title: Multicenter International Observational Study to Build and Validate Multidimensional Risk Score in the Clinical Setting of Kidney Allograft Biopsies to Predict Long-term Allograft Survival

acronym: iBOX

summary:
To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, clinical trials and clinical decision-making.

Despite a clear pressing need, no population-scale prognostication system exists that will combine traditional factors and biomarker candidates to represent the complete spectrum of risk predicting parameters. To adequately predict transplant patients' individual risks of allograft loss, this would require a complex integration of data, including: donor data, recipient characteristics, transplant characteristics, allograft precision phenotypes, ethnicity, immunosuppressive regimen monitoring, allograft infections, acute kidney injuries, and recipient immune profiles.

This project aims:

To develop a generalizable, transportable, mechanistically and data driven composite surrogate end point in kidney transplantation;
To validate several risk scores to predict kidney allograft survival and response to treatment of individual patients;

Eventually, it will provide an easily accessible tool to calculate individual patients' risk profiles after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.

ReferenceCitation: Aubert O, Divard G, Pascual J, Oppenheimer F, Sommerer C, Citterio F, Tedesco H, Chadban S, Henry M, Vincenti F, Srinivas T, Watarai Y, Legendre C, Bernhardt P, Loupy A. Application of the iBox prognostication system as a surrogate endpoint in the TRANSFORM randomised controlled trial: proof-of-concept study. BMJ Open. 2021 Oct 7;11(10):e052138. doi: 10.1136/bmjopen-2021-052138.

repositories_concat: PubMed Central

ReferenceCitation: Loupy A, Aubert O, Orandi BJ, Naesens M, Bouatou Y, Raynaud M, Divard G, Jackson AM, Viglietti D, Giral M, Kamar N, Thaunat O, Morelon E, Delahousse M, Kuypers D, Hertig A, Rondeau E, Bailly E, Eskandary F, Bohmig G, Gupta G, Glotz D, Legendre C, Montgomery RA, Stegall MD, Empana JP, Jouven X, Segev DL, Lefaucheur C. Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. BMJ. 2019 Sep 17;366:l4923. doi: 10.1136/bmj.l4923.

evidence: open (via page says license)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_country:
United States
Belgium
France

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: William J. von Liebig Center for Transplantation and Clinical Regeneration

location_facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France;

location_facility: Department of Nephrology and Organ Transplantation, CHU Rangueil

location_facility: Department of Surgery, Johns Hopkins University School of Medicine

location_facility: Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch, Suresnes, France

location_facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France ;

location_facility: Virginia Commonwealth University School of Medicine

location_facility: Department of Nephrology and Renal Transplantation, University Hospitals Leuven

location_facility: Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon


title: Life Experience of People Aged 60 and Over Living With HIV: Quantitative Sociological Study

acronym: PVVIH

summary: The purpose of this study is to Assess the impact of HIV on the life course of patients aged 60 and over.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Hôpital NOVO

location_facility: Hospital Delafontaine, Saint-Denis / Maladie infectieuse

location_facility: Hospital Beaujon, Clichy / Médecine Interne

location_facility: Hôpital Bichat Claude-Bernard - Service de Maladies Infectieuses et Tropicales

location_facility: Hôpital Bichat Claude-Bernard -COREVIH Ile de France Nord

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation

acronym: EVEROLD

summary: This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (>60 years old) recipients receiving graft from elderly donor(>60 years old).

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Novartis
Roche Pharma AG
Genzyme, a Sanofi Company
Ministry of Health, France

location_facility:
Hopitaux Universitaires de Strasbourg
CHU Montpellier
CHU Nice
CHRU de BREST
CHU Lille
AP-HP Hopital Necker
CHU Reims
CHU Rennes
CHU Tours
CHU Rangueil - Toulouse
CHU Poitiers
CHU Limoges
CHU Dijon
CHU Clermont Ferrand
CHU Rouen
CHU Pellegrin - Bordeaux
CHU Cote de Nacre
CHU Amiens

intervention_type: Drug


type: EudraCT Number

type: Other Identifier

title: An International Clinical Program for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Ependymoma

acronym: SIOP-EP-II

summary:
The overall aim of this project is to improve the outcome of patients diagnosed with ependymoma by improving and harmonising the staging and the standard of care of this patient population and to improve the investigators understanding of the underlying biology thereby informing future treatment.

The program will evaluate new strategies for diagnosis (centralized reviews of pathology and imaging) and new therapeutic strategies in order to develop treatment recommendations.

Patients will be stratified into different treatment subgroups according to their age, the tumour location and the outcome of the initial surgery. Each subgroup will be studied in a specific randomised study to evaluate the proposed therapeutic strategies.

Stratum 1:

The aim of the stratum 1 is to evaluate the clinical impact of 16-week chemotherapy regimen with VEC-CDDP following surgical resection and conformal radiotherapy in terms of progression free survival in patients who are > 12 months and < 22 years at diagnosis, with completely removed intra cranial Ependymoma.

Stratum 2:

This stratum is designed as a phase II trial for patients who are > 12 months and < 22 years at diagnosis, with residual disease to investigate the possible activity of HD-MTX by giving to all patients the benefit of VEC chemotherapy whilst randomising half of patients to receive additional HD-MTX.

Patients will receive conformal radiotherapy (cRT). For patients who remain with a residual inoperable disease after induction chemotherapy and cRT, an 8 Gy boost of radiotherapy to the residual tumour will be delivered immediately after the end of the cRT.

Stratum 3 This stratum is designed as a phase II trial to evaluate the benefit of postoperative dose intense chemotherapy administered alone or in combination with valproate in children <12 months of age or those not eligible to receive radiotherapy .

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Leblond P, Massimino M, English M, Ritzmann TA, Gandola L, Calaminus G, Thomas S, Perol D, Gautier J, Grundy RG, Frappaz D. Toward Improved Diagnosis Accuracy and Treatment of Children, Adolescents, and Young Adults With Ependymoma: The International SIOP Ependymoma II Protocol. Front Neurol. 2022 Jun 2;13:887544. doi: 10.3389/fneur.2022.887544. eCollection 2022.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: University of Nottingham - Repository@Nottingham

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

lead_sponsor: Centre Leon Berard

location_country:
Germany
Ireland
Italy
Slovenia
Norway
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Czechia
France

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Princess Maxima Center for pediatric oncology

location_facility: CHU de Bordeaux-Hôpital des enfants Pellegrin

location_facility: Hospitales Universitarios Virgen Macarena y Virgen del Rocío Avda

location_facility: Department of Paediatric, Haukeland University Hospital

location_facility: Medical University of Graz-Department of Pediatrics and Adolescent Medicine

location_facility: CHRU MONTPELLIER - Hôpital Arnaud de Villeneuve

location_facility: CHRU STRASBOURG - Hôpital de Hautepierre

status_simplified: Ongoing


lead_sponsor: Merck Sharp & Dohme LLC

summary:
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.

This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.

Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.

location_facility: Seoul National University Bundang Hospital ( Site 0951)

location_facility: Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava

location_facility: GBUZ LOKB-Oncology department #1 ( Site 1222)

location_facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2525)

location_facility: Hospital Universitari i Politecnic La Fe ( Site 0875)

location_facility: Bashkir State Medical University ( Site 1221)

location_facility: Universitaetsklinikum des Saarlandes-Klinik für Innere Medizin V-Pneumologie, Allergologie, Beatmun

location_facility: Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 2522)

location_facility: Tallaght University Hospital ( Site 1803)

location_facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi

location_facility: CHU Toulouse - Hopital Rangueil ( Site 2518)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 2521)

location_facility: Dana-Farber Cancer Institute ( Site 0006)

location_facility: UPR Comprehensive Cancer Center ( Site 1150)

location_facility: National Cancer Institute-Department of Minimally Invasive and Endoscopic Surgery, Interventional R

location_facility: Instituto Valenciano de Oncologia - IVO ( Site 0863)

location_facility: Oslo Universitetssykehus Ullevål-Avdeling for kreftbehandling, Ullevål ( Site 1452)

location_facility: Mater Misercordiae University Hospital ( Site 1800)

location_facility: Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1968)

location_facility: Mater Misericordiae Limited-Medical Oncology ( Site 3019)

location_facility: Royal Prince Alfred Hospital-A.W. Morrow Gastroenterology and Liver Centre ( Site 3016)

location_facility: Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 2751)

location_facility: Nippon Medical School Hospital ( Site 3139)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 1958)

location_facility: Bialostockie Centrum Onkologii ( Site 1610)

location_facility: Hyogo Medical University Hospital ( Site 3100)

location_facility: INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1102)

location_facility: Groupe hospitalier Paris saint Joseph-Service de Pneumologie-Allergologie -Oncologie Thoracique ( Si

location_facility: Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1412)

location_facility: West Cancer Center and Research Institute ( Site 0055)

location_facility: Hospital Universitario La Paz ( Site 0853)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1204)

location_facility: Nottingham University Hospitals NHS Trust ( Site 0510)

location_facility: Kitasato University Hospital ( Site 3142)

location_facility: Istanbul University Capa Campus ( Site 1314)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 1972)

location_facility: Helse Bergen Haukeland universitetssykehus ( Site 1451)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 0506)

location_facility: Instituto de de Educação, pesquisa e Gestão em Saúde ( Site 1014)

location_facility: Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 1224)

location_facility: Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0702)

location_facility: The First Affiliated Hospital, Sun Yat-sen University-pneumology department ( Site 3459)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 2757)

location_facility: Odense Universitetshospital ( Site 0650)

location_facility: Vanderbilt Health One Hundred Oaks Diagnostic ( Site 0060)

location_facility: Melanoma Institute Australia ( Site 3001)

location_facility: Centre Hospitalier du Mans-Pneumologie ( Site 2527)

location_facility: Hospital Clinico Universitario Lozano Blesa ( Site 0859)

location_facility: Istituto Europeo di Oncologia ( Site 1952)

location_facility: Klaipeda University Hospital-Oncology chemotherapy ( Site 3302)

location_facility: Acibadem Adana Hospital-Pediatric Hematology-Oncology ( Site 1312)

location_facility: National Cancer Center Hospital ( Site 3130)

location_facility: IRCCS CRO Aviano, Hematology/Oncology ( Site 1957)

location_facility: Yokohama City University Hospital ( Site 3163)

location_facility: Chaim Sheba Medical Center. ( Site 2052)

location_facility: Bezmialem Vakf Üniversitesi-Oncology ( Site 1308)

location_facility: H.R.U Málaga - Hospital General ( Site 0884)

location_facility: Tokyo Medical University Hospital ( Site 3170)

location_facility: Hospital Universitari Son Espases-Oncologia ( Site 0883)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 3206)

location_facility: Hospital São Lucas da PUCRS-Centro de Pesquisa em Oncologia ( Site 1006)

location_facility: Centro Medico San Roque-Oncology ( Site 1352)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 1400)

location_facility: Jilin Province Tumor Hospital ( Site 3484)

location_facility: Ankara University Hospital Cebeci ( Site 1306)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 3119)

location_facility: Sapporo Kosei General Hospital ( Site 3172)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 3109)

location_facility: Radboud University Medical Center ( Site 1554)

location_facility: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3008)

location_facility: Municipal institution of Lviv regional council Lviv Oncology-Chemotherapy ( Site 3653)

location_facility: National Hospital Organization Yamaguchi Ube Medical Center ( Site 3123)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 2807)

location_facility: Spitalul Județean Sfântul Ioan cel Nou Suceava-Oncology ( Site 3550)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1316)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 3167)

location_facility: Universitatsklinikum Carl Gustav Carus ( Site 2407)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 1409)

location_facility: Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 0054)

location_facility: Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 1415)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1402)

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda ( Site 0861)

location_facility: Aichi Cancer Center Hospital ( Site 3101)

location_facility: Providence Saint John's Health Center ( Site 0059)

location_facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0877)

location_facility: Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 3476)

location_facility: Acibadem Altunizade Hospital-Oncology ( Site 1317)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 3136)

location_facility: National Cancer Center Hospital East ( Site 3121)

location_facility: IRCCS A.O.U. San Martino - IST ( Site 1961)

location_facility: Medizinische Universität Wien ( Site 2953)

location_facility: Seoul National University Hospital ( Site 0953)

location_facility: Blod och Tumorssjukdomar. Akademiska sjukhuset ( Site 0801)

location_facility: Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 3487)

location_facility: Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0871)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 0878)

location_facility: Kobe City Medical Center General Hospital ( Site 3144)

location_facility: Instituto de Cancerología-Oncology ( Site 2702)

location_facility: Hadassah Ein Kerem Medical Center ( Site 2051)

location_facility: Nara Medical University Hospital ( Site 3110)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 2504)

location_facility: Saitama Medical University International Medical Center ( Site 3118)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1975)

location_facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 0880)

location_facility: Istituto di Candiolo - IRCCS ( Site 1960)

location_facility: New Cross Hospital-Department of Oncology ( Site 0517)

location_facility: Universitair Medisch Centrum Groningen ( Site 1550)

location_facility: LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2005)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0043)

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site

location_facility: Instytut Centrum Zdrowia Matki Polki-Klinika Onkologii ( Site 1609)

location_facility: Western Health-Sunshine & Footscray Hospitals ( Site 3023)

location_facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1614)

location_facility: Chonnam National University Hwasun Hospital-Hemato-Oncology ( Site 0959)

location_facility: Farkasgyepui Tudogyogyintezet-Pulmonologia ( Site 1414)

location_facility: Tampere University Hospital [Tampere Finland] ( Site 0600)

location_facility: Okayama University Hospital ( Site 3107)

location_facility: Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, ( Site 0

location_facility: Mid Essex Hospitals Service Trust. Broomfield Hospital ( Site 0503)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1203)

location_facility: UZ Leuven - Campus Gasthuisberg ( Site 2906)

location_facility: Clinica Universitaria de Navarra ( Site 0855)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004)

