title: A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Patients With Primary Progressive Multiple Sclerosis.

acronym: FENtrepid

summary: A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Canada
France
Colombia
Portugal
Hungary
Denmark
Switzerland
United States
Ukraine
North Macedonia
Peru
Puerto Rico
Italy
United Kingdom
Austria
Mexico
Spain
Greece
Bulgaria
Russian Federation
Israel

location_facility: Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken

location_facility: Tel Aviv Sourasky Medical Center; Department of Neurology

location_facility: Nottingham University Hospitals NHS Trust

location_facility: 401 Military Hospital of Athens; Neurology Department

location_facility: State Novosibirsk Regional Clinical Hospital

location_facility: Josephson Wallack Munshower Neurology PC

location_facility: London Health Sciences Centre Uni Campus

location_facility: Holy Name Hospital; Institute For Clinical Research

location_facility: Hospital Puerta del Mar; Sevicio de Neurologia

location_facility: Miami Valley Hospital South; Dayton Physician's Office

location_facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Box Hill Hospital; Department of Neurology

location_facility: Medical Clinical Research Center of Medical Center LLC Health Clinic

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: Austin Hospital; Department of Neurology

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: Separated structural unit ?University clinic? of Dnipro State Medical University

location_facility: Federal center of brain research and neurotechnologies

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

location_facility: A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Royal Melbourne Hospital; Department of Neurology

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

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: The Chaim Sheba Medical Center; Multiple Sclerosis Center

location_facility: Medizinische Universität Wien; Univ.Klinik fuer Neurologie

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Johns Hopkins University School Of Medicine; Outpatient Center

location_facility: Hospital Santo Antonio dos Capuchos; Servico de Neurologia

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

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

location_facility: Mersin University Medical Faculty; Neurology

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology

location_facility: Montreal Neurological Institute and Hospital

location_facility: Texas Institute for Neurological Disorders

location_facility: Palo Alto Medical Foundation Research Center

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: National Center of Social Significant Disease

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

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: Atrium Health Neurosciences Institute ? Charlotte

location_facility: Clinica Internacional; Unidad De Investigacion

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

location_facility: Instituto De Neurología Cognitiva - INECO

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: Hospital de Sao Joao; Servico de Neurologia

location_facility: UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases

location_facility: Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: OhioHealth Riverside Methodist Hospital; Pharmacy Services

location_facility: Van Yuzuncu Yil University Hospital; Neurology

location_facility: Regional Clinical Hospital; Neurology Department

location_facility: Markhot Ferenc Oktatokorhaz és Rendelointezet; Neurologiai és Stroke Osztaly

location_facility: Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

location_facility: Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD

location_facility: Rigshospitalet; Neurologisk Klinik Glostrup

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

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

location_facility: Centro de Especialidades Neurológicas y Rehabilitación - CENyR

location_facility: Instituto de Investigaciones Metabolicas (Idim)

location_facility: Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia

location_facility: Fraser Health Authority - Fraser Health Multiple Sclerosis

location_facility: Medical Centre of PE First Private Clinic

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru

location_facility: Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu

location_facility: Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet

location_facility: Santa Casa de Misericordia; de Belo Horizonte

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

location_facility: Studienzentrum für Neurologie und Psychiatrie

location_facility: Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie

location_facility: Charite - Universitatsmedizin Berlin; Klinik fur Neurologie

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: Uni of Texas Health Science Center At Houston

location_facility: Hospital Alvaro Cunqueiro; Servicio de Neurologia

location_facility: AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica

location_facility: City Clinical Hospital #24; Multipal Sclerosis department

location_facility: MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care

location_facility: Hopital Civil de Strasbourg; Service de Neurologie

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

location_facility: CNPE City Clinical Hospital #3 of Chernivtsi City Council

location_facility: Odesa Regional Clinical Hospital; Neurosurgery Department

location_facility: Sancaktepe Training and Research Hospital; Neurology

location_facility: City Hospital #40 of Resort Administrative District

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología

location_facility: University Clinic of Neurology; Movement Disorders

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: Regional health authority A vitalite health network

location_facility: The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis

location_facility: Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology

location_facility: CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie

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

location_facility: A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti)

location_facility: Hospital Eginition; First Department of Neurology

location_facility: Universitaetsklinikum Tuebingen; Abteilung Neurologie

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla


study_start_date_type: Actual

acronym: KALAHARI

intervention_type: Drug

lead_sponsor: Oxurion

summary:
Part A of the study is conducted to select the THR-149 dose level.

Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Northern California Retina Vitreous Associates Medical Group, Inc.

location_facility: London North West University Healthcare NHS Trust

location_facility: Fundación de Oftalmología Médica de la Comunitat Valenciana

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: University Hospitals Cleveland Medical Center

location_facility: METAVISIÓN ARRUZAFA, S.L.Clínica de Oftalmología de Córdoba S.L. (Hospital La Arruzafa)

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: King's College Hospital NHS Foundation Trust

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

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Retina-Vitreous Associates Medical Group

location_facility: South Tyneside and Sunderland NHS Foundation Trust

location_facility: Fakultná nemocnica s poliklinikou Žilina

location_facility: University Retina and Macula Associates, PC

location_facility: Retina-Vitreous Surgeons of Central New York, PC

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Instituto Clínico Quirúrgico de Oftalmología

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Mid and South Essex NHS Foundation Trust

location_facility: Azienda Sanitaria Universitaria Friuli Centrale

status: Completed

title: A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
Slovakia
United Kingdom
United States
Spain
Czechia
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Hoffmann-La Roche

summary: The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.

location_facility: Florida Cancer Specialists; Department of Oncology

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: Gazi University Medical Faculty, Oncology Hospital

location_facility: Ramathibodi Hospital; Medicine/Oncology; Clinical Research Center

location_facility: Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology

location_facility: Medisch Centrum Haaglanden, locatie Antoniushove

location_facility: Monash Health Translational Precinct; Clinical Trials Centre, Level 3

location_facility: Xiangya Hospital Central South University

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Beijing Cancer Center; Renal Cancer And Melanoma Department.

