acronym:
DELTA FORCE

 DELTA FORCE

lead_sponsor: LEO Pharma

summary:
This is a 24-week study in adult participants with severe chronic hand eczema (CHE) and with a documented inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable. Eligible participants will be randomised to receive topical administration of delgocitinib cream 20 mg/g, twice-daily, or oral administration of alitretinoin capsules 30 mg (with an option to reduce to 10 mg during trial conduct), once-daily. The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life.

The purpose of this trial is to compare the efficacy, health-related quality of life, and safety of delgocitinib cream and alitretinoin capsules.

location_facility:
LEO Pharma investigational site
LEO Pharma Investigational Site

status: Completed

title: A 24 Week, Randomised, Assessor Blinded, Active-controlled, Parallel Group, Phase 3, 2 Arm Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

study_completion_date_type: Actual

location_country:
Germany
Italy
Poland
Slovakia
Norway
United Kingdom
Austria
Spain
Canada
France

status_simplified: Completed


type: EudraCT Number

title: A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

summary: The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.

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: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

lead_sponsor: European Myeloma Network

sponsor_collaborators:
European Myeloma Network
Janssen Research & Development, LLC

location_country:
Germany
Italy
Israel
Norway
United Kingdom
Australia
Japan
Netherlands
Sweden
Belgium
Switzerland
United States
Korea, Republic of
Spain
Greece
Czechia
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: CHU Poitiers - Pôle régional de Cancérologie

location_facility: Oslo University Hospital Ullevål - Oncology

location_facility: Univ. of Pittsburgh Medical Center (UPMC)

location_facility: Attikon University General Hospital of Attica

location_facility: A.O.U. Policlinico S. Martino - Ematologia

location_facility: Hokkaido University Hospital-Department of Hematology

location_facility: Okayama University Hospital - Hematology/Oncology

location_facility: University of Texas Southwestern Medical Center

location_facility: Japanese Red Cross Medical Center - Hematology

location_facility: University of California San Francisco (UCSF)

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Nagoya City University Hospital - Department of Hematology & Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Universitätsklinikum Hamburg - Eppendorf

location_facility: (CHU) Centre Hospitalier Universitaire de Quebec Laval

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette, Turin

location_facility: Kyushu University Hospital - Hematology/Oncology

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Chonnam National University Hwasun Hospital

location_facility: Landstinget i Ostergotland-Universitetssjukhuset i Linkoping

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: 'G. Papanikolaou' Hospital of Thessaloniki

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

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) Abt. Medizinische Onkologie

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Di Ancona

location_facility: Hopital Saint Louis - Aphp Hôpitaux Universitaires Saint-Louis

location_facility: Universitaetsspital Basel - Zentrum fur Hamato-Onkologie

location_facility: University of Wisconsin Hospital and Clinics

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: A Randomized, Double-blind, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of Intra-articular Injections of RTX-GRT7039 in Adult Subjects With Pain Associated With Osteoarthritis of the Knee

summary: A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated injections of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.

ipd_sharing_description: Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.

lead_sponsor: Grünenthal GmbH

location_country: Germany Italy Poland Japan Netherlands Mexico Czechia Canada France

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Hopitaux de Paris (AP-HP) - Groupe Hospitalier Cochin -Assistance Publique

location_facility: Universita degli Studi della Campania Luigi Vanvitelli - Azienda Ospedaliera Universitaria

location_facility: Reumed Spolka z o.o. Zespol poradni Specjalistycznych Filia Nr 1 Wallenroda

location_facility: Synexus Polska Spolka z ograniczona odpowiedzialnoscia Oddzial we Wroclawiu

location_facility: Dr. Miguel Cortes Hernandez MD, Office of

location_facility: GRMO (Groupe de Recherche en Rhumatologie et Maladies Osseuses) Inc.

location_facility: Seiwa-kai medical corporation Hiroshima clinic

location_facility: CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.

location_facility: Medisch Spectrum Twente (MST) - Enschede Haaksbergerstraat

location_facility: Centro Integral en Reumatologia, SA de CV

location_facility: Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.

location_facility: Hopital Lariboisiere,Hospitalier Universitaire Nord

location_facility: Medical Corporation Teda Ooimachi Orthopaedic Surgery and Surgery Clinic

location_facility: Synexus Polska Sp. z o.o. Oddzial w Lodzi

location_facility: Centrum fuer Diagnostik und Gesundheit (CDG)

location_facility: Juntendo University Graduate School of Medicine

location_facility: Investigacion y Biomedicina de Chihuahua

location_facility: Fakultni Thomayerova nemocnice s poliklinikou

location_facility: AmBeNet, Practice Dr. Dr. med. Hans-Detlev Stahl

location_facility: Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud

location_facility: Morales Vargas Centro de Investigacion SC

location_facility: AOU Citta della Salute e della Scienza di Torino

location_facility: PV-MEDICAL s.r.o. Revmatologicka ambulance


type: Registry Identifier

title: A Randomized, Double-Blind, Phase 3 Study of MK-7684A in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer

summary: The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

status: Active, not recruiting

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Poland
Argentina
Japan
Brazil
Thailand
Turkey
Chile
France
Colombia
United States
China
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Israel

location_facility: Hospital Insular de Gran Canaria-Oncology ( Site 1102)

location_facility: Umraniye Training and Research Hospital-medical oncology ( Site 1206)

location_facility: Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)

location_facility: Klinik Penzing-2. Lungenabteilung ( Site 0702)

location_facility: The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613)

location_facility: Acibadem Altunizade Hospital-Oncology ( Site 1207)

location_facility: Hospital Civil Fray Antonio Alcalde ( Site 0307)

location_facility: Korea University Guro Hospital-Internal Medicine ( Site 2204)

location_facility: Centro de Investigación Oncológica del Norte ( Site 0504)

location_facility: Medizinische Universität Graz ( Site 0704)

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607)

location_facility: Administradora Country S.A. - Clinica del Country ( Site 0601)

location_facility: Centro de Oncología de Precisión ( Site 0515)

location_facility: Kanazawa University Hospital ( Site 2407)

location_facility: Trakya University-Medical Oncology ( Site 1203)

location_facility: Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)

location_facility: The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209)

location_facility: The First Affiliated hospital of Xiamen University ( Site 2626)

location_facility: Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)

location_facility: The Second People's Hospital of Yibin ( Site 2629)

location_facility: Hospital Provincial del Centenario ( Site 0212)

location_facility: The Second Xiangya Hospital of Central South University ( Site 2623)

location_facility: Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405)

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (

location_facility: Faculty of Medicine - Khon Kaen University ( Site 2303)

location_facility: The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625)

location_facility: Pusan National University Hospital ( Site 2205)

location_facility: Shaare Zedek Medical Center-Oncology ( Site 1306)

location_facility: Alivia Clínica de Alta Especialidad ( Site 0310)

location_facility: Xiangya Hospital Central South University-Oncology department ( Site 2627)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 1302)

