title: AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR

summary: The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
United States
Belgium
China
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Sweden

location_facility: Tianjin Medical University General Hospital

location_facility: QEII Health Sciences Centre - Victoria General Site

location_facility: Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)

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

location_facility: University of Miami Hospital and Clinics - Deerfield Beach

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

location_facility: Nanfang Hospital of Southern Medical University

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

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

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

location_facility: Sylvester Comprehensive Cancer Center - Plantation

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Sylvester Comprehensive Cancer Center - Coral Springs

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: FUNDALEU -Fundación para combatir la leucemia

location_facility: Sylvester Comprehensive Cancer Center - Aventura

location_facility: Universitätsklinik für Innere Medizin V Innsbruck

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Fujian Medical University Union Hospital

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Sylvester Comprehensive Cancer Center - Kendall

location_facility: Institute of hematology&blood disease hospital

location_facility: Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny

location_facility: Theageneio Cancer Hospital of Thessaloniki

location_facility: ASST Santi Paolo e Carlo Ospedale San Carlo Borromeo SSD di Onco-Ematologia (Edificio C-piano terra)

location_facility: Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: UCHealth - Medical Center of the Rockies

location_facility: ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Institut Català d'Oncologia - L'Hospitalet

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi

location_facility: Queen Elizabeth II Health Science Centre

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Instituto Veracruzano en Investigación Clínica S.C.

location_facility: The Second Hospital of Hebei Medical University

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Aydın Adnan Menderes Universitesi Hastanesi

location_facility: Instituto de Educação, Pesquisa e Gestão e Saúde

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: Memorial Sloan Kettering Cancer Center - Main Campus

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

location_facility: Christus St. Vincent Regional Medical Center

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

location_facility: Christus St. Vincent Regional Cancer Center

location_facility: Hospital Universitari De Girona Doctor Josep Trueta

location_facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: CHU de Poitiers, Hôpital de la Milétrie, Pôle Régional de Cancérologie

location_facility: Fondazione IRCCS San Gerardo dei Tintori

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

location_facility: Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: Sylvester Comprehensive Cancer Center - Hollywood

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu

location_facility: Beijing Peking Union Medical College Hospital

location_facility: Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

location_facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri

location_facility: Harbin Medical University Cancer Hospital

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: BP - A Beneficencia Portuguesa de São Paulo

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Universitätsklinikum rechts der Isar, Technische Universität München (TUM)

location_facility: FUNDALEU - Fundacion para combatir la Leucemia

location_facility: Te Whatu Ora Health New Zealand (Waikato), Waikato Hospital

location_facility: Inonu Universitesi Turgut Ozal Tıp Merkezi

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

location_facility: Waikato District Health Board, Waikato Hospital

location_facility: University of Miami Hospital And Clinics

location_facility: Hospital Santa Cruz / Centro de Pesquisa

location_facility: Azienda Ospedaliero Universitaria Senese

location_facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

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

location_facility: Centro de Pesquisa Clínica - Área Administrativa

location_facility: Hematológica Alta Especialidad SC, consultorio 830

location_facility: Capital, Coast and Hutt Valley District - Wellington Regional Hospital


type: U.S. NIH Grant/Contract

type: EudraCT Number

type: Other Identifier

title: A Phase 3, Randomized, Open-Label, Multicenter Study, to Compare T-Guard to Ruxolitinib for the Treatment of Patients With Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) (BMT CTN 2002)

summary: This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or IV Steroid-Refractory acute Graft-Versus-Host Disease (SR-aGVHD). The primary hypothesis is that T-Guard treatment will improve the Day 28 complete response (CR) rate in patients with Grades III and IV SR-aGVHD compared to ruxolitinib.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Xenikos

collaborators: National Heart, Lung, and Blood Institute (NHLBI)

collaborators: Blood and Marrow Transplant Clinical Trials Network

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
United States
Spain
Croatia
France

location_facility:
Site BE301
Site BE303
Site DE367
Site BE305
Site ES446
Wake Forest University
SiteFR348
Site FR351
SiteFR354
Site FR355
Site DE362
Site ES452
Site NL463
Duke University Medical Center
Site FR356
Site FR352
Site NL461
Site ES451
University of Wisconsin
Site BE307
Ohio State University
University of Alabama
Oregon Health & Science University
Site ES447
Washington University St. Louis
Site DE361
Site NL460
Site IT384
Site ES442
Site DE371
Site BE300
Sarah Cannon Research Institute
Site FR345
Site FR341
Site DE360
University of Utah
Site ES454
Site BE302
Site FR346
Site DE368
H. Lee Moffitt Cancer Center
SiteFR342
Mount Sinai Medical Center
Site ES453
Site GB483
Site DE364
Site HR320
City of Hope National Medical Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


lead_sponsor: Amgen

summary: The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) < 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 < 1% and in a subgroup of participants with STK11 co-mutation.

location_facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

location_facility: Arizona Oncology Associates Professional Corporation

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: Medical University of South Carolina, Hollings Cancer Center

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: State University of New York Upstate Medical University

location_facility: University of Pittsburgh Medical Center Cancer Pavillion

location_facility: Laura and Isaac Perlmutter Cancer Center at New York University Langone

location_facility: Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

location_facility: Northport Veterans Affairs Medical Center

location_facility: Centre Hospitalier Universitaire de Montpellier - Val d Aurelle

location_facility: Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Duke University Medical Center, Morris Cancer Clinic

location_facility: Allegheny Health Network Cancer Institute at Allegheny General Hospital

location_facility: Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo

location_facility: Centre Hospitalier de Nantes - Hôpital Nord Laënnec

location_facility: Asklepios - Fachkliniken München-Gauting

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi

location_facility: Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

status: Active, not recruiting

title: A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201)

source: euctr

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

study_completion_date_type: Anticipated

location_country:
Germany
Italy
Denmark
Sweden
Netherlands
Belgium
United States
Spain
Turkey
France

ipd_sharing: Yes

status_simplified: Ongoing


title: A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

acronym: BOUQUET

summary: This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

status: Recruiting

design_allocation: Non-Randomized

enrollment_type: Anticipated

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

lead_sponsor: Hoffmann-La Roche

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

location_country:
Germany
Italy
United Kingdom
Australia
Switzerland
Belgium
United States
Korea, Republic of
Spain
Turkey
Czechia
Canada
Russian Federation
France