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE-Oncologia Médica ( Site 1753)

location_facility: Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0705)

location_facility: Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA ( Site 1017)

location_facility: Queen Mary Hospital-Department of Medicine (Respiratory) ( Site 1900)

location_facility: Hospital Universitari Sant Joan de Reus-Oncology ( Site 0874)

location_facility: Azienda Ospedaliera Santa Maria ( Site 1962)

location_facility: Tartu University Hospital-Radiotherapy and oncology ( Site 3800)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1307)

location_facility: MNPE Regional Center of Oncology ( Site 3665)

location_facility: Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2954)

location_facility: Hospital Nossa Senhora da Conceição ( Site 1011)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 2403)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0032)

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin ( Site 2532)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 1303)

location_facility: Kaiser Permanente Moanalua Medical Center ( Site 0063)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2801)

location_facility: Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0704)

location_facility: A. C. Camargo Cancer Center ( Site 1002)

location_facility: I.E.U. Medical Point Hastanesi-Oncology ( Site 1310)

location_facility: Universitaetsklinikum Essen ( Site 2404)

location_facility: Medical Care and Research SA de CV ( Site 1103)

location_facility: Fakultni nemocnice v Motole ( Site 0700)

location_facility: SAIH of the Tyumen region, Multidisciplinary Clinical Medical Center "Medical town" ( Site 1220)

location_facility: Oaxaca Site Management Organization ( Site 1106)

location_facility: Hospital Clinico de Valencia ( Site 0858)

location_facility: Osaka International Cancer Institute-Gynecologic Oncology ( Site 3129)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 1608)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 3133)

location_facility: The Queen Elizabeth Hospital ( Site 3026)

location_facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1201)

location_facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1401)

location_facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 3452)

location_facility: Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0851)

location_facility: London Regional Cancer Program - LHSC ( Site 2806)

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1405)

location_facility: CHRU Lille Hospital Claude Huriez ( Site 2506)

location_facility: Powiatowe Centrum Zdrowia w Brzezinach Sp. z o. o. Oddział Dziennej Chemioterapii ( Site 1611)

location_facility: Hospital Clinico San Carlos ( Site 0857)

location_facility: National Hospital Organization Himeji Medical Center ( Site 3111)

location_facility: Marmara Universitesi Pendik Egitim Arastirma Hastanesi-Medical Oncology ( Site 1305)

location_facility: C.H.U. de Tours - Hopital Bretonneau ( Site 2515)

location_facility: Ballarat Oncology & Haematology Services ( Site 3022)

location_facility: Osaka City General Hospital ( Site 3125)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 2750)

location_facility: California Cancer Associates for Research & Excellence ( Site 0016)

location_facility: Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 1964)

location_facility: Universitaetsspital Zuerich ( Site 0750)

location_facility: Odessa Regional Oncology Center ( Site 3655)

location_facility: Complejo Hospitalario de Jaén-Servicio de Oncología Médica ( Site 0879)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 1301)

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1008)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0860)

location_facility: Osaka Habikino Medical Center ( Site 3138)

location_facility: Xiangya Hospital Central South University-Respiratory ( Site 3479)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1955)

location_facility: Memorial Antalya Hospital-Oncology ( Site 1315)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 3116)

location_facility: Mayo Clinic in Rochester, Minnesota ( Site 0002)

location_facility: James Graham Brown Cancer Center ( Site 0058)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0061)

location_facility: The Angeles Clinic and Research Institute ( Site 0005)

location_facility: St James University Hospital ( Site 0509)

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1010)

location_facility: Hospital Tengku Ampuan Afzan ( Site 0627)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0867)

location_facility: Ad-Vance Medical Research-Research ( Site 1151)

location_facility: Udmurtian Republican Clinical Oncology Center ( Site 1212)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1300)

location_facility: Shamir Medical Center Assaf Harofeh ( Site 2058)

location_facility: Markusovszky Egyetemi Oktatokorhaz-Onkológiai Osztály ( Site 1410)

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council ( Site 3650)

location_facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 3657)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 1450)

location_facility: Mount Sinai Medical Center Comprehensive Cancer Center ( Site 0031)

location_facility: Gallipoli Medical Research Foundation ( Site 3011)

location_facility: Austin Health-Austin Hospital ( Site 3004)

location_facility: Royal North Shore Hospital-Medical Oncology Clinical Trials ( Site 3025)

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház-l.Pulmonologia ( Site 1407)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 2

location_facility: Municipal non-profit enterprise "Zaporizhzhia Regional Antitumor Center" Zaporizhzhya Regional Counc

location_facility: Princess Margaret Cancer Centre ( Site 2803)

location_facility: Holy Cross Hospital, Michael & Dianne Bienes Comp Cancer Ctr ( Site 0022)

location_facility: Canterbury Regional Cancer & Blood Service ( Site 1500)

location_facility: Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302)

location_facility: University of Virginia Health System ( Site 0035)

location_facility: National University Hospital-Haematology -Oncology Research Group ( Site 2201)

location_facility: Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1750)

location_facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0872)

location_facility: Sapporo Medical University Hospital ( Site 3113)

location_facility: Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 3480)

location_facility: Japanese Foundation for Cancer Research ( Site 3146)

location_facility: Clinical Research Center of specialized types medical care-Oncology ( Site 1205)

location_facility: University of Colorado Cancer Center ( Site 0021)

location_facility: Centre Hopitalar Leon-Berard ( Site 2519)

location_facility: Hospital Universitario Gregorio Maranon ( Site 0864)

location_facility: China Medical University Hospital ( Site 3204)

location_facility: Fujian Provincial Cancer Hospital ( Site 3461)

location_facility: Princess Alexandra Hospital ( Site 3002)

location_facility: Shanghai Pulmonary Hospital ( Site 3470)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 3203)

location_facility: University of Arizona Cancer Center ( Site 0018)

location_facility: GBUZ SK Pyatigorsk Interdistrict Oncology dispensary ( Site 1223)

location_facility: National Cancer Institute-Chemotherapy departament with day care unit ( Site 3301)

location_facility: Dokkyo Medical University - Koshigaya Hospital ( Site 3152)

location_facility: The First Hospital of Jilin University-Oncology ( Site 3464)

location_facility: Universitaetsklinik Muenchen ( Site 2406)

location_facility: Hôpital Avicenne-Dermatologie ( Site 2538)

location_facility: UZ Leuven Gasthuisberg, Gynaecologie-Verloskunde ( Site 2907)

location_facility: Beijing Cancer hospital-Thoracic Cancer Department A ( Site 3454)

location_facility: Parc de Salut Mar - Hospital del Mar-Oncologia ( Site 0873)

location_facility: Fudan University Shanghai Cancer Center ( Site 3467)

location_facility: Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0065)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0056)

location_facility: Sir Charles Gairdner Hospital ( Site 3006)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 3169)

location_facility: Policlinico Universitario Agostino Gemelli ( Site 1965)

