summary: This study aimed to investigate the efficacy and safety of PDR001 in patients with advanced or metastatic, well-differentiated, non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin or poorly-differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) that progressed on prior treatment.

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: University of TX MD Anderson Cancer Center

title: An Open Label Phase II Study to Evaluate the Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC), That Have Progressed on Prior Treatment.

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
United Kingdom
Australia
Japan
Netherlands
Austria
Belgium
United States
Spain
Canada
France


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Hoffmann-La Roche

summary: This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.

ReferenceType: derived

ReferenceCitation: Szabados B, Ponz-Sarvise M, Machado R, Saldana D, Kadel EE, Banchereau R, Bouquet F, Garmhausen M, Powles T, Schroder C; imCORE Working Group of Early Career Investigators (imFLAME). Clinico-Genomic Characterization of Patients with Metastatic Urothelial Carcinoma in Real-World Practice Identifies a Novel Bladder Immune Performance Index (BIPI). Clin Cancer Res. 2022 Sep 15;28(18):4083-4091. doi: 10.1158/1078-0432.CCR-22-0200.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via page says license)

host_type: repository

license: cc-by

license_normalized: cc-by

version: submittedVersion

unpaywall_oa_status: bronze

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Vander Velde N, Guerin A, Ionescu-Ittu R, Shi S, Wu EQ, Lin SW, Hsu LI, Saum KU, de Ducla S, Wang J, Li S, Thastrom A, Liu S, Shi L, Leppert JT. Comparative Effectiveness of Non-cisplatin First-line Therapies for Metastatic Urothelial Carcinoma: Phase 2 IMvigor210 Study Versus US Patients Treated in the Veterans Health Administration. Eur Urol Oncol. 2019 Feb;2(1):12-20. doi: 10.1016/j.euo.2018.07.003. Epub 2018 Aug 4.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

location_facility: Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie

location_facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

location_facility: Beth Israel Deaconess Medical Center, Harvard Medical School; Department of Medicine

location_facility: Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

location_facility: The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis

location_facility: Willamette Valley Cancer Ctr - 520 Country Club

location_facility: Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Virginia Oncology Associates - Lake Wright Cancer Center

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: University of Chicago; Hematology/Oncology

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Urology Cancer Center & GU Research Network

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Institut Gustave Roussy; Oncologie Medicale

location_facility: Dana Farber Cancer Inst. ; Dept. of Medical Oncology

location_facility: The Angeles Clinic and Research Institute - W LA Office

location_facility: Kimmel Cancer Center Thomas Jefferson University

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Mount Sinai School of Medicine - Tisch Cancer Institute

location_facility: Indiana University Health; Goshen Center for Cancer Care

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

status: Completed

title: A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Actual

study_completion_date_type: Actual

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

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


intervention_type: Biological

lead_sponsor: Cellaion SA

summary: The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.

location_facility:
UZ Gent
Hôpital Paul Brousse
Cliniques St Luc
KU Leuven
CHU Brugmann
CHU de Liège
Hôpital de la Croix Rousse
UZ Antwerpen
Hôpital Beaujon
Hôpital Erasme

title: Multicenter Phase II Safety and Preliminary Efficacy Study of 2 Dose Regimens of HepaStem in Patients With Acute on Chronic Liver Failure

design_allocation: Non-Randomized

location_country: Belgium France


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Single Dose of ASN100 for the Prevention of Staphylococcus Aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects

summary: The purpose of this study is the prevention of Staphylococcus aureus pneumonia in mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis. Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is an investigational monoclonal antibody product that targets the toxins produced by S. aureus to protect subjects from developing S. aureus pneumonia.

status: Terminated

design_allocation: Randomized

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: Arsanis, Inc.

location_country:
Poland
India
Portugal
Hungary
Israel
Romania
Austria
United States
Spain
South Africa
Czechia
Ukraine
Georgia
Serbia
Russian Federation
France

location_facility:
Research Site 688-001
Research Site 688-003
Research Site 268-001
Research Site 040-001
Research Site 268-008
Research Site
Research Site 040-002
Research Site 268-011
Research Site 268-004
Research Site 268-002
Research Site 268-003
Research Site 268-009
Research Site 268-006
Research Site 268-005
Research Site 268-007
Research Site 688-002
Research Site 688-005
Research Site 688-004
Research Site 268-010

status_simplified: Unknown


title: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)

acronym: SOLVE-CRT

summary: This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Singh JP, Abraham WT, Auricchio A, Delnoy PP, Gold M, Reddy VY, Sanders P, Lindenfeld J, Rinaldi CA. Design and rationale for the Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in non-responders and previously untreatable patients (SOLVE-CRT) trial. Am Heart J. 2019 Nov;217:13-22. doi: 10.1016/j.ahj.2019.04.002. Epub 2019 Apr 9.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

unpaywall_oa_status: hybrid

lead_sponsor: EBR Systems, Inc.

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
United States
France

location_facility: Penn State Health, Hershey Medical Center

location_facility: Universitäres Herzzentrum Hamburg (UKE Hamburg) GmbH (UHZ)

location_facility: The University of Texas Health Science Center at Houston

location_facility: St. Vincent's Hospital and Healthcare Center

location_facility: Royal Melbourne Hospital / Royal Hobart Hospital

location_facility: CHU Grenoble - Hopital Michallon Service de Cardiologie

location_facility: Immanuel Klinikum Bernau - Herzzentrum Brandenburg

location_facility: Methodist Physicians Clinic Heart Consultants

intervention_type: Device

status_simplified: Ongoing


title: Efficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept Study

summary:
Primary Objective:

To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc).

Secondary Objectives:

To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in participants with dcSSc.
To evaluate the efficacy of SAR156597 compared to placebo on respiratory function of participants with dcSSc.
To evaluate the safety profile of SAR156597 compared to placebo in participants with dcSSc.
To evaluate the potential for immunogenicity (anti-drug antibodies response) of SAR156597 in participants with dcSSc.
To evaluate the pharmacokinetics (trough plasma concentrations) of SAR156597 administered subcutaneously for 24 weeks.

ReferenceCitation: Allanore Y, Wung P, Soubrane C, Esperet C, Marrache F, Bejuit R, Lahmar A, Khanna D, Denton CP; Investigators. A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis. Ann Rheum Dis. 2020 Dec;79(12):1600-1607. doi: 10.1136/annrheumdis-2020-218447. Epub 2020 Sep 22.

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

publisher_dissemination: British Medical Journal

ipd_sharing: Yes

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

lead_sponsor: Sanofi

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Romania
Mexico
Belgium
United States
Ukraine
Estonia
Russian Federation
France

location_facility:
Investigational Site Number 0560002
Investigational Site Number 8040002
Investigational Site Number 8400006
Investigational Site Number 3800006
Investigational Site Number 8400007
Investigational Site Number 0320005
Investigational Site Number 4840003
Investigational Site Number 2760003
Investigational Site Number 2500002
Investigational Site Number 2760001
Investigational Site Number 0320002
Investigational Site Number 6420004
Investigational Site Number 6420002
Investigational Site Number 8040003
Investigational Site Number 8260001
Investigational Site Number 3800005
Investigational Site Number 0560001
Investigational Site Number 6430001
Investigational Site Number 4840001
Investigational Site Number 4840002
Investigational Site Number 4840005
Investigational Site Number 6430002
Investigational Site Number 2760004
Investigational Site Number 6430004
Investigational Site Number 8040001
Investigational Site Number 6160002
Investigational Site Number 0320001
Investigational Site Number 2500004
Investigational Site Number 8400005
Investigational Site Number 6160001
Investigational Site Number 8400002
Investigational Site Number 2760002
Investigational Site Number 2330001
Investigational Site Number 8040004
Investigational Site Number 0320003
Investigational Site Number 3800004
Investigational Site Number 3800001
Investigational Site Number 6420005
Investigational Site Number 6160003
Investigational Site Number 6430005
Investigational Site Number 2500003
Investigational Site Number 6430003
Investigational Site Number 6420001
Investigational Site Number 6420003


acronym: OUTSTEP-HF

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary physical activity in HFrEF patients. Physical activity was assessed by the 6 minute walk test, and daily physical activity was continuously measured by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).