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

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: McGill University Health Centre - Glen Site

location_facility: Pinnacle Health; Harrisburg Hospital Pharmacy

location_facility: Hôpitaux Universitaires de Genève; Département d'oncologie

location_facility: Koc University Medical Faculty; Department of Gynecology & Obstetrics

location_facility: Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü

location_facility: FSBI "Federal Medical Research Center n.a. V.A.Almazov"

location_facility: Western General Hospital; Edinburgh Cancer Center

location_facility: University of Oklahoma Health Sciences Center; Stephenson Cancer Center

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: IRCCS S. Raffaele; Ginecologia Oncologica

location_facility: I.R.C.C. Candiolo; Oncologia Medica e Ematologia

location_facility: Policlinico Universitario Agostino Gemelli

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

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: University of Washington - Seattle Cancer Care Alliance; Medical Oncology

location_facility: A.O. U. Consorziale Policlinico di Bari; Oncologia Ginecologica

location_facility: Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Chelyabisnk regional clinical center for oncology and nuclear medicine

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

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

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


title: A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)

acronym: VITALIZE

summary: This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.

lead_sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)

location_country:
Poland
New Zealand
Hungary
Romania
Australia
United States
Spain
Canada
Serbia
France

location_facility: Christus St. Vincent Regional Cancer Center

location_facility: SzSzBM Korhazak es Egyetemi Oktatokorhaz

location_facility: Blood and Marrow Transplant Group of Georgia

location_facility: Bucharest Oncology Institute "Prof.Dr.Al. Trestioreanu"

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: Tulane Cancer Center Office of Clinical Research

location_facility: Allegheny Health Network (AHN) West Penn Hospital

location_facility: Brody School of Medicine at East Carolina University

location_facility: SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: The Oncology Institute "Prof. Dr. Ion Chiricuţă" I.O.C.H.

location_facility: Reading Hospital - McGlinn Cancer Institute

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: Narodowy Instytut Onkologii im. Marii, Skłodowskiej-Curie

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists


title: A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients With Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors

acronym: TRUST-II

summary: The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.

lead_sponsor: AnHeart Therapeutics Inc.

location_country:
Italy
Poland
Japan
United States
China
Korea, Republic of
Spain
Canada
France

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals L'Hospitalet de Llobregat

location_facility: Hospital Regional Universitario de Malaga

location_facility: Azienda Ospedaliera Universitaria- Università degli Studi della Campania

location_facility: Pusan National University Yangsan Hospital

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico

location_facility: Humanitas Istituto Clinico Catanese, Misterbinanoco

location_facility: Chonnam National University Hwasun Hospital

location_facility: Keck Medicine of University of Southern California

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

location_facility: McGill University Health Centre Research Institute

location_facility: AOU Cagliari- P.O. Policlinico Universitario Duilio Casula

location_facility: Hospital Clinico Universitario de Valencia

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Hospital Universitario Clinico San Carlos


title: A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants With Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer With Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST)

acronym: ZEST

summary: This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor [HR] status, including HR positive [+] and TNBC) or tumor BRCA wild type (tBRCAwt) TNBC with molecular disease based on the presence of circulating tumor Deoxyribonucleic acid (ctDNA) following surgery or completion of adjuvant therapy.

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Chile
Canada
France
Colombia
Portugal
Hungary
Switzerland
United States
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Spain
South Africa
Russian Federation
Israel


title: A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

acronym: ELEVATE HNSCC

summary: The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in patients with head and neck squamous cell carcinoma (HNSCC).

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Hong Kong
Australia
Belgium
United States
Spain
France

location_facility: Technische Universitat Munchen (TUM) - Klinikum Rechts der Isar

location_facility: Azienda Ospedaliero - Universitaria di Bologna - IRCCS

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

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Panstwowy Instytut Badawczy, Oddzial x Gliwicach

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil,E.P.E.

location_facility: Virginia Piper Cancer Center (Alliant Health

location_facility: Civils de Lyon-Centre Hopitalier Lyon Sud

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Fondazione IRCCS Istituto Nazionale Tumori Milano

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est

location_facility: Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie, Oddzial Onkologii Klinicznej i Immunookologii z Poddoddzialem Dziennym i Izba Przyjec

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Narodowy Instytut Onkologii im. M. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Glowy i Szyi

location_facility: Royal Marsden NHS Foundation Trust, Royal Marsden - Sutton

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Regional Universitario de Malaga

location_facility: Centro Hospitalar Universitario do Porto

location_facility: UniversitÃ¤tsklinikum Bonn, Medizinische Klinik und Poliklinik III

location_facility: Torrance Memorial Physician Network - Cancer Care Associates

location_facility: Washington University of Medicine- Siteman Cancer Center

location_facility: ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg

location_facility: Azienda Ospedaliero - Universitaria Senese

location_facility: Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA

location_facility: Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital

location_facility: Azienda Ospedaliero-Universitaria di Modena - Policlinico

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Wojewodzki Szpital Specjalistyczny w Siedlcach


type: Registry Identifier

title: The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis

acronym: ESSENCE

summary:
Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries.

Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance.

Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week.

The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day.

Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Croatia
Czechia
Canada
Serbia
France
Portugal
Slovakia
Denmark
Switzerland
United States
India
Romania
Belgium
China
Malaysia
Puerto Rico
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


acronym: CLARIFY MS Extension

lead_sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

summary: The purpose of the study is the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This is the extension study to CLARIFY MS (NCT03369665), to assess cognitive impairment and health related quality of life (HRQoL) in participants with highly active RMS, at 4 years after initial dose of Mavenclad® tablets.