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)

location_facility: Clínica de Oncologia Reichow ( Site 0407)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903)

location_facility: Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105)

location_facility: Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)

location_facility: Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602)

location_facility: Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619)

location_facility: Stony Brook University-Cancer Center ( Site 0013)

location_facility: Hyogo Cancer Center-Thoracic Oncology ( Site 2409)

location_facility: Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301)

location_facility: University College London Hospital-Cancer Clinical Trials Unit ( Site 1509)

location_facility: Institut de Cancérologie de l'Ouest ( Site 0802)

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)

location_facility: Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615)

location_facility: University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)

location_facility: CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806)

location_facility: Fujian Provincial Cancer Hospital-oncology department ( Site 2621)

location_facility: Meir Medical Center-oncology ( Site 1301)

location_facility: Medizinische Universitaet Innsbruck ( Site 0703)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 2414)

location_facility: New England Cancer Specialists ( Site 0008)

location_facility: Japanese Foundation for Cancer Research ( Site 2402)

location_facility: Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (

location_facility: Centre Hospitalier d'Avignon ( Site 0810)

location_facility: Hospital Clinico San Carlos-Oncology Department ( Site 1107)

location_facility: Centro de Oncología e Investigación de Buenos Aires ( Site 0203)

location_facility: Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

location_facility: Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)

location_facility: Rambam Health Care Campus-Oncology ( Site 1303)

location_facility: Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701)

location_facility: Sourasky Medical Center-Oncology ( Site 1305)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254)

location_facility: University of Virginia Cancer Center ( Site 0018)

location_facility: Mayo Clinic in Rochester, Minnesota ( Site 0030)

location_facility: National Taiwan University Hospital-Oncology ( Site 2255)

location_facility: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)

location_facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405)

location_facility: Fudan University Shanghai Cancer Center ( Site 2616)

location_facility: Okayama University Hospital ( Site 2410)

location_facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103)

location_facility: Harbin Medical University Cancer Hospital-oncology of department ( Site 2604)

location_facility: Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th

location_facility: GEFOS Gesellschaft f. onkologische Studien ( Site 0909)

location_facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 2617)

location_facility: Cancer and Hematology Centers of Western Michigan ( Site 0002)

location_facility: Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906)

location_facility: NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252)

location_facility: Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 2251)

location_facility: Liv Hospital Ankara-Oncology ( Site 1205)

location_facility: Zhejiang Cancer Hospital-Oncology ( Site 2612)

location_facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618)

location_facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)

location_facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403)

location_facility: Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)

location_facility: Kansai Medical University Hospital ( Site 2415)

location_facility: The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)

location_facility: CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106)

location_facility: Shandong Cancer Hospital-Oncology Department ( Site 2630)

location_facility: West China Hospital of Sichuan University ( Site 2610)

location_facility: Jilin Cancer Hospital-oncology department ( Site 2603)

location_facility: University of Chicago Medical Center ( Site 0015)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2412)

location_facility: Nippon Medical School Hospital ( Site 2404)

location_facility: Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 0502)

location_facility: CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204)

location_facility: Kepler Universitätsklinikum ( Site 0707)

location_facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)

location_facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208)

location_facility: Centre Hospitalier d'Annecy ( Site 0807)

location_facility: Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913

location_facility: Faculty of Medicine Siriraj Hospital ( Site 2304)

location_facility: UCHealth Memorial Hospital-Heme Onc ( Site 0003)

location_facility: China Medical University Hospital ( Site 2253)

location_facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 0603)

location_facility: Chungnam national university hospital-Department of Internal Medicine ( Site 2203)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 1202)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 2413)

location_facility: Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606)

location_facility: Oncomedica S.A.-Oncomedica S.A ( Site 0609)

location_facility: UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)

location_facility: Saitama Prefectural Cancer Center ( Site 2406)

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501)


acronym: FIONA

lead_sponsor: Bayer

summary:
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.

The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can improve kidney function by helping the renin-angiotensin-aldosterone system (RAAS) to work normally. The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can stop the kidneys from working properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system.

The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.

So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function.

The main purpose of this study is to learn more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a treatment but does not have any medicine in it. Participants will also continue to receive their other medications.

To see how the treatment work, the doctors will take samples of the participants' urine to measure their protein levels before and during taking treatment and after their last treatment. In addition, blood samples will be taken to monitor kidney function, electrolytes and the amount of finerenone in the blood as well as for other tests.

This study will include children with CKD and proteinuria aged from 6 months up to less than 18 years. The participants will take:

either finerenone or the placebo, in addition to
either ACEI or ARB, whichever they take as part of their normal treatment

Two visits are required up to 104 days, to check whether a child can take part in the treatment phase of the study. If participants qualify for the treatment phase, they will then undergo treatment for about 180 days. During this time, they will visit the study site at least 7 times. During these visits, the participants will:

have their blood pressure, heart rate, temperature, height and weight measured
have blood and urine samples taken
have physical examinations
have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart)
answer questions about their medication and whether they have any adverse events , or have their parents or guardians answer
answer questions about how they are feeling, or have their parents or guardians answer
answer question about how they like the study medication, or have their parents or guardians answer

The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

The doctors will check the participants' health about 30 days after the participants take their last treatment.

location_facility: Oregon Health and Science Univ | Doernbecher Childrens Hosp

location_facility: H Univ. 12 de Octubre | Unidad Pediátrica Inv y EECC (UPIC)

location_facility: Clalit Health Services Schneider Children's Medical Center

location_facility: Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob

location_facility: Baskent Universitesi Tip Fakultesi Hastanesi

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"

location_facility: Centro de Rehabilitacion Cardiovascular | San Luis, Argentina

location_facility: AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

location_facility: Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi

location_facility: Cukurova Univ. Tip. Fak. Balcali Hastanesi

location_facility: Pediatric Early Phase Trial Unit, Tampere University Hospita

location_facility: Universitätsklinikum Hamburg Eppendorf (UKE)

location_facility: Children's Hospital of Athens P&A Kyriakou

location_facility: Health Corporation of Galilee Medical Center

location_facility: Hospital of LT University of Health Sciences Kaunas Clinics

location_facility: Hôpital Arnaud de Villeneuve - Montpellier

location_facility: Hippokration General Hospital of Thessaloniki

location_facility: Virgen del Rocio University Hospital | Pediatric Nephrology Unit

location_facility: Uniklinikum Salzburg - Landeskrankenhaus

location_facility: Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital

location_facility: Medizinische Univ Graz | Kinder & Jugendheilkunde

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares - Santa Fe, Argentina

location_facility: The Hospital for Sick Children (SickKids)

location_facility: Pusan National University Yangsan Hospital

location_facility: Uniwersytecki Szpital Kliniczny UM we Wroclawiu

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

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

location_facility: South Broward Hosp. District dba Memorial Healthcare System

location_facility: Alberta Children's Hospital, University of Calgary

location_facility: Seoul National University Bundang Hospital

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Rigshospitalet, Dept Pediatrics & Adelescent Med.