location_facility: Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Leicester Royal Infirmary; Oncology Department

location_facility: Maidstone & Tonbridge Wells Hospital; Kent Oncology Center

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Fujian Medical University Union Hospital

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

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: National Hospital Organization Himeji Medical Center

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

location_facility: Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Beijing Chest Hospital; Oncology Department

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

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Princess Margaret Hospital, Oncology; Department of Oncology

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

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

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

location_facility: Policlinico Universitario Campus Biomedico; U.O.C. di Radioterapia Oncologica

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Pusan National University Yangsan Hospital

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

location_facility: Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie

location_facility: Chonnam National University Hwasun Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Institut Gustave Roussy; Pathologie Thoracique

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: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: CENTRE FRANCOIS BACLESSE; Oncologie- Pneumologie

location_facility: Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

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

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: General Hospital "G.Papanikolaou"; Pulmonogy Clinic

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: The affiliated hospital of Qingdao university

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Sir Run Run Shaw Hospital Zhejiang University

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

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: China Medical University Hospital; Pulmonary and Critical Care Medicine

location_facility: Calderdale & Huddersfield Nhs Trust; Oncology

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Titan Health Partners LLC, d/b/a Astera Cancer Care

location_facility: Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii; Oddz. Onkologii Klin. i Chemioterapii

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; U.O. Radioterapia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

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

location_facility: Medipol University Medical Faculty; Oncology Department

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

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

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten

location_facility: Ankara University Medical Faculty; Medikal Onkoloji

status: Active, not recruiting

title: A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation

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/members/ourmembers/). 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).

study_completion_date_type: Anticipated

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
Portugal
Hungary
Hong Kong
United States
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Israel

ipd_sharing: Yes

status_simplified: Ongoing


title: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

summary: This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib.

status: Recruiting

design_allocation: Non-Randomized

enrollment_type: Anticipated

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:
Italy
Poland
Hungary
Israel
Denmark
Japan
Norway
Sweden
Austria
Belgium
United Kingdom
United States
Korea, Republic of
Spain
Turkey
Czechia
France

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: California Cancer Associates For Research and Excellence

location_facility: Chru Hopitaux de Tours Hospital Bretonneau

location_facility: University of Bologna Institute of Haematology L E A Seragnoli

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Hca Midwest Health-Research Medical Center

location_facility: Knight Cancer Institute At Oregon Health and Science University

location_facility: Kobe City Medical Center General Hospital

location_facility: National Hospital Org. Hokkaido Cancer Center

location_facility: Centre Hospitalier Universitaire de Toulouse

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

location_facility: Univerzita Karlova V Praze 1. Lekarska Fakulta

location_facility: Hospital General Unviersitario de Alicante

location_facility: Hospital Universitario Fundacin Jimnez Daz

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Rush University Medical Center-Consultants in Hematology

location_facility: University of Arizona Cancer Center-Out Pt.

location_facility: Hospital Universitario Quironsalud Madrid

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

location_facility: Sjaellands Universitets Hospital Roskilde

location_facility: Baylor Scott White Univeristy Medical Center

location_facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

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

location_facility: Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

location_facility: University of Washington-Seattle Cancer Care Alliance

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: University Hospitals Case Medical Center

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Jrc Aichi Medical Center Nagoya Daini Hospital

location_facility: Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara

location_facility: Azienda Ospedaliero Universitaria Pisana


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

acronym: CAHtalyst

summary: This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6-month randomized, double-blind, placebo-controlled period, followed by 1 year of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per subject for the OLE (estimated to be approximately 3 years).

ipd_sharing: No

lead_sponsor: Neurocrine Biosciences

location_country:
Germany
Italy
Poland
Portugal
Israel
United Kingdom
Sweden
Netherlands
Austria
Belgium
United States
Spain
Greece
Czechia
Bulgaria
Canada
Serbia
France


lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: The main purpose of this study was to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test.

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

location_facility: Hospital Universitario Reina Sofia - Dept of Oncology

location_facility: Texas Oncology, P.A. - Austin - Austin Central Cancer Center

location_facility: Tomsk Research Instutite of Oncology - Chemotherapy

location_facility: SBIH " Clinical Oncological Dispensary # 1" - Location

location_facility: SBIH " Clinical Oncological Dispensary 1" - Location

location_facility: Charleston Hematology Oncology Associates, PA

location_facility: TheOhio State University, Stefanie Spielman Comprehensive Breast Center

location_facility: CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale - Dipartimento di Senologia

location_facility: Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale

location_facility: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

location_facility: IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2

location_facility: Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center, Suite 3400

location_facility: Texas Oncology, P.A. - Medical City Dallas - Pediatric Hematology/Oncology

location_facility: FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"

location_facility: Institut Curie - Centre René Huguenin - Service d'Oncologie Médicale

location_facility: SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

location_facility: Centre François Baclesse - Pathologies Gynecologiques

location_facility: Hospital Universitario Ramon y Cajal - Servicio de Oncologia

location_facility: UPMC Hillman Cancer Center - Hillman Cancer Center

location_facility: Universitair Ziekenhuis Brussel - Geriatrie

location_facility: Hospital Ruber Internacional - Servicio de Oncologia

location_facility: Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" - Chemotherapy

location_facility: Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

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

location_facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" - Moscow Cancer Research Centre

status: Terminated

title: A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer

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
Belgium
United States
Spain
Russian Federation
France

status_simplified: Unknown


title: Adaptive Design Phase 2 to 3, Randomized, Double-blind, to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BIO101 in the Prevention of the Respiratory Deterioration in Hospitalized COVID-19 Patients

acronym: COVA

summary: The COVA clinical study is a global multicentric, double-blind, placebo-controlled, group sequential and adaptive 2 parts phase 2-3 study targeting in patients with SARS-CoV-2 pneumonia. Part 1 is a Phase 2 exploratory Proof of Concept (PoC) study to provide preliminary data on the activity, safety and tolerability of BIO101 in the target population. Part 2 is a phase 3 pivotal randomized study to provide further evidence of safety and efficacy of BIO101 after 28 days of double-blind dosing. BIO101 is the investigational new drug that activates the Mas receptor (MasR) through the protective arm of the Renin Angiotensin System (RAS).