title: A Multi-center, Prospective, Randomized, Double-blind Study to Assess the Impact of Sacubitril/Valsartan vs. Enalapril on Daily Physical Activity Using a Wrist Worn Actigraphy Device in Adult Chronic Heart Failure Patients

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

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

location_country:
Finland
Germany
Ireland
Poland
Czechia
France
Lithuania
Denmark
Latvia
Iceland
Belgium
Estonia
Norway
United Kingdom
Netherlands
Spain
Greece
Bulgaria
Sweden


title: Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 18 Years of Age

summary: Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent participants with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.

lead_sponsor: H. Lundbeck A/S

location_country:
Germany
Poland
Canada
Serbia
France
Colombia
Hungary
United States
Latvia
Ukraine
Estonia
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Israel

location_facility: Medicorehabilitation Research Center Phoenix

location_facility: Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...

location_facility: Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri

location_facility: Lipetsk Regional Psychoneurological Hospital

location_facility: Odessa Regional Medical Centre of Mental Health

location_facility: Centrum Badan Klinicznych PI-House Sp. z o.o.

location_facility: Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C

location_facility: Arkhangelsk Regional Clinical Mental Hospital

location_facility: Child and Adolescent Neurology and Psychiatry Clinic

location_facility: LLC City Neurological Center Sibneuromed

location_facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Soon Chun Hyang University Hospital Cheonan

location_facility: Daily Hospital for Children and Adolescents

location_facility: Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...

location_facility: Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS

location_facility: CRI Centro Regiomontano de Investigacion SC

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Dip.Sc.Biomediche, Odont. e Imm.Funz.li, AOU Policlinico G. Martino

location_facility: Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...

location_facility: University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry

location_facility: Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny

location_facility: The University of Arizona Sarver Heart Center (SHC)

location_facility: Clinical Center of Vojvodina - Clinic of Psychiatry

location_facility: Klinik fur Kinderneurologie und Sozialpadiatrie Kinderzentrum Maulbronn gGmbH

location_facility: City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov

location_facility: Diagnostic Consultative Center Mladost-M Varna OOD

location_facility: Stavropol Region Psychiatric Hospital No.2

location_facility: State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...

location_facility: Scientific Institute Fondazione Stella Maris

location_facility: Filip Rybakowski Specjalistyczna Praktyka Lekarska

location_facility: U.O.C. Neuropsichiatria Infantile - IRCCS Istituto Giannina Gaslini

location_facility: Yaroslavl Regional Clinical Psychiatry Hospital

location_facility: E.S.E. Hospital Mental de Antioquia HOMO

location_facility: Kansas University School of Medicine-Wichita

location_facility: Guz Saratov Regional Psychiatric Hospital St. Sofii

location_facility: Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu

location_facility: Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.

location_facility: State Budgetary Healthcare Institution of Sverdlovsk Region Â¿Sverdlovsk Regional Clinical Psychi...

location_facility: Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)

location_facility: Vadaskert Child Psychiatric Hospital and Outpatient

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Przychodnia Syntonia Poradnia Zdrowia Psychicznego

location_facility: NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...


title: A Phase 2, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GS-5745 Combined With Nivolumab Versus Nivolumab Alone in Subjects With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

summary: The primary objective of this study is to evaluate and compare the efficacy of andecaliximab (GS-5745) in combination with nivolumab versus nivolumab alone in adults with recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma.

ReferenceCitation: Shah MA, Cunningham D, Metges JP, Van Cutsem E, Wainberg Z, Elboudwarej E, Lin KW, Turner S, Zavodovskaya M, Inzunza D, Liu J, Patterson SD, Zhou J, He J, Thai D, Bhargava P, Brachmann CB, Cantenacci DVT. Randomized, open-label, phase 2 study of andecaliximab plus nivolumab versus nivolumab alone in advanced gastric cancer identifies biomarkers associated with survival. J Immunother Cancer. 2021 Dec;9(12):e003580. doi: 10.1136/jitc-2021-003580.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of California - eScholarship University of California

repositories:
LIRIAS (KU Leuven)
PubMed Central
escholarship.org

repositories_concat: LIRIAS (KU Leuven);PubMed Central;escholarship.org

unpaywall_oa_status: gold

lead_sponsor: Gilead Sciences

location_country:
Italy
Poland
Hungary
United Kingdom
Australia
Belgium
United States
Spain
France


title: A Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With Relapsed or Refractory Malignant Mesothelioma With BAP1 Loss of Function

summary:
This is a Phase 2, multicenter, open-label, 2-part, single-arm, 2-stage study of tazemetostat 800 mg two times a day (BID) administered orally. Screening of subjects to determine eligibility for the study will be performed within 21 days of the first planned dose of tazemetostat.

In Part 1: planned to enroll 12 subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status will be treated and undergo pharmacokinetics (PK) blood sample collection after a single tazemetostat 800 mg.

Part 2 plans to include 55 subjects with BAP1-deficient relapsed or refractory malignant mesothelioma.

Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study. Response assessment will be evaluated after 6 weeks of treatment and then every 12 weeks thereafter while on study.

ReferenceCitation: Zauderer MG, Szlosarek PW, Le Moulec S, Popat S, Taylor P, Planchard D, Scherpereel A, Koczywas M, Forster M, Cameron RB, Peikert T, Argon EK, Michaud NR, Szanto A, Yang J, Chen Y, Kansra V, Agarwal S, Fennell DA. EZH2 inhibitor tazemetostat in patients with relapsed or refractory, BAP1-inactivated malignant pleural mesothelioma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2022 Jun;23(6):758-767. doi: 10.1016/S1470-2045(22)00277-7. Epub 2022 May 16.

ipd_sharing_description: To be determined.

lead_sponsor: Epizyme, Inc.

location_country:
United States
United Kingdom
France

location_facility: University of Leicester & Leicester University Hospitals


title: A Randomized, Double-blind, Placebo Controlled, 3- Part, Adaptive Design, Multicenter Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH): FLIGHT-FXR

acronym: FLIGHT-FXR

summary: The purpose of the study was to assess the effects of different doses of tropifexor (LJN452) with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

ReferenceCitation: Naoumov NV, Brees D, Loeffler J, Chng E, Ren Y, Lopez P, Tai D, Lamle S, Sanyal AJ. Digital pathology with artificial intelligence analyses provides greater insights into treatment-induced fibrosis regression in NASH. J Hepatol. 2022 Nov;77(5):1399-1409. doi: 10.1016/j.jhep.2022.06.018. Epub 2022 Jun 30.

ipd_sharing: Undecided

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

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

location_country:
Germany
Italy
India
Slovakia
Argentina
Singapore
Australia
Japan
Netherlands
Austria
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
France


acronym: HAVEN 3

summary: This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or older. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this population with emphasis on efficacy, safety, and pharmacokinetics.

