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

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia

location_facility: Hopital de Hautepierre - Service d'Hépatogastroentérolgie

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

location_facility: University of North Carolina Center for Inflammatory Bowel Disease

location_facility: Beijing Friendship Hospital Affiliate of Capital University

location_facility: Hospital Universitario Juan Ramon Jimenez

location_facility: National Hospital Organization Kyoto Medical Center

location_facility: University Medical Center "Bezanijska kosa"

location_facility: West China Hospital of Sichuan University

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Diaservis - Medical and Diagnostic Center

location_facility: Gen1 Research - Gastroenterology & Nutrition, PC

location_facility: The Second Hospital of Dalian Medical University

location_facility: Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo

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

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

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

location_facility: Multidisciplinary Medical Clinic "Anthurium"

location_facility: Clinical Center Kragujevac Gastroenterohepatology Clinic

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

location_facility: Hospital Privado Centro Medico de Cordoba SA

location_facility: University of Oklahoma Health Sciences Center

location_facility: Yaroslavl Municipal HI Clinical Hospital #8

location_facility: Sankikai Yokohama Shin midori General Hospital

location_facility: The First People's Hospital of Yunnan Province

location_facility: Azienda Ospedaliera Universitaria Policlinico de Modena

location_facility: Vilnius University Hospital Santariskiu Clinics

location_facility: National Hospital Organization Hirosaki General Medical Center

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

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

location_facility: Riga Eastern Clinical University Hospital

location_facility: Acibadem Universitesi - Acibadem Kozyatagi Hastanesi

location_facility: Scientific Centre of Reconstructive and Restorative Surgery

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

location_facility: Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho

location_facility: Centre de santé et de services sociaux Champlain-Charles-Le Moyne

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii


title: An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis

acronym: CONSONANCE

summary: This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

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:
Germany
Ireland
Poland
Brazil
Costa Rica
Bosnia and Herzegovina
Czechia
Canada
France
Colombia
Hungary
Denmark
United States
Morocco
Lebanon
Egypt
Italy
Guatemala
Netherlands
Mexico
United Arab Emirates
Spain
Panama
Russian Federation

location_facility: Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken

location_facility: University Clinical Center of the Republic of Srpska; Neurology Clinic

location_facility: Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

location_facility: CHU De Caen; Service De Neurologie Dejerine

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

location_facility: London Health Sciences Centre Uni Campus

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: Yale University Multiple Sclerosis Center

location_facility: Wayne State University School of Medicine

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

location_facility: Pécsi Tudományegyetem, Klinikai Központ Neurológiai Klinika; Klinikai Központ Neurológiai Klinika

location_facility: Szpital Uniwersytecki w Krakowie; Oddzia? kliniczny Neurologii

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

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: Hospital das Clinicas - FMUSP_X; Neurologia

location_facility: Hopital Militaire d'Instruction Mohamed V

location_facility: Groupe Hospitalo-Universitaire Caremeau; Service Neurologie

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

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

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

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

location_facility: St Vincents University Hospital; Carew House-Neurology Department

location_facility: Vladimirskiy Regional Scientific Research Inst.

location_facility: NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH

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

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

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

location_facility: University Hospital Mostar; Neurology Clinic

location_facility: Clinical Research Center-Alex university; Neurology Department

location_facility: National Center of Social Significant Disease

location_facility: Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie

location_facility: Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy

location_facility: Clinical Center University of Sarajevo; Neurology clinic

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

location_facility: University of British Columbia Hospital; Division of Neurology

location_facility: SP Swiecickiego UM Marcinkowskiego; Od. Klin. Neurologii z podod. Udarowym

location_facility: Universitätsmedizin Greifswald; Klinik und Poliklinik für Neurologie

location_facility: Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II

location_facility: Grupo Medico de Investigacion Clinica Multidisciplinaria

location_facility: Rigshospitalet; Neurologisk Klinik Glostrup

location_facility: University of Chicago; Neurology/MC 2030

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

location_facility: Centre Hospitalier Universitaire Hassan II

location_facility: A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Fakultní Nemocnice Olomouc; Neurologicka Klinika

location_facility: Fraser Health Authority - Fraser Health Multiple Sclerosis

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: Washington University School of Medicine

location_facility: Hospital das Clínicas Faculdades Médicas de Ribeirão Preto

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

location_facility: Ain Shams University Hospital; Clinical Research Center (MASRI-CRC)

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

location_facility: Beaumont Hospital; Clinical Research and Education Centre, Smurfit Building

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

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

location_facility: Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica

location_facility: Nemocnice Jihlava; NEU-Neurologicke oddeleni

location_facility: American University of Beirut - Medical Center

location_facility: City Clinical Hospital #24; Multipal Sclerosis department

location_facility: AOU Città della Salute e della Scienza; Neurologia 1

location_facility: Semmelweis Egyetem AOK; Neurologiai Klinika

location_facility: Hopital Civil de Strasbourg; Service de Neurologie

location_facility: Massachusetts General Hospital; Neurological Clinical Research Institute (NCRI)

location_facility: Rigshospitalet; Skleroseklinikken - Glostrup

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

location_facility: University Clinical Center Tuzla; Neurology

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di; Scienze Neurologiche

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika

location_facility: Scientific Neurology Center; Neurological department #6?

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: University of Cincinnati; Department of Neurology

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica

location_facility: Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas

location_facility: Lebanese American University Medical Center- Rizk Hospial

location_facility: Hospital Notre-Dame du Centre Hospitalier de l'Universite de Montreal