location_facility: Wilf Children's Hospital Shaare Zedek Medical Center

location_facility: Univ of Texas Health Science Center | Nephrology Res Dept

location_facility: Cincinnati Children's Hospital and Medical Center

location_facility: University General Hospital of Heraklion

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Great Ormond Street Hospital for Children

location_facility: Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

location_facility: Phoenix Children's Hospital | Main - Transplant Department

location_facility: CHULN - H. Sta.Maria (Centro de Investigacao Clinica)

location_facility: Hospital General de Niños Pedro de Elizalde

location_facility: Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics

location_facility: Dzieciecy Szpital Kliniczny im. Jozefa Brudzinskiego

location_facility: Istanbul Universitesi Cerrahpasa-Cocuk Nefrolojisi B. Dali

title: A 6-month Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and PK/PD of an age-and Body Weight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children, 6 Months to <18 Years of Age, With Chronic Kidney Disease and Proteinuria

source: euctr

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Finland
Germany
Poland
Argentina
Australia
Turkey
Czechia
Canada
France
Lithuania
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Israel

ipd_sharing: No


title: A Pivotal Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of DMX-200 in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving an Angiotensin II Receptor Blocker (ARB)

summary: DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor that, when administered concurrently with an ARB, is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. The purpose of this pivotal randomized double-blind study is to investigate the efficacy and safety of DMX-200 120 mg twice daily (BID) compared with placebo over a treatment period of 104 weeks in adult patients with FSGS who are being treated with an ARB. Given the rarity of the disease and the similarities between adults and pediatric patients with FSGS, Dimerix will also investigate the efficacy and safety of DMX 200 in adolescents aged 12 to 17 years. The double-blind period will be followed by an open-label extension (OLE) which aims to assess the long-term efficacy and safety of DMX 200 for up to 2 additional years.

lead_sponsor: Dimerix Bioscience Pty Ltd

location_country:
New Zealand
United Kingdom
Argentina
Denmark
Australia
Brazil
Hong Kong
United States
Spain
Taiwan
France

location_facility:
ACTION3 Investigational Site 10
ACTION3 Investigational Site 7
ACTION3 Investigational Site 16
ACTION3 Investigational Site 20
ACTION3 Investigational Site 8
ACTION3 Investigational Site 13
ACTION3 Investigational Site 1
Action3 Investigator Site 3
ACTION3 Investigational Site 12
ACTION3 Investigational Site 17
ACTION3 Investigational Site 14
Action3 Investigator Site 6
ACTION3 Investigational Site 6
ACTION3 Investigational Site 2
ACTION 3 Investigator Site 19
ACTION3 Investigational Site 3
ACTION3 Investigational Site 5
ACTION3 Investigational Site 21
ACTION3 Investigational Site 9
ACTION3 Investigational Site 18
ACTION3 Investigational Site 4
ACTION3 Investigational Site 15


title: A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination Pembrolizumab Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor

summary: The purpose of this trial is to investigate the safety and efficacy of acasunlimab (also known as GEN1046) as monotherapy and in combination with pembrolizumab in patients with non-small cell lung cancer who have progressed during or after treatment of previous standard of care

lead_sponsor: Genmab

sponsor_collaborators:
Genmab
BioNTech SE

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

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Med.Hochschule Hannover Klinik für Pneumologie

location_facility: Institut de Cancerologie Strasbourg Europe (ICANS)

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: Cancer & Hematology Centers of Western Michigan CHCWM P.C.

location_facility: Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Universitatsklinik Giessen und Marburg Standort Giessen

location_facility: Szpital Specjalistyczny w Prabutach Sp. z o.o.

location_facility: Instituto Portugues de Oncologio de Lisboa

location_facility: Oncology Clinical Trials Ascension Providence Hospital

location_facility: Centro Hospitalar Universitário do Porto - Hospital de Santo Antonio

location_facility: Penn State Cancer Institute Penn State Health Herhsey Medical Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

intervention_type: Biological


title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)

summary: The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Colombia
Denmark
United States
Belgium
China
Italy
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Russian Federation
Israel

location_facility: Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203)

location_facility: Iwate Medical University Hospital ( Site 1613)

location_facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804)

location_facility: West China Second University Hospital Sichuan University ( Site 0740)

location_facility: Westmorland General Hospital ( Site 2815)

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402)

location_facility: Nippon Medical School Musashi Kosugi Hospital ( Site 1614)

location_facility: ANIMI - Unidade de Tratamento Oncologico ( Site 0408)

location_facility: Roswell Park Cancer Institute ( Site 0039)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 0602)

location_facility: Seoul National University Hospital ( Site 2302)

location_facility: Clínica Vespucio-Hemato - Ocology ( Site 0607)

location_facility: The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706)

location_facility: Institut Curie - site Saint-Cloud ( Site 2909)

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 1603)

location_facility: Centre François Baclesse-Recherche clinique ( Site 2904)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 2707)

location_facility: The West Clinic, PLLC dba West Cancer Center ( Site 0058)

location_facility: Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507)

location_facility: Parkview Research Center at Parkview Regional Medical Center ( Site 0027)

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501)

location_facility: IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501)

location_facility: Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit

location_facility: McGill University Health Centre ( Site 0502)

location_facility: Institut Jules Bordet-Medicine Oncology ( Site 0302)

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (

location_facility: Istanbul Universitesi Cerrahpasa ( Site 2709)

location_facility: The Royal Cornwall Hospital ( Site 2804)

location_facility: St. Vincent Hospital and Health Care Center, Inc ( Site 0032)

location_facility: Aichi Cancer Center Hospital ( Site 1610)

location_facility: Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508)

location_facility: Brighton and Sussex University Hospitals NHS Trust ( Site 2803)

location_facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF-Chemotherapy #2 ( Site 2211)

location_facility: MetroHealth Medical Center-Cancer Care Center ( Site 0047)

location_facility: Advocate Medical Group-Oncology ( Site 0049)

location_facility: Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2304)

location_facility: Shaare Zedek Medical Center ( Site 1405)

location_facility: Instituto de Radiomedicina-hemato-oncologia ( Site 0604)

