title: An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

acronym: SOTERIA

summary:
This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin.

The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Portugal
Austria
Australia
Argentina
Israel
Mexico
Sweden
Brazil
Canada
Switzerland
Germany
Denmark
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Hospital Universitario Ramon y Cajal ( Site 1609)

location_facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)

location_facility: Medizinische Universität Graz ( Site 2003)

location_facility: Centro Oncologico de Rosario ( Site 1905)

location_facility: Lady Davis Carmel Medical Center ( Site 1705)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 1315)

location_facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 1001)

location_facility: Hospital Universitario 12 de Octubre ( Site 1603)

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)

location_facility: Norrlands Universitetssjukhus ( Site 3205)

location_facility: Instituto Cardiovascular de Rosario ( Site 1906)

location_facility: UPMC Presbyterian. UPMC Presbyterian Hospital ( Site 1059)

location_facility: Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

location_facility: Waikato District Health Board ( Site 2702)

location_facility: University of Rochester Medical Center - PPDS ( Site 1039)

location_facility: Hospital Universitario de Son Espases ( Site 1611)

location_facility: C.H.U de Grenoble - Hopital Albert Michallon ( Site 1303)

location_facility: Duke University Medical Center ( Site 1026)

location_facility: The Ohio State University Wexner Medical Center ( Site 1032)

location_facility: Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)

location_facility: Evangelismos General Hospital of Athens ( Site 3605)

location_facility: Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317)

location_facility: Universita "La Sapienza" Policlinico Umberto I ( Site 2402)

location_facility: CHU de la Miletrie Poitiers ( Site 1316)

location_facility: Universitatsklinikum Leipzig ( Site 1508)

location_facility: University of Cincinnati Medical Center ( Site 1035)

location_facility: Hospital São Lucas da PUCRS ( Site 1801)

location_facility: Klinicki Bolnicki Centar Zagreb ( Site 3902)

location_facility: Mayo Clinic Jacksonville - PPDS ( Site 1045)

location_facility: Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)

location_facility: C.H.U. de Tours - Hopital Bretonneau ( Site 1310)

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)

location_facility: Royal Free London NHS Foundation Trust ( Site 1202)

location_facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 1501)

location_facility: Gachon University Gil Medical Center ( Site 3103)

location_facility: New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 1046)

location_facility: Medical University of South Carolina - PPDS ( Site 1003)

location_facility: University of Nebraska Medical Center ( Site 1053)

location_facility: Royal Prince Alfred Hospital ( Site 1106)

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 2802)

location_facility: Hopital Civil - CHU Strasbourg ( Site 1307)

location_facility: Radboud University Nijmegen Medical Centre ( Site 2605)

location_facility: Institut klinicke a experimentalni mediciny (IKEM) ( Site 2202)

location_facility: Seoul National University Hospital ( Site 3102)

location_facility: Hospital Universitario La Paz ( Site 1610)

location_facility: Maastricht University Medical Center ( Site 2603)

location_facility: Renown Regional Medical Center ( Site 1055)

location_facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 3104)

location_facility: Hospital Universitario Austral ( Site 1901)

location_facility: Vseobecna fakultni nemocnice v Praze-Centrum srdečního selhání ( Site 2201)

location_facility: Unidad de Investigación Clínica en Medicina, S.C ( Site 2505)

location_facility: Golden Jubilee National Hospital ( Site 1204)

location_facility: University of Colorado Hospital ( Site 1013)

location_facility: University of California San Diego ( Site 1002)

location_facility: Barnes-Jewish Hospital Center for Outpatient Health ( Site 1022)

location_facility: Institute for pulmonary diseases of Vojvodina ( Site 2906)

location_facility: Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301)

location_facility: Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)

location_facility: Chonnam National University Hospital ( Site 3105)

location_facility: C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)

location_facility: Medizinische Hochschule Hannover ( Site 1505)

location_facility: Centro Hospitalar E Universitário De Coimbra ( Site 3502)

location_facility: University of California San Francisco ( Site 1019)

location_facility: University of Washington Medical Center ( Site 1067)

location_facility: Universataet des Saarlandes ( Site 1513)

location_facility: Centro Hospitalar de Lisboa Norte Hospital de Santa Maria ( Site 3503)

location_facility: University Clinical Center Nis ( Site 2904)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1601)

location_facility: University of Alberta Hospital ( Site 2101)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)

location_facility: Institute of Cardiovascular Diseases Dedinje ( Site 2903)

location_facility: Hospital Clinic de Barcelona ( Site 1602)

location_facility: AHEPA University General Hospital of Thessaloniki ( Site 3601)

location_facility: The George Washington University Medical Faculty Associates ( Site 1025)

location_facility: Hospital Dr. Jose Maria Cullen ( Site 1902)

location_facility: Tufts Medical Center - PPDS ( Site 1012)

location_facility: Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

location_facility: Skanes Universitetssjukhus Lund ( Site 3203)

location_facility: Norton Pulmonary Specialists ( Site 1066)

location_facility: Thoraxklinik-Heidelberg gGmbH ( Site 1509)