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Instituto Nazionale Neurologico "Carlo Besta"

location_facility: Policlinico Università della Campania L. Vanvitelli

location_facility: Instytut Psychiatrii i Neurologii - Dept of Neurology II

location_facility: Centre hospitalier de la Côte Basque - Saint Léon

location_facility: Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital de Sant Joan Despí Moisès Broggi

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: A.O. Ospedali Riuniti Villa Sofia-Cervello U.O. Endocrinolog

location_facility: Azienda Ospedaliera S. Camillo Forlanini

location_facility: Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie

location_facility: Ospedale Sant'Andrea Neurologia - Università La Sapienza

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

status: Completed

title: A 2-year Follow-up Study to Assess Cognition and Health-related Quality of Life in Participants With Highly-active Relapsing Multiple Sclerosis, Having Participated in the CLARIFY MS Trial (CLARIFY MS Extension)

primary_purpose: Other

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: Italy Poland Slovakia Hungary Denmark Netherlands Austria Spain Czechia France

status_simplified: Completed


title: An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

acronym: PSMAddition

summary: The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC. In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study.

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 www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

sponsor_collaborators:
Novartis Pharmaceuticals
Alliance Foundation Trials, LLC.
RTOG Foundation, Inc.

location_country:
Germany
Poland
Japan
Czechia
Canada
France
Denmark
Switzerland
United States
Belgium
China
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Sweden

location_facility: UT Health San Antonio Mays Cancer Center .

location_facility: Mayo Clinic - Arizona Mayo Clinic Hospital

location_facility: St. Louis University 3rd Floor Dermatology

location_facility: University of California San Diego - Moores Cancer Center

location_facility: University of Pittsburgh Cancer Institute SC-3

location_facility: Texas Oncology Texas Oncology - Plano West

location_facility: Anschutz Medical Center Anschutz Medical Campus

location_facility: Northwestern University Robert H. Lurie Comp Cancer

location_facility: Georgetown University/Lombardi Cancer Center

location_facility: Rocky Mountain Cancer Centers Rocky Mountain Cancer Centers

location_facility: St. Joseph Hospital Center for Cancer Prevention

location_facility: Oncology Hematology Associates of Southeast Virginia Roanoke Loc

location_facility: The Ohio State University Comprehensive Cancer Center .

location_facility: Dana Farber Cancer Institute Dana-Farber Cancer Institute_

location_facility: Washington University School of Medicine .


title: A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

acronym: innovaTV 301

summary:
This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent).

Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

lead_sponsor: Seagen Inc.

sponsor_collaborators:
Seagen Inc.
Genmab

location_country:
Finland
Germany
Ireland
Poland
Argentina
Japan
Brazil
Czechia
Canada
France
Hungary
Denmark
United States
Belgium
China
Peru
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Sweden

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Carbone Cancer Center / University of Wisconsin

location_facility: Institute Cancer De Lorraine (ICL) - Alexis Vautrin

location_facility: University of California Irvine Medical Center

location_facility: Jilin University - First Affiliated Hospital - Cancer Center

location_facility: Trondheim University Hospital, Trondheim

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: Instituto Brasileiro de Controle do Cancer

location_facility: University Health Network, Princess Margaret Hospital

location_facility: The Second Hospital of Shanxi Medical University

location_facility: Soon Chun Hyang University Hospital Seoul

location_facility: New York University (NYU) Cancer Institute

location_facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: Medical and Health Science Centre Debrecen Institution of Internal Medicine

location_facility: Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz

location_facility: Virginia Commonwealth University Medical Center

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Keimyung University Dongsan Medical Center

location_facility: Gynecological Cancer Institute of Chicago, LLC

location_facility: Nippon Medical School Musashi Kosugi Hospital

location_facility: Beijing Obstetrics and Gynecology Hospital

location_facility: The First Affiliated Hospital of Wenzhou Medical University

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

location_facility: The Second Hospital of Hebei Medical University

location_facility: The Affiliated Cancer Hospital of XinJiang Medical University

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Willis-Knighton Physician Network/Gynecologic Oncology Associates

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika

location_facility: National University Cancer Institute, Singapore

location_facility: Seoul National University Bundang Hospital

location_facility: Fondazione Policlinico Universitario Agostino

location_facility: Institut de cancerologie Strasbourg Europe

location_facility: Centre de Lutte contre le Cancer - François Baclesse

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centro de PesquisaemOncologia - HSL-PUCRS

location_facility: University of Alberta / Cross Cancer Institute

location_facility: CARIO - Centre Armoricain De Radiothérapie, D'imagerie Médicale Et D'oncologie

location_facility: Sungkyunkwan University of Medicine - Samsung Changwon Hospital

location_facility: Uppsala University Hospital (Akademiska Sjukhuset)

location_facility: Skanes University Hospital - Universitetssjukhus

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Avron (Hopital de la Croix Saint-Simon)

location_facility: Oslo University Hospital, Radiumhospitalet

location_facility: Fundação NAtonio Prudente (AC Camargo Cancer Center)

location_facility: Ohio State University Clinical Trials Management Office

location_facility: British Columbia Cancer Agency - Vancouver Centre

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer

summary: To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2).

lead_sponsor: Jiangsu HengRui Medicine Co., Ltd.

location_country:
Poland
Hungary
United Kingdom
Australia
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
Czechia
Russian Federation
France

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

location_facility: Chang Gung Memorial Hospital CGMH - Linkou Branch

location_facility: Cancer hospital Chinese academy of medical science

location_facility: The Second Hospital Of Anhui Medical University

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Bashkortostan Republican Clinical Oncology Dispensary

location_facility: Dolnoslaskie Centrum Onkologii - Lower Silesian Oncology Center