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)

location_facility: Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)

location_facility: Hokkaido University Hospital ( Site 1604)

location_facility: Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303)

location_facility: Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)

location_facility: T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma

location_facility: Saitama Medical University International Medical Center ( Site 1601)

location_facility: Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716)

location_facility: Novant Health Presbyterian Medical Center ( Site 0029)

location_facility: Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)

location_facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2107)

location_facility: Ege University Medicine of Faculty ( Site 2702)

location_facility: Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040)

location_facility: Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205)

location_facility: Osaka International Cancer Institute ( Site 1602)

location_facility: Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503)

location_facility: Centre de Cancérologie du Grand Montpellier ( Site 2908)

location_facility: Inova Schar Cancer Institute ( Site 0019)

location_facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901)

location_facility: Affiliated Hospital of Guangdong Medical University ( Site 0743)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504)

location_facility: Investigación Oncofarmacéutica-Investigación clínica ( Site 1706)

location_facility: National Cancer Center Hospital ( Site 1612)

location_facility: Aultman Hospital-Oncology Clinical Trials ( Site 0009)

location_facility: Bezmialem Vakf Üniversitesi-Oncology ( Site 2705)

location_facility: Tianjin Central Hosptial of Gynecology Obstetrics ( Site 0737)

location_facility: Japanese Foundation for Cancer Research ( Site 1605)

location_facility: Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701)

location_facility: Clínica Universitaria Colombia ( Site 0806)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 1505)

location_facility: Texas Oncology - Dallas (Presbyterian) ( Site 0065)

location_facility: Obstetrics & Gynecology Hospital of Fudan University ( Site 0715)

location_facility: COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 1703)

location_facility: Ankara University Hospital Cebeci ( Site 2701)

location_facility: Novant Health Forsyth Medical Center ( Site 0057)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2704)

location_facility: Providence Portland Medical Center ( Site 0048)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502)

location_facility: Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015)

location_facility: INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1701)

location_facility: Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214)

location_facility: Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0709)

location_facility: Xiangya Hospital Central South University-Gynecology ( Site 0705)

location_facility: WK Physicians Network / Hematology Oncology Associates ( Site 0034)

location_facility: iCan Oncology Center Centro Medico AVE ( Site 1704)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007)

location_facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 0717)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit

location_facility: Ninewells Hospital and Medical School ( Site 2826)

location_facility: Tianjin Medical University Cancer Institute and Hospital ( Site 0720)

location_facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 0808)

location_facility: St. John of God Subiaco Hospital ( Site 0203)

location_facility: Charité Campus Virchow-Klinikum ( Site 1201)

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202)

location_facility: Leids Universitair Medisch Centrum-Medical Oncology ( Site 1801)

location_facility: Universitätsklinikum Leipzig-Department of Gynecology and Obstetrics ( Site 1213)

location_facility: Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)

location_facility: Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001)

location_facility: Hammersmith Hospital-Medical Oncology ( Site 2818)

location_facility: Shandong Cancer Hospital-Oncology Department ( Site 0733)

location_facility: SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216)

location_facility: Emek Medical Center-Gyn-Onc ( Site 1406)

location_facility: Erasmus Medisch Centrum-Medical Oncology ( Site 1803)

location_facility: Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702)

location_facility: St. James's Hospital-Cancer clinical trials office ( Site 2821)

location_facility: CaritasKlinikum Saarbrücken St. Theresia ( Site 1211)

location_facility: Zhongda Hospital Southeast University ( Site 0723)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 21

location_facility: University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054

location_facility: The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741)

location_facility: Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207)

location_facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404)

location_facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-oncologie ( Site 2907)

location_facility: Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2106)

location_facility: Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog

location_facility: Fujian Provincial Cancer Hospital ( Site 0713)

location_facility: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609)

location_facility: Wuhan Union Hospital-Medical Oncology ( Site 0735)

location_facility: Ogarev Mordovia State University ( Site 2209)

location_facility: Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714)

location_facility: National Cancer Center Hospital East ( Site 1609)

location_facility: Aalborg Universitetshospital, Syd ( Site 0901)

location_facility: University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024)

location_facility: Lanzhou university second hospital ( Site 0734)

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku-Uniwersyteckie Centrum Onkologii ( Site 2104)

location_facility: Clinica de la Costa LTDA-Clinical Research Oncology & Hematology -Pediatric ( Site 0809)

location_facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 0403)

location_facility: Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0744)

location_facility: Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 2812)

location_facility: Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708)

location_facility: Texas Oncology - The Woodlands_Lee ( Site 0043)

location_facility: Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2103)

location_facility: Moscow City Oncology Hospital #62 ( Site 2214)

location_facility: Centro de Investigacion Clinica de Oaxaca ( Site 1705)

location_facility: Columbia University Medical Center ( Site 0010)

location_facility: The First Hospital of Jilin University ( Site 0710)

location_facility: Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508)

location_facility: University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003)

location_facility: Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 2905)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405)

location_facility: AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305)


acronym: ALPHABET

lead_sponsor: Spanish Breast Cancer Research Group

summary: Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer.

ReferenceType: result

ReferenceCitation: Perez-Fidalgo JA, Criscitiello C, Carrasco E, Regan MM, Di Leo A, Ribi K, Adam V, Bedard PL. A phase III trial of alpelisib + trastuzumab +/- fulvestrant versus trastuzumab + chemotherapy in HER2+ PIK3CA-mutated breast cancer. Future Oncol. 2022 Jun;18(19):2339-2349. doi: 10.2217/fon-2022-0045. Epub 2022 Apr 25.

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

sponsor_collaborators:
Spanish Breast Cancer Research Group
ETOP IBCSG Partners Foundation
Breast International Group
Novartis Pharmaceuticals

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Department of Oncology, ASUFC, PO Sm Misericordia

location_facility: Centre Régional De Lutte Contre Le Cancer Georges-François Leclerc

location_facility: Sant'Anna Hospital - Città della salute e della scienza

location_facility: Centre hospitalier universitaire de Poitiers

location_facility: Ospedale di Bolzano Azienda Sanitaria Alto Adige

location_facility: Medizinische Universität Wien - Univ.klinikum AKH Wien

location_facility: Hospital Clínico Universitario de Santiago CHUS

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Hospital Universitario Regional de Malaga

location_facility: Hospital de Terrassa - Consorci Sanitari de Terrassa

location_facility: Medizinische Universität Innsbruck - Univ.Klinik f. Frauenheilkunde Innsbruck

location_facility: Centre hospitalier universitaire à Limoges

location_facility: Azienda Ospedaliero-Universitaria Careggi, University of Florence

location_facility: Hospital Universitario Juan Ramón Jiménez

location_facility: Istituti Fisioterapici ospitaliersi - IFO - Istituti Regina Elena

location_facility: Hospital Universitario Arnau de Vilanova de Lleida

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: Hospital Provincial de Zamora (Complejo Asistencial de Zamora)