ReferenceType: derived

ReferenceCitation: Dioh W, Chabane M, Tourette C, Azbekyan A, Morelot-Panzini C, Hajjar LA, Lins M, Nair GB, Whitehouse T, Mariani J, Latil M, Camelo S, Lafont R, Dilda PJ, Veillet S, Agus S. Testing the efficacy and safety of BIO101, for the prevention of respiratory deterioration, in patients with COVID-19 pneumonia (COVA study): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 11;22(1):42. doi: 10.1186/s13063-020-04998-5.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central
Pure (Denmark)

repositories_concat: HAL;PubMed Central;Pure (Denmark)

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Biophytis

location_country:
Brazil
Belgium
United States
Puerto Rico
France

location_facility: FDI Clinical Research - San Juan City Hospital

location_facility: Hospital e Maternidade Celso Pierro - PUCCAMP

location_facility: Avenida Dr. Enéas de Carvalho Aguiar, 44 - Centro de Pesquisa Clínica Prof. Dr. Fúlvio Pileggi - Bloco 1 - 1º Andar

location_facility: Centre Hospitalier Universitaire Bordeaux

location_facility: CHU CLU Namur (Saint-Elisabeth) Place Louise Godin

location_facility: Hospital Municipal de Barueri Dr. Francisco Moran

location_facility: Unité ambulatoire Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR) 47-83 Boulevard de l'Hôpital

location_facility: Hôpital Pitié-Salpêtrière, 47 bd de l'Hôpital, 75013 Paris

location_facility: Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto

location_facility: Barnum Medical Research, Inc. 1029 Keyser Ave Suite H

location_facility: Centre Hospitalier Départemental de Vendée


type: Registry Identifier

title: A Phase 1/2, Multicenter, Open-label Study to Assess Safety, Pharmacokinetics, and Preliminary Efficacy of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas.

summary:
This Phase 1/2, multicenter, open-label study to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification.

Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion).

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

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

lead_sponsor: Celgene

location_country:
Germany
Italy
United States
Korea, Republic of
Taiwan
France

location_facility:
Local Institution - 204
Local Institution - 500
Local Institution - 106
Local Institution - 105
Local Institution - 602
Local Institution - 102
Local Institution - 501
Local Institution - 205
University of Rochester Cancer Center
Local Institution - 301
Local Institution - 300
Local Institution - 103
Local Institution - 202
Local Institution - 200
Local Institution - 601
Local Institution - 600
Local Institution - 401
Local Institution - 404
Local Institution - 303
Local Institution - 201
Local Institution - 502
Local Institution - 402
Local Institution - 403
Local Institution - 203
Local Institution - 100
Local Institution - 302


title: An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

summary: This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents.

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

location_country:
Germany
Italy
Belgium
United States
China
Greece
Georgia
France

location_facility: The Ohio State University Wexner Medical Center Division of Gynecologic Oncology

location_facility: The Affiliated Drum Tower Hospital of Nanjing University

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: Multiprofile Clinic Consilium Medulla Llc

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Advent Health Medical Group-Orlando 2501

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

location_facility: Mount Sinai Medical Center Comprehensive Cancer Center

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

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Presidio Ospedaliero Di Summa Antonio Perrino

location_facility: H. Lee Moffitt Cancer Center and Research Institute Hospital

location_facility: Texas Oncology-Fort Worth South Henderson

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie

location_facility: University Hospital of West Attica - Attikon

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

location_facility: University of North Carolina At Chapel Hill


title: Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment With GSK3228836 in Participants With Chronic Hepatitis B Virus (B-Clear)

acronym: B-Clear

summary: Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide therapy. This study is intended to evaluate if treatment with GSK3228836 can achieve sustained virologic response (SVR), that is hepatitis B virus surface antigen (HBsAg) less than (<) lower limit of quantitation (LLOQ) and HBV deoxyribonucleic acid (DNA) <LLOQ sustained for 24 weeks post-GSK3228836 treatment end. In addition, the study will also evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of GSK3228836 in the 4 dosing regimens. This study will assess the efficacy and safety of treatment with GSK3228836 in two populations of participants with CHB; participants on stable nucleos(t)ide treatment (Cohort 1) and participants who are not currently on nucleos(t)ide therapy (Cohort 2). For each population, participants will be randomized into one of the 4 different parallel arms to receive treatment. The study will consist of a screening, treatment, and post-treatment follow-up phase. Approximately, 440 participants will be enrolled in the study.

ReferenceType: background

ReferenceCitation: Yuen MF, Lim SG, Plesniak R, Tsuji K, Janssen HLA, Pojoga C, Gadano A, Popescu CP, Stepanova T, Asselah T, Diaconescu G, Yim HJ, Heo J, Janczewska E, Wong A, Idriz N, Imamura M, Rizzardini G, Takaguchi K, Andreone P, Arbune M, Hou J, Park SJ, Vata A, Cremer J, Elston R, Lukic T, Quinn G, Maynard L, Kendrick S, Plein H, Campbell F, Paff M, Theodore D; B-Clear Study Group. Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection. N Engl J Med. 2022 Nov 24;387(21):1957-1968. doi: 10.1056/NEJMoa2210027. Epub 2022 Nov 8.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
Argentina
Japan
Thailand
Canada
France
Hong Kong
United States
Romania
China
Malaysia
Philippines
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation


title: A Phase 3, Randomized, Open-label, Multicenter Study of the Efficacy and Safety of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Harboring a HER2 Exon 20 Mutation Who Progressed on or After Treatment With Platinum Based Chemotherapy

summary: This is a randomized, positive-controlled, open-label, international multicenter, Phase 3 clinical study to compare the efficacy and safety of pyrotinib versus docetaxel in patients with advanced non-squamous NSCLC harboring a HER2 exon 20 mutation who failed platinum based chemotherapy.

lead_sponsor: Jiangsu HengRui Medicine Co., Ltd.

location_country:
Germany
Italy
Poland
Australia
Belgium
United States
China
Korea, Republic of
Spain
Turkey
Taiwan
Russian Federation
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of California (UC) Davis Comprehensive Cancer Center