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805)

location_facility: Imperial College Healthcare NHS Trust ( Site 1203)

location_facility: Ospedale S. Giuseppe Multimedica ( Site 2403)

location_facility: University of Kansas Medical Center ( Site 1020)

location_facility: China Medical University Hospital ( Site 3701)

location_facility: Arizona Pulmonary Specialists ( Site 1010)

location_facility: Klinički Bolnički Centar Split ( Site 3901)

location_facility: Attikon University General Hospital of Athens ( Site 3604)

location_facility: Kaohsiung Veterans General Hospital ( Site 3702)

location_facility: Hospital Provincial del Centenario ( Site 1912)

location_facility: Universitaetsklinik Regensburg ( Site 1503)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 3201)

location_facility: Hospital Universitari Vall d'Hebron ( Site 1605)

location_facility: CHRU Brest - Hopital Cavale Blanche ( Site 1314)

location_facility: DRK Kliniken Berlin Westend ( Site 1507)

location_facility: Instituto do Coracao - HCFMUSP ( Site 1803)

location_facility: Saint Vincents Hospital Sydney ( Site 1102)

location_facility: The Oregon Clinic Pulmonary, Critical Care and Sleep Medicine - West ( Site 1054)

location_facility: University of South Florida ( Site 1043)

location_facility: The Prince Charles Hospital ( Site 1104)

location_facility: Hospital Universitario de Toledo ( Site 1607)

location_facility: Statcare Pulmonary Consultants - Knoxville ( Site 1031)

location_facility: Instituto Medico Rio Cuarto ( Site 1907)


title: Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

summary: The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: AstraZeneca

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Peru
Romania
Philippines
Belgium
Japan
South Africa
Austria
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Sweden
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Korea, Republic of
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


acronym: PADOVA

title: A Phase IIB, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

lead_sponsor: Hoffmann-La Roche

type: EudraCT Number

source: euctr

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:
Poland
Luxembourg
Spain
Italy
Austria
United Kingdom
Canada
United States
France

location_facility: The Cognitive and Research Center of New Jersey

location_facility: Indiana University Health University Hospital

location_facility: Aventura Neurologic Associates; Department of Research

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

location_facility: CenExel Rocky Mountain Clinical Research, LLC

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

location_facility: CHU Rouen Charles Nicolle; Centre Expert Parkinson Hôpitaux de Rouen

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

location_facility: IRCCS Istituto Neurologico Carlo Besta; UOC Neurologia 1

location_facility: Hospital General Universitario de Elche; Servicio de Neurología

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

location_facility: Medizinische Universität Graz; Universitätsklinik für Neurologie

location_facility: University of Florida Center For Movement Disorders And Neurorestoration

location_facility: A.O.U. Policlinico "G.Rodolico - San Marco"; Clinica Neurologica

location_facility: IRCCS San Raffaele Pisana; Clinical Trial Center

location_facility: Hôpital Michallon - Centre d'Investigation Clinique; Unité de Pharmacologie Clinique - Inserm

location_facility: Servicio de Neurología Hospital Viamed Montecanal.

location_facility: Hôpital Henri Mondor; Centre Expert Parkinson

location_facility: Abington Neurological Associates Willow Grove

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

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

location_facility: Hospital Universitario de Burgos. Servicio de Neurología

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

location_facility: Neurology Associates, PA; Research Department

location_facility: Baylor College of Medicine Medical Center

location_facility: Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego; Klinika Neurologii i Epileptologii

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Institute for Neurodegenerative Disorders

location_facility: Hospital Universitario Fundación Alcorcón; Servicio de Neurología

location_facility: Hospital San Pedro; Servicio de Neurología

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: Hospital General Universitario de Ciudad Real; Servicio de Neurologia

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

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: Montreal Neurological Institute and Hospital

location_facility: NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki

location_facility: Ospedale Bellaria; Istituto delle Scienze Neurologiche

location_facility: IRCCS Ospedale San Raffaele; U.O. di Neurologia

location_facility: Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona; Center for Neurodegenerative Disease

location_facility: Ninewells Hospital, Dundee- Scotland; Neurology

location_facility: Azienda Ospedaliera S. Maria; SC Neurologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Neurologia

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Hospital Universitari i Politecnic La Fe; Servicio de Neurología

location_facility: Hospital Virgen del Rocío; Servicio de Neurología

location_facility: Henry Ford Hospital; Henry Ford Medical Center

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.; Klinika Neurologii

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

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

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Azienda Ospedaliera di Padova; Dipartimento di Neuroscienze

location_facility: Policlínica Guipuzkoa; Servicio de Neurología

location_facility: Policlinico Universitario Agostino Gemelli; UOC Neurologia

location_facility: Szpital Sw. Wojciecha; Oddzial Neurologiczny

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Azienda Ospedaliera Spedali Civili; Scienze Neurologiche

location_facility: Klinik Ottakring; Neurologische Abteilung

location_facility: Southern Illinois University, School of Medicine

location_facility: Hospital Universitario de la Princesa; Servicio de Neurologia

summary: This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.


title: A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

summary: This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

ipd_sharing: No

lead_sponsor: Mirati Therapeutics Inc.

location_country:
Poland
Hong Kong
Portugal
Spain
Greece
Austria
Australia
Ireland
Italy
Russian Federation
Switzerland
United Kingdom
Hungary
Korea, Republic of
United States
France
Singapore
Belgium
Germany
Czechia

location_facility:
Research SIte
Research site
Research Site


acronym: ENCORE

title: A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobact

lead_sponsor: Insmed Incorporated

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Portugal
Austria
Australia
Argentina
Israel
Turkey
Canada
Hungary
Germany
Denmark
Taiwan
Greece
New Zealand
Korea, Republic of
France
Chile

summary: The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.


title: A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis

acronym: STARSCAPE

summary: This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).