ReferenceCitation: Kruse-Jarres R, Peyvandi F, Oldenburg J, Chang T, Chebon S, Doral MY, Croteau SE, Lambert T, Kempton CL, Pipe SW, Ko RH, Trzaskoma B, Dhalluin C, Bienz NS, Niggli M, Lehle M, Paz-Priel I, Young G, Jimenez-Yuste V. Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies. Blood Adv. 2022 Dec 27;6(24):6140-6150. doi: 10.1182/bloodadvances.2022007458.

repositories_concat: PubMed Central

publisher_dissemination: American Society of Hematology

ReferenceCitation: Kiialainen A, Niggli M, Kempton CL, Castaman G, Chang T, Paz-Priel I, Adamkewicz JI, Levy GG. Effect of emicizumab prophylaxis on bone and joint health markers in people with haemophilia A without factor VIII inhibitors in the HAVEN 3 study. Haemophilia. 2022 Nov;28(6):1033-1043. doi: 10.1111/hae.14642. Epub 2022 Jul 29.

publisher_dissemination: Wiley

ReferenceCitation: Mahlangu J, Oldenburg J, Paz-Priel I, Negrier C, Niggli M, Mancuso ME, Schmitt C, Jimenez-Yuste V, Kempton C, Dhalluin C, Callaghan MU, Bujan W, Shima M, Adamkewicz JI, Asikanius E, Levy GG, Kruse-Jarres R. Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors. N Engl J Med. 2018 Aug 30;379(9):811-822. doi: 10.1056/NEJMoa1803550.

oa_host_type: publisher

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
Hoffmann-La Roche
Chugai Pharmaceutical

location_facility: Cornell Univ Medical College; Hematology-Oncolog

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"

location_facility: CH de Bicetre; Centre de Traitement d' Hemophilie

location_facility: Georgetown Uni Medical Center; Lombardi Cancer Center

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hopital Cardio-vasculaire Louis Pradel; Hemostase clinique

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

location_facility: Children's Hospital of Michigan; Pediatrics

location_facility: Dana-Farber Cancer Institute; Brigham and Women's Cancer Center

location_facility: ALVAMED Lekarskie Gabinety Specjalistyczne

location_facility: Bloodworks Northwest (formerly Puget Sound Blood Center); Hemophilia

location_facility: Groupe Hospitalier Necker Enfants Malades

title: A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients Without Inhibitors

location_country:
Germany
Ireland
Italy
Poland
United Kingdom
Australia
Costa Rica
Japan
United States
Korea, Republic of
Spain
South Africa
Taiwan
France


acronym: Gemini 2

lead_sponsor: ViiV Healthcare

summary: This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC] fixed dose combination [FDC]) administered once daily in human immunodeficiency virus (HIV) 1 infected adult participants that have not previously received antiretroviral therapy. The study is designed to demonstrate the non inferior antiviral activity of DTG + 3TC regimen to that of DTG + TDF/FTC FDC and will characterise the long term antiviral activity, tolerability and safety of DTG plus 3TC through Week 148. Approximately, 700 participants will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Participants will be stratified by screening HIV 1 ribonucleotide nucleic acid (RNA) levels and by screening CD4+ (cluster of differentiation 4) cell count.

ReferenceType: background

ReferenceCitation: Cahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9. Erratum In: Lancet. 2018 Nov 28;:

ReferenceCitation: Ait-Khaled M, Sierra Madero J, Estrada V, Gulminetti R, Hagins D, Tsai HC, Man C, Sievers J, Grove R, Zolopa A, Wynne B, van Wyk J. Impact of treatment adherence on efficacy of dolutegravir plus lamivudine and dolutegravir plus tenofovir disoproxil fumarate/emtricitabine: pooled analysis of the GEMINI-1 and GEMINI-2 clinical studies. HIV Res Clin Pract. 2021 Dec 9;23(1):9-14. Epub 2021 Dec 16.

sponsor_collaborators:
ViiV Healthcare
GlaxoSmithKline

title: A Phase III, Randomised, Double-blind, Multicentre, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-naïve Adults

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Argentina
Romania
Australia
Switzerland
Mexico
Belgium
United States
Spain
Taiwan
Peru
Canada
Russian Federation
France


title: An Open Label, Phase I Study to Assess the Effect of Itraconazole (CYP3A4 and P-gp Inhibitor) on the Pharmacokinetics of Anetumab Ravtansine and to Assess the ECG Effects, Safety and Immunogenicity of Anetumab Ravtansine Given as a Single Agent and Together With Itraconazole in Subjects With Mesothelin-expressing Advanced Solid Cancers

summary: Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by concomitant administration of itraconazole in subjects with mesothelin-expressing advanced solid cancers

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Australia
Netherlands
Belgium
United States
Spain
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: Washington University School of Medicine

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)

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

location_facility: Universitair Medisch Centrum St. Radboud


acronym: CENTERA

summary:
Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood away from the retina (the very back portion of the eye) becomes blocked, causing the leakage of fluid into the retina and thereby causing a swelling of the macula (the portion of the retina responsible for fine vision). This swelling is called macular edema. When the macula swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown to reduce the amount of fluid and blood leaked into the retina. It can help to stabilize, and in many cases, improve the vision loss related to CRVO. Aflibercept has been approved for the treatment of macular edema secondary to CRVO in the United States (US), European Union (EU), Japan, and other countries.

The study was considered research because, although the study drug was already on the market for macular edema secondary to CRVO, there were no studies available that addressed the questions of what were useful intervals for treating and assessing patients, how did they differ among patients, and how were criteria applied for retreatment. The purpose of this study was to evaluate the effectiveness, treatment interval, and safety of the treatment regimen (pattern for administering treatment) in subjects with macular edema secondary to CRVO. In addition, this study explored new imaging methods for assessing the affected eye.

ReferenceCitation: Korobelnik JF, Larsen M, Eter N, Bailey C, Wolf S, Schmelter T, Allmeier H, Chaudhary V. Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend for Macular Edema in Central Retinal Vein Occlusion: the CENTERA Study. Am J Ophthalmol. 2021 Jul;227:106-115. doi: 10.1016/j.ajo.2021.01.027. Epub 2021 Feb 6.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

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

title: A Multi-center, Single-arm, Interventional Phase 4 Study to Evaluate a Treat and Extend Regimen of Intravitreal Aflibercept for Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Spain
Canada
France


acronym: HAVEN 2

summary: This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This study will open two additional non-randomized cohorts to investigate once every 2 weeks (Q2W) and once every 4 weeks (Q4W) regimens in pediatric participants.

ReferenceCitation: Young G, Liesner R, Chang T, Sidonio R, Oldenburg J, Jimenez-Yuste V, Mahlangu J, Kruse-Jarres R, Wang M, Uguen M, Doral MY, Wright LY, Schmitt C, Levy GG, Shima M, Mancuso ME. A multicenter, open-label phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors. Blood. 2019 Dec 12;134(24):2127-2138. doi: 10.1182/blood.2019001869.

repository_institution: PubMed Central - Europe PMC

location_facility: Ege University, School of Medicine; Pediatrics Department

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

location_facility: CH de Bicetre; Centre de Traitement d' Hemophilie

location_facility: Hospital of the University of Occupational and Environmental Health,Japan

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: University of Colorado Denver, Children's Hospital

location_facility: Istanbul University, Cerrahpasa Medical Faculty; Pediatrics Department

location_facility: Adana Acibadem Hospital; Pediatric Hematology

location_facility: Great Ormond street Hospital for Children NHS Foundation Trust; Haemophilia Centre

location_facility: Oregon Health & Science Uni ; Dept of Pediatrics

location_facility: North Shore/Long Island Jewish PRIME; Pediatric Hematology/Oncology & Stem Cell Transplantation

title: A Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Administration of Emicizumab in Hemophilia A Pediatric Patients With Inhibitors

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

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Germany
Italy
United Kingdom
Japan
Costa Rica
United States
Spain
South Africa
Turkey
France


title: A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Subjects With Solid Tumors and Non-Hodgkin's Lymphoma

acronym: Meteor 1

summary: This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL).

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

lead_sponsor: GlaxoSmithKline

location_country:
United States
Canada
Netherlands
France


lead_sponsor: Eli Lilly and Company

summary: The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer.

ReferenceCitation: Pujol JL, Vansteenkiste J, Paz-Ares Rodriguez L, Gregorc V, Mazieres J, Awad M, Janne PA, Chisamore M, Hossain AM, Chen Y, Beck JT. Abemaciclib in Combination With Pembrolizumab for Stage IV KRAS-Mutant or Squamous NSCLC: A Phase 1b Study. JTO Clin Res Rep. 2021 Sep 25;2(11):100234. doi: 10.1016/j.jtocrr.2021.100234. eCollection 2021 Nov.