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: The Urology Surgery department of Zhongshan Hospital

location_facility: The Fourth Hospital of Hebei Medical University

location_facility: San Bernardino Urological Associates Medical Group

location_facility: Urology Ward 2，Harbin Medical University Cancer Hospital

location_facility: Shanghai Tenth People's Hospital-Department of Urology

location_facility: Regionalny Szpital Specjalistyczny im.dr. Wladyslawa Bieganskiego

location_facility: The First Affiliated Hospital of Xinjiang Medical University

location_facility: Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary

location_facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital

location_facility: Changhai Hospital of Shanghai-Department of Urology

location_facility: Fujian Medical University Union Hospital

location_facility: Institut Univ du Cancer de Toulouse-Oncopole

location_facility: Affiliated Hospital of Guizhou Medical University

location_facility: The First Affiliated Hospital，ZheJiang University School of Medicine

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: The First Affiliated Hospital Of Anhui Medical University

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

location_facility: Centre Hospitalier Departemental Vendee CHD

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Wuxi People's Hospital-Department of Urinary Surgery

location_facility: Desert Hematology Oncology Medical Group Inc

location_facility: Urological Associates of Southern Arizona PC

location_facility: The First affiliatared hospital of Fujian medical university

location_facility: Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N. Blokhin

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

location_facility: Fundacion Instituto Valenciano de Oncologia IVO

location_facility: Pusan National University Yangsan Hospital

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

location_facility: The Affiliated Tumor Hospital of Xinjiang Medical University-Department of Urology

location_facility: Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika

location_facility: Seoul National University Bundang Hospital

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

location_facility: XiangYa hospital central south university

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

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Hospital General Universitario Gregorio Marano

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Centre Hospitalier Universitaire de Nimes, Institut de Cancerologie du Gard

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: The Second Affiliated Hospital of Nanchang University-DepartmentDepartment of Urology

location_facility: Instituto Catalán de Oncología - Hospital Universitario Dr. Josep Trueta

location_facility: National Taiwan University Hospital NTUH

location_facility: The Second Hospital Of TianJin medical University

location_facility: West China Hospital of Sichuan University

location_facility: The first affiliated hospital of guangxi medical university

location_facility: First Hospital of Shanxi Medical University

location_facility: Strasbourg Oncologie Liberale- Clinique Sainte Anne

location_facility: CHA Bundang Medical Center CHA University

location_facility: Genesis Cancer Care-CHURCHILL Hospital Headington


title: A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined With Nivolumab Versus Placebo With Nivolumab in Patients With Unresectable or Metastatic Melanoma Not Previously Treated With PD-1 or PD-L1 Inhibitors

summary: This is a phase 3 study to compare the efficacy and safety of HBI-8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma and eligible patients who are not adolescents or patients with new, progressive brain metastasis will be stratified by PD-L1 expression and LDH level.

lead_sponsor: HUYABIO International, LLC.

sponsor_collaborators:
HUYABIO International, LLC.
Bristol-Myers Squibb

location_country:
Germany
Italy
New Zealand
United Kingdom
Singapore
Australia
Brazil
Japan
Austria
Belgium
United States
Korea, Republic of
Spain
South Africa
Czechia
Puerto Rico
France

location_facility: CHRU Lille - Hôpital Claude Huriez, Clinique de Dermatologie

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

location_facility: Univ.-Lkinik für Dermatologie, Venerologie und Allergologie

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Fondazione IRCCS CA'Granda Ospedale Maggiore Policlinico-Oncologia Medica

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Universitaetsklinikum Mannheim, Klinik f. Dermatologie, Venerologie, Allergologle,

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Universitatsklinikum Essen Klinik fur Dermatologie Studienambulanz

location_facility: Severance Hospital Yonsei University Health System

location_facility: Ensino e Terapia de Inovação Clίnica AMO-ETICA

location_facility: Froedtert Hospital, Medical College of Wisconsin

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale, Oncologia Medica e Terapia Innovativa

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Universitaetsklinikum Koeln, Dermatologie und Venerologie,

location_facility: Severance Hospital Younsei University Health System,

location_facility: Boca Raton Regional Hospital, Lynn Cancer Institute

location_facility: Universitaetsklinikum Schleswig Holstein - Campus Luebeck

location_facility: Oncosite-Centro de Pesquisa Clίnica em Oncologia

location_facility: Institut Gustave Roussy, Service de Dermatologie

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Universitaetsklinikum Freiburg, Klinik fuer Dermatologie und Venerologie

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - U.O. Oncologia Medica

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie

location_facility: A.O.U Senese Policlinico Santa Maria alle Scotte-UOC Immunoterapia Oncologica

location_facility: Vivantes Klinikum Spandau, Dermatologie und Allergologie

location_facility: Studienzentrum Dermao-Onkologie, Universitaetsklinikum Tuebingen

location_facility: Instituto do Cancer do Estado de São Paulo - "Octavio Frias de Oliveira"-ICESP

location_facility: Policlinico G.B. Rossi-Borgo Roma-Centro Ricerche Cliniche di Verona

location_facility: Thomas Jefferson University Medical Oncology Clinic

location_facility: Cape Town Oncology Trials Cape Gate Oncology Centre

location_facility: Hospial Oncologico, Puerto Rico Medical Center

location_facility: Innovative Clinical Research Institute (ICRI)

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Hautklinik

location_facility: Fakultni nemocnice Ostrava Kozni oddeleni

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Regional Universitario de Málaga

location_facility: Helios Klinikum Erfurt, Dermatologie und Allergologie

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: A.O.S. Maria della Misericordia, Oncologia Medica

location_facility: Osaka Prefectural Hospital Organization Osaka International Cancer Institute

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

location_facility: Medical University of Graz Department of Dermatology and Venerology

location_facility: Humanitas Istituto Clinico Catanese, U.O. Oncologia Medica

location_facility: Edinburgh Cancer Center Western General Hospital

location_facility: Carolina Blood and Cancer Care Associates

location_facility: Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

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

location_facility: Hopital de Câncer de Barretos-Fundação Pio XII

location_facility: California Cancer Associates for Research and Excellence, Inc. (cCARE)

location_facility: IRCCS Giovanni Paolo II Oncologia Medica

location_facility: Hospital Universitario Fundación Jimenez Diaz

location_facility: ICO Badalona-Hospital Universitari Germans Trias I Pujol

location_facility: Centro Gaúcho Integrado de Oncologia, Hematologia


lead_sponsor: Merck Sharp & Dohme LLC

summary:
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer.