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:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Greece
New Zealand
Finland
Korea, Republic of
France
Netherlands

location_facility: CHU Tours - Hôpital Bretonneau; Pharmacie

location_facility: Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente

location_facility: Chelyabinsk Regional Clinical Hospital; Hematology

location_facility: Tianjin Medical University General Hospital

location_facility: National and Kapodistrian University of Athens EKPA Medical School

location_facility: Austin Hospital; Cancer Clinical Trials Centre

location_facility: The First Affilicated Hospital, Sun Yat-sen University

location_facility: Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almen

location_facility: Hospital Clinico Universitario de Valencia

location_facility: INER- Instituto Nacional de Enfermedades Respiratorias"Ismae

location_facility: Uppsala Universitet - Akademiska Sjukhuset

location_facility: Centro de Diagnóstico y Tratamiento de Enfermedades Respiratorias, Medica San Isidro

location_facility: Unidad Médica para la Salud Integral UMSI

location_facility: Universitatsklinikum Gießen und Marburg GmbH

location_facility: University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center

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

location_facility: CHU Dijon Bourgogne Hôpital François Mitterand

location_facility: Tel-Aviv Sourasky Medical Center; Department of Pulmonary

location_facility: Dr. Syed Anees Medicine Profession Corporation

location_facility: Borsod-Abauj-Zemplen (BAZ) Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: National Academy of Medical Science of Ukraine (NAMS); NRCRM

location_facility: Investigaciones en Patologias Respiratorias

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility

location_facility: Cairns Base Hospital; Cancer Care Centre

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Hospital is University General Hospital of Larissa

location_facility: Nippon Medical School Musashi Kosugi Hospital

location_facility: Santa Casa de Misericordia de Porto Alegre

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

location_facility: Huadong Hospital Affiliated to Fudan University

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

location_facility: Christiana Care Pulmonary Associates - Newark

location_facility: Royal Brompton Hospital; Respiratory Department

location_facility: Seoul National University Bundang Hospital

location_facility: Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung

location_facility: Hospital Ramón y Cajal;Servicio de Neumología

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche

location_facility: Parc Taulí Sabadell Hospital Universitari

location_facility: Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari

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

location_facility: Oslo University Hospital HF, Rikshospitalet

location_facility: Medical University of South Carolina Hospital

location_facility: McGill University, Montreal Chest Institute; Viral and other Infectious

location_facility: Universitatsklinikum Essen; Innere Klinik

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Jefferson University Physicians (JUP) - Jefferson Pulmonary

location_facility: University of Florida Health Pulmonology - Jacksonville

location_facility: Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)

location_facility: State Budgetary Educational Institution of Higher Professional Education

location_facility: Hospital Virgen de las Nieves; Servicio de Neumologia

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Cardiopulmonary Research Science and Technology Institute

location_facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics

location_facility: Inselspital Bern Universitätsklinik für Pneumologie

location_facility: Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute

location_facility: Hopital Neuchatelois Pourtales (Hopitaux Cadolles Pourtales)

location_facility: Kobe City Medical Center General Hospital

location_facility: Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: University of Louisville Health Sciences Center

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Yanovskyy Inst of Phth. & Pulm; Clinical-functional

location_facility: Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: The Third Xiangya Hospital Of Central South University

location_facility: Fondazione IRCCS Policlinico San Matteo; Divisione di Ematologia Dipartimento di Onco-Ematologia

location_facility: Zentralklinik Bad Berka GmbH; Pneumologie

location_facility: Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia

location_facility: Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Sarasota Memorial Health Care System; Cancer Research Program

location_facility: "Asst Rhodense - Unità operativa di pneumologia Ospedale ""Guido Salvini"" "

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

location_facility: Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken

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

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario

location_facility: Hospital d Instructions des Armees Percy

location_facility: Istanbul Universitesi Onkoloji Enstitüsü Hastanesi

location_facility: University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)

location_facility: The Ohio State University Wexner Medical Center

location_facility: Far Eastern Memorial Hospital; Department of Clinical Pathology

location_facility: Thomayerova nemocnice; Lekarna - pavilon H

location_facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

location_facility: University of Cincinnati Cancer Institute

location_facility: Sint Antonius Ziekenhuis, locatie Nieuwegein

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

location_facility: Banner University Medical Center Phoenix; Main Pharmacy

location_facility: Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

location_facility: Ospedale San Giuseppe; U.O. di Pneumologia

location_facility: Az. Osp. Univ. P. Giaccone; UOC di Pneumologia

location_facility: Evangelismos Hospital; Department of Critical Care and Pulmonary Services

location_facility: The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology

location_facility: Barzilai Medical Center; Neurology Department

location_facility: Akdeniz University Faculty of Medicine Department of Pulmonology

location_facility: Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Servie de Pneumologie et centre de Transplantation Pulmonaire

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii

location_facility: Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio

location_facility: Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche

location_facility: University of Cape Town Lung Institute; Lung Clinical Research

location_facility: IKF Pneumologie Mainz Helix Medical Excellence Center Mainz

location_facility: Carmel Medical Center; Obstetrics and Gynecology

location_facility: AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico

location_facility: Fakultni Nemocnice Plzen - Klinika Pneumologie a Ftizeologie

location_facility: Edinburgh Royal Infirmary; Respiratory Department

location_facility: University of Texas Medical Branch; Cardiology Department

location_facility: Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi

location_facility: Manchester University NHS Foundation Trust - Wythenshawe Hospital

location_facility: University of Kentucky Albert B. Chandler Hospital - Pavilion H

location_facility: Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia

location_facility: Into Research; Life Groenkloof Hospital Medical Centre

location_facility: CHUV Lausanne Médecine Oncologie ; Département d'Oncologie médicale - BH09 - Bureau 7

location_facility: Medizinische Hochschule Hannover; Zentrum Innere Medizin - Klinik fur Pneumologie

location_facility: Moscow State Medical and Dental University n. a. A.I. Evdokimova

location_facility: Soerlandet Sykehus Arendal; Medisinsk Avdeling

location_facility: Advanced Pulmonary & Sleep Research Institute of Florida

location_facility: Fundacion Respirar (Centro Medico Dra. De Salvo)

location_facility: A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale

location_facility: Dokuz Eylul University Faculty of Medicine; Chest Diseases

location_facility: Gaziantep Universitesi - Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: University of Texas Southwestern Medical Center; Heart and Lung Clinic

