acronym: The FUZE Clinical Trial

lead_sponsor: Debiopharm International SA

summary: The primary objective of this study is to assess the efficacy of Debio 1347 in terms of objective response rate (ORR) in participants with solid tumors harboring fibroblast growth factor receptor (FGFR)1-3 gene fusion/rearrangement.

sponsor_collaborators:
Debiopharm International SA
Caris Life Sciences
Optimal Research (Just In Time sites)

location_facility: Linear Clinical Research, B Block Sir Charles Gairdner Hospital

location_facility: Seoul National University Hospital (SNUH)

location_facility: Hospital de Caridade de Ijuí, Avenida David J Martins

location_facility: Taichung Veterans General Hospital, The Radiation Oncology Department

location_facility: Philippine General Hospital, Clinical Trial Unit Room 5, Medical Research Laboratory

location_facility: The Catholic University of Korea, St. Vincent's Hospital, CRC Room, 3F

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Taipei Veterans General Hospital, Medical Science & Technology Building

location_facility: Gachon University Gil Medical Center, CRC Room, 18F, Artificial intelligence hospital

location_facility: Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu

location_facility: CHU Bordeaux - Hôpital Saint André, Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: Taipei Medical University Hospital (TMUH)

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

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

location_facility: TSBHI "Altai Territorial oncological dispensary"

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

location_facility: University of North Carolina at Chapel Hill

location_facility: Cebu Doctors' University Hospital (CDUH), Research Office

location_facility: SI V.T. Zaycev Institute of general & urgent surgery of National academy medical sciences of Ukraine, Department of purulent surgery

location_facility: Ironwood Cancer & Research Centers - Scottsdale

location_facility: H. Lee Moffitt Cancer Center and Research Institute, Inc

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Ajou University Hospital, CRC room, Clinical Trial Center

location_facility: Tan Tock Seng Hospital, Communicable Disease Centre

location_facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L.

location_facility: Seoul National University Bundang Hospital, Department of Oncology Medical office

location_facility: Hospital Clinico Universitario de Valencia

location_facility: The Ohio State University Wexner Medical Center - James Cancer Hospital

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, Avenida Doutor Arnaldo

location_facility: General Hospital of Athens of Chest Diseases "SOTIRIA"

location_facility: St. Luke's Medical Center, Human Cancer Biobank Research Center

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Complex Oncological Center - Plovdiv, EOOD

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

location_facility: University Hospital Centre, Sestre Milosrdnice

location_facility: Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

title: A Phase II Basket Study of the Oral Selective Pan-FGFR Inhibitor Debio 1347 in Subjects With Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3

location_country:
Finland
Poland
Australia
Brazil
Croatia
Czechia
France
Denmark
United States
Ukraine
Romania
Philippines
Norway
Singapore
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Eli Lilly and Company

summary: The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: Prairie Education and Research Cooperative

location_facility: Gemeinschaftspraxis für innere Medizin und Diabetologie

location_facility: Centre hospitalier universitaire Lapeyronie

location_facility: Tacoma Center for Arthritis Research, PS

location_facility: Groupe hospitalier mutualiste Les Portes du sud

location_facility: Rocky Mountain Diabetes and Osteoporosis Center

location_facility: Texas Diabetes and Endocrinology-Austin South

location_facility: John Muir Physician Network Clinical Research Center

location_facility: Northwestern Feinberg School of Medicine

location_facility: Barbara Davis Center for Childhood Diabetes

location_facility: Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen

location_facility: Centro de Endocrinologia Alcantara Gonzalez

location_facility: Institut für Diabetesforschung Münster GmbH

location_facility: Southern New Hampshire Diabetes and Endocrinology

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Center of Excellence in Diabetes & Endocrinology

location_facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

status: Completed

title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Actual

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
Hungary
Israel
Australia
Austria
United States
Spain
Canada
Puerto Rico
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Subject and Investigator Blinded, Placebo-controlled and Multi-center Platform Study, to Assess Efficacy and Safety of Different Investigational Drugs in Patients With Moderate to Severe Hidradenitis Suppurativa

summary: The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006, MAS825 , LOU064 and VAY736 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: Undecided

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Hungary
Denmark
Netherlands
Austria
Belgium
United States
Spain
Czechia
Iceland
France

status_simplified: Ongoing


title: GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease

summary: This is a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease (AD) dementia.

ipd_sharing: No

lead_sponsor: Cortexyme Inc.

location_country:
Poland
United Kingdom
Netherlands
United States
Spain
France

location_facility: Hospital Universitari General de Catalunya

location_facility: Brain Matters Research at the Kane Center

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Isala Zwolle - Interne geneeskunde Centrum voor ouderengeneeskunde

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: ANI Neurology, PLLC dba Alzheimer's Memory Center

location_facility: Alzheimer's Research and Treatment Center

location_facility: Hôpitaux Universitaires de Strasbourg, Centre d'Investigation Clinique, Hôpital Hautepierre

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

location_facility: Neurology Specialists of Monmouth County

location_facility: CHRU de Nancy Hôpital de Brabois Service de Gériatrie

location_facility: Memory Health Center at Summit Research Network

location_facility: NZOZ Wrocławskie Centrum Alzheimerowskie

location_facility: Cognition Health Ltd. (private) Guildford

location_facility: Disease Research & Neurology Center of Neurological Associates of Albany

location_facility: Houston Methodist Department of Neurology

location_facility: The Cognitive Research Center of New Jersey

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Northeastern Pennsylvania Memory and Alzheimer's Center

location_facility: Memory Assessment and Research Centre, Moorgreen Hospital

location_facility: University Hospital La Timone, Department of Neurology and Neuropsychology

location_facility: RICE - The Research Institute for the Care of Older People

location_facility: Anil Nair MD, Alzheimer's Disease Center


title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.

status: Terminated

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

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

lead_sponsor: Incyte Corporation

location_country:
Germany
France
Italy
United Kingdom
Denmark
Japan
Switzerland
United States
Korea, Republic of
Spain
Israel

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Florida Cancer Specialists & Research Institute

location_facility: L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA ï¿½ MALPIGHI

location_facility: Hospital Universitario Y Politcnico de La Fe

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Multicare Institute For Research & Innovation

location_facility: Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

location_facility: Severance Hospital Yonsei University Health System

location_facility: Hospital General Universitario Vall D Hebron

location_facility: University of Texas Southwestern Medical Center

location_facility: Istituto Nazionale Tumori Regina Elena Irccs

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: University Medical Centre Hamburg-Eppendorf, Centre of Oncology

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Virginia Oncology Associates-Lake Wright

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

location_facility: Hospital Regional Universitario de Malaga

location_facility: University College London Hospitals (Uclh)

location_facility: Chao Family Comprehensive Cancer Center University of California, Irvine

location_facility: Cancer Institute of Greenville Health System

location_facility: Seoul National University Bundang Hospital

location_facility: Indiana University Health - Arnett Cancer Care

location_facility: Institut Universitaire Du Cancer de Toulouse Oncopole

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Centro Ricerche Cliniche Di Verona (Crc)

location_facility: Centro Integral Oncologico Clara Campal (Ciocc)

status_simplified: Unknown


intervention_type: Biological

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis results of Cohort 1. Cohort 2 will include participants in stable health with a history of urinary tract infection (UTI) in the past 5 years and will be included in the study to support the plan for late stage development of ExPEC vaccine.