The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2003)

location_facility: Queen Elizabeth II Health Sciences Centre ( Site 0101)

location_facility: Changzhou Cancer Hospital-Department of Oncology ( Site 2458)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2605)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1809)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0403)

location_facility: Princess Margaret Hospital. ( Site 2502)

location_facility: Hadassah Ein Kerem Medical Center ( Site 1501)

location_facility: Severance Hospital Yonsei University Health System ( Site 2800)

location_facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1604)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0003)

location_facility: The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si

location_facility: Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2005)

location_facility: Clinica Privada Dr Rixci Ramirez Fallas ( Site 0702)

location_facility: Kobe City Medical Center General Hospital ( Site 2606)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2612)

location_facility: Instituto Cancerologico de Narino Ltda ( Site 0504)

location_facility: Clinica Universidad Catolica del Maule ( Site 0411)

location_facility: Hospital General Gregorio Maranon de Madrid ( Site 1904)

location_facility: Humanitas Research Hospital ( Site 1600)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 2902)

location_facility: Universitaetsklinikum Regensburg ( Site 1203)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)

location_facility: Royal Marsden NHS Foundation Trust ( Site 2202)

location_facility: LinYi Cancer Hospital-Gastrology department ( Site 2463)

location_facility: Institut du Cancer Avignon-Provence ( Site 1103)

location_facility: Hamilton Health Sciences - Juravinski Site ( Site 0106)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1712)

location_facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1608)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1704)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0414)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0501)

location_facility: National Medical and Surgical Center n.a.N.I.Pirogov ( Site 1805)

location_facility: Kansai Medical University Hospital ( Site 2622)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2609)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 2000)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 2447)

location_facility: Hillel Yaffe Medical Center ( Site 1503)

location_facility: St Petersburg City Clinical Oncology Dispensary ( Site 1808)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1907)

location_facility: Washington University School of Medicine ( Site 0027)

location_facility: Universitaetsklinikum Leipzig ( Site 1211)

location_facility: Hallym University Sacred Heart Hospital ( Site 2806)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1816)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 2610)

location_facility: Sanatorio Nuestra Senora del Pilar ( Site 0705)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1821)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 2201)

location_facility: Blokhin National Medical Oncology ( Site 1800)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1610)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)

location_facility: AULSS8 Berica-Ospedale S.Bortolo ( Site 1607)

location_facility: Leningrad Regional Oncology Center ( Site 1810)

location_facility: Centre Georges Francois Leclerc ( Site 1106)

location_facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia ( Site 1609)

location_facility: Ninewells Hospital and Medical School ( Site 2207)

location_facility: The Christie NHS Foundation Trust ( Site 2209)

location_facility: James Graham Brown Cancer Center ( Site 0017)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 2204)

location_facility: Ibaraki Prefectural Central Hospital ( Site 2618)

location_facility: Seoul National University Hospital ( Site 2803)

location_facility: Central Clinical Hospital with Polyclinic ( Site 1801)

location_facility: Hospital Privado de Cordoba ( Site 0204)

location_facility: National Cheng Kung University Hospital ( Site 2904)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0032)

location_facility: Klinikum Rechts der Isar der TU Muenchen ( Site 1200)

location_facility: The Affiliated Hospital Of Hainan Medical University-Cancer rehabilitation and palliative treatment

location_facility: UMASS Memorial Medical Center ( Site 0020)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1902)

location_facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0207)

location_facility: Harbin Medical University Cancer Hospital ( Site 2410)

location_facility: National Taiwan University Hospital ( Site 2901)

location_facility: Sakarya Universitesi Tip Fakultesi ( Site 2007)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2428)

location_facility: Centre Hospitalier Annecy Genevois ( Site 1117)

location_facility: Nantong Tumor Hospital-Digestive Oncology ( Site 2464)

location_facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 2205)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 2403)

location_facility: Cancer and Hematology Centers of Western Michigan ( Site 0025)

location_facility: Hollywood Private Hospital-Medical Oncology ( Site 2308)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1702)

location_facility: Seoul National University Bundang Hospital ( Site 2804)

location_facility: First Hospital of Lanzhou University ( Site 2417)

location_facility: Georgetown University Medical Center ( Site 0009)

location_facility: National Cancer Center Hospital East ( Site 2601)

location_facility: Oncologos del Occidente S.A. ( Site 0525)

location_facility: Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0602)

location_facility: Instituto Medico Alexander Fleming ( Site 0208)

location_facility: China Medical University Hospital ( Site 2903)

location_facility: Medizinische Hochschule Hannover ( Site 1210)

location_facility: Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 2420)

location_facility: AHN West Penn Hospital-AHN Esophageal and Lung Institute ( Site 0058)

location_facility: Fujian Provincial Cancer Hospital ( Site 2408)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 2446)

location_facility: IRCCS Ospedale San Raffaele di Milano ( Site 1603)

location_facility: Osaka International Cancer Institute ( Site 2607)

location_facility: National Cancer Center Hospital ( Site 2602)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0508)

location_facility: Zhongshan Hospital Affiliated to Xiamen University ( Site 2421)

location_facility: Royal Brisbane and Women s Hospital ( Site 2304)

location_facility: The First Affiliated Hospital of Zhejiang University ( Site 2414)

location_facility: Charite Berlin Campus Virchow-Klinikum ( Site 1202)

location_facility: Nanjing Drum Tower Hospital ( Site 2419)

location_facility: Hospital Universitario General de Asturias ( Site 1901)

location_facility: Fourth Hospital Of Hebei Medical University ( Site 2441)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 1502)

location_facility: Korea University Guro Hospital ( Site 2808)

location_facility: CHU UCL Namur Site de Godinne ( Site 1005)

location_facility: Soluciones Gastrointestinales S.A. ( Site 0706)

location_facility: Aichi Cancer Center Hospital ( Site 2603)

location_facility: Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1611)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 1703)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2002)

title: Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy Compared With Standard of Care Therapy as First-line Intervention in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)

location_country:
Germany
Ireland
Poland
Argentina
Australia
Costa Rica
Japan
Turkey
Chile
Canada
France
Colombia
Hong Kong
United States
Belgium
China
Italy
Guatemala
United Kingdom
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


lead_sponsor: UCB Biopharma SRL

summary: The purpose of the study is to assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage Parkinson's Disease.