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone

location_facility: Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Henan University of Traditional Chinese Medicine (HUTCM) The First Affiliated Hospital

location_facility: University Of Utah Hosp & Clin; Investigational Pharmacy

location_facility: Xiangya Hospital Central South University

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Vancouver General Hospital; Gordon and Leslie Diamond Health Care

location_facility: University General Hospital of Heraklion

location_facility: Peking Union Medical College Hospital; Pharmacy

location_facility: Hospital Universitario Central de Asturias

location_facility: Centro de Alergia y Enfermedades Respiratorias

location_facility: Buddhist Tzu Chi Dalin General Hospital; Rheumatology

location_facility: European Hospital Georges Pompidou (HEGP)

location_facility: CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique

location_facility: Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche

location_facility: Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche

location_facility: Bnai Zion Medical Center; Internal Medicine

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Helse Bergen HF Haukeland universitetssykehus

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: University of Iowa Hospitals and Clinics; Investigational Drug Services

location_facility: Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration

location_facility: University Hospital of Ioannina; Pulmonology Department

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette

location_facility: Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

location_facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali; Onkologi

location_facility: Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum

location_facility: Hospital de Sao Joao; Centro de Investigacao

location_facility: Universidad de Navarra - Clinica Universitaria de Navarra (CUN)

location_facility: Azienda Sanitaria Universitaria Integrata di Trieste

location_facility: CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: The University of Hong Kong; Queen Mary Hospital

location_facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science

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

location_facility: Marmara Universitesi Hastanesi Marmara University Hospital

location_facility: Seoul National University Hospital (SNUH) - Medical Oncology Center

location_facility: Ospedale Morgagni Pierantoni; Patologia clinica

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: Southern Medical University Nanfang Hospital

location_facility: Centro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta (HSM)

location_facility: CMU-Beijing Chao-Yang Hospital-Beijing Institute of Respiratory Medicine

location_facility: Centro Medico de Enfermedades Respiratorias (CEMER)

location_facility: SBHI of Stavropol region "City Hospital #2" of Pyatigorsk

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedale Università Di Padova; Clinica Pneumologica

location_facility: Shengjing Hospital of China Medical University

location_facility: "General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic "

location_facility: Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie

location_facility: China Medical University (CMU) First Affiliated Hospital

location_facility: University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine

location_facility: Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin III

location_facility: Hospital Senhora da Oliveira - Guimarães, E.P.E

location_facility: National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research

location_facility: Shaare Zedek Medical Center; Nrphrology Dept.

location_facility: Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie

location_facility: Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik

location_facility: Hebei Medical University - The Second Hospital

location_facility: The Second Xiangya Hospital of Central South University

location_facility: National Hospital Organization Himeji Medical Center


title: A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)

summary: This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.

ReferenceType: derived

ReferenceCitation: Rao S, Jones M, Bowman J, Tian C, Spano JP. POD1UM-303/InterAACT 2: A phase III, global, randomized, double-blind study of retifanlimab or placebo plus carboplatin-paclitaxel in patients with locally advanced or metastatic squamous cell anal carcinoma. Front Oncol. 2022 Aug 24;12:935383. doi: 10.3389/fonc.2022.935383. eCollection 2022.

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:
Denmark
Spain
Italy
United Kingdom
Australia
Sweden
Puerto Rico
United States
France
Norway
Belgium
Japan
Germany

location_facility: Royal Cornwall Hospital Truro Sunrise Centre

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: University Di Cagliari-Presidio Policlinico Monserrato

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: I.R.C.C.S. Casa Sollievo Della Sofferenza

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

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

location_facility: Centre Hospitalier Universitaire de Bordeaux

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

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Saitama Medical University International Medical Center

location_facility: Panoncology Trials Pan American Center For Oncology Trials, Llc

location_facility: Baylor Scott and White Research Institute

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: Stockholm South General Hospital Sodersjukhuset

location_facility: Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Institut de Cancerologie de L Ouest - Site Paul Papin

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: Texas Oncology - Wichita Falls Texoma Cancer Center

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori


title: A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer

summary: This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.

ReferenceCitation: Agarwal N, Azad A, Carles J, Chowdhury S, McGregor B, Merseburger AS, Oudard S, Saad F, Soares A, Benzaghou F, Kerloeguen Y, Kimura A, Mohamed N, Panneerselvam A, Wang F, Pal S. A phase III, randomized, open-label study (CONTACT-02) of cabozantinib plus atezolizumab versus second novel hormone therapy in patients with metastatic castration-resistant prostate cancer. Future Oncol. 2022 Mar;18(10):1185-1198. doi: 10.2217/fon-2021-1096. Epub 2022 Jan 17.

lead_sponsor: Exelixis

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Singapore
Brazil
Canada
Hungary
Germany
Taiwan
Greece
Georgia
Korea, Republic of
France
Chile

location_facility: Odensklinikum Linz GmbH Elisabethinen #156


title: A DB, Placebo-Controlled, Two-Arm Parallel-Group, Phase 3 RCT to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients With SA-AKI

summary:
Clinical phase 3 study to investigate the effect of recAP on 28 day mortality in patients admitted to the ICU with acute kidney injury that is caused by sepsis.