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Universitario Nuestra Señora de la Candelaria

location_facility: Istituti Clinici Scientifici Maugeri SpA-SB

location_facility: Hospital Universitario Sant Joan de Reus

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

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Hospital Universitario HM Sanchinarro - CIOCC Clara Campal

location_facility: Hospital Universitario Arnau de Vilanova de Valencia

location_facility: ICO Badalona - Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Clinico Universitario Virgen de La Arrixaca

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Hospital Clínico Universitario de Valencia

location_facility: A.O. "SS Antonio e Biagio e Cesare Arrigo"

location_facility: Hospital Universitario Fundación Jiménez Díaz

title: A Randomized Phase III Trial of Trastuzumab + ALpelisib +/- Fulvestrant Versus Trastuzumab + Chemotherapy in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer. "ALPHABET Study".

location_country: Italy Netherlands Austria Switzerland Spain France


title: A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Head and Neck Squamous Cell Carcinoma (HNSCC)

summary:
The is a phase 2 multi-cohort, non-randomized, open-label, multi-center study assessing the clinical benefit of SAR444245 combined with other anticancer therapies for the treatment of participants aged 18 years and older with HNSCC. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies.

Substudy 1-Cohort A1 aims to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who are treatment-naïve for recurrent and/or metastatic (R/M) disease.

Substudy 4-Cohort B1 aims to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who have received treatment with PD1/PD-L1 and platinum-based regimen.

Substudy 5-Cohort B2 aims to establish proof-of-concept that SAR444245 combined with cetuximab will result in a significant increase in the observed number of objective responses in trial participants with HNSCC previously treated with platinum-based regimen & cetuximab-naive after failure of no more than 2 regimens for recurrent and/or metastatic (R/M) disease.

design_allocation: Non-Randomized

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

location_country:
Germany
Italy
Argentina
Netherlands
United States
Korea, Republic of
Spain
Chile
Taiwan
Canada
France

location_facility: University of Colorado Site Number : 8400004

location_facility: Thomas Jefferson University Hospital Site Number : 8400003

location_facility: University of Michigan Site Number : 8400008

location_facility: Seattle Cancer Care Alliance Site Number : 8400006


title: A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301).

summary:
The main aim of this study is to:

evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of tarlatamab for Part 1 only
evaluate anti-tumor activity of tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) for Part 1 and 2
evaluate safety of reduced mandatory monitoring period in Cycle 1 at selected dose of tarlatamab for Part 3

enrollment_type: Actual

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

lead_sponsor: Amgen

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Singapore
Denmark
Japan
Netherlands
Austria
Belgium
Switzerland
United States
Korea, Republic of
Spain
Greece
Taiwan
France

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: University of Pittsburgh Medical Center Cancer Pavillion

location_facility: General Hospital of Patras Agios Andreas

location_facility: Azienda Socio Sanitaria Territoriale dei Sette Laghi Ospedale di Circolo e Fondazione Macchi

location_facility: Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano

location_facility: University Hospitals Cleveland Medical Center

location_facility: Instituto Catalan de Oncologia Hospital Duran i Reynals

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: University of Arkansas for Medical Sciences

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Regional Universitario de Malaga

location_facility: Yonsei University Health System Severance Hospital

location_facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Seoul National University Bundang Hospital

location_facility: West Virginia University Health Sciences Center

location_facility: Grand Hopital de Charleroi - Site Saint Joseph

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Wake Forest Baptist Comprehensive Cancer Research Center

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio


title: A Multinational, Open-label, Randomised, Controlled Study to Investigate Efficacy and Safety of NNC0365-3769 (Mim8) in Adults and Adolescents With Haemophilia A With or Without Inhibitors

summary:
This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII).

When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.

The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Ireland
Poland
Japan
Turkey
Czechia
Canada
Serbia
France
Lithuania
Portugal
Slovakia
Denmark
Switzerland
United States
Latvia
India
Romania
Belgium
China
Malaysia
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
South Africa
Taiwan
Russian Federation
Israel


title: A Phase 3 Randomized, Open-label Trial of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

summary: This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD), proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody (mAb).

sponsor_collaborators:
European Myeloma Network
Karyopharm Therapeutics Inc

location_country:
Germany
Italy
Netherlands
United States
Spain
Greece
France

location_facility: Universitätsklinikum Hamburg - Eppendorf

location_facility: The Oncology Institute of Hope and Innovation

location_facility: CHU Poitiers - Pôle régional de Cancérologie

location_facility: Azienda Ospedaliera Universitaria di Udine

location_facility: Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

location_facility: ASST Spedali Civili di Brescia - Ematologia

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Di Ancona

location_facility: Institut Catala D Oncolocia Hospitalet - Hospital Duran i Reynals

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: A.O.U. Policlinico S. Martino - Ematologia

location_facility: General Hospital of Athens"Evangelismos"

location_facility: Reading Hospital - McGlinn Cancer Institute

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

location_facility: H. General Universitario Morales Meseguer

location_facility: Medical University of South Carolina. Hollings Cancer Center

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS)


title: A Phase 2 Randomized Study of BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer

summary: The purpose of this study is to determine the safety and efficacy of BMS-986207 in combination with nivolumab and ipilimumab as first-line treatment for participants with stage IV non-small cell lung cancer (NSCLC).

status: Terminated

ipd_sharing_description:
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Poland
Israel
Argentina
Australia
Belgium
United States
Spain
Turkey
Chile
France

location_facility:
Local Institution - 0075
Local Institution - 0017
Local Institution - 0057
Local Institution - 0030
Local Institution - 0031
Local Institution - 0021
Local Institution - 0003
Local Institution - 0011
Local Institution - 0009
Local Institution - 0041
Local Institution - 0077
Local Institution - 0035
Local Institution - 0067
Local Institution - 0059
Local Institution - 0081
Local Institution - 0072
Local Institution - 0054
Local Institution - 0080
Local Institution - 0044
Local Institution - 0015
Local Institution - 0002
Local Institution - 0070
Local Institution - 0040
Local Institution - 0032
Local Institution - 0039
Local Institution - 0058
Local Institution - 0024
Local Institution - 0038
Local Institution - 0028
Local Institution - 0064
Local Institution - 0005
Local Institution - 0034
Local Institution - 0061
Local Institution - 0073
Local Institution - 0012
Local Institution - 0063
Local Institution - 0052
Local Institution - 0043
Local Institution - 0037
Local Institution - 0016
Local Institution - 0068
Local Institution - 0020
Local Institution - 0062
Local Institution - 0023
Local Institution - 0001
Local Institution - 0022
Local Institution
Local Institution - 0033
Local Institution - 0076
Local Institution - 0065
Local Institution - 0013
Local Institution - 0053
Local Institution - 0049
Local Institution - 0045
Local Institution - 0056
Local Institution - 0050
Local Institution - 0078
Local Institution - 0048
Local Institution - 0026
Local Institution - 0074
Local Institution - 0079
Local Institution - 0066
Local Institution - 0051
Local Institution - 0019
Local Institution - 0006
Local Institution - 0046
Local Institution - 0036
Local Institution - 0042

status_simplified: Unknown


summary: The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Istituto Oncologico Veneto IRCCS-Oncologia del Melenoma

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie

location_facility: ospedale le scotte-U.O.C. Immunoterapia Oncologica

location_facility: University of Iowa-Holden Comprehensive Cancer Center

title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

location_country:
Finland
Germany
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Denmark
Switzerland
United States
Romania
Belgium
China
Italy
Norway
United Kingdom
Sweden
Austria
Mexico
Spain
Greece
Israel


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus

acronym: ALLEGORY

summary: This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.