location_facility: Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1411)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 2412)

location_facility: ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 1969)

location_facility: Taipei Veterans General Hospital ( Site 3202)

location_facility: University Malaya Medical Centre ( Site 0626)

location_facility: South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001)

location_facility: Affiliated Hospital of Military Medical Science Academy of the PLA ( Site 3465)

location_facility: West China Hospital Sichuan University-respiratory ( Site 3473)

location_facility: Hospital Universitario Quiron Madrid ( Site 0868)

location_facility: The First Affiliated Hospital of Guangzhou Medical University-thoracic surgery department ( Site 346

location_facility: Administradora Country S.A. ( Site 2701)

location_facility: Capital & Coast District Health Board - Wellington Hospital ( Site 1501)

location_facility: Hospital General Universitario de Alicante-Oncologia ( Site 0881)

location_facility: Centre Georges François Leclerc-Centre de recherche clinique ( Site 2536)

location_facility: Hospital Universitario Central de Asturias-Medical Oncology ( Site 0870)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 1215)

location_facility: Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2004)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 0513)

location_facility: Wojskowy Instytut Medyczny-Klinika Onkologii ( Site 1606)

location_facility: Hôpitaux Universitaires de Genève (HUG) ( Site 0753)

location_facility: The National Medico-Surgical Center N.I. Pirogov ( Site 1225)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0038)

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 2539)

location_facility: Hospital Privado Universitario de Córdoba ( Site 1354)

location_facility: Hospital General Universitario de Valencia ( Site 0854)

location_facility: Sunnybrook Research Institute ( Site 2802)

location_facility: Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 3466)

location_facility: Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre-Oncology ( Site 2809)

location_facility: Providence Portland Medical Center ( Site 0051)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 1304)

location_facility: Transcarpathian Regional Clinical Oncology Center-Chemotherapy dept. ( Site 3652)

location_facility: Kindai University Hospital- Osakasayama Campus ( Site 3166)

location_facility: White Plains Hospital-Center for Cancer Care ( Site 0069)

location_facility: Kochi Health Sciences Center ( Site 3145)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 2053)

location_facility: Belgorod Oncology Dispensary ( Site 1213)

location_facility: Guangdong Provincial People's Hospital-Cancer Center ( Site 3462)

location_facility: Yamaguchi University Hospital ( Site 3114)

location_facility: Vanderbilt Ingram Cancer Center ( Site 0015)

location_facility: Sun Yat-sen University Cancer Center-melanoma ( Site 3482)

location_facility: Jiangsu Cancer Hospital-Medical Oncotherapy ( Site 3469)

location_facility: Tianjin Medical University Cancer Institute and Hospital ( Site 3456)

location_facility: UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0009)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1001)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 1403)

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 31

location_facility: Norrlands Universitetssjukhus ( Site 0800)

location_facility: University of Iowa Hospital and Clinics ( Site 0026)

location_facility: St Vincent's Hospital-Oncology Clinical Trials ( Site 3018)

location_facility: Hokkaido University Hospital ( Site 3165)

location_facility: Avix Investigación Clinica, S.C.-Oncology ( Site 1104)

location_facility: Regional Budgetary Healthcare Institution 'Ivanovo Regional Oncology Dispensary'-Urology ( Site 1219

location_facility: N.N.Petrov Research Institute of Oncology-Department of Preclinical and Clinical Research ( Site 121

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0012)

location_facility: National Taiwan University Hospital ( Site 3200)

location_facility: Ogarev Mordovia State University ( Site 1206)

location_facility: Cliniques Universitaires de Bruxelles - CUB - Hopital Erasme ( Site 2905)

location_facility: Universitätsklinikum Erlangen ( Site 2408)

location_facility: University of North Carolina at Chapel Hill ( Site 0040)

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 1020)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 2365)

location_facility: Ankara City Hospital-Medical Oncology ( Site 1311)

location_facility: University of Texas MD Anderson Cancer Center ( Site 0007)

location_facility: Hospital Clinic de Barcelona ( Site 0852)

location_facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 1208)

location_facility: Harbin Medical University Cancer Hospital-Harbin Medical University Cancer Hospital ( Site 3475)

location_facility: Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1413)

location_facility: Chungnam national university hospital-Department of Internal Medicine ( Site 0958)

location_facility: Kindai University Hospital- Osakasayama Campus-Department of Gastroenterology and Hepatology ( Site

location_facility: Tasman Oncology Research Pty Ltd ( Site 3012)

location_facility: Tokyo Medical and Dental University Hospital ( Site 3149)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Wakayama Medical University Hospital ( Site 3124)

location_facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 1551)

location_facility: National Cheng Kung University Hospital ( Site 3201)

location_facility: Texas Oncology-Baylor Sammons Cancer Center ( Site 0062)

location_facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0876)

location_facility: CHA Bundang Medical Center CHA University ( Site 0957)

location_facility: P. A. Hertsen Moscow Oncology Research Center ( Site 1214)

location_facility: Hangzhou Cancer Hospital-Medical Oncology ( Site 3468)

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-UOC Oncologia ( Site 1967)

location_facility: Liverpool Hospital-Medical Oncology ( Site 3021)

location_facility: Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 3661)

location_facility: Japanese Foundation for Cancer Research ( Site 3164)

location_facility: Georgetown University Medical Center ( Site 0023)

location_facility: Northern Jiangsu People's Hospital-General Surgery Department ( Site 3474)

location_facility: Instituto de Oncologia de Rosario ( Site 1350)

location_facility: University College London Hospital-Cancer Clinical Trials Unit ( Site 0520)

location_facility: Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg

location_facility: Army Medical Center of People's Liberation Army-Oncology Department ( Site 3477)

location_facility: Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City

location_facility: Hiroshima University Hospital ( Site 3154)

location_facility: Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 2418)

location_facility: Centro Hospitalar de Sao Joao - Hospital de Sao Joao ( Site 1752)

location_facility: Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 0862)

location_facility: Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 3656)

location_facility: Universitaetsklinikum Tuebingen ( Site 2405)

location_facility: The Cancer Institute Hospital of JFCR ( Site 3108)

location_facility: Massachusetts General Hospital ( Site 0041)

location_facility: Tangdu Hospital of Fourth Military Medical University of Chi-department of radiotherapy ( Site 3455)

location_facility: Korea University Anam Hospital ( Site 0956)

location_facility: Amsterdam UMC, locatie VUmc ( Site 1555)

location_facility: St.Luke's International Hospital ( Site 3120)

location_facility: CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 2526)

location_facility: Sotiria Regional Chest Diseases Hospital of Athens ( Site 1850)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 1000)

location_facility: Instituto Nacional del Cancer-CR Investigación ( Site 2753)

location_facility: AO Santa Maria della Misericordia-Oncology Department ( Site 1971)

location_facility: MedStar Franklin Square Medical Center ( Site 0046)

location_facility: RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia-Out-patient and Day patient facility of Ch

location_facility: Centre Hopitalier Intercommunal Creteil ( Site 2514)