location_facility:
Hosp. Univ. de La Princesa
Rochester Clinical Research, Inc
CHU Lyon Sud
ATC Pharma
Qps-Mra, Llc
Chu Rennes - Hopital Pontchaillou
Optimal Research
CHRU Tours Hopital Bretonneau
Anima
Hosp. Virgen Macarena
EB Flevo Research
Clinical Pharmacology Unit
Synexus Clinical Research US, Inc
Hopital Cochin
Hosp. Del Mar
CHU Nantes
Hosp. Univ. Marques de Valdecilla
Hosp. Reina Sofia
Johnson County Clin-Trials
Hosp. Univ. La Paz
PRA Health Sciences
APHP - Hopital Bichat - Claude Bernard
Coastal Carolina Research Center

status: Active, not recruiting

title: A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

primary_purpose: Other

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

As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Netherlands
Belgium
United States
Spain
France


type: Registry Identifier

title: A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency

summary: The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

ReferenceType: derived

ReferenceCitation: Miller BS, Blair JC, Rasmussen MH, Maniatis A, Kildemoes RJ, Mori J, Polak M, Bang RB, Bottcher V, Stagi S, Horikawa R. Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial. J Clin Endocrinol Metab. 2022 Nov 25;107(12):3378-3388. doi: 10.1210/clinem/dgac513.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University of Florence - Florence Research

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;flore.unifi.it

unpaywall_oa_status: hybrid

publisher_dissemination: The Endocrine Society

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
Algeria
Japan
Thailand
Canada
Serbia
France
Slovenia
Switzerland
United States
Latvia
Ukraine
India
Estonia
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Russian Federation
Israel


acronym: Pembrolizumab plus lenvatinib as second-line plus intervention for select solid tumors

lead_sponsor: Merck Sharp & Dohme LLC

summary: The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210)

location_facility: Inselspital Universitaetsspital Bern ( Site 1705)

location_facility: Universitaetsklinikum Frankfurt ( Site 0306)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1701)

location_facility: Sunnybrook Research Institute ( Site 0207)

location_facility: West Cancer Center - East Campus ( Site 0018)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1600)

location_facility: University of Florida-Health Cancer Center-Orlando ( Site 0015)

location_facility: Hospital Clinic i Provincial ( Site 0703)

location_facility: National Cheng Kung University Hospital ( Site 3003)

location_facility: Sanford Fargo Medical Center ( Site 0059)

location_facility: Clinica Universitaria de Navarra ( Site 0704)

location_facility: Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604)

location_facility: Ospedale Regionale di Bellinzona e Valli ( Site 1703)

location_facility: Hospital Universitario Gregorio Maranon ( Site 0701)

location_facility: Princess Margaret Cancer Centre ( Site 0202)

location_facility: National Taiwan University Hospital ( Site 3000)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 0007)

location_facility: Royal Brisbane and Women s Hospital ( Site 0901)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208)

location_facility: Centro Investigación del Cáncer James Lind ( Site 1203)

location_facility: Universitaetsklinikum Regensburg ( Site 0304)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 1401)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0403)

location_facility: Hospital Britanico de Buenos Aires ( Site 2109)

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301)

location_facility: CHU de Quebec Universite de Laval ( Site 0206)

location_facility: Severance Hospital Yonsei University Health System ( Site 1001)

location_facility: Leningrad Regional Oncology Center ( Site 1609)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 1400)

location_facility: Fundacion Arturo Lopez Perez ( Site 1201)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610)

location_facility: Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)

location_facility: Christie NHS Foundation Trust ( Site 0805)

location_facility: Pontificia Universidad Catolica de Chile ( Site 1202)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 1402)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 1102)

location_facility: City Clinical Oncology Center ( Site 1608)

location_facility: Royal Marsden Hospital (Sutton) ( Site 0800)

location_facility: Instituto de Oncologia de Rosario ( Site 2105)

location_facility: Oncologos del Occidente S.A. ( Site 1106)

location_facility: University of California Davis Comprehensive Cancer Center ( Site 0005)

location_facility: Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106)

location_facility: University of Wisconsin Carbone Cancer Center ( Site 0017)

location_facility: Hospital Clinico Universidad de Chile ( Site 1200)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101)

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105)

location_facility: Cedars Sinai Medical Center ( Site 0003)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402)

location_facility: Seoul National University Hospital ( Site 1000)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0803)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0604)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0309)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 1403)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0009)

location_facility: Sir Charles Gairdner Hospital ( Site 0903)

location_facility: Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804)

location_facility: Lehigh Valley Hospital- Cedar Crest ( Site 0047)

title: A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)

location_country:
Germany
Italy
Colombia
Israel
Argentina
United Kingdom
Australia
Switzerland
United States
Korea, Republic of
Spain
Thailand
Chile
Taiwan
Canada
Russian Federation
France


acronym: ZEPHYR

lead_sponsor: Millendo Therapeutics SAS

summary: This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).

location_facility: Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

location_facility: Hospital General Universitario de Alicante

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: University of California - Irvine Medical Center

location_facility: New York Presbyterian Morgan Stanley Children's Hospital

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: University of Texas Southwestern Medical Center

location_facility: Children's Hospitals and Clinics of Minnesota-Minneapolis

title: A Phase 2b/3 Study to Evaluate the Safety, Tolerability, and Effects of Livoletide (AZP-531), an Unacylated Ghrelin Analogue, on Food-related Behaviors in Patients With Prader-Willi Syndrome

location_country:
Italy
United Kingdom
Australia
Netherlands
Belgium
United States
Spain
France


lead_sponsor: Nektar Therapeutics

summary: The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.

sponsor_collaborators:
Nektar Therapeutics
Bristol-Myers Squibb

location_facility: Helsingin Yliopistollinen Keskussairaala - PPDS

location_facility: Laura And Isaac Perlmutter Cancer Center

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

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: Centro de Investigación Clínica - Clínica Viedma

location_facility: Hôpital Privé TOULON/HYERES Sainte Marguerite

location_facility: Federal State Institution Medical Radiology Research Center

location_facility: San Francisco VA Medical Center - NAVREF - PPDS

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Health Pharma Professional Research S.A de C.V.

location_facility: Ankara University Medical Faculty - PPDS

location_facility: Southeastern Regional Medical Center - CTCA - PPDS

location_facility: Winship Cancer Institute, Emory University

location_facility: Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center

location_facility: CAIPO Centro para la atención integral del paciente oncológico

location_facility: Innovative Clinical Research Institute, LLC

title: A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients

location_country:
Finland
Germany
Italy
Portugal
Israel
Argentina
United Kingdom
Australia
Netherlands
Mexico
Belgium
United States
Spain
Greece
Turkey
Canada
Russian Federation
France


title: A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers

summary: The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in participants with advanced solid and hematologic cancers.

lead_sponsor: Celgene

location_country:
Italy
United Kingdom
Australia
United States
Korea, Republic of
Spain
Canada
France

location_facility: Rocky Mountain Cancer Centers, LLP [Aurora-COAU]


title: A Phase II Study Assessing the Efficacy of Osimertinib in Combination With Savolitinib in Patients With EGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Treatment With Osimertinib.

acronym: SAVANNAH

summary: This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib

ReferenceCitation: Schmid S, Fruh M, Peters S. Targeting MET in EGFR resistance in non-small-cell lung cancer-ready for daily practice? Lancet Oncol. 2020 Mar;21(3):320-322. doi: 10.1016/S1470-2045(19)30859-9. Epub 2020 Feb 3. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

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

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Hutchison MediPharma

location_country:
Italy
India
Denmark
Japan
Brazil
United States
Korea, Republic of
Spain
Vietnam
Chile
Taiwan
Canada
Puerto Rico
France


lead_sponsor: BeiGene

summary: This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

location_facility: General Hospital of Shenyang Military Region

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: The Affiliated Drum Tower Hospital of Nanjing University

location_facility: Tianjin Medical University General Hospital

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Osaka International Cancer Institute - Clinical Oncology

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

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

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

location_facility: Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.