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).

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Poland
New Zealand
United Kingdom
Argentina
Brazil
Mexico
United States
Spain
South Africa
Czechia
Peru
Russian Federation
France

location_facility: Rheumatology Associates of Central Florida

location_facility: The Ohio State University Wexner Medical Center

location_facility: Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova

location_facility: SBHI of Yaroslavl Region Clinical Hospital #3

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Royal Free Hospital; Department of Rheumatology

location_facility: Netcare Umhlanga Medical Centre; Rheumatology

location_facility: Aintree University Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna; Reumatologia

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: IRCCS S. Raffaele; U.O. Immunologia, Reumatologia, Allergologia e Malattie Rare

location_facility: Vladimirskiy Regional Scientific Research Inst.

location_facility: Suny Downstate Medical Center; Rheumatology

location_facility: Clínica San Juan Bautista CSJB; UNIDAD DE INVESTIGACION EN REUMATOLOGIA E INMUNOLOGIA CSJB

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: Columbia University Medical Center; Division of Rheumatology

location_facility: Centro de Investigacion Alberto Bazzoni S.A. de C.V.

location_facility: Metropolitan Clinical Research Institute

location_facility: Ser Servicos Especializados Em Reumatologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

location_facility: Ryazan State Medical University Named after I.P.Pavlov

location_facility: Inland Rheumatology Clinical Trials Incorporated

location_facility: Centro de Investigación y Tratamiento Reumatológico S.C.

location_facility: Hospital de Basurto; Servicio de Reumatologia

location_facility: Ch Pitie Salpetriere; Medecine Interne I

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust; Lancashire Clinical Research Facility

location_facility: Hospital Clinic i Provincial de Barcelona; Enfermedades Autoinmmunes

location_facility: FGBU ?Federal Medical and Research Center named after V.A.Almazov? Russian Ministry of Health

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Addenbrooke'S Hospital; Rheumatology Research Unit

location_facility: Prywatna Praktyka Lekarska; Prof.UM dr hab.med Pawel Hryc

location_facility: Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

location_facility: Northwell Health Division of Rheumatology

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital 9"

location_facility: Centro de Estudos em Terapias Inovadoras ? CETI

location_facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*

location_facility: Winelands Medical Research; Medical Research

location_facility: NIH "Departmental Hospital on Station Smolensk of OJSC "Russian Railways"

location_facility: Unity Health - White County Medical Center- Rheumatology

location_facility: Hôpital Sud - CHU de Rennes Service interne

location_facility: Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM; Oddzial Reumat Rehab i Chorob Wewnetrznych

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Uni Di Padova; Divisione Di Rheumatologia

location_facility: Arthritis & Rheumatism; Disease Specialities

location_facility: University of Colorado Denver, Barbara Davis Center, Center For Clinical Research

location_facility: Asst Degli Spedali Civili Di Brescia; Reumatologia Ed Immunologia Clinica

location_facility: Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Medicina Interna

location_facility: Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: Hospital das Clinicas - FMUSP Ribeirao Preto; Reumatologia

location_facility: SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF

location_facility: Middlemore Hospital; Dept of Rheumatology

location_facility: Republican clinical hospital named after G.G. Kuvatov

location_facility: REUMATOP Grzegorz Rozumek, Karin Pistorius Spó?ka Jawna

location_facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

location_facility: HOPITAL COCHIN; Internal Medicine Department

location_facility: Manchester Royal Infirmary; Kellgren Centre for Rheumatology

location_facility: Adventhealth Medical Group ? Tampa ? IM/Rheumatology


title: A Descriptive, Prospective, Multi-country, Multicentre Study to Assess Performance of Genital Herpes Simplex Virus-2 (HSV-2) Related Disease Endpoints Based on Patient-reported Health Outcomes, Self-swabbing Collected Via Decentralised Approach in Patients ≥ 18 Years of Age in the United States and Europe.

summary:
The aim of this study is to assess performance of using healthcare tools to understand genital Herpes Simplex Virus-2 (HSV-2) in patients ≥ 18 years of age in the United States and Europe.

More specifically, the study aims to evaluate patient-reported outcome and quality-of-life endpoints as well as the performance study procedures in a decentralised setting. Ultimately, this study will allow generating additional real-world evidence (RWE) on patterns of recurrences and other key parameters.

study_type: Observational

time_perspective: Prospective

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Italy
United Kingdom
United States
Spain
France

intervention_type: Procedure


acronym: COURAGE-ALS

lead_sponsor: Cytokinetics

summary: The purpose of this study is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.

location_facility: UZ Leuven Gasthuisberg, Department of Neurology

location_facility: VCU Neuroscience Orthopaedic and Wellness Center (NOW)

location_facility: Studieenheten Akademiskt Specialistcentrum, Sabbatsberg Hospital

location_facility: Vanderbilt University Medical Center - Clinical Research Center

location_facility: University of California Irvine - ALS & Neuromuscular Center

location_facility: RSCI Education and Research Centre, Beaumont Hospital

location_facility: UMC Utrecht, Department of Neurology, ALS Center

location_facility: University of South Florida - Carol and Frank Morsani Center for Advanced Health Care

location_facility: Deparment of Neurology Bispebjerg University Hospital

location_facility: Centro Clinical Nemo - Fondazione Serena Onlus

location_facility: University of Massachusetts Memorial Medical Center/Medical School

location_facility: CHRU de Tours, Hopital Bretonneau, Clinical Research Center

location_facility: AOU Città della Salute e Scienza (Molinette),

location_facility: Ottawa Hospital Research Institute - Civic Campus

location_facility: California Pacific Medical Center - Forbes Norris MDA/ALS Research Center

location_facility: Medical School Hannover - Department of Neurology

location_facility: Maurice Wohl Clinical Neuroscience Institute

location_facility: Centro Hospitalar Universitario Lisboa Norte, Department of Neurology

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: St. Joseph's Hospital & Medical Center - Barrow Neurological Institute

location_facility: Massachusetts General Hospital - Neurological Clinical Research Institute

location_facility: Atrium Health Neuroscience Institute - Charlotte

location_facility: Washington University School of Medicine - Center for Advance Medicine

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: McGill University, Montreal Neurological Institute & Hospital

location_facility: University of Calgary - Heritage Medical Research Clinic

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion

location_facility: Neurologimottagningen Skane University Hospital

location_facility: Lewis Katz School of Medicine at Temple University

location_facility: University of Iowa Hospitals and Clinics

title: A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

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


title: SPOTLITE: Prospective Observational Study on the Clinical Outcomes of Surgical Interventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF)

summary:
In this study, participants with complex fistulizing conditions will be treated with surgical interventions according to their clinic's standard practice.