The study has three distinct SA-AKI trial populations:

The main trial population: Patients with a pre-AKI reference eGFR ≥45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization.
A 'moderate' CKD population: Patients with a pre-AKI reference eGFR ≥25 and <45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization.
A Corona Virus Disease 2019 (COVID-19) population: Patients with proven or suspected SARS-CoV-2 at time of randomization with or without 'moderate' CKD. For patients in this population, COVID-19 should be the main cause of SA-AKI.

In the main study population approximately 1400 patients will be enrolled and in the two cohorts with moderate CKD and COVID-19 each up to 100 patients.

There are two arms in the study, one with active treatment and one with an inactive compound (placebo). Treatment is by 1 hour intravenous infusion, for three days. Patients are followed up for 28 days to see if there is an improvement on mortality, and followed for 90 and 180 days for mortality and other outcomes e.g. long-term kidney function and quality of life.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: AM-Pharma

location_country:
Denmark
Spain
Ireland
Austria
Australia
Netherlands
Canada
Finland
New Zealand
United Kingdom
United States
France
Belgium
Japan
Germany

location_facility: Sunshine Hospital ICU - Western Hospital

location_facility: Medizinische Universitaet Graz - Klinik fuer Innere Medizin

location_facility: Universitat de Barcelona - Hospital Universitari Mutua Terrassa (HUMT)

location_facility: Centre Hospitalier de Bethune Germon et Gauthier

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

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: Lakes District Health Board - Rotorua Hospital

location_facility: CHU de Nimes - Hopital Universitaire Caremeau

location_facility: University of New Mexico School of Medicine

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

location_facility: Helsinki University Central Hospital (HUCH)

location_facility: Hospital Universitari de Bellvitge (IDIBELL)

location_facility: Centre Hospitalier Départemental de Vendée - Les Oudairies

location_facility: University Hospital Jena - Klinik fur Neurologie

location_facility: Alberta Health Services - South Health Campus Hospital

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin I

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: The Ohio State University - Dorothy M. Davis Heart and Lung Research Institute

location_facility: The George Washington University Medical Faculty Associates - Anesthesiology

location_facility: Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Gastroenterologie und Rheumatologie

location_facility: Centre Hospitalier Universitaire (CHU) de Charleroi - Hopital Civil Marie Curie

location_facility: National Hospital Organization - Yokohama Medical Center

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Emory Clinical Cardiovascular Research Institute

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: UPMC CancerCenter at Magee - Womens Hospital

location_facility: Froedtert & the Medical College of Wisconsin Froedtert Hospital

location_facility: University of Cincinnati Cancer Institute

location_facility: Sjaellands Universitetshospital, Koge - Kardiologisk Afdeling

location_facility: Parc Taulí Sabadell Hospital Universitari

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: University of Kentucky College of Medicine (UKCM)

intervention_type: Biological

status_simplified: Unknown


title: A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

summary: The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.

ReferenceCitation: Eggermont AM, Ascierto PA, Khushalani NI, Schadendorf D, Boland G, Weber J, Lewis KD, Johnson D, Rivalland G, Khattak A, Majem M, Gogas H, Long GV, Currie SL, Chien D, Tagliaferri MA, Carlino MS, Diab A. PIVOT-12: a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence. Future Oncol. 2022 Mar;18(8):903-913. doi: 10.2217/fon-2021-1286. Epub 2022 Jan 25.

ipd_sharing: Undecided

lead_sponsor: Nektar Therapeutics

location_country:
Poland
Portugal
Spain
Greece
Austria
Australia
Italy
Netherlands
New Zealand
Russian Federation
United Kingdom
United States
France
Israel
Romania
Germany
Czechia

location_facility: University of North Carolina at Chapel Hill

location_facility: Washington University School of Medicine

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

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

location_facility: Southern California Permanente Medical Group

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Frontier Cancer Center and Blood Institute

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska

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

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Providence Cancer Institute, Franz Clinic

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

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

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Rocky Mountain Cancer Centers (Littleton) - USOR

location_facility: Columbia University Medical Center - PIN

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Hematology Oncology Medical Group of Orange County, Inc.

location_facility: Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Metropolitan Hospital - First Oncology Clinic

location_facility: Metropolitan Hospital - Fourth Oncology Clinic

location_facility: Department of Pharmacy Investigational Drug Services

location_facility: Kaiser Foundation Hospital, Inpatient Pharmacy

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: University Hospitals Cleveland Medical Center

location_facility: ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Utah Cancer Specialists (Salt Lake City)

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Theageneio Anticancer Oncology Hospital of Thessaloniki

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud

location_facility: University of Colorado - Cancer Center - PPDS

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: California Cancer Associates for Research and Excellence