title: A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's Disease

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

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


title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19.

acronym: PROVENT

summary: This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

repositories:
LIRIAS (KU Leuven)
Pure (Denmark)

repositories_concat: LIRIAS (KU Leuven);Pure (Denmark)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: CDC. (Centers for Disease Control and Prevention). Coronavirus Disease 2019 (COVID-19), Symptoms of Coronavrus. https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html. Published 2020. Accessed 01 July 2020.

ReferenceCitation: Domachowske JB, Khan AA, Esser MT, Jensen K, Takas T, Villafana T, Dubovsky F, Griffin MP. Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose Respiratory Syncytial Virus Prefusion F-targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. Pediatr Infect Dis J. 2018 Sep;37(9):886-892. doi: 10.1097/INF.0000000000001916.

ReferenceCitation: Furer V, Rondaan C, Heijstek MW, Agmon-Levin N, van Assen S, Bijl M, Breedveld FC, D'Amelio R, Dougados M, Kapetanovic MC, van Laar JM, de Thurah A, Landewe RB, Molto A, Muller-Ladner U, Schreiber K, Smolar L, Walker J, Warnatz K, Wulffraat NM, Elkayam O. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020 Jan;79(1):39-52. doi: 10.1136/annrheumdis-2019-215882. Epub 2019 Aug 14.

ReferenceCitation: Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.

ReferenceCitation: Griffin MP, Khan AA, Esser MT, Jensen K, Takas T, Kankam MK, Villafana T, Dubovsky F. Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e01714-16. doi: 10.1128/AAC.01714-16. Print 2017 Mar.

ReferenceCitation: Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, Simoes EAF, Esser MT, Khan AA, Dubovsky F, Villafana T, DeVincenzo JP; Nirsevimab Study Group. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556. Erratum In: N Engl J Med. 2020 Aug 13;383(7):698.

oa_host_type: publisher

repositories_concat: closed

ReferenceCitation: Lamb EJ, Levey AS, Stevens PE. The Kidney Disease Improving Global Outcomes (KDIGO) guideline update for chronic kidney disease: evolution not revolution. Clin Chem. 2013 Mar;59(3):462-5. doi: 10.1373/clinchem.2012.184259. No abstract available.

ReferenceCitation: Li F. Structure, Function, and Evolution of Coronavirus Spike Proteins. Annu Rev Virol. 2016 Sep 29;3(1):237-261. doi: 10.1146/annurev-virology-110615-042301. Epub 2016 Aug 25.

ReferenceCitation: Morand EF, Furie RA. Anifrolumab in Systemic Lupus Erythematosus. Reply. N Engl J Med. 2020 Apr 23;382(17):1666. doi: 10.1056/NEJMc2002191. No abstract available.

ReferenceCitation: Poland GA, Ovsyannikova IG, Kennedy RB. Personalized vaccinology: A review. Vaccine. 2018 Aug 28;36(36):5350-5357. doi: 10.1016/j.vaccine.2017.07.062. Epub 2017 Jul 31.

ReferenceCitation: Robbie GJ, Criste R, Dall'acqua WF, Jensen K, Patel NK, Losonsky GA, Griffin MP. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013 Dec;57(12):6147-53. doi: 10.1128/AAC.01285-13. Epub 2013 Sep 30.

ReferenceCitation: Wagner A, Weinberger B. Vaccines to Prevent Infectious Diseases in the Older Population: Immunological Challenges and Future Perspectives. Front Immunol. 2020 Apr 23;11:717. doi: 10.3389/fimmu.2020.00717. eCollection 2020.

ReferenceCitation: WHO. WHO Coronavirus Disease (COVID-19) Dashboard. 2020a.

ReferenceCitation: WHO. WHO R&D Blueprint COVID-19 Therapeutic Trial Synopsis Draft 18 February 2020. https://www.who.int/blueprint/priority-diseases/key-action/COVID19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf. Published 2020b. Accessed 25 September 2020.

ReferenceCitation: Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3. Erratum In: Nature. 2020 Dec;588(7836):E6.

ReferenceCitation: Zimmermann P, Curtis N. Factors That Influence the Immune Response to Vaccination. Clin Microbiol Rev. 2019 Mar 13;32(2):e00084-18. doi: 10.1128/CMR.00084-18. Print 2019 Mar 20.

ReferenceCitation: Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090.

ReferenceType: derived

ReferenceCitation: Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

oa_host_type: repository

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central;ora.ox.ac.uk;pure.eur.nl

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, Yuan Y, Seegobin S, Ellery A, Levinson DJ, Ambery P, Arends RH, Beavon R, Dey K, Garbes P, Kelly EJ, Koh GCKW, Near KA, Padilla KW, Psachoulia K, Sharbaugh A, Streicher K, Pangalos MN, Esser MT; PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022 Jun 9;386(23):2188-2200. doi: 10.1056/NEJMoa2116620. Epub 2022 Apr 20.

repositories_concat: PubMed Central

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

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Iqvia Pty Ltd

location_country:
United Kingdom
Belgium
United States
Spain
France


acronym: A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis

lead_sponsor: Vertex Pharmaceuticals Incorporated

summary: This study was evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF participants, 12 years of age and older who are heterozygous for the F508del mutation and a minimal function mutation (F/MF genotypes), with abnormal glucose metabolism.