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: the Second Affiliated Hospital of Anhui Medical University

location_facility: Shandong Cancer Hospital Affiliated to Shandong University

location_facility: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

location_facility: University of Kansas Medical Center (KUMC)

location_facility: The First Affiliated Hospital of Guangdong Pharmaceutical University

location_facility: Linkou Chang Gung Memorial Hospital (CGMHLK)

location_facility: Florida Cancer Specialists South Divisio

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: The Second Affiliated of Nanchang University

location_facility: ASST dei Sette Laghi-Ospedale di Circolo e Fondazione Macchi di Varese

location_facility: Cangzhou Hospital of Integrated Tcm-Wm.Hebei

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Baskent University Adana Application and Research Center

location_facility: Clinical hospital RZD-Medicine of St. Petersburg

location_facility: The second affiliated hospital of ChongQing medical university

location_facility: Hospital Regional Universitario de Malaga

location_facility: The affiliated hospital of inner mongolia medical univerity

location_facility: Necmettin Erbakan University Selcuklu Faculty of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Shanghai Pulmonary Hospital, Tongji University

location_facility: The First Affiliated Hospital，ZheJiang University

location_facility: University of California - Irvine Medical Center

location_facility: Florida Cancer Specialists North Divisio

location_facility: First Affiliated Hospital of ZhengzhouUniversity

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

location_facility: Pius-Hospital Oldenburg, Centre of Radiotherapy and Medical Oncology, Dept. Medical Oncology

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Petrov National Medical Research Center of Oncology

location_facility: beijing chest hospital,Capital medical university

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

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

location_facility: General Hospital of Tianjin Medical University

location_facility: Sir Run Run Shaw Hospital ZheJiang University School Of Medicine

location_facility: Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)

location_facility: Subei People's Hospital of Jiangsu Province


type: Other Identifier

title: TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)

summary:
The TRANSLATE study aims to better understand why tumors become resistant to standard anti-cancer therapies.

New tumor biopsy and blood samples are collected after disease progression on standard-of-care anti-cancer treatment and compared to the initial (archival) tumor biopsy sample taken from the same patient.

Annotated reports of results from clinical Next Generation Sequencing (NGS) gene panel tests of both tumor and blood are sent directly from the testing lab to the study physician for discussion with the patient during the study.

Patients may participate in interventional treatment clinical trials at the same time as participating in the TRANSLATE study.

Primary data will be publicly available after the study to support further research.

primary_purpose: Other

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:
United Kingdom
Argentina
Belgium
United States
France

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Centro de Educacion Medica e Investigaciones Clinicas"Norberto Quirno" CEMIC

location_facility: Grand Hôpital de Charleroi - Site Notre Dame

location_facility: Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

location_facility: UCI Medical Center-Chao Family Comprehensive Cancer Center

location_facility: The Oncology Institute of Hope Innovation

intervention_type: Procedure


title: A Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's Disease

summary: This is a Phase 2b study investigating the efficacy and safety of mesdopetam as adjunct therapy on daily ON-time without troublesome dyskinesia in patients with Parkinson disease. Mesdopetam is taken for 84 days.

ReferenceCitation: Becanovic K, Vittoria de Donno M, Sousa VC, Tedroff J, Svenningsson P. Effects of a Novel Psychomotor Stabilizer, IRL790, on Biochemical Measures of Synaptic Markers and Neurotransmission. J Pharmacol Exp Ther. 2020 Jul;374(1):126-133. doi: 10.1124/jpet.119.264754. Epub 2020 May 1.

ReferenceCitation: Waters S, Sonesson C, Svensson P, Tedroff J, Carta M, Ljung E, Gunnergren J, Edling M, Svanberg B, Fagerberg A, Kullingsjo J, Hjorth S, Waters N. Preclinical Pharmacology of [2-(3-Fluoro-5-Methanesulfonyl-phenoxy)Ethyl](Propyl)amine (IRL790), a Novel Dopamine Transmission Modulator for the Treatment of Motor and Psychiatric Complications in Parkinson Disease. J Pharmacol Exp Ther. 2020 Jul;374(1):113-125. doi: 10.1124/jpet.119.264226. Epub 2020 May 1.

ReferenceCitation: Svenningsson P, Johansson A, Nyholm D, Tsitsi P, Hansson F, Sonesson C, Tedroff J. Safety and tolerability of IRL790 in Parkinson's disease with levodopa-induced dyskinesia-a phase 1b trial. NPJ Parkinsons Dis. 2018 Dec 6;4:35. doi: 10.1038/s41531-018-0071-3. eCollection 2018.

lead_sponsor: Integrative Research Laboratories AB

location_country:
France
Italy
Poland
United States
Serbia
Israel

location_facility: Parkinson's Disease and Movement Disorders Center of Silicon Valley

location_facility: The Chaim Sheba Medical Centre, Department of Neurology

location_facility: University Clinical Center Kragujevac, Clinic for Neurology (Site 602)

location_facility: Rambam Health Care Campus, Department of Neurology

location_facility: Clinical Hospital Center Zvezdara, Clinical department of Neurology

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: AOU San Giovanni di Dio e Ruggi d'Aragona, Clinica Neurologica

location_facility: Hadassah University Hospital-Ein Kerem, Department of Neurology

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Tel Aviv Sourasky Medical Centre; Movement Disorders Unit

location_facility: University of Kentucky, Department of Neurology

location_facility: Collaborative Neuroscience Research (CNS Research)

location_facility: Colorado Springs Neurological Associates

location_facility: Elias Research Associates (Allied Biomedical Research Institute)

location_facility: University Clinical Center Kragujevac, Clinic for Neurology (Site 601)

location_facility: Rabin Medical Centre - Beilinson Hospital, Department of Neurology