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

location_facility: Hiroshima City Hiroshima Citizens Hospita

location_facility: Xiangya Hospital Central South University

location_facility: The First Hospital of China Medical University

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: The First Affiliated Hospital, Zhejiang University

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

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: The First Affiliated Hospital of Guilin Medical University

location_facility: The First Hospital of Lanzhou University

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

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Thomas Jefferson University Hospital - Central

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Saitama Medical University International Medical Center

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Hospital Regional Universitario de Malaga

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Fourth Hospital of Hebei Medical University

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Daping Hospital of The 3rd Military University

location_facility: SBIH " Volgograd Regional Clinical Oncological Dispensary # 1"

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

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

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Chinese PLA General Hospital Medical School of Chinese PLA

location_facility: RBIH "Ivanovo Regional Oncological Dispensary"

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

location_facility: University of California Davis Health System

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: The Second Hospital of Anhui Medical University

location_facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

location_country:
Italy
Poland
United Kingdom
Japan
United States
China
Korea, Republic of
Spain
Turkey
Taiwan
Puerto Rico
Russian Federation
France


lead_sponsor: MEI Pharma, Inc.

summary: This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Hospital Universitario Quiron Salud Madrid

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.

location_facility: Centre for Haematology, Imperial College London

location_facility: IRCCS Regina Elena National Cancer Institute

location_facility: C H de la Cote Basque, Service d'Hematologie

location_facility: Centro di Riferimento Oncologico di Aviano (CRO) IRCCS

location_facility: Belfast Health and Social Care Trust - Belfast City Hospital

location_facility: Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie

location_facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital

location_facility: The Catholic University of Korea-Seoul St. Marys Hospital

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Lewisham and Greenwich University Hospital Lewisham

location_facility: National Taiwan University Hospital NTUH

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Investigative Clinical Research of Indiana LLC

title: A Multicenter, Open Label Single-Arm, Phase 2 Study of Zandelisib (ME-401) in Subjects With Follicular Lymphoma and Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies (The TIDAL Study)

location_country:
Germany
Italy
Poland
New Zealand
United Kingdom
Australia
Switzerland
Austria
Belgium
United States
Korea, Republic of
Spain
Taiwan
France


title: Open-label, Multicentre, Phase Ib Dose-escalation Study of MEN1611, a PI3K Inhibitor Combined With Trastuzumab With or Without Fulvestrant, in Subjects With PIK3CA Mutated HER2 Positive Locally Recurrent Unresectable (Advanced) or Metastatic (a/m) Breast Cancer Progressed to Anti-HER2 Based Therapy

summary: The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer

lead_sponsor: Menarini Group

location_country:
Italy
United Kingdom
Belgium
United States
Spain
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Hospital Clínico Universitario Virgen de la Victoria

location_facility: Institut Régional du Cancer de Montpellier


lead_sponsor: Principia Biopharma, a Sanofi Company

summary: This was a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (blinded treatment [BT] period) followed by an open-label extension [OLE] period intended to evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After completing the open-label extension period, eligible participants might continue in a long term extension (LTE) Period of 48 weeks.

location_facility: Central Recruiting (Principia Biopharma)

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor Rilzabrutinib (PRN1008) in Moderate to Severe Pemphigus

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

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Croatia
Canada
Serbia
France
United States
Ukraine
Italy
United Kingdom
Spain
Greece
Taiwan
Bulgaria
Israel


title: FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)

acronym: FLASH

summary:
To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice.

Up to 300 additional patients with anticoagulation treatment as the initial planned primary treatment strategy for intermediate risk PE will also be evaluated (US only).

status: Enrolling by invitation

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Horowitz JM, Jaber WA, Stegman B, Rosenberg M, Fanola C, Bhat AP, Gondi S, Castle J, Ahmed M, Brown MA, Amin R, Bisharat M, Butros P, DuCoffe A, Savin M, Pollak JS, Weinberg MA, Brancheau D, Toma C. Mechanical Thrombectomy for High-Risk Pulmonary Embolism: Insights From the US Cohort of the FLASH Registry. JSCAI. 2023. (in press) doi: 10.1016/j.jscai.2023.101124

ReferenceCitation: Khandhar S, Jaber W, Bunte MC, Cho K, Weinberg MD, Mina B, Stegman B, Pollak J, Khosla A, Elmasri F, Zlotnick D, Brancheau D, Koenig G, Bisharat M, Li J, Toma C. Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-Risk Pulmonary Embolism: 6-Month FLASH Registry Results. JSCAI. 2023. 2:101000. doi: 10.1016/j.jscai.2023.101000

ReferenceCitation: Bangalore S, Horowitz JM, Beam D, Jaber WA, Khandhar S, Toma C, Weinberg MD, Mina B. Prevalence and Predictors of Cardiogenic Shock in Intermediate-Risk Pulmonary Embolism: Insights From the FLASH Registry. JACC Cardiovasc Interv. 2023 Apr 24;16(8):958-972. doi: 10.1016/j.jcin.2023.02.004.

ReferenceCitation: Toma C, Jaber WA, Weinberg MD, Bunte MC, Khandhar S, Stegman B, Gondi S, Chambers J, Amin R, Leung DA, Kado H, Brown MA, Sarosi MG, Bhat AP, Castle J, Savin M, Siskin G, Rosenberg M, Fanola C, Horowitz JM, Pollak JS. Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism. EuroIntervention. 2023 Feb 20;18(14):1201-1212. doi: 10.4244/EIJ-D-22-00732.

ReferenceCitation: Toma C, Bunte MC, Cho KH, Jaber WA, Chambers J, Stegman B, Gondi S, Leung DA, Savin M, Khandhar S, Kado H, Koenig G, Weinberg M, Beasley RE, Roberts J, Angel W, Sarosi MG, Qaqi O, Veerina K, Brown MA, Pollak JS. Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry. Catheter Cardiovasc Interv. 2022 Mar;99(4):1345-1355. doi: 10.1002/ccd.30091. Epub 2022 Feb 3.

lead_sponsor: Inari Medical

location_country:
Germany
United Kingdom
Netherlands
Austria
Belgium
Switzerland
United States
Spain
France

location_facility: Hopital de la Cavale Blanche - CHU Brest

location_facility: Charité Hospital - Campus Virchow-Klinikum

location_facility: Providence Regional Medical Center Everett

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of Arizona College of Medicine

location_facility: Metropolitan Heart and Vascular Institute

location_facility: The Royal London Hospital, Bart's Health

location_facility: HCL Hôpital Louis Pradel - Hôpital Cardiologique

location_facility: Centre Hospitalier Universitaire de Besançon

intervention_type: Device


acronym: Olaparib Monotherapy in HRRm or HRD Positive Cancer

summary: This study will evaluate the efficacy and safety of olaparib (MK-7339) monotherapy in participants with multiple types of advanced cancer (unresectable and/or metastatic) that: 1) have progressed or been intolerant to standard of care therapy; and 2) are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD).

sponsor_collaborators:
Merck Sharp & Dohme LLC
AstraZeneca

location_facility: St. Vincent's University Hospital ( Site 1653)

location_facility: Universitaetsspital Zuerich ( Site 1400)

location_facility: Ege Universitesi Tip Fakultesi ( Site 1502)