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

sponsor_collaborators:
Eli Lilly and Company
Merck Sharp & Dohme LLC

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Taipei Medical University- Shuang Ho Hospital

location_facility: University of Colorado School of Medicine

location_facility: CHU de Montpellier-Hopital Arnaud de Villeneuve

title: A Phase 1b Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer

location_country:
Italy
Belgium
United States
Spain
Turkey
Taiwan
France


title: A Study to Determine the Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma From Patients With Non Small Cell Lung Carcinoma (NSCLC)

summary: A study to determine the concordance of key actionable genomic alterations as assessed in tumor tissue and plasma from patients with non small cell lung carcinoma (NSCLC)

study_type: Observational

time_perspective: Prospective

lead_sponsor: Genomic Health®, Inc.

location_country:
Ireland
United Kingdom
Japan
United States
Spain
Chile
France

location_facility: Cancer Care Associates d/b/a Torrance Memorial Physician Network

location_facility: Clatterbridge Cancer Center NHS Foundation Trust

location_facility: Hospital Clinico Universitario Lozano Blesa


lead_sponsor: Amgen

summary: This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection

location_facility: Hospital Universitari i Politecnic La Fe

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

location_facility: Institut Hematologie et Oncologie Pediatrique

location_facility: Hospital Universitario Infantil Niño Jesus

location_facility: Centre Hospitalier Universitaire Sainte Justine

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

title: A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumors That Are Amenable to Direct Injection

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

location_country:
Italy
Switzerland
Belgium
United States
Spain
Canada
France


title: A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)

acronym: FRACTION-Lung

summary: The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Australia
Switzerland
Austria
United States
Spain
Canada
France

location_facility: University of Maryland - Marlene and Stewart Greenebaum Cancer Center

location_facility: University of Californa, Los Angeles (UCLA)

location_facility: University Of Ottawa - The Ottawa Hospital Cancer centre

location_facility: University of Washington-Seattle Cancer Care Alliance

location_facility: Washington University, The Center for Advanced Medicine

location_facility: Juravinski Cancer Centre, Hamilton Health Sciences-Mcmaster Univeristy's Faculty Of Health Sciences

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce

location_facility: Sidney Kimmel Comprehensive Cancer Center

location_facility: The West Clinic, P.C. d/b/a West Cancer Center


lead_sponsor: Institut de Recherches Internationales Servier

summary: The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.

ReferenceCitation: Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Fougeray R, Egorov A, Amellal N, Moiseyenko V. First-line trifluridine/tipiracil + bevacizumab in patients with unresectable metastatic colorectal cancer: final survival analysis in the TASCO1 study. Br J Cancer. 2022 Jun;126(11):1548-1554. doi: 10.1038/s41416-022-01737-2. Epub 2022 Apr 19.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repositories:
LIRIAS (KU Leuven)
PubMed Central
sdu.dk

repositories_concat: LIRIAS (KU Leuven);PubMed Central;sdu.dk

publisher_dissemination: Springer-Nature

ReferenceCitation: Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Kanehisa A, Egorov A, Aubel P, Amellal N, Moiseenko V. Trifluridine/tipiracil plus bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study. Ann Oncol. 2020 Sep;31(9):1160-1168. doi: 10.1016/j.annonc.2020.05.024. Epub 2020 Jun 1.

repositories_concat: LIRIAS (KU Leuven);sdu.dk

location_facility: Odense Universitetshospital - Department of Oncology

location_facility: Imperial healthcare NHS Trust Charing Cross Hospital

location_facility: Complejo Hospitalario de Navarra, Oncología Médica

location_facility: Instituto Catalan De Oncología, Hospitalet de Llobregat

location_facility: Hospital Ramón y Cajal, Oncología Médica

location_facility: Catharina Ziekenhuis, Interne Geneeskunde/Oncologie

location_facility: Hospital Universitario Reina Sofia, Deparatmento Oncología Médica

location_facility: Russian Cancer Research Center n.a. NN Blokhin, Department of Research for New Antitumour Medicines

location_facility: Instituto do Câncer do Estado de São Paulo - ICESP, Núcleo de Pesquisa

location_facility: Isala Klinieken, Medische oncologie, Dokter Van Heeweg 2

location_facility: Centro de Pesquisa Hospital de Caridade de Ijuí

location_facility: Austin Hospital Olivia Newton-John Cancer & Wellness Centre

location_facility: H. Universitario La Paz Oncología Médica

location_facility: Amphia Ziekenhuis, Interne Geneeskunde/Oncologie, Langendijk 75

location_facility: CHU Jean Minjoz, Service d'oncologie médicale

location_facility: Schwerpunktpraxis für Hämatologie und Onkologie

location_facility: A.O.U. SanMartino-IST, Unità Operativa Oncologia Medica 1

location_facility: Moscow City Oncology Hospital # 62, Chemotherapy

location_facility: Leicester Royal Infirmary, The HOPE Clinical Trials Unit

location_facility: Instituto Nacional do Câncer - INCA Unidade de Pesquisa ClínicaInstituto Nacional do Câncer - INCA Unidade de Pesquisa Clínica

location_facility: Seconda Università degli Studi di Napoli, U.O.C. di Oncologia Medica ed Ematologia

location_facility: Hospital de Base, Centro Intergrado de Pesquisa

location_facility: Martini Ziekenhuizen, Interne Geneeskunde/Oncologie, Van Swietenplein 1

location_facility: Scientific Centre for Specialized Medical Care (oncological)

location_facility: Mount Vernon Hospital Department of Oncology

location_facility: Städtisches Krankenhaus München Neuperlach, Klinik für Onkologie und Hämatologie

location_facility: AMC Academisch Medisch Centrum Medische Oncologie

location_facility: UZ Leuven Campus Gasthuisberg Digestieve Oncologie

location_facility: The Beatson West of Scotland Cancer Centre GI cancers

location_facility: NZOZ MAGODENT Oddzial Onkologii Klinicznej / Chemioterapii

location_facility: Fondazione Poliambulanza Istituto Ospedaliero, Clinical Oncology

location_facility: Sint Antonius Ziekenhuis Interne Geneeskunde/Oncologie

location_facility: A.O. Ospedale Niguarda Ca' Granda-Milano, Department of Onco-Haematology- Onoclogia Falck

location_facility: Zuyderland Medisch Centrum Interne Geneeskunde

location_facility: Hospital Valle de Hebrón, Servicio de Oncología

location_facility: Centre René Gauducheau, Oncologie Médicale

location_facility: Hôpital Saint Antoine, oncology department

location_facility: Tergooi Hilversum, Medische Oncologie, Van Riebeeckweg 212

location_facility: .O.U. Pisana-Ospedale Santa Chiara, U.O. di Oncologia Medica 2

location_facility: Hospital General Universitario, Oncología Médica

location_facility: The Queen Elizabeth Hospital Haematology and Oncology Unit

location_facility: Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii

location_facility: Hospital do Câncer de Barretos - Fundação Pio XII

location_facility: Centralny Szpital Kliniczny MSW Klinika Onkologii i Hematologii

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii

location_facility: Grand Hôpital de Charleroi Oncologie-Hématologie

location_facility: VieCurie Medisch Centrum, Interne Geneeskunde, Tegelseweg 210

location_facility: Christie Hospital NHS Foundation Trust, GI & Endocrine

title: An Open-label, Randomised, Non-comparative Phase 2 Study Evaluating S 95005 (TAS-102) Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Metastatic COlorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1 Study).