location_facility: St. Luke's University Health Network ( Site 0017)

location_facility: Kanazawa University Hospital ( Site 3140)

location_facility: Lung Center of the Philippines ( Site 1705)

location_facility: Seattle Cancer Care Alliance ( Site 0024)

location_facility: Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3020)

location_facility: Hospital Cayetano Heredia-Oncology ( Site 0675)

location_facility: Orange Hospital-Clinical Trials Unit ( Site 3027)

location_facility: Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 1406)

location_facility: Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2808)

location_facility: Cancer Institute of New Jersey ( Site 0025)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 0802)

location_facility: National Cancer Centre Singapore ( Site 2200)

location_facility: Kansai Medical University Hospital ( Site 3126)

location_facility: St John of God Subiaco Hospital ( Site 3013)

location_facility: Medizinische Universitaet Innsbruck ( Site 2951)

location_facility: Medizinische Hochschule Hannover ( Site 2402)

location_facility: Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 0882)

location_facility: Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 3300)

location_facility: Hospital General Universitario 12 de Octubre ( Site 0856)

location_facility: Jichi Medical University Hospital ( Site 3141)

location_facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0703)

location_facility: Royal Brisbane and Women s Hospital ( Site 3009)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1612)

location_facility: Kepler Universitätsklinikum ( Site 2955)

title: A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab

type: Registry Identifier

source: euctr

design_allocation: Non-Randomized

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Chile
Czechia
Canada
France
Lithuania
Colombia
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
Ukraine
Romania
Belgium
China
Malaysia
Peru
Estonia
Puerto Rico
Philippines
Italy
Guatemala
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

ipd_sharing: Yes

lead_sponsor_type: industriel


lead_sponsor: BeiGene

summary: This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese participants. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese participants are recruited in this Phase 3 study.

ReferenceType: result

ReferenceCitation: Qin S, Finn RS, Kudo M, Meyer T, Vogel A, Ducreux M, Macarulla TM, Tomasello G, Boisserie F, Hou J, Li X, Song J, Zhu AX. RATIONALE 301 study: tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma. Future Oncol. 2019 Jun;15(16):1811-1822. doi: 10.2217/fon-2019-0097. Epub 2019 Apr 10.

oa_colors: green hybrid

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repositories_concat: UCL Discovery

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Sun Yat-sen Memorial Hospital , Sun Yat-sen University

location_facility: University Hospital, Kyoto Prefectural Univ of Medicine

location_facility: Hahnemann University Hospital - Gastroenterology Hepatology

location_facility: Wojewodzki Szpital Specjalistyczny im. Gromkowskiego we Wroclawiu

location_facility: China Medical University Hospital - Transplantology - Taichung

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: Ehime Prefectural Central Hospital - Gastroenterology

location_facility: Queen Elizabeth Hospital - Clinical Reasearch

location_facility: Kinki University Hospital, Faculty of Medicine - Hematology & Clinical Oncology

location_facility: Cancer Treatment Centers of America - Oncology

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital

location_facility: Fujian Medical University Union Hospital

location_facility: Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncologia

location_facility: Ochsner Medical Center (OMC) - New Orleans ACCRU Network Sit

location_facility: Beijing YouAn Hospital, Capital Medical University

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

location_facility: The First Affiliated Hospital Of Anhui Medical University

location_facility: King's College Hospital NHS Foundation Trust

location_facility: CHU Amiens-Hopital Nord - Hépato-Gastroentérologie

location_facility: Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS

location_facility: The Affiliated Hospital Of Qingdao University

location_facility: IRCCS Saverio De Bellis, AO Gastroenterologia

location_facility: Sir Run Run Shaw Hospital, Zhejiang University

location_facility: Hospital Universitario Madrid Sanchinarro Centro integral Oncologico Clara Campal (CIOCC)

location_facility: The First Affiliated Hospital Of XI'AN Jiaotong University

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Gastroenterology

location_facility: Cancer Hopital Chinese Academy of Medical Sciences

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Precision Cancer Research / Dayton Physicians Network

location_facility: The Christie NHS Foundation Trust - Oak Road Treatment Centre

location_facility: Vanderbilt University Medical Center (VUMC)

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Bichat-Beaujon Service Inter Hospitalier De Cancerologie

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

location_facility: Hokkaido University Hospital - Gastroenterology

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Malattie

location_facility: Harbin Medical University Cancer Hospital

location_facility: PO di Cremona, ASST di Cremona - Oncologia - Cremona - Radiology

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Clinical Research Center Sp. z o.o., Medic-R Sp. K.

location_facility: CHU Cote De Nacre - Hepato-Gastro-Enterologie Et N

location_facility: Hôpital Privé des Côtes d'Armor - Service oncologie

location_facility: National Center for Global Health and Medicine

location_facility: The First Affiliated Hospital of Guangxi Medical University

location_facility: Hopital Paul Brousse- Aphp Hopitaux Universitairees Paris Su

location_facility: Nihon University Itabashi Hospital - Gastroenterological surgery

location_facility: White Plains Hospital Center for Cancer Care - Oncology

location_facility: Shanghai Cancer Hospital of Fudan University

location_facility: Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital

location_facility: Tri-Service General Hospital - Neihu Branch

location_facility: Anhui Medical University - The Second Hospital

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: University of California - Hematology and Oncology

location_facility: PO G.Rodolico, AOU Policlinico-Vittorio Emanuele di Catania

location_facility: Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

status: Active, not recruiting

title: RATIONALE-301: A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma

location_country:
Germany
Italy
Poland
United Kingdom
Japan
United States
China
Spain
Taiwan
Czechia
France


title: AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis

acronym: AURORA

summary: The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.

status: Terminated

lead_sponsor: Tobira Therapeutics, Inc.

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Chile
Canada
France
Portugal
Hungary
Hong Kong
Switzerland
United States
Latvia
Romania
Belgium
Puerto Rico
Italy
Norway
Singapore
United Kingdom
Austria
Mexico
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Consorci Hospital General Universitari de València

location_facility: Medical Professional Clinical Research Center, INC

location_facility: Centre Hospitalier Universitaire Grenoble

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft

location_facility: Synexus Polska Sp. z o.o. Oddział w Warszawie

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Wojewódzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Universitatsklinik far Innere Medizin II

location_facility: Centre Hospitalier Universitaire de Rouen CHU de Rouen Hopital Charles-Nicolle

location_facility: Hospital Universitário Clementino Fraga Filho

location_facility: Southern Star Research Institute, LLC SAGACT PLLC.

location_facility: Centre Hospitalier Regional et Universitaire de Besancon - L'Hopital Jean Minjoz

location_facility: Hospital Universitario Nuestra Senora de Valme

location_facility: SYNEXUS Magyarország Kft. - Budapest DRS

location_facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

location_facility: Centre Hospitalier Universitaire de Nice Hôpital l'Archet

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Investigational Drug Service, The University of North Carolina at Chapel Hill

location_facility: Consultorio Dra. Maria Sarai Gonzalez Huezo

location_facility: Hapital Sud Service d'Hepato- Gastroentarologie

location_facility: Synexus Polska Sp. Z o.o. Oddzial w Czestochowie

location_facility: Hull and East Yorkshire Hospitals NHS Trust

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Synexus Clinical Research GmbH, Prüfzentrum Frankfurt