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

location_facility: Sunnybrook Research Institute ( Site 0210)

location_facility: Cancer Partners of Nebraska ( Site 0051)

location_facility: Christie NHS Foundation Trust ( Site 1601)

location_facility: MNCCI Port Macquarie Base Hospital ( Site 2201)

location_facility: Policlinico Le Scotte di Siena ( Site 0704)

location_facility: SC Radiotherapy Center Cluj SRL ( Site 1105)

location_facility: Sanford Hematology Oncology-Sioux Falls SD ( Site 0012)

location_facility: Northern Centre for Cancer Care ( Site 1602)

location_facility: Hopitaux Universitaires de Geneve HUG. ( Site 1406)

location_facility: Institut de Cancerologie Strasbourg Europe ( Site 0613)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1212)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0703)

location_facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 3101)

location_facility: Severance Hospital Yonsei University Health System ( Site 2400)

location_facility: Mater Misericordiae University Hospital ( Site 1654)

location_facility: Centre Georges Francois Leclerc ( Site 0608)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 2809)

location_facility: National Cancer Center Hospital East ( Site 2600)

location_facility: Actualidad Basada en la Investigacion del Cancer ( Site 2903)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 3107)

location_facility: Ryazan Regional Clinical Oncology dispensary ( Site 1202)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0700)

location_facility: The University of Arizona Cancer Center - North Campus ( Site 0011)

location_facility: Seoul National University Bundang Hospital ( Site 2402)

location_facility: Ospedale Regionale di Bellinzona e Valli ( Site 1407)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 3106)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1505)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 2812)

location_facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126)

location_facility: Eastern Regional Medical Center, Inc. ( Site 0077)

location_facility: Hospital Britanico de Buenos Aires ( Site 2704)

location_facility: University of Massachusetts ( Site 0017)

location_facility: Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 3003)

location_facility: MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1213)

location_facility: Hospital Central de la Fuerza Aerea del Peru ( Site 3104)

location_facility: Instituto de Investigaciones Metabolicas ( Site 2700)

location_facility: Aichi Cancer Center Hospital ( Site 2602)

location_facility: Unidad Biomedica Avanzada Monterrey S. A. ( Site 2902)

location_facility: Clinical Hospital Saint Luka ( Site 1205)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1506)

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

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2901)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507)

location_facility: Hospital Militar Central Coronel Luis Arias Schereiber ( Site 3105)

location_facility: Akdeniz Universitesi Tip Fakultesi ( Site 1504)

location_facility: Clinica Internacional Sede San Borja ( Site 3100)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1208)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 2907)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 1206)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0026)

location_facility: National Cancer Center Hospital ( Site 2601)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2807)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1207)

location_facility: Hospital Universitari Vall d Hebron ( Site 1350)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 1500)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2808)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1204)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 0056)

location_facility: Herlev og Gentofte Hospital. ( Site 0401)

location_facility: Southwestern Regional Medical Center, Inc. ( Site 0079)

location_facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 3004)

location_facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 2900)

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1216)

location_facility: Virginia Mason Medical Center ( Site 0052)

location_facility: Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092)

location_facility: Administradora Country SA - Clinica del Country ( Site 2802)

location_facility: Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 3102)

location_facility: Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203)

location_facility: Weinberg Cancer Institute at Franklin Square ( Site 0054)

location_facility: Odense Universitetshospital ( Site 0400)

location_facility: C. Medico Imbanaco Cali S.A. ( Site 2810)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)

location_facility: Oaxaca Site Management Organization S.C. ( Site 2905)

location_facility: S.C. Pelican Impex S.R.L Spitalul Clinic Pelican Oradea ( Site 1102)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703)

location_facility: Tallaght University Hospital ( Site 1652)

location_facility: Winship Cancer Institute of Emory University ( Site 0025)

location_facility: VA New York Harbor Healthcare System Manhattan ( Site 0094)

location_facility: Oncosalud-Clinical Research ( Site 3108)

location_facility: Cedars Sinai Medical Center ( Site 0002)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 1211)

location_facility: Hospital Universitario Quiron Madrid ( Site 1352)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 1503)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0802)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0801)

location_facility: Linear Clinical Research Ltd ( Site 2202)

location_facility: Baskent University Adana Training Hospital ( Site 1508)

location_facility: Seoul National University Hospital ( Site 2401)

title: A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer

location_country:
Ireland
Argentina
Australia
Japan
Turkey
Canada
France
Colombia
Denmark
Switzerland
United States
Romania
Peru
Italy
Guatemala
United Kingdom
Mexico
Korea, Republic of
Spain
Russian Federation
Israel


acronym: Ph2 Platform Trial of Novel Regimens vs. SoC in NSCLC

lead_sponsor: GlaxoSmithKline

summary: This study will compare the clinical activity of novel regimens (in combination or as single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be conducted in two parts. Part 1 is an open-label, optional, non-randomized part based on safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to generate additional data to qualify novel regimens for the randomized study. Part 2 is a randomized, Phase II open-label part comparing the efficacy and safety of these novel regimens with SoC. Drug name mentioned as GSK4428859A (belrestotug) and EOS884448 are interchangeable for the same compound and will be referred to as GSK4428859A/EOS884448/belrestotug.

sponsor_collaborators:
GlaxoSmithKline
iTeos Belgium SA

title: A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

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

location_country:
Germany
Italy
Poland
Romania
Sweden
Netherlands
United States
Korea, Republic of
Spain
Canada
Russian Federation
France


summary: The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

sponsor_collaborators:
AstraZeneca
Merck Sharp & Dohme LLC

title: A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)

location_country:
Germany
Italy
Slovakia
United Kingdom
Australia
Brazil
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
Turkey
Chile
Czechia
Canada
France


title: A Multicenter, Randomized, Double-blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome

summary: This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome. Participants will be required to apply the investigational product for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new BCCs that develop over the 12 month period.

lead_sponsor: PellePharm, Inc.

location_country:
Germany
Italy
United Kingdom
Denmark
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: University of Michigan, Dept of Dermatology

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Clinical Trials Unit - The Skin Care Centre

location_facility: University of Utah Midvalley Dermatology

location_facility: University of Minnesota, Department of Dermatology

location_facility: Hospital of the University of Pennsylvania

location_facility: Maastricht University Medical Center - Dept of Dermatology

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Stanford University, Department of Dermatology

location_facility: Ospedale Vanvitelli-University della Campania-Dermatologia Edificio 9

location_facility: University of Miami Miller School of Medicine

location_facility: Klinik und Poliklinik fur Dermatologie und Allergologie

location_facility: Hospital Universitiario Virgen de la Macarena


acronym: NOVA

lead_sponsor: Biogen

summary:
Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) in participants who have previously been treated with natalizumab standard interval dosing (SID) for at least 12 months, in relation to continued SID treatment. The secondary objectives is to evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of EID in participants who have previously been treated with natalizumab SID for at least 12 months, in relation to continued SID treatment.

Part 2: The primary objective is to evaluate participant preference for subcutaneous (SC) versus intravenous (IV) route of natalizumab administration. The secondary objectives is to evaluate treatment satisfaction, drug preparation and administration time, safety and immunogenicity, efficacy and characterize pharmacokinetic (PK) and pharmacodynamic (PD) drug preparation and administration time of SC versus IV routes of natalizumab administration.

ReferenceCitation: Foley JF, Defer G, Ryerson LZ, Cohen JA, Arnold DL, Butzkueven H, Cutter G, Giovannoni G, Killestein J, Wiendl H, Smirnakis K, Xiao S, Kong G, Kuhelj R, Campbell N; NOVA study investigators. Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):608-619. doi: 10.1016/S1474-4422(22)00143-0. Epub 2022 Apr 25.

location_facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg

location_facility: Michigan Institute for Neurological Disorders

location_facility: Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. Rodolico)

location_facility: Dayton Center for Neurological Disorders

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

location_facility: Washington University, School of Medicine

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: North Central Neurology Associates, P.C.

location_facility: University of Colorado Hospital Anschutz Outpatient Pavillion

location_facility: Hospital Regional Universitario de Malaga

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Queen Elizabeth University Hospital Campus

location_facility: Beth Israel Deaconess Medical Center, Inc.

location_facility: I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo

location_facility: Zuyderland Medisch Centrum - Sittard-Geleen

location_facility: Newcastle University- Clinical Ageing Research Unit

location_facility: Montreal Neurological Institute Clinical Research Unit

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Walton Centre for Neurology & Neurosurgery.