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Australia
Brazil
Netherlands
Belgium
Spain
Russian Federation
France


summary: The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.

sponsor_collaborators: Institut de Recherches Internationales Servier

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Texas Southwestern Medical Center

location_facility: King's College Hospital NHS Foundation Trust

title: Long-term Follow-up Study of Patients Who Have Previously Been Exposed to UCART19 (Allogeneic Engineered T-cells Expressing a Lentiviral-based Anti-CD19 Chimeric Antigen Receptor)

primary_purpose: Other

location_country:
United Kingdom
Japan
United States
Spain
France


lead_sponsor: Avadel

summary: The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.

ReferenceCitation: Roth T, Dauvilliers Y, Thorpy MJ, Kushida C, Corser BC, Bogan R, Rosenberg R, Dubow J, Seiden D. Effect of FT218, a Once-Nightly Sodium Oxybate Formulation, on Disrupted Nighttime Sleep in Patients with Narcolepsy: Results from the Randomized Phase III REST-ON Trial. CNS Drugs. 2022 Apr;36(4):377-387. doi: 10.1007/s40263-022-00904-6. Epub 2022 Apr 5.

ReferenceCitation: Kushida CA, Shapiro CM, Roth T, Thorpy MJ, Corser BC, Ajayi AO, Rosenberg R, Roy A, Seiden D, Dubow J, Dauvilliers Y. Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. Sleep. 2022 Jun 13;45(6):zsab200. doi: 10.1093/sleep/zsab200.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

publisher_dissemination: Oxford University Press

location_facility: CIUSS de Nord-de-I'ile-de- Montreal- Hopital de Sacre-Coeur de Montreal

location_facility: OSF Healthcare Saint Francis Medical Center

location_facility: Medical University of South Carolina - Institute of Psychiatry

location_facility: Sleep Medicine Specialist of South Florida

location_facility: INSERM - Centre d'Investigation Clinque Hopital Robert Debre

location_facility: Yale-New Haven Hospital's Sleep Medicine Center

location_facility: Sleep Medicine Specialists of South Florida

location_facility: University Hospitals Case Medical Center

location_facility: NeuroMedical Research Institute/Global Research Holdings, LLC

location_facility: Baptist Health Center for Clinical Research

location_facility: NHMRC CEntre for Translational Sleep and Circadian Neurobiology

location_facility: Sleep Management Institute Intrepid Research

location_facility: Florida Pulmonary Research Institute LLC

title: A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy

location_country:
Germany
Australia
United States
Czechia
Canada
France


summary: Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).

ReferenceCitation: Findling RL, DelBello MP, Zuddas A, Emslie GJ, Ettrup A, Petersen ML, Schmidt SN, Rosen M. Vortioxetine for Major Depressive Disorder in Adolescents: 12-Week Randomized, Placebo-Controlled, Fluoxetine-Referenced, Fixed-Dose Study. J Am Acad Child Adolesc Psychiatry. 2022 Sep;61(9):1106-1118.e2. doi: 10.1016/j.jaac.2022.01.004. Epub 2022 Jan 13.

sponsor_collaborators:
H. Lundbeck A/S
Takeda

location_facility: US1385 Ericksen Research And Development

location_facility: RS1006 Clinic of Neurology and Psychiatry for Children and Adolescents

title: Interventional, Randomised, Double-blind, Placebo-controlled, Active Reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years, With Major Depressive Disorder (MDD)

location_country:
Germany
Poland
Canada
Serbia
France
Colombia
Hungary
United States
Latvia
Ukraine
Estonia
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation


summary: Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).

location_facility: Medicorehabilitation Research Center Phoenix

location_facility: Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...

location_facility: Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri

location_facility: Odessa Regional Medical Centre of Mental Health

location_facility: Centrum Badan Klinicznych PI-House Sp. z o.o.

location_facility: Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C

location_facility: Arkhangelsk Regional Clinical Mental Hospital

location_facility: Child and Adolescent Neurology and Psychiatry Clinic

location_facility: LLC City Neurological Center Sibneuromed

location_facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Medical Research Group of Central Florida

location_facility: Daily Hospital for Children and Adolescents

location_facility: Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS

location_facility: CRI Centro Regiomontano de Investigacion SC

location_facility: Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...

location_facility: University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry

location_facility: Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny

location_facility: Alliance for Wellness dba Alliance for Research

location_facility: ICARO Investigaciones en Medicina S.A. de C.V.

location_facility: Clinical Center of Vojvodina - Clinic of Psychiatry

location_facility: City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov

location_facility: Diagnostic Consultative Center Mladost-M Varna OOD

location_facility: Stavropol Region Psychiatric Hospital No.2

location_facility: Centro Investigacion Medico Biologica Y Terapia Avanzada

location_facility: State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...

location_facility: The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital

location_facility: Scientific Institute Fondazione Stella Maris

location_facility: Filip Rybakowski Specjalistyczna Praktyka Lekarska

location_facility: Yaroslavl Regional Clinical Psychiatry Hospital

location_facility: Children's National Medical Center Merge

location_facility: E.S.E. Hospital Mental de Antioquia HOMO

location_facility: Kansas University School of Medicine-Wichita

location_facility: Guz Saratov Regional Psychiatric Hospital St. Sofii

location_facility: Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu

location_facility: Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.

location_facility: State Budgetary Healthcare Institution of Sverdlovsk Region Â¿Sverdlovsk Regional Clinical Psychi...

location_facility: Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Przychodnia Syntonia Poradnia Zdrowia Psychicznego

location_facility: St. Charles Psychiatric Associates - Midwest Research Group

title: Interventional, Randomized, Double-blind, Placebo-controlled, Active-reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years, With Major Depressive Disorder (MDD)

location_country:
Germany
Poland
Canada
Serbia
France
Colombia
Hungary
United States
Latvia
Ukraine
Estonia
Italy
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Israel


summary: The primary objective of this study is to evaluate the effect of entospletinib (ENTO) on the best overall response rate in adults with chronic graft versus host disease (cGVHD) who are currently receiving systemic corticosteroids as part of first-line therapy for cGVHD.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Ohio State University, Wexner Medical Center

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Clinico Universitario de Valencia

title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Entospletinib, a Selective SYK Inhibitor, in Combination With Systemic Corticosteroids as First-Line Therapy in Subjects With Chronic Graft Versus Host Disease (cGVHD)

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


title: Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

summary:
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

ReferenceCitation: Ramlawi B, Deeb GM, Yakubov SJ, Markowitz AH, Hughes GC, Kiaii RB, Huang J, Kleiman NS, Reardon MJ. Mechanisms of Death in Low-Risk Patients After Transcatheter or Surgical Aortic Valve Replacement. Cardiovasc Revasc Med. 2022 Sep;42:1-5. doi: 10.1016/j.carrev.2022.03.027. Epub 2022 Mar 29.

ReferenceCitation: Forrest JK, Deeb GM, Yakubov SJ, Rovin JD, Mumtaz M, Gada H, O'Hair D, Bajwa T, Sorajja P, Heiser JC, Merhi W, Mangi A, Spriggs DJ, Kleiman NS, Chetcuti SJ, Teirstein PS, Zorn GL 3rd, Tadros P, Tchetche D, Resar JR, Walton A, Gleason TG, Ramlawi B, Iskander A, Caputo R, Oh JK, Huang J, Reardon MJ. 2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients. J Am Coll Cardiol. 2022 Mar 8;79(9):882-896. doi: 10.1016/j.jacc.2021.11.062.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Lanz J, Reardon MJ, Pilgrim T, Stortecky S, Deeb GM, Chetcuti S, Yakubov SJ, Gleason TG, Huang J, Windecker S. Incidence and Outcomes of Infective Endocarditis After Transcatheter or Surgical Aortic Valve Replacement. J Am Heart Assoc. 2021 Oct 5;10(19):e020368. doi: 10.1161/JAHA.120.020368. Epub 2021 Sep 28.

repositories_concat: PubMed Central;boris.unibe.ch

repositories_institution: University Library Bern - BORIS - Bern Open Repository and Information System

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Blanke P, Leipsic JA, Popma JJ, Yakubov SJ, Deeb GM, Gada H, Mumtaz M, Ramlawi B, Kleiman NS, Sorajja P, Askew J, Meduri CU, Kauten J, Melnitchouk S, Inglessis I, Huang J, Boulware M, Reardon MJ; Evolut Low Risk LTI Substudy Investigators. Bioprosthetic Aortic Valve Leaflet Thickening in the Evolut Low Risk Sub-Study. J Am Coll Cardiol. 2020 May 19;75(19):2430-2442. doi: 10.1016/j.jacc.2020.03.022. Epub 2020 Mar 28.