location_facility: Academisch Medisch Centrum (Academic Medical Centre)

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Centre Hospitalier Universitaire De Nantes - G. R. Laennec

location_facility: Azienda Ospedaliera di Verona - Ospedale Civile Maggiore

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: Hopital Foch (Suresnes), Hopital Foch, Adultes

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Azienda Ospedaliero Universitaria Federico II Napoli

title: A Phase 3b Open-label Study to Assess the Effect of Elexacaftor (ELX)/Tezacaftor (TEZ)/Ivacaftor (IVA) on Glucose Tolerance in Cystic Fibrosis Subjects With Abnormal Glucose Metabolism

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

location_country: Italy Australia Netherlands Belgium Spain Czechia France


title: A 56-week Phase IIIb/IV, Open-label, One-arm Extension Study to Assess the Efficacy and Safety of Brolucizumab 6 mg in a Treat-to-Control Regimen With Maximum Treatment Intervals up to 20 Weeks for the Treatment of Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study

acronym: TALON Ext

summary:
The purpose of this extension study is to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective is to assess brolucizumab's potential for long durability up to 20 weeks.

All eligible participants will be treated with brolucizumab regardless of their treatment in the TALON study.

The study period is 56 weeks including post-treatment follow-up.

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 https://www.clinicalstudydatarequest.com/

location_country:
Germany
Italy
Portugal
Israel
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Korea, Republic of
Spain
Malaysia
Taiwan
Czechia
France


title: A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid

summary: Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).

ReferenceCitation: Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available.

ReferenceCitation: European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.

lead_sponsor: Intercept Pharmaceuticals

location_country:
Germany
Lithuania
Poland
Hungary
Israel
Norway
Australia
United Kingdom
Netherlands
Austria
Belgium
Korea, Republic of
Spain
Greece
Croatia
Czechia
Estonia
France

location_facility: Consorcio Hospital General Universitario

location_facility: Hôpital de la Croix-Rousse - Hospices Civils de Lyon

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Artroscan s.r.o., Gastroenterologicka ambulance

location_facility: Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa

location_facility: Hadassah Ein-Karem Medical Center - Liver unit

location_facility: Universitetet i Oslo - Akershus Universitetssykehus (AHUS)

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

location_facility: Institute of Cellular Medicine, Newcastle University

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital General Universitario Gregorio Marañón

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

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

location_facility: Narodowy Instytut Onkologii, Klinika Gastroenterologii Onkologicznej

location_facility: Fundacio Clinic Per La Recerca Biomedica

location_facility: University of Athens - Hippokration General Hospital

location_facility: Groupe Hospitalier Pitié Salpêtrière - Assistance publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Universitaire Grenoble


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Combination of PI3Kδ Inhibitor Parsaclisib and Ruxolitinib in Participants With Myelofibrosis

summary: The purpose of the study is to compare the efficacy of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Finland
Germany
Italy
Poland
Israel
Norway
Denmark
Japan
United Kingdom
Austria
Belgium
United States
China
Korea, Republic of
Spain
Turkey
France

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Morristown Medical Center-Atlantic Health System

location_facility: Tianjin Medical University General Hospital

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Hospital of the University of Occupation and Environmental Health

location_facility: University College London Hospitals Nhs Foundation Trust

location_facility: Xiangya Hospital Central South University

location_facility: Aou San Giovanni Di Dio E Ruggi D'Aragona

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Samodzielny Publiczny Szpital Kliniczny Im. Andrzeja Mielckiego

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Centre Hospitalier de Versailles - Hopital Andre Mignot

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

location_facility: Azienda Sanitaria Universitaria Friuli Centrale Asu Fc

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Westchester Medical Center Advanced Oncology and Infusion Center

location_facility: Institute of Hematology and Transfusion Medicine

location_facility: Aormn Hospital Hematology and Bmt Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Providence Regional Medical Center Everett

location_facility: Fujian Medical University Union Hospital

location_facility: Shamir Medical Center Formerly Assaf Harofeh Medical Center

location_facility: Davidoff Cancer Center Rabin Medical Center

location_facility: Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or

location_facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

location_facility: Universita Degli Studi Di Genova - Facolta Di Medicina E Chirurgia

location_facility: Harbin Institute of Hematology and Oncology

location_facility: The First Hospital of Lanzhou University

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Hospital General Unviersitario de Alicante

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse

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

location_facility: The Second Hospital of Hebei Medical University

location_facility: Gazi University Hospital Gazi University Faculty of Medicine

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Stamford Hospital-Medical Oncology Hematology

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center

location_facility: New Jersey Hematology Oncology Associates Llc

location_facility: Peking University People'S Hospital (Pkuph) - Institute of Hematology

location_facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

location_facility: Ondokuz Mayis University Medicine Faculty

location_facility: Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: THE CATHOLIC UNIVERSITY OF KOREA SEOUL ST. MARYï¿½S HOSPITAL

location_facility: A.O. Universitaria Ospedale Di Circolo E Fondazione Macchi

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: University of Kentucky-Markey Cancer Center

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Barts Health Nhs Trust - St Bartholomews Hospital

location_facility: University Hospital of North Midlands Nhs Trust

location_facility: Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

location_facility: The Affiliated Hospital of Inner Mongolia Medical University

location_facility: Sheffield Teaching Hospitals Nhs Foundation Trust - Weston Park Hospital


title: A Randomized, Double-Blind, Placebo-Controlled Study of the PI3Kδ Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib

summary: The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy.

location_country:
Finland
Germany
Poland
Japan
Turkey
France
Hungary
United States
Romania
Belgium
China
Italy
Norway
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan
Israel

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Tianjin Medical University General Hospital

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon

location_facility: Samodzielny Publiczny Zoz Szpital Uniwersytecki W Krakowie

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Hospital of the University of Occupation and Environmental Health

location_facility: University College London Hospitals Nhs Foundation Trust

location_facility: The Catholic University of Korea Seoul St. Mary?S Hospital

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: National Cheng Kung University (Ncku) Hospital