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Multiple Sclerosis Center of Greater Washington

location_facility: Columbia University Hervert Irving Comprehensive Cancer Center

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Nottingham University Hospital, Queen's Medical Centre

title: A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration

ipd_sharing_description: Please refer data queries to DataSharing@biogen.com.

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


title: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine and Ibrutinib in Patients With Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (LOTIS-3)

summary: The purpose of this Phase 1/2 study is to evaluate the safety and efficacy of Loncastuximab Tesirine (ADCT-402) in combination with Ibrutinib in participants with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma.

design_allocation: Non-Randomized

lead_sponsor: ADC Therapeutics S.A.

location_facility: Centre Hospitalier Universitaire de Rennes Hôpital Pontchailou

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: Azienda Unita Sanitaria Locale de Ravenna

location_facility: University of California Irvine Health Chao Family Comprehensive Cancer Center

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: Centre Hospitalier Universitaire De Poitier - Hopital De La Miletrie - Hopital Jean Bernard

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: IRCCS istituto Clinico Humanitas U.O. di Oncologia ed Ematologia

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

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: The Blood and Marrow Transplant Group of Georgia

location_facility: Georgia Cancer Center at Augusta University

location_facility: University of Michigan Comprehensive Cancer Center


title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)

acronym: Nefigard

summary: The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

ReferenceCitation: Fellstrom BC, Barratt J, Cook H, Coppo R, Feehally J, de Fijter JW, Floege J, Hetzel G, Jardine AG, Locatelli F, Maes BD, Mercer A, Ortiz F, Praga M, Sorensen SS, Tesar V, Del Vecchio L; NEFIGAN Trial Investigators. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet. 2017 May 27;389(10084):2117-2127. doi: 10.1016/S0140-6736(17)30550-0. Epub 2017 Mar 28.

ReferenceCitation: Barratt J, Lafayette R, Kristensen J, Stone A, Cattran D, Floege J, Tesar V, Trimarchi H, Zhang H, Eren N, Paliege A, Rovin BH; NefIgArd Trial Investigators. Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy. Kidney Int. 2023 Feb;103(2):391-402. doi: 10.1016/j.kint.2022.09.017. Epub 2022 Oct 19.

lead_sponsor: Calliditas Therapeutics AB

location_country:
Finland
Germany
Poland
Argentina
Australia
Turkey
Czechia
Canada
France
Belarus
United States
Belgium
Italy
United Kingdom
Korea, Republic of
Spain
Greece
Taiwan
Sweden

location_facility: Universitaetsklinikum Regensburg, Abteilung für Nephrologie, Franz-Josef-Strauss Allee 11

location_facility: Danderyds sjukhus, Njurmedicinska kliniken

location_facility: Clinico de Nefrologia, Urologia Y Enfermedades Cardiovasculares, Av. Gdor Freyre 3074

location_facility: St James´s University Hospital, Beckett St.

location_facility: Clinical Research Consultants, LLC, 3930 Washington St

location_facility: Uniklinik RWTH Aachen, Medizinische Klinik II, Pauwelsstrasse 30

location_facility: Northshore University Health System, 2650 Ridge Av.

location_facility: Omega Research Maitland, 7912 Forest City Rd.

location_facility: CISSS de la Monteregie-Centre-Hopital Charles LeMoyne, Room E-304, 3120 Taschereau Blvd

location_facility: University of Kentucky Medical Center, 800 Rose St, Pavillion H 3rd floor

location_facility: Renal Disease Research Institute, 1250 Eighth Av. #135

location_facility: Centre Hospiitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord

location_facility: General Hospital of Nikaia Ag. Panteleimon, Nephrology Clinic, Mantouvalou 3 Str.

location_facility: University Hospital of Larissa Medical School, Nefrology Clinic, Mezourlo

location_facility: Universitatsklinik Schleswig-Holstein-Campus Lubek, Medizinische Klinik I, Nephrologie, Ratzeburger Allee 160

location_facility: Kaohsiung Medical Univ Chung-Ho Memorial Hospital

location_facility: Gloucestershire Royal Hospital, Great Western Rd

location_facility: Southmead Hospital, Southmead Rd, Westbury-on-Trym

location_facility: Grodno Regional Clinical Hospital, 52 Bulvar Leninskogo Komsomola

location_facility: The Ohio State University (OSU), Wexner Medical Center, 410 West 10th Av.

location_facility: Leicester General Hospital, John Walls Renal Unit, Gwendolen Rd

location_facility: Columbia Univ Medical Center, Div of Nephrology, 51 Audubon Av

location_facility: Helsinki University Central Hospital (HUCH), Nephrology Clinic, Meilahti Triangle Hospital

location_facility: Hospital Universitario Austral, Unidad de Investigacion Clinica, Av. J.D. Peron 1500, piso 4

location_facility: 4-th N.E. Savchenko City Clinical Hospital, 110, R. Luxemburg str.

location_facility: Queen Elizabeth II Health Sciences Centre, 1276 South Park St

location_facility: Sonomed Sp. z.o.o. ul. Bandurskiego 98/U12

location_facility: Brest Regional Hospital, 7 Meditsinskaya str.

location_facility: ASST di Lecco, Presidio Ospedaliero Alessandro Manzoni, Via dell´Eremo 9/11

location_facility: Box Hill Hospital, Dept of Renal Medicine, Arnold Str 5

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi, ul Pomorska 251

location_facility: Kyungpook National University Hospital, 130 Dongdeok-ro Jung-gu

location_facility: National Cheng Kung University Hospital, No 138 Sheng Li Rd

location_facility: Chu St Etienne-Hopital Nord, Service de Nephrologie Dialyse Transplantation renale, Av. Albert Raimond

location_facility: Centre Hospitalier Universitaire de Liege, Nephrology Dept. Domaine Universitaire de Sart-Tilman

location_facility: Seoul National University Hospital, 101 Daehak-Ro, Jongno-Gu

location_facility: Oregon Health & Science University, 3181 SW Sam Jackson Park Rd

location_facility: Southeastern Nephrology Associates-Wilmington, 1302 Medical Center Drive

location_facility: Kocaeli University Medical School-Internal Medicine, Nephrology, Umuttepe Yerleskesi

location_facility: Dong-A University Hospital, Won Suk An, 26 Daesingongwon-Ro Seogu

location_facility: Chung-Ang University Hospial, 102 Heukseok-ro, Dongiak-gu

location_facility: Nephrology Associates, P.C., 28 White Bridge Rd

location_facility: Fakultni nemocnice Kralovske Vinohrady, Linterni klinika, Srobarova 1150/50

location_facility: Centre Hospitalier de Valenciennes, Service de Nephrologie-Medecine Interne, Av. Desandrouin BP 379

location_facility: Stanford University Medical Center, 777 Welch Rd

location_facility: Western Health, Western Hospital-Sunshine Hospital, 176 Furlong Rd, Level 3, WHCRE Building

location_facility: Hopital Bichat-Claude Bernard, Service de Nephrologie, 46 rue Henri Huchard

location_facility: Fakultni nemocnice Hradec Kralove, Sokolska 581

location_facility: Erciyes University Faculty of Medicine,Semiha Kibar Organ Nakli ve Dyaliz Hastanesi, Kosk Mah. prof dr Turhan Feyziogly Cad. no 42

location_facility: Cleveland Clinic, Glickman Urological & Kidney Institute, 9500 Euclid Av.