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: University of Texas Southwestern Medical Center

location_facility: Lehigh Valley Physician Group (LVPG) - Hematology Oncology

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico


title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation

lead_sponsor: Novartis Pharmaceuticals

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:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Peru
Romania
South Africa
Poland
Hong Kong
Slovenia
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Malaysia
Slovakia
Brazil
Lebanon
Switzerland
Hungary
China
Germany
Bulgaria
Taiwan
Jordan
Korea, Republic of
France
Colombia

location_facility: Texas Oncology PA Dallas Presbyterian Hospital SC

location_facility: Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga

location_facility: Comprehensive Blood and Cancer Center Dept. of CBCC (2)

location_facility: Florida Cancer Specialists FL Cancer Specialists

location_facility: University of Pittsburgh Cancer Institute Cancer Pavilion, 5th floor

location_facility: UCLA Medical Center Santa Monica Location

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada (1)

location_facility: Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio

location_facility: Cleveland Clinic Foundation Taussig Cancer Center

location_facility: Florida Cancer Specialists Dept of Oncology (2)

location_facility: Research Medical Center HCA Midwest Division

location_facility: Tennessee Oncology Tennessee Oncology (3)

location_facility: Northwest Medical Specialties Northwest Medical - Puyallup

location_facility: University of Illinois Cancer Center at Chicago

location_facility: Sinai Hospital of Baltimore Dept of Sinai Hospital - 2

location_facility: Cancer Care Associates Medical Group Center

location_facility: University of Kansas Hospital and Medical Center DeptofUofKansas CancerCenter-2

location_facility: Fort Wayne Medical Oncology/Hematology, Inc. Jefferson Blvd

summary: The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)


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

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

status: Active, not recruiting

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

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

location_facility: Northeastern Pennsylvania Memory and Alzheimer's Center

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

location_facility: NZOZ Wroclawskie Centrum Alzheimerowskie

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

location_facility: National Clinical Research Inc.-Richmond

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

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

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

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

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

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Medical University of South Carolina (MUSC)

location_facility: The National Hospital for Neurology and Neurosurgery Centre

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Emory University Cognitive Neurology Clinic & ADRC

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

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

location_facility: Alexian Brothers Medical Center - Neuroscience Research Institute

location_facility: Institut fuer Schlaganfall- und Demenzforschung (ISD)

location_facility: University of California San Diego Medical Center

location_facility: Australian Alzheimer's Research Foundation

location_facility: Queen Elizabeth University Hospital Campus

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

location_facility: Montreal Neurological Institute Clinical Research Unit

location_facility: Klinikum rechts der Isar der TU Muenchen

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

location_facility: Christian-Doppler-Klinik - Universitätsklinikum Salzburg

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Lehigh Center for Clinical Research, LLC

location_facility: Azienda Ospedaliera e Universitaria di Perugia

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

location_facility: Centre Hospitalier Universitaire Vaudois

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

location_facility: Advanced Memory Research Inst. of NJ, PC

location_facility: University of Calgary - Heritage Medical Research Clinic

location_facility: Studienzentrum fur Neurologie und Psychiatrie

location_facility: Jacksonville Center for Clinical Research

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: California Neuroscience Research Medical Group Inc.

location_facility: University of Utah Health Sciences Center

location_facility: Charite Universitaetsmedizin Berlin - Campus Berlin Buch

location_facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit

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

location_facility: Gastroenterology Associates of the Piedmont

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

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

location_facility: Brigham and Women's Hospital Department of Neurology

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Seoul National University Bundang Hospital

location_facility: CHU de Lyon - Hopital Neurologique Pierre Wertheimer

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

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: SPZOZ Centralny Szpital Kliniczny UM w Lodzi

location_facility: Central Coast Neurosciences Research (Erina)

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: New York University Medical Center PRIME

location_facility: Georgetown University Clinical Research Unit (CRU)

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

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Ohio State University Wexner Medical Center

location_facility: Medical Research Health and Education Foundation, Inc

location_facility: True North Clinical Research - Halifax Inc.


acronym: MIRASOL

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

lead_sponsor: ImmunoGen, Inc.

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

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Arizona Oncology Associates, PC - HAL - USOR

location_facility: USOR: Willamette Valley Cancer Institute and Research Center

location_facility: National Cancer Center - Center for Uterine Cancer

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

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

location_facility: Ulm University Hospital Klinik für Frauenheilkunde und Geburtshilfe

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

location_facility: Centre Hospitalier de L'Universite de Montreal

location_facility: Wojewódzki Szpital Specjalistyczny, Oddzial Kliniczny Ginekologii Onkologiczne

location_facility: Grigoriev Institute for Medical Radiology NAMS of Ukraine

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

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

location_facility: Szpital Kliniczny im. Ks. Anny Mazowieckiej

location_facility: Florida Cancer Specialist South Division

location_facility: Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek

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

location_facility: Oncology Institute Vojvodina, Surgical Oncology Clinic

location_facility: The First Affiliated Hospital of Soochow University

location_facility: USOR: Texas Oncology - McAllen South Second

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

location_facility: Centre Hospitalier Universitaire de Sherbrooke

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

location_facility: Mammazentrum Hamburg am Krankenhaus Jerusalem

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

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

location_facility: WK Physicians Network/Gynecologic Oncology Associates

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

location_facility: Oncologia Azienda Osc-IRCCS Reggio Emilia

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

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

location_facility: USOR: Texas Oncology - Fort Worth Cancer Center

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Kaiser Permanente Oncology Clinical Trials

location_facility: USOR: Arizona Oncology Associates, PC - HOPE

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

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

location_facility: Oklahoma Cancer Specialists and Research Institute

location_facility: Mackay Memorial Hospital - Taipei Branch

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

location_facility: Princess Margaret Cancer Centre - University Health Network

location_facility: Women & Infants Hospital of Rhode Island

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

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: FirstHealth of the Carolinas Outpatient Cancer Center