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: University Clinical Center of Serbia, Clinic for Neurology

location_facility: University of Texas Southwestern Medical Center

location_facility: CHU Charles Nicolle; Service de Neurologie


title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema

acronym: Rhone-X

summary: This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Czechia
Canada
France
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Peru
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Cleveland Clinic Foundation; Cole Eye Institute

location_facility: Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia

location_facility: Hospital de Braga; Servico de Oftalmologia

location_facility: Retina Consultants of Southern California

location_facility: Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department

location_facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology

location_facility: Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Szemeszet

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: Hospital Universitario de Gran Canaria; Servicio de oftalmologia

location_facility: National Defense Medical College Hospital

location_facility: ?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic

location_facility: University of Utah; Division of Gastroenterology/Hepatology

location_facility: Selcuk University Faculty of Medicine; Department Of Ophthalmology

location_facility: University Retina and Macula Associates, PC

location_facility: Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Dipartimento Oculistica

location_facility: Tan Tock Seng Hospital; Ophthalmology Department

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Southeastern Retina Associates Chattanooga

location_facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia

location_facility: National University Hospital; Ophthalmology Department

location_facility: Fisabio-Ofalmologia Medica; Servicio de Oftalmología

location_facility: Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: Specialized Hospital for Active Treatment of Eye Diseases Zora

location_facility: California Retina Consultants - Santa Maria

location_facility: Prairie Eye & LASIK Center / Prairie Retina Center

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Medical Center for Eye Health ? Focus Ltd

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: ?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

location_facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

location_facility: Shiga University Of Medical Science Hospital

location_facility: University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET; Intezeti Gyogyszertar

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: Complejo Hospitalario de Navarra; Servicio de oftalmologia

location_facility: Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Universitätsklinikum Würzburg, Augenklinik und Poliklinik

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica

location_facility: LMU Klinikum der Universität, Augenklinik

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: National Taiwan University Hospital; Ophthalmology

location_facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

location_facility: Specjalistyczny O?rodek Okulistyczny Oculomedica

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Semmelweis Egyetem Szemészeti Vizsgálóhely

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

location_facility: Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology

location_facility: FN Hradec Králové, O?ní klinika; Ophthalmology clinic

location_facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Pentagram Eye Hospital (Medical Center "Pentagram")

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Hospital dos de maig; servicio de oftalmologia

location_facility: University Health Network Toronto Western Hospital

location_facility: Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik

location_facility: Queen Mary Hospital; Department of Ophthalmology

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

location_facility: FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

location_facility: King Chulalongkorn Memorial Hospital; Ophthalmology Department

location_facility: Spec. Ophth. Hospital for Active Treatment- Academic Pashev

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: California Eye Specialists Medical group Inc.

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia

location_facility: VISSUM Instituto Oftalmológico de Alicante

location_facility: Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch

location_facility: Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik

location_facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: St. Michael's Hospital; Department of Ophthalmology

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: Northern California Retina Vitreous Associates

location_facility: University of Colorado; dept of ophthalmology

location_facility: Southern California Permanente Medical Group

location_facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

location_facility: Beetham Eye Institute, Joslin Diabetes Center

location_facility: Faculty Hospital Ostrava; Ophthalmology clinic

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light

location_facility: Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia

location_facility: Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde

location_facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

location_facility: Rajavithi Hospital; Ophthalmology Department

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Seoul National University Bundang Hospital

location_facility: James Paget University Hospitals NHS Foundation Trust

location_facility: The Ohio State University Havener Eye Institute

location_facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

location_facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

location_facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: Mid Atlantic Retina - Wills Eye Hospital


title: A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain

summary: This is a Phase IIa randomized, double-blind, placebo-controlled study. The study objective is to investigate the efficacy and safety of repeat oral dosing of the investigational medicinal product (IMP) AP-325 for the treatment of peripheral post-surgical neuropathic pain (PPNP) after breast surgery (breast-conserving surgery, mastectomy, surgery to remove lymph nodes), chest surgery (e.g. thoracotomy, video assisted thoracoscopy and sternotomy), hernia repair of the abdominal wall (e.g. femoral hernia repairs, inguinal hernia repairs, umbilical hernia repair or incisional hernia repair), abdominal surgery (e.g. cholecystectomy, appendectomy but also see exclusion criterion 15), varicose vein surgery or gynecologic surgery (e.g. hysterectomy, C-section).

lead_sponsor: Algiax Pharmaceuticals GmbH

sponsor_collaborators:
Algiax Pharmaceuticals GmbH
FGK Clinical Research GmbH

location_country: Germany Belgium Spain Czechia France

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID#Cod. CNH: 281203#

location_facility: HOSPITAL UNIVERSITARI DE BELLVITGE#Cod. CNH: 080752#

location_facility: HOSPITAL UNIVERSITARIO LA MORALEJA#Cod. CNH: 281179#

location_facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH, (Ruhr-Universität Bochum) Neurologische Klinik und Poliklinik

location_facility: HOSPITAL UNIVERSITARIO 12 DE OCTUBRE#Cod. CNH: 280035#

location_facility: MP-neuro s.r.o., Poliklinika Modrý pavilon

location_facility: Florence-Nightingale-Krankenhaus der Kaiserswerther Diakonie, Klinik für Thoraxchirurgie

location_facility: Praxis Dr. med. J. Springub und W. Schwarz, Studienzentrum Nordwest

location_facility: Ziekenhuis Oost Limburg - campus St. Jan

location_facility: CLINICA UNIVERSIDAD DE NAVARRA#Cod. CNH: 310060#

location_facility: Hopital Ambroise Paré, Centre d'évaluation et de traitement de la douleur

location_facility: Polyclinique de Limoges - Site Chenieux, Centre d'Evaluation et de traitement de la Douleur

location_facility: HOSPITAL UNIVERSITARIO PUERTA DEL MAR#Cod. CNH: 110012#

location_facility: CHU Amiens-Picardie, Centre de Recherche Clinique

location_facility: Institut de Cancerologie de l'Ouest, Anesthésie/Douleur

location_facility: Vivantes Klinikum Neukölln, Klinik für Thoraxchirurgie

location_facility: Neurology and Physiotherapy Outpatient Clinic Skopalíkova

location_facility: Fakultní nemocnice Královské Vinohrady, Klinika anestezologie a resuscitace

location_facility: CHD Vendée, Département d'évaluation et du traitement de la douleur

location_facility: Hopîtal Cochin, Centre d'évaluation et du traitement de la douleur

location_facility: Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Holweide, Brustzentrum

location_facility: Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Merheim, Lungenklinik am Zentrum für Thoraxchirurgie, Pneumologie/ Onkologie, Schlaf- und Beatmungsmedizin, Klinikum der Universität Witten/Herdecke

location_facility: Universitätsklinikum Würzburg, Klinik und Poliklinik für Anästhesiologie, Zentrum für Interdisziplinäre Schmerzmedizin

location_facility: HOSPITAL UNIVERSITARIO LA PAZ#Cod. CNH: 280014#

location_facility: HOSPITAL CLINICO UNIVERSITARIO DE VALENCIA#Cod. CNH: 460044#


lead_sponsor: Merck Sharp & Dohme LLC

summary: This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.