location_facility: CHUQ-L'Hotel Dieu de Quebec, 11 côte du Palais

location_facility: Kidney Care and Transplant Services of New England, PC, 354 Birnie Av.

location_facility: Mountain Kidney & Hypertension Assoc, 10 McDowell St

location_facility: Hospital Privado-Centro Medico de Cordoba, Naciones Unidas 346, Nefrologia piso 1

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie, Oddzial Kliniczny Nefrologiczny, Hipertensjologii i Chorob Wewnetrznych, ul. Zolnierska 18

location_facility: Royal Inland Hospital, Kidney Clinic, 7 South, 311 Columbia Street

location_facility: Karolinska University Hospital-Huddinge, Njur-KBC M87

location_facility: Chungnam National University Hospital, 282 Munhwa-ro, Jung-gu

location_facility: Ege University Med Faculty Dept of Internal Disease, Div of Nephrology

location_facility: Allegheny General Hospital, 4800 Friendship Av.

location_facility: Universitaetsklinikum Erlangen, Medizinisches Klinik 4, Ulmenweg 18

location_facility: Yale University School of Medicine, 330 Cedar Street

location_facility: Seoul St. Mary´s Hospital, 222 Banpo-Daero, Seocho-gu

location_facility: Western Nephrology and Metabolic Bone Disease, PC-Westerminster, 8410 Decatur St.

location_facility: Prince of Wales Hospital, Nephrology Dept, Parkes 3 West

location_facility: Istituti Clinici Scientifici Maugeri Spa-Societa Benefit, Div. di Nephrologia ed Emodialist, Via S. Maugeri 10

location_facility: Southeastern Nephrology-Whiteville, 800 Jefferson St

location_facility: Hospital Universitario Vall d´Hebron, Passeig Vall d´Hebron 119-129

location_facility: Vancouver Coastal Health Authority, Gordon and Leslie Diamond Health Care Centre, 5 th floor, Diamond Building

location_facility: Hospital 12 de Octubre, Residencia General (Sotano 1)-Area de Ensayos Clinicos, Avda. Cordoba s/n

location_facility: University General Hospital of Patras, Rio

location_facility: Fakultni nemocnice Brno, Interni gastroenterologicka klinika, Jihlavska 20

location_facility: Icahn School of Medicine at Mount Sinai-James J. Peters VA Medical Center, One Gustave L. Levy Place

location_facility: University of Manchester, Manchester Royal Infirmary, Oxford Rd

location_facility: Interior Health-Kelowna General Hosp (IH KGH), 2268 Pandosy Str.

location_facility: Northwestern University the Feinberg School of Medicine, 633 North St. Clair

location_facility: Uniwersyteckie Centrum Kliniczne-Szpital Gdanskiego Uniwersytetu Medycznego

location_facility: Hallym University Sacred Heart Hospital,22 Gwanpyeong-ro 170 beon-gil, Dongan-gu, Anyang-si

location_facility: Westmead Hospital, Dept of Renal Medicine, Hawkesbury Rd.

location_facility: University Hospital of Heraklion, Nephrology Clinic, Diastaurosi Staurakion-Vouton

location_facility: University of North Carolina at Chapel Hill, Clinical & Translational Research Centre

location_facility: University Hospital Erasmus (Brussels), Recherche Clinique Nephrologie Transplantation, Route de Lennik 808

location_facility: Tampere University Hospital, P O Box 2000, Munuaiskeskus, Erakennus, 1. kerros

location_facility: University General Hospital of Ioannina, Nephrology Clinic, Leof. Stavros Niarchou

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden, Medizinische Klinik III, Nephrologie, Fetscherstr. 74

location_facility: Hospital Britanico de Buenos Aires, Pedriel 74

location_facility: Hospital Maisonneuve-Rosemont, CNIB 3rd Floor, 1929 Bayview Avenue

location_facility: Cukurova University Medical Faculty, Dept of Internal Disease, Div of Nephrology, Balcali

location_facility: Istanbul University Cerrahpasa, Medical Faculty-Dept of Internal Disease, Fatih-Cerrahpasa, Kocamustafapasa Caddesi No 53

location_facility: University Clinic Munich, LMU-Inner City Medical Polyclinic, Nephrologisches Zentrum, Medizinische Klinik und Poliklinik IV

location_facility: Fakultni nemocnice Olomouc, I.P. Pavlova 185/6

location_facility: Hippokration General Hosp of Thessaloniki, Nephrology Clinic, 49 Konstantinoupoleos Str

location_facility: Hospital Universitario Fundacion Alcorcon, C/Budapest 1

location_facility: Hospital Clinic Barcelona, Escalera 12, Planta 5, Calle Villaroel 170

location_facility: Melbourne Health, Royal Melbourne Hospital, Dept of Nephrology,Grattan Str.

location_facility: Los Angeles Biomedical Research Institute at HUMC, 1124 W. Carson Street

location_facility: University of Minnesota, 717 Delaware St. SE

location_facility: Hospital Universitari Arnau de Vilanova, Avenida Alcalde Rovire Roure 80

location_facility: Centre Hospitalier Boulogne sur Mer, 4eme etage Batiment Administratif, Allee Jacques Monod

location_facility: Gomel Regional Clinical Hospital, 5 Brat'ev Lizukovyh str.

location_facility: Austin Health, Dept of Nephrology, 145 Studley Rd.

location_facility: University Hospital Gent, Dept of Medical Nephrology, Corneel Heymanslaan 10

location_facility: University of Colorado Health Science Center, 1200 East 19th Av.

location_facility: China Medical University Hospital, No 2 Yude Rd

location_facility: Metro South Hospital and Health Service via Princess Alexandra Hospital, Dept of Nephrology, 199 Ipswich Rd.

location_facility: Universitaetsklinikum Heidelberg-Nephrologie, Renal Clinic, Im Neuenheimer Feld 162

location_facility: Sahlgrenska University Hospital, Njurmottagningen, Vita Stråket 12

location_facility: Cliniques Universitaires Saint-Luc, Nephrology Dept, Av. Hippocrate 10

location_facility: Uppsala University Hospital, Dept of Nephrology, ing 30, plan 5

location_facility: Lapeyronie Hospital, Univ Hospital Montpellier, 371 Av. du Doyen Gaston Giraud

location_facility: Toronto General Hospital, University Health Network, 200 Elizabeth St, 8 N-849

location_facility: University of Alabama at Birmingham, 1720 2nd Ave South

location_facility: Queen Elizabeth University Hosp-Glasgow, Glasgow Clin Research Facility 5th floor, Institute of Neurosciences

location_facility: Sanatorio Allende, Hipolito Yrigoyen 384, 2 Piso

location_facility: Universitetssjukhuset Linköping, Njurmedicinska kliniken

location_facility: Hospital General Universitario Gregorio Maranon, Servicio de Nefrologica, C/Dr. Esquerdo 46

location_facility: General Hospital of Athens-Laiko, Nephrology Clinic, 17 Agiou Thoma Street

location_facility: Vseobecna fakultni nemocnice v Praze, Klinik nefrologie, U Nemocnice 499/2

location_facility: Thomas Jefferson University, 211 S. 9th Street

location_facility: Ospedale San Carlo Borromeo, Via Pio II, 3

location_facility: CHU Grenoble-Hopital Michallon, Service Nephrologie-Hemodialyse-Aphereses-Transplantation Renale, Boulevard de la Chantourne CS 10217

location_facility: Washington Nephrology Associates-Washington DC, 730 24th Street NW