ReferenceCitation: Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.

ReferenceCitation: Leipsic J, Bax JJ, Webb JG, Martin R, Blanke P. Trials Testing the Value of Imaging Use in Valve Disease and in Transcatheter Valvular Interventions. JACC Cardiovasc Imaging. 2017 Mar;10(3):286-295. doi: 10.1016/j.jcmg.2016.09.031.

oa_host_type: repository

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

unpaywall_oa_status: green

lead_sponsor: Medtronic Cardiovascular

location_country:
New Zealand
Australia
Japan
Netherlands
United States
Canada
France

location_facility: National Cerebral and Cardiovasclular Center

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: University of Southern California University Hospital

location_facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital

location_facility: The University of Vermont Medical Center

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: University Hospitals Case Medical Center


lead_sponsor: Vifor Fresenius Medical Care Renal Pharma

summary: This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3 clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and adolescent patients with CKD, and to provide safety and dosing information for this patient population. The Phoslyra (comparator) group provides information for a descriptive comparison of PA21 against a commonly used calcium-based phosphate binder (calcium acetate).

location_facility: Service de Néphrologie et Endocrinologie pédiatriques

location_facility: St. Vladimir Children's City Clinical Hospital

location_facility: University of Alabama at Birmingham School of Medicine

location_facility: Washington University School of Medicine in St. Louis

location_facility: Spitalul Clinic de Urgenţă pentru copii "Maria Sklodowska Curie"

location_facility: Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku

location_facility: Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos

location_facility: Texas Children's Hospital - Texas Children's Feigin Center

location_facility: Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics

location_facility: The University of Texas Southwestern Medical Center

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie - Prokocimiu

location_facility: University of Iowa Hospitals and Clinics

location_facility: Oregon Health and Science University, Doernbecher Children's Hospital

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: The University of Texas Medical School at Houston

location_facility: University of Miami - Miller School of Medicine

location_facility: St. Petersburg GBUZ "Children's City Hospital No. 1"

title: An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients With Hyperphosphataemia

location_country:
Germany
Lithuania
Poland
Romania
United States
Russian Federation
France


summary:
This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study.

The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.

title: Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction

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 based on scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

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

location_country:
Finland
Germany
Poland
Taiwan
Argentina
Japan
Thailand
Turkey
Croatia
Czechia
Canada
France
Portugal
Hungary
Switzerland
United States
India
Lebanon
China
Italy
Singapore
Austria
Korea, Republic of
Saudi Arabia
Spain
Jordan
Bulgaria
Russian Federation
Israel


title: An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of Zorblisa™ (SD-101-6.0) in Patients With Epidermolysis Bullosa

summary: The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).

lead_sponsor: Scioderm, Inc.

sponsor_collaborators:
Scioderm, Inc.
Amicus Therapeutics

location_country:
Germany
Lithuania
Poland
Israel
United Kingdom
Australia
Netherlands
Austria
United States
Spain
Serbia
France


lead_sponsor: Hoffmann-La Roche

summary: The primary objective for this study is to assess the safety and tolerability as well as preliminary efficacy of venetoclax in combination with cobimetinib, and venetoclax in combination with idasanutlin in patients with relapsed or refractory acute myeloid leukemia (R/R) AML who are not eligible for cytotoxic therapy.

location_facility:
Univ of Calif, San Francisco
Wake Forest Baptist Medical Center
CHU de Bordeaux
Hopital Avicenne, Paris
University of Bologna
MD Anderson Cancer Center
Dana Farber Cancer Institute
Presidio san salvatore muraglia
Jewish General Hospital
University of Colorado
UC Davis; Comprehensive Cancer Center
Princess Margaret Cancer Center
Universita di Roma
USC Norris Cancer Center
University of Alberta Hospital
Institut Paoli Calmettes
Weill Cornell Medical College

title: A Phase IB Multi-Arm Study With Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

location_country:
United States
Italy
Canada
France


acronym: PDUS

lead_sponsor: Novartis Pharmaceuticals

summary: This study was designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR) synovitis score (GLOESS) and changes in joint enthesitis were assessed using the OMERACT enthesitis score.

ReferenceCitation: D'Agostino MA, Schett G, Lopez-Rdz A, Senolt L, Fazekas K, Burgos-Vargas R, Maldonado-Cocco J, Naredo E, Carron P, Duggan AM, Goyanka P, Boers M, Gaillez C. Response to secukinumab on synovitis using Power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE. Rheumatology (Oxford). 2022 May 5;61(5):1867-1876. doi: 10.1093/rheumatology/keab628.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

title: A 52-week, Multicenter Study to Assess the Time Course of Response to Secukinumab on Joint Inflammation Using Power Doppler Ultrasonography in Patients With Active Psoriatic Arthritis

location_country:
Germany
Ireland
Italy
Colombia
Hungary
Argentina
Norway
United Kingdom
Netherlands
Austria
Belgium
Mexico
United States
Spain
Czechia
Canada
France


acronym: BERSON

summary: The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.

ReferenceCitation: Blom DJ, Chen J, Yuan Z, Borges JLC, Monsalvo ML, Wang N, Hamer AW, Ge J. Effects of evolocumab therapy and low LDL-C levels on vitamin E and steroid hormones in Chinese and global patients with type 2 diabetes. Endocrinol Diabetes Metab. 2020 Mar 6;3(2):e00123. doi: 10.1002/edm2.123. eCollection 2020 Apr.

ReferenceCitation: Chen Y, Yuan Z, Lu J, Eliaschewitz FG, Lorenzatti AJ, Monsalvo ML, Wang N, Hamer AW, Ge J. Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre-specified analysis of the Chinese population from the BERSON clinical trial. Diabetes Obes Metab. 2019 Jun;21(6):1464-1473. doi: 10.1111/dom.13700. Epub 2019 Apr 14.

title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Diabetic Subjects With Hyperlipidemia or Mixed Dyslipidemia (BERSON)

location_country:
Colombia
Argentina
Brazil
United States
China
Korea, Republic of
Turkey
Canada
Russian Federation
France


title: A Phase 1b (Open-Label)/Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma

acronym: ANNOUNCE 2

summary: The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body.

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.

location_country:
Germany
Italy
Poland
Hungary
Israel
United Kingdom
Australia
United States
Spain
France

location_facility: Johns Hopkins University School of Medicine

location_facility: Oklahoma Cancer Specialists & Research Institute, LLC

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro

location_facility: Centrum Onkologii-Instytut im Marii Sklodowskiej-Curie

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

location_facility: University of Texas Southwestern Medical Center at Dallas


summary: The primary objective of this study was to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

ReferenceCitation: Harrington KJ, Kong A, Mach N, Chesney JA, Fernandez BC, Rischin D, Cohen EEW, Radcliffe HS, Gumuscu B, Cheng J, Snyder W, Siu LL. Talimogene Laherparepvec and Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY-232): A Multicenter, Phase 1b Study. Clin Cancer Res. 2020 Oct 1;26(19):5153-5161. doi: 10.1158/1078-0432.CCR-20-1170. Epub 2020 Jul 15.

sponsor_collaborators:
Amgen
Merck Sharp & Dohme LLC

title: A Phase 1b/3 Multicenter, Randomized, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab for the Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

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

location_country:
Italy
United Kingdom
Australia
Switzerland
Austria
Belgium
United States
Spain
Greece
Canada
France


acronym: Avelumab in Third-Line Gastric Cancer

lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: The purpose of this study was to demonstrate superiority of treatment with avelumab plus best supportive care (BSC) versus physician's choice (chosen from a pre-specified list of therapeutic options) plus BSC.