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

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 1582)

location_facility: Perlmutter Cancer Center at Winthrop Oncology Hematology Associates NYU Langone Health ( Site 1597)

location_facility: St Francis Cancer Center-Research Office ( Site 1607)

location_facility: Gallipoli Medical Research Foundation-GMRF CTU ( Site 0105)

location_facility: Oslo universitetssykehus, Radiumhospitalet ( Site 1102)

location_facility: Medical University of South Carolina ( Site 1579)

location_facility: National Taiwan University Hospital ( Site 1200)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1400)

location_facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1702)

location_facility: Hospital General de Valencia ( Site 0703)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1508)

location_facility: University of Kansas Cancer Center ( Site 1538)

location_facility: Taipei Veterans General Hospital ( Site 1201)

location_facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0509)

location_facility: University of Massachusetts Chan Medical School ( Site 1616)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 1555)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1704)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 0909)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0700)

location_facility: Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0404)

location_facility: Sunnybrook Research Institute ( Site 0308)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 0508)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 1706)

location_facility: The Center For Cancer And Blood Disorders ( Site 1569)

location_facility: Our Lady of the Lake RMC-Clinical Research ( Site 1624)

location_facility: Guy s and St Thomas Hospital NHS Foundation Trust ( Site 0903)

location_facility: UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)

location_facility: University Hospital Southampton NHS Foundation Trust ( Site 0905)

location_facility: University of Maryland Greenebaum Cancer Center ( Site 1522)

location_facility: Mercy Health-Paducah Medical Oncology and Hematology ( Site 1623)

location_facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 0510)

location_facility: Inova Schar Cancer Institute ( Site 1550)

location_facility: MultiCare Health System-MultiCare Oncology - Puget Sound ( Site 1609)

location_facility: Soroka Medical Center-Oncology ( Site 0604)

location_facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 1505)

location_facility: Taichung Veterans General Hospital ( Site 1206)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 1566)

location_facility: Norton Hospital-Norton Cancer Institute - Downtown ( Site 1601)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 1523)

location_facility: Administradora Country S.A.S - Clínica del Country ( Site 0407)

location_facility: The Christie NHS Foundation Trust ( Site 0907)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 1204)

location_facility: Penn State Hershey Medical Center ( Site 1561)

location_facility: Severance Hospital Yonsei University Health System ( Site 1800)

location_facility: IU Health Ball Memorial Hospital, Inc.-IU Health Ball Memorial Cancer Center ( Site 1612)

location_facility: University Of Nebraska Medical Center ( Site 1570)

location_facility: NorthShore University HealthSystem - Evanston Hospital ( Site 1614)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0307)

location_facility: Hospital Universitari Vall d Hebron ( Site 0701)

location_facility: Seoul National University Bundang Hospital ( Site 1801)

location_facility: Medical College of Wisconsin Clinical Cancer Center ( Site 1574)

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521)

location_facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 1627)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0601)

location_facility: Mid Florida Hematology and Oncology Center ( Site 1606)

location_facility: Centro Hospitalar Vila Nova de Gaia. Espinho EPE ( Site 1401)

location_facility: Jackson Oncology Associates, PLLC-Clinical Trials ( Site 1625)

location_facility: Georgetown University Medical Center ( Site 1520)

location_facility: Rigshospitalet University Hospital Copenhagen ( Site 1000)

location_facility: Hematology Oncology Associates of Fredericksburg ( Site 1537)

location_facility: Georgia Cancer Center at Augusta University ( Site 1575)

location_facility: Memorial Health University Medical Center ( Site 1626)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0602)

location_facility: Hospital Virgen de la Victoria ( Site 0702)

location_facility: Mary Bird Perkins Cancer Center Baton Rouge ( Site 1622)

location_facility: Mid North Coast Cancer Institute ( Site 0109)

location_facility: University Hospital Cleveland ( Site 1578)

location_facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 1203)

location_facility: St. Vincent Frontier Cancer Center ( Site 1507)

location_facility: Centro Oncologico de Galicia ( Site 0706)

location_facility: HOSPITAL CLÍNIC DE BARCELONA ( Site 0707)

location_facility: VA Ann Arbor Healthcare System ( Site 1584)

location_facility: China Medical University Hospital ( Site 1205)

location_facility: Rush University Medical Center ( Site 1560)

location_facility: Washington University School of Medicine ( Site 1500)

location_facility: National Cheng Kung University Hospital ( Site 1202)

title: A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy (PD-1/PD-L1 Inhibitors) (LEAP-009)

location_country:
Colombia
Portugal
Israel
Norway
Denmark
Australia
Romania
United Kingdom
United States
Korea, Republic of
Spain
Taiwan
Canada
France


title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

acronym: DELIVER

summary: Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments.