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

ReferenceCitation: Eter N, Singh RP, Abreu F, Asik K, Basu K, Baumal C, Chang A, Csaky KG, Haskova Z, Lin H, Ruiz CQ, Ruamviboonsuk P, Silverman D, Wykoff CC, Willis JR. YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale. Ophthalmol Sci. 2021 Dec 30;2(1):100111. doi: 10.1016/j.xops.2021.100111. eCollection 2022 Mar.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

unpaywall_oa_status: gold

ReferenceCitation: Wykoff CC, Abreu F, Adamis AP, Basu K, Eichenbaum DA, Haskova Z, Lin H, Loewenstein A, Mohan S, Pearce IA, Sakamoto T, Schlottmann PG, Silverman D, Sun JK, Wells JA, Willis JR, Tadayoni R; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755. doi: 10.1016/S0140-6736(22)00018-6. Epub 2022 Jan 24.

oa_host_type: repository

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

version: acceptedVersion

unpaywall_oa_status: green

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Poland
Slovakia
Hungary
Israel
Japan
Austria
Mexico
United States
Spain
Turkey
Peru
Bulgaria
Russian Federation
France

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

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Specialized Hospital for Active Treatment of Eye Diseases Zora

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

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Tokyo Medical University Hachioji Medical Center

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

location_facility: Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia

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

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica

location_facility: Tokyo Women's Medical University Hospital

location_facility: Shiga University Of Medical Science Hospital

location_facility: Retina Consultants of Southern California

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

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: Hospital Universitario de Gran Canaria; Servicio de oftalmologia

location_facility: California Eye Specialists Medical group Inc.

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: National Defense Medical College Hospital

location_facility: Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia

location_facility: VISSUM Instituto Oftalmológico de Alicante

location_facility: University of California, Davis, Eye Center

location_facility: University of Utah; Division of Gastroenterology/Hepatology

location_facility: Selcuk University Faculty of Medicine; Department Of Ophthalmology

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

location_facility: University of Vermont Medical Center; Investigational Drug Service, Pharmacy Department/Baird 1

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde 3.B1.266

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

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: Medical Center for Eye Health - Focus Ltd

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

location_facility: Kaiser Permanente Riverside Medical Center

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

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

location_facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik

location_facility: Ambulatory - Medical Center for Specialized Medical Assistance - "Eye Clinic Sveta Petka" Ltd

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde

location_facility: Instituto Mexicano de Oftalmologia I.A.P.

location_facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

location_facility: Beetham Eye Institute, Joslin Diabetes Center

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

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

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

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

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: Centre Odeon; Exploration Ophtalmologique


title: A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)

summary:
Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

ReferenceCitation: Canon J, Rex K, Saiki AY, Mohr C, Cooke K, Bagal D, Gaida K, Holt T, Knutson CG, Koppada N, Lanman BA, Werner J, Rapaport AS, San Miguel T, Ortiz R, Osgood T, Sun JR, Zhu X, McCarter JD, Volak LP, Houk BE, Fakih MG, O'Neil BH, Price TJ, Falchook GS, Desai J, Kuo J, Govindan R, Hong DS, Ouyang W, Henary H, Arvedson T, Cee VJ, Lipford JR. The clinical KRAS(G12C) inhibitor AMG 510 drives anti-tumour immunity. Nature. 2019 Nov;575(7781):217-223. doi: 10.1038/s41586-019-1694-1. Epub 2019 Oct 30.

ReferenceCitation: Skoulidis F, Li BT, Dy GK, Price TJ, Falchook GS, Wolf J, Italiano A, Schuler M, Borghaei H, Barlesi F, Kato T, Curioni-Fontecedro A, Sacher A, Spira A, Ramalingam SS, Takahashi T, Besse B, Anderson A, Ang A, Tran Q, Mather O, Henary H, Ngarmchamnanrith G, Friberg G, Velcheti V, Govindan R. Sotorasib for Lung Cancers with KRAS p.G12C Mutation. N Engl J Med. 2021 Jun 24;384(25):2371-2381. doi: 10.1056/NEJMoa2103695. Epub 2021 Jun 4.

ReferenceCitation: Fakih MG, Kopetz S, Kuboki Y, Kim TW, Munster PN, Krauss JC, Falchook GS, Han SW, Heinemann V, Muro K, Strickler JH, Hong DS, Denlinger CS, Girotto G, Lee MA, Henary H, Tran Q, Park JK, Ngarmchamnanrith G, Prenen H, Price TJ. Sotorasib for previously treated colorectal cancers with KRASG12C mutation (CodeBreaK100): a prespecified analysis of a single-arm, phase 2 trial. Lancet Oncol. 2022 Jan;23(1):115-124. doi: 10.1016/S1470-2045(21)00605-7. Epub 2021 Dec 15.

ReferenceCitation: Hong DS, Fakih MG, Strickler JH, Desai J, Durm GA, Shapiro GI, Falchook GS, Price TJ, Sacher A, Denlinger CS, Bang YJ, Dy GK, Krauss JC, Kuboki Y, Kuo JC, Coveler AL, Park K, Kim TW, Barlesi F, Munster PN, Ramalingam SS, Burns TF, Meric-Bernstam F, Henary H, Ngang J, Ngarmchamnanrith G, Kim J, Houk BE, Canon J, Lipford JR, Friberg G, Lito P, Govindan R, Li BT. KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors. N Engl J Med. 2020 Sep 24;383(13):1207-1217. doi: 10.1056/NEJMoa1917239. Epub 2020 Sep 20.

ReferenceCitation: Zhao Y, Murciano-Goroff YR, Xue JY, Ang A, Lucas J, Mai TT, Da Cruz Paula AF, Saiki AY, Mohn D, Achanta P, Sisk AE, Arora KS, Roy RS, Kim D, Li C, Lim LP, Li M, Bahr A, Loomis BR, de Stanchina E, Reis-Filho JS, Weigelt B, Berger M, Riely G, Arbour KC, Lipford JR, Li BT, Lito P. Diverse alterations associated with resistance to KRAS(G12C) inhibition. Nature. 2021 Nov;599(7886):679-683. doi: 10.1038/s41586-021-04065-2. Epub 2021 Nov 10.

ReferenceCitation: Strickler JH, Satake H, George TJ, Yaeger R, Hollebecque A, Garrido-Laguna I, Schuler M, Burns TF, Coveler AL, Falchook GS, Vincent M, Sunakawa Y, Dahan L, Bajor D, Rha SY, Lemech C, Juric D, Rehn M, Ngarmchamnanrith G, Jafarinasabian P, Tran Q, Hong DS. Sotorasib in KRAS p.G12C-Mutated Advanced Pancreatic Cancer. N Engl J Med. 2023 Jan 5;388(1):33-43. doi: 10.1056/NEJMoa2208470. Epub 2022 Dec 21.