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

location_facility: Städtisches Klinikum Dessau, Zentrum für Klinische Studien

location_facility: The Ohio State University Wexner Medical Center

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

location_facility: University Hospitals Coventry and Warwickshire

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

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

location_facility: Samodzielny publiczny szpital kliniczny nr 1

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

location_facility: BIH of Omsk Region "Clinical Oncology Dispensary"

location_facility: Florida Cancer Specialist North Division

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

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

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Tennessee Oncology / Sarah Cannon Research Institute

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


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

lead_sponsor: Bristol-Myers Squibb

type: Other Identifier

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

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

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

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


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

lead_sponsor: Janssen Research & Development, LLC

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

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

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

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

location_facility: CIMET's Inamdar Multispeciality Hospital

location_facility: Praxisklinik Urologie Rhein/Ruhr - Germany

location_facility: Chonnam National University Hwasun Hospital

location_facility: Emory University - Winship Cancer Institute

location_facility: Universirty of Sheffield Teaching Hospitals NHS Trust

location_facility: Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Rajiv Gandhi Cancer Institute & Research Centre

location_facility: Ochsner LSU Health Shreveport - Regional Urology

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine

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

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Ente Ecclesiastico Ospedale Generale Regionale F. Miulli

location_facility: Meenakshi Mission Hospital and Research Center

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP de Ribeirao Preto

location_facility: Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

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

location_facility: The Christie NHS Foundation Trust - Christie Hospital

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Kyungpook National University Chilgok Hospital

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

location_facility: Medical College of Wisconsin-Froedtert Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: CUROS - Uberörtliche urologische Gemeinschaftspraxis

location_facility: UOC Oncologia Ospedale Provinciale di Macerata

location_facility: Instituto de Medicina Integral Professor Fernando Figueira

location_facility: Saitama Medical University International Medical Center

location_facility: Kliniczny Szpital Wojewodzki nr 1 w Rzeszowie

location_facility: Tokyo Medical and Dental University Hospital

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

location_facility: The Ohio State University- James Cancer Hospital

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

location_facility: South Tees Hospital NHS Foundation Trust-The James Cook University Hospital

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital Central

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

location_facility: Universitätsklinikum Schleswig Holstein Campus Lübeck

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

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

location_facility: Strong Memorial Hospital University of Rochester

location_facility: University of Pittsburgh Medical Center - Cancer Centers

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

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

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


acronym: CheckMate 8HW

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

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

location_facility: Pan American Center for Oncology Trials, LLC

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

location_facility: Oncology & Hematology Associates Of Southwest Virginia, Inc.

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


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

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

lead_sponsor: Galderma R&D

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

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


title: Careful Ventilation in Acute Respiratory Distress Syndrome

acronym: CAVIARDS

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

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

lead_sponsor: Unity Health Toronto

location_country:
Spain
Italy
Argentina
Canada
United States
Chile
France

location_facility: Centre hospitalier universitaire d'Angers

location_facility: Hopital de la Cavale Blanche - CHRU Brest

location_facility: New York University Grossman School of Medicine

location_facility: Policlinico Universitario Agostino Gemelli IRCCS

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

location_facility: Complejo Médico Policía Federal Argentina Churruca Visca

location_facility: Pontificia Universidad Católica de Chile

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

intervention_type: Other


type: Registry Identifier

title: A Phase I, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed OR Refractory Non-Hodgkin Lymphomas (R/R NHL).

summary: The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.

design_allocation: Non-Randomized

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:
Denmark
Spain
Italy
Austria
United Kingdom
Argentina
Canada
United States
Chile
France
Israel
Belgium

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: ASST Grande Ospedale Metropolitano Niguarda, Milano

location_facility: Perlmutter Cancer Center at NYU Langone Hospital-Long Island

location_facility: Hospital Universitario Virgen De La Victoria

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

location_facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Oncology Institute of Hope and Innovation

location_facility: Cross Cancer Institute University of Alberta

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"


intervention_type: Procedure

acronym: A Phase 3 trial of perioperative pembrolizumab for cisplatin-ineligible patients with MIBC

title: A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)

lead_sponsor: Merck Sharp & Dohme LLC

ReferenceCitation: Galsky MD, Hoimes CJ, Necchi A, Shore N, Witjes JA, Steinberg G, Bedke J, Nishiyama H, Fang X, Kataria R, Sbar E, Jia X, Siefker-Radtke A. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncol. 2021 Aug;17(24):3137-3150. doi: 10.2217/fon-2021-0273. Epub 2021 May 19.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Philippines
South Africa
Poland
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location_facility: AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 0562)

location_facility: Instituto Nacional de Cancerologia. ( Site 0256)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1012)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0841)

location_facility: Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)

location_facility: Hopital Europeen Georges Pompidou ( Site 0476)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 0959)

location_facility: Hospital San Pedro de Alcantara ( Site 0697)

location_facility: UCL Saint-Luc - Oncologie Medicale ( Site 0357)

location_facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0253)

location_facility: Yitzhak Shamir Medical Center ( Site 0848)

location_facility: Clinic of Bashkortostan State Medical University ( Site 0873)

location_facility: Inova Schar Cancer Institute ( Site 0007)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0116)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)

location_facility: Imperial College Healthcare NHS Trust ( Site 0745)

location_facility: UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 1452)

location_facility: University of Colorado Hospital ( Site 0098)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0532)

location_facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490)

location_facility: Greater Baltimore Medical Center ( Site 0014)