ReferenceCitation: Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.

oa_host_type: closed

publisher_dissemination: Elsevier

lead_sponsor: H. Lundbeck A/S

location_country:
Finland
Germany
Italy
Poland
Slovakia
Hungary
United Kingdom
Denmark
Sweden
Belgium
United States
Spain
Czechia
Bulgaria
Georgia
Russian Federation
France

location_facility: Synexus - Merseyside Clinical Research Centre

location_facility: Northern Care Alliance NHS Foundation Trust

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

location_facility: IRCCS Istituto Delle Scienze Neurologiche di Bologna

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

location_facility: Clinical Research Institute Inc. - Minneapolis

location_facility: Assistance Publique Hôpitaux de Marseille

location_facility: Indywidualna Praktyka Lekarska dr hab. n. med. Anna Szczepanska-Szerej

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

location_facility: Synexus Midlands Clinical Research Centre

location_facility: Synexus - Thames Valley Clinical Research Centre

location_facility: Simon Khechinashvili University Hospital

location_facility: Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: First Multiprofile Hospital for Active Treatment - Sofia

location_facility: Northwest Clinical Research Center (NWCRC)

location_facility: Hometown Urgent Care & Occupational Health/Hometown Research - Huber Heights

location_facility: Archangel Saint Michael Multiprofile Clinical Hospital

location_facility: Synexus - Scotland Clinical Research Centre

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Helsicore - Israeli-Georgian Medical Research Clinic

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Center

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Alvaro Cunqueiro - Clinico Universitario Vigo

location_facility: Medicínske Centrum Konzílium - Dubnica nad Vahom

location_facility: Migräne- und Kopfschmerzklinik Königstein

location_facility: Michigan Headache and Neurological Institute

location_facility: Concept Medica Trials Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

location_facility: Clinica Universidad de Navarra - Pamplona

location_facility: Multiprofile Hospital for Active Treatment Heart and Brain EAD

location_facility: Clinical Neuroscience Solutions - Memphis

location_facility: Synexus - Manchester Clinical Research Centre

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Azienda Ospedaliera - Universitaria Sant' Andrea

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Lynn Health Science Institute - Oklahoma City

location_facility: MUDr. Helena Hojdíkova s.r.o. Neurologicka Ambulance

location_facility: Neurologicka ambulancia MUDr. Dupejova s.r.o.

location_facility: Neurologie, MP-neuro s.r.o., poliklinika Modry pavilon


lead_sponsor: Novartis Pharmaceuticals

summary: The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in previously treated unresectable or metastatic melanoma

ReferenceCitation: Moschos SJ. War against NRAS-Mutant Melanoma Using Targeted Therapies Remains Challenging. Clin Cancer Res. 2022 Jul 15;28(14):2977-2979. doi: 10.1158/1078-0432.CCR-22-1256.

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Association for Cancer Research

location_facility: Dana Farber Cancer Institute Dept.of DFCI

location_facility: Florida Cancer Specialists Sarasota Office

location_facility: NYU Laura and Isaac Perlmutter Cancer Center

location_facility: The Angeles Clinic and Research Institute .

location_facility: H Lee Moffitt Cancer Center and Research Institute Moffitt McKinley Outpatient Ct

location_facility: Massachusetts General Hospital Massachusetts General Hospital

location_facility: University of TX MD Anderson Cancer Center .

title: A Randomized, Open-label, Multi-arm, Two-part, Phase II Study to Assess Efficacy and Safety of Multiple LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma

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.

location_country:
Germany
Italy
Israel
Argentina
Norway
Australia
United Kingdom
Netherlands
Switzerland
Belgium
United States
France


summary: This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.

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

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Hematologii

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

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

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

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I

location_facility: Institut Bergonie; Hematologie Oncologie

location_facility: PanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Royal Adelaide Hospital; Haematology Clinical Trials

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Seoul National University Bundang Hospital

location_facility: Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej

location_facility: Harbin Medical University Cancer Hospital

location_facility: Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: UCLH - Clinical Trials Pharmacy B&D Centre

location_facility: CHU DE MONTPELLIER-ST ELOI; Département d'Hématologie Clinique

location_facility: Katharinenhospital Stuttgart; Klinik für Hämatologie, Onkologie und Palliativmedizin

location_facility: Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny

location_facility: Aarhus Universitetshospital Skejby; Blodsygdomme

location_facility: Christie Hospital; Department of Haematology and Transplant

location_facility: University of Mississippi Medical Center

location_facility: Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli

location_facility: St James's Institute of Oncology; Dept of Haematology

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

title: A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

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
United Kingdom
Denmark
Australia
Switzerland
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
Puerto Rico
France


lead_sponsor: AstraZeneca

summary: This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicenter study assessing the efficacy and safety of durvalumab versus placebo following SoC chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post surgery

title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination With Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MERMAID-1)

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

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Czechia
Canada
France
Hungary
Hong Kong
Denmark
Switzerland
United States
India
Romania
Belgium
Peru
Italy
Singapore
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel


acronym: NeoADAURA

summary: This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

ReferenceCitation: Tsuboi M, Weder W, Escriu C, Blakely C, He J, Dacic S, Yatabe Y, Zeng L, Walding A, Chaft JE. Neoadjuvant osimertinib with/without chemotherapy versus chemotherapy alone for EGFR-mutated resectable non-small-cell lung cancer: NeoADAURA. Future Oncol. 2021 Nov;17(31):4045-4055. doi: 10.2217/fon-2021-0549. Epub 2021 Jul 19.

oa_colors: green hybrid

repository_institution: PubMed Central - Europe PMC

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

repository_institution: California Digital Library - eScholarship

version: submittedVersion

repositories_concat: PubMed Central;escholarship.org

title: A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer

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

location_country:
Germany
Poland
Japan
Brazil
Thailand
Vietnam
Turkey
Chile
Canada
France
Switzerland
United States
India
China
Peru
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


lead_sponsor: Vertex Pharmaceuticals Incorporated

summary: This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-147 in participants with apolipoprotein L1 (APOL1)-mediated focal segmental glomerulosclerosis (FSGS).

ReferenceCitation: Bruggeman LA, Sedor JR, O'Toole JF. Apolipoprotein L1 and mechanisms of kidney disease susceptibility. Curr Opin Nephrol Hypertens. 2021 May 1;30(3):317-323. doi: 10.1097/MNH.0000000000000704.

oa_host_type: repository

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

location_facility: Nephrology and Hypertension Associates, LTD

location_facility: Renal and Transplant Associates of New England, PC

location_facility: Duke University School of Medicine - Duke Molecular Physiology Institute

location_facility: King's College Hospital NHS Foundation Trust - Guthrie Clinic

location_facility: South Carolina Nephrology and Hypertension Center, Inc.

location_facility: Nevada Kidney Disease and Hypertension Centers

location_facility: UNC Kidney Center Division of Nephrology & Hypertension

location_facility: Service de Nephrologie - Hopital Universitaire Necker

location_facility: Hopitaux Universitaires Est Parisien - Hopital Tenon

location_facility: University Hospitals of Leicester NHS Trust - Leicester General Hospital

location_facility: Kidney and Hypertension Specialists of Miami

location_facility: Morehouse School of Medicine, Grady Memorial Hospital

location_facility: The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension

location_facility: Université Paris-Descartes / Hôpital Européen Georges Pompidou

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: University of Alabama at Birmingham - The Kirklin Clinic

location_facility: Paragon Health, PC d/b/a Nephrology Center, PC

title: A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis

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:
United States
United Kingdom
Puerto Rico
France


title: Registry of Asthma Patients Initiating DUPIXENT® (RAPID)

acronym: RAPID

summary:
The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life.