The aim of the study is to generate real-world evidence on standard of care for surgical interventions and related outcomes when treating complex fistulizing conditions.

The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Italy
Israel
United Kingdom
Netherlands
Austria
Belgium
United States
Czechia
Canada
France

location_facility: Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

location_facility: Vanderbilt University Medical Center- GI Endoscopy Lab

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

location_facility: Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk Mortality

acronym: ZENITH

summary: The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus maximum tolerated background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality.

lead_sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Netherlands
Mexico
Belgium
United States
Spain
Canada
France

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden. ( Site 1501)

location_facility: CHU de Nancy - Hôpital de Brabois Adultes ( Site 1308)

location_facility: Duke University Medical Center ( Site 1026)

location_facility: The Cleveland Clinic Foundation. ( Site 1065)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

location_facility: University of California Irvine ( Site 1086)

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

location_facility: David Geffen School of Medicine at UCLA ( Site 1068)

location_facility: University of Nebraska Medical Center ( Site 1053)

location_facility: Centre Hospitalier Universitaire de Toulouse. ( Site 1315)

location_facility: Medizinische Hochschule Hannover ( Site 1505)

location_facility: Instituto Nacional De Cardiologia Dr. Ignacio Chavez ( Site 2503)

location_facility: University of California San Diego Medical Center ( Site 1002)

location_facility: Brigham and Women's Hospital ( Site 1014)

location_facility: University Of Texas Southwestern Medical Center ( Site 1038)

location_facility: Washington University School of Medicine ( Site 1022)

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

location_facility: Mayo Clinic Jacksonville - PPDS ( Site 1045)

location_facility: St Vincent's Hospital Sydney ( Site 1102)

location_facility: La Sapienza-Università di Roma-Policlinico Umberto I ( Site 2402)

location_facility: Statcare Pulmonary Consultants - Knoxville ( Site 1031)

location_facility: Hospital Universitario 12 de Octubre ( Site 1603)

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

location_facility: Tufts Medical Center - PPDS ( Site 1012)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2504)

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

location_facility: University of California San Francisco ( Site 1019)

location_facility: Imperial College Healthcare NHS Trust ( Site 1203)

location_facility: UZ Leuven Campus Gasthuisberg ( Site 1401)

location_facility: Arizona Pulmonary Specialists ( Site 1010)

location_facility: Hôpitaux Universitaires de Strasbourg ( Site 1307)

location_facility: Ospedale S. Giuseppe Multimedica ( Site 2403)

location_facility: University of Kansas Medical Center ( Site 1020)

location_facility: University of Colorado Hospital ( Site 1013)

location_facility: University of New Mexico Health Sciences Center ( Site 1048)

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

location_facility: AdventHealth Medical Group Advanced Lung Disease ( Site 1058)

location_facility: Lady Davis Carmel Medical Center ( Site 1705)

location_facility: Universitätsklinikum des Saarlandes ( Site 1513)

location_facility: University Of Iowa Hospitals and Clinics ( Site 1050)

location_facility: University of Cincinnati Medical Center ( Site 1035)

location_facility: Thoraxklinik-Heidelberg gGmbH ( Site 1509)


summary: The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.

location_facility: Greater Chicago Specialty Physicians - Orland Park

location_facility: The Feinstein Institute for Medical Research

location_facility: UCSD - Altman Clinical and Translational Research Institute (ACTRI)

location_facility: Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas

location_facility: CHU Strasbourg-Hautepierre-Service de Rhumatologie

location_facility: The Ohio State University Wexner Medical Center (OSUWMC) - CarePoint East-Rheumatology and Immunolog

location_facility: Centre Hospitalier Universitaire de Caen Normandie

location_facility: Hôpital Européen Marseille-Service de recherche clinique

location_facility: St Joseph Heritage Healthcare-Rheumatology

location_facility: GCM Medical Group, PSC - Hato Rey Site-Hato Rey

location_facility: Centro Multidisciplinar de Estudos Clinicos

location_facility: Centro de Estudos em Terapias Inovadoras-Rheumatology

location_facility: UCLA Clinical & Translational Research Center (CTRC)

location_facility: Washington University/ Barnes Jewish Hospital

location_facility: Amarillo Center for Clinical Research-Research

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: Bordeaux University Hospital - Pellegrin-Rhumatologie

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Arthritis & Rheumatology Research Institute

location_facility: Oklahoma Medical Research Foundation-Multiple Sclerosis Center of Excellence

location_facility: Clin-Med Research & Development - 6141 Sunset Drive

title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Chile
France
Colombia
United States
India
Romania
China
Puerto Rico
United Kingdom
Mexico
Spain
Taiwan


title: Phase 2 Study: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post- Essential Thrombocythemia Myelofibrosis Previously Treated With Ruxolitinib

summary: This was an open-label, randomized, dose-finding study in patients with primary or secondary MF (Dynamic International Prognostic Scoring System [DIPSS] risk score of Intermediate-1 to High-Risk) who were previously treated with ruxolitinib. The study was designed to support a pacritinib dosage selection decision with evaluation of 3 dosages.

ReferenceType: derived

ReferenceCitation: Verstovsek S, Mesa R, Talpaz M, Kiladjian JJ, Harrison CN, Oh ST, Vannucchi AM, Rampal R, Scott BL, Buckley SA, Craig AR, Roman-Torres K, Mascarenhas JO. Retrospective analysis of pacritinib in patients with myelofibrosis and severe thrombocytopenia. Haematologica. 2022 Jul 1;107(7):1599-1607. doi: 10.3324/haematol.2021.279415.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: Washington University School of Medicine - Digital Commons@Becker

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;digitalcommons.wustl.edu

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

lead_sponsor: CTI BioPharma

location_country:
Italy
Hungary
United Kingdom
Sweden
United States
Korea, Republic of
Spain
France

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Centre Hospitalier Universitaire de Toulouse- Hôpital Purpan

location_facility: Florida Cancer Specialists & Research Institute

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: Washington University School of Medicine in St. Louis

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

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

location_facility: Barts Health NHS Trust - The Royal London Hospital

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: University of Texas Health Science Center at San Antonio School of Medicine

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

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

location_facility: Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: CHU de Nimes - Hopital Universitaire Caremeau

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The University of Chicago Medical Center

location_facility: University of Michigan Comprehensive Cancer Center


lead_sponsor: UCB Biopharma SRL

summary: The purpose of the study is to assess the efficacy of rozanolixizumab as measured by seizure freedom, change in cognitive function, use of rescue medication, onset of seizure freedom and to assess safety and tolerability.