location_facility: Kent and Canterbury Hospital ( Site 0733)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0845)

location_facility: Leningrad Regional Oncology Center ( Site 0868)

location_facility: Clinical Hospital Saint Luka ( Site 0867)

location_facility: Rigshospitalet University Hospital ( Site 0411)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0865)

location_facility: Lviv State Regional Oncological Center ( Site 0967)

location_facility: Lviv Regional Clinical Hospital ( Site 0955)

location_facility: Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)

location_facility: University Malaya Medical Centre ( Site 1702)

location_facility: Medical Sanitary Unit Neftyannik ( Site 0888)

location_facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)

location_facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004)

location_facility: Bialostockie Centrum Onkologii ( Site 1072)

location_facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548)

location_facility: Herlev og Gentofte Hospital. ( Site 0412)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0486)

location_facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)

location_facility: Urology Associates [Nashville, TN] ( Site 0053)

location_facility: Shaare Zedek Medical Center ( Site 0842)

location_facility: Centro de Tratamiento de Cancer ( Site 0266)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1212)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0691)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921)

location_facility: Hospital Universitario de Girona Doctor Josep Trueta ( Site 0700)

location_facility: Kursk Regional Clinical Oncology Dispensary ( Site 0854)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 0561)

location_facility: Carolina Urologic Research Center ( Site 0062)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0860)

location_facility: Central Clinical Hospital with outpatient Clinic ( Site 0856)

location_facility: National University Hospital ( Site 1802)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0254)

location_facility: Steve Biko Academic Hospital ( Site 1601)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)

location_facility: Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0973)

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 1582)

location_facility: Walsall Manor Hospital-Oncology ( Site 0743)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0962)

location_facility: Hospital Clinic i Provincial ( Site 0674)

location_facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929)

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)

location_facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 0878)

location_facility: Maharaj Nakorn Chiangmai Hospital ( Site 1453)

location_facility: Bon Secours St. Francis Health System ( Site 1572)

location_facility: Odense Universitetshospital ( Site 0413)

location_facility: Texas Oncology-Baylor Sammons Cancer Center ( Site 1552)

location_facility: Abramson Cancer Center of the University of Pennsylvania ( Site 0074)

location_facility: Georgetown University Medical Center ( Site 0022)

location_facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0492)

location_facility: John H. Stroger Jr. Hospital of Cook County ( Site 1551)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0884)

location_facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)

location_facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)

location_facility: Seoul National University Hospital ( Site 1352)

location_facility: Providence Portland Medical Center [Portland, OR] ( Site 0095)

location_facility: Policlinico Gemelli di Roma ( Site 0558)

location_facility: Tallaght University Hospital ( Site 0734)

location_facility: Europejskie Centrum Zdrowia Otwock ( Site 1058)

location_facility: Hospital Universitario Quiron Madrid ( Site 0694)

location_facility: Clatterbridge Oncology Centre ( Site 0731)

location_facility: Centre Georges Francois Leclerc ( Site 0488)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0535)

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)

location_facility: Hospital Universitario la Paz ( Site 0690)

location_facility: Sunnybrook Research Institute ( Site 0110)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0112)

location_facility: Thomas Jefferson University ( Site 1579)

location_facility: Regional Oncology Center of Kharkiv ( Site 0958)

location_facility: Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)

location_facility: John Wayne Cancer Institute ( Site 0075)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0926)

location_facility: The James Cook University Hospital ( Site 0730)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0031)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)

location_facility: New England Cancer Specialists ( Site 0070)

location_facility: Vanderbilt University Medical Center ( Site 0017)

location_facility: Fondazione Salvatore Maugeri IRCCS ( Site 0554)

location_facility: Bayandin Murmansk Regional Clinical Hospital ( Site 0859)

location_facility: Instituto Valenciano de Oncologia - IVO ( Site 0679)

location_facility: Seoul National University Bundang Hospital ( Site 1356)

location_facility: Korea University Anam Hospital ( Site 1351)

location_facility: Aarhus University Hospital Skejby ( Site 0418)

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)

location_facility: Sakarya Universitesi Tip Fakultesi ( Site 0933)

location_facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 1051)

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924)

location_facility: Zhytomyr Regional Oncology Center ( Site 0971)

location_facility: University Hospital Waterford ( Site 0747)

location_facility: CHU UCL Namur Site de Godinne ( Site 0354)

location_facility: Western Sydney Local Health District ( Site 1259)

location_facility: M Health Fairview Ridges Hospital ( Site 1555)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 0874)

location_facility: Charleston Area Medical Center ( Site 0023)

location_facility: First St. Petersburg State Medical University n.a. acad. I.P. Pavlov ( Site 0872)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0456)

location_facility: St. Joseph Heritage Healthcare ( Site 0046)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 0852)

location_facility: Princess Margaret Cancer Centre ( Site 0107)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061)

location_facility: Hospital de Nuestra Senora de Valme ( Site 0693)

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)

location_facility: New York University Perlmutter Cancer Center ( Site 0008)

location_facility: Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)

location_facility: The Royal Marsden Foundation Trust ( Site 0726)

location_facility: A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)

location_facility: Kyungpook National University Chilgok Hospital-Urology ( Site 1357)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0931)

location_facility: Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675)

location_facility: Hospital Universitario San Carlos ( Site 0678)

location_facility: Northwell Health- Monter Cancer Center ( Site 0083)

location_facility: Kyiv City Clinical Oncology Center ( Site 0960)

summary:
This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).

The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone.

With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed.

With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.