This includes characterization of:

Patient demographics (eg, gender, age, and race)
Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height)

The secondary objectives of the study are:

To characterize real-world use patterns of DUPIXENT® for asthma
To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting
To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT®
To collect long-term safety data on study participants in the real-world setting

study_type: Observational

time_perspective: Prospective

lead_sponsor: Regeneron Pharmaceuticals

sponsor_collaborators:
Regeneron Pharmaceuticals
Sanofi

location_country:
Italy
United Kingdom
Denmark
Japan
Sweden
United States
Spain
Canada
Puerto Rico
France

location_facility: Dr. Henry J. Kanarek Allergy, Asthma & Immunology

location_facility: Centre Hospitalier du Pays d'Aix - Maladies Respiratoires

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) - Universite Laval

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne (CHU Dijon) - Hôpital Francois Mitterrand

location_facility: La Fondazione IRCCS Policlinico "San Matteo"

location_facility: A Atat Progressive Pulmonary & Sleep Medicine

location_facility: Incorporated Medical Corporation, Jinyukai, Jinyu Clinic

location_facility: Allergy & Asthma Medical Group and Research, A PC

location_facility: University of Michigan Allergy Specialty Clinic and Food Allergy Clinic

location_facility: Ospedale Luigi Sacco, PU, ASST Fatebenefratelli Sacco

location_facility: Tokyo Women's Medical University Hospital

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Instituto Pulmonary Diseases Torre Medica San Lucas

location_facility: Allergy & Asthma Diagnostic Treatment Center

location_facility: Istituto Clinico Himanitas, Humanitas Mirasole S.p.a.

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Seattle Allergy & Asthma Research Institute

location_facility: Clinical Research Center of Alabama, LLC

location_facility: Columbo Asthma, Allergy and Immunology, LLC

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: Complexo Hospialario Universitario A Coruña

location_facility: Northwell Health Division of Allergy & Immunology

location_facility: Ospedale dei Bambini Vittore Buzzi ASST Fatebenefratelli Sacco

location_facility: Royal Devon University Healthcare NHS Foundation Trust

location_facility: Sygehus Lillebaelt - Vejle Sygehus - Lungemedicinsk afdeling

location_facility: Javara Inc. and Tryon Medical Partners, PLLC

location_facility: Ocean Allergy & Respiratory Research Center

location_facility: Northwestern Medical Group Allergy & Immunology Clinic

location_facility: Allergy Partners of Western North Carolina

location_facility: Asthma, Nasal Disease & Allergy Research Center of New England

location_facility: Medical Research of Arizona, a Division of Allergy, Asthma & Immunology Associates, Ltd.

location_facility: Istituto Nazionale di Riposo e Cura per Anziani

location_facility: Oklahoma Institute of Allergy and Asthma Clinical Research, LLC

location_facility: University of Puerto Rico Medical Sciences Campus

location_facility: Northwell Health Physician Partners Pulmonary Medicine and Cardiology at Manhasset

location_facility: Nebraska Medical Research Institute, Inc.

location_facility: Incorporated Medical Corporation, Shishin Iryokai, Respiratory Care Clinic Tokyo

location_facility: University of Mississippi Medical Center

location_facility: Allergy, Asthma and Clinical Research Center

location_facility: National Allergy and Asthma Research, LLC

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Dr. Syeed Anees Medicine Professional Corporation


summary:
This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who have an indication for treatment with azacitidine in first-line setting and are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator.

The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with IPSS-R intermediate, high, very high risk MDS and CMML-2.

location_facility: University of Virginia University of Virginia

location_facility: University of Rochester Medical Center Dept.ofUniv.Rochester/JPWilmot

location_facility: Yale University School Of Medicine Smilow Cancer Hospital

location_facility: Northwestern University Div of Hematology/Oncology

title: A Randomized, Double-blind, Placebo-controlled Phase III Multi-center Study of Azacitidine With or Without MBG453 for the Treatment of Patients With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

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 expert 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.

location_country:
Finland
Germany
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Chile
Czechia
Canada
France
Lithuania
Colombia
Portugal
Switzerland
United States
India
Lebanon
Belgium
China
Malaysia
Oman
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
Taiwan
Russian Federation
Israel


title: Micra AV Transcatheter Pacing System Post-Approval Registry

acronym: Micra AV PAS

summary:
Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release.

The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

lead_sponsor: Medtronic

location_country:
Germany
Czechia
Canada
Serbia
France
Slovenia
Portugal
Denmark
Switzerland
United States
Belgium
Malaysia
Italy
Norway
United Kingdom
Netherlands
Saudi Arabia
Spain
Greece
Israel

location_facility: TidalHealth Peninsula Regional Medical Center

location_facility: University of Kansas Medical Center Research Institute

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand-Gabriel-Montpied

location_facility: The Ohio State University Wexner Medical Center

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Atlantic Health/Morristown Medical Center

location_facility: Universitätsklinikum Jena - Friedrich Schiller Universität

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Manchester University NHS Foundation Trust- Manchester Royal Infirmary

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: Azienda Ospedaliera Sepdali Civili di Brescia

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz

location_facility: New York-Presbyterian Hospital/Columbia University Medical Center

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: King Salman Heart Center - King Fahad Medical City

location_facility: University of Pittsburgh Medical Center UPMC Shadyside

location_facility: Indiana University Health Methodist Research Institute

location_facility: The James Cook University Hospital - South Tees Hospitals NHS