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: The First Hospital of China Medical University

location_facility: Azienda Sanitaria Universitaria Friuli Centrale Asu Fc

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Institute of Hematology and Transfusion Medicine

location_facility: University of Texas Southwestern Medical Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Providence Regional Medical Center Everett

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Fujian Medical University Union Hospital

location_facility: Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or

location_facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

location_facility: Harbin Institute of Hematology and Oncology

location_facility: The First Hospital of Lanzhou University

location_facility: The Second Affiliated Hospital of Kunming Medical University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Hospital General Unviersitario de Alicante

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures

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

location_facility: Gazi University Hospital Gazi University Faculty of Medicine

location_facility: Chu Ucl Namur University Hospital Mont-Godinne

location_facility: Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

location_facility: Westchester Medical Center Advanced Oncology

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

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

location_facility: Tongji Hospital Huazhong University of Science and Technology

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Morristown Medical Center - Atlantic Health System

location_facility: Stamford Hospital - Medical Oncology Hematology

location_facility: Samson Assuta Ashdod University Hospital

location_facility: Advent Health Hendersonville Park Ridge Hospital Hendersonville

location_facility: Pusan National University Yangsan Hospital

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center

location_facility: New Jersey Hematology Oncology Associates Llc

location_facility: Chu Vandoeuvre-Les-Nancy Hopital Brabois

location_facility: Peking University People'S Hospital (Pkuph) - Institute of Hematology

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Augusta University - Medical College of Georgia

location_facility: Institut Universitaire Du Cancer de Toulouse Oncopole

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Univ. Di Roma Facolta Di Armacia E Medicina

location_facility: Irccs Azienda Ospedaliera Universitaria San Martino

location_facility: University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)

location_facility: The Second Affiliated Hospital of Xi an Jiaotong University

location_facility: Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Spitalul Clinic Coltea - Clinica Hematologie


lead_sponsor: Hoffmann-La Roche

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

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

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

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

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

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

location_facility: Compassionate Cancer Care Medical Group, Inc

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

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Cancer Hospital of Shantou University Medical College

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

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Viszeralonkologisches Zentrum

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

location_facility: The First Affiliated Hospital of Xinxiang Medical University

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

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

location_facility: Szegedi Tudományegyetem; Onkoterápiás Klinika

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani

location_facility: Affiliated Hospital of Bengbu Medical College

location_facility: Hopital Timone Adultes; Oncologie Digestive

location_facility: Chulalongkorn Hospital; Medical Oncology

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

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

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

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

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

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: China Medical University Hospital; Oncology and Hematology

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

location_facility: Heping Hospital Affiliated to Changzhi Medical College

location_facility: European Hospital Georges Pompidou (HEGP)

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

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

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

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

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

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie

location_facility: Saitama Medical University International Medical Center

location_facility: Taipei Veterans General Hospital; Department of Oncology

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

location_facility: Van Yuzuncu Yil University Hospital; Medical Oncology

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

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: St John of God Hospital; Bendat Cancer Centre

location_facility: Centre Hospitalier Universitaire Hassan II

location_facility: Instituto de Investigaciones Metabolicas (Idim)

location_facility: Städtisches Klinikum Dresden; IV. Medizinische Klinik

location_facility: Clinique specialise Menara; Oncology Medical

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Ankara University Faculty of Medicine Cebeci Hospital

location_facility: National Taiwan University Hospital; Oncology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii; ZAK?.I O.KLINICZNY RADIOTERAPII

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

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

location_facility: CHU Dijon Bourgogne Hôpital François Mitterand

location_facility: Universitätsklinikum Essen Klinik f.Strahlentherapie

location_facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Hospital Clinico Universitario de Valencia

location_facility: National Cheng Kung University Hospital; Oncology

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

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

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: Institut National D'oncologie Sidi Med Benabdellah; Oncolgy Medical

location_facility: Hopital Du Haut-Leveque; Gastro-Enterologie

location_facility: Compassionate Care Research Group Inc. Corona

location_facility: Compassionate Care Research Group Inc. Riverside

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

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

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

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

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

location_facility: Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii

location_facility: Chu La Miletrie; Gastro Enterologie Endoscopies

location_facility: Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center

location_facility: Hopital Rangueil; Gastro Enterologie Et Nutrition

location_facility: Austin Health; Cancer Clinical Trial Centre

location_facility: CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ?W. JANA Z DUKLI; II Oddzia? Onkologii Klinicznej

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Universitätsklinikum Klinik u.Poliklinik f.Strahlentherapie

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

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

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

location_facility: Vinnytsya Regional Clinical Oncology Dispensary

location_facility: Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Kyungpook National University Chilgok Hospital

location_facility: AUSL-IRCCS di Reggio Emilia; Oncologia Medica

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

location_facility: Klinikum der Philipps-Universität Marburg

location_facility: Ospedale Degli Infermi - Faenza; Oncologia Medica

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

location_facility: Rambam Health Corporation; Oncology Institute

location_facility: Affiliated Hospital of Jining Medical University

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

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

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


intervention_type: Other

acronym: Ravulizumab in TMA after HSCT

lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab in adult and adolescent participants with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In Stage 1, an open-label, single-arm period, the dosing regimen will be confirmed. In Stage 2, participants will be randomized to receive either blinded ravulizumab plus best supportive care or matching placebo plus best supportive care. The treatment period is 26 weeks (open-label for Stage 1, and randomized, double-blind, and placebo-controlled for Stage 2) followed by a 26-week follow-up period.

location_facility:
Clinical Trial Site
Clinical Study Site
Clinical Trial Manager
ClinicalTrial Site

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Ravulizumab in Adult and Adolescent Participants Who Have Thrombotic Microangiopathy (TMA) After Hematopoietic Stem Cell Transplant (HSCT)

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Australia
Brazil
Japan
Netherlands
Belgium
Sweden
United States
China
Korea, Republic of
Spain
Greece
Canada
France