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: University Hospital of South Manchester NHS Foundation Trust

location_facility: Baylor Scott & White All Saints Medical Center - Ft. Worth

location_facility: Centro de Investigaciones Clínicas Viña del Mar

location_facility: Synexus Polska Sp z o o Oddzial w Poznaniu

location_facility: Texas Digestive Disease Consultants - Fort Worth

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH

location_facility: Azienda Ospedaliera Universitaria Careggi SOD Medicina Interna ed Epatologia

location_facility: Diabetes & Glandular Disease Clinic, P.A. (DGD)

location_facility: Washington University School of Medicine

location_facility: Digestive Health Associates of Texas-Rockwall

location_facility: Digestive Healthcare of Georgia - Atlanta

location_facility: GI Specialists of Georgia - Marietta Office

location_facility: Gastroenterology Associates of Northern Virginia

location_facility: William Osler Health Centre, Brampton Memorial Hospital Campus

location_facility: Rambam Health Care Campus - Rambam Medical Center

location_facility: Objective GI D/B/A North Alabama GI Research Center

location_facility: NYU Langone Health - Perlmutter Cancer Center

location_facility: Faculdade de Medicina de São José do Rio Preto Hospital de Base

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Nottingham Digestive Diseases Biomedical Research Unit

location_facility: Stanford School of Medicine, Center for Clinical Sciences Research

location_facility: Digestive Health Specialists of the Southeast

location_facility: University of Texas Southwestern Medical Center

location_facility: Synexus Clinical Research GmbH, Prüfzentrum Berlin

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Sklifosovsky Scientific Research Institution of Emergency Care

location_facility: UT-Memphis, Methodist University Hospital

location_facility: Consultorio Médico Dr. Alma Laura Ladron de Guevara

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Gastroenterology Consultants of Southwest Virginia Research

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Eastern Pennsylvania Gastroenterology and Liver Specialist

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Marshall University Joan C. Edwards School of Medicine

location_facility: Ruane Medical and Liver Health Institute

location_facility: Moscow Regional Research and Clinical Institute M.F. Vladimirsky

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

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

location_facility: Advanced Clinical Research - Center for Digestive Health

location_facility: Southern California Kaiser Permanente, Los Angeles Medical Center

location_facility: Gastroenterology Associates of Pensacola

location_facility: Hadassah Medical Center, Institute of Gastroenterology and Liver Diseases

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska

location_facility: Southern California Permanente Medical Group

location_facility: University of Iowa Hospitals and Clinics

location_facility: Luton and Dunstable Hospital NHS Foundation Trust

location_facility: Synexus Polska Sp. z o.o. Oddział w Łodzi

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Hospital das Clínicas da Universidade Federal de Minas Gerais

location_facility: CHU De Bordeaux - Hôpital Haût-Lévèque CMC Magellan Unita de Recherche Clinique

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Bruce W. Carter Department of Veterans Affairs Medical Center

location_facility: National Diabetes and Obesity Research Institute

location_facility: Barts Health NHS Trust The Royal London Hospital

location_facility: Centre Hospitalier Universitaire de Rennes- Hôpital Pontchaillou

location_facility: The Ohio University - Gastroenterology, Hepatology

location_facility: University of San Francisco, Fresno Medical Education Program

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni ul.

location_facility: Michael E. DeBakey VA Medical Center (MEDVAMC)

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. O Fodor

location_facility: Center Hospitalier Universitaire d'Angers

location_facility: Gastroenterology Associates - Crystal River

location_facility: Hospital Clínico Universitario Virgen de la Victoria

location_facility: Gastroenterology Associates of Fairfield County

location_facility: Chang Gung Medical Foundation-LinKou Branch

status_simplified: Unknown


title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis

acronym: AFFIRM-AL

summary: A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.

ipd_sharing: No

lead_sponsor: Prothena Biosciences Ltd.

location_country:
Germany
Ireland
Poland
Australia
Japan
Turkey
Czechia
Canada
France
Portugal
Hungary
Denmark
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Israel

location_facility: Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria

location_facility: Centro Hospitalar e Universitário de Coimbra

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Smilow Cancer Hospital Care Center at Trumbull

location_facility: Semmelweis Egyetem - I. sz. Belgyógyászati Klinika

location_facility: Theagenio Anti-Cancer Hospital of Thessaloniki

location_facility: University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Froedtert and Medical College of Wisconsin

location_facility: Manchester University NHS Foundation Trust

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona

location_facility: Cancer Clinical Trials and Research Unit, Beaumont Hospital

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clínico

location_facility: The Ohio State University College of Medicine

location_facility: Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco

location_facility: Centre Hospitalier Universitaire Poitiers

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Hospital Universitari i Politècnic la Fe

location_facility: Clinica Universidad de Navarra - Pamplona

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

location_facility: University Hospital Marqués de Valdecilla

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: University of Michigan Rogel Cancer Center

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

location_facility: New York University Langone Hospital - Long Island

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals

location_facility: Institut Català d'Oncologia - Hospital Germans Trias i Pujol

location_facility: Wake Forest Baptist Health - Comprehensive Cancer Center


summary: The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.

sponsor_collaborators: European Network for Gynaecological Oncological Trial Groups

location_facility: Bristol Haematology and Oncology Centre ( Site 2244)

location_facility: The Cancer Institute Hospital of JFCR ( Site 4196)

location_facility: Instituto de Oncologia de Rosario ( Site 1004)

location_facility: Centro Oncologico Internacional. SEDNA ( Site 1121)

location_facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 3071)

location_facility: Sidney Kimmel Cancer Center - Jefferson Health ( Site 3078)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 4091)

location_facility: Yunnan Province Cancer Hospital-Gynecology Department ( Site 4055)

location_facility: Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2355)

location_facility: I Can Oncology Center SA de CV ( Site 1126)

location_facility: Nizhegorodsky Regional Oncology Dispensary-chemotherapy department (Branch№1) ( Site 2639)

location_facility: SLK-Kliniken Heilbronn GmbH ( Site 2116)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 4193)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli ( Site 2124)

location_facility: Edith Wolfson Medical Center ( Site 2306)