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

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

location_country:
Germany
Italy
Portugal
United Kingdom
Australia
Netherlands
Belgium
United States
Korea, Republic of
Spain
France


summary:
This is a Phase II, randomized, blinded, active-controlled, global, multicenter study designed to evaluate the safety and efficacy of lomvastomig and tobemstomig, compared with nivolumab, in patients with advanced or metastatic esophageal squamous-cell carcinoma (ESCC) refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimen.

Following approval of the protocol amendment version 3, recruitment into the lomvastomig arm has been stopped. The decision to stop recruitment for lomvastomig was based on strategic considerations and not based on emerging safety and/or efficacy data. The benefit/risk assessment for lomvastomig remains unchanged.

The study was planned to enroll participants randomized in a 1:1:1 ratio to receive lomvastomig, tobemstomig, or nivolumab. With version 3 of the protocol, recruitment into the lomvastomig arm has stopped, and moving forward, participants will be randomized in a 1:1 ratio to receive either tobemstomig or nivolumab.

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

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Taipei Veterans General Hospital; Department of Oncology

location_facility: Complejo Hospitalario de Navarra; Servicio de Oncologia

location_facility: Dicle Uni Medical Faculty; Internal Medicine

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont

location_facility: National Cancer Centre; Medical Oncology

location_facility: Van Yuzuncu Yil University Hospital; Medical Oncology

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

location_facility: Hopital Timone Adultes; Oncologie Digestive

location_facility: Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

location_facility: Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol.

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

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

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

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Szpital Morski im. PCK; Poradnia Onkologiczna

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: National Taiwan University Hospital; Oncology

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

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

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

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Songklanagarind Hospital; Department of Oncology

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

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

title: A 3-Arm, Randomized, Blinded, Active-Controlled, Phase II Study of RO7121661, a PD1-TIM3 Bispecific Antibody and RO7247669, a PD1-LAG3 Bispecific Antibody, Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

location_country:
Italy
Poland
Hungary
Argentina
Denmark
Singapore
Brazil
United Kingdom
Korea, Republic of
Spain
Thailand
Turkey
Taiwan
Czechia
Kenya
Ukraine
Russian Federation
France


lead_sponsor: Alzheon Inc.

summary: This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.

sponsor_collaborators:
Alzheon Inc.
National Institute on Aging (NIA)

location_facility: Centre Hospitalier Universitaire de Marseille - Hôpital de la Timone

location_facility: Memory Clinic Geriatric Department Landspitali University Hospital

location_facility: Hospices Civils de Lyon - Institut du vieillissement

location_facility: Centro Hospital Universitario Dr. Preset

location_facility: Fakultní nemocnice u sv. Anny v Brně (St. Anne's University Hospital)

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Alzheimer's Research and Treatment Center

location_facility: CHU Toulouse - Centre de Recherche Clinique du Gérontopôle

location_facility: Klinikum der Universitaet Muenchen Innenstadt

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Fundacia ACE - Institut Catala de Neurociencies Aplicadas

location_facility: Kline Institute for Psychiatric Research

location_facility: Louisiana State University Health Sciences Center (LSUHSC)

location_facility: Centre Mémoire de Ressources et de Recherche (CM2R) des Hôpitaux Universitaires de Strasbourg

location_facility: Uniklinik RWTH Aachen Medizinische Klinik III

location_facility: UCSD Shiley-Marcos Alzheimer's Disease Research Center

location_facility: Klinik fuer Psychiatrie und Psychotherapie

location_facility: CHU De Montpellier - Hôpital Gui De Chauliac

location_facility: Wake Research - Clinical Research Center of Nevada

location_facility: Groupe Hospitalier Saint-Louis, Lariboisière, Fernand Widal

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype

type: U.S. NIH Grant/Contract

location_country:
Germany
United Kingdom
Netherlands
United States
Spain
Iceland
Czechia
Canada
France


title: 58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)

summary: The purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with Parkinson's Disease.

status: Enrolling by invitation

lead_sponsor: Cerevel Therapeutics, LLC

location_country:
Germany
Italy
Poland
Hungary
Israel
Australia
United States
Spain
Czechia
Ukraine
Bulgaria
Canada
Serbia
France

location_facility: Centrum Medyczne Hope Clinic Sebastian Szklener


title: Single-arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects With Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)

summary: This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Germany
Italy
United Kingdom
Australia
Japan
Netherlands
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University Health Network Princess Margaret Hospital

location_facility: Ospedale S.Maria della Misericordia, AO di Perugia, Università degli Studi di Perugia

location_facility: CHRU de Lille - Hôpital Claude Huriez - Maladies du Sang

location_facility: Hokkaido University Hospital - Medical Oncology Center

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology

location_facility: Stanford University Medical Center - Cancer Clinical Trials Office - ONCOLOGY

location_facility: Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori

location_facility: National Taiwan University Hospital - Hematology And Oncology

location_facility: Seoul National University Hospital - Department of Internal

location_facility: Centre Hospitalier Lyon Sud - Hématologie

location_facility: Washington University School of Medicine

location_facility: University Hospital - Kyoto Prefectural University of Medicine

location_facility: Universiteit Maastricht Academisch Ziekenhuis Maastricht

location_facility: Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV

location_facility: Northwestern University - Feinberg School of Medicine

location_facility: National Hospital Organization Nagoya Medical Center - Hematology

location_facility: National Cheng Kung University Hospital - Internal Medicine

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

location_facility: Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology

location_facility: Memorial Sloan-Kettering Cancer Center at Memorial Hospital

location_facility: Emory University Hospital - Winship Cancer Institute

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

location_facility: Nottingham City Hospital - Clinical Haematology

location_facility: Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)

location_facility: University of Pennsylvania Perelman Center for Advanced Medicine

location_facility: Samsung Medical Center - Hematology-Oncology


acronym: COSTAR Lung

summary: This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced Non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

title: A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Nonsmall Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden


title: A Phase 2 Randomized Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Chile
France
Switzerland
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Russian Federation

location_facility: FSBI &quot,Research Institute of Influenza named after A.A. Smorodintsev &quot,of the MoH of the Rus

location_facility: Arkhangelsk Clinical Oncological Dispensary