ReferenceCitation: Lanman BA, Allen JR, Allen JG, Amegadzie AK, Ashton KS, Booker SK, Chen JJ, Chen N, Frohn MJ, Goodman G, Kopecky DJ, Liu L, Lopez P, Low JD, Ma V, Minatti AE, Nguyen TT, Nishimura N, Pickrell AJ, Reed AB, Shin Y, Siegmund AC, Tamayo NA, Tegley CM, Walton MC, Wang HL, Wurz RP, Xue M, Yang KC, Achanta P, Bartberger MD, Canon J, Hollis LS, McCarter JD, Mohr C, Rex K, Saiki AY, San Miguel T, Volak LP, Wang KH, Whittington DA, Zech SG, Lipford JR, Cee VJ. Discovery of a Covalent Inhibitor of KRASG12C (AMG 510) for the Treatment of Solid Tumors. J Med Chem. 2020 Jan 9;63(1):52-65. doi: 10.1021/acs.jmedchem.9b01180. Epub 2019 Dec 24.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Chemical Society

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
Portugal
Hungary
Romania
Australia
Brazil
Japan
Austria
Belgium
Switzerland
United States
Korea, Republic of
Spain
Greece
Canada
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Sarah Cannon Research Institute at HealthONE

location_facility: University of Pittsburgh Medical Center Cancer Pavillion

location_facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

location_facility: Medical Oncology Hematology Consultants Helen F Graham Cancer Center

location_facility: Institutul Oncologic, Prof Dr Alexandru Trestioreanu

location_facility: Duke University Medical Center, Morris Cancer Clinic

location_facility: Severance Hospital Yonsei University Health System

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: American Oncology Partners of Maryland, PA

location_facility: University of Texas Southwestern Medical Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: Gibbs Cancer Center and Research Institute - Spartanburg

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente

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

location_facility: Hospital General Universitario de Valencia

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Vanderbilt University Ingram Cancer Center

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Klinikum der Universität München Campus Grosshadern

location_facility: McGill University Health Centre Glen Site

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: US Oncology Research Investigational Products Center

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

location_facility: Seoul National University Bundang Hospital

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre, Nucleo de Novos Tratamentos em Cancer

location_facility: Centre Hospitalier Intercommunal de Créteil

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

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


lead_sponsor: Sanofi

summary:
Primary Objective:

To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course.

Secondary Objective:

To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to:
Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time.
Cumulative CS (including prednisone) exposure.
To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with GCA.
To measure sarilumab serum concentrations in participants with GCA.
To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility:
Investigational Site Number 8260005
Investigational Site Number 5280005
Investigational Site Number 7240011
Investigational Site Number 7560002
Investigational Site Number 2760007
Investigational Site Number 5280009
Investigational Site Number 1240001
Investigational Site Number 7520003
Investigational Site Number 1910001
Investigational Site Number 3760006
Investigational Site Number 7240015
Investigational Site Number 8400019
Investigational Site Number 2760003
Investigational Site Number 1240010
Investigational Site Number 2500002
Investigational Site Number 2760001
Investigational Site Number 7240016
Investigational Site Number 0320002
Investigational Site Number 7240010
Investigational Site Number 8260003
Investigational Site Number 2500005
Investigational Site Number 0560001
Investigational Site Number 3800005
Investigational Site Number 1240007
Investigational Site Number 0360006
Investigational Site Number 2500001
Investigational Site Number 8260011
Investigational Site Number 0360003
Investigational Site Number 6200005
Investigational Site Number 8400011
Investigational Site Number 6430002
Investigational Site Number 2760004
Investigational Site Number 7050001
Investigational Site Number 7240014
Investigational Site Number 0320001
Investigational Site Number 8400014
Investigational Site Number 3760004
Investigational Site Number 5280001
Investigational Site Number 2500003
Investigational Site Number 2500007
Investigational Site Number 8400002
Investigational Site Number 2760002
Investigational Site Number 2330001
Investigational Site Number 6200001
Investigational Site Number 8260006
Investigational Site Number 6200004
Investigational Site Number 2500006
Investigational Site Number 7520001
Investigational Site Number 8260004
Investigational Site Number 8400017
Investigational Site Number 2080003
Investigational Site Number 3800001
Investigational Site Number 8400018
Investigational Site Number 5280007
Investigational Site Number 6430005
Investigational Site Number 2080002
Investigational Site Number 0360001
Investigational Site Number 3480001
Investigational Site Number 6430003
Investigational Site Number 1240005
Investigational Site Number 1240003

title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis

location_country:
Germany
Argentina
Australia
Croatia
Canada
France
Slovenia
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Estonia
Italy
United Kingdom
Sweden
Netherlands
Spain
Russian Federation
Israel


acronym: LATTICE

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.

location_facility: Hospital das Clinicas da Faculdade de Medicina de Botucatu

location_facility: New York-Presbyterian Columbia University Medical Center

location_facility: Kaiser Permanente Colorado Institute for Health Research

location_facility: Hunter Holmes McGuire Veterans Administration Medical Center

location_facility: Polo Universitario - LAzienda Ospedaliera Luigi Sacco

location_facility: Spring Gastroenterology Associates - Houston

location_facility: University of Florida Health - Jacksonville

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz

location_facility: New York Langone Long Island Clinical Research Associates

location_facility: Digestive Health Associates of Texas - Richardson

location_facility: South Edmonton Gastroenterology Research Clinic

location_facility: Multidisciplinary Consultative and Diagnostic Center

location_facility: University of Miami Miller School of Medicine

location_facility: Florida Medical Clinic - Clinical Research Division

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Clinica Medica Azienda Ospedaliera Universitaria

location_facility: Republican Clinical Hospital Ministry of Health Republic of Tatarstan

location_facility: Warrington and Halton Hospitals NHS Foundation Trust

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario

location_facility: Advanced Research Institute - New Port Richey

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: The Medical Research Center of Connecticut

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Mississippi Medical Center

location_facility: Gastroenterology Research of San Antonio

location_facility: Vanderbilt Inflammatory Bowel Disease Clinic

location_facility: US Digestive Disease Associates - Wyomissing

title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease

location_country:
Germany
Ireland
Poland
Australia
Brazil
Japan
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Romania
Belgium
China
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


acronym: BELINDA

lead_sponsor: Novartis Pharmaceuticals

summary: This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.

ReferenceCitation: Bishop MR, Dickinson M, Purtill D, Barba P, Santoro A, Hamad N, Kato K, Sureda A, Greil R, Thieblemont C, Morschhauser F, Janz M, Flinn I, Rabitsch W, Kwong YL, Kersten MJ, Minnema MC, Holte H, Chan EHL, Martinez-Lopez J, Muller AMS, Maziarz RT, McGuirk JP, Bachy E, Le Gouill S, Dreyling M, Harigae H, Bond D, Andreadis C, McSweeney P, Kharfan-Dabaja M, Newsome S, Degtyarev E, Awasthi R, Del Corral C, Andreola G, Masood A, Schuster SJ, Jager U, Borchmann P, Westin JR. Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma. N Engl J Med. 2022 Feb 17;386(7):629-639. doi: 10.1056/NEJMoa2116596. Epub 2021 Dec 14.

oa_colors: green other

evidence: open (via free article)

repository_institution: Max-Delbrueck-Center for Molecular Medicine - MDC Repository

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

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

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

repositories_concat: PubMed Central;ora.ox.ac.uk

publisher_dissemination: Wiley

ReferenceCitation: Kambhampati S, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.

location_facility: University of Texas MD Anderson Cancer Center MD Anderson Cancer Center

location_facility: Emory University School of Medicine/Winship Cancer Institute SC

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: University of Pennsylvania, Abramson Cancer Center

location_facility: University of California Los Angeles University of California LA

location_facility: University of Chicago Medical Center Hematology and Oncology

location_facility: Wayne State University - Karmanos Cancer Institute SC

title: Tisagenlecleucel Versus Standard of Care in Adult Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma: A Randomized, Open Label, Phase III Trial (BELINDA)

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Germany
Italy
Norway
Hong Kong
Singapore
Australia
Brazil
Japan
Austria
Belgium
Netherlands
United States
China
Spain
Switzerland
United Kingdom
Taiwan
France