ReferenceType: result

ReferenceCitation: Bang YJ, Ruiz EY, Van Cutsem E, Lee KW, Wyrwicz L, Schenker M, Alsina M, Ryu MH, Chung HC, Evesque L, Al-Batran SE, Park SH, Lichinitser M, Boku N, Moehler MH, Hong J, Xiong H, Hallwachs R, Conti I, Taieb J. Phase III, randomised trial of avelumab versus physician's choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300. Ann Oncol. 2018 Oct 1;29(10):2052-2060. doi: 10.1093/annonc/mdy264.

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repositories:
LIRIAS (KU Leuven)
PubMed Central
publikationen.ub.uni-frankfurt.de

repositories_concat: LIRIAS (KU Leuven);PubMed Central;publikationen.ub.uni-frankfurt.de

location_facility: Texas Oncology, P.A. - Denton 3720 South I-35 East

location_facility: Texas Oncology, P.A. 3410 Worth Street, Suites 300 & 400

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Penn State University Milton S. Hershey Medical Center 500 University Drive

location_facility: Texas Oncology, P.A. - Tyler 910 E. Houston St, Suite 100

location_facility: Hospital Universitario la Paz - site 546

location_facility: Carle Cancer Center 509 W. University Avenue

location_facility: Metairie Oncologist, LLC Office of Jayne Gurtler MD, Laura Brinz MD, Janet Burroff MD 3939 Houma Blvd, Suite 6

location_facility: New York Oncology Hematology, P.C. 400 Patroon Creek Blvd, Suite 1

location_facility: Southern Nevada Cancer Research Foundation 601 S Rancho Drive

location_facility: Advanced Medical Specialties 8940 North Kendall Drive, Suite 300E

location_facility: Rocky Mountain Cancer Centers 1800 Williams Street, Suite 100

location_facility: Henry Ford Health System 2799 West Grand Boulevard

location_facility: Texas Oncology Bedford 1609 Hospital Parkway

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

location_facility: Hematology and Oncology Associates of SC, LLC 900 West Faris Rd, 3rd Floor

location_facility: Oncology Specialists, S.C. 1700 Luther Ln, Ste 2200, Park Ridge, IL 60068 7900 Milwaukee Ave, Ste 16

location_facility: Kyungpook National University Medical Center

location_facility: Cotton-O'Neil Clinical Research Center, Hematology and Oncology and Stormont Vail Cancer Center 1414 SW 8th St

location_facility: Florida Cancer Specialists 560 Jackson Street, Suite 220

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Schwerpunktpraxis für Haematologie und OnkologieOnkologische Schwerpunktpraxis Eppendorf

location_facility: Nemocnice Rudolfa a Stefanie Benesov, a. s.

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

location_facility: Texas Oncology, P.A. - McAllen 1901 South 2nd Street

location_facility: Minnesota Oncology Hematology, P.A. 910 East 26th Street, Suites 100 and 200

location_facility: Illinois Cancer Specialists 8915 W. Golf Rd.

location_facility: Ocala Oncology Center, P.L. 433 S.W. 10th Street

location_facility: Ingalls Memorial Hospital One Ingalls Drive, W741

location_facility: Northwest Cancer Specialists, P.C. 265 N Broadway

location_facility: A.O.U. Ospedali Riuniti Ancona- Clinica Oncologica

location_facility: Rocky Mountain Cancer Centers, LLP 3676 Parker Blvd #350

location_facility: Scott and White Memorial Hospital and Clinic 2401 South 31st Street

location_facility: Oncology Consultants, P.A. 2130 W. Holcombe Blvd. 10th Floor

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo

location_facility: Sanford Roger Maris Cancer Center - Fargo 801 Broadway North Route 1058

title: A Phase III Open-label, Multicenter Trial of Avelumab (MSB0010718C) as a Third-line Treatment of Unresectable, Recurrent, or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

location_country:
Germany
Italy
Poland
Australia
Belgium
United States
Korea, Republic of
Spain
Czechia
France


title: A Phase IB Multicenter, Open-label Study To Determine The Recommended Dose And Regimen Of Durvalumab (MEDI4736) Either As Monotherapy or In Combination With Pomalidomide (POM) With Or Without Low-Dose Dexamethasone (DEX) In Subjects With Relapsed And Refractory Multiple Myeloma (RRMM)

summary:
This is a multicenter, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion portion to determine the optimal dose and regimen.

On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.

ReferenceCitation: Young MH, Pietz G, Whalen E, Copeland W, Thompson E, Fox BA, Newhall KJ. Immunomodulation by durvalumab and pomalidomide in patients with relapsed/refractory multiple myeloma. Sci Rep. 2021 Aug 12;11(1):16460. doi: 10.1038/s41598-021-95902-x.

lead_sponsor: Celgene

location_country:
Germany
Italy
Netherlands
United States
Spain
Canada
France

location_facility: Froedtert Hospital BMT Medical College of Wisconsin

location_facility: Weill Medical College Of Cornell University


acronym:
AIPAC

 AIPAC

lead_sponsor: Immutep S.A.S.

summary: The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer.

location_facility: NCT - Nationales Centrum für Tumorerkrankungen

location_facility: UZ Leuven, campus Gasthuisberg Department of General Medical Oncology and Multidisciplinary Breast Centre

location_facility: GZA Ziekenhuizen campus Sint-Augustinus Oncologische Research

location_facility: Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit

location_facility: UFKT - Universitäts-Frauenklinik Tübingen

location_facility: The Christie NHS Foundation Trust The Christie Clinic - Medical Oncology

location_facility: Cliniques universitaires Saint-Luc - Institut Roi Albert II - Cancérologie et Hématologie Oncologie clinique

location_facility: MH Egészségügyi Központ Onkológiai Osztály

location_facility: Institut Claudius Regaud - IUC Toulouse - Oncopôle

location_facility: Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Centrum für Hämatologie und Onkologie

location_facility: Kierownik Oddziału Onkologii i Radioterapii Szpital Morski im. PCK w Gdyni

location_facility: KEM- Brustzentrum der Kliniken Essen-Mitte

location_facility: Nottingham University Hospitals NHS Trust

title: AIPAC (Active Immunotherapy PAClitaxel): A Multicentre, Phase IIb, Randomised,Double Blind, Placebo-controlled Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients Receiving IMP321 (LAG-3Ig Fusion Protein) or Placebo as Adjunctive to a Standard Chemotherapy Treatment Regimen of Paclitaxel

location_country:
Germany
Poland
Hungary
United Kingdom
Netherlands
Belgium
France


lead_sponsor: Millennium Pharmaceuticals, Inc.

summary: The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.

ReferenceCitation: Sekeres MA, Watts J, Radinoff A, Sangerman MA, Cerrano M, Lopez PF, Zeidner JF, Campelo MD, Graux C, Liesveld J, Selleslag D, Tzvetkov N, Fram RJ, Zhao D, Bell J, Friedlander S, Faller DV, Ades L. Randomized phase 2 trial of pevonedistat plus azacitidine versus azacitidine for higher-risk MDS/CMML or low-blast AML. Leukemia. 2021 Jul;35(7):2119-2124. doi: 10.1038/s41375-021-01125-4. Epub 2021 Jan 22. No abstract available. Erratum In: Leukemia. 2021 Dec;35(12):3637.

location_facility: University Multi-Profile Hospital for Active Treatment Dr Georgi Stranski

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

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Hospital Regional Universitario de Malaga - Hospital Universitario Virgen de la Victoria

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino

location_facility: University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Smilow Cancer Center at Yale New Haven Hospital

location_facility: Compassionate Cancer Care Medical Group Incorporated

location_facility: Marien Hospital Akademisches Lehrkrankenhaus

location_facility: ICO I'Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet (ICO)

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University of North Carolina at Chapel Hill

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Specialized Hospital for Active Treatment of Haematological Diseases - Sofia

location_facility: University of Miami Miller School of Medicine

title: A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myelogenous Leukemia

type: Registry Identifier

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

location_country:
Germany
Ireland
Italy
Israel
Netherlands
Belgium
United States
Spain
Czechia
Bulgaria
Canada
France


lead_sponsor: Kite, A Gilead Company

summary: The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).