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

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2641)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2636)

location_facility: University Hospital of North Norway ( Site 2153)

location_facility: Beatson West of Scotland Cancer Centre ( Site 2247)

location_facility: Hospital Universitario Reina Sofia ( Site 2183)

location_facility: SO Grigoriev Institute for Medical Radiology and Oncology of NAMS of Ukraine ( Site 2363)

location_facility: Institut De Cancerologie De Lorraine ( Site 2072)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 2637)

location_facility: Ege University Medical Faculty ( Site 2351)

location_facility: Geniko Panepistimako Nosokomeio ARETEIO ( Site 2423)

location_facility: Tampere University Hospital ( Site 2541)

location_facility: Istituto di Candiolo - IRCCS ( Site 2125)

location_facility: Odense Universitetshospital ( Site 2512)

location_facility: Athens University Hospital ATTIKON ( Site 2424)

location_facility: Obstetrics and Gynecology Hosp. Fudan University ( Site 4041)

location_facility: Hospital Britanico de Buenos Aires ( Site 1002)

location_facility: Centro Oncologico Riojano Integral ( Site 1007)

location_facility: Nanjing Drum Tower Hospital ( Site 4037)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 4192)

location_facility: Harbin Medical University Cancer Hospital ( Site 4033)

location_facility: General Hospital of Patras. St Andrews ( Site 2421)

location_facility: Christus Muguerza Clinica Vidriera ( Site 1125)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 4054)

location_facility: Universitaetsklinikum Tuebingen ( Site 2113)

location_facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2486)

location_facility: Arizona Oncology Associates PC- HOPE ( Site 3049)

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2487)

location_facility: Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2366)

location_facility: Women s Hospital School of Medicine Zhejiang University ( Site 4032)

location_facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)

location_facility: Hospital Clinic i Provincial ( Site 2185)

location_facility: Medizinische Universitaet Innsbruck ( Site 2001)

location_facility: Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 2644)

location_facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 4049)

location_facility: Peking Union Medical College Hospital ( Site 4036)

location_facility: Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 2394)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 4045)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 2354)

location_facility: Institut Regional du Cancer de Montpellier - ICM ( Site 2069)

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 2634)

location_facility: Lviv State Regional Oncological Center ( Site 2361)

location_facility: The First Affiliated Hospital ( Site 4043)

location_facility: CHU Besancon - Hopital Jean Minjoz ( Site 2068)

location_facility: Iwate Medical University Hospital ( Site 4189)

location_facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 4056)

location_facility: Niigata Cancer Center Hospital ( Site 4185)

location_facility: Euromedica General Clinic of Thessaloniki ( Site 2422)

location_facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 2105)

location_facility: Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2631)

location_facility: Hokkaido University Hospital ( Site 4194)

location_facility: Jiangxi Maternal and Child Health Hospital ( Site 4051)

location_facility: Vseobecna fakultni nemocnice v Praze ( Site 2391)

location_facility: Royal Marsden NHS Foundation Trust ( Site 2248)

location_facility: Instituto Cancerologico de Narino Ltda ( Site 1092)

location_facility: Universitetssjukhuset i Linkoping. ( Site 2222)

location_facility: Centro Investigación del Cáncer James Lind ( Site 1061)

location_facility: Centre Hospitalier Lyon Sud ( Site 2064)

location_facility: Taipei Veterans General Hospital ( Site 4093)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 2303)

location_facility: Hospital San Lucas Cardiologica del Sureste ( Site 1122)

location_facility: Tomsk Scientific Research Institute of Oncology-Chemotherapy ( Site 2638)

location_facility: Samara Regional Clinical Oncology Center-Chemotherapy Dapartment ( Site 2649)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 1006)

location_facility: Hospital Universitario La Paz ( Site 2186)

location_facility: C.I.U. Hopital Ambroise Pare ( Site 2039)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2127)

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole ( Site 2065)

location_facility: University of Alabama - Birmingham ( Site 3061)

location_facility: Taichung Veterans General Hospital ( Site 4094)

location_facility: Universitätsklinikum Schleswig-Holstein ( Site 2101)

location_facility: Chernihiv Medical Center of Modern Oncology ( Site 2368)

location_facility: The Christie Hospital NHS Foundation Trust ( Site 2243)

location_facility: IRCCS Ospedale San Raffaele ( Site 2130)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 2135)

location_facility: The First Affiliated Hospital, Zhejiang University-Gynecology ( Site 4002)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 3058)

location_facility: Hospital Clinico San Carlos ( Site 2187)

location_facility: Aalborg Universitetshospital ( Site 2511)

location_facility: I.E.U. Medical Point Hastanesi ( Site 2356)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 1062)

location_facility: Fakultni nemocnice Kralovske Vinohrady ( Site 2393)

location_facility: Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 2249)

location_facility: Medipol Universite Hastanesi ( Site 2352)

location_facility: Medizinische Hochschule Hannover-Department of Obstetrics and Gynecology ( Site 2109)

location_facility: University of Massachusetts Medical School ( Site 3037)

location_facility: WK Physicians Network/Gynecologic Oncology Associates ( Site 3047)

location_facility: Perifereiako Geniko Nosokomeio ALEXANDRA ( Site 2425)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2122)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2482)

location_facility: The Municipal Enterprise Volyn Regional Medical Oncology Centre ( Site 2362)

location_facility: Royal Marsden Hospital Sutton-Surrey ( Site 2241)

location_facility: IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 1010)

location_facility: Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2481)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 3070)

location_facility: Severance Hospital Yonsei University Health System ( Site 4062)

location_facility: Sanford Gynecology Oncology ( Site 3045)

location_facility: McGill University Health Centre ( Site 3005)

location_facility: Rigshospitalet University Hospital ( Site 2515)

location_facility: Hôpital Privé Des Côtes d'Armor ( Site 2063)

location_facility: Centro de Oncología e Investigación de Buenos Aires ( Site 1005)

location_facility: Abington Hospital - Asplundh Cancer Center ( Site 3073)

location_facility: Saitama Medical University International Medical Center ( Site 4182)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 2132)

location_facility: Seoul National University Bundang Hospital ( Site 4063)

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ ( Site 2485)

location_facility: The First Bethune Hospital of Jilin University ( Site 4057)

location_facility: Norton Cancer Institute - St. Matthews ( Site 3056)

location_facility: MNE "Khmelnytskyi regional antitumor center" ( Site 2365)

location_facility: Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 4034)

location_facility: Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 2350)

location_facility: Clinica Universitaria de Navarra ( Site 2181)

location_facility: Investigacion Onco Farmaceutica S de RL de CV ( Site 1127)

location_facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 3076)

location_facility: Clínica Vida Fundación - Sede Poblado ( Site 1096)

location_facility: University of the Ryukyus Hospital ( Site 4184)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 3006)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2646)

location_facility: National Cancer Center Hospital East ( Site 4197)

location_facility: LISOD - Israeli Oncological Hospital MedX-ray International Group, LLC ( Site 2364)

location_facility: Cukurova Uni. Tip Fakultesi ( Site 2353)

location_facility: Gunma Prefectural Cancer Center ( Site 4183)

location_facility: Northwestern Memorial Hospital ( Site 3044)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 2151)

location_facility: Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 2484)

location_facility: Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 4053)

location_facility: Osaka International Cancer Institute ( Site 4188)

location_facility: Istituto Oncologico Veneto IRCCS-Oncologia 2 ( Site 2134)

location_facility: Krasnoyarsk Regional Clinical oncology dispensary ( Site 2643)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 4060)

location_facility: Universitätsklinikum Bonn-Gynaecological oncology ( Site 2103)

location_facility: Medizinische Universitat Graz ( Site 2004)

location_facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 1003)

location_facility: HonorHealth Research Institute - Biltmore ( Site 3043)

location_facility: Bialostockie Centrum Onkologii ( Site 2483)

location_facility: Changhua Christian Hospital ( Site 4095)

location_facility: Instituto Nacional de Cancerología E.S.E ( Site 1094)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 3042)

location_facility: Soerlandet sykehus HF Kristiansand ( Site 2152)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 4181)

location_facility: University of Iowa Hospital and Clinics ( Site 3046)

location_facility: Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 2121)

location_facility: Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 4001)

location_facility: Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3080)