ReferenceCitation: Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.

repository_institution: King's College London - Research Portal

repositories_concat: PubMed Central;kclpure.kcl.ac.uk

repositories_institution:
King's College London - Research Portal
PubMed Central - Europe PMC

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Locke F, Wang M, Siddiqi T, Castro J, Shah B, Lee H, et al. ZUMA-2: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 (Anti-CD19 CAR T cells) in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL). American Society Of Clinical Oncology (ASCO) Annual Meeting 2016.

ReferenceCitation: Wang M, Locke F, Siddiqi T, Castro J, Shah B, Lee H, et al. ZUMA-2: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 (Anti-CD19 CAR T cells) in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL). European Society for Medical Oncology (ESMO) Congress 2016;Abstract 3305

ReferenceCitation: Wang M, Locke FL, Munoz J, Goy A, Holmes HE, Siddiqi T, et al. ZUMA-2: Phase 2 Multicenter Study Evaluating Efficacy of Kte-C19 in Patients with Relapsed/Refractory Mantle Cell Lymphoma [Abstract]. J Clin Oncol 2018;36 (Suppl 15):TPS3102.

ReferenceCitation: Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA, Miklos DB, Pagel JM, Kersten MJ, Milpied N, Fung H, Topp MS, Houot R, Beitinjaneh A, Peng W, Zheng L, Rossi JM, Jain RK, Rao AV, Reagan PM. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med. 2020 Apr 2;382(14):1331-1342. doi: 10.1056/NEJMoa1914347.

version: acceptedVersion

ReferenceCitation: Wang, Michael; Rossi, John M.; Munoz, Javier; Goy, Andre; Lundry Locke, Frederick; Michael Reagan, Patrick; Jacobson, Caron A.; Hill, Brian T; Holmes, Houston; Mary Jaglowski, Samantha; Peng, Weimin; Zheng, Lianqing; Fang, Xiang; Xue, Allen; Rao, Arati V.; Bot, Adrian

ReferenceCitation: Wang, Michael(1); Munoz, Javier(2); Goy, Andre(3); Locke, Frederick L.(4); Jacobson, Caron A.(5); Hill, Brian T.(6); Timmerman, John M.(7); Holmes, Houston(8); Jaglowski, Samantha(9); Flinn, Ian W.(10); McSweeney, Peter A.(11); Miklos, David B.(12); Pagel, John M.(13); José Kersten, Marie(14); Peng, Weimin(15); Zheng, Lianqing(15); Rossi, John M.(15); Jain, Rajul K.(15); Rao, Arati V.(15); Reagan, Patrick M.(16)

ReferenceCitation: Wang, M.(1); Munoz, J.(2); Goy, A.(3); Locke, F.(4); Jacobson, C.(5); Hill, B.(6); Timmerman, J.(7); Holmes, H.(8); Jaglowski, S.(9); Flinn, I.(10); McSweeney, P.(11); Miklos, D.(12); Pagel, J.(13); Kersten, M. J.(14)(15)

ReferenceCitation: Michael Wang,1 Javier Munoz,2 Andre Goy,3 Frederick L. Locke,4 Caron A. Jacobson,5 Brian T. Hill,6 John M. Timmerman,7 Houston Holmes,8 Samantha Jaglowski,9 Ian W. Flinn,10 Peter A. McSweeney,11 David B. Miklos,12 John M. Pagel,13 Marie José Kersten,14 Noel Milpied,15 Henry Fung,16 Max S. Topp,17 Roch Houot,18 Amer Beitinjaneh,19 Weimin Peng,20 Lianqing Zheng,20 John M. Rossi,20 Rajul K. Jain,20 Arati V. Rao,20 and Patrick M. Reagan21

ReferenceCitation: Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA,Miklos DB, Pagel JM, Kersten MJ, Peng W,Zheng L,Rossi JM, Jain RK, Rao AV, Reagan PM

ReferenceCitation: Wang, Michael L., MD(1); Munoz, Javier, MD(2); Goy, Andre, MD(3); Locke, Frederick L., MD(4); Jacobson, Caron A., MD, MMSc(5); Hill, Brian T., MD(6); Timmerman, John M., MD(7); Holmes, Houston, MD(8); Jaglowski, Samantha, MD, MPH(9); Flinn, Ian W., MD, PhD(10); McSweeney, Peter A., MD(11); Miklos, David B., MD, PhD(12); Pagel, John M., MD, PhD, DSc(13); Jose Kersten, Marie, MD, PhD(14); Peng, Weimin, MS(15); Zheng, Lianqing, PhD(15); Rossi, John M., MS(15); Jain, Rajul K., MD(15); Rao, Arati V., MD(15); Reagan, Patrick M, MD(16)

ReferenceCitation: Wang, Michael; Lundry Locke, Frederick; Munoz, Javier; Goy, Andre; Eccleston Holmes, Houston; Siddiqi, Tanya; Flinn, Ian; McSweeney, Peter A; Michael Reagan, Patrick; Thomas Hill, Brian; Jacobson, Caron A.; Rizzieri, David A.; Heffner, Leonard T.; Mary Jaglowski, Samantha; Bernard Miklos, David; Shaughnessy, Paul; Unabia, Sherry; Rossi, John M.; Jiang, Yizhou; Jain, Rajul K.

ReferenceCitation: Wang M, Jain P, Chi TL, Chen SE, Heimberger A, Weathers SP, Zheng L, Rao AV, Rossi JM. Management of a patient with mantle cell lymphoma who developed severe neurotoxicity after chimeric antigen receptor T-cell therapy in ZUMA-2. J Immunother Cancer. 2020 Oct;8(2):e001114. doi: 10.1136/jitc-2020-001114.

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University California Los Angeles (UCLA)

location_facility: Winship Cancer Institute of Emory University

title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma

location_country:
United States
Netherlands
Germany
France


summary: The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.

ReferenceCitation: Heinhuis KM, Carlino M, Joerger M, Di Nicola M, Meniawy T, Rottey S, Moreno V, Gazzah A, Delord JP, Paz-Ares L, Britschgi C, Schilder RJ, O'Byrne K, Curigliano G, Romano E, Patah P, Wang R, Liu Y, Bajaj G, Siu LL. Safety, Tolerability, and Potential Clinical Activity of a Glucocorticoid-Induced TNF Receptor-Related Protein Agonist Alone or in Combination With Nivolumab for Patients With Advanced Solid Tumors: A Phase 1/2a Dose-Escalation and Cohort-Expansion Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):100-107. doi: 10.1001/jamaoncol.2019.3848.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: American Medical Association

location_facility:
Linear Clinical Research Ltd
Cantonal Hospital St. Gallen
The Ohio State University
Providence Portland Medical Center
Local Institution - 0014
UCSD Moores Cancer Center
Local Institution - 0012
Institut Claudius Regaud
Local Institution - 0015
Thomas Jefferson University Hospital
Princess Alexandra Hospital
Local Institution
Emory University
Institut Gustave Roussy
Liverpool Cancer Therapy Center
The West Clinic, P.C.
University Of Alabama At Birmingham

title: A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors

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