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

location_facility: Instituto Nacional de Cancerologia ( Site 1124)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 2220)

location_facility: Aichi Cancer Center Hospital ( Site 4190)

location_facility: Kingston Health Sciences Centre ( Site 3003)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 2645)

location_facility: Castle Hill Hospital-Academic Oncology ( Site 2252)

location_facility: Azienda Ospedaliera Universitaria Federico II ( Site 2123)

location_facility: UT Southwestern Medical Center ( Site 3063)

location_facility: Universitair Ziekenhuis Gent ( Site 2037)

location_facility: National Research Ogarev Mordovia State University ( Site 2648)

location_facility: Xiangya Hospital Central-South University ( Site 4035)

location_facility: Legacy Good Samaritan Medical Center ( Site 3033)

title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

location_country:
Finland
Germany
Poland
Argentina
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Denmark
United States
Ukraine
Belgium
China
Italy
Norway
United Kingdom
Sweden
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

collaborators: European Network for Gynaecological Oncological Trial Groups


acronym: ADMIRE-CD-II

lead_sponsor: Tigenix S.A.U.

summary: The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.

location_facility: UC Irvine Medical Center - Chao Family Comprehensive Cancer

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: University Colleague London Hospital (UCLH)

location_facility: Virginia Mason Medical Center - Gastroenterology

location_facility: Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery

location_facility: University of Puerto Rico School of Medicine

location_facility: Weill Medical College of Cornell University

location_facility: Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia

location_facility: AZ Groeninge - Campus Kennedylaan - Gastro-enterology

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center

location_facility: Aarhus University Hospital - Department of Hepatology and Gastroenterology, Lever-Mave- og Tarmsygdomme Klinik, krydspunkt C216

location_facility: MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly

location_facility: Harvard Medical School-Beth Israel Deaconess Medical Center

location_facility: Klinikum der Universitat Munchen - Campus Grosshadern

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: University of Massachusetts - colon & rectal surgery

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - I. sz. Belgyogyaszati Klinika

location_facility: UT Southwestern Medical Center - Gastroenterology - Gastroenterology

location_facility: Hopital Saint Louis - Gastro-hepatoenterologie

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Centre Hospitalier Universitaire De Toulouse - Hopital De Ra

location_facility: North Shore University Hospital - Gastroenterology

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (AOUI) -

location_facility: GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology

location_facility: University of Kansas Sxchool of Medicine

location_facility: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow

location_facility: Nottingham University Hospitals NHS Trust - Surgery

location_facility: University Surgical Associates-Rhode Island Hospital

location_facility: CHRU de Nancy -Hopital Brabois Adultes - Service d'Hepato- Gastroenterologie

location_facility: Penn State Hershey Medical Center - Surgery

location_facility: University of Southern California (USC) Norris Comprehensive Cancer Center

location_facility: Policlinico Universitario Campus Biomedico - UOC di Gastroenterologia

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-

location_facility: Baylor College of Medicine (BCM) - Gastroenterology

location_facility: Klinikum der Johann Wolfgang Goethe-Universitat

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: AOU Policlinico di Modena - Gastroenterologia

location_facility: USF Health South Tampa Center for Advanced Healthcare

location_facility: Shaare Zedek Medical Center - Gastroenterology

location_facility: The University of Chicago Medicine - Colon & Rectal Surgery

location_facility: CHU de Liege - Domaine Universitaire du Sart Tilman

location_facility: Dartmouth Hitchcock Medical Center - Cancer Center

location_facility: Policlinico S. Orsola Malpighi, AOU di Bologna-U.O. di Medicina Interna.

location_facility: Linkoping University Hospital - Department of Surgery

location_facility: Kensington Screening Clinic - Gastroenterology

location_facility: McGill University Health Centre - Montreal General Hospital

location_facility: Morristown Medical Center - Gastroenterology

location_facility: Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology

location_facility: CHRU De Lille - Hopital Claude Huriez - Hepato-Gastro-Enterologie

location_facility: NHS Greater Glasgow and Clyde - Glasgow Royal Infirmary (GRI)

location_facility: Barnes-Jewish Hospital - Gastroenterology

location_facility: Mount Sinai Hospital - Toronto - Gastroenterology

location_facility: Johns Hopkins Medicine - The Johns Hopkins Hospital

title: A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks

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
Italy
Poland
Hungary
Israel
Denmark
United Kingdom
Sweden
Belgium
United States
Spain
Czechia
Canada
Puerto Rico
France


title: A Phase 2, Randomized, Open-label, Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer

acronym: Tamarack

summary:
Study CP-MGC018-03 is a randomized, open-label, Phase 2 study. The study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior taxane-containing regimen, but no other chemotherapy agents.

The study will assess efficacy and tolerability of two vobramitamab duocarmazine (MGC018) experimental arms (2.0 mg/kg every 4 weeks [Q4W] and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1.

Vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered for up to 26 cycles, approximately 2 years, until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor.

An analysis of radiographic progression-free survival (rPFS) will occur after 100 participants have been on-study for at least 6 months.

lead_sponsor: MacroGenics

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

location_facility: Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara

location_facility: Masonic Cancer Center, University of Minnesota

location_facility: Centre Hospitalier Universitaire (CHU) - Universite Catholique de Louvain (UCL) - Namur - Site Godinne (Cliniques Universitaires UCL de Mont-Godinne)

location_facility: AOU San Luigi Gonzaga Oncology Department

location_facility: Mid Florida Hematology and Oncology Center

location_facility: Barbara Ann Karmanos Cancer Institute - Hudson-Webber Cancer Research Center

location_facility: Institut de Cancerologie Strasbourg Europe (ICANS)

location_facility: The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)

location_facility: University of California Los Angeles (UCLA) Community Cancer Care

location_facility: Ramsay Health Care - Westmead Private Hospital

location_facility: Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

location_facility: The University of Florida Health System - UF Health Urology - Jacksonville

location_facility: Yonsei University Health System, Severance Hospital

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika

location_facility: Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence

location_facility: Centre Hospitalier de Ardenne - Libramont - Clinique du Sein

location_facility: Kyungpook National University Chilgok Hospital

location_facility: University of Virginia Comprehensive Cancer Center

location_facility: Oxford University Hospitals NHS- Churchill Hospital

intervention_type: Biological